(52 days)
The ResControl II is intended to be used by clinicians with ResMed flow generators that have software incorporating ResMed's proprietary communication protocol. ResControl II displays data, relays data to a polysomnograph and acts as a manometer. ResControl II also provides functionality for setting flow generator parameters.
The performance and functional characteristics of the ResControll II system includes all the user friendly features of the predicate device. UCU. ResControl II is designed to transfer data from a CPAP or birevel Flow Generator to a polysomnograph display system such as Sommitigica (K971813). ResControl 11 also provides parameter setting of Flow Generators within the hospital or sleep lab facilities.
The provided 510(k) summary for ResControl™ II (K040944) focuses on establishing substantial equivalence to a predicate device (ResMed UCU, K961783) through similar intended use, operating principles, technologies, and manufacturing processes. It states that "Design and Verification activities were performed on the ResControl II as a result of the risk and product requirements. All tests confirmed the product met the acceptance criteria."
However, this submission does not contain specific details about the acceptance criteria nor the study that proves the device meets them. It asserts that such testing was done, but gives no quantitative data, sample sizes, or methods used to establish performance.
Therefore, most of the requested information cannot be extracted from the provided text.
Here's an attempt to answer based on the available information, with specific notes where information is missing:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not provided. The submission states "All tests confirmed the product met the acceptance criteria." | Not provided. No specific performance metrics or values are reported. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Test Set Sample Size: Not provided.
- Data Provenance: 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)
- Not applicable as no specific test set or ground truth establishment method is described for device performance. The submission discusses compliance with guidance documents and risk/product requirements for design and verification.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable as no specific test set or adjudication method for performance evaluation is described.
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
- No MRMC comparative effectiveness study is mentioned. This device is a measurement and control device, not one involving AI for image interpretation or diagnosis.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- The device functions as a data display, relay, manometer, and parameter setting tool for clinicians using flow generators. The concept of "standalone algorithm only" performance as typically applied to diagnostic AI is not directly relevant here. However, the submission implies that the device's functional performance (displaying data, relaying data, acting as a manometer, setting parameters) was verified to meet its specified requirements. No specific standalone performance metrics are provided.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- N/A. The "ground truth" for a device of this nature would likely refer to engineering specifications, accuracy of measurements against calibrated standards, and successful execution of its intended functions. No details on how this "ground truth" was established are provided.
8. The sample size for the training set
- Not applicable. This device is not an AI/ML diagnostic algorithm that would typically require a training set.
9. How the ground truth for the training set was established
- Not applicable. This device is not an AI/ML diagnostic algorithm that would typically require a training set.
§ 868.5905 Noncontinuous ventilator (IPPB).
(a)
Identification. A noncontinuous ventilator (intermittent positive pressure breathing-IPPB) is a device intended to deliver intermittently an aerosol to a patient's lungs or to assist a patient's breathing.(b)
Classification. Class II (performance standards).