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Curbell patient cables are used to connect electrodes and/or sensors placed at the appropriate sites on the patient to a monitoring device for general monitoring and/or diagnostic evaluation by a healthcare professional.

Curbell Patient Monitoring Cables comprise cables and lead wires that connect from sensors and/or electrodes to a monitor for the purpose of conducting ECG diagnosis, monitoring, and SPO2 monitoring. As per 21CFR801.109, this device is a prescription device.

The provided text describes the regulatory clearance of "Curbell Patient Monitoring Cables" (K182220) and outlines the product's characteristics, intended use, and substantial equivalence to predicate devices. However, the text does not contain information about acceptance criteria or a study that proves the device meets specific performance criteria in the format requested.

The document focuses on demonstrating substantial equivalence to predicate devices through comparisons of intended use, technological characteristics, and compliance with recognized standards for biocompatibility, electrical performance, and electrical safety. It lists the standards that the device has been assessed against (e.g., ANSI/AAMI EC53:2013, IEC 60601-1:2005) and the types of tests performed (e.g., cable and lead wire noise, flex life, tensile strength, connector retention force, contact resistance, dielectric withstand voltage).

The submission is a 510(k) premarket notification, which is a regulatory pathway to demonstrate that a device is as safe and effective as a legally marketed predicate device. This process typically relies on comparing the new device to existing ones rather than presenting novel clinical performance data or statistically robust performance studies with detailed acceptance criteria and ground truth establishment as outlined in your request.

Therefore, I cannot provide the requested information in the specified format because it is not present in the provided text.

Here's an explanation of why each point of your request cannot be fulfilled based on the given document:

1. A table of acceptance criteria and the reported device performance: While the document lists standards (e.g., ANSI/AAMI EC53:2013) that the device was assessed against, it does not provide specific numerical acceptance criteria (e.g., "noise must be less than X dB") nor the actual measured performance values of the Curbell Patient Monitoring Cables. It only states that the device "have been assessed to" these standards and that engineering verification and validation protocols have been used.

2. Sample size used for the test set and the data provenance: The document mentions "Engineering Verification and Validation Protocols" and "Inspection Report" but does not specify the sample sizes used for testing nor the provenance of any data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: This information is not applicable and not provided for a device like patient monitoring cables. Ground truth relevant to expert opinion is typically associated with diagnostic or prognostic devices where clinical interpretation is paramount. For cables, performance is primarily assessed against engineering and safety standards.

4. Adjudication method for the test set: This is not applicable and not provided for the same reasons as point 3.

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: This is not applicable. The device is patient monitoring cables, not an AI-powered diagnostic or assistive tool.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: This is not applicable. The device is patient monitoring cables, not an algorithm.

7. The type of ground truth used: For a device like patient monitoring cables, the "ground truth" is defined by compliance with established engineering and safety standards (e.g., electrical safety, biocompatibility, mechanical integrity like flex life and tensile strength). The document indicates assessment against these standards (IEC 60601-1, ANSI/AAMI EC53, ISO 10993). However, it does not explicitly detail how the "ground truth" for each specific test parameter was established beyond referencing these standards.

8. The sample size for the training set: This is not applicable as the device is not an AI/ML algorithm that requires a training set.

9. How the ground truth for the training set was established: This is not applicable as the device is not an AI/ML algorithm.

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