(59 days)
The Minispir and Spirolab III spirometers and pulse oximeters are intended to be used by either a physician, respiratory therapist or technician. The devices are intended to test lung function and can make: - spirometry testing in people of all ages, excluding infants and neonates. . - oximetry testing in people of all ages. ● They can be used in any setting.
Minispir is a spirometer and pulse oximeter (optional) connected to a Personal Computer using a USB cable. The device measures a range of respiratory parameters, and the saturation of oxygen in the blood and the heart pulse rate.
The provided text describes a 510(k) premarket notification for the Minispir device, which functions as both a spirometer and a pulse oximeter. The submission aims to demonstrate substantial equivalence to a predicate device (Minispir, K082766).
Here's an analysis of the acceptance criteria and study information provided:
1. Table of Acceptance Criteria and Reported Device Performance:
The document implicitly refers to industry standards as acceptance criteria rather than explicitly listing them.
| Acceptance Criteria (Standard/Guideline) | Reported Device Performance |
|---|---|
| Spirometry: American Thoracic Society (ATS) Standards | "Spirometry testing was performed according with American Thoracic Society (ATS) Standards. The results obtained were within the range of accuracy required by ATS." |
| Oximetry: Required Accuracy (details not specified) | "A clinical investigation has been carried out to validate the new oximetry board. The results demonstrated required accuracy." |
| Safety and Environmental: EN 60601-1:2006 and EN 60601-1-2:2007 (EMC, electrical, mechanical durability, safety (operator and patient), temperature/humidity) | "Testing was done to ensure that the Minispir would perform safely and accurately within the environments for which it is to be marketed... The results demonstrates that the Minispir is in compliance with the guidelines and standards referenced and that it performs within its specifications." |
2. Sample Size Used for the Test Set and Data Provenance:
- Spirometry: No specific sample size for a test set is mentioned. The document states "Spirometry testing was performed according with American Thoracic Society (ATS) Standards." This implies a set of tests conforming to ATS guidelines, but the number of subjects or tests is not provided.
- Oximetry: A "clinical investigation" was carried out for oximetry, but no sample size for this investigation is provided.
- Data Provenance: Not explicitly stated, but given the applicant is "MIR Medical International Research" located in "Roma - Italy," it is reasonable to infer the studies might have been conducted in Italy or other European locations. The document does not specify if the data was retrospective or prospective.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications:
- The document does not mention the use of experts or a ground truth established by experts for either spirometry or oximetry testing.
- For spirometry, the ground truth is implicitly defined by the ATS Standards, which govern the expected physical characteristics and accuracy of the device.
- For oximetry, the "clinical investigation" validated the accuracy, but the method for establishing the true oxygen saturation for comparison (the "ground truth") is not detailed. Typically, this would involve a co-oximeter or arterial blood gas analysis, but this is not stated.
4. Adjudication Method:
- Not applicable/Not mentioned. The testing described for spirometry and oximetry appears to be direct device performance measurement against a standard or a reference, rather than a subjective assessment requiring adjudication.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
- No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not explicitly mentioned or performed. This type of study typically assesses the improvement in human reader performance (e.g., radiologists interpreting images) with AI assistance. The Minispir is a diagnostic device for measuring physiological parameters, not an AI-powered image interpretation tool.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study:
- Yes, the studies described are essentially standalone performance evaluations.
- Spirometry: The device's spirometry function was tested against ATS standards, meaning the algorithm's measurements were compared to the accuracy requirements.
- Oximetry: A "clinical investigation... to validate the new oximetry board" also implies evaluation of the device's output (SpO2, pulse rate) directly against a reference, without human intervention in the measurement process itself, although a human operates the device.
7. Type of Ground Truth Used:
- Spirometry: Indirectly, the "ground truth" is derived from the American Thoracic Society (ATS) Standards. These standards define the expected accuracy and performance range for spirometers, so the device's measurements are compared against these established technical and physiological benchmarks rather than individual patient-specific "ground truth" established by an expert or pathology.
- Oximetry: For the clinical investigation, the ground truth for oximetry (SpO2 and pulse rate) would typically be established by a reference method such as an arterial blood gas analyzer or a co-oximeter. However, the document only states that "results demonstrated required accuracy" without specifying the reference method used to establish this truth.
8. Sample Size for the Training Set:
- The document does not provide any information about a training set. This is consistent with the nature of the device, which relies on established physiological measurement principles and algorithms rather than machine learning models that require training data. The algorithms for spirometry and oximetry are stated to be the "same algorithms" as the predicate device, implying they are well-established.
9. How the Ground Truth for the Training Set Was Established:
- Not applicable, as no training set is mentioned or implied for a device of this nature.
§ 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).