(43 days)
The Magnum Nail is intended for use in fixation of stable and unstable fractures of the proximal femur. The types of proximal femoral fractures include pertrochanteric, intertrochanteric, basal neck fractures, high subtrochanteric fractures and combinations of these fractures. The Magnum Nail is also indicated for use in osteotomy, nonunions and malunions, bone reconstruction following tumor resection, grafting and pathological fractures and revision procedures.
The Magnum Nail consists of nails, distal bone screws, cannulated lag screws, cannulated blades and set screws in a variety of sizes to accommodate differing anatomic requirements.
The provided text {0} discusses substantial equivalence based on basic design, intended use, indications, anatomic sites, and "mechanical performance." However, it does not explicitly define acceptance criteria or detail a specific study proving the device meets these criteria in the context of clinical performance or diagnostic accuracy. The document is a 510(k) summary for a medical device (Magnum Nail) and focuses on demonstrating substantial equivalence to predicate devices, primarily through design, intended use, and mechanical properties, not through a study demonstrating acceptance criteria for an AI/algorithm-driven device.
Therefore, most of the requested information (items 1-9) cannot be extracted directly from this document as it pertains to a different type of device evaluation (mechanical fixation rather than AI/algorithm performance).
However, I can extract the following relevant information based on the provided text:
1. A table of acceptance criteria and the reported device performance
Not applicable. The document assesses "mechanical performance" for substantial equivalence of a fixative nail, not diagnostic or algorithmic performance. No specific acceptance criteria or quantitative performance metrics are provided in the context of an AI/algorithm evaluation.
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
Not applicable. No test set for an AI/algorithm is mentioned.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
Not applicable. No ground truth establishment for an AI/algorithm is mentioned.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. No test set for an AI/algorithm is mentioned.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not applicable. No MRMC study is mentioned.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. No standalone algorithm performance is mentioned.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Not applicable. No ground truth for an AI/algorithm is mentioned.
8. The sample size for the training set
Not applicable. No training set for an AI/algorithm is mentioned.
9. How the ground truth for the training set was established
Not applicable. No training set for an AI/algorithm is mentioned.
§ 888.3020 Intramedullary fixation rod.
(a)
Identification. An intramedullary fixation rod is a device intended to be implanted that consists of a rod made of alloys such as cobalt-chromium-molybdenum and stainless steel. It is inserted into the medullary (bone marrow) canal of long bones for the fixation of fractures.(b)
Classification. Class II.