(210 days)
The Spirotel spirometer and pulse oximeter is intended to be used by a physician or by a patient under the instruction of a physician or paramedic to test lung function in people of all ages. It is also intended to be used as a single-patient device and can be used in any setting – home, factory, pharmacy, hospital or physician's office.
MIR Spirotel is a simple to operate precise pocket spirometer and pulse oximeter (weight only 100g). It measures the most important functional respiratory parameters and monitors the oxygen saturation and pulse rate.
The provided document is a 510(k) summary for the MIR Spirotel device, which combines a spirometer and a pulse oximeter. It details the device's characteristics, intended use, and comparison to predicate devices, but it does not contain detailed acceptance criteria or a multi-reader multi-case (MRMC) comparative effectiveness study.
However, it does mention standalone performance testing. Here's what can be extracted and inferred based on the provided text:
Acceptance Criteria and Reported Device Performance
The document generally states compliance with standards rather than specific numerical acceptance criteria.
| Acceptance Criteria Category | Reported Device Performance (as stated or inferred) |
|---|---|
| Spirometry Performance | "Testing was performed according with American Thoracic Society (ATS) Standards. The results obtained were within the range of accuracy required by ATS." |
| Pulse Oximetry Performance | "For oximetry testing a desaturation trial was conducted. The results obtained were within specification." |
| Safety and Environmental Compliance | "Safety and environmental testing was conducted in accordance with EN 60601-1:1990... The MIR Spirotel is in compliance with the guideline and standards referenced and that it performs within its specifications." (Covers EMC, electrical, mechanical durability, safety, temperature/humidity). |
Study Details
The document describes performance testing for both spirometry and pulse oximetry.
1. Sample size used for the test set and the data provenance:
- Test Set Sample Size: Not specified for either spirometry or pulse oximetry. The document only mentions "clinical testing."
- Data Provenance: Not specified. It's unclear if the testing was retrospective or prospective, or the country of origin of the data.
2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not specified. The document only states that spirometry testing was against "American Thoracic Society (ATS) Standards" and oximetry results were "within specification," implying comparison to a reference standard, but it doesn't detail human expert involvement in establishing ground truth for the test data itself.
3. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable/Not specified. The testing described focuses on device performance against established standards rather than diagnostic agreement adjudicated by multiple experts.
4. If a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was done:
- No. The document does not describe an MRMC study comparing human readers with and without AI assistance. The device is a measurement tool (spirometer and pulse oximeter), not an AI-based diagnostic interpretation tool.
- Effect size improvement without AI: Not applicable, as no MRMC study was conducted, and the device itself is a measurement tool, not an AI for human reader assistance.
5. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Yes. The described clinical testing for both spirometry and pulse oximetry appears to be standalone performance testing of the device itself against established standards or specifications. The document states:
- "Testing of device performance included clinical testing of both spirometry and pulse oximetry functions."
- "Spirometry testing was performed according with American Thorotic Society (ATS) Standards. The results obtained were within the range of accuracy required by ATS."
- "For oximetry testing a desaturation trial was conducted. The results obtained were within specification."
6. The type of ground truth used:
- Spirometry: Inferred to be a reference standard compliant with "American Thoracic Society (ATS) Standards." This typically involves a highly accurate and calibrated spirometer as a reference.
- Pulse Oximetry: Inferred to be a reference standard for oxygen saturation measurement during a "desaturation trial." This usually involves co-oximetry (blood gas analysis) for accurate SpO2 reference values.
7. The sample size for the training set:
- Not applicable/Not specified. The Spirotel described here is a hardware device for measurement, not an AI/machine learning algorithm that requires a training set in the conventional sense.
8. How the ground truth for the training set was established:
- Not applicable. (See point 7).
§ 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).