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The Ultrasonic TableTop Doppler is intended to be used by health care professionals including registered nurses, practical nurses, midwives, ultrasound technicians, and physician assistants, by prescription from licensed physicians in hospitals, clinics and private offices. The 2 MHz and/or 3 MHz 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.

Ultrasonic TableTop Doppler (Models SD5, SD6) provides the following primary features:

• Basic parameters: FHR
• 240 seconds fetal heart sound record and playback
• Infrared communication(for SD6 only)
• Ni-MH battery for 20 hours continuous working of main unit
• Li-ion battery for 2.5 hours continuous working of SD6 probe
• Charge the SD6 probe battery by main unit
• Continuous wave Doppler transducer for FHR detection

Here's a breakdown of the acceptance criteria and the study information for the Edan Instruments, Inc. Ultrasonic TableTop Doppler (Models SD5 and SD6), based on the provided text:

Based on the provided text, the submission is a 510(k) Summary of Safety and Effectiveness, which aims to demonstrate substantial equivalence to predicate devices rather than proving performance against specific acceptance criteria in a clinical study with detailed performance metrics. Therefore, the "acceptance criteria" here refer to the regulatory standard of substantial equivalence, and the "study" is the overall verification and validation testing, not a traditional clinical trial with a test set, ground truth, and statistical analysis of performance metrics.

Acceptance Criteria and Reported Device Performance

Study Details (Based on the provided 510(k) summary)

The provided document describes a 510(k) premarket notification, which focuses on demonstrating substantial equivalence to previously cleared devices rather than a standalone clinical performance study with explicit acceptance criteria for diagnostic accuracy. Therefore, many of the typical elements of a clinical study, such as specific sample sizes for test sets, expert-established ground truth, adjudication methods, or MRMC studies, are not detailed in this summary.

1. Sample size used for the test set and the data provenance:

   • Sample Size: Not specified in the provided summary.
   • Data Provenance: Not specified. The document only mentions "Verification and validation testing."

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

   • Not specified. The 510(k) summary does not detail the methodology for establishing ground truth for any specific performance metrics.

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

   • Not specified.

4. 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. This device is a fetal heart rate Doppler, not an AI-assisted diagnostic tool for image interpretation by human readers.

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

   • The document implies general "Hardware testing" and "Software testing," but it does not specify a standalone performance study in the context of an algorithm's diagnostic accuracy. The device itself is a standalone fetal Doppler used by healthcare professionals.

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

   • Not specified. The "Test Summary" only lists generic quality assurance measures like "Software testing," "Hardware testing," "Safety testing," "Environment test," and "Risk analysis." For a fetal Doppler, ground truth might involve comparisons against other established methods for FHR detection, but the details are not provided.

7. The sample size for the training set:

   • Not applicable as this documentation pertains to a traditional medical device (fetal Doppler) and not an AI/ML algorithm that requires a training set.

8. How the ground truth for the training set was established:

   • Not applicable.

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