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510(k) Data Aggregation
(53 days)
TSRH SPINAL SYSTEMS
When used as a pedicle screw fixation system of the non-cervical posterior spine in skeletally mature patients using allograft and/or autograft, the TSRH®Spinal System is Indicated as an adjunct to fusion for one or more of the following: (1) degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), (2) degenerative spondylolisthesis with objective evidence of neurologic impairment, (3) fracture, (4) disiocation, (5) scollosis, (6) kyphosis, (7) spinal tumor, and/or (8) failed previous fusion (pseudanthrosis).
In addition, when used as a pedicle screw fixation system, the TSRH® Spinal System is indicated as an adjunct to fusion for skeletally mature patients using allograft and/or autograft: (1) having severe spondylolisthesis (Grades 3 and 4) of the fifth lumbar-first sacral (LS-S1) vertebral joint: (2) who are receiving fusions using autogenous bone graft only: (3) who are having the device fixed or attached to the lumbar and sacral spine (L3 and below); and (4) who are having the device removed after the development of a solld fusion mass.
When used as a posterior, non-cervical, non-pedicle screw fixation system, the TSRH® Spinal System is intended for the following indications: (1) degenerative disc disease (as defined by back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), (2) spondylolisthesis, (3) fracture, (4) spinal deformities (1.e., scollosis, kyphosis, and/or lordosis), (5) spinal stenosis, (6) pseudarthrosis, (7) tumor resection, and/or (8) unsuccessful previous attempts at spinal fusion.
When used as a unilateral supplemental fixation device in the antero-lateral thoracic/lumbar region, the TSRH® L-Plate and VANTAGE™ screws are intended for the following indications: spondylollsthesis; trauma (i.e., fracture or dislocation); spinal stenosis; curvatures (i.e., scollosis, kyphosis and/or lordosis); tumor; pseudarthrosls; and/or failed previous fusion.
For anterior use only the TSRH® Spinal System has the additional indication of: spondylolysis.
When used for posterior non-cervical pedicle screw fixation in pediatric patients, the TSRH® Spinal System implants are indicated as an adjunct to fusion to treat adolescent idlopathic scollosis. The TSRH® Pedlatric Spinal System Is Intended to be used with allograft and/or autograft. Pediatric pedicle screw fixation is limited to a posterior approach.
The TSRH® Spinal System consists of a variety of shapes and sizes of rods, hooks, screws, cross connectors, staples, plates, and connecting components, as well as implant components from other Medtronic spinal systems, which can be rigidly locked into a variety of configurations, with each construct being tailor-made for the individual case.
A subset of TSRH® Spinal System components may be used for posterior pedicle screw fixation in pediatric cases. These constructs may be comprised of a variety of shapes and sizes of rods, hooks, screws, CROSSLINK® Plates, plates, and connecting components as well as CD HORIZON® Spinal System components cleared for pediatric use such as Low Profile MULTI-SPAN® CROSSLINK® Plates, and CD HORIZON® rods, screws, set screws and locking screws. Similarly to the TSRH® implants used in adult case, these components can be rigidly locked into a variety of configurations, with each construct being tailored-made for the individual case. All screws used In pediatric cases are only cleared for use via a posterior approach. All of the components used in pediatric cases are fabricated from medical grade stainless steel, medical grade titanium alloy and medical grade cobalt -chromiummolybdenum alloy.
TSRH® Spinal System staples, unit rods, s-rods and 7:0 mm diameter rods are specifically excluded for use in pediatric patients.
Certain implant components from other Medtronic spinal systems can be used with the TSRH® Spinal System in non-pediatric components. These components include GDLH® rods, rod/bolt connectors, Variable Angle T-bolts, set screws and locking screws; DYNALOK® PLUS bolts, and VANTAGE™ Anterior Fixation System screws.
The hooks are Intended for posterior use only. The staples are for anterior use only. The TSRH-3D® and TSRH® 3Dx™ connectors, and TSRH-3D® and TSRH® 3Dx™ screws are intended for posterior use only. Within the TSRH® family, the cobalt chromium rods should only be used with TSRH® 3Dx™ Spinal System. All CROSSLINK® Plates are for posterior use and the CROSSLINK® Axial and Offset Plates may be used anteriorly as well.
The TSRH® Spinal System Implant components are fabricated from medical grade stainless steel, medical grade titanium alloy, and/or medical grade cobalt-chromiummolybdenum alloy. Medical grade titanium, titanium alloy, and/or cobalt-chromiummolybdenum alloy may be used together. Certain TSRH® Spinal System components may be coated with hydroxyapatite. Never use titanium, titanium alloy, and/or cobalt-chromiummolybdenum alloy with stainless steel in the same construct.
The acceptance criteria and study proving device efficacy for the TSRH® Spinal System are detailed below.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Criteria | Reported Device Performance/Testing |
|---|---|---|
| Material Equivalence | The subject device (TSRH® 3Dx Chromaloy Plus Straight 5.5mm Diameter Rod) should use materials substantially equivalent to legally marketed predicate devices. | The subject device is fabricated from Wrought Cobalt-28Chromium-6Molybdenum, Single Annealed (ASTM F1537), which is identical in material to the predicate TSRH® Spinal System (K103049) and very similar to the CD HORIZON® Spinal System (K093058) which uses a double annealed version of the same material. The difference in annealing was deemed not to introduce new issues of safety or effectiveness. |
| Dimensional Equivalence | The subject device dimensions (length and diameter) should be within acceptable ranges compared to predicate devices. | The subject device is a 5.5mm diameter rod, which is identical in diameter to both predicate devices. The length is 500mm, which is identical to the length of the CD HORIZON® Spinal System predicate (K093058) and within the range for the TSRH® Spinal System predicate (K103049), which has lengths of 30mm-120mm. The specific length of 500mm for the subject device is directly comparable to a predicate. |
| Mechanical Performance | The subject device must demonstrate equivalent mechanical properties (static and fatigue) to predicate devices, ensuring it can withstand physiological loads without failure. This is often assessed by demonstrating compliance with relevant ASTM standards for spinal implants. | Non-clinical mechanical testing was performed:1. ASTM F1798-97 (2008), "Standard Guide for Evaluating the Static and Fatigue Properties of Interconnection Mechanisms and Subassemblies Used in Spinal Arthrodesis Implants." Specifically, an axial grip test around the rod was performed.2. ASTM F2193 (2002), "Standard Specifications and Test Methods for Components Used in the Surgical Fixation of the Spinal Skeletal System." Specifically, four-point fatigue testing was performed.Medtronic believes that the results of this testing, combined with supporting documentation, demonstrate that the subject device does not introduce new issues of safety, effectiveness, or performance. This implies that the device met the performance requirements/benchmarks established by these ASTM standards, which are considered appropriate for spinal fixation components. The submission states that the device is "substantially equivalent to its predicate devices" based on this testing, indicating that its mechanical performance is comparable and acceptable. |
| Indications for Use | The indications for use of the subject device should be substantially equivalent to those of the predicate devices. | The subject device, the TSRH® 3Dx CHROMALOY™ + Straight 5.5mm Diameter Rod, is stated to be identical to its predicate devices in its indications. The broad indications for the TSRH® Spinal System, including its use as a pedicle screw fixation system in specific conditions (degenerative disc disease, spondylolisthesis, fracture, dislocation, scoliosis, kyphosis, spinal tumor, failed fusion, severe spondylolisthesis) and as a non-pedicle screw fixation system, as well as for anterior use and in pediatric patients for adolescent idiopathic scoliosis, are maintained. This identity in indications serves as an acceptance criterion for substantial equivalence. |
| Fundamental Technology | The fundamental scientific technology of the subject device should be consistent with that of the predicate devices, meaning it operates on the same basic principles for spinal fixation. | The fundamental scientific technology (rod and screw system) of the subject device is stated to be identical to both predicate devices (CD HORIZON® Spinal System K093058 and TSRH® Spinal System K103049). This confirms that the mechanical principles of stabilization and fusion it employs are the same as previously cleared devices. |
| Safety and Effectiveness | The subject device must not introduce new issues of safety or effectiveness compared to the predicate devices. This is a general overarching criterion. A risk analysis should be completed. | A risk analysis was completed, and the non-clinical mechanical testing (ASTM F1798-97 and ASTM F2193) was performed. These activities, along with the device's technological characteristics being largely identical or substantially equivalent to the predicates, led Medtronic to conclude that the device does not introduce new issues of safety, effectiveness, or performance. This effectively serves as the performance outcome, showing the acceptance criteria for safety and effectiveness have been met. |
2. Sample Size Used for the Test Set and Data Provenance
No sample size for a test set (clinical or otherwise) is specified in the provided document, as the study described is a non-clinical bench testing study focusing on mechanical properties and material equivalence. There is no human or animal data referenced, thus no data provenance (e.g., country of origin, retrospective/prospective) is applicable.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
Not applicable. This was a non-clinical bench study. Ground truth, in the context of clinical studies, typically refers to a definitive diagnosis or outcome confirmed by expert consensus, pathology, or other objective measures. For mechanical testing, the "ground truth" is defined by the performance standards outlined in the ASTM specifications.
