FDA 510(k) Search - By Innolitics (SaMD and AI Experts)

The Stryker Spine AVS™ PL PEEK Spacer is a vertebral body replacement indicated for use in the thoraco-lumbar spine (T1-L5) to replace a collapsed, damaged, or unstable vertebral body resected or excised during partial and total vertebrectomy procedure due to tumor or trauma, to achieve anterior decompression of the spinal cord and neural tissues, and to restore the height of a collapsed vertebral body. It is recommended to pack bone graft material inside the implant. The Stryker Spine AVS™ PL PEEK Spacer is intended for use with supplemental fixation. The supplemental fixation systems that may be used with the Stryker Spine AVS™ PL PEEK Spacer include, but are not limited to, Stryker Spine plate or rod systems (XIA, Spiral Radius 90D, and Trio).

Device Description

AI/ML Overview

This 510(k) premarket notification describes a spinal implant (Stryker Spine AVS™ PL PEEK Spacer), not a diagnostic device with performance metrics like sensitivity, specificity, or AUC. Therefore, much of the requested information regarding acceptance criteria for device performance, ground truth establishment, sample sizes for test/training sets, and expert consensus is not applicable in the context of this product type and submission.

The "acceptance criteria" for a device like this primarily revolve around substantial equivalence to predicate devices in terms of materials, intended use, and mechanical/biological function, as demonstrated through documentation and specific testing as required by FDA guidance for spinal systems.

Here's an attempt to address the applicable parts of your request based on the provided document:

Acceptance Criteria and Study to Prove Device Meets Acceptance Criteria

For the Stryker Spine AVS™ PL PEEK Spacer, the primary acceptance criterion for its 510(k) clearance was demonstrating substantial equivalence to legally marketed predicate devices. This means showing that the new device is as safe and effective as existing spinal vertebral body replacement devices.

The "study" to prove this involves providing documentation and testing to compare the new device to its predicates.

1. Table of Acceptance Criteria and Reported Device Performance

Given this is a spinal implant for structural support, not a diagnostic AI device, the "performance" is assessed through material properties, mechanical testing, and biocompatibility, rather than diagnostic metrics.

Acceptance Criterion (Demonstrating Substantial Equivalence)	Reported Device Performance (as summarized in the 510(k))
Material Equivalence: PEEK polymer	Documentation provided demonstrating equivalence in material to predicate devices. (The document mentions "material" in the summary of technological characteristics).
Sizes (Dimensions): New implant sizes for use.	Documentation provided demonstrating equivalence in sizes to predicate devices, and additional new implant sizes are introduced.
Indications for Use: Thoraco-lumbar spine (T1-L5) for vertebral body replacement, anterior decompression, and height restoration, with bone graft and supplemental fixation.	The Indications for Use are consistent with, or expanded from, the predicate devices, for vertebral body replacement due to tumor or trauma. The intended use of packing bone graft and supplemental fixation is specified.
Biocompatibility: Safe for implantation.	Not explicitly detailed in the provided summary, but is a standard requirement for implants and would have been part of the "compliance with FDA's Guidance for Spinal System 510(k)'s" which includes material safety assessments.
Mechanical Performance/Structural Integrity: Ability to support spinal loads.	"Testing to demonstrate compliance with FDA's Guidance for Spinal System 510(k)'s May 3, 2004 was completed for the Stryker Spinal AVS™ PL PEEK Spacer." This guidance typically outlines required mechanical tests (e.g., compression, subsidence, fatigue).

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

Test Set Sample Size: Not applicable in the traditional sense of a diagnostic test set with patient data. The "test set" here would refer to the number of devices or materials subjected to engineering and biocompatibility tests. This information is not detailed in the provided 510(k) summary (e.g., number of implants tested for fatigue, number of material samples for biocompatibility).
Data Provenance: Not applicable as there's no patient data involved in a retrospective or prospective manner for this type of submission. The data provenance would be from internal lab testing (mechanical, material) and literature reviews for material safety, conducted by the manufacturer (Stryker Spine).

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

Number of Experts: Not applicable. For a spinal implant, "ground truth" isn't established by expert review of patient cases in the same way as for diagnostic devices. Mechanical performance standards, material science principles, and biocompatibility guidelines form the basis for "truth" in these evaluations.
Qualifications of Experts: Not applicable directly. The "experts" involved would be regulatory affairs specialists, engineers (mechanical, materials), and potentially surgeons for clinical input on intended use, but not for establishing a "ground truth" for a test set in the diagnostic sense.

4. Adjudication Method for the Test Set

Adjudication Method: Not applicable. There is no "adjudication" in the sense of reconciling differing expert opinions on a diagnostic case. Compliance to engineering standards and biocompatibility tests are objective measures.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

MRMC Study: No, an MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic imaging devices where human readers interpret images with and without AI assistance. This 510(k) is for a physical implant.
Effect Size of Human Reader Improvement: Not applicable.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study Was Done

Standalone Study: No, this is not applicable. There is no algorithm or AI component in this spinal implant. "Standalone performance" refers to the diagnostic accuracy of an AI algorithm without human input.

7. The Type of Ground Truth Used

Type of Ground Truth: The "ground truth" for this device's safety and effectiveness determination is based on:
- Engineering Standards and Bench Testing: Compliance with recognized mechanical testing standards (e.g., ISO, ASTM) for spinal implants, as referenced by "FDA's Guidance for Spinal System 510(k)'s May 3, 2004." This includes tests for static and dynamic (fatigue) compression, expulsion, and subsidence.
- Material Characterization: Verification of material properties (e.g., PEEK) against specifications and established biocompatibility data.
- Clinical Experience/History of Predicate Devices: The long-standing safe and effective use of the predicate devices provides a foundational "truth" that the new device, being substantially equivalent, should also be safe and effective.

8. The Sample Size for the Training Set

Training Set Sample Size: Not applicable. There is no AI algorithm or "training set" for an implant designed to provide structural support.

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

Ground Truth for Training Set Establishment: Not applicable.

Summary

Regulation Number and Section

§ 888.3060 Spinal intervertebral body fixation orthosis.

(a)
Identification. A spinal intervertebral body fixation orthosis is a device intended to be implanted made of titanium. It consists of various vertebral plates that are punched into each of a series of vertebral bodies. An eye-type screw is inserted in a hole in the center of each of the plates. A braided cable is threaded through each eye-type screw. The cable is tightened with a tension device and it is fastened or crimped at each eye-type screw. The device is used to apply force to a series of vertebrae to correct “sway back,” scoliosis (lateral curvature of the spine), or other conditions.(b)
Classification. Class II.