(152 days)
The Patriot SI Implant System is intended for sacroiliac joint fusion for conditions including sacroiliac joint disruptions and degenerative sacroiliitis.
The Patriot SI Implant System is a minimally invasive sacroiliac joint fusion implant that pierces the cortical bone of the ilium and sacrum and is intended for the purpose of stabilizing and fusing the sacroiliac joint with intrinsic fixation features. It is available in one size and may be implanted using the designated surgical instruments into the SI joint space. Bone graft materials may be used with the Patriot SI Implant System. The Patriot SI Implant System device is made from additively manufactured titanium alloy, Ti-6Al-4V-ELI per ASTM F3001 and is offered with or without a hydroxyapatite (HA) coating per ASTM F1185. The Patriot SI Implant System device is provided sterile and individually packed.
The provided FDA 510(k) clearance letter for the Patriot SI Implant System does not contain any information regarding acceptance criteria or the study that proves the device meets those criteria for the purposes of an AI/software device.
The document is for a physical medical implant device (sacroiliac joint fusion implant). The information it provides is:
- Device Type: Patriot SI Implant System (a physical implantable device)
- Intended Use: Sacroiliac joint fusion for conditions including sacroiliac joint disruptions and degenerative sacroiliitis.
- Materials: Additively manufactured titanium alloy, Ti-6Al-4V-ELI, with or without hydroxyapatite (HA) coating.
- Testing Information: "Non-clinical cadaveric biomechanical testing was performed to support substantial equivalence of the Patriot SI Implant system." This type of testing is relevant for mechanical implants, not AI/software.
- Predicate Device: Patriot-SI Posterior Implant System (K232259).
Therefore, I cannot provide details on acceptance criteria and study design for an AI/software device based on this document. The questions posed in your request (sample size, expert qualifications, MRMC studies, standalone performance, ground truth types) are universally applicable to AI/software performance studies, but the source document is entirely about a physical hardware device.
If you have a document describing an AI/software medical device, I would be happy to analyze it according to your criteria.
§ 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.