4. Adjudication Method for the Test Set
Not applicable. This was a non-clinical bench study. Adjudication methods like 2+1 or 3+1 are used in clinical studies to resolve discrepancies among expert readers/diagnosticians.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, an MRMC comparative effectiveness study was not done. This submission pertains to a medical device's substantial equivalence based on material and mechanical performance, not a diagnostic or screening algorithm requiring assessment of human reader performance.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Not applicable. This document describes a physical medical device (spinal rod), not an algorithm or AI system.
7. The Type of Ground Truth Used
For this non-clinical study, the "ground truth" is effectively the established performance specifications and methodologies dictated by recognized industry standards:
- ASTM F1798-97 (2008): "Standard Guide for Evaluating the Static and Fatigue Properties of Interconnection Mechanisms and Subassemblies Used in Spinal Arthrodesis Implants."
- ASTM F2193 (2002): "Standard Specifications and Test Methods for Components Used in the Surgical Fixation of the Spinal Skeletal System."
Meeting the requirements set forth in these standards, as interpreted and applied by the manufacturer, constitutes the "ground truth" for mechanical equivalence.
8. The Sample Size for the Training Set
Not applicable. This was a non-clinical bench study, not an AI or machine learning study, so there is no concept of a "training set."
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there was no training set.
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(149 days)
TSRH SPINAL SYSTEM
When used as a pedicle screw fixation system of the non-cervical posterior spine in skeletally mature patients using allograft and/or autograft, the TSRH® Spinal System is indicated for one or more of the following: (1) degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), (2) degenerative spondylolisthesis with objective evidence of neurologic impairment, (3) fracture, (4) dislocation, (5) scoliosis, (6) kyphosis, (7) spinal tumor, and/or (8) failed previous fusion (pseudarthrosis).
In addition, when used as a pedicle screw fixation system, the TSRH® Spinal System is indicated for skeletally mature patients using allograft and/or autograft: (1) having severe spondylolisthesis (Grades 3 and 4) of the fifth lumbar-first sacral (L5-S1) vertebral joint: (2) who are receiving fusions using autogenous bone graft only: (3) who are having the device fixed or attached to the lumbar and sacral spine (L3 and below); and (4) who are having the device removed after the development of a solid fusion mass.
When used as a posterior, non-cervical, non-pedicle screw fixation system, the TSRH® Spinal System is intended for the following indications: (1) degenerative disc disease (as defined by back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), (2) spondylolisthesis, (3) fracture, (4) spinal deformities (i.e., scoliosis, kyphosis, and/or lordosis), (5) spinal stenosis, (6) pseudarthrosis, (7) tumor resection, and/or (8) unsuccessful previous attempts at spinal fusion.
When used as a unilateral supplemental fixation device in the antero-lateral thoracic/lumbar region, the TSRH® L-Plate and VANTAGE™ screws are intended for the following indications: spondylolisthesis; trauma (i.e., fracture or dislocation); spinal stenosis; curvatures (i.e., scoliosis, kyphosis and/or lordosis); tumor; pseudarthrosis; and/or failed previous fusion.
For anterior use only the TSRH® Spinal System has the additional indication of: spondylolysis.
When used for posterior non-cervical pedicle screw fixation in pediatric patients, the TSRH® Spinal System Implants are indicated as an adjunct to fusion to treat adolescent idiopathic scoliosis. The TSRH® Pediatric Spinal System is intended to be used with allograft and/or autograft. Pediatric pedicle screw fixation is limited to a posterior approach.
The TSRH® Spinal System is intended to help provide immobilization and stabilization of solnal segments as an adjunct to fusion of the thoracic. Iumbar. and/or sacral spine.
The TSRH® Spinal System consists of a variety of shapes and sizes of rods, hooks, screws, cross connectors, staples, plates and connecting components as well as implant components from other Medtronic spinal systems, which can be rigidly locked into a variety of configurations, with each construct being tallor-made for the individual case.
A subset of TSRH® Spinal System components may be used for posterior pedicle screw fixation in pediatric cases. These constructs may be comprised of a variety of shapes and sizes of rods, hooks, screws, CROSSLINK® Plates, and connecting components as well as CD HORIZON® Spinal System components cleared for pediatric use. Similarly to the TSRH® implants used in adult case, these components can be rigidly locked into a variety of configurations, with each construct being tailored-made for the individual case. All screws used in pediatric cases are only cleared for use via a posterior approach. All of the components used in pediatric cases are fabricated from medical grade stainless steel, medical grade titanium, titanium alloy and medical grade cobalt -chromium-molybdenum alloy.
TSRH® Spinal System staples are specifically excluded for use in pediatric patients.
Certain implant components from other Medtronic spinal systems can be used with the TSRH® Spinal System. These components include GDLH® rods, rod/bolt connectors, Variable Angle T-bolts, set screws and locking screws; DYNALOK® PLUS bolts, and Vantage™ Anterior Fixation System screws.
The hooks are intended for posterior use only. The staples are for anterior use only. The TSRH-3D® and TSRH® 3Dx™ connectors, and TSRH-3D® and TSRH® 3Dx™ screws are intended for posterior use only. Within the TSRH® family, the cobalt chromium rods should only be used with TSRH® 3Dx™ Spinal System. All CROSSLINK® Plates are for posterior use and the CROSSLINK® Axial and Offset Plates may be used anteriorly as well.
The TSRH® Spinal System implant components are fabricated from medical grade stainless steel, medical grade titanium or titanium alloy, and/or medical grade cobalt-chromium-molybdenum alloy. Medical grade titanium, titanium alloy, and/or cobalt-chromium-molybdenum alloy may be used together. Certain TSRH® Spinal System components may be coated with hydroxyapatite. Never use titanium, titanium alloy, and/or cobalt-chromium-molybdenum alloy with stainless steel in the same construct.
The purpose of this 510(k) submission is to expand the indications of use to allow for use of pedicle screw based constructs to treat pediatric patients.
The provided document describes the Medtronic TSRH® Spinal System, a medical device for spinal fixation, and its 510(k) submission for an expanded indication for use in pediatric patients.
Here's an analysis of the acceptance criteria and study information contained within the document:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state numerical acceptance criteria in the traditional sense (e.g., specific thresholds for success, failure rates, or statistical significance levels). Instead, the performance is demonstrated through the concept of "substantial equivalence" to a predicate device and positive clinical data.
| Acceptance Criterion (Implicit) | Reported Device Performance |
|---|---|
| Material Equivalence | The TSRH® Spinal System implant components are fabricated from medical grade stainless steel, medical grade titanium or titanium alloy, and/or medical grade cobalt-chromium-molybdenum alloy. This is implicitly accepted as equivalent to the predicate. |
| Mechanical Strength Equivalence | "The design features, material and mechanical strength of the TSRH® Spinal System are substantially equivalent to the CD HORIZON® Spinal System previously cleared in K091445 (S.E. 09/27/2010)." This affirms mechanical equivalence through substantial equivalence. |
| Design/Geometry Equivalence | "Therefore the subject TSRH® Spinal System is identical to the predicate TSRH® Spinal System in terms of device design, geometry, materials, sterilization, and intended use." This states design equivalence. |
| Sterilization Equivalence | "Therefore the subject TSRH® Spinal System is identical to the predicate TSRH® Spinal System in terms of device design, geometry, materials, sterilization, and intended use." This confirms sterilization equivalence. |
| Safety and Effectiveness for Expanded Pediatric Indication | "Published retrospective clinical data for pediatric patients diagnosed with adolescent idiopathic scoliosis and treated specifically with TSRH® Spinal System pedicle screw instrumentation was provided in support of this submission. The data included results of 40 pediatric patients treated with TSRH® pedicle screws only and 105 pediatric patients treated with a hybrid of TSRH® hooks and pedicle screws." |
"The safety and effectiveness of the TSRH® Spinal System for this expanded indication has been adequately supported by reported clinical results of this and similar devices which are contained within this premarket notification." |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size:
- 40 pediatric patients treated with TSRH® pedicle screws only.
