(79 days)
The Stryker Spine AVS® TL PEEK Spacers are intervertebral body fusion devices indicated for use with autogenous bone graft bone 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® TL Spacers are to be implanted via posterior approach.
The AVS® TL 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 AVS® TL Peek Spacers are intervertebral body fusion devices intended for use as an aid in spinal fixation. The Stryker Spine AVS® TL PEEK Spacer is a "banana" shaped, hollow frame implant with lateral fenestrations. The spacers incorporate three (3) Tantalum marker pins to aid in radiographic visualization.
The Stryker Spine AVS® TL PEEK Spacer is available in a variety of sizes, from 7 mm to 18mm in height, two (2) lengths: 25 mm and 30 mm and one (1) width: 9 mm. There are also 0° parallel and 4° wedge shaped options, which allows the surgeon to best choose the size suited to the patient's anatomy and pathology.
The provided text describes a 510(k) premarket notification for a medical device, the Stryker Spine AVS® TL PEEK Spacers. This is a submission for a spinal implant, which typically focuses on demonstrating substantial equivalence to a predicate device through non-clinical performance data (e.g., mechanical testing, biocompatibility) rather than clinical studies on human performance or AI performance.
Therefore, many of the requested categories related to acceptance criteria, AI performance, ground truth, and expert adjudication are not applicable (N/A) to this type of submission. The provided document is a regulatory submission for a physical medical device, not an AI/ML software device.
Here's a breakdown of the applicable and non-applicable information based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
Note: For a medical device like a spinal spacer, "acceptance criteria" and "reported device performance" are typically related to mechanical properties, biocompatibility, and material characteristics, which are implicitly covered by demonstrating compliance with FDA guidance and substantial equivalence. The document does not provide a specific table of numerical acceptance criteria or performance metrics in the format usually requested for AI/ML devices.
| Acceptance Criteria Category | Specific Acceptance Criteria (Not Explicitly Stated for this type of device in the provided text) | Reported Device Performance (Summary) |
|---|---|---|
| Mechanical Performance | Compliance with FDA's "Class II Special Controls Guidance Document: Intervertebral Body Fusion Device" | Demonstrated "substantial equivalent performance characteristics to the identified predicate device systems." |
| Material Properties | Biocompatibility, PEEK material specifications | Not explicitly detailed, but implied to be equivalent to predicate devices and suitable for implantation. |
| Radiographic Visibility | Ability to visualize post-implantation | Incorporates "three (3) Tantalum marker pins to aid in radiographic visualization." |
| Design Specifications | Range of sizes, shapes (banana-shaped, hollow frame, lateral fenestrations) | Available in 7mm to 18mm height, 25mm and 30mm lengths, 9mm width, 0° parallel and 4° wedge shaped options. |
2. Sample size used for the test set and the data provenance
N/A. This device submission does not involve a "test set" in the context of AI/ML performance evaluation. The "testing" referred to is likely a battery of non-clinical mechanical and material tests.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
N/A. Ground truth and expert establishment are not relevant for this type of device submission.
4. Adjudication method for the test set
N/A. Adjudication methods are not relevant for this type of device submission.
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
N/A. This is a physical medical device, not an AI/ML software, so MRMC studies are not applicable.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
N/A. This is a physical medical device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
N/A. Ground truth for AI/ML is not relevant for this device. For this type of spinal implant, the "truth" is established by adherence to design specifications, material standards, and successful performance in biomechanical testing.
8. The sample size for the training set
N/A. This device submission does not involve a "training set" for AI/ML.
9. How the ground truth for the training set was established
N/A. This device submission does not involve a "training set" or its ground truth establishment.
Summary of the Study that Proves the Device Meets Acceptance Criteria:
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® TL PEEK Spacers and demonstrated substantial equivalent performance characteristics to the identified predicate device systems."
This indicates that the "study" was a series of non-clinical tests (likely mechanical, material, and possibly biocompatibility tests) conducted according to the guidelines outlined in the FDA's special controls guidance for intervertebral body fusion devices. The primary goal of this testing was to demonstrate that the AVS® TL PEEK Spacers are substantially equivalent in performance and safety to the predicate devices (Stryker Spine AVS® PL PEEK Spacers: K073470 and DePuy AcroMed, Inc. Lumbar I/F Cage® with VSP Spine System: P960025). This implies that the device met the performance and safety criteria established by the FDA for such devices, as evidenced by its substantial equivalence to already cleared devices.
§ 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.