(27 days)
The S2 Femoral Nail is indicated for long bone fracture fixation specifically femoral fracture fixation, which may include the following: - Open and closed femoral fractures - Pseudoarthrosis and correction osteotomy - Pathologic fractures, impending pathologic fractures, and tumor resections - Supracondylar fractures, including those with intra-articular extension - Ipsilateral femur fractures - Fractures proximal to a total knee arthroplasty - Fractures distal to a hip joint - Nonunions and malunions
The subject S2 Femoral Nail System, like the predicate T2" Femoral Nail System, is a fracture fixation device comprised of femoral nails and the related locking screws, compression screws, and end caps. The subject and predicate devices are intended to provide strong and stable internal fracture fixation with minimal soft tissue irritation. This device is utilized as an aid to healing, not as a substitute for normal intact bone and tissue.
The provided text describes a Special 510(k) Premarket Notification for the S2 Femoral Nail System, a device that is a design modification to the T2™ Femoral Nail System. This notification is primarily focused on demonstrating substantial equivalence to a predicate device, rather than proving a device meets specific acceptance criteria through a clinical study with detailed performance metrics.
Therefore, many of the requested categories for acceptance criteria and study details are not directly applicable or available in the provided document. The submission relies on bench testing (FEA analysis and mechanical testing) to demonstrate comparable mechanical properties to the predicate device, not on clinical performance metrics or human reader studies.
Here's the breakdown of the information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Acceptance Criteria (Not explicitly stated as numerical targets, but implied to be comparable to predicate) | Reported Device Performance (Summary from text) |
|---|---|---|
| Mechanical Properties | Comparable strength and stability to the predicate T2™ Femoral Nail System. | FEA analysis and mechanical testing demonstrates the comparable mechanical properties of the subject S2 Femoral Nail System to the predicate T2™ Femoral Nail System. |
| Material | Change from Ti-6A1-4V Alloy to 316L Stainless Steel must maintain equivalent performance. | Material changed from Ti-6A1-4V Alloy to 316L Stainless Steel. (Performance assessed via mechanical comparability). |
| Design Change (Cross-section) | New cross-section must maintain equivalent performance. | Cross-section changed. (Performance assessed via mechanical comparability). |
| Design Change (Screw Hole Config.) | New screw hole configuration must maintain equivalent performance. | Proximal and distal screw hole configuration changed. (Performance assessed via mechanical comparability). |
| Device Lengths | Additional lengths of nails incorporated. | Additional lengths of nails added. (Implies functional equivalence across new lengths). |
| Intended Use | No change in intended use compared to the predicate device. | No change in intended use for the modified device when compared to the previously cleared device. |
| Safety/Effectiveness | Implied to be safe and effective for indicated uses, comparable to predicate. | No direct safety/effectiveness metrics for this specific device modification; relies on established safety/effectiveness of predicate. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: Not applicable. The study was based on FEA analysis and mechanical testing of the device itself, not on biological samples or patient data.
- Data Provenance: Not applicable. The data is generated from engineering analysis and laboratory testing.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
- Not applicable. Ground truth in this context would refer to clinical outcomes or expert readings of medical images. The studies performed were engineering-based mechanical evaluations, which do not involve expert ground truthing in the medical sense.
4. Adjudication Method for the Test Set
- Not applicable. No clinical test set or human adjudication was involved.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
- No such study was done. This submission is for a medical implant and relies on mechanical testing, not a diagnostic imaging or clinical effectiveness study involving human readers.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done
- Not applicable. This relates to algorithmic performance, which is not relevant to a physical medical implant.
7. The Type of Ground Truth Used
- Engineering specifications and mechanical testing standards. The "ground truth" for the mechanical properties would be defined by established engineering principles, material properties, and relevant mechanical testing standards to ensure the new design and material meet performance expectations comparable to the predicate.
8. The Sample Size for the Training Set
- Not applicable. There is no "training set" in the context of a physical medical implant undergoing mechanical testing. FEA models might be developed, but they are not "trained" in the machine learning sense.
9. How the Ground Truth for the Training Set Was Established
- Not applicable. As there is no training set, this question is not relevant.
§ 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.