Search Results

The Stryker Spine AVS PL PEEK Spacers are intervertebral body fusion devices indicated for use with autogenous bone graft in patients with degenerative disc disease (DDD) at one level or two contiguous levels from L2 to S1.

DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The DDD patients may also have up to Grade I spondylolisthesis at the involved level(s). These patients should be skeletally mature and have six months of nonoperative therapy.

The AVS PL PEEK. Spacers are to be implanted via posterior approach.

The AVS PL PEEK Spacers are intended to be used with supplemental spinal fixation systems that have been cleared for use in the lumbosacral spine (i.e., posterior pedicle screw and rod systems).

The subject AVST™ PL PEEK Spacers and the predicates AVST™ PL PEEK Spacers and DePuy's Lumbar I/F Cage (i.e., Brantigan Cage) share similar design features:
• Hollow frame PEEK Implant
• Lateral fenestrations
• Serrations on the superior and inferior surfaces
• Comparable heights, widths, and angles
• Materials and mechanical testing results are similar between the subject device and the listed predicates.

This Special 510(k) premarket notification is intended to introduce the following modifications to the AVSTM PL PEEK Spacers approved under K073470, K080758, and K082014:

A range of 0° and 4° AVSTM PL PEEK Spacers (6-13mm in height, 30 and 33mm lengths with an 11mm width) were found to be substantially equivalent to the Brantigan Cage in K073470. In K080758, minor design changes were introduced to the 0° degree spacers. K082014 added four (4) implants in a 14 mm height. The minor design modifications approved under K080858 had been incorporated in these 14 mm implants.

The AVSTM PL PEEK Spacers that are the subject of this application add the design modifications that were approved on the 0 ° implants under K080758, to the 4 ° implants previously approved under K073470 and K082014. The lengths, width, and angles are the same as the predicate AVS® PL PEEK Spacers previously approved. The modifications include replacing the ogival shaped nose of the implant with the wedge-shaped design to facilitate insertion of the spacer between adjacent vertebral endplates. The threaded hole on the front side was removed as it is not needed to retrieve the implant and field feedback has confirmed that it would likely not be used. In the smaller heights, the back side threaded hole has been adapted to the various heights of the spacers to remain consistent with the existing instruments (i.e., the two Inserters), and the back side of the spacer has been tapered in the frontal plane to match the geometry of the vertebral endplates and the size of the two flat surfaces has been increased to improve the connection with the Inserters.

Note that the AVS™ PL PEEK Spacers may also be referred to as AVS™M Plus or UniLIF.

This document describes a Special 510(k) Premarket Notification for modifications to the AVS™ PL PEEK Spacer System, an intervertebral body fusion device. The purpose of this submission is to demonstrate substantial equivalence to previously cleared predicate devices, not to establish new clinical efficacy or safety claims through a clinical study with acceptance criteria.

Therefore, many of the requested categories in your prompt are not applicable to this type of submission. This document primarily focuses on demonstrating that the modified device is still substantially equivalent to the original cleared device and previously cleared predicate devices based on design features, materials, and mechanical testing, rather than reporting on a study designed to establish performance against specific acceptance criteria for a novel device.

Here's an analysis based on the provided text, indicating where information is not available or not applicable:

1. Table of Acceptance Criteria and Reported Device Performance:

This information is not applicable in the context of this 510(k) submission. This is a Special 510(k) for modifications to an already cleared device, demonstrating substantial equivalence rather than presenting performance against new clinical acceptance criteria through a clinical trial. The text states:

"Testing in compliance with FDA's June 12, 2007 'Class II Special Controls Guidance Document: Intervertebral Body Fusion Device' was performed for the AVS PL PEEK Spacers and demonstrated substantially equivalent performance characteristics to the identified predicate device systems."

This indicates that mechanical and material testing was performed to show the modified device performs similarly to the predicate devices, not to meet specific clinical acceptance criteria.

2. Sample Size Used for the Test Set and Data Provenance:

This information is not provided in the document. As this is a submission for device modifications and substantial equivalence, detailed clinical study data with test sets and provenance are not typically required or included. The "test set" would primarily refer to physical devices subjected to mechanical testing.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications:

This information is not applicable/not provided. There was no clinical "test set" in the sense of patient data requiring expert ground truth establishment for performance evaluation.

4. Adjudication Method for the Test Set:

This information is not applicable/not provided. No clinical test set requiring adjudication was used.

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 the impact of AI assistance on human reader performance, which is not relevant for this medical device (spinal intervertebral body fusion device).

