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510(k) Data Aggregation
(149 days)
The APEX-DL Spine System with APEX Spine System Components is intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the following acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine: severe spondylolisthesis (grades 3 and 4) of the L5-S1 vertebra; degenerative spondylolisthesis with objective evidence of neurologic impairment; fracture; dislocation; scoliosis; kyphosis; spinal tumor; and failed previous fusion (pseudoarthrosis).
The APEX-DL Spine System with APEX Spine System Components is also indicated for pedicle screw fixation for the treatment of severe spondylolisthesis (Grades 3 and 4) of the L5-S1 vertebra in skeletally mature patients receiving fusion by autogenous bone graft, with the device fixed or attached to the lumbar and sacral spine (levels of pedicle screw fixation are L3 to S1), and for whom the device is intended to be removed after solid fusion is attained.
The APEX-DL Spine System with APEX Spine System Components is also a sacraliliac screw fixation system of the non-cervical spine indicated for degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (fracture and/or dislocation), spinal stenosis, deformities (scoliosis, lordosis and/or kyphosis), tumor, and previous failed fusion (pseudo-arthrosis).
When used in a percutaneous posterior approach with AIM MIS instrumentation, the APEX-DL Spine System with APEX Spine System Components is intended for non-cervical pedicle fixation for the following indications: degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (i.e., fracture or dislocation), spinal stenosis, curvatures (i.e., scoliosis, and/or lordosis), tumor, pseudoarthrosis, and failed previous fusion in skeletally mature patients . Levels of fixation are for the thoracic, lumbar and sacral spine.
When used for posterior non-cervical pediatic patients, the APEX-DL Spine System implants with APEX Spine System Components are indicated as an adjunct to treat adolescent idiopathic scoliosis. The APEX DL Spine System is intended to be used with autograft. Pediatric pedicle screw fixation is limited to a posterior approach.
The APEX-DL Spine System includes Monoaxial, Uniplanar, and Polyaxial Double Lead Thread Screws in the cannulated and non-cannulated versions and in regular and reduction (extended tab) versions. APEX-DL Spine System is a low profile thoracolumbar implant for use with wide range of patient statures. The APEX-DL Spine System Polyaxial screws feature a friction head, which is designed to provide precise reduction mechanism as a result of easier rod capturing. The APEX-DL Spine System also includes Lordosed Percutaneous Rods. The APEX-DL Spine System is compatible with the APEX Spine System 5.5mm and 6.0mm rods, hooks, side-by-side connectors, iliac connectors, cross connectors, and washers.
The APEX-DL Spine System is a spinal implant for immobilization and stabilization of spinal segments. The document indicates that no clinical studies were performed. The acceptance criteria and testing are based on non-clinical (mechanical) tests.
1. Table of Acceptance Criteria and Reported Device Performance
| Test Type | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| ASTM F1717 (Vertebrectomy Model) | ||
| Static Compression Bending | Not explicitly stated (comparison to predicates) | Results were "equal or higher than the predicate systems" |
| Static Torsion | Not explicitly stated (comparison to predicates) | Results were "equal or higher than the predicate systems" |
| Dynamic Compression Bending | Not explicitly stated (comparison to predicates) | Results were "equal or higher than the predicate systems" |
| ASTM F1798 (Interconnection Mechanisms) | ||
| Static Axial Gripping Capacity | Not explicitly stated (comparison to predicates) | Results were "equal or higher than the predicate systems" |
| Axial Torque Gripping Capacity | Not explicitly stated (comparison to predicates) | Results were "equal or higher than the predicate systems" |
| Static Flexion-Extension | Not explicitly stated (comparison to predicates) | Results were "equal or higher than the predicate systems" |
| Dynamic Flexion-Extension | Not explicitly stated (comparison to predicates) | Results were "equal or higher than the predicate systems" |
Note: The acceptance criteria are implicitly defined as demonstrating mechanical properties that are "equal or higher" than the identified predicate devices, based on the testing standards.
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: Not explicitly stated in the provided document. For each of the ASTM tests listed, a specific number of samples (implants/constructs) would have been used, but this detail is not provided.
