(165 days)
The STALIF C® is intended to be used as an intervertebral body fusion cage as a standalone system used with bone screws provided and requires no additional supplementary fixation systems. It is inserted between the vertebral bodies into the disc space from levels C2 to T1 for the treatment of cervical degenerative disc disease (defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies). The device system is designed for use with autograft bone to facilitate fusion. STALIF C® is intended to be used at one level.
The cervical cage is to be used in a skeletally mature patient who has had six weeks of nonoperative treatment prior to implantation of the cage.
STALIF C® is a radiolucent intervertebral body fusion cage with unicortical cancellous bone screws. It is intended to be used as an IBF cage without supplementary fixation. The cross section profile of the STALIF C® is similar to that of the vertebral body endplate with central sevity that can be packed with autograft. STALIF C® is manufactured from PEEK-OPTIMA® LT1 with titanium alloy screws and X-ray marker wires manufactured from unalloyed Tantalum (ASTM F-560).
The provided text describes a medical device, the STALIF C®, and its substantial equivalence to predicate devices, but does not contain information regarding an acceptance criteria study for device performance in the context of AI/ML or diagnostic accuracy.
The provided document, K120819, is a 510(k) summary for a medical device (intervertebral body fusion cage) which is primarily concerned with demonstrating substantial equivalence to previously cleared devices through mechanical testing and FEA simulation. This is a premarket notification for a physical medical device, not a software as a medical device (SaMD) or AI-powered diagnostic tool.
Therefore, I cannot fulfill the request as it pertains to AI/ML specific criteria and studies, as this information is not present in the provided text.
The closest relevant information is about the mechanical testing performed:
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria (Defined in Design Control Activities Summary) | Device Performance |
|---|---|
| Mechanical testing per ASTM F2077 (static and dynamic compression) | Met acceptance criteria |
| Mechanical testing per ASTM F2077 (static and dynamic compression-shear) | Met acceptance criteria |
| Mechanical testing per ASTM F2077 (static and dynamic torsion testing) | Met acceptance criteria |
| FEA simulation on worst-case subject STALIF C® and predicate STALIF C™ | Showed previous testing in K072415 was adequate (implying equivalence met) |
The following points cannot be answered from the provided text as they relate to AI/ML or diagnostic performance studies, which are not detailed in this 510(k) submission for a physical implantable device:
- Sample size used for the test set and the data provenance.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts.
- Adjudication method for the test set.
- If a multi reader multi case (MRMC) comparative effectiveness study was done, and its effect size.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done.
- The type of ground truth used.
- The sample size for the training set.
- How the ground truth for the training set was established.
§ 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.