6. If a Standalone (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:

This information is not applicable. For this device, "ground truth" would relate to the physical and mechanical properties of the device (e.g., strength, durability, biocompatibility), which are assessed through engineering and material testing, not through expert consensus, pathology, or outcomes data in the typical sense of a diagnostic or therapeutic clinical study. The "ground truth" for showing substantial equivalence relies on comparing the modified device's characteristics to those of the predicate devices.

8. The Sample Size for the Training Set:

This information is not applicable. This submission does not involve an AI algorithm that requires a training set.

9. How the Ground Truth for the Training Set was Established:

This information is not applicable. No AI algorithm with a training set requiring ground truth establishment was involved.

In summary, this 510(k) submission is for demonstrating substantial equivalence of a modified intervertebral body fusion device to existing predicate devices, primarily through engineering and material testing. It does not involve algorithms, clinical trials with specific acceptance criteria for performance, or human-in-the-loop studies as typically seen with diagnostic AI devices.

Ask a specific question about this device

The Stryker Spine AVS® PL PEEK Spacers are intervertebral body fusion devices indicated for use with autogenous bone graft in patients with degenerative disc disease (DDD) at one level or two contiguous levels from L2 to S1.

DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The DDD patients may also have up to Grade I spondylolisthesis at the involved level(s). These patients should be skeletally mature and have six months of non-operative therapy.

The AVS® PL PEEK Spacers are to be implanted via posterior approach.

The AVS® PL PEEK Spacers are intended to be used with supplemental spinal fixation systems that have been cleared for use in the lumbosacral spine (i.e., posterior pedicle screw and rod systems).

The subject AVS PL PEEK Spacers and the predicates AVS PL PEEK Spacers and DePuy's Lumbar I/F Cage (i.e., Brantigan Cage) share similar design features:
• Hollow frame PEEK Implant
• Lateral fenestrations
• Serrations on the superior and inferior surfaces
• Comparable heights, widths, and angles
• Materials and mechanical testing results are similar between the subject device and the listed predicates.
This Special 510(k) premarket notification is intended to introduce the following line extensions to the AVS® PL PEEK Spacers approved under K073470: The addition of 20 and 25 mm lengths, 14, 15, 16 and 18 mm heights, 8 and 9 mm widths, and 8° angle. Additions to implants approved under K080758 include: Addition of a 14 mm length (4 implants).

All other attributes remain the same. Note that the AVS® PL PEEK Spacers may also be referred to as AVS Plus.

The provided text discusses a Special 510(k) Premarket Notification for a line extension to the AVS™ PL PEEK Spacer System. This document does not describe a study involving an artificial intelligence (AI) or machine learning device, nor does it involve the evaluation of a diagnostic or assistive technology where performance metrics like sensitivity, specificity, or reader improvement would be relevant.

Instead, this document is for a medical device (spinal implant) and focuses on demonstrating substantial equivalence to previously cleared predicate devices for regulatory approval. The "study" mentioned here refers to mechanical testing of the device, not a clinical study involving human readers or AI performance.

Therefore, most of the requested information regarding acceptance criteria, device performance, sample sizes for test/training sets, expert ground truth, adjudication methods, MRMC studies, and standalone performance for an AI device cannot be extracted from this document because it pertains to a different type of medical device and regulatory submission.

However, I can extract the information that is relevant to the document for the physical device:

1. Table of Acceptance Criteria and Reported Device Performance:

The document states: "Testing in compliance with FDA's June 12, 2007 'Class II Special Controls Guidance Document: Intervertebral Body Fusion Device' was performed for the AVS PL PEEK Spacers and demonstrated substantially equivalent performance characteristics to the identified predicate device systems."

2. Sample Size Used for the Test Set and Data Provenance:

• Sample Size: Not specified in the provided text. The "test set" here refers to the number of physical devices or models subjected to mechanical testing.
• Data Provenance: Not applicable in the context of a retrospective/prospective study with human or AI data. The "provenance" refers to the results of internal mechanical testing performed by Stryker Spine.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications:

Not applicable. This document is about the physical testing of a medical device, not a diagnostic or AI performance study requiring expert ground truth for interpretation.

4. Adjudication Method for the Test Set:

Not applicable. This concept pertains to resolving discrepancies in expert interpretations in diagnostic studies, which is not relevant here.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

No. This is a special 510(k) for a physical medical device, not an AI or diagnostic tool.

6. Standalone Performance Study (Algorithm Only Without Human-in-the-loop Performance):

No. This is a physical medical device.

7. Type of Ground Truth Used:

Mechanical properties and performance characteristics, as defined by FDA guidance for intervertebral body fusion devices, established through engineering testing.

8. Sample Size for the Training Set:

Not applicable. This is not an AI/ML device.

9. How the Ground Truth for the Training Set Was Established:

Not applicable. This is not an AI/ML device.

Ask a specific question about this device