(30 days)
The SureMAX™ Family of Cervical Spacers is intended for anterior intervertebral body fusion in skeletally mature patients who have had at least six weeks of non-operative treatment. The SureMAX™ Family of Cervical Spacers is indicated to treat cervical disc degeneration and/or cervical spinal instability, as confirmed by imaging studies (radiographs, CT, MRI), that results in radiculopathy, myelopathy, and/or pain at multiple contiguous levels from C2 - T1. The SureMAX™ Family of Cervical Spacers is to be used with supplemental fixation; the hyperlordotic implants (≥10°) are required to be used with an anterior cervical plate. The implants are designed for use with autogenous and/or allogeneic bone graft comprised of cancellous and/or corticocancellous bone to facilitate fusion.
The SureMAX™ Family of Cervical Spacers is an additively manufactured interbody system. These cervical implants have basic keystone shape and an open architecture. A variety of height, length, width and anteroposterior angulation combinations are available to accommodate the anatomic requirements of individual patients. The SureMAX™ Family of Cervical Spacers is provided sterile.
The provided text is a 510(k) Summary for a medical device (SureMAX™ Family of Cervical Spacers) and does not describe an AI/ML-based medical device. Therefore, it does not contain the information needed to answer the questions about acceptance criteria and study proving device performance for an AI/ML device.
The document discusses:
- Device: SureMAX™ Family of Cervical Spacers, an additively manufactured interbody system used for anterior intervertebral body fusion.
- Indication: Treatment of cervical disc degeneration and/or cervical spinal instability.
- Performance Data: Mechanical testing per ASTM F2077 (static and dynamic compression and torsion), ASTM F2267 (subsidence), and expulsion studies.
- Conclusion: The device's performance is substantially equivalent to a predicate device based on these mechanical tests.
The information requested in the prompt, such as acceptance criteria based on accuracy metrics (e.g., sensitivity, specificity), sample sizes for test and training sets, expert ground truth establishment, adjudication methods, MRMC studies, or standalone algorithm performance, is not present in this document as it pertains to AI/ML device evaluation.
§ 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.