(185 days)
The Stryker Spine AVS® AS PEEK Spacers are indicated for use in cervical interbody fusion procedures in skeletally mature patients with degenerative disc disease (DDD) at one level from the C2-C3 disc to the C7-T1 disc. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The AVS® AS PEEK Spacers are to be used with autogenous bone graft and implanted via an open, anterior approach.
The AVS® AS PEEK Spacers are intended to be used with supplemental fixation systems that have been cleared for use in the cervical spine. This cervical device is to be used in patients who have had six weeks of non-operative treatment.
The Stryker Spine AVS® AS PEEK Spacer is a hollow, ring-shaped PEEK Optima® LT1 cage (per ASTM F2026) with three Tantalum marker pins (per ASTM F560). It is intended for use as an interbody fusion device of the cervical spine and is offered in a variety of lengths, heights, and lordotic angles to adapt to varying patient anatomies. The hollow, ring-shaped implant has serrations on the top and bottom for fixation. The hollow space of the implant is intended to hold bone graft material for fusion purposes.
The provided text describes a medical device, the "AVS® AS PEEK Spacer," and references a 510(k) summary (K120486) for its clearance. However, this document does not contain information about acceptance criteria or a study that proves the device meets specific performance metrics in the way typically expected for AI/ML-driven devices (e.g., sensitivity, specificity, accuracy).
Instead, the document details a mechanical and material-based device and its substantial equivalence to a predicate device. The "study" mentioned is a series of mechanical tests performed in compliance with FDA guidance for intervertebral body fusion devices.
Therefore, the requested AI/ML-specific information (such as sample size for test sets, data provenance, number of experts for ground truth, adjudication methods, MRMC studies, standalone performance, training set details) is not applicable to this submission.
Below is the information that can be extracted or reasonably inferred from the provided text, adapted to the context of this type of medical device submission:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Mechanical Performance, per ASTM F2077 and F2267) | Reported Device Performance |
|---|---|
| Static Compression: Must demonstrate performance comparable to predicate devices. | Performed a study in compliance with FDA's "Class II Special Controls Guidance Document: Intervertebral Body Fusion Device." |
| Static Compression Shear: Must demonstrate performance comparable to predicate devices. | Demonstrated substantially equivalent performance to the identified predicate device systems. |
| Static Torsion: Must demonstrate performance comparable to predicate devices. | (Specific quantitative results for each test are not provided in this summary, only that "substantially equivalent performance" was demonstrated.) |
| Subsidence (per ASTM F2267): Must demonstrate performance comparable to predicate devices. | |
| Dynamic Compression: Must demonstrate performance comparable to predicate devices. | |
| Dynamic Compression Shear: Must demonstrate performance comparable to predicate devices. | |
| Dynamic Torsion: Must demonstrate performance comparable to predicate devices. | |
| Material Properties: PEEK Optima® LT1 (per ASTM F2026), Tantalum marker pins (per ASTM F560). | Device is made of PEEK Optima® LT1 and contains Tantalum marker pins as specified. |
| Design Characteristics: Graft windows, serrations, comparable heights, widths, depths, and lordotic angles to predicate. | Subject device shares similar design features: graft windows, serrations on superior/inferior surfaces, comparable dimensions. |
2. Sample size used for the test set and the data provenance
- Test Set Sample Size: Not applicable in the context of a clinical or image-based test set. The "test set" here refers to physical devices subjected to mechanical testing. The number of devices tested for each mechanical test is not specified in this summary.
- Data Provenance: Not applicable in the context of clinical data. The tests were performed in compliance with FDA guidance and ASTM standards, presumably in a laboratory setting. There is no mention of country of origin of data or retrospective/prospective studies in a clinical sense.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not applicable. Ground truth for mechanical testing is established by compliance with standardized test methods (ASTM F2077, F2267, F2026, F560) and comparison to predicate device performance. This does not involve expert adjudication of clinical outcomes or interpretations.
4. Adjudication method for the test set
- Not applicable. Mechanical testing results are typically evaluated against predefined specifications or compared to predicate device performance data, not through human expert adjudication.
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 device is a physical intervertebral body fusion spacer, not an AI/ML-driven diagnostic or assistive tool.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- Not applicable. This device is a physical implant.
7. The type of ground truth used
- Ground Truth Type: Compliance with established industry standards for mechanical properties and performance (ASTM F2077, F2267, F2026, F560), and demonstration of "substantially equivalent performance" to a legally marketed predicate device (ORTHOVITA PEEK SPACER, 510(k) #K101171).
8. The sample size for the training set
- Not applicable. This is not an AI/ML device that requires a training set.
9. How the ground truth for the training set was established
- Not applicable. This is not an AI/ML device.
§ 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.