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Locking Plate System can be used for adult patients with age above 21 as indicated for fixation of fractures, including ulna, radius, humerus, femur, tibia and fibula.

The proposed product, Locking Plate System, contains (1) Locking Plates, (2) Locking screws and (3) various specific instruments. The raw material of the plate, titanium, conforms to ASTM F67-13, Standard Specification for Unalloyed Titanium for Surgical Implant Applications (UNS R50250, UNS R50400, UNSR50550, UNS R50700). The bone screws are made of titanium alloy (TI-6AL-4V ELI), which complies with ASTM F136-13, Standard Specification for Wrought Titanium-6 Aluminum-4 Vanadium ELI (Extra Low Interstitial) Alloy for Surgical Implant Applications (UNS R56401). The devices are provided un-sterilized, but shall be sterilized via autoclave method to achieve Sterility Assurance Level of 10-6 by hospital prior to use.

The provided text describes a 510(k) submission for a Locking Plate System. This is a medical device for bone fixation, and the documentation focuses on demonstrating its substantial equivalence to previously cleared devices through non-clinical testing. No acceptance criteria for device performance in the context of diagnostic accuracy, image quality, or clinical effectiveness (as would be applicable to AI/ML software or imaging devices) are provided.

Instead, the "acceptance criteria" here refer to the device's ability to meet established ASTM standards for metallic bone plates and screws, as well as material specifications. The "study that proves the device meets the acceptance criteria" refers to non-clinical bench testing performed according to these ASTM standards.

Here's the information extracted from the document, framed in the context of device performance in a non-clinical setting:

1. A table of acceptance criteria and the reported device performance

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 does not explicitly state the sample sizes (e.g., number of plates or screws tested) for the non-clinical bench tests.
• The data provenance is from non-clinical (bench) testing performed by the manufacturer, Beijing Keyi Medical Device Technology Co., Ltd., based in China.

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)

• This is not applicable to this type of submission. Performance is judged against engineering standards, not expert interpretation of clinical data.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

• This is not applicable as there is no human interpretation or adjudication involved for the non-clinical bench tests against specified engineering 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

• No MRMC or studies involving human readers or AI assistance were performed. This device is a passive metallic implant, not an AI/ML diagnostic or imaging device.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done

• Not applicable. This is a physical medical device, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

• The "ground truth" for the non-clinical tests is defined by the specifications and methodologies outlined in the referenced ASTM international standards. These standards set physical and mechanical requirements (e.g., strength, torque, pull-out force) that the device must meet.

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 as there is no training set.

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Locking Plate System can be used for adult patients with age above 21 as indicated for fixation of fractures, including ulna, radius, humerus, femur tibia and fibula.

The proposed products, Locking Plate System, contain (1) locking plates (1.Ps) with various specifications. (2) locking screws with various specifications and (3) various specific instruments. Locking Plates are the plates that made of Titanium. The limited-contact design of LPs reduces plate-to-bone contact, thus limiting vascular trauma. The screws are available in three kinds, which are 3.5mm Hexagonal Locking Screws with hexagonal interface, 3.5mm Stardrive Locking Screws with Torx interface, and 5.0mm Locking Screws with hexagonal interface. There are various instruments specific to the proposed device intend for completing the surgery.

This document is a 510(k) summary for a Locking Plate System, which is a Class II medical device. The submission focuses on demonstrating substantial equivalence to predicate devices through non-clinical testing.

Here's an analysis of the provided text based on your request:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size Used for the Test Set and Data Provenance

The document explicitly states: "No clinical study is included in this submission."
Therefore, there is no patient-specific test set, sample size, or data provenance (e.g., country of origin, retrospective/prospective) related to clinical outcomes. All testing was non-clinical (laboratory/bench testing).

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

Not applicable. As no clinical studies were performed, there was no need for experts to establish ground truth from patient data. The "ground truth" for non-clinical testing is adherence to established engineering standards (ASTM and ISO).

4. Adjudication Method for the Test Set

Not applicable. No clinical studies were performed, so no adjudication method for human decisions on patient cases was required.

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 not an AI/software device. It's a hardware medical device (bone plates and screws), and no MRMC studies or AI involvement are mentioned.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable. This is not an algorithm/software device.

7. The Type of Ground Truth Used

The "ground truth" for this submission are the performance requirements and specifications defined by the referenced international standards (ASTM F382, ASTM F543, ISO 17665-1). The non-clinical tests' goal was to demonstrate compliance with these established engineering standards.

8. The Sample Size for the Training Set

Not applicable. There is no training set mentioned, as this is not a machine learning or AI device.

9. How the Ground Truth for the Training Set was Established

Not applicable. There is no training set for this type of device.

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