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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

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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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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Ask a specific question about this device

When used as a pedicle screw fixation system in the non-cervical posterior spine in skeletally mature patients, the TSRH® 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: (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) turnor 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 purpose of this 510(k) submission is to add modified TSRH® Spinal System 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, 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 provided text is a 510(k) summary for a medical device (TSRH® Spinal System) and the FDA's clearance letter. This type of document is a premarket notification for devices that are "substantially equivalent" to an already legally marketed device. It does not typically contain information about formal acceptance criteria or detailed studies proving device performance against such criteria in the same way a new, high-risk device might.

Instead, the primary "study" and "acceptance criteria" here revolve around demonstrating substantial equivalence to a predicate device.

Here's an analysis based on the provided text, highlighting what is and isn't present:

Acceptance Criteria and Device Performance Study (TSRH® Spinal System)

The regulatory pathway for the TSRH® Spinal System, as described in the 510(k) summary, is based on demonstrating substantial equivalence to a previously cleared predicate device. This means the "acceptance criteria" are intrinsically tied to showing that the new device shares similar technological characteristics and/or indications for use with the predicate, without raising new questions of safety or effectiveness.

1. A table of acceptance criteria and the reported device performance

2. Sample size used for the test set and the data provenance

The provided text does not include information about a "test set" in the context of clinical or performance data for the modified screws. For a 510(k) submission focused on substantial equivalence, the "test set" is often the comparison of the new device's specifications (design, materials, indications) against the predicate device's specifications.

• Sample Size for Test Set: Not applicable/not provided for a clinical or performance study. The "sample" here refers to the specific modified TSRH® screws being compared to the predicate.
• Data Provenance: Not applicable/not provided for a clinical or performance study. Comparisons would be based on internal design and testing data against predicate data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

This information is not provided in the 510(k) summary. For substantial equivalence, the "ground truth" is largely established by regulatory precedent (the predicate device's clearance) and engineering/risk analysis rather than expert clinical consensus on a new test set.

4. Adjudication method

Not applicable/not provided. There is no mention of a human-reviewed test set or an adjudication process in this summary.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done or at least not reported in this 510(k) summary. MRMC studies are typically for evaluating the diagnostic performance of software or imaging devices, not for surgical implants like spinal systems.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done

Not applicable. The device is a surgical implant, not an algorithm.

7. The type of ground truth used

The "ground truth" in this context is the established safety and effectiveness of the predicate device. The modified TSRH® screws are deemed safe and effective if they are "substantially equivalent" to this predicate, meaning they share the same fundamental characteristics and indications for use without raising new safety concerns.

8. The sample size for the training set

Not applicable. There is no training set in the context of an AI/algorithm. For a medical device implant, the "training" would be the development and testing data that led to the original TSRH® Spinal System, but this specific information is not in the summary for the modified screws.

9. How the ground truth for the training set was established

Not applicable. There is no training set mentioned. The "ground truth" for the predicate device would have been established through its own 510(k) clearance or other regulatory pathways, which would have involved demonstrating its safety and effectiveness (e.g., through performance testing, biocompatibility, and potentially clinical data, although often not required for 510(k)). This information is not detailed for the predicate in this document.

Ask a specific question about this device

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) degencrative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic sudies), (2) degenerative spondylolisthesis with objective evidence of neurologic impartment, (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: (1) having severe spondylolisthesis (Grades 3 and 4) of the fifth lumbar-first sacral (15-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 (LS 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) spondylolisthess, (3) fracture, (4) spinal deformines (i.e., scoliosis, 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 stemosis and/or, (2) spondylolysis.

The purpose of this 510(k) submission is to incorporate additional TSRH®-3D connecting components into the 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, and connecting components. In addition, GDLH® rods, DYNALOK PLUSTM 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-3DG connectors and TSRH-3D® screws are intended for posterior use only. All CROSSLINK® Plates are for posterior use and the CROSSLINK® Axial and Offset Plates may be used auteriorly as well.

The TSRH® Spinal System components are fabricated from stainless steel conforming to A STM F-138 or ISO 5832-1 or ISO 5832-9. Alternatively, they may be fabricated from medical grade titanium alloy conforming to ASTM F-136 or ISO 5832-3 or medical grade titanium conforming to ASTM F67. The TSRH® Spinal System may be sold sterile or non-sterile.

The provided text does not contain information about acceptance criteria or a study that proves the device meets those criteria. The document is a 510(k) summary for the TSRH® Spinal System, outlining its description, indications for use, and a declaration of substantial equivalence to a predicate device.

Therefore, I cannot provide the requested table or answer the questions related to acceptance criteria, device performance, study design, expert involvement, or ground truth establishment.