- 105 pediatric patients treated with a hybrid of TSRH® hooks and pedicle screws.
- Total patients in the reported clinical data = 145 patients.
- Data Provenance:
- Country of origin: Not explicitly stated.
- Retrospective or Prospective: "Published retrospective clinical data" indicates it was a retrospective study.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
The document does not mention the use of experts to establish a "ground truth" for the clinical data in the context of a specific reader study or algorithm evaluation. Instead, the "truth" is based on the clinical outcome of the patients as documented in the retrospective data. It is implied that the diagnoses (adolescent idiopathic scoliosis) and treatment outcomes were established by the treating physicians and documented in patient medical records.
4. Adjudication Method for the Test Set
Not applicable. The document does not describe a process for adjudicating interpretations or measurements in the clinical data. The clinical data appears to be a record of patient treatments and outcomes.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. The document discusses a spinal system (an implantable device), not an imaging or diagnostic AI algorithm that would typically involve human readers. Therefore, there is no mention of human readers improving with or without AI assistance.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
No, a standalone performance study in the context of an algorithm or AI without human intervention was not conducted. This document describes a physical medical device (spinal system), not a software algorithm.
7. Type of Ground Truth Used
The "ground truth" for the clinical data used to support the expanded indication is based on clinical outcomes data and patient diagnoses. Specifically:
- Diagnosis of "adolescent idiopathic scoliosis."
- Treatment with TSRH® Spinal System (pedicle screws or hybrid).
- Presumably, the success or failure of the fusion and correction of scoliosis as observed in the clinical follow-up of these patients.
8. Sample Size for the Training Set
Not applicable. This is a 510(k) submission for a physical medical device, not an AI/ML algorithm that requires a training set. The clinical data mentioned is for validating the device's expanded indication, not for training a model.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no training set for an AI/ML algorithm in this context.
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(74 days)
TSRH SPINAL SYSTEM
When used as a pedicle screw fixation system of the non-cervical posterior spine in skeletally mature patients using bone graft, the TSRH® Spinal System is indicated as an adjunct to fusion for one or more of the following: (1) degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), (2) degenerative spondylolisthesis with objective evidence of neurologic impairment, (3) fracture, (4) dislocation, (5) scoliosis, (7) spinal tumor, and/or (8) failed previous fusion (pseudarthrosis).
In addition, when used as a pedicle screw fixation system, the TSRH® Spinal System is indicated as an adjunct to fusion for skeletally mature patients using bone graft: (1) having severe spondylolisthesis (Grades 3 and 4) of the fifth lumbar-first sacral (LS-S1) vertebral joint: (2) who are receiving fusions using autogenous bone graft only: (3) who are having the device fixed or attached to the lumbar and sacral spine (L3 and below); and (4) who are having the device removed after the development of a solid fusion mass.
When used as a posterior, non-cervical, non-pedicle screw fixation system, the TSRH® Spinal System is intended for the following indications: (1) degenerative disc disease (as defined by back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), (2) spondylolisthesis, (3) fracture, (4) spinal deformities (i.e., scoliosis, kyphosis, and/or lordosis), (5) spinal stenosis, (6) pseudarthrosis, (7) tumor resection, and/or (8) unsuccessful previous attempts at spinal fusion.
When used as a unilateral supplemental fixation device in the antero-lateral thoracic/lumbar region, the TSRH® L-Plate and VANTAGE™ screws are intended for the following indications: spondylolisthesis; trauma (i.e., fracture or.dislocation); spinal stenosis; curvatures (i.e., scoliosis, kyphosis and/or lordosis); tumor; pseudoarthrosis; and/or failed previous fusion.
For anterior use only the TSRH® Spinal System has the additional indication of: spondylolysis.
The purpose of this Special 510(k) is to add additional sizes of Unit Rods and S-Rods to the TSRH® Spinal System.
The TSRH® Spinal System is intended to help provide immobilization and stabilization of spinal segments as an adjunct to fusion of the thoracic, lumbar, and/or sacral spine.
The TSRI4 Spinal System consists of a variety of shapes and sizes of rods, hooks, screws, cross connectors, staples, plates and connecting components as well as implant components from other Medtronic spinal systems, which can be rigidly locked into a variety of configurations, with each construct being tailor-made for the individual case.
Certain implant components from other Medtronic spinal systems can be used with the TSRH® Spinal System. These components include GDLH® rods, rod/bolt connectors, Variable Angle T-Bolts, set screws and locking screws; DYNALOK® PLUS™ bolts, CD HORIZON® Low Profile MULTI-SPAN® CROSSLINK® Plates, VANTAGE™ Anterior Fixation System screws, and CD HORIZON® rods, screws, set screws and locking screws.
The hooks are intended for posterior use only and the staples are for anterior use only. The TSRH-3D® and TSRH-3Dx™ connectors and TSRH-3D® and TSRH-3Dx™ screws are intended for posterior use only. Within the TSRH® family, the cobalt chromium rods should only be used with TSRH® 3Dx™ Spinal System. All CROSSLINK® Plates are for posterior use and the CROSSLINK® Axial and Offset Plates may be used anteriorly as well.
The TSRH Spinal System implant components are fabricated from medical grade stainless steel, medical grade titanium alloy, and/or medical grade cobalt-chromium-Medical grade titanium, titanium alloy, and/or cobalt-chromiummolybdenum alloy. molybdenum alloy may be used together. Certain TSRH® Spinal System components may be coated with hydroxyapatite. The TSRH® Spinal System may be sold sterile or nonsterile.
The provided text is a 510(k) summary for the TSRH® Spinal System, a medical device. It details the device's description, indications for use, and a comparison to predicate devices for substantial equivalence.
However, the document explicitly states:
- "No non-clinical testing was performed."
- "No clinical testing was performed."
Therefore, I cannot provide the information requested regarding acceptance criteria and the study that proves the device meets them because such studies were not performed for this specific 510(k) submission. The approval was based on demonstrating substantial equivalence to legally marketed predicate devices, not on proving new performance criteria through testing.
The acceptance criteria for this device would have been implicitly met by demonstrating its technological characteristics, intended use, and indications for use were substantially equivalent to those of the predicate devices.
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(69 days)
TSRH SPINAL SYSTEM
When used as a pedicle screw fixation system of the non-cervical posterior spine in skeletally mature patients, the TSRH® Spinal System is Indicated for one or more of the following: (1) degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), (2) degenerative spondylolisthesis with objective evidence of neurologic impairment, (3) dislocation, (5) scoliosis, (6) kyphosis, (7) spinal tumor, and/or (8) failed previous fusion (pseudarthrosis).
In addition, when used as a pedicle screw fixation system, the TSRH® Spinal System is indicated for skeletally mature patients: (1) having severe spondylolisthesis (Grades 3 and 4) of the fifth lumbar-first sacral (L5-S1) vertebral joint: (2) who are receiving fusions using autogenous bone graft only: (3) who are having the device fixed or attached to the lumbar and sacral spine (L3 and below); and (4) who are having the device removed after the development of a solid fusion mass.
When used as a posterior, non-cervical, non-pedicle screw fixation system, the TSRH® Spinal. System is intended for the following indications: (1) degenerative disc disease (as defined by back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), (2) spondylolisthesis, (3) fracture, (4) spinal deformities (i.e., scoliosis, kyphosis, and/or lordosis), (5) spinal stenosis, (6) pseudarthrosis, (7) tumor resection, and/or (8) unsuccessful previous attempts at spinal fusion.
When used as a unilateral supplemental fixation device in the antero-lateral thoracic/lumbar region, the TSRH® L-Plate and VANTAGE™ screws are intended for the following indications: spondylolisthesis; trauma (l.e., fracture or dislocation); spinal stenosis; curvatures (i.e., scoliosis, kyphosis and/or lordosis); tumor; pseudarthrosis; and/or failed previous fusion.