- Data Provenance: The data is from non-clinical (mechanical) testing conducted presumably by SpineCraft, LLC or a contracted testing facility. It is not patient or human data; therefore, country of origin or retrospective/prospective does not apply in the typical sense.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
Not applicable. This is a non-clinical, mechanical testing study, not a study requiring expert clinical assessment or ground truth establishment in a medical imaging or diagnostic context. The "ground truth" here is the objective measurement of mechanical properties according to established ASTM standards.
4. Adjudication Method for the Test Set
Not applicable. This is a non-clinical, mechanical testing study. Adjudication methods like 2+1 or 3+1 are used for expert consensus in clinical or imaging studies.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No. An MRMC study is a clinical study involving multiple human readers interpreting medical cases. The provided document explicitly states, "No clinical studies were performed."
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Not applicable. This device is a physical spinal implant, not an algorithm or AI system.
7. The Type of Ground Truth Used
The "ground truth" for this device's performance is based on objective mechanical measurements according to recognized industry standards (ASTM F1717 and ASTM F1798). The performance is then compared to "predicate systems" as a benchmark for substantial equivalence.
8. The Sample Size for the Training Set
Not applicable. This is a physical medical device undergoing mechanical testing, not a machine learning model that requires a training set.
9. How the Ground Truth for the Training Set Was Established
Not applicable. As described in point 8, there is no "training set" for this type of device evaluation.
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(90 days)
The ASTRA System is intended to provide immobilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine: severe spondylolisthesis (grades 3 and 4) of the L5-S1 vertebra; degenerative spondylolisthesis with objective evidence of neurologic impairment; fracture; dislocation; scoliosis; spinal tumor; and failed previous fusion (pseudo-arthrosis).
The ASTRA Spine System is also indicated for pedicle screw fixation for the treatment of severe spondylolisthesis (Grades 3 and 4) of the L5-S1 vertebra in skeletally mature patients receiving fusion by autogenous bone graft, with the device fixed or attached to the lumbar and sacral spine (levels of pedicle screw fixation are L3 to S1), and for whom the device is intended to be removed after solid fusion is attained.
The ASTRA System is also a sacral/iliac screw fixation system of the non-cervical spine indicated for degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radies), spondylolisthesis, trauma (fracture and/or dislocation), spinal stenosis, deformities (scoliosis, lordosis and/or kyphosis), tumor, and previous failed fusion (pseudo-arthrosis).
When used in a percutaneous, posterior approach with AVANT Spine MIS instrumentation, the ASTRA Spine System is intended for non-cervical pedicle fixation for the following indications: degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (i.e., fracture or dislocation), spinal stenosis, curvatures (i.e., scoliosis, kyphosis), tumor, pseudo-arthrosis, and failed previous fusion in skeletally mature patients . Levels of fixation are for the thoracic, lumbar and sacral spine.
The ASTRA Spine System is a top loading, multiple component, posterior spinal fixation system which consists of rods, cannulated and non-cannulated monoaxial, uniplanar and polyaxial screws, hooks, iliac connectors, rod connectors, and cross connectors. Most of the components are available in a variety of sizes to more closely match the patient's anatomy.
Materials:
Titanium alloy
CoCr alloy
Here's an analysis of the provided text regarding the ASTRA Spine System, focusing on acceptance criteria and study details.
Important Note: The provided document is a 510(k) summary for a medical device (Spine System), not an AI/ML device. Therefore, many of the requested fields related to AI/ML specific studies (like sample sizes for test/training sets, data provenance, expert ground truth, MRMC studies, standalone performance) are not applicable to this type of medical device submission. This document focuses on demonstrating substantial equivalence to predicate devices through non-clinical (mechanical) testing.
