(104 days)
The Hip Fracture Nail System is intended to treat stable and unstable proximal fractures of the femur including pertrochanteric fractures, intertrochanteric fractures, high subtrochanteric fractures and combinations of these fractures, including non-union, malunion and tumor resections. The Long Nail system is additionally indicated to treat pertrochanteric fractures associated with shaft fractures, pathologic fractures in osteoporotic bone (including prophylactic use) of the trochanteric and diaphyseal areas, impending pathological fractures, long subtrochanteric fractures, ipsilateral femoral fractures, proximal or distal non-unions, malunions, revision procedures and tumor resections.
The Hip Fracture Nail System consists of an intramedullary nail, lag screw, distal screws, end cap and optional antirotation screw all manufactured from titanium allov and used to treat fractures in the proximal portion of the femur. The system offers 125° and 130° angle nails with 9-15mm distal diameters and a 180-460mm length range.
The provided text describes a 510(k) premarket notification for a medical device called the "Hip Fracture Nail System." It primarily focuses on demonstrating substantial equivalence to predicate devices through pre-clinical data (cyclical testing).
Here's an analysis of the requested information based on the provided text, noting where specific details are not available:
1. Table of acceptance criteria and the reported device performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Achieved higher maximum loads prior to failure | "Cyclical testing demonstrated that the new Hip Fracture Nail System achieved higher maximum loads prior to failure when compared to both predicate devices successfully meeting the pre-defined acceptance criteria." |
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
- Sample Size for Test Set: Not specified in the provided text. The study describes "cyclical testing" of the Hip Fracture Nail System and two predicate devices, but the number of units tested for each is not explicitly mentioned.
- Data Provenance: Not specified. As this is a pre-clinical study involving mechanical testing rather than patient data, country of origin is less relevant than with clinical trials. It is implicitly a prospective study in the sense that the mechanical tests were designed and conducted specifically for this submission.
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)
- This question is not applicable to the provided context. The "ground truth" here is based on physical mechanical properties (maximum load prior to failure) measured during cyclical testing, not on expert interpretation of medical data or images. Therefore, clinical experts are not involved in establishing this "ground truth."
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
- Not applicable. As noted above, the "test set" involves mechanical properties, not expert consensus or medical diagnosis.
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. This is a submission for a mechanical implant (Hip Fracture Nail System), not an AI/imaging device. The study involves pre-clinical mechanical testing, not a clinical study involving human readers or AI assistance.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This is not an AI/algorithm device. The "standalone" performance here refers to the mechanical performance of the device itself.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- The "ground truth" for this pre-clinical study is defined by the objective measurement of mechanical failure points (maximum loads prior to failure) under cyclical stress testing. It's a physical, engineering-based ground truth.
8. The sample size for the training set
- Not applicable. This is not an AI/machine learning device that requires a training set. The study compares the mechanical performance of the new device against predicate devices.
9. How the ground truth for the training set was established
- Not applicable. As this is not an AI/machine learning device, there is no "training set" or "ground truth for the training set" in the conventional sense. The study's focus is on direct experimental comparison of mechanical properties.
§ 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.