(281 days)
The ResQPOD™ Circulatory Enhancer is indicated for use in people with poor circulation. The ResQPOD™ Circulatory Enhancer is indicated for home and hospital use for the temporary increase in blood circulation as prescribed by a physician or licensed practitioner.
The ResQPOD Circulatory Enhancer is a patient powered pump that uses a person's own negative intrathoracic pressures to create a vacuum in the chest cavity. The vacuum allows the heart to preload with more blood, thereby increasing blood circulation.
The provided text is a 510(k) summary for the ResQPOD™ Circulatory Enhancer and the associated FDA approval letter. It outlines the device description, intended use, predicate devices, and a non-clinical test summary. However, it does not contain detailed information about acceptance criteria, specific device performance metrics, the setup of a study proving those metrics, sample sizes, expert qualifications, adjudication methods, or direct comparisons with human readers.
Therefore, many of the requested categories cannot be filled from the provided text.
Here's what can be extracted and what cannot:
1. A table of acceptance criteria and the reported device performance
- Acceptance Criteria: Not specified in the document.
- Reported Device Performance: The document states "Animal studies demonstrated an increase in circulation with the use of the ResQPOD Circulatory Enhancer device." This is a qualitative statement, not a quantitative performance metric.
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not specified | Animal studies demonstrated an increase in circulation with the use of the ResQPOD Circulatory Enhancer device. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size (Test Set): Not specified. The study mentioned is "animal studies," so the "test set" would refer to the animals in these studies.
- Data Provenance: Not specified, beyond being "Animal studies." It doesn't mention country of origin, retrospective, or prospective.
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. The study mentioned is an animal study demonstrating an increase in circulation. Ground truth in this context would likely be physiological measurements, not expert interpretation of outputs.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
- Not applicable. Adjudication methods are typically used for subjectively interpreted data by human experts, which is not the case for animal studies measuring physiological responses.
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. This is explicitly not an AI device and not an MRMC study. The device is a patient-powered pump designed to physically enhance circulation.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
- The device is a physical circulatory enhancer, not an algorithm. So, this question is not applicable.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- The ground truth in the "animal studies" would have been physiological measurements demonstrating an increase in circulation, likely direct measurements of blood flow or pressure, rather than expert consensus, pathology, or outcomes data in the traditional sense of diagnostic devices.
8. The sample size for the training set
- Not applicable. This is not a machine learning/AI device, and thus there is no "training set" in the computational sense. The "animal studies" were likely part of the investigational work to confirm the device's mechanism of action.
9. How the ground truth for the training set was established
- Not applicable, as there is no training set for an AI device.
§ 868.5690 Incentive spirometer.
(a)
Identification. An incentive spirometer is a device that indicates a patient's breathing volume or flow and that provides an incentive to the patient to improve his or her ventilation.(b)
Classification. Class II (performance standards).