(239 days)
The SDI Astra 300 Spirometer is a freestanding laboratory instrument for performing basic lung function tests and oximetry in people of all ages. It is intended to be used by physicians or professional medical personnel for testing in any setting.
The ASTRA 300 Diagnostic Spirometer is a hand-held portable diagnostic spirometer for the measurement of patient breath flow and volume. The device uses a turbine transducer that measures flow via infrared interruption. Algorithms are used to determine values based on this flow measurement. Tabular and graphical data are displayed on the spirometer LCD display. With the optional Pulse Oximeter module, the specific patient parameters oxygen saturation in the blood (SpO2) and pulse rate, both relating to the patient's pulmonary condition, may be measured and displayed.
The provided text lacks specific details about acceptance criteria, a detailed study design, and the performance characteristics of the SDI ASTRA 300 Diagnostic Spirometer that would allow for a comprehensive answer to your request. The document is a 510(k) summary and an FDA clearance letter, which primarily focuses on establishing substantial equivalence to predicate devices rather than providing detailed performance study results.
However, based on the information available, here's what can be extracted and what is missing:
Acceptance Criteria and Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not Explicitly Stated in Document | Not Explicitly Stated in Document |
| (Typically, spirometer acceptance criteria would involve parameters like accuracy, precision, linearity, and repeatability for flow and volume measurements against recognized standards (e.g., ATS/ERS guidelines).) | (While the device measures flow and volume, specific performance numbers are not provided in this 510(k) summary.) |
Study Details (Based on available information and assumptions about typical 510(k) submissions for such devices)
2. Sample size used for the test set and the data provenance:
- Sample Size: Not specified in the provided document.
- Data Provenance: Not specified. For 510(k) substantial equivalence, data might come from internal testing, comparisons to predicate devices, or adherence to recognized standards. It's likely involved a combination of bench testing and potentially clinical data, but the specifics are absent.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not specified. This type of information is typically not included in a 510(k) summary for a diagnostic spirometer, as the "ground truth" for spirometry measurements is usually established by highly calibrated reference devices and standardized test gases/flows rather than expert interpretation of patient data in the same way it would be for imaging diagnostics.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not specified. Given the nature of a spirometer, adjudication methods like 2+1 or 3+1 are generally not applicable. Performance is assessed against objective flow and volume measurements.
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:
- No, an MRMC comparative effectiveness study was likely not performed. This device is a diagnostic spirometer, which directly measures physiological parameters (flow and volume). It does not involve "readers" in the context of interpreting complex images or data that require AI assistance for improved human performance. The device provides raw and calculated spirometric values.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- The device inherently operates as a standalone diagnostic tool. The algorithms determine values based on flow measurement. Its performance would be evaluated in a standalone manner against a gold standard for spirometry. The 510(k) process typically requires demonstrating that the device alone performs comparably to its predicate.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The ground truth for spirometers is typically established using highly accurate and calibrated reference spirometers, flow meters, or syringes that deliver known volumes and flows. Performance is then compared against these physical standards according to international guidelines (e.g., ATS/ERS).
- For the pulse oximetry function, ground truth would involve co-oximetry readings from arterial blood samples.
8. The sample size for the training set:
- Not applicable/Not specified. This device primarily uses algorithms based on physics principles (flow measurement via turbine transducer and infrared interruption) and established spirometric calculations, rather than machine learning models that require large training datasets in the traditional sense. Therefore, a "training set" as understood in AI/ML is unlikely to have been used or reported.
- If any modeling or calibration was done, it would be based on engineering principles and calibration data, not a "training set" of patient data.
9. How the ground truth for the training set was established:
- Not applicable (see point 8).
Summary of Limitations:
The provided document, being a 510(k) summary, focuses on establishing "substantial equivalence" to predicate devices (SDI Spirolab II Spirometer and Motion Media Technology CareStation 126S). It does not contain the detailed performance study results, specific acceptance criteria with numerical targets, or comprehensive methodologies that would be found in a full technical report or peer-reviewed publication. Its purpose is to demonstrate that the new device is as safe and effective as a legally marketed device, not to present a detailed scientific validation study in the way you might find for a novel AI diagnostic.
§ 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).