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The SpiroSphere is a compact device to measure inspiratory and expiratory lung function parameters in adults and children aged 4 years and older.

It can be used by physicians in the office or hospital.

The SpiroSphere is a compact spirometry device. It's Sensor Unit is battery-powered. The Main Unit can be powered by battery or power supply. The SpiroSphere is used to measure inspiratory and expiratory lung function parameters in adults and children 4 years and older. The measured data is saved into the device and can be read out at any time.

A printer can be connected with the SpiroSphere and all needed data (e.g. reports, Screenshots) can be printed. Moreover it is possible to transfer data by USB, Wifi, 3G, and Ethernet.

Pulmonary functions

• Slow Spirometry
• Forced Spirometry
• Flow-Volume loop and Volume-Time tracing, pre/post tests
• Trending capabilities

The provided text describes the SpiroSphere, a device for measuring lung function, and its substantial equivalence to a predicate device (SpiroPro). However, it does not contain the detailed information required to answer your specific questions about acceptance criteria and a study proving the device meets them.

The document is a 510(k) summary for premarket notification to the FDA. It focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than providing the detailed clinical or performance study results you're asking for.

Here's a breakdown of why the requested information is absent:

• Acceptance Criteria and Reported Device Performance (Table): The document states adherence to ATS/ERS standards (2005) for spirometry accuracy and precision and lists various parameters measured (FEV1, FVC, PEF, etc.). However, it does not provide a specific table of acceptance criteria (e.g., +/- x% accuracy) or numerical reported device performance against those criteria. It only generally states that "Tests were performed to confirm that the SpiroSphere meets the recommendations for accuracy and precision for Spirometry of the American Thoracic Society (ATS) according to ATS/ERS standards 2005."
• Sample Size, Data Provenance, Ground Truth Experts, Adjudication Method, MRMC Study, Standalone Performance, Training Set Sample Size/Ground Truth: These details are typically found in a dedicated clinical or performance study report, which is not included in this summary. The 510(k) summary only mentions general verification and validation activities and conformance to standards.

In summary, based only on the provided text, I cannot complete the table or answer the specific questions about the study details because that level of detail is not present in this FDA 510(k) summary.

The document discusses:

• Device Name: SpiroSphere
• Predicate Device: SpiroPro (K000648) and SpiroPro with BT (K092324)
• Intended Use/Indications for Use: To measure inspiratory and expiratory lung function parameters in adults and children aged 4 years and older, usable by physicians in office or hospital.
• Technological Characteristics: Uses a pneumotachograph (Lilly Type) for pressure to flow conversion, measures various parameters (FEV1, FVC, PEF, FEF25-75, VC, IC, ERV) conforming to ATS/ERS Spirometry Standards (2005).
• Testing Mentioned: Software verification and validation (IEC 62304), Risk analysis (ISO 14971), electrical safety (IEC 60601-1:2012), EMC (IEC 60601-1-2:2014), wireless technology (FDA Guidance 2013), Human Factors/Usability (IEC 62366), Biocompatibility (ISO 10993-1:2009, ISO 18562:2017), Cybersecurity (FDA Guidance 2014), Reprocessing (FDA Guidance 2015).

To answer your questions thoroughly, a complete performance study report would be required, which typically contains the specific data and methodologies.

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The MicroLab / MicroLoop spirometer is intended, for prescription use only, to measure the maximal volume and flow of air that can be moved in and out of a patient's lungs and for pulse oximetry measurements. The system is intended for use with pediatric (4 to 17 years) and adult (18 to 99 years) patients in hospitals, physician offices, laboratories and occupational health testing environments.

The optional Nonin IPOD® Integrated Pulse Oximetry Device is designed to measure pulse rate and oxygen saturation in adult patients. The sensor is designed for use on the fingers of patients weighing more than 30 kilograms, where the finger tissue is between 5 and 21 millimeters.

