(22 days)
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:
- Equivalent Design Features: The device shares design characteristics with established predicate devices.
- Equivalent Materials: Uses similar materials to predicate devices.
- 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
| Acceptance Criteria (Inferred from Substantial Equivalence Claim) | Reported Device Performance |
|---|---|
| Design Feature Equivalence: | The subject AVS® PL PEEK Spacers and the predicates (AVS® PL PEEK Spacers and DePuy's Lumbar I/F Cage) share similar design features including: |
| - Hollow frame | - Hollow frame PEEK Implant |
| - Lateral fenestrations | - Lateral fenestrations |
| - Serrations on superior/inferior surfaces | - Serrations on the superior and inferior surfaces |
| - Comparable dimensions (heights, widths, angles) | - Comparable heights, widths, and angles |
| Material Equivalence: | "Materials... are similar between the subject device and the listed predicates." |
| Mechanical Testing Equivalence: | "Mechanical testing results are similar between the subject device and the listed predicates." Also, "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." |
| Intended Use Equivalence: (Implied, for regulatory acceptance) | The device shares the same intended use: intervertebral body fusion with autogenous bone graft in patients with degenerative disc disease (DDD) at L2-S1, with or without Grade I spondylolisthesis, for skeletally mature patients after six months of non-operative therapy, implanted via posterior approach, and used with supplemental spinal fixation systems. |
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."
§ 888.3080 Intervertebral body fusion device.
(a)
Identification. An intervertebral body fusion device is an implanted single or multiple component spinal device made from a variety of materials, including titanium and polymers. The device is inserted into the intervertebral body space of the cervical or lumbosacral spine, and is intended for intervertebral body fusion.(b)
Classification. (1) Class II (special controls) for intervertebral body fusion devices that contain bone grafting material. The special control is the FDA guidance document entitled “Class II Special Controls Guidance Document: Intervertebral Body Fusion Device.” See § 888.1(e) for the availability of this guidance document.(2) Class III (premarket approval) for intervertebral body fusion devices that include any therapeutic biologic (e.g., bone morphogenic protein). Intervertebral body fusion devices that contain any therapeutic biologic require premarket approval.
(c)
Date premarket approval application (PMA) or notice of product development protocol (PDP) is required. Devices described in paragraph (b)(2) of this section shall have an approved PMA or a declared completed PDP in effect before being placed in commercial distribution.