(58 days)
The Cervical Implant is intended for spinal fusion procedures at one level (C2 to T1) 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. Implants are intended via an open, anterior approach and packed with autogenous bone graft. The Cervical Implant is intended to be used with supplemental fixation system.
Not Found
The provided document is an FDA 510(k) clearance letter for the Sapphire Cervical Implant System. This letter is for a medical device (an implant), not an AI/Software as a Medical Device (SaMD) product. Therefore, the questions related to AI/SaMD performance, such as acceptance criteria based on metrics like sensitivity/specificity, sample sizes for training/test sets, expert adjudication methods, MRMC studies, or standalone algorithm performance, are not applicable to this document.
The document confirms that the Sapphire Cervical Implant System is substantially equivalent to legally marketed predicate devices. The "Indications for Use" section (page 2) describes its intended purpose and target patient population.
Therefore, I cannot provide the requested information as the document does not contain data or information related to the acceptance criteria and study proving performance for an AI/SaMD 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.