For anterior use only the TSRH® Spinal System has the additional indication of: spondylolysis.
The TSRH® Spinal System is intended to help provide immobilization and stabilization of spinal segments as an adjunct to fusion of the thoracic, lumbar, and/or sacral spine.
The TSRH® Spinal System consists of a variety of shapes and sizes of rods, hooks, screws, cross connectors, staples, plates and connecting components as well as implant components from other Medtronic spinal systems, which can be rigidly locked into a variety of configurations, with each construct being tailor-made for the individual case.
Certain implant components from other Medtronic spinal systems can be used with the TSRH® Spinal System. These components include GDLH® rods, GDLH® rod/bolt connectors, GDLH® Variable Angle T-Bolts, GDLH® set screws and locking screws, DYNALOK® PLUS™ bolts, CD HORIZON® Low Profile MULTI-SPAN® CROSSLINK® Plates, VANTAGE™ Anterior Fixation System screws, and CD HORIZON® rods, set screws and locking screws.
The hooks are intended for posterior use only and the staples are for anterior use only. The TSRH-3D® and TSRH-3Dx™ connectors and TSRH-3D® and TSRH-3Dx™ screws are intended for posterior use only. ALL CROSSLINK® Plates are for posterior use and the CROSSLINK® Axial and Offset Plates may be used anteriorly as well.
The TSRH® Spinal System implant components are fabricated from medical grade stainless steel, medical grade titanium or titanium alloy, and/or medical grade cobalt-chromium-molybdenum alloy. Medical grade titanium, titanium alloy, and/or cobalt-chromium-molybdenum alloy may be used together. Certain TSRH® Spinal System components may be coated with hydroxyapatite. Never use titanlum, titanlum alloy, and/or cobait-chromlum-molybdenum alloy with stainless steel in the same construct.
The purpose of this submission is to add 3Dx Chromaloy Plus (cobalt-chromiummolybdenum alloy) Pre-Cut Contoured Rods to the TSRH® Spinal System.
Here's an analysis of the provided text regarding the acceptance criteria and study for the TSRH® Spinal System, specifically focusing on the addition of 3Dx Chromaloy Plus Pre-Cut Contoured Rods.
It's important to note that this is a 510(k) summary, which typically focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than presenting a full clinical trial with "acceptance criteria" in the same way one might find for a novel device. The "acceptance criteria" here are implicitly tied to demonstrating mechanical safety and performance comparable to the predicate devices.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Mechanical Performance (Fatigue Resistance): Comparable fatigue strength to predicate devices when subjected to relevant orthopedic loading. (Based on ASTM F2193-02) | The submission implies that the 3Dx Chromaloy Plus Pre-Cut Contoured Rods demonstrated mechanical performance (specifically Four Point Bending Fatigue) that does not introduce new issues of safety or effectiveness when compared to the predicate devices. The text states: "Medtronic believes that documentation provided demonstrates that the TSRH® 3Dx Chromaloy Plus Pre-Cut Contoured Rods do not introduce new issues of safety or effectiveness." |
| Mechanical Performance (Interconnection/Static & Fatigue): Comparable static and fatigue properties of interconnection mechanisms and subassemblies to predicate devices. (Based on ASTM F1798-97) | The submission implies that the 3Dx Chromaloy Plus Pre-Cut Contoured Rods demonstrated mechanical performance (specifically axial grip per ASTM F1798-97) that does not introduce new issues of safety or effectiveness when compared to the predicate devices. The text states: "Medtronic believes that documentation provided demonstrates that the TSRH® 3Dx Chromaloy Plus Pre-Cut Contoured Rods do not introduce new issues of safety or effectiveness." |
| Biocompatibility: Material (Cobalt-Chromium-Molybdenum Alloy) is medical-grade and suitable for implantation without adverse biological reactions. (Implied, as ASTM F1537 is a standard for this material) | The device uses "medical grade ... cobalt-chromium-molybdenum alloy" (ASTM F1537), suggesting it meets industry standards for biocompatibility. No specific test results for biocompatibility are detailed in this summary, but its use of a recognized medical-grade material implies compliance. |
| Dimensions and Form: Rods meet specified dimensions (5.5mm diameter, 30-120mm length, contoured shape) as intended. | The device consists of "precut, contoured 5.5mm diameter rods in lengths from 30mm to 120mm." |
2. Sample Size Used for the Test Set and Data Provenance
- Test Set Sample Size: Not explicitly stated in the provided summary. For mechanical testing, this typically refers to the number of test articles (rods) used per test condition.
- Data Provenance: This is a non-clinical study involving in-vitro mechanical testing. There is no "country of origin of data" in the typical clinical sense, nor is it retrospective or prospective clinical data. The data provenance is from laboratory testing performed according to recognized ASTM standards.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
- Not applicable. This summary describes non-clinical mechanical testing, not a study requiring expert clinical "ground truth" establishment. The "truth" is established by adhering to widely accepted engineering standards (ASTM F2193-02 and ASTM F1798-97) for implantable devices.
4. Adjudication Method for the Test Set
- Not applicable. This is non-clinical mechanical testing, not a clinical study requiring adjudication of expert interpretations.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- Not applicable. This document describes a medical device (spinal implant) and its mechanical testing, not an AI or imaging diagnostic tool.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
- Not applicable. This document describes a medical device (spinal implant) and its mechanical testing, not an algorithm.
7. The Type of Ground Truth Used
- For this non-clinical testing, the "ground truth" is established by the definitions and specifications outlined in the referenced ASTM standards (ASTM F2193-02 and ASTM F1798-97). These standards define how the tests should be conducted and what constitutes acceptable mechanical behavior for spinal implants. There is no pathology, outcomes data, or expert consensus in the clinical sense for this type of submission.
8. The Sample Size for the Training Set
- Not applicable. This is a non-clinical submission for a physical medical device. There is no "training set" in the context of machine learning or AI.
9. How the Ground Truth for the Training Set was Established
- Not applicable. As there is no training set for this type of submission, there is no ground truth to establish for it.
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(317 days)
TSRH SPINAL SYSTEM
When used as a pedicle screw fixation system of the non-cervical posterior spine in skeletally mature patients using bone graft, the TSRH® Spinal System is indicated as an adjunct to fusion for one of the following: (1) degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), (2) degenerative spondylolisthesis with objective evidence of neurologic impairment, (3) fracture, (4) dislocation, (5) scoliosis, (6) kyphosis, (7) spinal tumor, and/or (8) failed previous fusion (pseudarthrosis).
In addition, when used as a pedicle screw fixation system, the TSRH® Spinal System is indicated as an adjunct to fusion for skeletally mature patients using bone graft: (1) having severe spondylolisthesis (Grades 3 and 4) of the fifth lumbar-first sacral (L5-S1) vertebral joint: (2) who are receiving fusions using autogenous bone graft only: (3) who are having the device fixed or attached to the lumbar and sacral spine (L3 and below); and (4) who are having the device removed after the development of a solid fusion mass.
When used as a posterior, non-cervical, non-pedicle screw fixation system, the TSRH® Spinal System is intended for the following indications: (1) degenerative disc disease (as defined by back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), (2) spondylolisthesis, (3) fracture, (4) spinal deformities (i.e., scoliosis, and/or lordosis), (5) spinal stenosis, (6) pseudarthrosis, (7) tumor resection, and/or (8) unsuccessful previous attempts at spinal fusion.
When used as a unilateral supplemental fixation device in the antero-lateral thoracic/lumbar region, the TSRH® L-Plate and VANTAGE™ screws are intended for the following indications: spondylolisthesis; trauma (i.e., fracture or dislocation); spinal stenosis; curvatures (i.e., scoliosis, kyphosis and/or lordosis); tumor; pseudarthritis; and/or failed previous fusion.
For anterior use only the TSRH® Spinal System has the additional indication of: spondylolysis.
The TSRH® Spinal System is intended to help provide immobilization and stabilization of spinal segments as an adjunct to fusion of the thoracic, lumbar, and/or sacral spine.
The TSRH® Spinal System consists of a variety of shapes and sizes of rods, hooks, screws, cross connectors, staples, plates and connecting components as well as implant components from other Medtronic spinal systems, which can be rigidly locked into a variety of configurations, with each construct being tailor-made for the individual case.