1. Table of Acceptance Criteria and Reported Device Performance
For this medical device, the "acceptance criteria" are implicitly defined by performance equivalence to predicate devices in standardized mechanical tests. The "reported device performance" is a statement of comparative equivalence.
| Acceptance Criteria (Implicit) | Reported Device Performance (Summary) |
|---|---|
| Static Compression Bending: Must perform at least equivalent to predicate systems. | "The results of this testing were compared to predicate systems, with the results being equal to or higher than the predicate systems." |
| Static Torsion: Must perform at least equivalent to predicate systems. | "The results of this testing were compared to predicate systems, with the results being equal to or higher than the predicate systems." |
| Dynamic Compression Bending: Must perform at least equivalent to predicate systems. | "The results of this testing were compared to predicate systems, with the results being equal to or higher than the predicate systems." |
| Axial Gripping: Must perform at least equivalent to predicate systems. | "The results of this testing were compared to predicate systems, with the results being equal to or higher than the predicate systems." |
| Torsional Gripping: Must perform at least equivalent to predicate systems. | "The results of this testing were compared to predicate systems, with the results being equal to or higher than the predicate systems." |
| Static Flexion-Extension: Must perform at least equivalent to predicate systems. | "The results of this testing were compared to predicate systems, with the results being equal to or higher than the predicate systems." |
| Dynamic Flexion-Extension: Must perform at least equivalent to predicate systems. | "The results of this testing were compared to predicate systems, with the results being equal to or higher than the predicate systems." |
| Overall Substantial Equivalence: Must be substantially equivalent in intended use, design, material, performance, and function. | "The ASTRA Spine System is substantially equivalent to the predicate devices in terms of indications for use, design, material, performance and function." |
2. Sample Size Used for the Test Set and the Data Provenance
This is a physical device, and the "test set" refers to the tested device components.
- Sample Size: Not explicitly stated in terms of number of components tested for each test, but standard engineering practices for medical device testing would involve a sufficient number (e.g., n=5 or n=10 per test) to ensure statistical significance, though the exact numbers are not provided in this summary.
- Data Provenance: The tests are non-clinical, meaning they were conducted in a laboratory setting. There is no patient data provenance (e.g., country of origin, retrospective/prospective) since no human data was used for these mechanical tests.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
- Not Applicable. For mechanical testing of a physical device, ground truth is established by standardized testing protocols (e.g., ASTM standards) and measured physical properties, not by expert consensus on clinical data. Engineers and lab technicians perform and analyze the tests according to these standards.
4. Adjudication Method for the Test Set
- Not Applicable. There is no adjudication in the sense of reconciling human expert opinions for clinical images or data. The results of mechanical tests are objective measurements against defined criteria.
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 physical spinal implant, not an AI/ML diagnostic or assistive device. No MRMC studies were performed.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
- Not Applicable. This is a physical spinal implant; there is no algorithm or standalone performance.
7. The Type of Ground Truth Used
- Mechanical Test Standards and Predicate Device Performance: The "ground truth" for the non-clinical tests is based on the established performance characteristics and safety profiles of legally marketed predicate devices, as defined by FDA regulations for substantial equivalence, and adherence to relevant ASTM standards (ASTM F1717 and ASTM F1798).
8. The Sample Size for the Training Set
- Not Applicable. This is a physical device; there is no AI/ML model or "training set" in the context of machine learning. The device design and materials are based on engineering principles and knowledge of predicate devices.
9. How the Ground Truth for the Training Set Was Established
- Not Applicable. As there is no training set for an AI/ML model, this question is not relevant. The "ground truth" for developing the physical device is based on established biomechanical and medical understanding of spinal fixation and the performance of existing, cleared devices.
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(93 days)
The CosmoLock Pedicle Screw System is intended to provide immobilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of thoracic, lumbar, and sacral spine: degenerative spondylolisthesis with objective evidence of neurological impairment, fracture, dislocation, deformities or curvatures (i.e. scoliosis, and/or lordosis), spinal tumor, pseudarthrosis and failed previous fusion.
The CosmoLock Pedicle Screw System is also intended for non-cervical pedicle screw fixation for the following indications: severe spondylolisthesis (grades 3 and 4) of the L5-S1 vertebra in skeletally mature patients receiving fusion by autogenous bone graft having implants attached to the lumbar and sacral spine (L3 to sacrum) with removal of the implants after the attainment of a solid fusion. It is also intended for the following indications: trauma (i.e. fracture or dislocation); spinal stenosis; deformities or curvatures (i.e. scoliosis, and/or lordosis), tumor; pseudoarthrosis; and failed previous fusion.