The document primarily focuses on:

• Device Description: What the TSRH® Spinal System is and its components.
• Indications for Use: The specific medical conditions for which the device is intended.
• Substantial Equivalence: A statement that the updated components are substantially equivalent to previously marketed versions of the system.
• Regulatory Information: FDA correspondence regarding the 510(k) clearance.

Ask a specific question about this device

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 degeneration of the disc confirmed by patient history and radiographic studies), (2) degenerative spondylolisthesis with objective evidence of neurologic imparment, (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 purpose of this 510(k) submission is to add a variety of modified TSRH® components (rods, screws and connectors) to the 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® 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. 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 conforming to ASTM F-138 or ISO 5832-1 or ISO 5832-9. Alternatively, they may be fabricated from medical grade titanium alloy conforming to ASTM F-136 or ISO 5832-3 or medical grade titanium conforming to ASTM F67. The TSRH® Spinal System may be sold sterile or non-sterile.

The provided document is a 510(k) summary for the TSRH Spinal System, an orthopedic implant. It describes the device's indications for use and states that the components were declared substantially equivalent to previously cleared components.

However, the document specifically states that a "Failure Mode and Effects Criticality Analysis/Design Verification" was provided. It does not include information about specific acceptance criteria or a study proving that the device meets those criteria, especially in the context of device performance as one might expect for a digital health or AI-driven medical device. The 510(k) clearance process primarily focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than detailed performance studies against pre-defined acceptance criteria as would be required for a novel device or AI product.

Therefore, many of the requested fields cannot be answered from the provided text because they pertain to a type of device performance evaluation that is not detailed in this 510(k) summary for a spinal implant system.

Here's an attempt to answer the questions based only on the provided text, with clear indications where the information is not present:

1. A table of acceptance criteria and the reported device performance

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Sample size for the test set: Not applicable and not mentioned. This type of information would be relevant for clinical performance studies, which are not detailed in this 510(k) summary. The "test set" for this type of substantial equivalence submission primarily involves engineering design verification/validation (e.g., mechanical testing, material characterization), not a clinical data set in the same way an AI product would.
• Data provenance: Not applicable and not mentioned.

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 and not mentioned. This is typically relevant for clinical studies where expert consensus might define a ground truth for diagnostic accuracy, which is not the subject of this 510(k). The "ground truth" for the TSRH Spinal System would be its mechanical integrity and biocompatibility, as confirmed through design verification processes.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

• Not applicable and not 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

• No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done and is not mentioned. This is relevant for AI-assisted diagnostic devices, which is not what the TSRH Spinal System is.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

• Not applicable and not mentioned. The TSRH Spinal System is a physical orthopedic implant, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

• The document implies that the ground truth for the device's acceptable performance is its substantial equivalence to predicate devices and adherence to established material and mechanical standards (e.g., ASTM F-138, ISO 5832-1, ASTM F-136). The "Failure Mode and Effects Criticality Analysis/Design Verification" mentioned would likely involve engineering analyses and testing against established safety and performance benchmarks for spinal implants, rather than clinical ground truth as defined by pathology or outcomes data in a prospective study for a novel device.

8. The sample size for the training set

• Not applicable and not mentioned. This applies to machine learning models, not physical orthopedic implants.

9. How the ground truth for the training set was established

• Not applicable and not mentioned.

Ask a specific question about this device

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 spondylolisthesis with objective evidence of neurologic impairment, (2) fracture, (3) dislocation, (4) scoliosis, (5) kyphosis, (6) spinal tumor, and/or (7) failed previous fusion (pseudarthrosis).

In addition, when used as a pedicle screw fixation system, the TSRH® Spinal System is indicated for skeletally mature patients: (a) having severe spondylolisthesis (Grades 3 and 4) of the fifth lumbar-first sacral (L5-S1) vertebral joint; (b) who are receiving fusions using autogenous bone graft only; (c) 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) spinal stenosis, (3) spondylolisthesis, (4) deformities (i.e., scoliosis, kyphosis, and/or lordosis), (5) fracture, (6) spinal pseudarthrosis, (7) tumor resection, and/or (8) failed previous fusion.

When used as an anterolateral thoracic/lumbar 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) spinal stenosis, (3) spondylolisthesis, (4) spinal deformities (i.e., scoliosis, kyphosis, and/or lordosis), (5) fracture, (6) pseudarthrosis, (7) tumor resection, and/or (8) failed previous fusion.

The purpose of this Special 510(k) is to add the use of rods which are physically identical to the rods already cleared in the TSRH® Spinal System (K014076).

