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AirStrip OB® is intended to be used by Obstetricians for the following purposes:
To more rapidly and thoroughly respond to a nurse call regarding fetal heart tracings or maternal contraction patterns by viewing the real time waveforms remotely using a Windows-based handheld device
To proactively review a fetal heart or maternal contraction tracing of a patient in Labor and Delivery for whom they are responsible but are unable to be present in the hospital at that time.
To review the current Labor and Delivery patient census list.
Provide a request for remote consultation regarding a fetal heart tracing.
To remotely review other standard or critical real-time numeric data from Labor and Delivery.

Not Found

I am sorry, but based on the provided text, I cannot provide the detailed information requested regarding the acceptance criteria and the study that proves the device meets them.

This document is a 510(k) clearance letter from the FDA, which primarily states that the product AirStrip OB® Remote Data Viewing software is substantially equivalent to a legally marketed predicate device. While it lists the indications for use, it does not contain details about specific acceptance criteria or the study design and results that would demonstrate the device meets those criteria.

Therefore, I cannot extract the following information from the provided text:

1. A table of acceptance criteria and the reported device performance: This information is not present.
2. Sample size used for the test set and the data provenance: Not mentioned.
3. Number of experts used to establish the ground truth for the test set and their qualifications: Not mentioned.
4. Adjudication method for the test set: Not mentioned.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, and its effect size: Not mentioned.
6. If a standalone performance study was done: Not mentioned.
7. The type of ground truth used: Not mentioned.
8. The sample size for the training set: Not mentioned.
9. How the ground truth for the training set was established: Not mentioned.

To obtain this information, you would typically need to review the actual 510(k) submission summary or predicate device documentation, which would include the performance data and methodology used to demonstrate substantial equivalence.

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AirStrip OB® is intended to be used by Obstetricians for the following purposes
To more rapidly and thoroughly respond to a nurse call regarding fetal heart tracings or maternal contraction patterns by viewing the real time waveforms remotely using a Windows-based handheld device
To proactively review a fetal heart or maternal contraction tracing of a patient in Labor and Delivery for whom they are responsible but are unable to be present in the hospital at that time
To review the current Labor and Delivery patient census list
Provide a request for remote consultation regarding a fetal heart tracing
To remotely review other standard or critical real-time numeric data from Labor and Delivery

Not Found

This document is a 510(k) premarket notification acceptance letter for the AirStrip OB Remote Data Viewing software. It acknowledges the substantial equivalence of the device to legally marketed predicate devices.

However, the provided text does not contain acceptance criteria for the device, nor a study proving it meets such criteria.

The document primarily focuses on the regulatory approval process, stating that the device is substantially equivalent to existing devices and can therefore be marketed. It lists the "Indications for Use" for the AirStrip OB® Remote Data Viewing software, which describe how the device is intended to be used by obstetricians, but these are not performance acceptance criteria.

Therefore, I cannot provide the requested information from the given input.

Ask a specific question about this device

AirStrip OB® is intended to be used by Obstetricians for the following purposes:

• To more rapidly and thoroughly respond to a nurse call regarding fetal heart tracings or maternal contraction by viewing the real time waveforms remotely using a mobile device such as a PDA or Smart Phone
• To proactively review a fetal heart or maternal contraction tracing of a patient in Labor and Delivery for whom they are responsible but are unable to be present in the hospital at that time.
• To review the current Labor and Delivery patient census list.
• Provide a request for remote consultation regarding a fetal heart tracing.
• To remotely review other standard or critical real-time numeric data from Labor and Delivery.

Not Found

This document is a 510(k) clearance letter for the AirStrip OB® device. It does not contain information about acceptance criteria or a study proving the device meets acceptance criteria. The letter acknowledges that the device is substantially equivalent to legally marketed predicate devices for its stated indications for use.

Therefore, I cannot provide the requested information from the provided text.

Ask a specific question about this device