The CosmoLock Pedicle Screw System is a top loading, multiple component, posterior spinal fixation system which consists of pedicle screws, rods and cross links. All of the components are available in a variety of sizes to match more closely the patient's anatomy.
Materials:
Ti-6Al-4V per ASTM F136 CoCr per ASTM F1537
This document is a 510(k) Summary for the CosmoLock Pedicle Screw System. It describes the device and its intended use and claims substantial equivalence to predicate devices. However, it does not contain the detailed information needed to answer many of your questions, as it explicitly states that no clinical studies were performed.
Here's an analysis based on the provided text:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (Test) | Reported Device Performance |
|---|---|
| Static compression per ASTM F1717 | Equivalent to predicate devices (implied: met criteria) |
| Dynamic compression per ASTM F1717 | Equivalent to predicate devices (implied: met criteria) |
| Static torsion per ASTM F1717 | Equivalent to predicate devices (implied: met criteria) |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not provided in the document. The studies mentioned are non-clinical (mechanical tests), and details about sample sizes for these tests are not specified.
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)
This information is not applicable/provided. No clinical studies were performed, and therefore no ground truth established by experts is relevant to the data presented.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not applicable/provided. No clinical studies were performed.
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. This document states, "No clinical studies were performed."
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is not applicable. The device is a mechanical pedicle screw system, not an AI or algorithm-based device. No standalone performance study in this context was performed.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
The ground truth for the non-clinical tests would be the established mechanical testing standards (ASTM F1717) and the performance of the predicate devices. There is no biological or expert-defined "ground truth" in the typical medical imaging/diagnosis sense, as this is a mechanical implant.
8. The sample size for the training set
This information is not applicable/provided. No clinical studies were performed, and there is no mention of an algorithm or AI requiring a training set.
9. How the ground truth for the training set was established
This information is not applicable/provided. No training set or associated ground truth was established, as no clinical studies or AI development are described. The focus is on demonstrating mechanical equivalence to predicate devices.
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(61 days)
The MANTIS® Spinal System and MANTIS® Redux Spinal System is intended for percutaneous, posterior, non-cervical pedicle and non-pedicle fixation of the spine to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion for the following indications: Degenerative Disc Disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies); Spondylolisthesis; Trauma (i.e. fracture or dislocation); Spinal Stenosis; Curvature (i.e. scoliosis, kyphosis, and/or lordosis); Tumor; Pseudoarthrosis; and Failed Previous Fusion.
The Radius® Spinal System is intended for use in the noncervical spine. When used as an anterior/anterolateral and posterior, noncervical pedicle and non-pedicle fixation system, the Radius® Spinal system is intended to provide additional support during fusion using autograft or allograft in skeletally mature patients in the treatment of the following acute and chronic instabilities or deformities: Degenerative Disc Disease (DDD) (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies); Spondylolisthesis; Trauma (i.e. fracture or dislocation); Spinal Stenosis; Curvature (i.e. scoliosis, kyphosis, and/or lordosis); Tumor; Pseudoarthorisis; and Failed Pervious Fusion. The Radius® Spinal System can also be linked to the XIA® Titanium Spinal System via the Ø5.5mm to Ø6.0mm Radius® rod-to-rod connector.
The Stryker Spine TRIO® Plate System is intended for posterior, noncervical (T10-S1) pedical and nonpedical fixation of the spine for the following indications: Degenerative Disc Disease (DDD) (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies); Spondylolisthesis; Trauma (i.e. fracture or dislocation); Spinal Stenosis; Curvature (i.e. scoliosis, kyphosis, and/or lordosis); Tumor; Pseudoarthorisis; and Failed Pervious Fusion.
The Stryker Spine TRIO® Spinal Fixation System is intended for posterior, noncervical pedicle and non-pedicle fixation of the spine. The Stryker Spine TRIO® Spinal Fixation System is indicated for: Degenerative Disc Disease (DDD) (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies); Spondylolisthesis; Trauma (i.e. fracture or dislocation); Spinal Stenosis; Curvature (i.e. scoliosis, kyphosis, and/or lordosis); Tumor; Pseudoarthorisis; and Failed Pervious Fusion. The TRIO® Spinal Fixation Sytem is intended to be used in conjunction with the OSS Diapason Rods, Opus Spinal System Rods, and the Multi-Axis Cross Connectors.
