(86 days)
The IdentiTi™ II Cervical Interbody System is an anterior cervical interbody fusion system intended for spinal fusion procedures in skeletally mature 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 IdentiTi II Cervical Interbody System is intended for use with supplemental fixation systems. The system is designed for use with autograft, allograft comprised of cortical, cancellous, and/or corticocancellous bone graft, demineralized allograft with bone marrow aspirate, or a bone void filler as cleared by FDA for use in intervertebral body fusion to facilitate fusion.
The IdentiTi II Cervical Interbody System is a cervical intervertebral body fusion system designed to be inserted through an anterior surgical approach. The interbody implants are additively manufactured from titanium powder per ASTM F3001 using a powder bed fusion method. The IdentiTi II Cervical Interbody System includes the following subsystems: IdentiTi II Cervical and IdentiTi II Cervical Max Contact. The endplates of the interbody implants contain roughened surface features to mitigate the risk of expulsion. Additionally, the IdentiTi II Cervical implants are offered with a microporous/macroporous lattice structure that spans the entirety of the implant and extends to the superior and inferior surfaces of the device for biological fixation. The implants consist of various lengths, widths, heights and lordotic options to accommodate individual patient anatomy. All interbody spacers feature an internal graft aperture for placement of graft material to promote fusion through the cage. The internal lattice structure provides additional space for graft packing.
The provided FDA 510(k) clearance letter and summary concern the IdentiTi II Cervical Interbody System, which is a medical device for spinal fusion. This document does not describe an AI/ML-based medical device. Therefore, it does not contain information about acceptance criteria, study designs, sample sizes, ground truth establishment, or expert involvement as typically required for AI/ML device clearances.
The performance data section (VII. PERFORMANCE DATA) specifically lists non-clinical testing for mechanical properties, material properties, and biocompatibility, as is standard for intervertebral body fusion devices. These tests include:
- ASTM F2077 static and dynamic axial compression, compression shear and torsion
- ASTM F2267 static subsidence
- ASTM F1714 gravimetric analysis
- ASTM F1877 particle analysis
- Static push-out
- ASTM F1854 stereological analysis
- Bacterial endotoxin testing per ANSI/AAMI ST72
Since the request is to "describe the acceptance criteria and the study that proves the device meets the acceptance criteria" as if it were an AI/ML device, and the provided text explicitly indicates it is a non-AI/ML medical device, I cannot fulfill the request directly with the given input. The information points to a traditional medical device clearance, not an AI/ML one.
To answer your question based on the provided document, I must state that the information requested (acceptance criteria for AI/ML performance, study details for AI/ML, human expert consensus, etc.) is not present because the device described is a physical intervertebral body fusion system, not an AI/ML algorithm.
The document confirms that this device is a Class II medical device (Product Code ODP: Intervertebral Body Fusion Device), and its clearance is based on substantial equivalence to predicate devices through engineering and material testing, not through AI/ML performance 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.