(91 days)
The PB700 Renaissance II Spirometry System is a diagnostic tool to measure the maximal volume and flow of air that can be moved in and out of a patient's lungs. The system is intended for use with pediatric (4 to 17 years) and adult (18 to 99 years) patients in hospitals, physician's offices, laboratories, and occupational health testing environments.
The PB700 Spirometry System consists of the Renaissance II Spirometer, the PB710 Base Station, AC Adapter, the disposable FSII Flow Sensor, a syringe adapter (for calibration), and nose clips. Optional accessories include calibration syringe, printer and serial communications cables, and a compatible printer. The Renaissance II Spirometry System is designed for use in the diagnosis, assessment, and monitoring of certain lung diseases.
The provided document is a 510(k) summary for the PB700 Renaissance II Spirometry System. It primarily focuses on demonstrating substantial equivalence to a predicate device (PB100 Renaissance Spirometry System) rather than detailing specific acceptance criteria and a comprehensive study report with the requested metrics.
Here's an analysis based on the provided text, addressing each point to the best of its ability or explaining why the information is not available:
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A table of acceptance criteria and the reported device performance
The document explicitly states: "The modified PB700 Renaissance II Spirometry System has been tested and found to meet all design criteria." However, it does not provide a table outlining specific acceptance criteria (e.g., flow measurement accuracy, volume measurement accuracy, specific ranges of operation) nor the quantitative reported performance for these criteria. The submission relies on establishing substantial equivalence to the predicate device, implying that if the device meets its design criteria, and those designs are equivalent to a legally marketed device, then it is acceptable.
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Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not available in the provided text. The document states "The modified PB700 Renaissance II Spirometry System has been tested..." but does not detail the nature of this testing, the sample size of any test sets (patient or otherwise), or the provenance of any data.
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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)
This information is not available in the provided text. As the submission focuses on functional equivalence of a diagnostic spirometer, the concept of "ground truth" derived from expert review (as in image analysis) is not directly applicable in the same way. Performance would typically be assessed against calibrated reference instruments.
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Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not available in the provided text. Adjudication methods are typically relevant for studies involving human interpretation or subjective assessments, which is not the primary focus of this type of device submission.
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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
This information is not applicable and not available in the provided text. The PB700 Renaissance II Spirometry System is a diagnostic spirometer measuring physiological parameters (volume and flow); it is not an AI-assisted diagnostic tool that would involve "human readers" interpreting outputs in the sense of image analysis or similar diagnostic aids. Therefore, an MRMC study with AI assistance is not relevant to this device.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
The device is a standalone diagnostic tool in the sense that it measures and calculates spirometry parameters. Its performance is inherent in its measurements. The document implies performance was assessed in a "standalone" fashion as it states "has been tested and found to meet all design criteria." However, specific details of how this "standalone" performance was measured (e.g., tests against known flow/volume standards, clinical trials) are not provided. The comparison is primarily against the predicate device's technological characteristics.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For a spirometer, "ground truth" would typically be established using calibrated reference instruments (e.g., highly accurate flow/volume simulators or calibration syringes with known volumes). The document mentions a "syringe adapter (for calibration)" as part of the system, suggesting calibration against known standards. However, the specific type of ground truth used during the validation testing is not detailed.
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The sample size for the training set
This information is not applicable and not available in the provided text. Spirometers like the PB700 Renaissance II are typically based on established physical principles (e.g., pressure differential across a pneumotachograph) and calibration, not machine learning algorithms that require "training sets" in the conventional sense. The "calculations to express the volume in clinically relevant terms" refer to standard physiological equations and comparisons to published reference values, not a trained model.
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How the ground truth for the training set was established
This information is not applicable and not available due to the reasons stated in point 8.
§ 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).