(16 days)
The Biofusion Medical SI-Restore® Sacroiliac Joint Fixation Screw is intended for sacroiliac joint fusion for conditions including sacroiliac joint disruptions and degenerative sacroiliitis.
The SI-Restore® Sacroiliac Joint Fixation Screw consists of a cannulated, smooth or textured, titanium (Ti 6Al-4V ELI, per ATSM F136) screw with a titanium (Ti 6Al-4V ELI, per ATSM F136) washer affixed to the head of the screw for full cortex engagement. The implant is designed to prevent motion of the sacroiliac (SI) joint. The delivery system uses guide pins for accurate preparation and placement of the implant.
The provided document is a 510(k) Pre-market Notification from the FDA regarding a medical device, the SI-Restore® Sacroiliac Joint Fixation System. This type of document primarily focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than presenting new clinical study data with acceptance criteria for device performance (like an AI algorithm would need).
Therefore, the information requested in the prompt (acceptance criteria, details of a study proving the device meets them, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth, and training set details) is NOT present in this document.
The document explicitly states:
- "Performance Data: Performance data is not included in this submission. The design changes being included for review do not present a new worst-case configuration that would require additional performance testing."
This indicates that clinical performance data of the type expected for an AI-powered diagnostic device, as outlined in your prompt, was not required or provided for this 510(k) submission because the changes to the device (a bone fixation screw) were considered minor and did not introduce new safety or effectiveness concerns requiring new performance data. The FDA's determination of substantial equivalence relies on comparison to existing, already cleared devices based on intended use, materials, and technological characteristics.
In summary, this document does not contain the information needed to answer your questions about acceptance criteria and a study proving device performance in the context of an AI/diagnostic device.
§ 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.