(62 days)
Synthes 3.5mm LCP Posteromedial Proximal Tibia Plates are indicated for internal fixation of posteromedial proximal tibia fractures including buttressing of fractures of the proximal, distal, and metaphyseal areas of the tibia.
The Synthes 3.5mm LCP Posteromedial Proximal Tibia Plates are pre-contoured bone fixation plates intended for the treatment of fractures of the tibia. The plates are offered sterile and non-sterile and are available in stainless steel and titanium.
Here's an analysis of the provided text regarding the acceptance criteria and study for the Synthes (USA) 3.5mm LCP Posteromedial Proximal Tibia Plates:
Based on the provided [K082624](https://510k.innolitics.com/search/K082624) document, there is no study described that establishes acceptance criteria for device performance in the context of human or AI-assisted interpretation.
This document is a 510(k) summary for a medical device (bone fixation plates), which primarily focuses on demonstrating substantial equivalence to a legally marketed predicate device. This type of submission typically relies on design, material, and mechanical testing to ensure safety and effectiveness, rather than clinical studies involving diagnostic accuracy or human performance with or without AI.
Therefore, most of the requested information regarding acceptance criteria, study design, expert involvement, and AI performance is not present in this document.
Here's a breakdown of what can be extracted and what is not present:
1. Table of Acceptance Criteria and Reported Device Performance
Not applicable as an AI/human interpretation study is not described. The acceptance criteria for this device would typically be related to mechanical properties (e.g., strength, fatigue life), biocompatibility, and sterilization, which are not detailed in this 510(k) summary beyond the general statement of substantial equivalence.
2. Sample Size Used for the Test Set and Data Provenance
Not applicable. No test set for an AI/human interpretation study is described.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
Not applicable. No ground truth for an AI/human interpretation study is described.
4. Adjudication Method for the Test Set
Not applicable. No adjudication method for an AI/human interpretation study is described because there is no such study.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No. The document makes no mention of an MRMC study or any study comparing human readers with and without AI assistance. This device is a passive implant, not a diagnostic or interpretive tool.
6. Standalone (Algorithm Only) Performance Study
No. This is not an AI algorithm.
7. Type of Ground Truth Used
Not applicable. No ground truth (in the context of diagnostic performance or interpretation) is mentioned. For this type of device, "ground truth" would relate to the successful fixation of fractures, assessed by clinical outcomes and imaging following surgery, which are not part of this 510(k) clearance document.
8. Sample Size for the Training Set
Not applicable. There is no AI algorithm being trained.
9. How the Ground Truth for the Training Set Was Established
Not applicable. There is no AI algorithm being trained.
In summary: The provided document [K082624](https://510k.innolitics.com/search/K082624) is a 510(k) summary for a physical medical device (bone plates). It demonstrates substantial equivalence to predicate devices, which is a regulatory pathway that does not typically involve the kind of performance studies you're asking about (e.g., AI performance, human reader studies, diagnostic accuracy, etc.). Therefore, the information requested in your prompt is not contained within this document.
§ 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.