(48 days)
The VLP MINI-MOD Small Bone Plating System and VLP MINI-MOD Talus Plates are indicated for adolescent (12–18 years) and transitional adolescent (18–21 years) subpopulations and adults, as well as patients with osteopenic bone.
The VLP MINI-MOD Small Bone 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 VLP MINI-MOD 2.0mm Column Plates are line addition plates to the VLP MINI-MOD Small Bone Plating System. The VLP MINI-MOD Small Bone Plating System was initially cleared for market via K132886 as the Smith & Nephew Variable-Angle Locking Mini-Fragment Plating System. The proposed plates are intended to be used with the 2.0mm Locking and Cortex screws previously cleared via K132886.
This is a 510(k) premarket notification for a medical device (VLP MINI-MOD 2.0mm Column Plates), not an AI/ML medical device. Therefore, much of the requested information regarding AI/ML device studies, such as sample sizes for test and training sets, expert consensus, MRMC studies, and ground truth establishment, is not applicable.
However, I can extract the acceptance criteria and the study type for this specific medical device.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Mechanical Performance (Fatigue): Non-inferiority to previously cleared predicate | Achieved the acceptance criteria by being found non-inferior to the fatigue log cycles to failure of a previously cleared predicate when tested at the same bending moment. (Leveraged existing four-point bend fatigue testing on the worst-case plate of the VLP MINI-MOD product family (K132886) because the subject plate did not represent a new worst case). |
| Bacterial Endotoxin Limits: Met acceptable endotoxin limits | Met the acceptable endotoxin limits as stated in the FDA Guidance, "Submission and Review of Sterility Information in Premarket Notification (510(k)) Submissions for Devices Labeled as Sterile", "Pyrogen and Endotoxins Testing: Questions and Answers", and ANSI/AAMI ST72. (Performed bacterial endotoxin testing). |
| Worst-Case Design Assessment (FEA): Did not represent a new worst case | The subject plate did not represent a new worst case compared against existing MINI-MOD plates cleared via K132886. (Based on Finite Element Analysis (FEA)). |
| Substantial Equivalence: Similar intended use, indications for use, and performance characteristics to predicates | Device comparisons demonstrated that the proposed VLP MINI-MOD 2.0mm Column Plate is substantially equivalent to the legally marketed predicate devices (K132886, K993106) with regard to intended use, indications for use, and performance characteristics. (Based on device comparisons, engineering rationale, and mechanical testing). |
2. Sample size used for the test set and the data provenance:
- Mechanical Testing (Four-point bend fatigue): The document refers to "the worst-case plate of the VLP MINI-MOD product family cleared via K132886". It does not specify the exact number of samples used in that previous testing, but it was sufficient to establish non-inferiority.
- Bacterial Endotoxin Testing: The number of samples tested is not specified, but it was conducted to meet regulatory standards.
- FEA: This is a computational analysis; it doesn't involve a "test set" in the traditional sense of physical samples, but rather a model of the device.
Data provenance is not explicitly stated in terms of country of origin or retrospective/prospective, but these are pre-clinical (in vitro/computational) tests conducted by the manufacturer.
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. This is a submission for a metallic bone fixation device, not an AI/ML imaging device that requires expert interpretation for ground truth. The "ground truth" here is based on engineering principles, material science, and established regulatory standards for mechanical and biological performance.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
Not applicable. This is not an AI/ML diagnostic or prognostic device involving human adjudication of results.
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 medical device and does not involve human readers or AI assistance in diagnostic interpretation.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
Not applicable. This is a physical medical device, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
The "ground truth" for this device is based on:
- Engineering Standards: Meeting established mechanical performance requirements (e.g., fatigue resistance).
- Regulatory Standards: Compliance with bacterial endotoxin limits as specified in FDA guidance and ANSI/AAMI ST72.
- Comparability: Demonstrating substantial equivalence to predicate devices based on intended use, indications for use, and performance characteristics.
8. The sample size for the training set:
Not applicable. This is not an AI/ML device that requires a training set.
9. How the ground truth for the training set was established:
Not applicable.
§ 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.