(163 days)
The Atlas Spine Expandable Cervical Standalone Interbody System is a stand-alone anterior cervical interbody fusion system intended for use as an adjunct to fusion at one or two contiguous levels (C2-T1) in skeletally mature patients for the treatment of degenerative disc disease (defined as discogenic neck pain with degeneration of the disc confirmed by history and radiographic studies). These patients should have received at least six weeks of nonoperative treatment prior to treatment with the device. The Atlas Spine Expandable Cervical Standalone Interbody System is to be used with autograft bone graft and/or allogeneic bone graft composed of cancellous bone and implanted via an open, anterior approach. The Atlas Spine Expandable Cervical Standalone Interbody System is intended to be used with the bone screw fixation provided by the V3 Segmental Plating system and requires no additional fixation.
Atlas Spine Expandable Cervical Standalone Interbody System
I am sorry, but the provided text from the FDA 510(k) letter for the Atlas Spine Expandable Cervical Standalone Interbody System does not contain any information about acceptance criteria or a study that proves the device meets those criteria.
This document is primarily a letter from the FDA to Atlas Spine, Inc. indicating that their device has been found substantially equivalent to legally marketed predicate devices. It covers:
- The FDA's decision regarding substantial equivalence.
- Regulatory information and requirements for the device (e.g., general controls, potential additional controls, reporting adverse events).
- Details about the device name, regulation number, product code, and regulatory class.
- The Indications for Use for the device.
There is no mention of:
- Specific performance acceptance criteria (e.g., accuracy, sensitivity, specificity, or mechanical performance thresholds).
- Any in-vitro, in-vivo, or clinical studies conducted to demonstrate the device meets performance claims or specific acceptance criteria.
- Sample sizes, data provenance, expert qualifications, ground truth establishment, or multi-reader multi-case studies.
Therefore, I cannot fulfill your request for a table of acceptance criteria and reported performance, or details about the study, as this information is not present in the provided text.
§ 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.