(559 days)
SpiroHome is intended to be used by adults and children over 5 years old in physician's offices, clinics and home setting to conduct basic lung function and spirometry testing.
The SpiroHome Ultrasonic Spirometer (SUS) is a portable spirometer designed to perform pulmonary function tests in patients over the age of 5 in office (clinical) and home settings. The SpiroHome spirometer is used together with a SpiroWay mouthpiece that is inserted into and lines the entire airway of the device. SpiroHome derives pulmonary function data from airflow measurements taken by its ultrasonic sensors during a spirometry test. All of the information recorded by the device is displayed on the relevant SpiroHome app running on a Bluetoothconnected device. The pulmonary function test (PFT) data recorded by the SpiroHome device during a spirometry test is also compared against the patient's predicted values which are obtained from internationally accepted PFT equations. The user interfaces with the SpiroHome app during the entire use of the SpiroHome spirometer.
The associated accessories include: SpiroWay mouthpiece
The SpiroHome Ultrasonic Spirometer's acceptance criteria and performance are detailed in comparison to predicate and reference devices, and through various performance, electrical, and biocompatibility tests.
1. Table of Acceptance Criteria and Reported Device Performance:
| Attribute | Acceptance Criteria (from Subject Device - SpiroHome) | Reported Device Performance (from Subject Device - SpiroHome) |
|---|---|---|
| Functional Requirements | ATS 2019 / ERS waveform simulator testing | Meets |
| ISO 26782:2009 | Meets | |
| ISO 23747:2015 | Meets | |
| High Altitude Performance | Meets | |
| Flow Resistance | Meets | |
| Electrical Requirements | AAMI ANSI ES 60601-1 | Meets |
| IEC 60601-1-11 | Meets | |
| IEC 60601-1-2 | Meets | |
| Biocompatibility | ISO 10993-1 | Meets |
| (Contact Type & Duration: | ISO 10993-3 | Meets |
| Surface Contact, Mucosa, | ISO 10993-5 | Meets |
| Externally Communicating, | ISO 10993-10 | Meets |
| Tissue; permanent (>30 days)) | ISO 10993-11 | Meets |
| ISO/FDIS 18562-1 | Meets | |
| ISO/FDIS 18562-2 | Meets | |
| ISO/FDIS 18562-3 | Meets | |
| Shipping Requirements, | ASTM D4332 | Meets |
| Packaging and Distribution | ASTM D7386 | Meets |
| ASTM F1886/F1886M | Meets | |
| ISO 17664 | Meets | |
| ISO 11737-1 | Meets | |
| Cleaning | ISO 17664 | Meets |
| AAMI TIR30 | Meets | |
| AAMI TIR12 | Meets | |
| ASTM E2314 | Meets | |
| ISO 15883-1 | Meets | |
| ISO 11737-1 | Meets | |
| ISO/TS 15883-5 | Meets | |
| Software and System | Guidance for the Content of Premarket Submissions for | Meets |
| Verification and Validation | Software Contained in Medical Devices | |
| IEC 62304 | Meets | |
| Human Factors Study | Guidance for Applying Human Factors and Usability | Meets |
| Engineering to Medical Devices | ||
| AAMI/ANSI HE75:2009 | Meets | |
| ANSI/AAMI/IEC 62366-1:2015 | Meets | |
| Volume Range & Accuracy | 0-10 L, ± 2.5% or ± 0.050 L | Conforms to permissible margins in ATS guidelines and ISO 286782 |
| Flow Range & Accuracy | 0 - 14 L/s, ±10% or ± 170 mL/s | Conforms to permissible margins in ISO 286782 |
Note: The document states "Meets" for all listed performance and safety standards, implying the device successfully passed the tests conducted against these criteria.
2. Sample Size Used for the Test Set and Data Provenance:
The document does not explicitly state the sample size for any specific test set or the data provenance (e.g., country of origin, retrospective or prospective) for the performance data.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications:
This information is not provided in the document. The performance data seems to be based on compliance with established standards (e.g., ATS, ERS, ISO) rather than expert-established ground truth from a test set of patient data.
4. Adjudication Method for the Test Set:
The document does not describe any adjudication method as it appears to rely on objective testing against technical and safety standards rather than expert consensus on diagnostic outcomes.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done:
No, an MRMC comparative effectiveness study is not mentioned in the provided document. The study focuses on demonstrating substantial equivalence through technical and performance comparisons with predicate and reference devices, and by meeting various regulatory standards.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) Was Done:
The document does not specifically detail a standalone algorithm-only performance study. The performance testing section outlines functional, electrical, biocompatibility, shipping, cleaning, software, and human factors tests. For a device like a spirometer, "standalone" performance typically refers to the accuracy of its physical measurements and calculations, which are covered by the functional and electrical requirements. The software verification and validation would also assess the algorithm's performance.
7. The Type of Ground Truth Used:
For the technical performance of the device (e.g., volume and flow accuracy), the ground truth appears to be based on internationally accepted performance standards and guidelines, such as ATS guidelines and ISO 286782. For other aspects like electrical safety and biocompatibility, the ground truth is adherence to the specified IEC, AAMI, and ISO standards.
8. The Sample Size for the Training Set:
This information is not provided in the document. The document refers to the device's technological characteristics and its compliance with standards, not typically a "training set" in the machine learning sense for a diagnostic device that performs direct physiological measurements.
9. How the Ground Truth for the Training Set Was Established:
As there's no mention of a training set for an AI/ML algorithm in the context of this traditional medical device submission, the method for establishing ground truth for a training set is not applicable or provided. The device's operation is based on ultrasonic sensor technology and PFT equations, not a learning algorithm that requires a labeled training set.
§ 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).