(111 days)
The MD500B Vital Signs Monitor is intended to be used to monitor physiologic parameters including SpO2, Pulse Rate (PR) and Non-Invasive Blood Pressure (NIBP) on adult patients in healthcare facilities by clinical physicians or appropriate medical staff under the direction of physicians. It is not intended for transport or home use.
The proposed device, MD500B Vital Signs Monitor, is a battery-driven device, which is intended for measuring pulse oxygen saturation (SpO2), pulse rate (PR), systolic pressure (S) and diastolic pressure (D) on adult.
The provided text describes the 510(k) submission for the MD500B Vital Signs Monitor. It mentions that performance testing, including clinical and laboratory testing, was conducted to validate and verify that the device met all design specifications and was substantially equivalent to the predicate device. However, the document does not contain the specific details required to complete your request for acceptance criteria, study methodologies, and performance metrics.
The text is a regulatory summary (510(k) summary and FDA letter), which often summarizes testing without providing the raw data, specific acceptance criteria values, or detailed study designs.
Therefore, I cannot populate the requested table or answer most of your detailed questions based solely on the provided text. I will indicate where information is missing.
1. Table of acceptance criteria and the reported device performance
| Parameter | Acceptance Criteria (e.g., Accuracy, Range) | Reported Device Performance |
|---|---|---|
| SpO2 Accuracy | Not specified in provided text | Not specified in provided text |
| Pulse Rate (PR) Accuracy | Not specified in provided text | Not specified in provided text |
| NIBP Accuracy (Systolic) | Not specified in provided text | Not specified in provided text |
| NIBP Accuracy (Diastolic) | Not specified in provided text | Not specified in provided text |
| Measurement Range (SpO2) | Not specified in provided text | Not specified in provided text |
| Measurement Range (PR) | Not specified in provided text | Not specified in provided text |
| Measurement Range (NIBP) | Not specified in provided text | Not specified in provided text |
| Substantial Equivalence | Met design specifications and substantial equivalence to predicate device | Met design specifications and substantial equivalence to predicate device |
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
- Sample Size: Not specified in the provided text.
- Data Provenance: Not specified in the provided text (e.g., country, retrospective/prospective). The sponsor is based in Beijing, China, but this does not confirm the origin of the clinical data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)
- Not specified within the provided text.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
- Not specified within the provided 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
- No. This is a vital signs monitor, not an AI-assisted diagnostic device that involves human reader interpretation. Therefore, an MRMC study with AI assistance is not applicable to this device type.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Yes, implicitly. Vital signs monitors are standalone devices that provide physiological measurements directly. The performance testing (clinical and laboratory) would have evaluated the device's accuracy in producing these measurements directly.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not explicitly stated, but for vital signs monitors, the ground truth typically involves reference standards like:
- Direct arterial blood pressure measurement for NIBP accuracy.
- Co-oximetry for SpO2 accuracy.
- Electrocardiogram (ECG) or manual pulse counting for pulse rate accuracy.
- The document only mentions "clinical and laboratory testing," which would have used such reference standards.
8. The sample size for the training set
- Not specified within the provided text. Note: Training sets are typically associated with machine learning or AI models. While the device is electronic, the description does not indicate it uses a machine learning algorithm that would require a separate "training set" in the common sense of AI development. It's more likely validated against established physiological models and clinical data.
9. How the ground truth for the training set was established
- Not applicable as a distinct "training set" in the context of an AI model is not detailed or implied for this device type within the provided text.
§ 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).