(8 days)
The subject S2 Nail System is a fracture fixation device comprised of femoral and tibial nails and the related accessories such as washers, locking screws, compression screws, end caps, condyle screws and a condyle screw nut. The subject and predicate devices are intended to provide strong and stable internal fracture fixation with minimal soft tissue irritation of the tibia and femur. This device is utilized as an aid to healing, not as a substitute for normal intact bone and tissue.
The S2 Tibial Nail is intended to provide temporary stabilization of various types of fractures, malunion and nonunion of the tibia. The nails are inserted using an opened or closed technique and can be statically, dynamically and compression locked. The S2 Tibial Nail System is indicated for long bone fracture fixation, specifically tibial fracture fixation, which may include the following:
- Open and closed tibial fractures
- Pseudoarthrosis and correction osteotomy .
- Pathologic fractures, impending pathologic fractures, and tumor resections .
- . Nonunion and malunion
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 Nail System is a fracture fixation device comprised of femoral and tibial nails and the related accessories such as washers, locking screws, compression screws, end caps, condyle screws and a condyle screw nut. The line extension involves design modifications to the femoral and tibial nails with additional diameters plus additional accessories.
This document describes a Special 510(k) Premarket Notification for a line extension to the S2 Nail System, specifically for femoral and tibial nails. This submission focuses on design modifications and additional accessories, not a new type of device or a new AI/software-driven diagnostic tool. Therefore, the typical acceptance criteria and study design elements you've requested for AI/diagnostic devices (e.g., performance metrics like sensitivity/specificity, sample sizes for test/training sets, expert ground truth, MRMC studies) are not applicable here.
The provided text primarily focuses on demonstrating substantial equivalence to a predicate device through:
- Identical material: The material used for the line extension is identical to the predicate device.
- Mechanical testing and FEA analysis: These were performed to demonstrate comparable mechanical properties to the predicate devices.
Since this submission is for a physical orthopedic implant system (intramedullary nails) and not a software device or diagnostic tool, the concept of "acceptance criteria" is based on mechanical performance, material compatibility, and demonstration of substantial equivalence to a legally marketed predicate device, rather than diagnostic accuracy metrics.
Therefore, many of the requested fields cannot be filled as they pertain to the evaluation of AI/diagnostic devices, which is not the subject of this 510(k) submission.
Here's a breakdown of what can be inferred or stated from the provided text, recognizing the different nature of this medical device submission:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Material composition identical to predicate device. | Material used is "identical to that of the predicate." |
| Mechanical properties comparable to predicate devices. | "FEA analysis and mechanical testing demonstrates the comparable mechanical properties of the subject S2 Nail System to the predicate devices." |
| No change in intended use compared to predicate. | "There is no change in intended use for the modified device when compared to the previously cleared device." |
| Device provides strong and stable internal fracture fixation. | Intended to "provide strong and stable internal fracture fixation with minimal soft tissue irritation." (This is part of the intended use for both subject and predicate). |
2. Sample size used for the test set and the data provenance
- Not applicable for this type of device. The "test set" in this context would refer to the physical specimens used for mechanical testing and FEA analysis, not patient data for diagnostic accuracy. Specific numbers for these mechanical/FEA tests are not provided in this summary.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not applicable. Ground truth in the context of material science and mechanical engineering for orthopedic implants is established through standardized testing protocols (e.g., ASTM, ISO standards) and engineering analysis (FEA). "Experts" in this context would be engineers performing the tests and analysis, but their specific number or qualifications are not relevant to a 510(k) summary focused on substantial equivalence.
4. Adjudication method for the test set
- Not applicable. This concept pertains to resolving discrepancies among expert evaluations in diagnostic studies, which is not relevant for mechanical testing of an implant.
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 physical implant, not a diagnostic AI system.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
- Not applicable. This is a physical implant, not an algorithm or software.
7. The type of ground truth used
- Mechanical properties and material composition. For this type of device, ground truth is established by objective engineering measurements of material composition (e.g., chemical analysis) and mechanical properties (e.g., tensile strength, fatigue life, bending stiffness) verified against established industry standards and predicate device performance.
8. The sample size for the training set
- Not applicable. There is no "training set" as this is not an AI/machine learning device.
9. How the ground truth for the training set was established
- Not applicable. There is no "training set."
§ 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.