(343 days)
The Respifit S is indicated for use as a training device used for conducting strength and endurance training by breathing into a patient module that contains an aperture. The purpose of this training is to improve inspiratory muscle strength and endurance. Training with the Respifit S can be performed in adults and patients with neuromuscular disease and cystic fibrosis in the hospital, clinic and home.
The Respifit S is a portable device for training the respiratory muscles for strength and endurance.
The provided text is a 510(k) summary for a medical device called "Respifit S," an inspiratory muscle trainer. It does not contain a study section describing acceptance criteria or performance data as one would typically find in a detailed study report. The document is primarily focused on establishing substantial equivalence to predicate devices for regulatory approval.
Therefore, for aspects of your request such as "acceptance criteria," "reported device performance," "sample size," "ground truth," "MRMC study," or "standalone study," the information is not available in the provided text. The document only states: "All tests were verified to meet the required acceptance criteria." Without further detail, it's impossible to elaborate on those points.
Here's a breakdown of what can be extracted from the provided text based on your request:
1. A table of acceptance criteria and the reported device performance
This information is not available in the provided text. The document states "All tests were verified to meet the required acceptance criteria" but does not specify what those criteria were or detail the performance metrics.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not available in the provided text. The document mentions "tests" but provides no details about sample sizes, data provenance, or study design.
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)
This information is not available in the provided text. There is no mention of an "expert" review or ground truth establishment for a test set.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not available in the provided text. There is no mention of adjudication methods.
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
This information is not available in the provided text. The Respifit S is described as an "Inspiratory Muscle Trainer" and a "Spirometer," not an AI-assisted diagnostic tool involving human "readers." The document does not describe any MRMC study.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is not available in the provided text. The device is a physical inspiratory muscle trainer, not a standalone algorithm.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
This information is not available in the provided text. There is no mention of ground truth types for any testing.
8. The sample size for the training set
This information is not available in the provided text. There is no mention of a "training set" as this device is not an AI/machine learning model.
9. How the ground truth for the training set was established
This information is not available in the provided text. As there is no training set mentioned, there is no explanation of how ground truth was established for it.
§ 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).