(191 days)
The Talos®-C Cervical Intervertebral Body Fusion Device is an intervertebral body device intended for use in skeletally mature patients with Degenerative Disc Disease (DDD) of the cervical spine at one level from C2-T1. Cervical degenerative disc disease is defined as intractable radiculopathy and/or myelopathy with herniated disc and/or osteophyte formation on the posterior vertebral endplates producing symptomatic nerve root and/or spinal cord compression confirmed by history and radiographic studies. Talos®-C Cervical IBF Devices are intended to be used with autologous bone graft to facilitate fusion,
Non-operative treatment prior to treatment with Talos®-C Cervical Intervertebral Body Fusion Devices is six (6) weeks.
Talos®-C Cervical IBF Devices are to be implanted via an open anterior approach. Talos®-C Cervical IBF Devices are also to be used with supplemental fixation.
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I apologize, but the provided text from the FDA 510(k) clearance letter for the Talos®-C Cervical Intervertebral Body Fusion Devices does not contain the information necessary to describe the acceptance criteria and the study proving the device meets those criteria in the context of an AI/ML medical device.
The document is a traditional 510(k) clearance letter for a physical medical device (an intervertebral body fusion device). It focuses on substantial equivalence to a predicate device, manufacturing regulations, and labeling requirements. It does not discuss:
- Acceptance Criteria for AI/ML performance: The concept of sensitivity, specificity, AUC, etc., for an AI/ML algorithm.
- Device Performance Metrics: There are no reported performance metrics for an AI/ML model here.
- Sample Size, Ground Truth, Expert Annotations: These are specific to the validation of AI/ML algorithms and are not relevant to the clearance of an orthopedic implant like the Talos®-C.
- MRMC Studies or Standalone AI Performance: These study designs are used to evaluate diagnostic AI and are not applicable to the clearance of a surgical implant.
Therefore, I cannot fulfill your request based on the provided text. To answer your question, I would need a document related to the clearance or validation of an AI/ML 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.