(58 days)
The HammerTech device is indicated for the fixation of osteotomies and reconstruction of the lesser toes following correction procedures for hammertoe, claw toe and mallet toe.
The HammerTech Fixation System consists of PEEK (Polyetheretherketone (ASTM F2026)) and titanium alloy (Ti6Al4V ELI (ASTM F136)) threaded bone implants intended for fixation of the interphalangeal joint of the lesser toes. The device is offered in three configurations; straight cannulated PEEK, straight cannulated titanium, and angled solid titanium. Each configuration is offered in five different sizes to address to a variety of patient anatomy. The specialized instruments are made primarily of surgical grade stainless steel (ASTM F899). The implant and associated instrumentation is supplied sterile and non-sterile.
This document is a 510(k) premarket notification for the HammerTech™ Fixation System, a bone fixation device. As such, it does not contain any information about a study proving that an AI/software device meets acceptance criteria.
The document primarily focuses on demonstrating substantial equivalence to predicate devices based on:
- Intended Use: Fixing osteotomies and reconstructing lesser toes for hammertoe, claw toe, and mallet toe correction.
- Design & Materials: PEEK and titanium alloy threaded bone implants, offered in various configurations and sizes.
- Mechanical Safety and Performance: Non-clinical tests like static/dynamic 4-point bending, pull-out, torsion, and insertion torque were conducted to show equivalence to predicate devices, and pyrogenicity was evaluated.
- No Clinical Studies: The document explicitly states, "No clinical studies were performed."
Therefore, I cannot provide the requested information regarding:
- A table of acceptance criteria and reported device performance for an AI/software.
- Sample sizes or data provenance for an AI/software test set.
- Number of experts or their qualifications for ground truth establishment for an AI/software.
- Adjudication method for an AI/software test set.
- MRMC comparative effectiveness study for AI assistance.
- Standalone performance of an AI algorithm.
- Type of ground truth used for AI.
- Sample size for the training set for AI.
- How ground truth for the training set was established for AI.
The document pertains to a physical medical device (bone fixation system) and its mechanical and material properties, not an AI or software-as-a-medical-device (SaMD).
§ 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.