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The Compartmental Compressibility Monitoring System (CPM#1) is intended for real-time and intermittent monitoring of relative compartment compressibility.
The relative compartment compressibility (CP Value) is not meant for trend analysis.

The Compartmental Compressibility Monitoring System (CPM#1) is a point-of-care device for non-invasive, real-time, and intermittent monitoring of relative compartment compressibility.
The device combines a linear ultrasound array with an integrated pressure sensor into a single handheld probe (CP Probe) to obtain cross-section ultrasound views of the compartment of interest. The device provides a surrogate metric of the compartment's compressibility in one ultrasound image plane only, using a linear measurement of distance between two points of the compartment, as a function of applied external pressure.
Based on this measurement, a relative compartment compressibility value is calculated and displayed on-screen as the CP Value.

The provided text does not contain detailed information about the acceptance criteria or a specific study proving the device meets those criteria with a comparison table. The "Performance Data" section lists several types of testing performed but does not quantify acceptance criteria or present the results in a comparative manner with specific metrics.

However, based on the types of performance data mentioned and the overarching purpose of a 510(k) submission, we can infer some general categories of acceptance criteria and the nature of the "studies" conducted.

Here's an attempt to answer the questions based on the available information, noting where details are not provided:

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

The document does not provide a table of acceptance criteria with specific quantitative targets and corresponding reported device performance for the CPM#1 System's functional output (CP Value). It lists types of tests conducted:

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

• CP Value Performance (Clinical Testing): "A study was performed to validate the repeatability and reproducibility of the CPM#1 System relative compartment compressibility measurements in healthy volunteers."
  • Sample Size: Not specified.
  • Data Provenance: Not specified (country of origin or retrospective/prospective). Given it's a "study...in healthy volunteers," it is typically prospective.
• CP Value Performance (Bench Test Model): "The accuracy, repeatability, and reproducibility of the CP Value was confirmed using an in-vitro bench test model."
  • Sample Size: Not specified (for the bench test).
  • Data Provenance: Not applicable as it's an in-vitro test.

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. The device measures "relative compartment compressibility" (CP Value) as a direct output. The ground truth for CP Value performance would likely come from established measurement techniques/standards for compressibility in the bench model, and the clinical study would assess repeatability and reproducibility of the device's own measurements, not against an expert-established ground truth for a diagnostic interpretation.

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

Not applicable. This type of adjudication method is relevant for studies where expert interpretation or consensus is required to establish ground truth for a diagnostic task. The CPM#1 System directly measures a physical property (compressibility) and its performance is assessed based on the accuracy, repeatability, and reproducibility of these measurements.

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 comparative effectiveness study was mentioned. The device is not an AI-assisted diagnostic tool that human readers would use to improve their performance over a baseline. It is a measurement device.

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

Yes, the various performance tests listed (Biocompatibility, Electrical Safety, Usability, Cleaning and Disinfection, Ultrasound Performance, and particularly CP Value Performance) describe the standalone performance of the device and its algorithms. The CP Value is "calculated and displayed on-screen as the CP Value" by the device itself.

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

• CP Value Performance (in-vitro): The ground truth for accuracy, repeatability, and reproducibility would be established by the design specifications of the device and reference standards or methods for measuring compressibility in the bench model.
• CP Value Performance (clinical): The clinical study assessed the repeatability and reproducibility of the device's own measurements in healthy volunteers, rather than comparing against a clinical "ground truth" diagnosis, as the "CP Value is not meant for trend analysis" and not for diagnosis of compartment syndrome.

8. The sample size for the training set

Not applicable. This device does not appear to be an AI/machine learning-based diagnostic device that requires a training set in the conventional sense. Its "performance" relies on the accuracy and precision of its physical sensors and calculations.

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

Not applicable, as it's not an AI/machine learning device with a training set.

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