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The PD-100 series Ultrasonic Pocket Doppler are intended for use by health care professionals including registered nurses, practical nurses, midwives, ultrasound technicians, and physicians' assistants, by prescription from licensed physicians in hospitals, clinics and private offices. The 2 MHz and 3 MHz obstetrical probes are indicated for the detection of fetal heart rate from early gestation thru delivery and as a general indication of fetal well being. They can also be used to verify fetal heart viability following patient trauma. The 4 MHz, 5 MHz and/or 8 MHz vascular probes are indicated for the detection of blood flow in veins and arteries for assisting in the detection of peripheral vascular disease.

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This is most likely a 510(k) premarket notification letter for the PD-100 Series Ultrasonic Doppler. This type of document generally does not contain acceptance criteria or study results in the detail you are requesting.

Instead, 510(k) submissions demonstrate substantial equivalence to a legally marketed predicate device, often relying on existing validated technology and established performance characteristics rather than novel clinical studies with specific acceptance criteria as you've outlined.

Therefore, many of your questions cannot be answered from the provided text.

Here is what can be inferred or stated about the provided document:

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

• Cannot be provided. This document is a clearance letter, not a detailed technical report or study submission. It does not list specific acceptance criteria or reported device performance metrics in the format requested. The FDA's determination is based on the submission demonstrating substantial equivalence to a predicate device, which inherently means performance is considered "equivalent" to the predicate, but specific performance values are not typically part of the clearance letter itself.

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

• Cannot be provided. This information is not present in the clearance letter.

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)

• Cannot be provided. This information is not present in the clearance letter.

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

• Cannot be provided. This information is not present in the clearance letter.

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

• Cannot be provided. This device is an ultrasonic Doppler, not an AI-assisted diagnostic tool for interpretation by human readers. Therefore, an MRMC study comparing human readers with and without AI assistance is not applicable and would not have been performed.

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

• N/A. This device is a hardware device (ultrasonic Doppler) that produces signals (fetal heart rate, blood flow). It is not an algorithm that performs standalone diagnoses. Its performance is related to its ability to detect these physiological signals, which is then interpreted by a healthcare professional.

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

• Cannot be provided. This information is not present in the clearance letter. For Doppler devices, ground truth often involves comparison to established clinical methods or other validated Doppler devices, but the specific details are not here.

8. The sample size for the training set

• Cannot be provided. This information is not present in the clearance letter and is typically more relevant for machine learning/AI models.

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

• Cannot be provided. Same as above.

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