(263 days)
The Optovent™ RR 9700 is intended as an adjunct to patient assessment and is used to continuously monitor the respiratory rate of adult patients. The device is intended to be used by qualified health care professionals trained in the use of the equipment. The device is not intended for home use.
Not Found
This appears to be a 510(k) clearance letter from the FDA for a medical device called the "Optovent™ RR 9700 Respiratory Monitor." The provided document is a regulatory approval, not a detailed study report. Therefore, most of the requested information about acceptance criteria, study design, and ground truth is not present in this document.
The document confirms that Optovent™ RR 9700 is considered substantially equivalent to a legally marketed predicate device, allowing it to proceed to market. This substantial equivalence is based on the device's indications for use and a comparison to existing devices, implying that the device meets some level of performance and safety comparable to these predicates. However, the specific acceptance criteria and the detailed study proving they are met are not described in this letter.
Here's a breakdown of what can and cannot be answered based solely on the provided text:
1. A table of acceptance criteria and the reported device performance
- Not provided in the document. This document is an FDA clearance letter, not a performance study report. It states that the device is "substantially equivalent" to predicate devices, implying it meets comparable performance and safety standards, but the specific metrics are not detailed.
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not provided in the document. No information about a test set sample size, data provenance, or study design is included.
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)
- Not provided in the document. There is no mention of ground truth establishment or experts in this regulatory letter.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not provided in the document. This level of detail regarding a test set or adjudication is not present.
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
- Not applicable/Not provided. This device is a "Respiratory Monitor," likely a sensor or a device that directly measures a physiological parameter (respiratory rate), not an AI-driven image analysis tool for human readers. Therefore, an MRMC study comparing human readers with and without AI assistance is unlikely and not mentioned.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable/Not provided. Given that the device is a "Respiratory Monitor R 9700" and "is intended as an adjunct to patient assessment," it implies a device that generates data for healthcare professionals, rather than an AI algorithm acting in a standalone capacity that would typically require such a study.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not provided in the document. There is no mention of how any ground truth was established for performance validation. For a respiratory monitor, ground truth would typically refer to a highly accurate reference method for measuring respiratory rate, but this is not detailed.
8. The sample size for the training set
- Not provided in the document. There is no mention of a training set, which would be relevant for machine learning algorithms, but this device appears to be a direct physiological monitor.
9. How the ground truth for the training set was established
- Not provided in the document. As above, no mention of a training set or its ground truth.
§ 868.2375 Breathing frequency monitor.
(a)
Identification. A breathing (ventilatory) frequency monitor is a device intended to measure or monitor a patient's respiratory rate. The device may provide an audible or visible alarm when the respiratory rate, averaged over time, is outside operator settable alarm limits. This device does not include the apnea monitor classified in § 868.2377.(b)
Classification. Class II (performance standards).