(45 days)
Knee Fusion Nails are intended for intramedullary knee arthrodesis.
The Knee Fusion Nail is inserted in the medullary canal of long bones for knee arthrodesis. The Knee Fusion Nail features holes/slots on both ends of the nail for optional locking screws. The nails and screws are made of Stainless Steel. The screws were previously cleared in 510(k) K983942.
Here's an analysis of the provided text regarding the acceptance criteria and supporting study for the Knee Fusion Nail, formatted as requested:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Performance Metric) | Reported Device Performance |
|---|---|
| Bending Strength | Equivalent or superior to predicate Knee Fusion Nails (K893377 and K983942) |
| Flexural Rigidity | Equivalent or superior to predicate Knee Fusion Nails (K893377 and K983942) |
| Yield Strength | Equivalent or superior to predicate Knee Fusion Nails (K893377 and K983942) |
2. Sample Size Used for the Test Set and Data Provenance
The review states "an analysis of bending strength and flexural rigidity based on the cross-sectional geometry of the nail's shaft region and the material strength properties using hand calculations." This implies a theoretical analysis based on design specifications and material properties rather than a test performed on a sample set of physical devices. Therefore, a traditional "sample size" for a test set and associated data provenance (country of origin, retrospective/prospective) are not applicable to this type of analysis.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
- Number of Experts: Not applicable. The "ground truth" was established through engineering calculations and material property comparisons.
- Qualifications of Experts: Not applicable. The analysis was based on engineering principles and material science, not expert consensus on observations.
4. Adjudication Method for the Test Set
Not applicable, as there was no test set requiring expert adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. The submission describes a device (Knee Fusion Nail) which is a physical implant, not a diagnostic or assistive technology that would be used by human readers for interpretation.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
No, a standalone performance study was not done. The "device" in question is a physical medical implant, not an algorithm.
7. The Type of Ground Truth Used
The "ground truth" for the performance evaluation was established using engineering principles, material strength properties, and design specifications (cross-sectional geometry of the nail's shaft region). The performance of the subject device was then compared against these established properties for predicate devices.
8. The Sample Size for the Training Set
Not applicable. The submission describes a physical medical device, not a machine learning model, so there is no concept of a "training set."
9. How the Ground Truth for the Training Set Was Established
Not applicable. There was no training set.
§ 888.3030 Single/multiple component metallic bone fixation appliances and accessories.
(a)
Identification. Single/multiple component metallic bone fixation appliances and accessories are devices intended to be implanted consisting of one or more metallic components and their metallic fasteners. The devices contain a plate, a nail/plate combination, or a blade/plate combination that are made of alloys, such as cobalt-chromium-molybdenum, stainless steel, and titanium, that are intended to be held in position with fasteners, such as screws and nails, or bolts, nuts, and washers. These devices are used for fixation of fractures of the proximal or distal end of long bones, such as intracapsular, intertrochanteric, intercervical, supracondylar, or condylar fractures of the femur; for fusion of a joint; or for surgical procedures that involve cutting a bone. The devices may be implanted or attached through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.