(263 days)
Condition: Viridia 24 CT is generally indicated when the clinician decides there is a need to measure and display multiple physiological parameters and waves, to generate alarms and recordings of adult, pediatric, or neonatal patients.
Part of Body or Type of Tissue with Which the Device Interacts: Viridia 24 CT does not contact the body or tissue of the patient. Signals are obtained from accessory electrode, transducer, and sensor devices.
Frequency of Use: Viridia 24 CT is indicated for use when prescribed by a clinician.
Physiological Purpose: Viridia 24 CT is indicated when the purpose is to gain information for treatment, to assess adequacy of treatment, or to rule out causes of symptoms. Viridia 24 CT is well suited for patient monitoring.
Patient Population: Adult, pediatric, and neonatal non-ambulatory patients.
Prescription Versus Over-the-Counter: Viridia 24 CT is a prescription device.
Viridia 24 CT is a patient monitor. This submission notifies the FDA that the power source was modified. No other significant changes were made to the device.
The provided text describes a 510(k) submission for the Hewlett-Packard M1205A Viridia 24 CT, a patient monitor. This document focuses on the regulatory approval process for a medical device and its intended use, rather than a study evaluating its performance against specific acceptance criteria in the way an AI algorithm or a diagnostic tool would be evaluated.
Therefore, many of the requested elements for an acceptance criteria study, such as sample size, data provenance, ground truth establishment, expert qualifications, and comparative effectiveness studies, are not present in this type of regulatory submission. The document states that the device has undergone "Verification and Validation" and "extensive testing" to show "substantial equivalence" to legally marketed predicate devices, but it does not detail the specific performance metrics or the studies conducted to meet them.
Here's an analysis based on the information provided:
1. A table of acceptance criteria and the reported device performance
The document does not provide a table of specific quantitative acceptance criteria (e.g., sensitivity, specificity, accuracy, or a specific range of measurement error) or reported device performance for these criteria. Instead, the "acceptance criteria" are broad statements related to safety, effectiveness, and substantial equivalence to predicate devices.
| Acceptance Criteria (Inferred from Document) | Reported Device Performance (Inferred from Document) |
|---|---|
| Safe and Effective when used as labeled | "Documented test results obtained from extensive testing coupled with detailed user documentation... produces a very high confidence level that the device is safe and effective when used as intended." |
| Substantial Equivalence to predicate devices | "Viridia 24 CT has been verified and validated to provide the test results needed to show substantial equivalence to legally marketed devices." |
| Measures and displays multiple physiological parameters and waves | Intended purpose of the device. |
| Generates alarms and recordings | Intended purpose of the device. |
| Exchanges information with compatible devices | Intended purpose of the device. |
| Suitable for intra-facility transport | Stated intended use. |
2. Sample size used for the test set and the data provenance
The document does not specify a "test set" in the context of an AI/diagnostic algorithm evaluation. It mentions "extensive testing" but provides no details on sample sizes, data provenance (country of origin, retrospective/prospective nature), or patient characteristics for these tests. The focus is on the device's functional integrity and its ability to perform its stated purpose, not on its diagnostic accuracy or predictive power.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. This device is a physiological monitor, not a diagnostic tool that relies on expert interpretation for "ground truth" establishment in the way an AI algorithm would.
4. Adjudication method for the test set
Not applicable. There is no mention of a test set with human assessments requiring adjudication.
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. This is a standalone patient monitor, not an AI-assisted diagnostic tool.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
This device is not an algorithm, but a hardware patient monitor. Its performance is inherent in its measurement capabilities. The document states it is "not a therapeutic device" and "not intended for home use," aligning with a "standalone" monitoring function used by clinicians. The device's "performance" would be related to the accuracy and reliability of its physiological parameter measurements, which are not detailed here.
7. The type of ground truth used
For a physiological monitor, the "ground truth" would implicitly be the actual physiological parameters being measured by the device (e.g., heart rate, blood pressure, etc.), typically established through direct physical measurement or comparison with established gold-standard instruments. The document does not specify how this "ground truth" was established for verification/validation.
8. The sample size for the training set
Not applicable. This is a hardware patient monitor, not an AI algorithm that requires a training set.
9. How the ground truth for the training set was established
Not applicable. As above, this device does not utilize a training set in the AI sense.
§ 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.