The Stryker Spine TRIO® Spinal System is intended for posterior, noncervical pedicle and nonpedicle fixation of the spine to provide immobilization and stabilization of spinal segements in skeletally mature patients as an adjunct to fusion for the following indications: Degenerative Disc Disease (DDD) (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies); Spondylolisthesis; Trauma (i.e. fracture or dislocation); Spinal Stenosis; Curvature (i.e. scoliosis, kyphosis, and/or lordosis); Tumor; Pseudoarthorisis; and Failed Pervious Fusion. The TRIO® + Spinal System is intended to be used in conjunction with the OSS/Diapason Rods or Opus Rods, XIA® Pre-bent Rods, and the Multi-Axis Cross Connectors.
The Stryker Spine TRIO® TRAUMA Spinal System is intended for percutaneous, posterior, non-cervical pedicle fixation of the spine to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion for the following indications: Degenerative Disc Disease (DD) (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies); Spondylolisthesis; Trauma (i.e. fracture or dislocation); Spinal Stenosis; Curvature (i.e. scoliosis, kyphosis, and/or lordosis); Tumor; Pseudoarthorisis; and Failed Pervious Fusion.
The XIA® Spinal System and XIA® 4.5 Spinal System are intended for anterior/anterolateral and posterior, noncervical pedicle and non-pedicle fixation for the following indications: Degenerative Disc Disease (DDD) (Defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies); Spondylolisthesis; Trauma (i.e., fracture or dislocation); Spinal Stenosis; Curvatures (i.e., Scoliosis, Kyphosis, and/or Lordosis); Tumor; Pseudoarthrosis and; Failed previous fusion. The 6mm diameter rods from the DIAPASON® Spinal System and OPUS® Spinal System are intended to be used with the other components of the XIA® Titanium Spinal System. The Titanium Multi-Axial Cross Connector are intended to be used with the other components of the XIA® Titanium Spinal System.
The XIA® 3 Spinal System is intended for use in the noncervical spine. When used as an anterior/anterolateral and posterior, noncervical pedicle fixation system, the XIA® 3 Spinal System is intended to provide additional support during autograft or allograft in skeletally mature patients in the treatment of the following acute and chronic instabilities or deformities: Degenerative Disc Disease (DDD) (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies); Spondylolisthesis; Trauma (i.e. fracture or dislocation); Spinal Stenosis; Curvature (i.e. scoliosis, kyphosis, and/or lordosis); Tumor, Pseudoarthorisis; and Failed Pervious Fusion. The Ø5.5mm rods from the Stryker Spine Radius® Spinal System and the Ø6.0mm Vitallium Rods from the XIA® Spinal System are intended to be used with the other components of the XIA® 3 Spinal System. When used for posterior noncervical pedicle screw fixation in pediatric patients, the XIA® Spinal System implants are indicated as an adjunct to fusion to treat adolescent idiopathic scollosis. The XIA® 3 Spinal System for pediatic use is intended to be used with autograft and/or allograft. Pediatric pedicle screw fixation is limited to a posterior approach.
The XIA® 4.5 Spinal System is intended for anterior/anteriolateral and posterior, noncervical pedicle and non-pedicle fixation for the following indications: Degenerative Disc Disease (DD) (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies); Spondylolisthesis; Trauma (i.e. fracture or dislocation); Spinal Stenosis; Curvature (i.e. scoliosis, kyphosis, and/or lordosis); Tumor; Pseudoarthorisis; and Failed Pervious Fusion. The Stryker Spine DIAPASON® Spinal System, OPUS® Spinal System and XIA® 4.5 Spinal System can be linked to the XIA® 4.5 Spinal System via the rod-to-rod connector when used for the aforementioned indications in skeletally mature patients as an adjunct to fusion. Except for the staples, the XIA® 4.5 Spinal System is indicated as an adjunct to fusion to treat adolescent idiopathic scoliosis when used for posterior noncervical pedicle screw fixation in pediatric patients. The XIA® 4.5 Spinal System for pediatric use in intended to be used with autograft and/or allograft. Pediatric pedicle screw fixation is limited to a posterior approach.
