(284 days)
The Life Spine HAMMERTOE Correction System is indicated for small bone reconstruction limited to inter-digital repar and fusion of the lesser toes.
The Hammertoe Correction System is an implant with dual threaded design and is inserted between the proximal and middle phalanges, so the opposing threads fixate on the phalangeal canal of the toe and compress the joint. The implant is fabricated and manufactured from Titanium (Ti 6A1-4V ELI)
All implants are intended for single use only and should not be reused under any circumstances. Do not use any of the Hammertoe Correction System components with components from any other system or manufacturer. The Hammertoe Correction System components should never be reused under any circumstances.
I am sorry, but based on the provided text, there is no information about an AI/ML-driven medical device, its acceptance criteria, or a study proving its performance. The document is an FDA 510(k) clearance letter for a mechanical medical device called "The Hammertoe Correction System."
The document primarily covers:
- The FDA's decision to clear the device based on substantial equivalence.
- The device's trade name, regulation number, regulatory class, and product code.
- Contact information for the manufacturer.
- Indications for use of the Hammertoe Correction System.
- A brief description of the device and its material (Titanium).
- Mention of performance data (Finite Element Analysis, Custom Shear Testing, and Bench Top Validations) used to demonstrate substantial equivalence to predicate devices, but no specifics about the results or how they relate to acceptance criteria are provided.
Therefore, I cannot provide the requested information regarding acceptance criteria and a study proving an AI/ML device meets them because the provided text describes a traditional orthopedic implant, not an AI/ML 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.