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510(k) Data Aggregation
(294 days)
The Spirobank Oxi Spirometer and Pulse Oximeter is intended to be used by a physician or by a patient under the prescribed use of a physician. The equipment is intended to test lung function and can perform tests in adult and pediatric patients greater than 5 years. When used as Oximeter, the Spirobank Oxi is intended for spot-checking of functional oxygen saturation of arterial haemoglobin (SpO2) and Pulse Rate (PR) from the patient finger. The Spirobank Oxi has been designed for use in the physician's office, in hospital, or directly by the patient to monitor her/his physical conditions at home.
Spirobank Oxi 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, using a microprocessor based system. It operates via a Bluetooth connection
- a removable sensor for the measurement of respiratory air flow and volume,
- a pulse oximetry sensor using reflective technology. -
The device is powered by two AAA alkaline batteries.
Spirometry: the device is equipped with a plastic mouthpiece connected to a turbine flow meter based on the infrared interruption principle. The device detects the signals generated by the turbine, and measures flow and volume. At the end of the expiration, the device calculates the respiratory parameters.
Oximetry: the device measures functional oxygen saturation of arterial haemoglobin (SpO2) and pulse rate (PR) by means of a reflective light sensor. Specifically, it uses a two-wavelength sensor to measure the indicated parameters based on light reflection principles of oxygenated blood and deoxygenated blood, which generates a photoplethysmogram. From the photoplethysmogram the device calculates SpO2 and PR
Spirobank Oxi connects via Bluetooth to a device (PC, tablet or smartphone) which allows to insert patient data, perform spirometry manoeuvres and oximetry tests, as well as display the results, including the relative graphs.
Acceptance Criteria and Study for Spirobank Oxi
This document describes the acceptance criteria and a detailed study supporting the substantial equivalence of the Spirobank Oxi device.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Criteria | Reported Device Performance (Spirobank Oxi) | Complies? |
|---|---|---|---|
| Spirometry | |||
| Volume Accuracy | American Thoracic Society (ATS) 2019 guidelines | $\pm$ 2.5% | Yes |
| Linearity | ATS 2019 guidelines | $\pm$ 2.5% | Yes |
| Repeatability | ATS 2019 guidelines | $\pm$ 2.5% | Yes |
| Expiratory Impedance | ATS 2019 guidelines: < 0.15 kPa/(L/s) | < 0.15 kPa/(L/s) | Yes |
| Flow Accuracy | ATS 2019 guidelines: $\pm$ 5% or $\pm$ 200 mL/s | $\pm$ 5% or $\pm$ 200 mL/s | Yes |
| Dynamic Resistance | ATS 2019 guidelines (at 12 L/s): < 0.5 cm H2O/L/s | < 0.5 cm H2O/L/s | Yes |
| Linearity (Flow) | ATS 2019 guidelines: $\pm$ 5% or $\pm$ 0.17L/s | $\pm$ 5% or $\pm$ 0.17L/s | Yes |
| Resistance to Flow | ATS 2019 guidelines: <0.36 kPa/(L/s) | <0.36 kPa/(L/s) | Yes |
| Frequency Response | ATS 2019 guidelines: $\pm$ 12% or $\pm$ 0.25L/s | $\pm$ 12% or $\pm$ 0.25L/s | Yes |
| Pulse Oximetry (SpO2) | |||
| SpO2 Accuracy (Overall) | ISO 80601-2-61:2017 and FDA Guidance for Pulse Oximeters | A_rms = 1.9004% | Yes |
| SpO2 Accuracy (90%-100%) | ISO 80601-2-61:2017 and FDA Guidance for Pulse Oximeters | A_rms = 1.4861% | Yes |
| SpO2 Accuracy (80%-90%) | ISO 80601-2-61:2017 and FDA Guidance for Pulse Oximeters | A_rms = 1.7059% | Yes |
| SpO2 Accuracy (70%-80%) | ISO 80601-2-61:2017 and FDA Guidance for Pulse Oximeters | A_rms = 2.3315% | Yes |
| Pulse Rate (PR) | ISO 80601-2-61:2017 and FDA Guidance for Pulse Oximeters | $\pm$ 3% (Maximum absolute error up to 3 bpm at 200 bpm, conforming to standard) | Yes |
| Biocompatibility | ISO 10993-1:2009 (cytotoxicity, irritation, sensitization) | Materials are biocompatible. Conformance to ISO 18562-1, -2, -3 followed. | Yes |
| Electrical Safety & EMC | EN 60601-1:2005 + Amd 2012, EN 60601-1-2:2015 | Complies with referenced guidelines and standards. Performs within specifications. | Yes |
| Software V&V | FDA Guidance "Content of Premarket Submissions for Software" | Conducted and documented for "moderate" level of concern. | Yes |
| Cybersecurity | FDA Guidance "Postmarket Management of Cybersecurity" | Conducted and documented. | Yes |
| Human Factors | FDA Guidance "Applying Human Factors and Usability Engineering" | Conducted. | Yes |
| Cleaning & Disinfection | FDA Guidance "Reprocessing Medical Devices..." | Validated. | Yes |
2. Sample Size Used for the Test Set and Data Provenance
Spirometry Testing:
- Sample Size: Not explicitly stated as a "test set" sample size of human subjects. The testing was conducted on a bench using a Pulmonary Waveform Generator.
