(88 days)
The Nexis® osteosynthesis compressive screws are single use devices indicated for the fixing and stabilizing the elective osteotomies of the mid foot bones and the metatarsal and phalanges of the foot only.
Nexis® osteosynthesis compressive screws are single-use bone fixation devices intended to be permanently implanted. Nexis® osteosynthesis compressive screws are canulated compressive screws made of Titanium (Alloy Ti-6Al-4V ELI). Nexis® osteosynthesis compressive screws are compressive canulated bone screws which allow a permanent compression, thus supporting a secure osseous restoration.
The provided text describes the 510(k) premarket notification for the Nexis® osteosynthesis compressive screws. This is a medical device application for bone fixation, and the document focuses on demonstrating substantial equivalence to legally marketed predicate devices, rather than establishing acceptance criteria and testing for a new or novel device's performance against specific metrics.
Therefore, the requested information regarding acceptance criteria, study details, sample sizes, expert involvement, and ground truth for a software algorithm/AI device is not applicable to this document.
Here's why and what information is provided:
- Device Type: The Nexis® osteosynthesis compressive screws are physical implants (canulated compressive screws made of Titanium). They are not an AI/software device.
- Regulatory Pathway: The 510(k) pathway demonstrates that the new device is "substantially equivalent" to predicate devices already on the market. This involves comparing characteristics like material, mechanical properties, and intended use. It does not typically require the establishment of new, performance-based acceptance criteria in the way an AI/software device would, nor does it conduct studies to prove the device meets such criteria in terms of diagnostic accuracy or output performance.
- "Performance data" in this context refers to engineering and biocompatibility testing, not diagnostic performance. The document states:
- "The biocompatibility evaluation for new devices Nexis® osteosynthesis compressive screws was conducted in accordance with Blue Book Memorandum #G95-1... and International Standard ISO 10993-1..."
- "The new devices Nexis® osteosynthesis compressive screws have similar technological characteristics in terms of design and mechanical characteristics (Driving and removal torque, pull-out strength, torsional resistance) and thus are believed to be substantially equivalent to the predicate Memometal Fixos screws (device references: S-Fix/C-Fix/P-Fix) (K070039) and SBI Autofix™ System (K052576)."
- Clinical and Animal Studies: The document explicitly states: "Clinical studies were not required for this submission. Animal studies were not required for this submission."
In summary, none of the requested information regarding acceptance criteria, study design for performance metrics, sample sizes for test/training sets, expert ground truth establishment, or AI-specific study types (MRMC, standalone algorithm performance) can be extracted from the provided text because it pertains to a different type of medical device and regulatory 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.