(301 days)
The COSMED microQuark pulmonary function testing system is a modular laboratory device for performing the basic lung function tests (Basic Spirometry: Forced Vital Capacity, Slow Vital Capacity, Maximum Voluntary Ventilation).
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Here's an analysis of the provided text regarding the COSMED microQuark device:
Based on the provided FDA 510(k) summary for the COSMED microQuark device, the information required to fully answer your questions regarding acceptance criteria and study details is not present. The FDA letter primarily states that the device is substantially equivalent to a predicate device and outlines general regulatory information. The "INDICATIONS FOR USE STATEMENT"
section only describes the intended use of the device.
However, I can extract what is available and indicate what information is missing.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not specified | Not specified |
Explanation: The document does not contain any specific acceptance criteria for the device's performance (e.g., accuracy, precision, sensitivity, specificity, or specific tolerances for pulmonary function measurements). Consequently, there is no reported device performance against such criteria.
2. Sample size used for the test set and the data provenance
- Sample Size for Test Set: Not specified.
- Data Provenance: Not specified (e.g., country of origin, retrospective or prospective).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Number of Experts: Not specified.
- Qualifications of Experts: Not specified.
4. Adjudication method for the test set
- Adjudication Method: Not specified.
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
- MRMC Study: Not applicable. The device is described as a "Pulmonary Function Data Calculator" for "performing the basic lung function tests." This suggests it's a measurement device, not an AI-assisted diagnostic tool that would involve human "readers" or an "effect size of human readers improving with AI."
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- Standalone Study: The document does not describe the methodology of any performance studies, standalone or otherwise. The device appears to be a hardware/software system for direct measurement, rather than a purely algorithmic diagnostic tool.
7. The type of ground truth used
- Type of Ground Truth: Not specified. For a pulmonary function device, ground truth would typically be established by established reference methods or highly accurate gold-standard equipment, but this is not detailed.
8. The sample size for the training set
- Sample Size for Training Set: Not specified. (It's unclear if a "training set" in the machine learning sense is even applicable, as the device is described as a "calculator" rather than a learning algorithm).
9. How the ground truth for the training set was established
- Ground Truth Establishment for Training Set: Not specified.
Summary of Missing Information:
The provided document is a boilerplate FDA 510(k) clearance letter and an "Indications for Use" statement. It confirms the device's regulatory clearance based on substantial equivalence to a predicate device but does not contain any details about the performance studies (validation, clinical, or technical) that would typically include acceptance criteria, test set sizes, ground truth methodology, or expert involvement. These details would usually be found in the 510(k) submission itself, which is a much more comprehensive document than the clearance letter.
§ 868.1890 Predictive pulmonary-function value calculator.
(a)
Identification. A predictive pulmonary-function value calculator is a device used to calculate normal pulmonary-function values based on empirical equations.(b)
Classification. Class II (performance standards).