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The Spirotel spirometer and pulse oximeter is intended to be used by a physician or by a patient under the instruction of a physician or paramedic to test lung function in people of all ages. It is also intended to be used as a singlepatient device and can be used in any setting - home, factory, pharmacy, hospital or physician's office.

Spirotel is a pocket spirometer that can also feature a pulse oximeter function (optional). It measures a range of functional respiratory parameters, and the oxygen saturation and pulse rate. The device can operate completely autonomously or can be connected to a personal computer by means of various types of connections: USB, Bluetooth, GSM.

Here's a breakdown of the acceptance criteria and the study information for the Spirotel device, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Sizes and Data Provenance

• Test Set Sample Size: The document does not specify the exact sample sizes used for the spirometry or oximetry accuracy tests, nor for the safety and environmental testing, or data transmission tests. It states that "Testing was done" and "The results obtained were within the range of accuracy required."
• Data Provenance:
  • Spirometry: The spirometry testing was performed "according with American Thoracic Society (ATS) Standards." This suggests an in-house evaluation against established clinical standards.
  • Oximetry: The oximetry accuracy was "verified in-house using an optical simulator." This indicates an in-house, lab-based study.
  • Safety and Environmental: Testing was conducted in accordance with EN 60601-1:2006 and EN 60601-1-2:2007, implying adherence to international standards.
  • Battery, USB, Bluetooth, GSM: These were "carried out in-house" or by "a third party laboratory" (for Bluetooth FCC certification) or "by the manufacturer of the module" (for GSM integration). The data is retrospective, as the tests were completed before submission.
  • Country of Origin: The submitter is MIR Medical International Research, located in Rome, Italy. The testing was largely "in-house," implying it was conducted by MIR.

3. Number of Experts and Qualifications for Ground Truth for Test Set

• The document does not specify the number of experts or their qualifications used to establish the ground truth for the device's performance tests.
• For spirometry, the implicitly accepted ground truth is the performance criteria set by American Thoracic Society (ATS) Standards.
• For oximetry, the implicitly accepted ground truth is the performance criteria set by FDA guidelines on Pulse Oximeters and ISO 9919:2005, realized via an "optical simulator."

4. Adjudication Method for the Test Set

• The document does not describe any adjudication method (e.g., 2+1, 3+1, none) for the test set results. The evaluations seem to be direct comparisons against established technical and clinical standards.

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

• No MRMC comparative effectiveness study is mentioned. The submission focuses on device performance against technical standards and equivalence to a predicate device, not on human reader performance with or without AI assistance.

6. Standalone (Algorithm Only Without Human-in-the-Loop) Performance

• The device itself (Spirotel) is a measurement device that provides physiological data (spirometry and oximetry parameters). The testing described focuses on the accuracy and reliability of these measurements in a standalone fashion, adhering to technical and clinical standards. There is no "algorithm only" performance separate from the device's inherent function, as it is not an AI-driven interpretive system in the sense of image analysis, for example. The various communication modules (USB, Bluetooth, GSM) facilitate data transmission, and their standalone performance for data integrity was tested.

7. Type of Ground Truth Used

• Spirometry: Ground truth is implicitly defined by American Thoracic Society (ATS) Standards for volume and flow rate accuracy.
• Oximetry: Ground truth is implicitly defined by FDA guideline on Pulse Oximeters and ISO 9919:2005, implemented and verified using an optical simulator.
• Safety & Environmental: Ground truth is based on compliance with international standards EN 60601-1:2006 and EN 60601-1-2:2007.
• Data Transmission: Ground truth is the integrity of data transmission (i.e., no corruption), verified by in-house testing.

8. Sample Size for the Training Set

• The document does not refer to any "training set." The Spirotel device is a measurement instrument, not a machine learning or AI algorithm that requires a training set in the typical sense. Its performance is validated against established physical and clinical standards rather than through learning from data.

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

• As there is no mention of a "training set" for the device's core functionality, this question is not applicable to the information provided.

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