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Androflo™ is intended for use as an adjunct to patient assessment in continuous monitoring of respiratory rate (breathing frequency).

Androflo™ is indicated for clinical use in adult patients under the supervision of qualified health care professionals trained in the use of the equipment.

Androflo™ is not intended for home use or for use as an apnea monitor.

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The provided text is a 510(k) clearance letter from the FDA for a device called "ANDROFLOW-RESPIRATORY RATE MONITOR." It confirms that the device has been found substantially equivalent to a predicate device. However, this document does not contain any information regarding acceptance criteria, device performance studies, sample sizes, ground truth establishment, or expert qualifications.

Therefore, I cannot fulfill your request for this information based on the provided text. To answer your questions, I would need a different document, such as a summary of safety and effectiveness (SSE) or a clinical study report that was part of the 510(k) submission.

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The i-Stethos Link Electronic Stethoscope is intended for the purpose of electronically amplifying and listening to biological sounds, such as those produced by the heart, lungs, arteries and veins, and other internal organs and systems. The i-Stethos Link may also be used to display the heart rate, which is calculated as the number of heartbeats per minute.

In addition, the i-Stethos Link is equipped with an analog I/O port to interface with external devices such as a computer and to accept input from other compatible devices such as the biological sound monitor (BSM) sensor or another i-Stethos Link.

The i-Stethos Link Electronic Stethoscope is indicated for use under the same conditions that would otherwise require the use of an acoustic (non-electronic) stethoscope.

The i-Stethos Link Electronic Stethoscope is not intended as a substitute for medical care or for diagnosis and treatment by unlicensed or unqualified persons.

Not Found

The provided document is a 510(k) premarket notification letter for the i-Stethos Link Electronic Stethoscope. This document focuses on demonstrating substantial equivalence to a predicate device and does not contain information about specific performance acceptance criteria, detailed study designs, or results from such studies (like multi-reader multi-case studies, standalone performance, training sets, or adjudication methods). It is primarily a regulatory clearance document.

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

The document does not include:

• A table of acceptance criteria and reported device performance.
• Sample sizes used for the test set or data provenance.
• Number and qualifications of experts for ground truth.
• Adjudication method for the test set.
• Results from a multi-reader multi-case comparative effectiveness study.
• Standalone performance data.
• Type of ground truth used (e.g., pathology, outcomes data).
• Sample size for the training set.
• How ground truth for the training set was established.

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The Biological Sound Monitor Sensor is intended for the purpose of capturing, detecting and transmitting biological sounds such as those produced by the heart, lungs, arteries and veins, and other internal organs and systems. The Biological Sound Monitor Sensor may be used with any compatible devices that may amplify biological sound signals for auscultation, display or further processing.

The Biological Sound Monitor Sensor is indicated for use with children and adults under the supervision of a physician or other trained health care professional. It is indicated for use during routine exam in clinical or other suitably prescribed environment in conjunction with such devices as an electronic stethoscope.

In no way are any of the sensor functions represented as being in and of themselves diagnostic. Sound signals must be reviewed and interpreted by a physician or other trained health care professional who will exercise professional judgment in using this information.

Biological Sound Monitor (BSM) Sensor

This document is a 510(k) clearance letter for the "Biological Sound Monitor (BSM) Sensor". It does not contain information about acceptance criteria or a study proving the device meets them. The document primarily confirms that the FDA finds the device substantially equivalent to legally marketed predicate devices.

Therefore, I cannot fulfill your request for:

1. A table of acceptance criteria and the reported device performance
2. Sample size used for the test set and the data provenance
3. Number of experts used to establish the ground truth for the test set and their qualifications
4. Adjudication method for the test set
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done
6. If a standalone performance study was done
7. The type of ground truth used
8. The sample size for the training set
9. How the ground truth for the training set was established

Ask a specific question about this device

Ask a specific question about this device

Ask a specific question about this device