Certain implant components from other Medtronic spinal systems can be used with the TSRH® Spinal System. These components include GDLH® rods, GDLH® rod/bolt connectors, GDLH® Variable Angle T-Bolts, GDLH® set screws and locking screws, DYNALOK® PLUS™ bolts, CD HORIZON® Low Profile MULTI-SPAN® CROSSLINK® Plates, VANTAGE™ Anterior Fixation System screws, and CD HORIZON® rods, set screws and locking screws.
The hooks are intended for posterior use only and the staples are for anterior use only. The TSRH-3D® and TSRH-3Dx™ connectors and TSRH-3D® and TSRH-3Dx™ screws are intended for posterior use only. Within the TSRH® family, the cobalt chromium rods should only be used with TSRH® 3Dx™ Spinal System. All CROSSLINK® Plates are for posterior use and the CROSSLINK® Axial and Offset Plates may be used anteriorly as well.
The TSRH® Spinal System components are fabricated from medical grade stainless steel, medical grade titanium alloy, and/or medical grade cobalt-chromiummolybdenum alloy. Medical grade titanium, titanium alloy, and/or cobalt-chromiummolybdenum alloy may be used together. Certain TSRH® Spinal System components may be coated with hydroxyapatite. The subject components will be manufactured from medical grade titanium alloy described by such standards as ASTM F 136 or ISO 5832-3. The TSRH® Spinal System may be sold sterile or non-sterile.
The purpose of this 510(k) submission is to include hydroxyapatite coated screws into the TSRH® Spinal System.
Here's an analysis of the provided text regarding the acceptance criteria and study for the TSRH® Spinal System, structured according to your request:
Acceptance Criteria and Device Performance Study for TSRH® Spinal System
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Non-Clinical Mechanical Tests) | Reported Device Performance |
|---|---|
| Static Tensile Testing per ASTM F1147-05 | Study performed with results supporting substantial equivalence. (Specific numerical performance metrics are not provided in the summary, only that tests were performed and supported equivalence.) |
| Average Coating Thickness Analysis per ASTM F1854-01 | Study performed with results supporting substantial equivalence. (Specific numerical performance metrics are not provided in the summary, only that tests were performed and supported equivalence.) |
| Requirements of FDA guidance document "510(k) Information Needed for Hydroxyapatite Coated Implants" | Existing testing was provided to demonstrate compliance with these requirements. (Specific details of how these requirements were met are not provided in the summary, but it's stated they were addressed.) |
2. Sample Sizes and Data Provenance
This submission is a 510(k) for a medical device (spinal implant system), not an AI/software device. Therefore, the concepts of "test set," "training set," "data provenance," "country of origin," "retrospective or prospective," "number of experts," "adjudication method," and "ground truth" as they relate to clinical studies for AI/software are not applicable here.
The "studies" conducted are non-clinical mechanical tests, not studies involving human subjects or data sets in the way AI/ML models are evaluated.
3. Number of Experts and Qualifications
Not applicable, as this is a mechanical device evaluation, not an AI/software diagnostic or prognostic study.
4. Adjudication Method
Not applicable.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
Not applicable, as this is a mechanical device evaluation. It doesn't involve human readers assisted by AI.
6. Standalone (Algorithm Only Without Human-in-the-Loop) Performance
Not applicable, as this is a mechanical device. There is no algorithm.
7. Type of Ground Truth Used
The "ground truth" in this context refers to the standards defined by ASTM (American Society for Testing and Materials) for mechanical properties and FDA guidance documents for material and coating characteristics of medical implants. The tests performed are designed to demonstrate that the device meets these established engineering and regulatory 'truths'.
8. Sample Size for the Training Set
Not applicable.
9. How the Ground Truth for the Training Set Was Established
As this is a mechanical device, there is no "training set" in the AI/ML sense. The "ground truth" for the non-clinical tests is established by industry standards (ASTM) and regulatory guidance (FDA). These standards define the acceptable mechanical performance and material characteristics required for such implants.
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(26 days)
TSRH SPINAL SYSTEM
When used as a pedicle screw fixation system of the non-cervical posterior spine in skeletally mature patients using bone graft, the TSRH® Spinal System is indicated for one or more of the following: (1) degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), (2) degenerative spondylolisthesis with objective evidence of neurologic impairment, (3) fracture, (4) dislocation, (5) scoliosis, (6) kyphosis, (7) spinal tumor, and/or (8) failed previous fusion (pseudarthrosis).
In addition, when used as a pedicle screw fixation system, the TSRH® Spinal System is indicated for skeletally mature patients using bone graft: ( 1 ) having severe spondylolisthesis (Grades 3 and 4) of the fifth lumbar-first sacral (LS-S1) vertebral joint: (2) who are receiving fusions using autogenous bone graft only: (3) who are having the device fixed or attached to the lumbar and sacral spine (L3 and below); and (4) who are having the device removed after the development of a solid fusion mass.
When used as a posterior, non-cervical, non-pedicle screw fixation system, the TSRH® Spinal System is intended for the following indications: (1) degenerative disc disease (as defined by back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), (2) spondylolisthesis, (3) fracture, (4) spinal deformities (i.e., scoliosis, kyphosis, and/or lordosis), (5) spinal stenosis, (6)pseudarthrosis, (7) tumor resection, and/or (8) unsuccessful previous attempts at spinal fusion.
When used as a unilateral supplemental fixation device in the antero-lateral thoracic/lumbar region, the TSRH® L-Plate and VANTAGE™ screws are intended for the following indications: spondylolisthesis; trauma (i.e., fracture or dislocation); spinal stenosis; curvatures (i.e., scoliosis, kyphosis and/or lordosis); tumor; pseudarthritis; and/or failed previous fusion.
For anterior use only the TSRH® Spinal System has the additional indication of: spondylolysis.
The TSRH® Spinal System consists of a variety of shapes and sizes of rods, hooks, screws, cross connectors, staples, plates, and connecting components, as well as implant components from other Medtronic spinal systems, which can be rigidly locked into a variety of configurations, with each construct being tailor-made for the individual case.
Certain implant components from other Medtronic spinal systems can be used with the TSRH® Spinal System. These components include GDLH® rods, rod/bolt connectors, Variable Angle T-bolts, set screws and locking screws; DYNALOK@ PLUS bolts, CD HORIZON® Low Profile MULTI-SPAN® CROSSLINK® Plates, VANTAGE™ Anterior Fixation System screws, as well as CD HORIZON® rods, screws, set screws and locking screws.
The hooks are intended for posterior use only and the staples are for anterior use only. The TSRH-3D® and TSRH-3DX™ connectors, and TSRH-3D® and TSRH-3DX™ screws are intended for posterior use only. The cobalt chromium rods should only be used with TSRH® 3Dx™ Spinal System. All CROSSLINK® Plates are for posterior use and the CROSSLINK® Axial and Offset Plates may be used anteriorly as well.
Currently, the TSRH® System components are fabricated from medical grade stainless steel, medical grade titanium alloy, or medical grade titanium. The subject components will be manufactured from medical cobalt-chromium-molybdenum alloy described by ASTM F1537. Medical grade titanium, titanium alloy, and/or cobaltchromium-molybdenum alloy may be used together. Never use titanium, titanium alloy, and/or cobalt-chromium-molybdenum alloy with stainless steel in the same construct. The TSRH® Spinal System may be sold sterile or non-sterile.
To achieve best results, do not use any of the TSRH® Spinal System implant components with components from any other system, except those components listed above, or any other manufacturer. As with all orthopaedic and neurosurgical implants, none of the TSRH® Spinal System components should ever be reused under any circumstances.
The provided text is a 510(k) summary for the TSRH® Spinal System, which is a medical device. This type of document is for regulatory clearance and focuses on demonstrating substantial equivalence to existing devices rather than proving a device meets specific performance criteria through a controlled study, especially in the context of an AI/ML device.
Therefore, the document does not contain the information requested for acceptance criteria and a study proving a device meets those criteria, as typically found for AI/ML performance evaluations.
Specifically, the document discusses:
- Device Description: The TSRH® Spinal System consists of various components for spinal fixation.
- Purpose of Submission: To add cobalt chrome rods (already cleared with another system) to the TSRH® Spinal System.
