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The Spirodoc Spirometer and pulse oximeter is intended to be used by a physician or by a patient under the prescribed use of a physician.

The device is intended to test lung function and can perform spirometry testing in adult and pediatric patients, excluding infants and neonates, and oximetry readings in patients of all ages.

Spirodoc is a pocket-size spirometer and oximeter.

The device is made up of:

• a central unit which measures and collects information related to the state of health of the patient, with wireless or cable transmission of the collected data using a microprocessor based system with a touch screen display, USB communication port and Bluetooth, .
• a removable sensor for the measurement of respiratory air flow and volume, ﮯ
• a removable pulse oximetry sensor -

Stored data can be then delivered through landline, broadband, wireless and cell-phone technology to be received by a web server and can then be accessed by medical staff.

Here's an analysis of the provided text regarding the acceptance criteria and supporting study for the Spirodoc device:

Acceptance Criteria and Device Performance for Spirodoc

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size Used for the Test Set and Data Provenance

• Spirometry: "Clinical testing of both spirometry and pulse oximetry functions" was performed. The specific sample size (number of patients) used for spirometry testing is not explicitly stated in the provided document. The data provenance is clinical testing, implying prospective data collection during the study. The country of origin for the data is not specified.
• Pulse Oximetry: "Accuracy of SpO2 and pulse rate have been verified in-house using an optical simulator." The specific sample size (number of data points or tests) for the optical simulator is not explicitly stated. This suggests the data was generated in a lab setting rather than from human subjects.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications

• Spirometry: For the clinical spirometry testing, the document states "Spirometry testing was performed according with American Thoracic Society (ATS) Standards." While ATS standards involve expert interpretation and quality control, the document does not explicitly state the number of experts or their specific qualifications (e.g., "radiologist with 10 years of experience") used to establish the ground truth for the test set of patients. It implies that the test results were compared against ATS accuracy requirements, which are derived from a consensus of experts in the field.
• Pulse Oximetry: Ground truth was established using an "optical simulator." This is an artificial standard, not based on human expert review. No human experts were involved in establishing this ground truth.

4. Adjudication Method for the Test Set

• The document does not describe any specific adjudication method (e.g., 2+1, 3+1) for either the spirometry or pulse oximetry test sets. For spirometry, it simply states results were compared against ATS standards. For oximetry, an optical simulator was used.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

• No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done or reported. The study focused on the device's standalone performance against established standards and an optical simulator. There is no mention of human readers or AI assistance.

6. Standalone Performance Study

• Yes, a standalone study was done. The entire clinical and nonclinical testing described is focused on the device's inherent performance (algorithm only, in a sense, as it refers to the device's computational outputs) without a human-in-the-loop component being evaluated for its impact on human performance. The device's spirometry measurements were compared against ATS standards, and its oximetry readings against an optical simulator, both representing standalone performance evaluations.

7. Type of Ground Truth Used

• Spirometry: The ground truth used was adherence to American Thoracic Society (ATS) Standards. While ATS standards are developed by experts and based on clinical evidence, the document doesn't detail how "ground truth" was established for individual patient cases in the test set. It suggests that the device's output itself was evaluated for accuracy against these established norms.
• Pulse Oximetry: The ground truth for SpO2 and pulse rate was established using an optical simulator, which provides a known, precise input for testing.

8. Sample Size for the Training Set

• The document does not provide any information regarding the sample size for a training set. As this is a medical device approval that primarily focuses on equivalence and performance against established standards, and not an AI/machine learning algorithm that typically requires a large training set, the concept of a "training set" in the context of this 510(k) summary is not applicable or discussed. The device uses known measurement methods and sensors.

9. How the Ground Truth for the Training Set Was Established

• Not applicable. As no training set is mentioned or implied for an AI/machine learning model, the method for establishing its ground truth is not discussed.

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