(59 days)
The Cannulated Screw Internal Fixation System is intended to be used for alignment and stabilization of small bone fractures. Specifically:
· Fixation of small bones, such as those in the foot, ankle, wrist, elbow and hand for treatment of fractures, or mal-unions
• Ligament reconstruction
- · Osteochondritis dissecans
· Arthrodesis of the foot, ankle, wrist, elbow and hand
· Small bone osteotomies, including first metatarsal head osteotomies, phalangeal osteotomies, and carpal/metacarpal osteotomies
These procedures may be indicated as a result of trauma, deformity, osteoarthritis, and rheumatoid arthritis.
The Life Spine Cannulated Screw Internal Fixation System is comprised of Cannulated Headed and Headless Screws intended to align and stabilize small bone fragments around articular regions. It is fabricated and manufactured from titanium alloy (Ti 6A1-4V-ELI per ASTM F 136). Screws offer a variety of sizes of non-sterile, single-use implantable components. Longer pitched threads on the distal tip of the screw penetrates bone at a faster rate than the shorter trailing threads for headless screws, allowing interfragmentary compression as the screw is advanced and countersunk. The nonthreaded portion facilitates compression of the joint surfaces through a lag technique.
All implants are provided non-sterile and intended for SINGLE USE ONLY and should not be reused under any circumstances. Do not use any of the Cannulated Screw Internal Fixation System components with components from any other system or manufacturer. The Cannulated Screw Internal Fixation System components should never be reused under any circumstances.
The provided text is a 510(k) premarket notification for a medical device called the "Cannulated Screw Internal Fixation System." This type of document focuses on demonstrating that a new device is "substantially equivalent" to predicate devices already on the market, rather than proving that the device meets specific acceptance criteria through a clinical study or performance evaluation with AI.
Therefore, the document does not contain the information requested regarding:
- Acceptance criteria and reported device performance (in the context of AI or clinical efficacy). The performance data presented is mechanical testing to demonstrate substantial equivalence, not clinical performance.
- Sample size and data provenance for a test set.
- Number of experts and their qualifications for establishing ground truth.
- Adjudication method.
- Multi-reader multi-case (MRMC) comparative effectiveness study.
- Standalone (algorithm only) performance.
- Type of ground truth used (expert consensus, pathology, outcomes data, etc.).
- Sample size for the training set.
- How ground truth for the training set was established.
The document primarily addresses the regulatory path for a traditional medical device (implantable screws) and emphasizes physical and material properties, along with manufacturing standards, to establish substantial equivalence to existing devices. There is no mention of artificial intelligence (AI) or machine learning (ML) in this submission.
§ 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.