- Data Provenance: Conducted in MIR facilities.
Pulse Oximetry Clinical Performance Testing:
- Sample Size: 10 healthy volunteers (5 males, 5 females). The study explicitly states meeting the requirement of at least 2 darkly pigmented subjects or 15% of the subject pool, whichever is larger.
- Data Provenance: Single-arm desaturation study conducted in the US, at the Clinimark Desaturation Laboratory (Louisville, CO 80027, USA). The study was prospective as it involved inducing hypoxia in volunteers for data collection.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
Spirometry Testing:
- Ground Truth: Established by conformance to the American Thoracic Society (ATS) Statement on the "Standardization of Spirometry - 2019", ISO 26782:2009, and ISO 23747:2015, utilizing a Pulmonary Waveform Generator for bench testing. This implies widely accepted industry standards and validated equipment serve as the "ground truth" rather than individual experts.
- Experts: Not applicable in the context of expert review for ground truth, as it's a bench test against standardized waveforms and parameters.
Pulse Oximetry Clinical Performance Testing:
- Ground Truth: Established by Reference CO-Oximetry using arterial blood samples drawn from the subjects. This value was obtained as the mean of the SaO2 values measured by Radiometer ABL 80 Flex OSM and Instrumentation Laboratory IL 682.
- Experts: Not explicitly mentioned in terms of "experts establishing ground truth". However, the use of two "Reference CO-Oximeters" suggests a highly calibrated and standardized method, likely operated by qualified laboratory personnel, which serves as the gold standard for oxygen saturation measurement. The qualifications of the operators of these reference devices are not specified but are presumed to be appropriate for clinical laboratory analysis.
4. Adjudication Method for the Test Set
Spirometry Testing: Not applicable, as judgment is based on objective measurements against engineering standards.
Pulse Oximetry Clinical Performance Testing: No explicit adjudication method (e.g., 2+1, 3+1) is mentioned, as the ground truth (SaO2) is established by highly accurate chemical analysis (Reference CO-Oximetry) rather than subjective expert interpretation from multiple individuals. The methodology involves direct comparison of the device's SpO2 readings with the objective SaO2 values.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, an MRMC comparative effectiveness study was not conducted. The studies described are focused on verifying the technical performance of the device against established industry standards and, for oximetry, against a "gold standard" clinical measurement, not on comparing human reader performance with and without AI assistance.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Yes, the studies are explicitly standalone performance evaluations of the device's measurement capabilities.
- Spirometry: Bench testing against ATS standards.
- Pulse Oximetry: Comparison of the device's automated SpO2 calculation against reference CO-Oximetry, without human interpretation of the device's raw outputs for diagnosis. The device generates the SpO2 values directly.
7. The Type of Ground Truth Used
- Spirometry: Objective, standardized measurements against a Pulmonary Waveform Generator adhering to the American Thoracic Society (ATS) Statement on the "Standardization of Spirometry - 2019" and ISO 26782:2009, ISO 23747:2015.
- Pulse Oximetry: Physiological/Outcomes Data (Reference CO-Oximetry) from arterial blood samples, which is considered the gold standard for functional oxygen saturation (SaO2).
8. The Sample Size for the Training Set
The document does not mention any "training set" or "training data" for the device. This implies that the device's algorithms or measurement principles are based on established scientific and engineering principles rather than machine learning models that require a distinct training phase on a dataset. For example, spirometry uses infrared interruption principles, and oximetry uses reflection principles and calibration functions.
9. How the Ground Truth for the Training Set Was Established
Since no training set is mentioned or implied for a machine learning model, this question is not applicable. The device relies on established physical and biological measurement principles rather than learned patterns from a training dataset requiring ground truth establishment.
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