(88 days)
The intended device takes spirometer readings of a patient during exhalation. The output readings are FEV1 and FVC.
A hand-held portable electronic spirometer measuring FEV1 and FVC
The provided text is a non-confidential summary of safety and effectiveness for the Micro Spirometer, comparing it to a predicate device, the Spirometrics Model 2600 Micro Spirometer (K901057).
1. A table of acceptance criteria and the reported device performance
Based on the document, the acceptance criteria are implicitly defined by the attributes of the predicate device, which the new device claims to match exactly. The reported device performance is that it matches all acceptance criteria because it is stated: "There is no difference between the intended device and the listed predicate device." and "Exact same unit as supplied to and marketed by Spirometrics and approved under K901057".
| Acceptance Criteria (from Predicate Device - Spirometrics Model 2600) | Reported Device Performance (Micro Spirometer) |
|---|---|
| Intended as a spirometer | Yes |
| Intended to measure lung function FEV1 and FVC | Yes |
| Indicated for measuring patient's lung function | Yes |
| Indicated for use by a clinician in environments such as home or hospital | Yes |
| Manufactured by Micro Medical | Yes |
| Transducer - flow sensing turbine | Yes |
| No output (assumed as in 'no external output' as opposed to 'no data output') | Yes |
| Flow range lps BTPS 0-12 | Yes |
| Volume range liters 0-9.99 | Yes |
| Measures - FVC - FEV1 | Yes |
| Accuracy + / - 3 | Yes |
| Display LCD | Yes |
| Transducer cleaned after use | Yes |
| Utilizes paper mouthpiece | Yes |
| Same materials as K901057 | Yes |
| Performance Testing - None applicable | Yes |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document explicitly states "Performance Testing - None applicable" and later "There is no difference between the intended device and the listed predicate device." This indicates that no new performance testing (and thus no test set or associated data provenance) was conducted for this specific submission to demonstrate the device meets acceptance criteria. The claim of equivalence to the predicate device, which was already approved (K901057), is the basis for approval.
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, as no new performance testing with a test set was conducted for this submission. The device's safety and effectiveness are based on its equivalence to an already approved predicate device.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable, as no new performance testing with a test set was conducted for this submission.
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
Not applicable. This device is a diagnostic spirometer, not an AI-powered image analysis tool or a device requiring human reader interpretation in the context of an MRMC study.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is a physical diagnostic device, not an algorithm, and its performance is assessed against established spirometry standards, not in an AI standalone context.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Not explicitly stated for the predicate device's original approval, but for spirometers, ground truth is typically established against calibrated flow/volume simulators and established clinical guidelines for spirometry. For this specific submission, the "ground truth" for the new device's acceptability is its equivalence to the predicate device (Spirometrics Model 2600 Micro Spirometer).
8. The sample size for the training set
Not applicable. This is not an AI/ML device that requires a training set.
9. How the ground truth for the training set was established
Not applicable, as there is no training set for this device.
§ 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).