(56 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 fragments. This system is also indicated for nonload bearing stabilization and reduction of bone fragments in long bones.
Bone plates and bone screws from the Smith & Nephew Variable-Angle Locking Mini-Fragment Plating System are for single use only.
The subject premarket notification describes 1.5mm line additions to the VLP Mini-Mod Small Bone Plating System. The subject internal fixation plating system is comprised of assorted implantable, locking bone plates and compatible locking and non-locking bone screws to be used on various small bones and fragments. The VLP Mini-Mod Small Bone Plating System is a subset of the Smith & Nephew Variable-Angle Locking Mini-Fragment Plating System, which was previously cleared via Traditional 510(k) K132886. Subject plates consist of groups of devices with a radiused cross-section where the number of holes in the plates will range from 6 through 24. Specific plate designs include Y-plates, Straight plates, and Column plates. All described implant devices are manufactured from implant-grade titanium alloy material (Ti-6Al-4V) and designed for single-use. They will be provided in a sterile packaged option and will be sterilized via Gamma irradiation. Bone screws will be offered in both locking and non-locking options in a variety of lengths.
The provided document describes a 510(k) premarket notification for the "VLP Mini-Mod Small Bone Plating System 1.5mm Plates and Screws." The information presented is for a medical device (bone plates and screws) and is primarily focused on demonstrating "substantial equivalence" to predicate devices through mechanical testing, not on clinical performance or diagnostic accuracy. Therefore, many of the requested categories for AI/clinical studies are not applicable.
Here's an analysis based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Test Type | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Finite Element Analysis (FEA) for Plate Strength | Subject bone plates exhibited similar or superior structural strength compared to existing 1.5mm predicates. | The acceptance criteria was met in that the subject bone plates exhibited similar or superior structural strength compared to the existing 1.5mm predicates. Results of the FEA demonstrated that the plates identified for mechanical testing were the appropriate bone plates because they possessed the highest stress concentrations. |
| Four-Point Bend Fatigue Testing for Plates | The number of log cycles to failure achieved by the proposed bone plates met the acceptance criteria by being non-inferior to the fatigue log cycles to failure of a previously cleared predicate. | Results of the testing concluded that the number of log cycles to failure achieved by the proposed bone plates met the acceptance criteria in that they were found to be non-inferior to the fatigue log cycles to failure of a previously cleared predicate. |
| Torque-to-Failure Testing for Screws | All tested 1.5mm screws met the minimum torsional strength requirement dictated by ASTM F543-07. | The acceptance criterion was met in that all tested 1.5mm screws met the minimum torsional strength requirement dictated by ASTM F543-07. |
| Axial Pull-out Testing for Screws | The maximum pull-out force of the subject screws was non-inferior to the maximum pull-out force of the predicate. | The subject implants met the acceptance criteria in that the maximum pullout force of the subject screws was non-inferior to the maximum pull-out force of the predicate. |
Regarding the requested details that are not applicable to this type of device (bone plates and screws) or document (510(k) summary focused on substantial equivalence through mechanical testing):
This document describes a mechanical device (bone fixation system), not a diagnostic AI medical device or a device requiring a clinical study with human subjects to evaluate performance in the way described by the prompts (e.g., diagnostic accuracy, reader improvement, ground truth establishment with experts). The "performance" here refers to mechanical integrity and comparison to existing, cleared devices.
Therefore, the following information is not available or not applicable in this document:
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not Applicable: This refers to mechanical testing of physical device samples, not data sets for an AI model. The sample sizes would be the number of test articles for each mechanical test (e.g., number of plates for fatigue testing, number of screws for torque/pull-out), but these specific numbers are not provided in this summary. Data provenance (country, retrospective/prospective) is irrelevant for mechanical bench testing.
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)
- Not Applicable: There is no "ground truth" in the diagnostic sense for these mechanical tests. Standards (ASTM F543-07) and engineering principles (FEA, mechanical testing protocols) define the acceptance.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not Applicable: This relates to human expert review for establishing ground truth, which is not relevant here.
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: No clinical or AI-assisted diagnostic study was performed. This is a mechanical device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not Applicable: No algorithm performance in a standalone capacity was assessed. This is a physical device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not Applicable: As mentioned, ground truth in the diagnostic sense is not relevant. The "ground truth" for mechanical testing is established by recognized engineering standards and the performance of predicate devices.
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: 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.