(44 days)
Intended for monitoring, recording, and alarming of multiple physiological parameters of adults, pediatrics, and neonates in hospital and medical transport environments.
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Here's an analysis of the provided text regarding the acceptance criteria and study for the Philips M2/M3/M4 Compact Portable Patient Monitor:
This document primarily describes the substantial equivalence of the new device to previously cleared devices (M3 K971910 and K981576) and highlights a modification related to auscultatory validation. As such, the information provided is limited in detail regarding acceptance criteria and study specifics for the new device as a standalone entity, beyond the specific mention of non-invasive blood pressure (NIBP) validation.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Auscultatory validation reference according to subclause 4.4.2.1 of AAMI SP-10 for pediatric and adult patients. | Device performance correlates to auscultatory reference standard according to subclause 4.4.2.1 of AAMI SP-10 for pediatric and adult patients. |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the sample size used for the test set or the data provenance (e.g., country of origin, retrospective/prospective). It only mentions a "validation study."
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
The document does not explicitly state the number of experts used or their qualifications. It refers to "auscultatory reference standard," which typically implies human observers.
4. Adjudication Method for the Test Set
The document does not explicitly state the adjudication method. The reference to "auscultatory reference standard" might suggest a consensus among observers if multiple were used, but this is not specified.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
A multi-reader multi-case (MRMC) comparative effectiveness study was not done or at least not described in this document. The focus is on the device's performance against a reference standard, not its impact on human reader performance.
6. Standalone (Algorithm Only Without Human-in-the-Loop) Performance
A standalone performance study was done. The validation study evaluates the device's "performance correlates to auscultatory reference standard," implying the device's output is directly compared to the reference.
7. Type of Ground Truth Used
The type of ground truth used is an expert consensus/reference standard, specifically the "auscultatory reference standard according to subclause 4.4.2.1 of AAMI SP-10" for non-invasive blood pressure measurements. Auscultatory methods rely on human listeners (experts) using a stethoscope to determine systolic and diastolic pressures.
8. Sample Size for the Training Set
The document does not explicitly state the sample size for any training set. Given the context of a 510(k) for a patient monitor predominantly focused on substantial equivalence and a specific validation for NIBP, it's possible that a separate "training set" in the modern machine learning sense was not explicitly defined or extensively documented in this submission.
9. How the Ground Truth for the Training Set Was Established
The document does not explicitly describe how ground truth for a training set was established. The validation study focuses on comparing the device's NIBP measurements to an established auscultatory reference standard.
§ 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.