(135 days)
The Stryker Spine AVS® Navigator 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® Navigator PEEK Spacers are to be implanted via a posterior or posterolateral approach.
The AVS® Navigator PEEK Spacers are intended to be used with supplemental fixation systems that have been cleared for use in the lumbosacral spine.
The AVS® Navigator PEEK Spacer is intended for use as an interbody fusion device. It is offered in a variety of lengths, heights and lordotic angles. The hollow implant has serrations on the top and bottom for fixation. Three (3) Tantalum Radiopaque markers have been embedded within the implant to help allow for visualization in radiographic images.
The provided text describes a 510(k) summary for the Stryker Spine AVS® Navigator PEEK Spacers, an intervertebral body fusion device. The document primarily focuses on demonstrating substantial equivalence to predicate devices through mechanical testing rather than presenting a study of AI-powered device performance.
Therefore, many of the requested categories related to AI/algorithm performance and ground truth data are not applicable or cannot be extracted from this document.
Here's the information that can be extracted, along with an explanation of why other fields are not applicable:
Acceptance Criteria and Device Performance (Not an AI Device)
This device is not an AI/ML-powered diagnostic or predictive tool, but rather a physical medical implant. The "acceptance criteria" here refer to demonstrating mechanical equivalence to predicate devices under specific testing conditions as per FDA guidance for Intervertebral Body Fusion Devices.
| Component of Evaluation | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|
| Mechanical Testing | Substantial equivalent performance to identified predicate devices as per FDA's June 12, 2007 "Class II Special Controls Guidance Document: Intervertebral Body Fusion Device". | The device demonstrated substantial equivalent performance characteristics to the identified predicate device systems for all tests. |
| Tests Performed | (Compliance with specific test methodologies outlined in the guidance document) | • Static Compression |
| • Dynamic Compression | ||
| • Static Compression Shear | ||
| • Dynamic Compression Shear |
Study Details (Not an AI Study)
Since this is not an AI device, a "study" in the context of an algorithm's performance, test sets, ground truth, or human-in-the-loop analysis is not applicable. The "study" here refers to mechanical bench testing.
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Sample size used for the test set and the data provenance: Not applicable for an AI device. For mechanical testing, the "samples" would be the physical devices tested according to specific protocols. The document does not specify the number of devices tested for each mechanical test. Data "provenance" is not relevant in the context of AI data for this type of device.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth as typically understood for AI devices (e.g., diagnostic labels, disease presence) is not relevant for mechanical testing.
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Adjudication method: Not applicable.
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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. This is not an AI device.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an AI algorithm.
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The type of ground truth used: For this device, the "ground truth" (if analogies must be made) would be the established mechanical performance characteristics of the predicate devices and the performance standards dictated by the FDA guidance document. The test results of the AVS® Navigator PEEK Spacers were compared against these established benchmarks.
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The sample size for the training set: Not applicable. This is not an AI device that requires a training set.
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How the ground truth for the training set was established: Not applicable.
§ 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.