(85 days)
The STALIF C® and STALIF C® Ti devices are 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 and/or allogenic bone graft composed of cancellous and/or corticocancellous bone graft, to facilitate fusion. STALIF C® and STALIF C® Ti are 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 non-operative 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 cavity that can be packed with autograft or allograft. 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 STALIF C® Ti is identical to this design with a titanium plasma spray coating on the device endplates.
The provided text describes a 510(k) submission for the STALIF C® and STALIF C® Ti intervertebral body fusion devices, seeking to expand their indications to include use with allograft. This is a regulatory submission for a medical device, and the content focuses on demonstrating "substantial equivalence" to a predicate device rather than presenting a study proving a device meets specific performance acceptance criteria.
Therefore, most of the requested information regarding acceptance criteria, device performance derived from a study, sample sizes, expert involvement, and ground truth cannot be extracted directly from this document. The FDA 510(k) process for this type of device typically relies on demonstrating that the new device is as safe and effective as a legally marketed predicate device, often through engineering tests, material compatibility, and sometimes clinical literature reviews, rather than a clinical effectiveness study with defined performance metrics, a test set, and ground truth as might be seen for AI/diagnostic devices.
Here's what can be inferred or stated based on the provided text, and what cannot:
1. A table of acceptance criteria and the reported device performance:
- Cannot be provided directly. The document does not specify quantitative acceptance criteria for device performance (e.g., fusion rates, pain reduction scores, range of motion values) or report specific performance metrics from a study related to these criteria. The submission is about expanding indications based on clinical literature for allograft use.
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective):
- Cannot be provided directly. No "test set" in the context of a performance study (like for an AI algorithm) is mentioned. The submission refers to a "comprehensive, clinical literature review" and "PearlDiver reimbursement data." These are not a single, defined test set with a specific sample size for a device performance study. Details on country of origin or retrospective/prospective nature of the literature reviewed are also not provided.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience):
- Cannot be provided directly. Since no specific "test set" requiring ground truth establishment by experts is described, this information is not available. The clinical literature review would involve evaluation of published studies, whose ground truth and expert evaluations would have been established within those individual studies.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Cannot be provided directly. This is not applicable as there is no described test set requiring expert adjudication for ground truth.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- No such study was done. This type of study (MRMC for AI assistance) is not relevant for this device, which is an intervertebral body fusion cage, not an AI diagnostic tool.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- No such study was done. This question pertains to AI algorithms. The STALIF C® and STALIF C® Ti are physical medical implants.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Implied ground truth from literature review: The submission relies on "clinical literature review" and "PearlDiver reimbursement data" to suggest the benefits and risks of allograft. For fusion cages, the ultimate 'ground truth' related to effectiveness would typically be radiographic evidence of fusion and patient-reported outcomes (e.g., pain, disability scores) from clinical studies. The document states, "The clinical literature suggests that there is a positive benefit associated with allograft with minimal risk."
8. The sample size for the training set:
- Not applicable. There is no "training set" as this is not an AI/machine learning device.
9. How the ground truth for the training set was established:
- Not applicable. There is no "training set" as this is not an AI/machine learning device.
Summary of what the document does state regarding demonstrating device appropriateness:
- The submission aims to demonstrate "substantial equivalence" of the STALIF C® and STALIF C® Ti to the predicate ANATOMIC PEEK™ CERVICAL FUSION SYSTEM.
- The primary purpose of this specific 510(k) was to expand the indications to include use with allograft.
- This expansion was supported by:
- A "comprehensive, clinical literature review" to investigate risks and benefits associated with using allogenic bone graft with the STALIF C®.
- "PearlDiver reimbursement data" also provided for the same purpose.
- No new mechanical tests were performed because there were no design changes to the device itself. The original device would have undergone mechanical testing to demonstrate safety and function.
In conclusion, the document provided is a regulatory clearance letter for a physical medical device (intervertebral body fusion cage) seeking an expanded indication. It does not contain information typically found in a study proving an AI device meets specific performance acceptance criteria.
§ 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.