(224 days)
The Stryker Spine AVS® Anchor-C Cervical Cage System is indicated for anterior cervical interbody fusion procedures in skeletally mature patients with cervical disc disease at one level from the C2-C3 disc to the C7-T1 disc. Cervical disc disease is defined as intractable radiculopathy and/or myelopathy with herniated disc and/or osteophyte formation on posterior vertebral endplates producing symptomatic nerve root and/or spinal cord compression confirmed by radiographic studies. The AVS® Anchor-C Cervical Cage is to be used with autogenous bone graft and implanted via an open, anterior approach.
The AVS® Anchor-C Cervical Cage must be used with the internal screw fixation provided by AVS® Anchor-C Fixation Screws. This cervical device is to be used in patients who have had six weeks of non-operative treatment.
The AVS® Anchor-C Cervical Cage is a hollow, rectangular-shaped PEEK Optima® LT1 (per ASTM F2026) cage assembled to a titanium alloy Ti6Al4V (per ASTM F136 and ISO 5832-3) plate and has one tantalum marker (per ASTM F560). It is intended for use as an interbody fusion device and is offered in a variety of heights, footprints, and lordotic angles to adapt to varying patient anatomies. The PEEK Optima® LTI cage portion consists of one closed pocket for graft containment and has serrations on the superior and inferior surfaces of the cage. The implant is designed to be used exclusively with the internal supplemental fixation provided (AVS® Anchor-C Fixation Screws). The AVS® Anchor-C Fixation Screws are constructed from titanium alloy Ti6Al4V (per ASTM F136 and ISO 5832-3) and possess clips (also constructed from titanium alloy Ti6Al4V per ASTM F136 and ISO 5832-3) that mate with internal features located within the AVS® Anchor-C Cervical Cage. Once fully seated into the holes, the screws are designed to lock into the titanium plate.
The provided document describes the Stryker Spine AVS® Anchor-C Cervical Cage System, a medical device. It focuses on the mechanical testing performed to demonstrate substantial equivalence to predicate devices, rather than the performance of an AI system. Therefore, many of the requested fields regarding AI system performance, ground truth, and expert evaluation are not applicable or cannot be extracted from this document.
Here's an analysis of the available information:
Acceptance Criteria and Device Performance
The document states that "Testing in compliance with FDA's June 12, 2007 'Class II Special Controls Guidance Document: Intervertebral Body Fusion Device' was performed for the AVS® Anchor-C implant system and demonstrated substantially equivalent performance to the identified predicate device systems."
The acceptance criteria are implicitly defined by the successful demonstration of "substantially equivalent performance" to predicate devices based on the mechanical tests listed. The document does not provide specific numerical acceptance thresholds or reported performance values for the device itself. Instead, it indicates that the device met the criteria by performing comparably to already approved devices.
Table of Acceptance Criteria and Reported Device Performance:
| Test Method (per ASTM/Draft Standard) | Acceptance Criteria (Implicit) | Reported Device Performance |
|---|---|---|
| Static Compression (ASTM F2077) | Substantially equivalent to predicate devices (e.g., LDR MC+, Surgicraft STALIF C, etc.) | Demonstrated substantially equivalent performance. |
| Dynamic Compression (ASTM F2077) | Substantially equivalent to predicate devices | Demonstrated substantially equivalent performance. |
| Static Compression Shear (ASTM F2077) | Substantially equivalent to predicate devices | Demonstrated substantially equivalent performance. |
| Dynamic Compression Shear (ASTM F2077) | Substantially equivalent to predicate devices | Demonstrated substantially equivalent performance. |
| Static Torsion (ASTM F2077) | Substantially equivalent to predicate devices | Demonstrated substantially equivalent performance. |
| Dynamic Torsion (ASTM F2077) | Substantially equivalent to predicate devices | Demonstrated substantially equivalent performance. |
| Expulsion (ASTM F04-25-02-02 Draft) | Substantially equivalent to predicate devices | Demonstrated substantially equivalent performance. |
| Subsidence (ASTM F2267) | Substantially equivalent to predicate devices | Demonstrated substantially equivalent performance. |
Additional Requested Information:
2. Sample size used for the test set and the data provenance:
- Sample Size: The document does not specify the sample size for each mechanical test. Mechanical tests typically use a small number of physical samples (e.g., 3-6) per test condition to represent the device.
- Data Provenance: The data is from mechanical testing of the device, performed in compliance with FDA guidance. The country of origin of the data is not specified but is implicitly associated with the manufacturer (Stryker Spine, located in New Jersey, USA). The data is prospective, generated specifically for this 510(k) submission.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not Applicable. This device is a physical implant, and the "ground truth" for mechanical testing is based on the physical properties and performance measured against established engineering standards (ASTM and ISO). There are no human "experts" establishing ground truth in the context of diagnostic interpretation for this type of submission.
4. Adjudication method for the test set:
- Not Applicable. As this is mechanical testing of a physical device, there is no adjudication method in the context of human interpretation or AI output. The evaluation is based on engineering measurements and comparisons to predicate device performance.
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-enabled device or a diagnostic imaging device requiring human reader studies.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- Not Applicable. This is a physical medical implant, not an algorithm or AI system.
7. The type of ground truth used:
- For the mechanical tests, the "ground truth" is defined by the objective measurements obtained from the various tests (e.g., compression strength, shear strength, expulsion resistance) and their comparison to the performance of predicate devices as per the relevant ASTM and ISO standards and FDA guidance.
8. The sample size for the training set:
- Not Applicable. This is a physical medical implant. There is no training set in the context of machine learning or AI.
9. How the ground truth for the training set was established:
- Not Applicable. As there is no training set, this question is not relevant.
§ 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.