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, DYNA-LOK® 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. All CROSSLINK® Plates are for posterior use and the CROSSLINK Axial and Offset Plates may be used anteriorly as well. The TSRH-3D connectors and TSRH-3D screws are intended for posterior use only.

The TSRH® Spinal System implant components are fabricated from medical grade stainless steel described by such standards as ASTM F138 or ISO 5832-1 or ISO 5832-9. Alternatively, the entire system may be made out of medical grade titanium alloy described by such standards as ASTM F136 or ISO 5832-3.

This is a 510(k) summary for a spinal system, specifically a Special 510(k) to add new rods to an already cleared system. This type of submission focuses on demonstrating substantial equivalence to a predicate device, rather than proving efficacy or safety through clinical studies with acceptance criteria.

Therefore, the requested information regarding acceptance criteria, study details, and performance metrics (such as effect size, sample sizes for test/training sets, expert qualifications, and ground truth establishment) is not applicable to this document.

The document states:

• "The TSRH® Spinal System was declared substantially equivalent to the TSRH® Spinal System manufactured by Medtronic Sofamor Danek. A design review, engineering drawings and other data were provided in this application."

This indicates that the submission relied on design review, engineering drawings, and other non-clinical data to demonstrate that the new rods are physically identical to those already cleared. There is no mention of a clinical study with performance metrics or acceptance criteria for the device itself.

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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 spondylolisthesis with objective evidence of neurologic impairment, (2) fracture, (3) dislocation, (4) scoliosis, (5) kyphosis, (6) spinal tumor, and/or (7) failed previous fusion (pseudarthrosis).

In addition, when used as a pedicle screw fixation system, the TSRH® Spinal System is indicated for skeletally mature patients: (a) having severe spondylolisthesis (Grades 3 and 4) of the fifth lumbar-first sacral (L5-S1) vertebral joint; (b) who are receiving fusions using autogenous bone graft only; (c) 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) spinal stenosis, (3) spondylolisthesis, (4) spinal deformities (i.e., scoliosis, kyphosis, and/or lordosis), (5) fracture, (6) pseudarthrosis, (7) tumor resection, and/or (8) failed previous fusion.

When used as an anterolateral thoracic/lumbar 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) spinal stenosis, (3) spondylolisthesis, (4) spinal deformities (i.e., scoliosis, kyphosis, and/or lordosis), (5) fracture, (6) pseudarthrosis, (7) tumor resection, and/or (8) failed previous fusion.

The purpose of this Special 510(k) is to modify the threaded screw post connector to allow for medical pivot of the screw post.

The TSRH® Spinal System consists of a variety of shapes and sizes of rods, hooks, screws, The FBRIP Symal Byecennecting components. In addition, GDLH® rods, DYNA-LOK S eross commoners, and voor enomine MULTI-SPAN™ CROSSLINK® Plates, GDLH® rod/bolt connectors, GDLH® Variable Angle T-Bolts, and GDLH® and CD HORLZON® roti both connected in screws may be used with the TSRH® Spinal System.

The TSRH® Spinal System implant components can be rigidly locked into a variety of The rereas ns, 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. All CROSSLINK® Plates are for posterior use and the CROSSLINK Axial and Offset Plates may be used anteriorly as well. The TSRH-3D connectors and TSRH-3D screws are intended for posterior use only.

The TSRH Spinal System components are fabricated from either stainless steel conforming to ASTM F-138, ASTM F-136 titanium alloy, or ASTM F 67 titanium (or their ISO equivalent 5832-1, 5832-3 and 5832-2, respectively). The TSRH Spinal System may be sold sterile or non-sterile.

The provided text describes a Special 510(k) submission for a modification to the TSRH® Spinal System to allow for medical pivot of the screw post. However, the document does not contain information regarding objective acceptance criteria, a study proving the device meets said criteria, or any details about performance metrics, sample sizes, ground truth establishment, or expert involvement commonly associated with device performance studies.

Instead, the document focuses on:

• Device Description: Describing the components, materials, and general function of the TSRH® Spinal System.
• Indications for Use: Listing the specific conditions for which the device is intended.
• Substantial Equivalence: Stating that the modified device was declared substantially equivalent to a previously cleared TSRH® Spinal System.
• FDA Communication: The FDA's letter confirming substantial equivalence and outlining regulatory responsibilities.

Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets the acceptance criteria, as this information is not present in the provided text.

The document states: "A design review, engineering drawings and other data were provided in this application." This implies that data supporting the modification was submitted, but the nature of that data (e.g., bench testing, mechanical testing, clinical data) and any acceptance criteria or reported performance metrics are not included in this summary.

To answer your questions, I would need a different type of document, such as a detailed design verification and validation report or a clinical study report.

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Ask a specific question about this device

Ask a specific question about this device