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PRCT2 is indicated for use in fractures and fracture dislocations, osteotomies, and non-unions of the proximal humerus.

The PRCT2 is a system of plates and screws intended to be used in the fixation of fractures of the humerus. PRCT2 consists of 5 components:

1. Humeral Plates
2. Diaphyseal Plates
3. Screws (Locking and Standard)
4. Trials
5. Instruments
   All implants and trials in the PRCT2 system are manufactured from medical grade titanium alloy (TA6V ELI) according to ISO 5832-3.

The device in question is a medical device for bone fixation (PRCT2, a system of plates and screws for fractures of the humerus). The provided text describes the 510(k) submission for this device. For medical devices seeking 510(k) clearance, the primary "study" is usually a demonstration of substantial equivalence to a legally marketed predicate device, often through mechanical testing, rather than clinical trials with human subjects as might be seen for AI algorithms.

Here's an analysis based on the provided text, using the requested categories. Please note that several categories related to AI performance, human readers, and ground truth in a clinical context are not applicable to this type of medical device clearance document, which focuses on mechanical performance.

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

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Sample Size: Not explicitly stated for each test, but implied to be sufficient for mechanical testing according to ASTM standards. Mechanical testing typically involves multiple samples for statistical validity, but the exact number is not provided in this summary.
• Data Provenance: The testing was mechanical bench testing, not clinical data from patients. The location of the testing is not specified, but the applicant (Fx Solutions) is based in France, and the US contact is in Virginia Beach, USA.

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. This document describes mechanical bench testing of a bone fixation device, not an AI algorithm that would require expert-established ground truth from clinical data.

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

• Not Applicable. Mechanical testing results are typically quantifiable and do not require expert adjudication in the same way clinical image interpretation or AI output evaluation would. The "ground truth" here is the physical measurement against an established standard.

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 medical device (bone plate and screw system) clearance, not an AI algorithm. Therefore, no MRMC study or assessment of human reader improvement with AI assistance was performed.

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 this study was defined by established engineering standards and specifications (ASTM F382-99 and ASTM F543-13) for mechanical properties of bone plates and screws. The performance of the device was compared against these standards and against a predicate device.

8. The sample size for the training set

• Not Applicable. There is no "training set" in the context of mechanical bench testing for medical device clearance. This is not an AI algorithm or a statistical model that requires training data.

9. How the ground truth for the training set was established

• Not Applicable. As there is no training set for this type of study, this question is not relevant.

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