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TraumaCad Neo is indicated for assisting healthcare professionals to analyze orthopedic conditions and to plan orthopedic procedures by overlaying on relevant radiological images visual information such as measurements and prosthesis templates. Clinical judgment and experience are required to properly use the software is not intended for primary radiological image interpretation or radiological appraisal. Device is not intended for use on mobile phones.

TraumaCad Neo allows surgeons to evaluate digital images while performing various pre-operative surgical planning and evaluation of images. This software application enables surgeons to plan operations on screen, execute measurements, and facilitates the film-less orthopedic practice. TraumaCad Neo allows post-operative review of images obtained after the surgical procedure. The program features an extensive regularly updated library of digital templates from leading manufacturers. TraumaCad Neo supports DICOM and is integrated to communicate with Quentry®, a proprietary web-based cloud service from Brainlab. It is through Quentry®, where the medical staff can upload images to plan their expected results prior to the procedure to create a smooth surgical workflow from start to finish.

The provided text describes the regulatory clearance of a medical device, TraumaCad Neo, and compares it to a predicate device, TraumaCad Mobile 2.0. However, it does not contain specific acceptance criteria, reported device performance metrics, or details about a study designed to prove the device meets acceptance criteria.

Instead, the document highlights that:

• The performance evaluation was based on "well-established test methods which demonstrated conformity to the intended use."
• These methods were the "same which were used to demonstrate the substantial equivalence of the predicate device TraumaCad Mobile 2.0."
• "The performance tests have been completed and successfully confirm the performance of the device."

Without an actual study described, I cannot populate the table or answer most of the requested questions. The document focuses on regulatory equivalence rather than a detailed performance study with specific metrics.

Here's how I can address the request based on the absence of the detailed information you are looking for in the provided text:

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

Note: The provided document states that "Performance Evaluation... was based upon well-established test methods which demonstrated conformity to the intended use" and "confirm the performance of the device." However, specific quantitative acceptance criteria and corresponding reported device performance metrics are not included in the provided text.

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

This information is not provided in the text. The document refers to "performance tests" that "successfully confirm the performance" but does not detail the sample size, data provenance, or whether the study was retrospective or prospective.

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 information is not provided in the text. The document does not describe how ground truth was established for any test set.

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

This information is not provided in the text. There is no mention of an adjudication method for a test set.

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

There is no indication of a multi-reader, multi-case (MRMC) comparative effectiveness study being performed or reported in this document. The device "assists healthcare professionals" but no study comparing human performance with and without the device is detailed.

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

While the device's performance was evaluated, the document does not explicitly state whether a standalone (algorithm only) performance study was conducted. It emphasizes that "Clinical judgment and experience are required to properly use the software."

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

This information is not provided in the text. The document does not specify how ground truth was established for any performance evaluation.

8. The sample size for the training set

This information is not provided in the text. The document focuses on performance evaluation for regulatory purposes rather than the development and training of an AI algorithm.

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

This information is not provided in the text. As there is no mention of a training set, the method for establishing its ground truth is also absent.

Summary of what is stated about performance evaluation:

The document indicates that TraumaCad Neo's performance evaluation was conducted using "well-established test methods" that were consistent with those used for its predicate device, TraumaCad Mobile 2.0. These tests "demonstrated conformity to the intended use" and "successfully confirm the performance of the device," leading to the conclusion that the device is substantially equivalent to the predicate. However, detailed results, specific metrics, study design, and sample information are not included in this regulatory summary.

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