(111 days)
The restor3d Cervical Interbody Fusion Device is indicated for use as an intervertebral body fusion device in sketally mature patients with degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies) at one level of the cervical spine with accompanying radicular symptoms. Implants are used to facilitate fusion in the cervical spine (C3-C7) and are placed via an anterior approach using autogenous bone as graft material for the interior graft window. The device is intended to be used with supplemental fixation systems that have been cleared for use in the cervical spine.
The proposed ADI Cervical Interbody Fusion Device is a sterile, single use implant grade titanium alloy (Ti-6Al-4V) device, available in varied footprints and heights, designed for supplemental stabilization of the cervical spinal column in anterior cervical discectomy and fusion (ACDF) procedures. The device is intended for spinal fusion procedures at one level (C3-C7) in skeletally mature patients with degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies) of the cervical spine. The implant is intended to be used with cleared fixation devices such as an anterior cervical plate system. The ADI device is comprised of a single, continuous piece of titanium alloy fabricated via additive manufacturing. The ADI device has a porous structure throughout the body of the implant, a circular window for the packing of graft material, a threaded hole for insertion, teeth on the surfaces of the perimeters to aid expulsion resistance, and side windows on the walls of the implant.
The provided text describes a 510(k) premarket notification for a medical device, the ADI Cervical Interbody Fusion Device. However, it does not contain information about an AI/ML-based device or any study that proves an AI/ML device meets acceptance criteria.
The document focuses on the substantial equivalence of a physical medical implant (a cervical interbody fusion device) to a predicate device. The performance testing mentioned (ASTM F2077-18, ASTM F2267-04) relates to the mechanical properties of the implant, such as static and dynamic compressive strength, torsional strength, wear analysis, expulsion resistance, and subsidence testing.
Therefore, I cannot fulfill your request for information regarding acceptance criteria and studies for an AI/ML device based on the provided text. The document does not discuss:
- Acceptance criteria for an AI/ML model (e.g., sensitivity, specificity, AUC).
- Sample sizes for test or training sets related to AI/ML data.
- Data provenance for AI/ML training/testing (e.g., country of origin, retrospective/prospective).
- Number of experts or their qualifications for establishing ground truth for AI/ML.
- Adjudication methods for AI/ML ground truth.
- MRMC studies or effect sizes for human readers with/without AI assistance.
- Standalone AI algorithm performance.
- Type of ground truth used for AI/ML (e.g., pathology, outcomes data).
- How ground truth for training sets was established for an AI/ML model.
§ 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.