(184 days)
The Locking Compression Plate System can be used for adult patients with age above 21 as indicated for fixation of fractures, including ulna, radius, humerus, femur and tibia.
The applicant device of Locking Compression Plate System consist of plates and screws, made of titanium alloy (Ti6AI4V ELI ) which meets the requirements of ASTM F136-08e1, Standard Specification for Wrought Titanium-6 Aluminum-4 Vanadium ELI (Extra Low Interstitial) Alloy for Surgical Implant Applications (UNS R56401). The proposed devices are not provided sterile. It is required to be sterilized via autoclave method to reach a SAL of 10-6 by the hospital prior to surgery. The validated sterilization method is presented in the user manual. The plates vary through lengths and number of plate holes, and the screws vary through diameters and lengths.
The provided document is a 510(k) summary for a "Locking compression plate system" submitted by Shanghai MicroPort Orthopedics Co., Ltd. It describes the device, its intended use, and the regulatory pathway. However, the document does not contain information related to software or AI/ML-driven medical devices. As such, most of the requested information regarding acceptance criteria, study details, sample sizes, expert involvement, and ground truth establishment, which are typical for AI/ML device evaluations, are not present in this document.
Here's an attempt to answer the questions based only on the provided text, recognizing that it primarily describes a physical orthopedic implant and its mechanical testing for substantial equivalence to predicate devices.
Acceptance Criteria and Device Performance
1. A table of acceptance criteria and the reported device performance
Since this is a physical medical device (orthopedic implant), the "acceptance criteria" and "device performance" are primarily related to meeting specific engineering standards and demonstrating mechanical equivalence to predicate devices. The document states that "bench tests were conducted to verify that the proposed device met all design specifications as was Substantially Equivalent (SE) to the predicate device." It also lists the standards used for testing.
| Acceptance Criteria (based on standards) | Reported Device Performance |
|---|---|
| Mechanical Performance: | |
| ASTM F543-07 Standard Specification and Test Methods for Metallic Medical Bone Screws | "test results demonstrated that they have similar performances" (compared to predicate devices) |
| ASTM F382-99 (Reapproved 2008) Standard Specification and Test Method for Metallic Bone Plates | "test results demonstrated that they have similar performances" (compared to predicate devices) |
| ASTM F897-02 (Reapproved 2007) Method for Measuring Fretting Corrosion of Osteosynthesis Plates and screws | "test results demonstrated that they have similar performances" (compared to predicate devices) |
| Material Composition: | |
| ASTM F136-08e1, Standard Specification for Wrought Titanium-6 Aluminum-4 Vanadium ELI (Extra Low Interstitial) Alloy for Surgical Implant Applications (UNS R56401) | Device made of Titanium alloy (Ti6AI4V ELI) which "meets the requirements of ASTM F136-08e1" |
| Sterilization: | |
| Achievement of a SAL of 10-6 (Sterility Assurance Level) via autoclave | "The proposed devices are not provided sterile. It is required to be sterilized via autoclave method to reach a SAL of 10-6 by the hospital prior to surgery. The validated sterilization method is presented in the user manual." |
| Design Specifications: | |
| (Implicit: meeting pre-defined dimensional and functional specs) | "bench tests were conducted to verify that the proposed device met all design specifications" |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document refers to "bench tests" and "mechanical testing." These typically involve testing physical samples of the device and are not directly analogous to "test sets" in an AI/ML context. The sample size (number of physical devices tested) is not specified.
Data provenance is not applicable in the typical sense for AI/ML. The "data" here refers to mechanical test results. The device sponsor is Shanghai MicroPort Orthopedics Co., Ltd., which implies the testing likely occurred in China or at a contract lab, but the specific origins of the test data (e.g., specific lab location) are not provided. These tests are inherently prospective in terms of the test execution, but they are evaluating a manufactured item, not clinical patient data.
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. Expert involvement in establishing "ground truth" (as in clinical diagnosis or image interpretation) is not relevant for the mechanical testing of a physical implant. The "ground truth" in this context is adherence to engineering standards and mechanical performance equivalence, evaluated by engineers and testing facilities.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. This is not a clinical study involving human interpretation or adjudication of results. Mechanical testing has objective pass/fail criteria based on standards.
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 orthopedic implant, not an AI/ML device that assists human readers.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
Not applicable. This is a physical orthopedic implant.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
For this device, the "ground truth" is adherence to established international engineering standards (ASTM standards for materials, bone screws, plates, and fretting corrosion) and the demonstrated mechanical performance equivalence to legally marketed predicate devices. It is not an expert consensus on a diagnosis, pathology, or outcomes data in a clinical sense.
8. The sample size for the training set
Not applicable. There is no training set as this is not an AI/ML device.
9. How the ground truth for the training set was established
Not applicable. There is no training set as this is not an AI/ML device.
Summary regarding AI/ML relevance:
The provided document describes a traditional, physical medical device (orthopedic implant), and its regulatory clearance process based on substantial equivalence to predicate devices through mechanical bench testing. The questions posed are highly relevant to the evaluation of AI/ML medical devices, which operate on data (images, signals, etc.) and involve algorithms. Therefore, most of the detailed information requested regarding sample sizes, expert involvement, ground truth establishment, and comparative effectiveness studies is not contained in this document because it pertains to a different type of medical device evaluation.
§ 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.