(422 days)
The Multi-parameter detector is intended to be used for measuring and displaying of non-invasive blood pressure (NBP). non-invasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2), pulse rate (PR), forehead temperature (TEMP), weight and height in adults.
The Multi-parameter detector is also intended to estimate body mass index (BMI), Body fat percentage, basal metabolism and free fat mass, bone mass and body water percentage) using the BIA (Bio-electrical Impedance Analysis) method.
The Multi-parameter detector is a device designed for measuring of the patient's physiological parameters. The Multi-parameter detector can monitor the patient's blood oxygen saturation (SpO2) and pulse rate (PR) non-invasively by the photoelectric method. It can also measure non-invasive blood pressure (NIBP, the pressures of systolic and diastolic) by the oscillating method and body temperature (TEMP) by the infrared radiation energy technology.
The Multi-parameter detector are non-invasive body composition analyzers. The devices employ BIA (Bio-electrical Impedance Analysis) method and then measure body composition using an experimentally derived algorithm.
The Multi-parameter detector integrates an FDA market cleared devices, All-in-One Health Monitor (K170047) for measurement of oxygen saturation of arterial hemoqlobin (SpO2).
The provided document is a 510(k) summary for a "Multi-parameter detector." It outlines the device's characteristics, intended use, and substantial equivalence to predicate devices, along with non-clinical and clinical testing performed. However, it does not provide the detailed acceptance criteria and "study that proves the device meets the acceptance criteria" in the format requested, particularly for an AI/algorithm-based device study.
The document primarily focuses on demonstrating substantial equivalence based on performance standards for traditional medical devices (blood pressure, SpO2, temperature, body composition) rather than the rigorous evaluation of a new AI/ML-driven diagnostic or assistive technology.
Here's a breakdown of what can be extracted and what is missing based on your prompt:
Extracted Information:
1. Table of Acceptance Criteria and Reported Device Performance:
The document provides performance standards and reports whether the device met them, rather than a direct "acceptance criteria" table with specific quantitative thresholds and exact results for each parameter alongside performance metrics like sensitivity/specificity for an AI.
| Parameter | Acceptance Standard (from document) | Reported Device Performance (from document) |
|---|---|---|
| NIBP (Non-Invasive Blood Pressure) | Average difference: ≤ ±5.0 mmHg; Standard deviation: ≤ 8.0 mmHg (per ISO 81060-2:2018) | Achieved: Average value of difference within ±5.0mmHg, standard deviation not greater than 8.0mmHg. (Based on 119 subjects) |
| TEMP (Forehead Temperature) | Max allowable error: ±0.2°C for 35.0-42.0°C; Clinical repeatability: ≤ ±0.3°C (per ISO 80601-2-56:2017+AMD1:2018) | Achieved: 105 subjects did not exceed max allowable error of ±0.2°C (in 35.0°C-42.0°C range); Clinical repeatability did not exceed ±0.3°C. |
| SpO2 (Pulse Oximetry) | Accuracy claim: ±3% for 70%-100% range (per ISO 80601-2-61:2017) | Verified via prior clearance (K170047, which inherited from K063641 compliant with ISO 9919:2005). ARMS of 1.49 for 70%-100%, meeting ±3% claim. |
| PR (Pulse Rate) | (Implicitly tied to SpO2, no specific criteria or performance given) | Verified via prior clearance (K170047, which inherited from K063641). |
| Height/Weight/Impedance | Internal standards applied. | "Tested... according to our internal standards." (No specific acceptance criteria or performance numbers reported in this summary.) |
2. Sample Size Used for the Test Set and Data Provenance:
- NIBP: 119 subjects.
- TEMP: 105 subjects.
- SpO2: 10 healthy subjects (aged 22-40, Fitzpatrick 2-6), but this was for the integrated FDA cleared device (K170047), not a new test for this submission's SpO2 component.
- Data Provenance: The NIBP and TEMP clinical studies were described as "single-center, randomized, self-controlled clinical trial[s]" conducted by Zhongshan Jinli Electronic Weighing Equipment Co., Ltd. This implies prospective data, likely from China given the company's location.
3. Number of Experts Used to Establish Ground Truth and Qualifications:
- Not explicitly stated in the document.
- For NIBP and TEMP, the ground truth was established by comparison with "registered mercury thermometer and desktop sphygmomanometer." This implies these are the "gold standard" reference devices, not human experts.
4. Adjudication Method for the Test Set:
- Not applicable/Not stated. The ground truth was based on direct measurements from reference devices.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and Effect Size:
- No. This type of study is typical for AI/ML diagnostic tools assisting human readers (e.g., radiologists). The device in question is a multi-parameter measurement device, not an AI diagnostic tool requiring human reader studies to demonstrate assistance.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Yes, in spirit. The performance metrics (accuracy, standard deviation) for NIBP, TEMP, and SpO2 are reported for the device itself compared to reference standards, indicating standalone performance. The document describes the device directly measuring these parameters.
7. The Type of Ground Truth Used:
§ 870.2770 Impedance plethysmograph.
(a)
Identification. An impedance plethysmograph is a device used to estimate peripheral blood flow by measuring electrical impedance changes in a region of the body such as the arms and legs.(b)
Classification. Class II (special controls). The device, when it is a body composition analyzer which is not intended to diagnose or treat any medical condition, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 870.9.