(304 days)
The HP M3000A/M3046A Compact Portable Patient Monitor is indicated for use in health care facilities by health care professionals when the patient's clinician deems it appropriate to use a device that:
- Can measure and display multiple physiological parameters and waves' of a) one patient, and can generate alarms and printouts based on those measurements.
- Can be used on adult, pediatric, and neonatal patients as specified in the b) Technical Data Sheets. The non-intrasive pressure can be used for adult and pediatric patients.
-
- List of supported measurements
- ECG (a)
- Respiration (b)
- Invasive blood pressure (c)
- Non-invasive blood pressure (d)
- SpO2 and Pleth (e)
- Temperature (f)
-
M3000A/M3046A Compact Portable Patient Monitor
Here's an analysis of the provided text regarding the acceptance criteria and study information for the Hewlett-Packard Models M3000A Multi-Measurement Server and M3046A Compact Portable Patient Monitor.
Based on the provided document, which is an FDA 510(k) clearance letter, there is no detailed information about the acceptance criteria or a specific study that proves the device meets these criteria in the manner expected for a typical AI/ML device submission.
This document is a 510(k) clearance letter from 1998 for a patient monitor, not an AI/ML diagnostic device. Therefore, the questions related to AI performance metrics, ground truth establishment, training sets, and expert adjudication are mostly not applicable to this type of device and submission.
The document primarily focuses on establishing "substantial equivalence" to a predicate device marketed before May 28, 1976. This is a regulatory pathway that doesn't typically require the detailed performance study data that would be relevant for an AI/ML device.
However, I will extract any relevant information that can be inferred from the text regarding the device's intended performance and "acceptance" in a regulatory context, and explicitly state what information is not present.
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (Inferred) | Reported Device Performance | Comments |
|---|---|---|
| Regulatory Substantial Equivalence: | Device deemed "substantially equivalent" to predicate devices. | This is the primary "acceptance criterion" for a 510(k) submission. It means the device is as safe and effective as a legally marketed device. |
| Indications for Use: | Monitor physiological parameters and waves (ECG, Respiration, Invasive BP, Non-invasive BP, SpO2/Pleth, Temperature) for adult, pediatric, and neonatal patients. | The device's ability to measure these parameters as specified in Technical Data Sheets is implied. Specific performance metrics (e.g., accuracy, precision) are not detailed in this clearance letter. |
| Alarm Generation: | Device can generate alarms based on measurements. | Functionality is stated. No specific alarm sensitivity or specificity performance data is provided. |
| Printout Capability: | Device can generate printouts based on measurements. | Functionality is stated. |
| Patient Population: | Adult, pediatric, and neonatal patients (with non-invasive pressure for adult and pediatric only). | The device's applicability to these populations is cleared. Specific performance across these populations is not detailed here. |
| Clinical Environment: | Used in healthcare facilities by healthcare professionals. | This defines the intended use environment and user. |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not Applicable/Not Provided. The 510(k) clearance letter does not describe a clinical performance test set, its sample size, or the provenance of data for specific performance evaluation in the way it would for an AI/ML device. The "test" for a traditional 510(k) is primarily a demonstration of equivalence to a predicate device, often through bench testing and review of existing predicate data, rather than a de novo clinical study with a dedicated test set.
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 Applicable/Not Provided. No mention of a test set requiring expert-established ground truth. This is not relevant for a patient monitor's 510(k) clearance.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not Applicable/Not Provided. No test set or adjudication method is described.
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
- Not Applicable/Not Provided. This is a clearance for a patient monitor, not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not Applicable/Not Provided. The device is a "Multi-Measurement Server and Compact Portable Patient Monitor," implying human users. It is not an algorithm-only device.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
- Not Applicable/Not Provided. The concept of "ground truth" for diagnostic accuracy (as would be relevant for AI/ML) is not present in this document. The "ground truth" for a patient monitor would be the true physiological state, measured by gold-standard instruments, but such comparative validation details are not in this clearance letter.
8. The sample size for the training set
- Not Applicable/Not Provided. This device is a hardware patient monitor, not an AI/ML system that undergoes "training."
9. How the ground truth for the training set was established
- Not Applicable/Not Provided. Not an AI/ML device.
§ 870.1025 Arrhythmia detector and alarm (including ST-segment measurement and alarm).
(a)
Identification. The arrhythmia detector and alarm device monitors an electrocardiogram and is designed to produce a visible or audible signal or alarm when atrial or ventricular arrhythmia, such as premature contraction or ventricular fibrillation, occurs.(b)
Classification. Class II (special controls). The guidance document entitled “Class II Special Controls Guidance Document: Arrhythmia Detector and Alarm” will serve as the special control. See § 870.1 for the availability of this guidance document.