The STRYKER Spine thoraco-lumbar spinal fixation systems, subject of this 510(k), are non-cervical, pedicle and non-pedicle fixation systems comprised of screws, rods, plates, hooks, connectors, washers and staples. The components are manufactured from either Titanium (Titanium Alloy and CP Titanium), Stainless Steel or Cobalt-Chromium-Molybdenum Alloy (Vitallium®). This Special 510(k) submission seeks clearance for sterile labeling of the listed STRYKER Spine thoraco-lumbar spinal fixation systems. All of the components of the subject devices will be sterilized by gamma radiation, a traditional sterilization method as per FDA guidance document, Updated 510(k) Sterility Review Guidance K90-1; Guidance for Industry and FDA.
This is a 510(k) Premarket Notification for sterile packaging of a range of spinal systems. The key claim is substantial equivalence to previously cleared non-sterile versions of the same devices. Therefore, the "device" in question for this submission is specifically the sterile packaging and the sterilization process, not the spinal implant itself as a medical device performing a physiological function. The "performance" being evaluated is the ability to maintain sterility and the structural integrity of the device within its packaging over its shelf life.
Here's the breakdown of the acceptance criteria and the study that proves the device meets them:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Sterilization Effectiveness | Demonstrated by gamma radiation, a traditional sterilization method per FDA guidance document, Updated 510(k) Sterility Review Guidance K90-1; Guidance for Industry and FDA. |
| Sterile Barrier Packaging System | Demonstrated effective in maintaining sterility for the recommended 5-year shelf-life. |
| Impact on Device Characteristics | No design modifications were incorporated to facilitate sterile packaging. The sterile-packed implant components maintain the same technological characteristics (design, technical requirements, materials of construction, indications/intended use) as the non-sterile predicate devices. |
| Shelf Life | Demonstrated a 5-year shelf life in sterile packaging. |
| Safety and Effectiveness | Concluded to be safe and effective, retaining the same intended use, indications, technological characteristics, and mode of operation as the predicate non-sterile devices. |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document primarily discusses the sterilization process and packaging rather than clinical performance of the implant itself. Therefore, typical "test set" in the context of clinical or diagnostic AI/software devices (e.g., patient data) is not applicable here.
- Sterilization and Packaging Validation Data: The document mentions "accelerated aging data" for validating the 5-year shelf life. It does not specify the sample size for this testing, nor the country of origin or whether it was retrospective or prospective. However, these types of tests are typically prospective laboratory studies conducted in controlled environments.
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. This submission is about the sterility and packaging of medical implants, not a diagnostic or clinical performance study that would require expert ground truth labeling. The "ground truth" here is the scientific validation of sterilization methods and shelf life according to recognized standards and FDA guidance.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. Adjudication methods are typically used in clinical studies for establishing ground truth, which is not relevant to this submission on sterile packaging.
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 not an AI/software device and no MRMC study was conducted.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an AI/software device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for this submission relies on:
- Scientific Validation of Sterilization: Adherence to established scientific principles and FDA guidance for sterilization (gamma radiation), demonstrating a Sterility Assurance Level (SAL).
- Accelerated Aging Data: Laboratory testing to simulate real-time aging and demonstrate that the sterile barrier packaging system maintains sterility for the stated shelf life.
- Material and Design Specification Conformity: Confirmation that the components are manufactured from specified materials and that their design, technical requirements, and intended use are identical to the non-sterile predicate devices.
8. The sample size for the training set
Not applicable. This is not a machine learning or AI device that requires a training set.
9. How the ground truth for the training set was established
Not applicable. As this is not a machine learning or AI device, there is no training set and therefore no ground truth establishment for a training set.
