(295 days)
The INTEGRATE™-C Interbody Fusion System is indicated for intervertebral body fusion of the spine in skeletally mature patients. The INTEGRATE™-C Interbody Fusion is intended for use for anterior cervical interbody fusion in patients with 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 INTEGRATE™-C Interbody Fusion System is intended to be used with supplemental fixation. The INTEGRATE™-C Interbody Fusion System is designed for use with autograft or allogenic bone graft comprising cancellous and/or corticocancellous bone graft and/or demineralized allograft bone with bone marrow aspirate as an adjunct to fusion. Nonoperative treatment prior to treatment with INTEGRATE™-C Interbody Fusion System is six (6) weeks. INTEGRATE™-C Interbody Fusion Systems are to be implemented via an open anterior approach.
The INTEGRATE™-C Interbody Fusion System implant is made of a single, continuous piece of hydroxyapatite impregnated polyetheretherketone polymer (ASTM F2026 & F1185). The INTEGRATE™-C Interbody Fusion System implant body is monolithic with porous regions derived directly from the implant body, not a sintered or otherwise additive coating, and extended through the device. The device is available in a variety of footprints, lordosis and heights to accommodate variations in the individual pathology and anatomic of the patient. The superior and inferior surfaces of the device contain a pattern of teeth to provide for initial stability. Tantalum (ASTM F560) radiopaque markers are placed in the device to aid in determining the location of the implant intra- and post-operatively.
The provided document is an FDA 510(k) Premarket Notification for a medical device called "INTEGRATE™-C Interbody Fusion System." This type of document is filed for medical devices that are substantially equivalent to a legally marketed predicate device. The primary focus of a 510(k) submission is to demonstrate this substantial equivalence through various assessments including technological characteristics, performance data (often mechanical testing for implants), and indications for use.
Crucially, this document does NOT describe the acceptance criteria and the study that proves a digital health or AI/ML device meets those criteria. The device in question is a physical intervertebral body fusion system, an implant, not an AI/ML diagnostic or assistive device. The "Performance Data" section specifically lists mechanical tests (e.g., static and dynamic compression, shear, torsion, subsidence) that are relevant for a physical implant.
Therefore, I cannot extract the information requested about acceptance criteria and study design for an AI/ML device from this document. The questions posed (regarding human readers, MRMC studies, ground truth establishment, training set size, etc.) are pertinent to AI/ML device validation, but this document describes the validation of a physical surgical implant.
In summary, none of the requested information about AI/ML device acceptance criteria and study data can be found in the provided text. The document describes a traditional medical device (interbody fusion system) and its mechanical performance testing for FDA clearance, not a digital health or AI/ML product.
§ 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.