(169 days)
The Spirovit SP-250 can be used to measure Forced Vital Capacity (FVC), Forced Expiratory Volume in one second (FEV1), FEV 10/ FVC, FEF 0.2.1.2, FEF 25.75%, FEF 75.85% , PEF 50%, FEF 50%, FEF 75%, FIVC, FIV 10, FIV 10 / FIVC, PIF, FIF 50%, SVC, ERV, IRV, TV, MVV, RR, TV, in patients 6 years of age or older.
Not Found
Here's an analysis of the provided text to extract the acceptance criteria and study details for the SPIROVIT SP-250 device:
Acceptance Criteria and Device Performance
The document does not explicitly state quantitative "acceptance criteria" for the device's performance in terms of accuracy for the spirometry measurements (FVC, FEV1, etc.). Instead, the device's performance is asserted by demonstrating compliance with existing standards and deeming it "as safe and effective as the Predicate (SP-100) Device."
However, the "Non-Clinical Tests B1" section implicitly sets compliance with certain standards as the acceptance criteria. Based on the provided text, the criteria and the device's reported performance are:
| Acceptance Criteria (Standard Compliance) | Reported Device Performance |
|---|---|
| ATS Spirometry Statement Medical Section of the American Lung Association November - 11th 1994 | All tests passed |
| IEC 601-1-1 (Safety) | All tests passed |
| IEC 601-1-2 (EMC) | All tests passed |
| IEC 601-1-4 (Software Quality) | All tests passed; review of software development process compliant with "reviewer guidance for computer controlled medical devices undergoing 510 (k) review" |
Study Information
Based on the provided text, there is no detailed information about a clinical study with a test set, ground truth experts, or training data. The document explicitly states:
- B2 Clinical Tests: n.a. (not applicable)
This indicates that a formal clinical study, as one might expect for a diagnostic device with specific performance metrics, was not conducted or at least not reported in this 510(k) summary. The submission relies on non-clinical testing and substantial equivalence to the predicate device.
Given the "n.a." for clinical tests, the following points cannot be answered from the provided document:
- Sample size used for the test set and the data provenance: Not applicable (no clinical test set described).
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable (no clinical test set described).
- Adjudication method for the test set: Not applicable (no clinical test set described).
- 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: Not applicable (no clinical study, no mention of AI assistance).
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable (no standalone performance study described beyond compliance with technical standards).
- The type of ground truth used: Not applicable (no clinical test set described).
- The sample size for the training set: Not applicable (no training set described for an algorithm, as this is a device for vital capacity measurement, not an AI/ML diagnostic).
- How the ground truth for the training set was established: Not applicable.
Summary of Device Proving Acceptance:
The device, SPIROVIT SP-250, proves it meets its "acceptance criteria" by demonstrating compliance with established medical and electrical safety standards: the ATS Spirometry Statement, IEC 601-1-1 (Safety), IEC 601-1-2 (EMC), and IEC 601-1-4 (Software Quality). The submission asserts that "All tests are passed." The FDA's 510(k) clearance is based on this non-clinical testing and the device's substantial equivalence to a legally marketed predicate device (SPIROVIT SP-100), rather than a specific clinical performance study detailing accuracy metrics.
§ 868.1840 Diagnostic spirometer.
(a)
Identification. A diagnostic spirometer is a device used in pulmonary function testing to measure the volume of gas moving in or out of a patient's lungs.(b)
Classification. Class II (performance standards).