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 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.

The provided document is a 510(k) Premarket Notification for a medical device (AVS® PL PEEK Spacer System) and is primarily focused on demonstrating substantial equivalence to a predicate device, rather than presenting a study with specific acceptance criteria and detailed performance metrics for a novel AI/software device. As such, most of the information requested in your prompt (especially regarding AI/software performance, ground truth, sample sizes for training/test sets, expert adjudication, MRMC studies, and standalone performance) is not available in these documents.

However, I can provide the information that is present in the document which relates to the device's acceptable performance and the study (or rather, testing) that supports it, tailored to the context of a spinal implant.

Here's an analysis based on the provided text:

Acceptance Criteria and Device Performance for AVS® PL PEEK Spacer System

The acceptance criteria for this device are not explicitly stated in a quantitative table within the provided text. Instead, the document emphasizes substantial equivalence to predicate devices by demonstrating similar design features, materials, and mechanical testing results. The "study" mentioned isn't a clinical trial in the traditional sense, but rather "testing in compliance with FDA's June 12, 2007 'Class II Special Controls Guidance Document: Intervertebral Body Fusion Device'." This compliance is the core of its "performance."

Therefore, the "acceptance criteria" can be inferred as successful demonstration of:

1. Equivalent Design Features: The device shares design characteristics with established predicate devices.
2. Equivalent Materials: Uses similar materials to predicate devices.
3. Equivalent Mechanical Performance: Achieves mechanical testing results comparable to predicate devices, in accordance with FDA guidance for intervertebral body fusion devices.

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size: Not specified in the provided text. The "testing" likely refers to benchtop mechanical and material testing, not human subject data.
• Data Provenance: Not explicitly stated for specific test data beyond "Testing in compliance with FDA's June 12, 2007 'Class II Special Controls Guidance Document: Intervertebral Body Fusion Device' was performed." This strongly implies lab-based, pre-clinical testing data rather than clinical patient data. There is no mention of country of origin or retrospective/prospective human data.

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

• Not applicable as this is a device modification for a spinal implant, not an AI/software device requiring expert interpretation of diagnostic images or patient outcomes. The "ground truth" for a mechanical device is its physical and material properties meeting specified engineering standards.

4. Adjudication method for the test set:

• Not applicable for the type of device and testing described. Adjudication typically applies to expert consensus in clinical data review.

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.

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:

• The "ground truth" for this device's performance would be established through engineering specifications, material science testing standards, and established mechanical testing protocols (e.g., fatigue testing, static compression, subsidence testing as outlined in relevant ASTM or ISO standards for spinal implants, which would be referenced by the FDA guidance document). The results of these tests are compared against performance criteria derived from the predicate devices and the FDA guidance.

8. The sample size for the training set:

• Not applicable. This is not an AI/software device that utilizes a "training set."

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

• Not applicable. This is not an AI/software device that utilizes a "training set."

Ask a specific question about this device

The Spinal USA Interbody Fusion Device is indicated for intervertebral body fusion of the spine in skeletally mature patients. The device system is designed for use with autograft to facilitate fusion. One device is used per intervertebral space for the ALIF and TLIF system. Two devices are used per intervertebral space for the PLIF system.

The Spinal USA Interbody Fusion Device ALIF, PLIF, TLIF System are intended for use at either one level or two contiguous levels in the lumbar spine, from L2 to S1, for the treatment of degenerative disc disease (DDD) with up to Grade I spondylolisthesis. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The lumbar device is to be used with supplemental fixation and autogenuos bone graft. Patients should have at least six months of non-operative treatment prior to treatment with a lumbar intervertebral fusion device.

The Spinal USA Interbody Fusion Device consists of implants with various widths, heights and lengths to accommodate individual patient anatomy and graft material size. All components are manufactured from medical grade polyetheretherketone (Peek, LT1). The products are supplied clean and "NON-STERILE".

The provided text does not contain information about acceptance criteria or a study proving the device meets them. Instead, it describes a 510(k) summary for an Intervertebral Body Fusion Device, focusing on its intended use, device description, and substantial equivalence to predicate devices. There is no mention of specific performance metrics, test sets, ground truth establishment, or clinical studies involving AI or human readers.

Therefore, I cannot provide a table of acceptance criteria and reported device performance or answer the questions regarding sample size, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth types, or training set details based on the provided document.

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