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The Pocket Fetal Doppler (Models CONTEC10C and CONTEC10CL) is used to detect the fetal heart rate. The device should be used by health care professionals including nurses, midwives, and specialized technicians in the hospital, clinic, community and home. The device is intended for use at or after 12 weeks gestation.

The Pocket Fetal Doppler is a hand-held FHR detection device, it is used for non-invasive measurement and display of the fetal heart rate (FHR) utilizing Doppler ultrasound. The Pocket Fetal Doppler consists of two models (CONTEC10C, CONTEC10CL). Both models have two hand-held components, a main unit and a probe. The device contains components of ultrasonic signal transmitter and receiver, analog signals processing unit, FHR calculating unit, and LCD display control unit.

The provided text is a 510(k) Premarket Notification for a Pocket Fetal Doppler. It details the device's characteristics, indications for use, comparison to a predicate device, and results of non-clinical testing. However, it does not include information about acceptance criteria for performance metrics (beyond resolution and accuracy values), NOR does it describe a study involving human readers or experts to prove the device meets these criteria.

Therefore, many of the requested points cannot be extracted from the provided text.

Based on the information available:

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

The document provides performance specifications for the device and a predicate, but doesn't explicitly state "acceptance criteria" in a pass/fail sense in this section. It lists the device's performance characteristics.

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

Not provided in the document. The testing described is non-clinical performance and safety testing, not human use studies with a test set of data.

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. No human experts were used for a test set in the context of device performance claims based on this document. The testing focused on device specifications and compliance with standards.

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

Not applicable. No test set involving human interpretation/adjudication was described.

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 device is a direct measurement tool (Fetal Doppler) and does not involve AI assistance or human interpretation/improvement studies as described in the document.

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

This largely describes the type of testing performed. The device's performance (FHR range, resolution, accuracy) was tested in a standalone capacity against specifications, not as part of an algorithm's performance in image interpretation. The testing validated the device's ability to measure FHR.

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

For the device performance metrics (FHR range, resolution, accuracy), the "ground truth" would be established by calibrated measurement equipment and reference standards typically used in medical device testing, not biological ground truth like pathology or outcomes.

8. The sample size for the training set

Not applicable. This document does not describe the development or testing of an AI algorithm with training data.

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

Not applicable. No training set for an AI algorithm was described.

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