(35 days)
The VLP Mini-Mod Talus Plates can be used in adolescent (12-18 years) and transitional adolescent (18-21 years) subpopulations and adults, as well as patients with osteopenic bone. The VLP Mini-Mod Talus Plates are indicated for fracture fixation, reconstruction or arthrodesis of small bones, in the forefoot, midfoot and hindfoot.
The subject premarket notification describes talus plate line additions to the VLP Mini-Mod Small Bone Plating System. Subject plates consist of several varieties of medial and lateral talus plates in left and right designs. 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.
The provided text describes the 510(k) premarket notification for the VLP Mini-Mod Talus Plates. It includes information about the device, its indications for use, and a summary of pre-clinical testing conducted. However, it does not contain a table of acceptance criteria or detailed results of a study designed to directly prove these criteria were met in a comparative performance study with reported device performance against those criteria.
Here's a breakdown of the available information based on your request:
1. A table of acceptance criteria and the reported device performance:
The document does not provide a specific table of acceptance criteria with corresponding device performance metrics in the format you requested (e.g., specific quantitative values for strength, durability, etc.). Instead, it summarizes the outcome of the testing:
- Acceptance Criteria (Implied): The fatigue log cycles to failure should be non-inferior to a previously cleared predicate.
- Reported Device Performance (as stated in the conclusion of the fatigue testing): "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."
2. Sample size used for the test set and the data provenance:
- Sample Size:
- For Finite Element Analysis (FEA), no specific sample size is given, as FEA is a computational method. The document mentions it was conducted on "the proposed talus plate designs."
- For Four-point bend fatigue testing, it was conducted on "worst-case examples of the proposed bone plates, as identified through FEA testing." The exact number (sample size) of these "worst-case examples" is not specified.
- For Packaging testing, no specific sample size (i.e., number of packages tested) is provided.
- Data Provenance: The studies were pre-clinical (laboratory testing) conducted by the manufacturer, Smith & Nephew, Incorporated. No information about country of origin of data beyond "Smith & Nephew, Inc." is given, nor is it described as retrospective or prospective (which would typically apply to clinical studies rather than material/mechanical testing).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
This information is not applicable to the pre-clinical mechanical and packaging testing described. Ground truth and expert consensus are relevant for clinical studies, especially those involving image interpretation or diagnostic accuracy, which are not detailed here. The "ground truth" for mechanical testing is typically defined by engineering standards and predicate device performance.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
This information is not applicable for the type of pre-clinical testing described. Adjudication methods are typically used in clinical trials to resolve discrepancies among expert readers or reviewers.
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:
This information is not applicable. The document describes a medical device (bone plates), not an Artificial Intelligence (AI) diagnostic or interpretive device. Therefore, no MRMC study or AI assistance evaluation was performed or mentioned.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
This information is not applicable. As mentioned above, this is not an AI/algorithm-based device. "Standalone" performance would typically refer to the algorithm's performance without human intervention, which is not relevant here.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- For the Finite Element Analysis (FEA), the "ground truth" for evaluation would be accepted engineering principles, material science properties, and established failure criteria.
- For Four-point bend fatigue testing, the "ground truth" for determining acceptance was comparison against a previously cleared predicate device. The performance of the predicate device serves as the benchmark against which the new device is judged for "non-inferiority."
- For Packaging testing, the "ground truth" for acceptance would be industry standards for sterility maintenance, package integrity, and product protection during shipping.
8. The sample size for the training set:
This information is 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:
This information is not applicable as there is no training set.
§ 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.