(59 days)
The UNITY Sacroiliac Joint Fixation System is indicated for use in skeletally mature patients for sacroiliac joint fusion for conditions including sacroiliac joint disruptions and degenerative sacroiliitis.
The UNITY Sacroiliac Joint Fixation System consists of screws designed to enhance sacroiliac joint fusion. The UNITY Sacroiliac Joint Fixation System is offered in various diameters, lengths, and three screw types in cannulated form to accommodate patient anatomy. The three design types of the subject device are: 1. Standard Thread Screw (with and without slots) 2. Lag Screw (with and without slots) and 3. Washer Screw (with slots)
This appears to be an FDA 510(k) clearance letter and a 510(k) summary for the UNITY Sacroiliac Joint Fixation System. This type of documentation permits a device to be legally marketed, but it typically does not contain detailed information about the acceptance criteria and study results in the way you've requested for proving a device meets acceptance criteria, especially regarding AI or diagnostic performance studies.
The document states: "The UNITY Sacroiliac Joint Fixation does not create a new worst case for device performance; additional testing is not needed." This is a key statement indicating that the device is cleared based on substantial equivalence to an existing predicate device, not on new clinical performance data demonstrating its effectiveness in a traditional clinical trial or AI performance study.
Therefore, I cannot provide the requested information from this document. The questions you've asked (sample sizes for test/training sets, expert consensus, MRMC studies, standalone performance, etc.) are common for AI/diagnostic device clearances, but this particular device is a fixation system (essentially, screws for the sacroiliac joint), which falls under a different regulatory pathway.
To directly answer your points based on the provided text:
- A table of acceptance criteria and the reported device performance: Not present. The device is cleared based on equivalence to a predicate, not performance against specific criteria.
- Sample sized used for the test set and the data provenance: Not applicable. No new test set data for performance was generated as per the document.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable.
- Adjudication method for the test set: Not applicable.
- 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: Not applicable. This is not an AI device.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an AI device.
- The type of ground truth used: Not applicable.
- The sample size for the training set: Not applicable.
- How the ground truth for the training set was established: Not applicable.
§ 888.3040 Smooth or threaded metallic bone fixation fastener.
(a)
Identification. A smooth or threaded metallic bone fixation fastener is a device intended to be implanted that consists of a stiff wire segment or rod made of alloys, such as cobalt-chromium-molybdenum and stainless steel, and that may be smooth on the outside, fully or partially threaded, straight or U-shaped; and may be either blunt pointed, sharp pointed, or have a formed, slotted head on the end. It may be used for fixation of bone fractures, for bone reconstructions, as a guide pin for insertion of other implants, or it may be implanted through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.