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(49 days)
The XIA® 4.5 Spinal System is intended for anterior/anteriolateral and posterior, noncervical pedicle and non-pedicle fixation for the following indications:
- Degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies);
- Spondylolisthesis:
- Trauma (i.e. fracture or dislocation);
- Spinal stenosis;
- Curvatures (i.e. scoliosis, kyphosis, and/or lordosis);
- Tumor;
- Pseudoarthrosis: and
- Failed previous fusion.
The Stryker Spine DIAPASON™ Spinal System, OPUS™ Spinal System and XIA® 4.5 Spinal System can be linked to the XIA® 4.5 Spinal System via the rod-to-rod connector.
When used for posterior noncervical pedicle screw fixation in pediatric patients, the XIA 4.5 Spinal System implants are indicated as an adjunct to fusion to treat adolescent idiopathic scoliosis. The XIA 4.5 Spinal System for pediatric use is intended to be used with autograft and/or allografi. Pediatric pedicle screw fixation is limited to a posterior approach.
The XIA® 4.5 Spinal System consists of a variety of titanium Monoaxial & Polyaxial Bone Screws, Monoaxial & Polyaxial Reduction Screws, Hooks, Blockers, Rod Connectors, Dual Staples and Connectors. The existing components of the XIA 4.5 Spinal System were determined substantially equivalent through K050461 for class II indications consistent with 21 CFR 888.3070 (b) (1). The indications were expanded through K060361 to include class III indications per product code NKB, 21 CFR 888.3070 (b) (2). Subsequent line extensions have been cleared through K060748, and K092605.
The expansion of indications for the XIA 4.5 Spinal System is proposed for the inclusion of adolescent idiopathic scoliosis alone, and not other indications for a pediation. As pediatric patients are unlikely to exhibit symptoms of degenerative disc disease (DDD) or stenosis due to the wear and tear on the spine necessary to develop these diseases, expansion of these indications to a pediation is not warranted.
This document (K121342) is a 510(k) premarket notification for the Stryker XIA® 4.5 Spinal System, seeking clearance for expanded indications, specifically for adolescent idiopathic scoliosis.
The acceptance criteria and study information indicate that the device's substantial equivalence relies on biomechanical testing and a clinical literature analysis, not on a clinical ground truth study as typically seen for AI/ML devices. Therefore, many of the requested fields are not applicable.
Here's the information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Static compression bending (per ASTM F1717) | Substantially Equivalent: Testing demonstrated equivalence to predicate devices. |
| Dynamic compression bending (per ASTM F1717) | Substantially Equivalent: Testing demonstrated equivalence to predicate devices. |
| Static torsion testing (per ASTM F1717) | Substantially Equivalent: Testing demonstrated equivalence to predicate devices. |
| Interconnection strength testing (per ASTM F1798) | Substantially Equivalent: Testing demonstrated equivalence to predicate devices. |
| Clinical Literature Analysis | Substantially Equivalent: Analysis supported equivalence to predicate devices. |
| Dimensional Comparisons | Substantially Equivalent: Comparisons supported equivalence to predicate devices. |
| Engineering Analyses | Substantially Equivalent: Analyses supported equivalence to predicate devices. |
2. Sample size used for the test set and the data provenance
- Sample Size: Not applicable. The submission relies on biomechanical testing and literature review rather than a clinical test set in the context of an AI/ML device.
- Data Provenance: Not applicable for a clinical test set. Biomechanical testing would have been conducted in a lab environment.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Number of Experts: Not applicable. Ground truth from experts is not mentioned for this type of submission.
- Qualifications of Experts: Not applicable.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Adjudication Method: Not applicable. There is no clinical test set requiring adjudication in this submission.
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/ML diagnostic or assistive device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Standalone Study: No. This product is a physical spinal implant, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Type of Ground Truth: For the biomechanical testing, the "ground truth" would be the established performance characteristics of the predicate devices and the relevant ASTM standards for spinal implants. For the clinical literature analysis, the literature itself serves as the basis for comparison. No clinical "ground truth" as in pathology or outcomes data from a prospective study of this device.
8. The sample size for the training set
- Sample Size for Training Set: Not applicable. This is not an AI/ML device requiring a training set.
9. How the ground truth for the training set was established
- Ground Truth Establishment for Training Set: Not applicable.
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