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510(k) Data Aggregation
(210 days)
Shanghai Sonmol Medical Equipment Co., Ltd.
This device is intended to monitor a patient's Peak Expiratory Flow (PEF) and Forced Expiratory Volume in one second (FEV1) at home. The device is designed for adults and children over 5 years of age with caregiver supervision. The device is intended for monitoring respiratory conditions such as asthma. The device is for Over-The-Counter Use.
The Peak flow meter is composed of Main Unit and Mouthpiece.
Mouthpiece: Mouth blowing.
Main Unit: Containing a segment LCD, a pressure sensor and a Microcontroller Unit.
The pressure sensor records the gas flow rate in real time and delivers to MCU for processing, to get the flow volume of gas and volume, after the measurement, LCD displays the measurement results.
The provided document describes the Shanghai Sonmol Medical Equipment Co., Ltd. Peak Flow Meter (models SMPF-2S, SMPF-3A) and its substantial equivalence to a predicate device. Below is a breakdown of the acceptance criteria and study information:
1. Table of Acceptance Criteria and Reported Device Performance
The document refers to performance tests conducted according to the American Thoracic Society Standard of Spirometry (2005 Revision). The acceptance criteria are implicit in the accuracy specifications, which are compared to the predicate device.
| Parameter | Acceptance Criteria (Targeted Device) | Reported Device Performance (Targeted Device) |
|---|---|---|
| Accuracy (PEF) | ±10% or ±18 L/min (whichever is greater) | Meets criteria (comparable to predicate K191239) |
| Accuracy (FEV1) | ±3% or ±0.05L (whichever is greater) | Meets criteria (comparable to predicate K191239) |
| Measuring Range (PEF) | 60 L/min ~ 840 L/min | Meets criteria (overlaps predicate K191239 and reference K053156) |
| Measuring Range (FEV1) | 0.5L ~ 8L | Meets criteria (similar to reference K053156) |
| Measuring Resolution (PEF) | 1 L/min | Meets criteria (identical to predicate K191239; better than reference K053156) |
| Measuring Resolution (FEV1) | 0.01L | Meets criteria (identical to predicate K191239; better than reference K053156) |
| Intra-instrument Repeatability | Meets requirements in standards (implicit in performance test claim) | Meets criteria |
| Inter-instrument Repeatability (PEF) | Meets requirements in standards (implicit in performance test claim) | Meets criteria |
| Electrical Safety | Conformance to IEC 60601-1 and IEC 60601-1-11 | Passed tests |
| EMC | Conformance to IEC 60601-1-2 | Passed tests |
| Biocompatibility | Conformance to ISO 10993-1 | Passed tests |
| Software Verification & Validation | Software functions as specified in requirements (for "moderate" level of concern) | Validated |
| Human Factors | Device and application are as safe and effective as predicate | Study results demonstrate conformance |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the sample size for the performance test set. It mentions "Performance test has also been conducted to verify the measurement accuracy, intra instrument repeatability, PEF inter instrument repeatability and performance of the device according to American Thoracic Society Standard of Spirometry (2005 Revision)."
The data provenance is not explicitly mentioned as country of origin, retrospective or prospective. However, based on the context of a 510(k) submission, these would typically be controlled laboratory or simulated environment tests, not involving human patient data collection in a clinical setting in the same way a clinical trial would.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not provided in the document. The performance tests appear to be based on engineering and standardized testing rather than expert-established ground truth from clinical cases.
4. Adjudication Method for the Test Set
Adjudication methods (e.g., 2+1, 3+1, none) are not applicable or mentioned as the testing performed is based on direct measurement validation against established standards for spirometry devices, not interpretation by human readers.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, an MRMC comparative effectiveness study was not done. The device is a measurement instrument, not an AI diagnostic tool that assists human readers in interpreting images or data.
6. If a Standalone Study (Algorithm Only Without Human-in-the-Loop Performance) Was Done
While not an "algorithm" in the AI sense, the performance tests (accuracy, repeatability, range) are essentially standalone studies of the device's measurement capabilities. The device is intended for direct measurement by the patient/user, not for interpretation by a human-in-the-loop in a collaborative diagnostic setting.
7. The Type of Ground Truth Used
The ground truth for the performance tests appears to be based on:
- Established physical standards: The American Thoracic Society Standard of Spirometry (2005 Revision) provides the specifications for expected performance.
- Reference measurements: The accuracy and range are compared against predicate and reference devices, implying a standard of truth is upheld by these devices or by the testing methodologies described in the ATS standard.
- Engineering specifications: The device is tested against its own design specifications and regulatory standards (e.g., IEC 60601 series).
8. The Sample Size for the Training Set
This information is not applicable and not provided. The device is a hardware measurement tool; it does not involve a "training set" in the context of machine learning algorithms.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable and not provided, as there is no machine learning training set for this device.
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