(29 days)
The HEALIX Compression Screw (HCS) System is indicated for Bone Fractures, Osteotomies, Arthrodeses, Osteochondritis, and Tendon Reattachment. It is intended for, but not limited to, Hand Surgery, Orthopedic Surgery, and Podiatric Surgery but is not intended for attachment or fixation to the posterior elements (pedicles) of the spine.
The Healix Compression Screw (HCS) System consists of cannulated, solid titanium allov. headless, headed screws and specialized instrumentation. This submission expands the Healix offering and includes longer screws ranging from 31 to 130mm in length for the 2.0 to 7.5mm diameters.
The provided text is a 510(k) summary for the Nvision Biomedical Technologies' Healix Compression Screw System. This document focuses on demonstrating substantial equivalence to predicate devices, primarily through engineering analysis. It does not contain information about acceptance criteria or a study proving that a device meets those criteria in the context of AI/ML or diagnostic performance.
Instead, this document is a regulatory submission for a physical medical device (bone fixation screws) and relies on mechanical performance characteristics and a comparison to existing predicate devices.
Therefore, I cannot extract the requested information (items 1-9) as it pertains to AI/ML device performance from the provided text. The document clearly states:
- "No FDA performance standards have been established for the Healix Compression Screw System."
- "The following was performed to demonstrate safety per methods of the previous submission: . Engineering analysis comparison of mechanical performance characteristics"
- "The results of the engineering analysis indicate that the Healix Compression Screw System is substantially equivalent to the predicate devices."
This indicates the evaluation was based on engineering analysis and comparison against physical predicate devices, not on a study proving a device meets acceptance criteria related to diagnostic performance, human-in-the-loop improvements, or ground truth establishment for AI/ML.
§ 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.