(141 days)
The Smith & Nephew Variable-Angle Locking Mini-Fragment Plating System is indicated for adolescent (12-18 years) and transitional adolescent (18-21 years) subpopulations and adults, as well as patients with osteopenic bone. The Smith & Nephew Variable-Angle Locking Mini-Fragment Plating System is indicated for fracture fixation, arthrodesis, reconstruction, replantation or reduction of small bones and small bone fragments. This system is also indicated for non-load bearing stabilization and reduction of bone fragments in long bones.
The subject Smith & Nephew Variable-Angle Locking Mini-Fragment Plating System is an internal fixation plating system comprised of assorted small. implantable utility locking bone plates and compatible locking and non-locking bone screws and washers to be used on various small bones and small bone fragments and non-load bearing stabilization and reduction of bone fragments in long bones. Plates consist of groups of devices with a flat cross-section and others with a radiused cross-section where of holes in plates will range from 4 through 20. All described implant devices are manufactured from implant-grade titanium alloy material and will be available in a sterile packaged condition.
Here's a breakdown of the acceptance criteria and the study details for the Smith & Nephew Variable-Angle Locking Mini-Fragment Plating System, based on the provided 510(k) summary:
This device is a physical medical device (bone plates, screws, and washers), not an AI/Software as a Medical Device (SaMD). Therefore, many of the typical acceptance criteria and study components associated with AI/SaMD (like ground truth, expert consensus, MRMC studies, training sets, etc.) are not applicable in this context. The evaluation focuses on physical performance and substantial equivalence to existing devices.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Criteria (Implicit for physical devices) | Reported Device Performance |
|---|---|---|
| Mechanical Performance | Demonstrated equivalent or superior mechanical properties to predicate devices. | - Finite Element Analysis (FEA): Used to predict worst-case plates. |
- Four-point bend fatigue testing: Performed on bone plates and screws.
- Torque-to-failure testing: Performed on bone screws.
- Axial pull-out testing: Performed on bone screws. |
| Material Composition | Made from implant-grade materials suitable for long-term implantation. | Manufactured from implant-grade titanium alloy material. |
| Biocompatibility | Materials are biocompatible and safe for implantation. | Implied by use of implant-grade titanium alloy, which is a well-established biocompatible material, and substantial equivalence to predicate devices. |
| Sterility | Provided in a sterile condition. | Will be available in a sterile packaged condition. |
| Intended Use Fit | Suitable for internal fixation of small bone fragments and non-load bearing stabilization/reduction in long bones. | Bench testing results "demonstrated that the proposed devices are substantially equivalent to one or more of the previously cleared predicate devices described above" for the stated intended use. |
| Substantial Equivalence | Demonstrates similar intended use, indications for use, materials, and performance characteristics to predicate devices. | Substantial equivalence is the primary acceptance criterion, explicitly stated and supported by the non-clinical testing. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: Not explicitly stated in terms of a specific number of devices. The non-clinical testing involved various tests (FEA, fatigue, torque, pull-out) which would have used multiple samples of plates and screws to generate statistically relevant data.
- Data Provenance: The testing was "non-clinical bench (mechanical) testing" conducted by the manufacturer, Smith & Nephew, Inc. This is laboratory-based testing on manufactured devices, not patient data. Therefore, concepts like country of origin or retrospective/prospective do not apply.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
- Not Applicable. This is a physical medical device. "Ground truth" in the context of expert consensus as described for AI/SaMD (e.g., radiologists interpreting images) is not relevant. The "ground truth" for mechanical testing is established by engineering standards, test methodologies, and material science. The experts involved would be mechanical engineers, material scientists, and quality assurance professionals within Smith & Nephew, as well as external notified bodies or testing laboratories that might be accredited for such tests. Their qualifications would be in these engineering and scientific disciplines.
4. Adjudication Method for the Test Set
- Not Applicable. As this is mechanical testing of physical devices, there's no "adjudication method" in the sense of reconciling divergent expert interpretations. Results are typically quantitative measurements, and acceptance is determined by comparing these measurements against predetermined specifications and predicate device performance. Any discrepancies would be addressed through repeat testing, calibration checks, or investigation into methodology.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done
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No. This type of study (MRMC) is used for evaluating human performance, typically in diagnostic tasks, and is therefore not applicable to a physical bone plating system.
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Effect Size: Not applicable.
6. If a Standalone (i.e. algorithm only without human-in-the loop performance) was done
- No. This concept is only applicable to AI/software. The "device" itself is a physical implant.
7. The Type of Ground Truth Used
- Not Applicable / Engineering Standards and Predicate Device Performance. For mechanical testing, the "ground truth" is typically defined by:
- Applicable international and national consensus standards (e.g., ASTM, ISO standards for implants).
- Performance data from the legally marketed predicate devices, against which the new device is compared for substantial equivalence.
- Engineering calculations and material properties.
8. The Sample Size for the Training Set
- Not Applicable. There is no "training set" in the context of a physical device. Training sets are relevant for machine learning algorithms.
9. How the Ground Truth for the Training Set was Established
- Not Applicable. As there is no training set, this question is not relevant.
§ 888.3030 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.