(354 days)
M800 handheld monitor is intended for continuously monitoring or spot checking of SpO2, PR, ECG and HR of adult, pediatric and neonatal patients in hospital type facilities as well as in the home care environment.
The proposed device, M800 is a handheld patient monitor for continuously monitoring and spot checking of SpO2, PR, ECG and HR of adult, pediatric and neonatal patients.
The proposed device includes three display modes for monitoring results, data review function, and audio and visual alarming function.
It consists of four functional modules, which are power supply module, parameter measurement module, main control and human-device interface.
The provided text describes the M800 Handheld Monitor and its substantial equivalence to a predicate device (M Series Patient Monitor K100046), rather than detailing a study proving the device meets specific acceptance criteria with defined metrics.
However, based on the information provided, we can infer the "acceptance criteria" are compliance with established medical device standards and the "study" is the non-clinical testing performed to demonstrate this compliance and substantial equivalence to the predicate device.
Here's an analysis based on the provided text, addressing the requested points where information is available or can be reasonably inferred:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are primarily defined by compliance with various IEC, ISO, and AAMI/ANSI standards for medical electrical equipment and specific monitoring functions (pulse oximetry, ECG). The "reported device performance" is the claim of compliance with these standards and the listed technical specifications being "Same" or "Similar" to the predicate device.
| Acceptance Criteria Category | Specific Acceptance Criteria (Standard/Metric) | Reported Device Performance |
|---|---|---|
| General Safety & Performance | IEC 60601-1 (General requirements) | Complies with IEC 60601-1 |
| Electromagnetic Compatibility (EMC) | IEC 60601-1-2 | Complies with IEC 60601-1-2 |
| Pulse Oximetry | ISO 9919 (Pulse oximeter equipment) | Complies with ISO 9919. |
| SpO2 Range (BLT Module): 0-100% (Same as predicate) | ||
| SpO2 Range (Necllor Module): 0-100% (Same as predicate) | ||
| SpO2 Accuracy (BLT Module): 70-100%: ±2%; 0-69%: unspecified (Same as predicate) | ||
| SpO2 Accuracy (Necllor Module): 70-100%: ±2% (adult/pediatric), ±3% (neonate), ±2% (low perfusion); 0-69%: unspecified (Same as predicate) | ||
| Heart Rate (PR) | ISO 9919 (Pulse Oximeter PR) | PR Range (BLT Module): 25-255 bpm (Same as predicate) |
| PR Range (Necllor Module): 20-300 bpm (Same as predicate) | ||
| PR Accuracy (BLT Module): ±1% or ±1 bpm, whichever is greater (Same as predicate) | ||
| PR Accuracy (Necllor Module): 20-250bpm: ±3 bpm; 251-300bpm: unspecified (Same as predicate) | ||
| Electrocardiography (ECG) | IEC 60601-2-27 (Electrocardiographic monitoring equipment) | Complies with IEC 60601-2-27. |
| ECG Lead: 3 lead: I, II, III (Same as predicate) | ||
| ECG Gain: 2.5mm/mV(×0.25), 5mm/mV(×0.5), 10mm/mV(×1) (Same as predicate) | ||
| Sweep Speed: 12.5mm/s, 25mm/s (Same as predicate) | ||
| Heart Rate (HR) | AAMI/ANSI EC13 (Cardiac monitors, heart rate meters, and alarms) | Complies with AAMI/ANSI EC13. |
| HR Range: 10-300 bpm (Same as predicate) | ||
| HR Accuracy: ±1% or ±1 bpm, whichever is the greater (Same as predicate) | ||
| Patient-Contact Material | Not explicitly stated as a numerical criterion, but TPU for ECG cable. | ECG Cable: TPU (Same as predicate) |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify a "test set" in the context of clinical data for performance evaluation. The non-clinical tests relate to engineering and safety standards. Therefore, specific sample sizes for patients or data provenance (country of origin, retrospective/prospective) are not mentioned as this was likely an engineering verification and validation effort against standards, not a clinical trial with patient data.
3. Number of Experts Used to Establish Ground Truth and Qualifications
Not applicable. This was not a study involving expert-established ground truth on clinical data. The "ground truth" for the non-clinical tests would be the compliance requirements of the referenced standards.
4. Adjudication Method for the Test Set
Not applicable. No clinical test set or adjudication method is mentioned.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No. The document makes no mention of an MRMC comparative effectiveness study or human readers improving with AI assistance. The device is a patient monitor, not an AI diagnostic tool.
6. Standalone (Algorithm Only) Performance Study
Yes, in essence. The "non-clinical tests" described are a form of standalone performance evaluation, confirming the device's adherence to technical standards and specifications directly, without human interpretation in the loop. The device itself is a measurement tool, and its performance is assessed against known physical or electrical standards.
7. Type of Ground Truth Used
The ground truth used for these non-clinical tests would be the requirements and specifications within the referenced international and national medical device standards (IEC 60601-1, IEC 60601-1-2, ISO 9919, IEC 60601-2-27, AAMI/ANSI EC13). For example, for an SpO2 accuracy test, the ground truth would be a precisely calibrated oxygen saturation level from a reference device or method.
8. Sample Size for the Training Set
Not applicable. This device is not described as utilizing an AI or machine learning algorithm that would require a "training set" of data. Its functionality is based on established physiological measurement principles.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no mention of a training set or AI/ML components for this device.
§ 870.2300 Cardiac monitor (including cardiotachometer and rate alarm).
(a)
Identification. A cardiac monitor (including cardiotachometer and rate alarm) is a device used to measure the heart rate from an analog signal produced by an electrocardiograph, vectorcardiograph, or blood pressure monitor. This device may sound an alarm when the heart rate falls outside preset upper and lower limits.(b)
Classification. Class II (performance standards).