(182 days)
The PEEK PREVAIL™ Cervical Interbody Device 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 PEEK PREVAIL™ Cervical Interbody Device must be used with internal screw fixation provided by ZEPHIR® Anterior Cervical Screws. The PEEK PREVAIL™ Cervical Interbody Device implants are to be used with autograft and implanted via an open, anterior approach. This cervical device is to be used in patients who have had six weeks of non-operative treatment.
The PEEK PREVAIL™ Cervical Interbody Device is an intervertebral body fusion device with internal screw fixation. The screws protrude through the interbody portion of the device and stabilize the vertebral body while preventing expulsion of the implant. The implant is "I-Beam" shaped with a 2 screw midline configuration. This device is intended to be radiolucent and the interior space of the product is to be used with bone graft.
The key difference between the predicate PEEK PREVAIL™ Cervical Interbody Device and the subject PEEK PREVAIL™ Cervical Interbody Device is the reduction of the device footprint by 2mm in the anterior/posterior dimension (i.e., adding a smaller footprint cage).
This product will be manufactured from PEEK Optima and will have tantalum radiopaque markers and a nitinol screw locking mechanism. The screw designed to be used with this device will be manufactured from titanium alloy.
Here's an analysis of the provided text regarding the PEEK PREVAIL™ Cervical Interbody Device, addressing your requested information:
This submission (K094042) is a 510(k) summary for a medical device, which typically focuses on demonstrating substantial equivalence to a predicate device rather than conducting extensive clinical studies to establish new safety and effectiveness. Therefore, many of your requested points regarding clinical study design, ground truth, and expert evaluation will not be directly relevant or available in this type of document.
1. Table of Acceptance Criteria and Reported Device Performance
| Test | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Static axial torsion | In accordance with ASTM F2077-03 "Test Methods for Intervertebral Body Fusion Devices," approved April 10, 2003. | The acceptance criteria was/were met. |
| Dynamic axial torsion | In accordance with ASTM F2077-03 "Test Methods for Intervertebral Body Fusion Devices," approved April 10, 2003. | The acceptance criteria was/were met. |
Study Proving Device Meets Acceptance Criteria:
The study that proves the device meets the acceptance criteria is described as "Non-Clinical Testing" and specifically mentions the mechanical tests performed.
2. Sample size used for the test set and the data provenance
- Sample Size for Test Set: Not specified. For mechanical testing of medical devices, sample sizes are typically determined by the relevant ASTM standard (ASTM F2077-03 in this case), often involving a small number of devices (e.g., 5-10) per test condition.
- Data Provenance: Not applicable in the context of this 510(k) submission, as it relies on non-clinical, in-vitro mechanical testing rather than patient data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- This is not applicable. The "ground truth" for mechanical testing is defined by the objective pass/fail criteria set forth in the ASTM standard, not by expert consensus on clinical findings.
4. Adjudication method for the test set
- This is not applicable. Adjudication methods are relevant for subjective evaluations, typically in clinical studies or image interpretation. Mechanical testing results are objectively measured against predefined criteria.
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
- No MRMC comparative effectiveness study was done. This device is a physical implant (interbody fusion device), not an AI diagnostic tool. Therefore, MRMC studies and AI assistance are irrelevant to this submission.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This device is a physical implant, not an algorithm, so standalone AI performance is not relevant.
7. The type of ground truth used
- The "ground truth" for this device's evaluation is defined by the objective, quantitative results of mechanical tests performed according to the specified ASTM standard (F2077-03). The standard itself outlines the methods and criteria for evaluating the mechanical properties of intervertebral body fusion devices.
8. The sample size for the training set
- Not applicable. This is not an AI/machine learning device. No "training set" in that sense was used. The design and manufacturing processes are based on engineering principles and material science, validated through benchtop testing.
9. How the ground truth for the training set was established
- Not applicable. As no training set for an AI/ML model was used, there's no ground truth to establish for it. The design of the device is informed by engineering knowledge, material properties, and surgeon feedback (as mentioned, to accommodate variations in patient anatomies by providing a smaller footprint).
§ 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.