(239 days)
Synthes 2.7mm / 3.5mm LCP Anterolateral Distal Tibia Plates are indicated for fractures, osteotomies, and non-unions of the distal tibia, especially in osteopenic bone.
The Synthes 2.7mm / 3.5mm LCP Anterolateral Distal Tibia Plates are low-profile plates with a pre-contoured shape designed to conform to the distal tibia. The plates are available in stainless steel and feature specific versions for the right and left tibia.
The provided document is a 510(k) summary for the Synthes (USA) 2.7mm / 3.5mm LCP Anterolateral Distal Tibia Plates. It states that the device's substantial equivalence is supported by preclinical bench testing and analyses, as well as a published clinical literature review, rather than a study involving human subjects or AI performance.
Therefore, the requested information regarding acceptance criteria, device performance from clinical studies, sample sizes, ground truth establishment, expert involvement, and MRMC studies is not applicable in this context, as the provided document focuses on mechanical and design equivalence to predicate devices.
However, based on the provided text, I can infer the acceptance criteria were related to mechanical performance and design specifications to demonstrate substantial equivalence to existing predicate devices.
Here's a breakdown of the relevant information provided:
1. A table of acceptance criteria and the reported device performance:
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Substantial Equivalence to Predicate Devices: | Information presented supports the substantial equivalence of the Synthes 2.7mm / 3.5mm LCP Anterolateral Distal Tibia Plates to the predicate devices. The proposed plate has the same indications for use, incorporates the same fundamental product technology and is composed of the same material. |
| Mechanical Performance (Geometric Bending Strength): | Geometrical bending strength analysis was conducted. |
| Mechanical Performance (Static Bend Testing): | Static bend testing was conducted. |
| Mechanical Performance (Dynamic Fatigue Testing): | Dynamic fatigue testing was conducted. |
| Clinical Literature Review for Safety/Effectiveness: | Published clinical literature review was conducted. |
2. Sample size used for the test set and the data provenance:
- Sample Size for Test Set: Not applicable. The "test set" in this context refers to the physical devices undergoing mechanical testing, not a dataset of patient information. The number of plates tested is not specified.
- Data Provenance: Not applicable for a human data test set. The data provenance would be from the engineering lab where the mechanical tests were conducted.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. Ground truth for mechanical testing is established by engineering standards and measurement equipment, not clinical experts.
4. Adjudication method for the test set:
- Not applicable. Mechanical testing results are objective measurements, not subject to adjudication in the clinical sense.
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:
- No, an MRMC comparative effectiveness study was not done. This device is a bone fixation appliance, not an AI diagnostic or assistive device.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- No, a standalone algorithm performance study was not done. This device is a physical implant, not an algorithm.
7. The type of ground truth used:
- Engineering specifications and measurements from mechanical testing (e.g., force, displacement, cycles to failure) consistent with industry standards for medical implants.
8. The sample size for the training set:
- Not applicable. There is no concept of a "training set" for the evaluation of this device, as it is not an AI/machine learning product.
9. How the ground truth for the training set was established:
- Not applicable. There is no training set for this type of device.
§ 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.