Search Results

The ResQPOD Circulatory Enhancer is indicated for home, hospital, clinic and emergency care use, for the temporary increase in blood circulation as directed by a physician or licensed practitioner.

The modified ResQPOD Circulatory Enhancer (CE) device is mechanically and functionally equivalent to the unmodified, predicate ResQPOD CE reviewed and cleared for market in 510(k) K022906. This 510(k) submission was provided to review the following feature additions:
a) The addition of timing assist lights as a convenience to encourage proper inspiration rate through the ResQPOD CE;
b) Modified labeling to support use of the ResQPOD CE on alternative adjunctive airway devices, such as a mouthpiece, facemask with an ISO standard 22 mm connector, and endotracheal tube;
c) Provision for an ISO standard 15 mm to 22 mm adapter connector between the ResOPOD CE and the mouthpiece or facemask; and
d) Modified labeling to support use of the ResOPOD CE in clinic and emergency care locations with patients who, in the judgment of a physician or licensed professional, may need circulatory enhancement as provided by the ResQPOD CE.

The provided text describes a 510(k) submission for a modified ResQPOD™ Circulatory Enhancer. It outlines the changes made to the device and asserts its substantial equivalence to a predicate device. However, the document does not contain the detailed information requested regarding specific acceptance criteria, study designs, sample sizes, ground truth establishment, or expert involvement.

Here's a breakdown of what can be extracted and what is missing:

1. Table of Acceptance Criteria and Reported Device Performance

Missing. The document states that "The safety and effectiveness of use of the modified ResQPOD CE device was demonstrated by testing in compliance with the Design Control process." However, it does not specify what those acceptance criteria were (e.g., specific performance metrics, thresholds) nor does it report any quantitative performance results from such testing.

2. Sample Size Used for the Test Set and Data Provenance

Missing. The document refers to "testing in compliance with the Design Control process" but does not provide any specifics about a test set, its sample size, or the provenance of the data (e.g., country of origin, retrospective/prospective).

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications

Missing. Given that no specific test set or performance evaluation is detailed, there is no mention of experts establishing ground truth.

4. Adjudication Method for the Test Set

Missing. No information on adjudication methods is present.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

Missing. There is no mention of an MRMC study or any comparative effectiveness study involving human readers.

6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) Was Done

Missing. This device is a mechanical circulatory enhancer, not an algorithm. Therefore, the concept of "standalone algorithm performance" is not applicable here.

7. The Type of Ground Truth Used

Missing. As no specific performance data or studies are detailed, the type of ground truth used is not mentioned.

8. The Sample Size for the Training Set

Missing. No training set is mentioned as this device is not a machine learning algorithm.

9. How the Ground Truth for the Training Set Was Established

Missing. Not relevant as it's not an AI/ML device.

Summary of available information related to acceptance criteria and study:

The document states that the modified device is "mechanically and functionally equivalent to the unmodified, predicate ResQPOD CE" and that its "intended use and technology...is substantially equivalent to the predicate, unmodified device." The primary basis for the 510(k) submission is to review feature additions and modified labeling, not to demonstrate new performance insights through extensive clinical trials.

The "study" referred to is the internal "testing in compliance with the Design Control process." This implies that the device satisfied internal design verification and validation requirements, but these are not explicitly detailed in terms of public acceptance criteria or reported performance metrics within this 510(k) summary. The FDA's letter acknowledges this submission as a review for "substantial equivalence" to the predicate device, meaning its safety and effectiveness are deemed comparable, without requiring extensive new clinical performance data to be presented in this document.

Ask a specific question about this device