- Indications for Use: Detailed surgical conditions for which the system is intended.
- Substantial Equivalence: The primary focus is on demonstrating that the new cobalt-chrome rods are substantially equivalent to previously cleared components and predicate devices (other spinal systems) through mechanical testing.
There is no mention of:
- Acceptance criteria for performance metrics (e.g., sensitivity, specificity, accuracy).
- A study involving a test set, training set, ground truth establishment, expert readers, or comparative effectiveness with AI.
- Any AI/ML components in the device.
This document pertains to the regulatory clearance of a physical medical implant (spinal system), not a software or AI-driven diagnostic/decision support tool where the requested performance metrics and study details would be relevant.
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(31 days)
TSRH SPINAL SYSTEM
When used as a pedicle screw fixation system of the non-cervical posterior spine in skeletally mature patients using bone graft, the TSRH® Spinal System is indicated for one or more of the following: (1) degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), (2) degenerative spondylolisthesis with objective evidence of neurologic impairment, (3) fracture, (4) dislocation, (5) scoliosis, (6) kyphosis, (7) spinal tumor, and/or (8) failed previous fusion (pseudarthrosis).
In addition, when used as a pedicle screw fixation system, the TSRH® Spinal System is indicated for skeletally mature patients using bone graft: (1) having severe spondylolisthesis (Grades 3 and 4) of the fifth lumbar-first sacral (L5-S1) vertebral joint: (2) who are receiving fusions using autogenous bone graft only: (3) who are having the device fixed or attached to the lumbar and sacral spine (L3 and below); and (4) who are having the device removed after the development of a solid fusion mass.
When used as a posterior, non-cervical, non-pedicle screw fixation system, the TSRH® Spinal System is intended for the following indications: (1) degenerative disc disease (as defined by back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), (2) spondylolisthesis, (3) fracture, (4) spinal deformities (i.e., scoliosis, kyphosis, and/or lordosis), (5) spinal stenosis, (6)pseudarthrosis, (7) turnor resection, and/or (8) unsuccessful previous attempts at spinal fusion.
When used as a unilateral supplemental fixation device in the antero-lateral thoracic/lumbar region, the TSRH® L-Plate and VANTAGE™ screws are intended for the following indications: spondylolisthesis; trauma (i.e., fracture or dislocation); spinal stenosis; curvatures (i.e., scoliosis, kyphosis and/or lordosis); tumor; pseudarthritis; and/or failed previous fusion.
For anterior use only the TSRH® Spinal System has the additional indication of: spondylolysis.
The purpose of this Special 510(k) is to add additional bone screws (TSRH® 3Dx™ Threaded Post Screws, TSRH® 3Dx™ Threaded Multi-Planar Adjusting (MPA) Post Screws, and TSRH® 3Dx™ Short MPA Post Screws) to the TSRH® Spinal System.
The TSRH® Spinal System is intended to help provide immobilization and stabilization of spinal segments as an adjunct to fusion of the thoracic, lumbar, and/or sacral spine.
The TSRH® Spinal System consists of a variety of shapes and sizes of rods, hooks, screws, cross connectors, staples, plates and connecting components as well as implant components from other Medtronic spinal systems, which can be rigidly locked into a variety of configurations, with each construct being tailor-made for the individual case.
Certain implant components from other Medtronic spinal systems can be used with the These components include GDLH® rods, GDLH® rod/bolt TSRH® Spinal System. connectors, GDLH® Variable Angle T-Bolts, GDLH® set screws and locking screws, DYNALOK® PLUS™ bolts, CD HORIZON® Low Profile MULTI-SPAN® CROSSLINK® Plates, VANTAGE™ Anterior Fixation System screws, and CD HORIZON® rods, screws, set screws and locking screws.
The hooks are intended for posterior use only and the staples are for anterior use only. The TSRH-3D® and TSRH-3Dx™ connectors and TSRH-3D® and TSRH-3Dx™ screws are intended for posterior use only. ALL CROSSLINK® Plates are for posterior use and the CROSSLINK® Axial and Offset Plates may be used anteriorly as well.
The TSRH® Spinal System components are fabricated from medical grade stainless steel. Alternatively, they may be fabricated from medical grade titanium alloy or medical grade titanium. The subject components will be manufactured from medical grade titanium alloy described by such standards as ASTM F136 or ISO 5832-3. The TSRH® Spinal System may be sold sterile or non-sterile.
The provided text is a 510(k) summary for a medical device (TSRH® Spinal System) and explicitly states that the purpose of the submission is to add additional bone screws to an existing system. It describes the device, its indications for use, and confirms its substantial equivalence to previously cleared devices.
Crucially, this document does not contain any information about acceptance criteria, performance studies, sample sizes, expert qualifications, adjudication methods, or multi-reader multi-case studies related to the performance of the device in meeting specific clinical or diagnostic criteria.
The "Substantial Equivalence" section states: "Documentation, including a risk analysis, was provided which demonstrated the subject screws to be substantially equivalent to TSRH® Spinal System components manufactured by Medtronic Sofamor Danek and cleared by the FDA in K072429 (S.E. 09/28/2007) and K090740 (S.E. 08/14/2009)."
This indicates that the manufacturer demonstrated substantial equivalence, likely through material testing, mechanical testing, and comparison of design features and indications for use against predicate devices, rather than through a clinical performance study in the context of diagnostic accuracy or a similar measure that would have acceptance criteria and a detailed study design as requested.
Therefore, I cannot extract the requested information from the provided text. The document focuses on regulatory approval through substantial equivalence, not on a detailed clinical performance study with acceptance criteria for a new diagnostic or assistive technology.
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(147 days)
MODIFICATION TO: TSRH SPINAL SYSTEM
When used as a pedicle screw fixation system of the non-cervical posterior spine in skeletally mature patients using bone graft, the TSRH® Spinal System is indicated for one or more of the following: (1) degenerative disc disease(defined as back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), (2) degenerative spondylolisthesis with objective evidence of neurologic impairment. (3) fracture, (4) dislocation, (5) scoliosis, (6) kyphosis, (7) spinal turnor, and/or (8) failed previous fusion (pseudarthrosis).
In addition, when used as a pedicle screw fixation system, the TSRH® Spinal System is indicated for skeletally mature patients using bone graft: (1) having severe spondylolisthesis (Grades 3 and 4) of the fifth lumbar-first sacral (L5-S1) vertebral joint: (2) who are receiving fusions using autogenous bone graft only: (3) who are having the device fixed or attached to the lumbar and sacral spine (L3 and below); and (4) who are having the device removed after the development of a solid fusion mass.
When used as a posterior, non-cervical, non-pedicle screw fixation system, the TSRH® Spinal System is intended for the following indications: (1) degenerative disc disease (as defined by back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), (2) spondylolisthesis, (3) fracture, (4) spinal deformities (i.e., scoliosis, kyphosis, and/or lordosis), (5) spinal stenosis, (6)pseudarthrosis, (7) tumor resection, and/or (8) unsuccessful previous attempts at spinal fusion.
When used as a unilateral supplemental fixation device in the antero-lateral thoracic/lumbar region, the TSRH® L-Plate and VANTAGE™ screws are intended for the following indications: spondylolisthesis; trauma (i.e., fracture or dislocation); spinal stenosis; curvatures (i.e., scoliosis, kyphosis and/or lordosis); tumor, pseudarthritis; and/or failed previous fusion.
For anterior use only the TSRH® Spinal System has the additional indication of: spondylolysis.
The purpose of this Special 510(k) is to add the subject devices which consist of bone screws, set screws, and connectors to the TSRH® Spinal System.
The TSRH® Spinal System is intended to help provide immobilization of spinal segments as an adjunct to fusion of the thoracic, lumbar, and/or sacral spine.
The TSRH® Spinal System consists of a variety of shapes and sizes of rods, hooks, screws, cross connectors, staples, plates and connecting components as well as implant components from other Medtronic spinal systems, which can be rigidly locked into a variety of configurations, with each construct being tailor-made for the individual case.
Certain implant components from other Medtronic spinal systems can be used with the These components include GDLH® rods, GDLH® rod/bolt TSRH® Spinal System. connectors, GDLH® Variable Angle T-Bolts, GDLH® set screws and locking screws, bolts, CD HORIZON® MULTI-SPAN® DYNALOK® PLUSTM Low Profile CROSSLINK® Plates, VANTAGE™ Anterior Fixation System screws, and CD HORIZON® rods, set screws and locking screws.
