(33 days)
The Spiro-Ball is a product for use in respiratory therapy and for adult people. It is intended for a single patient use, and it can be used both in the medical center and out of it (homecare therapies).
SPIRO-BALL is a Volumetric Incentive Spirometer. It is a nonsterile device, which operates by inspiration, that lifts the piston placed inside the chamber.
The provided text is a 510(k) summary for the SPIRO-BALL Incentive Spirometer. It describes the device, its intended use, and its substantial equivalence to a predicate device. However, it does not contain specific acceptance criteria or a study detailing device performance against such criteria.
Therefore, I cannot provide a table of acceptance criteria and reported device performance from this document. I also cannot describe the sample sizes, data provenance, expert ground truth details, adjudication methods, MRMC study results, or training set information because these details are not present in the provided text.
Here's what I can extract and what is explicitly stated:
1. A table of acceptance criteria and the reported device performance:
- Not provided in the document. The document states: "Non-clinical tests have been performed in SPIRO-BALL to confirm that the device complies the established specifications. These tests have been done on products in normal conditions of use, but also in products subjected to extreme conditions of use." However, the specific established specifications (acceptance criteria) and the results of these tests (reported device performance) are not detailed.
2. Sample size 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. The document mentions "non-clinical tests" but does not specify sample sizes or data provenance.
- Clinical tests: The document explicitly states: "Clinical tests have not been performed in SPIRO-BALL."
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. No clinical tests were performed, and no external ground truth establishment is described for the non-clinical tests.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable. No clinical tests or expert review processes are 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. This device is an incentive spirometer, not an AI-powered diagnostic tool. No MRMC study was performed.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This device is a physical medical device, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- For the non-clinical tests, the "ground truth" would be the "established specifications." The document doesn't detail how these specifications were derived or what specific metrics were used.
8. The sample size for the training set:
- Not applicable. No machine learning model or "training set" is relevant to this device's regulatory submission.
9. How the ground truth for the training set was established:
- Not applicable. No machine learning model or "training set" is relevant to this device's regulatory submission.
Summary of available information regarding compliance:
The device's "acceptance criteria" appear to be its "established specifications" as assessed by "Non-clinical tests." The document states: "All the tests performed in SPIRO-BALL (bench tests and physical and biological assays) demonstrate this device operates correctly, is safe for the user and is effective according its intended use." This is the general conclusion, but specific performance metrics are not provided. The basis for clearance is substantial equivalence to a predicate device (DHD EMERALD PRODUCT (COACH 2) K970596), suggesting that its performance is expected to be similar to that legally marketed 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).