(19 days)
SCARLET® AC-T cages are indicated for use in skeletally mature patients with degenerative disc disease (defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies) of the cervical spine. Patients should have at least six (6) weeks of non-operative treatment with an intervertebral cage. SCARLET® AC-T cages are intended to be used at one level from the C2-C3 disc to the C7-T1 disc to facilitate intervertebral body fusion with autogenous bone graft and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft.
The SCARLET® AC-T Secured Anterior Cervical Cage is intended to be used as a standalone system used with the two bone screws provided and requires no additional supplementary fixation systems. When used without the two bone screws, SCARLET AC-T cages are to be used with supplemental fixation which has been cleared by the FDA for use in the cervical spine.
The Scarlet® AC-T is a box-shaped spacer with a central cavity that can be filled with autogenous bone graft and/or allogenic bone graft comprised of cancellous and/ or corticocancellous bone graft to facilitate fusion. Scarlet® AC-T is available in convex or lordotic profiles. Scarlet® AC-T comes in two footprints and six heights in order to accommodate different patient anatomies. The Scarlet® AC-T fixation screws are available with diameters 3.0 mm and 3.5 mm and come in various sizes so as to accommodate different patient anatomies. The SCARLET® AC-T spacer and screws are made of Titanium alloy Ti6Al4V ELI conforming to ISO 5832.3 and ASTM F136. SCARLET® AC-T is single-use device provided sterile (gamma radiation) and supplied with dedicated surgical instruments. Bacterial endotoxin testing as specified in USP standard is used for pyrogenicity testing to achieve the Endotoxin limit of 20 EU / device.
The provided text describes a 510(k) submission for the SCARLET® AC-T Secured Anterior Cervical Cage, specifically a "SPECIAL 510k DEVICE MODIFICATION" related to an "Extension of the range of SCARLET® AC-T screws."
This document is a regulatory filing for a medical device and not a study that proves a device meets acceptance criteria in the context of an AI/ML algorithm's performance. The information requested (acceptance criteria, study details, sample size, ground truth, expert qualifications, etc.) is typically found in performance studies for diagnostic or prognostic devices, especially those utilizing AI/ML.
The SCARLET® AC-T device is an intervertebral body fusion device made of titanium alloy, and the modification involves adding new screw sizes with a modified distal tip. The regulatory submission states that "No additional testing has been performed for the added Scarlet® AC-T fixation screws. A risk analysis was performed to determine that additional testing was not needed."
Therefore, I cannot provide the requested information because:
- There are no acceptance criteria or reported device performance for an AI/ML algorithm. This document is for a physical orthopedic implant.
- No study, as understood in the context of evaluating an AI/ML algorithm, was performed for this specific modification. The submission explicitly states no additional testing was done.
- There is no "test set," "ground truth," or "experts" involved in determining the performance of a software or AI component. The evaluation here is based on substantial equivalence to existing predicate devices, considering material properties, design features, and a risk analysis.
In summary, the provided text does not contain the information needed to answer the prompt as it pertains to the performance evaluation of an AI or software 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.