The hooks are intended for posterior use only and the staples are for anterior use only. The TSRH-3D® and TSRH-3Dx™ connectors and TSRH-3D® and TSRH-3Dx™ screws are intended for posterior use only. ALL CROSSLINK® Plates are for posterior use and the CROSSLINK® Axial and Offset Plates may be used anteriorly as well.
The TSRH® Spinal System components are fabricated from medical grade stainless steel. Alternatively, they may be fabricated from medical grade titanium alloy or medical grade titanium. The subject components will be manufactured from medical grade titanium or titanium alloy described by such standards as ASTM F67 or ASTM F136 or ISO 5832-3 or ISO 5832-2. The TSRH® Spinal System may be sold sterile or non-sterile.
This 510(k) summary for the TSRH® Spinal System describes adding new components (bone screws, set screws, and connectors) to an existing system. The primary method for demonstrating substantial equivalence is through mechanical test results and comparison to predicate devices, rather than a clinical study involving human or algorithmic performance. Therefore, many of the requested categories related to clinical study design and AI performance are not applicable.
Here's an analysis based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Description from Document |
|---|---|
| Mechanical Performance | Substantially equivalent mechanical test results for bone screws, set screws, and connectors compared to predicate devices. |
| Material Composition | Fabricated from medical grade stainless steel, titanium alloy (ASTM F67 or ASTM F136), or titanium (ISO 5832-3 or ISO 5832-2). |
| Indications for Use | Identical to those cleared in K052054 (bone screws) and K072317 (set screws and connectors). This implies the new components maintain the same intended uses and safety profiles as the predicate devices. |
| Labeling | Identical to that cleared in K052054 (bone screws) and K072317 (set screws and connectors). |
| Sterility | May be sold sterile or non-sterile. |
Reported Device Performance: The document states that "Mechanical test results were provided in support of this submission." The conclusion is that the new components "were demonstrated to be substantially equivalent" to the predicate devices in terms of mechanical performance and other characteristics. Specific quantitative performance metrics (e.g., maximum load, fatigue cycles) are not detailed in this summary but would have been part of the full 510(k) submission.
2. Sample Size Used for the Test Set and Data Provenance
This submission relies on mechanical testing of the device components, not a clinical test set with patient data. Therefore:
- Sample Size for Test Set: Not applicable in the context of clinical data. The sample size would refer to the number of devices or components tested in the mechanical studies. This information is not provided in the summary.
- Data Provenance: Not applicable in the context of clinical data. The data originates from laboratory mechanical testing.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
Not applicable. Ground truth in this context would refer to the established mechanical specifications and performance standards for spinal fixation devices, which are defined by regulatory bodies and consensus standards, not by individual clinical experts in a test set.
4. Adjudication Method for the Test Set
Not applicable. Adjudication methods are relevant for human interpretation of clinical data. This submission is based on mechanical testing.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, an MRMC comparative effectiveness study was not done. This type of study assesses human reader performance (with or without AI assistance) on clinical cases and is not relevant for a device submission focused on mechanical equivalence of new components to an existing spinal system.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
No, a standalone algorithm performance study was not done. This device is a physical medical implant, not an AI algorithm.
7. The Type of Ground Truth Used
The ground truth used for this submission is based on established mechanical performance standards and specifications for spinal fixation devices, as demonstrated through laboratory testing and comparison to legally marketed predicate devices. This is a technical/engineering ground truth rather than a clinical ground truth like pathology or expert consensus on patient outcomes.
8. The Sample Size for the Training Set
Not applicable. There is no "training set" in the context of a mechanical device submission demonstrating substantial equivalence. Training sets are relevant for machine learning algorithms.
9. How the Ground Truth for the Training Set Was Established
Not applicable for the same reasons as above.
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(219 days)
TSRH SPINAL SYSTEM
When used as a pedicle screw fixation system of the non-cervical posterior spine in skeletally mature patients, the TSRH® Spinal System is indicated for one or more of the following: (1) degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), (2) degenerative spondylolisthesis with objective evidence of neurologic impairment, (3) fracture, (4) dislocation, (5) scoliosis, (6) kyphosis, (7) spinal tumor, and/or (8) failed previous fusion (pseudarthrosis).
In addition, when used as a pedicle screw fixation system, the TSRH® Spinal System is indicated for skeletally mature patients: (1) having severe spondylolisthesis (Grades 3 and 4) of the fifth lumbar-first sacral (L5-S1) vertebral joint: (2) who are receiving fusions using autogenous bonc graft only: (3) who are having the device fixed or attached to the lumbar and sacral spine (L3 and below); and (4) who are having the device removed after the development of a solid fusion mass.
When used as a posterior, non-cervical, non-pedicle screw fixation system, the TSRH® Spinal System is intended for the following indications: { }) degenerative disc disease (as defined by back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), (2) spondylolisthesis, (3) fracture, (4) spinal deformities (i.e., scoliosis, kyphosis, and/or lordosis), (5) spinal stenosis, (6) pseudarthrosis, (7) tumor resection, and/or (8) unsuccessful previous attempts at spinal fusion,
When used as a unilateral supplemental fixation device in the antero-lateral thoracic/lumbar region, the TSRH® L-Plate and VANTAGE™ screws are intended for the following indications: spondylolisthesis; trauma (i.e., fracture or dislocation); spinal stenosis; curvatures (i.e., scoliosis, kyphosis and/or lordosis); tumor; pseudarthritis; and/or failed previous fusion.
For anterior use only the TSRH® System has the additional indication of: spondylolysis.
The TSRH® Spinal System consists of a variety of shapes and sizes of rods, hooks, screws, cross connectors, staples, plates, and connecting components, as well as implant components from other Medtronic spinal systems, which can be rigidly locked into a variety of configurations, with each construct being tailor-made for the individual case.
Certain implant components from other Medtronic spinal systems can be used with the TSRH® Spinal System. These components include GDLH® rods, rod/bolt connectors, Variable Angle Tbolts, set screws and locking screws; DYNALOK® PLUS bolts, CD HORIZON® Low Profile MULTI-SPAN® CROSSLINK® Plates, VANTAGE™ Anterior Fixation System screws, as well as CD HORIZON® rods, screws, set screws and locking screws.
The hooks are intended for posterior use only and the staples are for anterior use only. The TSRH-3D® and TSRH-3DX™ connectors, and TSRH-3D® and TSRH-3DX™ screws are intended for posterior use only. All CROSSLINK® Plates are for posterior use and the CROSSLINK® Axial and Offset Plates may be used anteriorly as well.
The TSRH® Spinal System components are fabricated from stainless steel. Alternatively, they may be fabricated from medical grade titanium alloy or medical grade titanium. Never use stainless steel and titanium implant components in the same construct. The TSRH® Spinal System may be sold sterile or non-sterile.
The purpose of this submission is to add TSRH® Anterior L-Plates to the TSRH® Spinal System. Indications for the TSRH® Spinal System will be updated in this submission.
This document describes the TSRH® Spinal System, specifically focusing on the addition of TSRH® Anterior L-Plates. It is a 510(k) summary, which means it describes how the new components are substantially equivalent to previously cleared devices rather than providing a study for novel acceptance criteria.
Therefore, the information requested in your prompt regarding acceptance criteria, device performance, sample sizes, ground truth establishment, expert involvement, adjudication methods, MRMC studies, or standalone algorithm performance, as typically found in clinical validation studies for AI/software devices, is not applicable to this submission.
The acceptance criteria for this device are implicitly tied to demonstrating substantial equivalence to predicate devices. This is achieved through engineering and preclinical testing to ensure the new components meet established performance standards for medical implants in terms of "Indications for Use" and "Technological Characteristics," typically through mechanical testing.
Here's how the document addresses the concept of "acceptance criteria" and "proof" in the context of a 510(k) submission:
1. Table of Acceptance Criteria and Reported Device Performance
As this is a 510(k) submission for a spinal implant system component, the "acceptance criteria" are not reported as specific performance metrics and thresholds like sensitivity, specificity, or AUC, as would be the case for an AI/software device. Instead, the acceptance criteria are based on demonstrating that the TSRH® Anterior L-Plate and VANTAGE™ Screws are substantially equivalent to existing, legally marketed predicate devices.
