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The provided text is a 510(k) clearance letter from the FDA for a medical device called the "Stella Cervical Plate." This type of document does not contain any information about acceptance criteria or a study proving device performance against such criteria.
The purpose of a 510(k) clearance is to establish that a new medical device is "substantially equivalent" to a legally marketed predicate device, meaning it has the same intended use and similar technological characteristics. This process typically relies on demonstrating equivalence in design, materials, and sometimes testing that compares the new device to the predicate device, but it does not involve clinical effectiveness studies or the establishment of specific acceptance criteria for a device's performance in the way implied by your request.
Therefore, I cannot provide the requested information based on the input text. The text does not describe:
- A table of acceptance criteria and reported device performance: This is not present.
- Sample size used for the test set and data provenance: No such test set is described.
- Number of experts used to establish ground truth and qualifications: Not applicable, as no ground truth is established in this context.
- Adjudication method: Not applicable.
- Multi-reader multi-case (MRMC) comparative effectiveness study: Not conducted or mentioned.
- Standalone (algorithm only) performance study: Not applicable, as this is a physical medical device, not an AI algorithm.
- Type of ground truth used: Not applicable.
- Sample size for the training set: Not applicable (no AI training set).
- How ground truth for the training set was established: Not applicable.
The letter simply states that the FDA reviewed the premarket notification and found the device substantially equivalent to a predicate device, thereby allowing it to be marketed.
§ 888.3060 Spinal intervertebral body fixation orthosis.
(a)
Identification. A spinal intervertebral body fixation orthosis is a device intended to be implanted made of titanium. It consists of various vertebral plates that are punched into each of a series of vertebral bodies. An eye-type screw is inserted in a hole in the center of each of the plates. A braided cable is threaded through each eye-type screw. The cable is tightened with a tension device and it is fastened or crimped at each eye-type screw. The device is used to apply force to a series of vertebrae to correct “sway back,” scoliosis (lateral curvature of the spine), or other conditions.(b)
Classification. Class II.