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This product will be used to detect fetal heartbeats to help determine fetal viability.

OB1 Obstetrical Doppler is a handheld, internally-powered Doppler audio instrument used for detecting fetal heart beats. There are only four user controls; Up and Down audio volume, Freeze Display, and Power On/Off. A three inch loudspeaker provides good Doppler audio. A digital LCD readout shows the fetal heart rate when it is stable for three or four seconds.

The provided text is a 510(k) summary for the OB1 Obstetrical Doppler, a handheld fetal Doppler. However, it does not contain the detailed information necessary to answer all parts of your request regarding acceptance criteria and a specific study proving the device meets those criteria.

The 510(k) summary focuses on demonstrating substantial equivalence to existing predicate devices. This means the manufacturer is asserting their device is as safe and effective as devices already on the market, rather than conducting a de novo study to establish new performance metrics against specific acceptance criteria.

Here's a breakdown of what can and cannot be answered based on the provided document:

1. Table of acceptance criteria and the reported device performance:

This information is not present in the document. A 510(k) submission for this type of device typically relies on demonstrating that the new device performs similarly to predicate devices, rather than setting and meeting specific, quantifiable acceptance criteria in a dedicated performance study. The "Technology Summary" states, "Recursive filter techniques are used to detect the fetal heart rate displayed on the digital readout. This achieves similar results as the techniques (not published) in the predicate devices." This implies performance is judged by its similarity to existing, cleared devices.

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

This information is not present in the document. Since a specific performance study with a test set is not described, these details are not provided.

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):

This information is not present in the document. As no specific test set or ground truth establishment process is described, this data is unavailable.

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

This information is not present in the document.

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 information is not present in the document. An MRMC study is not mentioned. Also, this device is a handheld fetal Doppler, not an AI-assisted diagnostic tool for "human readers." Therefore, the concept of "human readers improve with AI vs without AI assistance" does not apply directly to this device.

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

This information is not present in the document. The OB1 Obstetrical Doppler is described as a "handheld, internally-powered Doppler audio instrument used for detecting fetal heart beats." It's a direct-use device, and the concept of an "algorithm only" performance study in the context of AI is not relevant here. Its performance would be assessed through its ability to detect fetal heartbeats and display the rate, likely compared to known standards or predicate devices.

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

This information is not present in the document. For a device like this, the "ground truth" for basic function would typically involve physical measurements (e.g., accuracy of heart rate detection against a known signal generator or a highly accurate reference method) rather than a clinical ground truth like pathology.

8. The sample size for the training set:

This information is not present in the document. This type of device relies on established Doppler ultrasound technology and recursive filter techniques, not machine learning or AI models that require a training set in the conventional sense.

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

This information is not present in the document for the reasons explained in point 8.

Summary regarding the provided text:

The 510(k) summary for the OB1 Obstetrical Doppler demonstrates substantial equivalence to predicate devices (Huntleigh Dopplex II, Medasonics Cadance, Summit LifeDop). The "technology summary" highlights that its Doppler ultrasound technology and recursive filter techniques achieve "similar results" to these predicate devices. The review process involved assessing device features, materials, intended use, and performance characteristics in comparison to these already-cleared devices, as is standard for 510(k) submissions.

The clearance letter also mandates a post-clearance special report containing "complete information, including acoustic output measurements based on production line devices." This indicates that quantifiable performance data (specifically acoustic output) was required, but this is a post-market requirement to ensure the manufactured devices conform to the design, not a pre-market study establishing acceptance criteria in the manner you've described for a diagnostic AI device.

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