(189 days)
The SALVATION™ Midfoot Reconstruction System is indicated for fracture fixation, osteotomies, reconstruction procedures, non-unions, and fusions of bones in the foot and ankle including the metatarsals, cuneiforms, cuboid, navicular, calcaneus and talus; specific examples include: intramedullary medial column fusion and lateral column fusion resulting from neuropathic osteoarthropathy (Charcot).
The SALVATION Midfoot Reconstruction System, introduced as SALVATION Beams and Bolts in K140741, is being expanded to include the SALVATION Midfoot Nail. Designed to address the demands of advanced midfoot reconstruction, the subject nail features proximal threads and a distal cross screw to ensure fixation and rotational stability.
The provided text is a 510(k) summary for the "SALVATION Midfoot Reconstruction System - Midfoot Nail Line Extension," a medical device. This document does not describe a study that involves software, AI, or diagnostic performance and therefore does not have the information requested in points 1-9 of the prompt.
The document focuses on demonstrating substantial equivalence to a predicate device through non-clinical evidence (material, design, and mechanical testing) for a physical orthopedic implant.
Here's a breakdown of why the requested information cannot be provided from this document:
- No AI/Software Component: The device is a physical "Smooth Or Threaded Metallic Bone Fixation Fastener" (midfoot nail). There is no mention of any AI component, software, or diagnostic function.
- No Performance Metrics for AI: Consequently, there are no acceptance criteria, reported device performance (in terms of sensitivity, specificity, accuracy, etc., typically associated with diagnostic AI), sample sizes for test sets, expert ground truth establishment, or adjudication methods described for AI performance.
- No MRMC or Standalone Studies for AI: Since there's no AI, there are no multi-reader multi-case studies or standalone algorithm performance studies.
- No Ground Truth for AI: The concept of "ground truth" (expert consensus, pathology, outcomes data) as it applies to evaluating AI diagnostic performance is not relevant to this physical implant.
- No Training Set: As there's no AI model, there's no training set or ground truth establishment for a training set.
Instead, the document details:
- Device Name: SALVATION Midfoot Reconstruction System - Midfoot Nail Line Extension
- Intended Use: Fracture fixation, osteotomies, reconstruction procedures, non-unions, and fusions of bones in the foot and ankle, including treatment for neuropathic osteoarthropathy (Charcot).
- Predicate Device: SALVATION Beams and Bolts (K140741)
- Technological Characteristics Comparison (Table 1): Compares material (Type II Anodized Titanium Alloy), central shaft design (cannulated or solid core), and size offerings between the subject device and the predicate.
- Non-Clinical Evidence (b)(1): Static Bend Testing, Construct Fatigue Testing, and Pyrogenicity Testing were conducted. These are mechanical and biocompatibility tests for physical implants, not performance studies for AI.
- Clinical Evidence (b)(2): N/A (Not Applicable), indicating no human clinical trials were deemed necessary to demonstrate substantial equivalence for this device.
- Conclusion: The device is substantially equivalent to the predicate based on non-clinical evidence, with no new questions of safety or effectiveness.
§ 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.