(129 days)
Prase PEEK Anterior Cervical Interbody Spacer is indicated for use in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine with accompanying radicular symptoms at one disc level. DDD is defined as discogenic pain with degeneration of the disc confirmed by patient history and radiographic studies. Prase PEEK Anterior Cervical Interbody Spacer is used to facilitate intervertebral body fusion in the cervical spine from the C3 to C7 disc levels using autograft bone. Prase PEEK Anterior Cervical Interbody Spacer is to be used with supplemental fixation. Patients should have at least six (6) weeks of non-operative treatment with an intervertebral cage.
The Prase PEEK Anterior Cervical Interbody Spacer is intervertebral body fixation devices intended for use as an aid in spinal fusion. The Prase PEEK Anterior Cervical Interbody Spacer is made from PEEK as per ASTM F2026 and Tantalum marker as per ASTM F560. X-ray markers system on the cages permits the identification of cage position and allows post-operative assessment. The devices are available in a variety of different sizes and heights to match more closely the patient's anatomy. The ends of the implants have machined teeth which are designed to engage with the vertebral body end plates. The devices are supplied non-sterile. The device is supplied with their specific instruments. The specific instruments are supplied dedicated tray and non-sterile. The device must be used in combination with the dedicated instruments supplied.
The provided document, K202872, is a 510(k) premarket notification for a medical device called "Prase PEEK Anterior Cervical Interbody Spacer." This document describes the device, its indications for use, and its substantial equivalence to previously marketed predicate devices.
However, this document does NOT contain information about acceptance criteria or a study proving that an AI/software device meets acceptance criteria related to its performance.
The "Performance Testing" section (Section 7) of the summary states that mechanical tests were performed according to ASTM standards for intervertebral body fusion devices (e.g., static compression, fatigue, subsidence). These are physical performance tests for the implant itself, not a study evaluating the performance of a digital health or AI-driven device.
Therefore, I cannot provide the requested information regarding:
- A table of acceptance criteria and reported device performance for an algorithm.
- Sample sizes, data provenance, number of experts, adjudication methods, MRMC studies, standalone performance, or ground truth details for an AI-related study.
The document discusses the regulatory clearance of a physical medical implant (a PEEK interbody spacer), not an AI/software as a medical 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.