(35 days)
The Stryker Spine AVS™ ASL 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 procedures 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™ ASL PEEK Spacer is intended for use with supplemental fixation. The supplemental fixation systems that may be used with the Stryker Spine AVS™ ASL PEEK Spacer include, but are not limited to, Stryker Spine plate or rod systems (XIA, Spiral Radius 90D, and Trio).
This Special 510(k) submission is intended to introduce sixteen new sizes of the AVSTM AS PEEK Spacer to the Stryker Spine AVSTM ASL PEEK Spacer, determined Substantially Equivalent via 510(k) #K051205. The new sizes all have the Anterior/Posterior (AP) and Medial/Lateral (ML) footprint of 12mm x 14mm, and range in height from 9mm to 20mm. Each new size is available in a 0 degree and 4 degree angle.
The provided text describes a Special 510(k) submission for a line extension to a spinal implant system called the AVS™ ASL PEEK Spacer System. This submission is for new sizes of an existing device, and the focus of the documentation is to demonstrate substantial equivalence to its predicate device rather than to conduct a de novo clinical study to establish performance against specific acceptance criteria.
Therefore, the document does not contain specific acceptance criteria, reported device performance metrics in the way one would see for a diagnostic or AI-based device, or details about a study designed to prove the device meets such criteria. Instead, the "study" referred to is the submission itself, which primarily relies on technological comparison and engineering testing to demonstrate equivalence.
Here's a breakdown of why many of your requested points are not applicable or cannot be extracted from the provided text:
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A table of acceptance criteria and the reported device performance
- Not applicable/Not present. The document focuses on demonstrating substantial equivalence of new sizes to an already cleared predicate device. It doesn't present a table of performance acceptance criteria (e.g., sensitivity, specificity, accuracy) that are typically associated with diagnostic devices, nor does it report specific performance outcomes in that manner. Instead, the "acceptance" is based on meeting the criteria for substantial equivalence, which is assessed through material, design, and indications for use comparisons, and compliance with general spinal system guidance.
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Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not applicable/Not present. This refers to a medical device, specifically a spinal implant. There is no "test set" of patient data in the context of diagnostic performance. The document mentions "Testing to demonstrate compliance with FDA's Guidance for Spinal System 510(k)'s May 3, 2004 was completed," but these are typically mechanical, biomechanical, and material property tests on the device itself, not tests on patient outcomes data. Thus, there is no sample size of patients or data provenance to report.
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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/Not present. As this is not a diagnostic device, there is no "ground truth" established by experts in the context of interpreting medical images or clinical outcomes from a test set.
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Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable/Not present. See point 3.
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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/Not present. This device is a physical implant, not an AI-assisted diagnostic tool.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable/Not present. This is not an algorithm or software device.
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The type of ground truth used (expert concensus, pathology, outcomes data, etc)
- Not applicable/Not present. For a physical implant, "ground truth" would relate to its structural integrity, biocompatibility, and mechanical performance. These are established through engineering standards, material testing, and preclinical studies, not typically through expert consensus on clinical cases in the way that would apply to diagnostic tools.
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The sample size for the training set
- Not applicable/Not present. There is no "training set" as this is not an AI/machine learning device.
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How the ground truth for the training set was established
- Not applicable/Not present. See point 8.
Summary of the Study and "Acceptance Criteria" from the Provided Text:
The "study" in this context is the Special 510(k) submission K061836 for a line extension to the AVS™ ASL PEEK Spacer System.
- Objective: To demonstrate substantial equivalence of sixteen new sizes of the AVSTM ASL PEEK Spacer to its legally marketed predicate device (K051205).
- "Acceptance Criteria" (Implicit for Substantial Equivalence):
- Material Equivalence: The new sizes must use the same material (PEEK) as the predicate.
- Design Equivalence: The fundamental design principles and features (e.g., Anterior/Posterior and Medial/Lateral footprint) must be similar, with the primary difference being size variation (heights from 9mm to 20mm, 0-degree and 4-degree angles).
- Indications for Use Equivalence: The intended use (vertebral body replacement in the thoraco-lumbar spine (T1-L5) due to tumor or trauma, for anterior decompression and height restoration, with bone graft and supplemental fixation) must be identical to the predicate.
- Performance Equivalence: Testing, implicitly mechanical and biomechanical, must demonstrate compliance with FDA's Guidance for Spinal System 510(k)'s May 3, 2004, ensuring the new sizes perform comparably to the predicate in terms of safety and effectiveness.
- "Reported Device Performance": The document states: "Documentation is provided which demonstrates the additional sizes of the Stryker Spine AVS™ ASL PEEK Spacer to be substantially equivalent to its predicate device in terms of its material, design, and indications for use. Testing to demonstrate compliance with FDA's Guidance for Spinal System 510(k)'s May 3, 2004 was completed for the Stryker Spinal AVSTM ASL PEEK Spacer." This statement itself is the reported "performance" in the context of a 510(k) for a line extension – that it met the criteria for substantial equivalence.
In conclusion, for this specific type of device and submission, the detailed criteria regarding clinical performance, expert ground truth, and reader studies are not applicable. The primary "acceptance criterion" is the demonstration of substantial equivalence to a predicate device through material, design, and functional comparisons, supported by engineering tests rather than clinical data analysis.
§ 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.