(13 days)
The Stryker Spine AVS® PL 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 non-operative therapy.
The AVS® PL PEEK Spacers are to be implanted via posterior approach.
The AVS® PL PEEK Spacers are intended to be used with supplemental spinal fixation systems that have been cleared for use in the lumbosacral spine (i.e., posterior pedicle screw and rod systems).
The subject AVS PL PEEK Spacers and the predicates AVS PL PEEK Spacers and DePuy's Lumbar I/F Cage (i.e., Brantigan Cage) share similar design features:
• Hollow frame PEEK Implant
• Lateral fenestrations
• Serrations on the superior and inferior surfaces
• Comparable heights, widths, and angles
• Materials and mechanical testing results are similar between the subject device and the listed predicates.
This Special 510(k) premarket notification is intended to introduce the following line extensions to the AVS® PL PEEK Spacers approved under K073470: The addition of 20 and 25 mm lengths, 14, 15, 16 and 18 mm heights, 8 and 9 mm widths, and 8° angle. Additions to implants approved under K080758 include: Addition of a 14 mm length (4 implants).
All other attributes remain the same. Note that the AVS® PL PEEK Spacers may also be referred to as AVS Plus.
The provided text discusses a Special 510(k) Premarket Notification for a line extension to the AVS™ PL PEEK Spacer System. This document does not describe a study involving an artificial intelligence (AI) or machine learning device, nor does it involve the evaluation of a diagnostic or assistive technology where performance metrics like sensitivity, specificity, or reader improvement would be relevant.
Instead, this document is for a medical device (spinal implant) and focuses on demonstrating substantial equivalence to previously cleared predicate devices for regulatory approval. The "study" mentioned here refers to mechanical testing of the device, not a clinical study involving human readers or AI performance.
Therefore, most of the requested information regarding acceptance criteria, device performance, sample sizes for test/training sets, expert ground truth, adjudication methods, MRMC studies, and standalone performance for an AI device cannot be extracted from this document because it pertains to a different type of medical device and regulatory submission.
However, I can extract the information that is relevant to the document for the physical device:
1. Table of Acceptance Criteria and Reported Device Performance:
The document states: "Testing in compliance with FDA's June 12, 2007 'Class II Special Controls Guidance Document: Intervertebral Body Fusion Device' was performed for the AVS PL PEEK Spacers and demonstrated substantially equivalent performance characteristics to the identified predicate device systems."
| Acceptance Criteria Category | Reported Device Performance |
|---|---|
| Mechanical Testing | Demonstrated substantially equivalent performance characteristics to the identified predicate device systems. |
| Material Properties | Similar to predicate devices. |
| Dimensions | Comparable heights, widths, and angles to predicate devices. |
2. Sample Size Used for the Test Set and Data Provenance:
- Sample Size: Not specified in the provided text. The "test set" here refers to the number of physical devices or models subjected to mechanical testing.
- Data Provenance: Not applicable in the context of a retrospective/prospective study with human or AI data. The "provenance" refers to the results of internal mechanical testing performed by Stryker Spine.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications:
Not applicable. This document is about the physical testing of a medical device, not a diagnostic or AI performance study requiring expert ground truth for interpretation.
4. Adjudication Method for the Test Set:
Not applicable. This concept pertains to resolving discrepancies in expert interpretations in diagnostic studies, which is not relevant here.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
No. This is a special 510(k) for a physical medical device, not an AI or diagnostic tool.
6. Standalone Performance Study (Algorithm Only Without Human-in-the-loop Performance):
No. This is a physical medical device.
7. Type of Ground Truth Used:
Mechanical properties and performance characteristics, as defined by FDA guidance for intervertebral body fusion devices, established through engineering testing.
8. Sample Size for the Training Set:
Not applicable. This is not an AI/ML device.
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.