(27 days)
The Hewlett-Packard family of patient monitor products is intended for monitoring, recording, and alarming of multiple physiological parameters. The devices are indicated for use in health care facilities by health care professionals whenever there is a need for monitoring the physiological parameters of adult, neonatal, and pediatric patients.
The name of this device is the Hewlett-Packard family of Viridia Patient Monitors individually known as the M1175A/76A/77A (Viridia CMS), the M1205A (Viridia 24/26), and the M3000A/M3046A (Viridia M3/4). The common name is patient monitor. The modification is a software based change that involves only the SpO2 algorithm of the measurement computer processing unit of each device.
The provided text describes a 510(k) submission for a software-based change to the SpO2 algorithm within the Hewlett-Packard family of Viridia Patient Monitors. Here's a breakdown of the acceptance criteria and study details based on the input:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Specifications cleared for predicate devices (SpO2 algorithm performance) | All tested sensor-monitor combinations passed test criteria. Test results showed substantial equivalence to the predicate devices. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size:
- Neonatal patient data: Not explicitly stated, but clinical performance evaluations were conducted with "ICU neonates."
- Adult patient data: Not explicitly stated, but a "desaturation study" was conducted with "adults."
- Data Provenance: Not explicitly stated, but the studies were clinical performance evaluations. It's not specified whether the data was retrospective or prospective, or the country of origin, though the submitter is based in Germany.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
Not explicitly stated. The text mentions "co-oximeters as a reference" for the adult desaturation study, implying a quantitative, objective ground truth rather than expert consensus for that specific measurement.
4. Adjudication Method for the Test Set
Not applicable/mentioned. The ground truth for the adult study was established using co-oximeters. The method for the neonatal data ground truth is not detailed.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, an MRMC comparative effectiveness study was not done. The study focused on the performance of the updated SpO2 algorithm and its equivalence to predicate devices, not on the improvement of human readers with AI assistance.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done
Yes, the studies described appear to be standalone performance evaluations of the SpO2 algorithm. The text states: "Clinical performance evaluations using the new algorithm were conducted..." and describes validating the measurement of oxygen saturation.
7. The Type of Ground Truth Used
- Adult Study: Co-oximeters were used as a reference to validate the accuracy of the SpO2 measurement during a desaturation study. Co-oximetry is a gold standard for blood oxygen saturation measurement.
- Neonatal Study: The type of ground truth used to validate the measurement of oxygen saturation in ICU neonates is not explicitly stated.
8. The Sample Size for the Training Set
Not applicable/mentioned. The text describes verification, validation, and testing activities for a software change to an existing algorithm. There's no indication of a new algorithm being "trained" on a specific dataset in the context of this 510(k) summary. These are performance evaluations of an updated algorithm.
9. How the Ground Truth for the Training Set Was Established
Not applicable/mentioned, as a training set for a new algorithm is not described. The evaluation focused on the performance of a modified SpO2 algorithm against established predicate device specifications and clinical references.
§ 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.