The document states:
"Documentation, including mechanical test results, provided has demonstrated that the TSRH® Anterior L-Plate and VANTAGE™ Screws are substantially equivalent to similar previously cleared devices such as the TSRH® Spinal System (K072317 SE 9/18/07) and CD HORIZON® Spinal System (K042025 SE 8/25/04). The VANTAGE™ Screws were previously cleared in K023797 (SE 12/16/02)."
This implies that the acceptance criteria are met if the mechanical performance of the new components is comparable to the predicate devices. Specific quantitative values for these mechanical tests (e.g., fatigue strength, pull-out strength, bending stiffness) are not provided in this summary but would have been part of the full 510(k) submission.
| Acceptance Criterion (Implicit) | Reported Device Performance (Implicit) |
|---|---|
| Mechanical performance comparable to predicate devices (e.g., TSRH® Spinal System K072317, CD HORIZON® Spinal System K042025, VANTAGE™ Screws K023797) | Mechanical test results as submitted to the FDA demonstrate substantial equivalence. |
The Study that Proves the Device Meets Acceptance Criteria
The "study" undertaken is a preclinical engineering study (mechanical testing) comparing the new components to predicate devices.
2. Sample size used for the test set and the data provenance
- Sample Size (Test Set): Not specified in this summary. For mechanical testing of implantable devices, the sample size would typically be determined by engineering standards (e.g., ASTM, ISO) to ensure statistical significance for the performance characteristics being evaluated.
- Data Provenance: The data would originate from laboratory bench testing conducted by Medtronic Sofamor Danek USA. It is prospective in the sense that the tests were specifically conducted for this submission, but it's not "clinical" prospective data. The "country of origin" would be the manufacturing/testing location, likely the USA.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Number of Experts/Qualifications: This is not applicable. The "ground truth" for mechanical performance of a medical device implant is established through standardized engineering tests, not expert consensus on clinical data. The tests are designed and interpreted by qualified engineers.
4. Adjudication method for the test set
- Adjudication Method: Not applicable. Mechanical test results are objective measurements against predefined engineering standards or comparative data from predicate devices. There is no expert adjudication process in this context.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- MRMC Study: No. This is a spinal implant, not an AI/software device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Standalone Performance: Not applicable. This is a spinal implant, not an AI/software device.
7. The type of ground truth used
- Type of Ground Truth: The ground truth for this device's performance is based on objective mechanical measurements obtained from laboratory testing (e.g., strength, fatigue, material properties), demonstrating compliance with relevant industry standards and comparability to predicate devices.
8. The sample size for the training set
- Sample Size (Training Set): Not applicable. There is no "training set" in the context of a 510(k) submission for a mechanical implant. The design and manufacturing processes are informed by existing engineering knowledge, standards, and previous device experience.
9. How the ground truth for the training set was established
- Ground Truth for Training Set: Not applicable. There is no "training set" or "ground truth" in the AI/ML sense for a mechanical implant. Device design and manufacturing follow established engineering principles and regulatory guidelines.
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MODIFICATION TO TSRH SPINAL SYSTEM
When used as a pedicle screw fixation system in the non-cervical posterior spine in skeletally mature patients, the TSRH® Spinal System is indicated for one or more of the following: (1) degenerative disc disease (defined as back pain of discogenic origin with degencration of the disc confirmed by patient history and radiographic studies), (2) degencrative spondylolisthesis with objective evidence of neurologic impairment, (3) fracture, (4) dislocation, (5) scoliosis, (6) kyphosis, (7) spinal tumor, and/or (8) failed previous fusion (pseudarthrosis).
In addition, when used as a pedicle screw fixation system, the TSRH® Spinal System is indicated for skeletally mature patients: (1) having severe spondylolisthesis (Grades 3 and 4) of the fifth lumbar-first sacral (L5-S1) joint; (2) who are receiving fusions using autogenous bone graft only; (3) who are having the device fixed or attached to the lumbar and sacral spine (L3 and below); and (4) who are having the device removed after the development of a solid fusion mass.
When used as a posterior, non-cervical, non-pedicle screw fixation system, the TSRH® Spinal System is intended for the following indications: (1) degenerative disc disease (as defined by back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), (2) spondylolisthesis, (3) fracture, (4) spinal deformities (i.e., scoliosis, kyphosis, and/or lordosis), (5) spinal stenosis, (6) pseudarthrosis, (7) tumor resection, and/or (8) unsuccessful previous attempts at spinal fusion.
For anterior use only the TSRH® Spinal System has the additional indications of: (1) spinal stenosis and/or, (2) spondylolysis.
The TSRH® Spinal System is intended to help provide immobilization and stabilization of spinal segments as an adjunct to fusion of the thoracic, lumbar, and/or sacral spine.
The TSRH® Spinal System consists of a variety of shapes and sizes of rods, hooks, screws, cross connectors, and connecting components. In addition, GDLH® rods, DYNALOK® PLUS bolts, CD HORIZON® Low Profile MULTI-SPAN® CROSSLINK® Plates, GDLH® rod/bolt connectors, GDLH® Variable Angle T-Bolts, and GDLH® and CD HORIZON® set screws and locking screws may be used with the TSRH® Spinal System.
The TSRH® Spinal System implant components can be rigidly locked into a variety of configurations, with each construct being tailor-made for the individual case. The hooks are intended for posterior use only and the staples are for anterior use only. The TSRH-3D® connectors and TSRH-3D® screws are intended for posterior use only.
The TSRH® Spinal System components are fabricated from stainless steel. Alternatively, they may be fabricated from medical grade titanium alloy or medical grade titanium. The TSRH® Spinal System may be sold sterile or non-sterile.
The purpose of this 510(k) submission is to add modified bone screws to the TSRH® Spina] System.
The provided document is a 510(k) summary for the TSRH® Spinal System, specifically an amendment to add modified bone screws. It primarily focuses on demonstrating substantial equivalence to previously cleared predicate devices rather than presenting a de novo study with acceptance criteria and device performance results.
Therefore, most of the requested information cannot be extracted from this document. Here's what can be inferred or stated as not applicable:
1. A table of acceptance criteria and the reported device performance
- Not Applicable. This document is a 510(k) summary for substantial equivalence, not a clinical study report or a performance validation report against specific acceptance criteria. The device performance is implicitly demonstrated through the substantial equivalence to predicate devices, which are already deemed safe and effective.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not Applicable. No test set, clinical data, or patient data (retrospective or prospective) is mentioned for this 510(k) submission. The submission is based on engineering documentation and comparison to predicates.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Not Applicable. No test set requiring ground truth establishment by experts is mentioned.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not Applicable. No test set or ground truth adjudication method is mentioned.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- Not Applicable. This is a spinal implant device, not an AI-assisted diagnostic device. Therefore, no MRMC study or AI performance evaluation is relevant or mentioned.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- Not Applicable. This is a spinal implant device, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not Applicable. No clinical ground truth data is presented. The "ground truth" for a substantial equivalence determination often refers to the predicate device's established safety and effectiveness.
8. The sample size for the training set
- Not Applicable. This document does not describe an AI/ML device that requires a training set.
9. How the ground truth for the training set was established
- Not Applicable. As there is no training set mentioned, there is no ground truth establishment for it.
Summary based on the provided document:
The 510(k) summary demonstrates substantial equivalence of the modified bone screws for the TSRH® Spinal System to legally marketed predicate devices. This approach, common for medical devices, means that the new device shares fundamental technological characteristics and indications for use with devices already cleared by the FDA, implying similar safety and effectiveness without requiring new clinical studies to establish acceptance criteria and performance from scratch.
- Acceptance Criteria & Device Performance: Not explicitly stated as this is a substantial equivalence submission. The implicit acceptance criteria is that the modified screws are as safe and effective as the predicate devices (K011067, K020699, K021170, K022778, K041282, K052054, and K062807). Performance is considered equivalent to these predicates based on documentation, including a risk analysis.
- Study Type: Substantial Equivalence Comparison.
- Data Provenance/Sample Size/Experts/Adjudication/MRMC/Standalone Performance/Ground Truth (for test or training sets): Not applicable or not detailed in this 510(k) summary, as the submission focuses on engineering documentation and comparison to predicate devices, rather than a de novo clinical study with these elements.
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