(83 days)
Versalock Mini and Micro Plating System is intended for fracture fixation, arthrodesis, reconstruction, and osteotomy fixation of the hand and foot. The use of locking plate/screw systems is suited for treatment of fractures in osteopenic bone.
Versalock Mini and Micro Plating System consists of plates and screws in a variety of designs and sizes that are commonly used in trauma and reconstructive surgery. The bone plates are made from commercially pure titanium allov and the bone screws are manufactured from titanium alloy only. The plates range in thickness from 0.6 to 1.7 mm, and the screws range in diameter from 1.3 to 2.7 mm. They are available on different sizes and shapes, according to the implantation site and the extension of the fracture. Versalock Mini and Micro Plating System are for single use. The devices are provided non-sterile and must being properly cleaned and sterilized before use, according to the recommendations provided in the Instructions for Use.
This document is a 510(k) premarket notification for a medical device called the "Versalock Mini and Micro Plating System." As such, it describes the device and its intended use, and argues for its substantial equivalence to previously cleared predicate devices. It does not present acceptance criteria for a device's performance, nor a study proving it meets such criteria in terms of clinical or diagnostic efficacy.
Instead, the provided text describes the mechanical performance testing conducted to demonstrate substantial equivalence to predicate devices, which is a different type of evaluation.
Therefore, many of the requested items (e.g., sample size for test set, number of experts for ground truth, adjudication method, MRMC study effect size, standalone performance, training set details) are not applicable or available in this document.
Here's a breakdown of what is available based on the given text:
1. A table of acceptance criteria and the reported device performance
This document does not present specific acceptance criteria in terms of clinical or diagnostic performance, nor does it report such performance for the device. Instead, it states that:
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Mechanical performance in accordance with ASTM F382 (for plates), ASTM F3437 (for screws), and ASTM F543 (for screws). | "Based on submitted testing data, the subject device is equivalent to the predicate devices." (Page 5) |
2. Sample size used for the test set and the data provenance
- Test Set Sample Size: Not applicable. This document refers to mechanical testing, not a clinical trial or diagnostic study with a "test set" of patient data. The "sample size" would refer to the number of plates and screws tested mechanically. This specific number is not provided in the document.
- Data Provenance: Not applicable. The data provenance would be from laboratory mechanical testing.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. This device is for fracture fixation, and the evaluation here is mechanical equivalence, not a diagnostic or clinical efficacy study requiring expert-established ground truth on patient data.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. There is no "adjudication method" described for mechanical testing.
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 bone plating system, not an AI-powered diagnostic device, and therefore no MRMC study would be relevant.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
Not applicable. This is a physical bone plating system, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Not applicable. For the mechanical testing, the "ground truth" would be established by the ASTM standard test methods (e.g., defined load limits, displacement measurements, failure points).
8. The sample size for the training set
Not applicable. This is a physical device, and the evaluation is for mechanical equivalence to predicate devices, not an AI model requiring a training set.
9. How the ground truth for the training set was established
Not applicable. See above.
§ 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.