(58 days)
The PMS8210A Multi Parameter Patient Monitor is a multi-parameters monitor used on human patients. The target populations are adult, pediatric and neonatal patients. The PMS8210A Patient Monitor has certain features and functions.
The patient parameters that can be monitored by PMS8210A Patient Monitor are: ECG(3-lead or 5-lead selectable), Heart Rate(HR), Pulse Rate(PR), Respiration Rate(RESP), Non-invasive Blood Pressure (NIBP), Arterial Hemoglobin Oxygen Saturation(SpO2) and Temperature (TEMP). Its design allows the operator to adjust the settings of parameter alarms that audibly and visually notify the operator when an excursion occurs.
The PMS8210A Patient Monitor is intended for use in a health care facility setting. It is intended for use by qualified medical personnel trained in the use of the equipment.
The PMS8210A Patient Monitor is not recommended for use in a patient's home or residence, or when it has not been ordered by a physician.
PMS8210A Patient Monitor is a battery or line-powered patient monitor. The Patient Monitor acquires the physiological signals such as ECG, respiration (RESP), Non-Invasive blood pressure (NIBP), Saturation of pulse oxygen (SPO2), Temperature (TEMP), Heart rate (HR) and Pulse Rate (PR), The signals are converted into digital data and processed, examines the data for alarm conditions and displays the data. The monitor also provides operating control for the user.
The provided text does not contain detailed information about specific studies, acceptance criteria, or performance data for the PMS8210A (IRIS) Multi-parameter Patient Monitor. Instead, it focuses on comparing the device's technical specifications and adherence to various medical standards with a predicate device (PM-9000 EXPRESS PATIENT MONITOR).
Therefore, I cannot provide a table of acceptance criteria and reported device performance, nor details about sample sizes, data provenance, expert ground truth, adjudication methods, MRMC studies, standalone performance, or training set information.
The document primarily acts as a 510(k) summary, which is a premarket notification to the FDA to demonstrate substantial equivalence to a legally marketed predicate device. This typically involves showing that the new device has the same intended use and the same technological characteristics, or different technological characteristics that do not raise different questions of safety and effectiveness and are as safe and effective as the predicate device.
The study described is a comparison of the PMS8210A Multi-parameter Patient Monitor's specifications and compliance with relevant medical standards against a predicate device, the PM-9000 EXPRESS PATIENT MONITOR (K053234). The intent is to demonstrate that the subject device is substantially equivalent to the predicate device.
Here's what can be extracted:
1. Table of Acceptance Criteria and Reported Device Performance:
The document lists various technical specifications and accuracy claims for the PMS8210A device (Subject Device) and compares them to the predicate device. While these are performance characteristics, they are not explicitly labeled as "acceptance criteria" through a formal study results table. The implication is that meeting or being comparable to the predicate's performance, and adhering to referenced standards, constitutes meeting acceptance criteria for substantial equivalence.
| Parameter | Acceptance Criteria (Implied by Predicate/Standard) | PMS8210A Reported Performance |
|---|---|---|
| ECG | ||
| Gain | Predicate: ×0.125; ×0.25; ×0.5; ×1; ×2; auto. | ×0.5; ×1. |
| Range of Heart Rate Monitoring | Adult: 15 | Adult: 20 |
| Resolution (HR) | 1 bpm (Predicate) | 1 bpm |
| Precision (HR) | 1 bpm or ±1% (Predicate) | 20 |
| CMRR | Diagnostic mode: ≥90dB; Monitoring mode: ≥105dB; Surgical mode: ≥105dB (Predicate) | ≥89 dB |
| Frequency Characteristic (Mode 1) | 0.05Hz-100Hz (Diagnostic), 0.5Hz-40Hz (Monitoring), 1Hz-20Hz (Surgical) (Predicate) | Mode 1: 0.1Hz-40Hz; Mode 2: 0.67Hz-40Hz; Mode 3: 1Hz-25Hz |
| Respiration | ||
| Measuring Range | Adult: 0 | 15 ~ 120 rpm |
| Resolution | 1 rpm (Predicate) | 1 rpm |
| Precision | 0 | The bigger one between ±2 rpm or ±2% |
| NIBP | ||
| BP Accuracy | Arithmetic mean values: ±5 mmHg; Standard deviation no greater than 8 mmHg (Predicate, also stated by ANSI/AAMI SP10:2002; EN1060-4) | Arithmetic mean values: ±5 mmHg; Standard deviation no greater than 8 mmHg |
| SpO2 | ||
| SpO2 Measurement Range | 0~100% (Predicate) | 0~100% |
| SpO2 Measurement Accuracy | Adult/Pediatric: 70 | Adult/Pediatric: 70 |
| Pulse Rate Measurement | 20 to 250 BPM (Predicate) | 20~250bpm |
| Temperature | ||
| Measurement Range | 0°C | 0°C |
| Measurement Accuracy | ±0.1°C (±0.2°F) (Predicate, also stated by ASTM E1112:00) | ±0.1°C (±0.2°F) |
2. Sample size used for the test set and the data provenance:
This information is not provided in the given text. The document refers to "performance testing in accordance with IEC standards" but does not detail the size or nature of the test set or its provenance.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
This information is not provided in the given text. The document focuses on technical specifications and standard compliance, not clinical ground truth establishment by experts.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
This information is not provided in the given text.
5. 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:
This information is not applicable/provided. The device is a multi-parameter patient monitor, not an AI-assisted diagnostic tool involving human readers.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
The device itself is a standalone monitor. Its performance is assessed against technical specifications and standards (e.g., IEC, AAMI, EN, ISO). The document states the device has "software of Moderate concern" and that "the appropriate level of Software evaluation was performed," but does not detail the standalone performance study specific to an algorithm. The overall product performance is standalone.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
The ground truth for evaluating the device's technical specifications and accuracy is largely based on measurements against established reference standards and calibrated equipment, as implied by adherence to standards like ANSI/AAMI SP10 for NIBP accuracy and ASTM E1112 for temperature accuracy. For SpO2, it leverages the Nellcor SpO2 module, implying its proven accuracy. There is no mention of expert consensus, pathology, or outcomes data as ground truth in this document.
8. The sample size for the training set:
This information is not provided in the given text. As a patient monitor rather than an AI/ML algorithm requiring a training set in the typical sense, this concept might not directly apply or is not detailed. The "software of Moderate concern" does not imply a classical AI/ML model.
9. How the ground truth for the training set was established:
This information is not provided in the given text, and likely not applicable in the context of this traditional medical 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).