The MicroLab / MicroLoop is a mains/battery operated desktop spirometer. It has context sensitive help screens, accessed at the touch of a button, that explain its features and navigational aides, making it easy to use. The results may be uploaded to a PC using the optional "Spirometry PC" software and patient details may be downloaded to the MicroLab / MicroLoop. Using spirometry PC software (SPCS) and the MicroLab / MicroLoop, live blows can be performed with the PC directly controlling the operation of the MicroLab / MicroLoop. The results and graphs produced are displayed directly on the PC screen. Stored data on the devices can be printed on an external printer using the USB cable supplied or uploaded to the PC. In addition the MicroLab is able to print the data on its integral thermal printer. Optional a Nonin Ipod® SpO2 sensor can be connected to the MicroLab / MicroLoop.

The scientific concept which forms the basis of the MicroLab / MicroLoop is the CareFusion Digital Volume Transducer, a stable form of volume transducer, which measures expired air directly at B.T.P.S (Body Temperature and Pressure with Saturated water vapour) thus avoiding the inaccuracies of temperature corrections. The transducer is insensitive to the effects of condensation and temperature and avoids the need for individual calibration prior to performing a test.

The provided document is a 510(k) Pre-market Notification for the MicroLab/MicroLoop spirometer and its optional SpO2 module. It focuses on demonstrating substantial equivalence to a predicate device rather than presenting a novel study to prove device meets acceptance criteria through specific quantitative performance metrics beyond what's stated for regulatory compliance.

However, based on the Summary of Device Testing (Section 5.15) and the Summary Discussion of Bench Performance Data in the document, I can infer the acceptance criteria and study approach.

Key takeaway: The submission emphasizes compliance with recognized standards rather than detailing specific de novo performance studies with novel clinical endpoints or expert ground truth.

Here's the breakdown based on the information provided:

1. A table of acceptance criteria and the reported device performance

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document does not specify the sample sizes for the test sets used in the bench testing. It refers to "applicable tests and standards" and "validation and verification testing" but does not provide details on the number of subjects or samples for any specific performance measurement. The focus is on demonstrating compliance with standards rather than a clinical study with a specific patient cohort. The testing was non-clinical (bench testing) and likely conducted in Germany where the company is based.

3. 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 applicable and not provided. The testing described is primarily bench testing against established engineering and performance standards (e.g., ATS/ERS for spirometry, Nonin's own specifications for oximetry accuracy) and regulatory safety standards. There is no mention of human expert-derived ground truth as would be required for diagnostic image analysis or similar AI/ML-driven devices.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable. Adjudication methods typically relate to expert consensus on ground truth in a clinical study. The document describes non-clinical bench testing.

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 MRMC comparative effectiveness study was done. The device is a diagnostic spirometer and pulse oximeter, not an AI-assisted diagnostic tool for interpretation by human readers. The submission explicitly states: "Clinical testing was not performed with this device."

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Yes, the performance testing described is standalone algorithm/device performance. The device provides direct measurements (spirometry parameters, SpO2, pulse rate). The "Summary of Device Testing" (Section 5.15) and "Summary Discussion of Bench Performance Data" (Section 11) describe non-clinical bench tests confirming the device's technical performance against established standards, independent of human interpretation or assistance beyond operating the device.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

For spirometry, the ground truth would be precise, calibrated flow and volume simulators/generators that meet the reproducibility and accuracy requirements of standards like ATS/ERS.

For oximetry, the ground truth for SpO2 and pulse rate accuracy would be from a reference oximeter or a controlled human desaturation study (though the document states "clinical testing was not performed," implying it relies on the Nonin module's pre-established accuracy or simulated scenarios). The "Accuracy Testing" for the oximetry module would compare its measurements to highly accurate reference instruments under various conditions.

In essence, the ground truth is derived from validated engineering measurement standards and reference devices.

8. The sample size for the training set

Not applicable. This device does not appear to employ machine learning or AI that would require a "training set" in the conventional sense of AI development. It's a traditional medical device based on established physical principles (digital volume transducer for spirometry, light absorption for oximetry).

9. How the ground truth for the training set was established

Not applicable, as there is no training set for an AI/ML algorithm.

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