(249 days)
This device is intended for monitoring PEF (Peak Expired Flow Rate) and FEV 1 (Forced Expiratory Volume in one second) for patient home use. The device is designed for pediatric to adult patients. The device is intended for monitoring respiratory conditions such as asthma.
MSA100BT Peak Flow Meter is a hand-held pulmonary function measuring medical device that measures patient's maximum possible exhalation which is called peak expiratory flow (PEF) and forced expiratory volume in 1 second (FEV1). The accuracy meets American Thoracic Society (ATS) Standard 2005 Revision. The MSA100BT is designed for pediatric to adult patients for home use and for single user, and is intended for monitoring respiratory conditions such as asthma. The MSA100BT has an automatic memory of 250 recordings and can connect to cell phone by Bluetooth. Patients can transfer the records to phone via BLE4.0, then using app to help save and track long term. The MSA100BT is capable of measuring PEF from 50 to 900 L/min and FEV1 from 0.01 to 9.99 L. Its measuring accuracy is ± 20 L/min or ± 10% of the reading for PEF, and ± 0.050 L or ± 3% of the reading for FEV1. The MSA100BT is composed of main unit, turbine sensor, and mouth piece. After each use, the mouthpiece and turbine of the device should be cleaned by soap solution and water within 30 minutes.
The provided document is a 510(k) premarket notification for the MSA100BT Peak Flow Meter. It focuses on demonstrating substantial equivalence to a predicate device, the MSA100 Peak Flow Meter, rather than detailing a study that establishes acceptance criteria for a novel AI device and proves its performance.
Therefore, the specific information requested about acceptance criteria, a study proving device meeting criteria, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth types, and training set details for an AI-powered device cannot be extracted directly from this document. This document pertains to a physical medical device (peak flow meter) and its performance validation using non-clinical testing and comparison to an existing device, not an AI algorithm.
However, I can extract the performance criteria and the testing performed to demonstrate that the device complies with certain standards, which can be interpreted as fulfilling "acceptance criteria" in the context of this device's submission.
Here's the closest information I can provide based on the document:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Standard Requirement) | Reported Device Performance |
|---|---|
| Accuracy: | |
| PEF: ± 20 L/min or ± 10% of the reading | PEF: ± 20 L/min or ± 10% of the reading (Stated as identical to predicate and meets ATS Standard 2005 Revision) |
| FEV1: ± 0.05 L or ± 3% of the reading | FEV1: ± 0.05 L or ± 3% of the reading (Stated as identical to predicate and meets ATS Standard 2005 Revision) |
| Biocompatibility: (According to ISO 10993-1:2009/(R)2013) | |
| Non-cytotoxic | Test article confirmed non-cytotoxic (Complied with ISO 10993-5:2009) |
| Non-irritating (oral mucosa) | Test article confirmed non-oral-mucosal-irritating (Complied with ISO 10993-10:2010) |
| Non-sensitizing | Test article confirmed non-sensitizing (Complied with ISO 10993-10:2010) |
| Electrical Safety: (According to IEC 60601-1) | Device complies with IEC 60601-1:2012 |
| Electromagnetic Compatibility (EMC): (According to IEC 60601-1-2) | Device complies with IEC 60601-1-2:2014 |
| Wireless Compliance: (According to FDA Guidance on RF Wireless Tech) | Device complies with FDA's guidance: "Guidance Radio Frequency Wireless Technology in Medical Devices Guidance for Industry and Food and Drug Administration Staff." |
| Performance Parameters: (According to Standards of Spirometry 2005) | All of the tested parameters (accuracy, intra instrument repeatability, PEF inter instrument repeatability, performance of flow resistance) meet the requirements in the standards. The performance of the proposed device is demonstrated to be comparable with the predicate device. The accuracy meets American Thoracic Society (ATS) Standard 2005 Revision. (Range: PEF 50 to 900 L/min, FEV1 0.01 to 9.99 L; Measuring solution: PEF 1 L/min; FEV1 0.01 L). |
| Software Verification & Validation: (According to FDA Guidance) | Software validation demonstrated that the software functions as specified in the software requirement specifications. (For "moderate" level of concern software) |
Regarding the specific questions about AI/ML device studies, the document does not contain this information as it is not about such a device.
- Sample size used for the test set and the data provenance: Not applicable. The testing described is for a physical device, not an AI algorithm evaluated on a data test set from specific provenance.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. The ground truth for performance is established by reference standards for spirometry or laboratory tests for biocompatibility/electrical safety.
- Adjudication method: Not applicable.
- 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, this is not an AI-assisted diagnostic device.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: No, this is not an AI algorithm.
- The type of ground truth used:
- Performance: Reference standards specified by Standards of Spirometry (2005 Revision) and American Thoracic Society (ATS) Standard 2005 Revision.
- Biocompatibility: Laboratory testing results against ISO 10993 standards.
- Electrical Safety & EMC: Compliance with IEC 60601 standards.
- Wireless: Compliance with FDA guidance.
- Software: Software requirement specifications.
- The sample size for the training set: Not applicable, as this is not an AI/ML device.
- How the ground truth for the training set was established: Not applicable.
§ 868.1860 Peak-flow meter for spirometry.
(a)
Identification. A peak-flow meter for spirometry is a device used to measure a patient's maximum ventilatory flow rate.(b)
Classification. Class II (performance standards).