(30 days)
Indications: For central monitoring of multiple adult, pediatric, and neonatal patients. For monitoring cardiac arrhythmia of adult patients to gain information for addition of treatment, or to exclude causes of symptoms. For monitoring ST Segment of adult patients to gain information for addition of treatment, or to exclude causes of symptoms.
The modification is primarily a software based change that expands Remote Services Access capability to allow on-line troubleshooting while in the monitoring mode, and enhances both standalone and networking capabilities. Also, improvements were made to upgrade the hardware and operating system environments.
Here's a breakdown of the acceptance criteria and study information based on the provided text, recognizing that this document is a 510(k) summary and not a detailed clinical study report:
I. Acceptance Criteria and Reported Device Performance
The provided 510(k) summary for the Hewlett-Packard Viridia Information Software, Release B.01, does not detail specific, quantitative acceptance criteria common in clinical studies (e.g., sensitivity, specificity, accuracy thresholds). Instead, it focuses on demonstrating substantial equivalence to a predicate device (HP CentralVue Software, K964832) through verification, validation, and testing activities.
The acceptance criteria can be inferred as:
- The device performing according to the specifications established for the predicate device.
- Meeting performance, functionality, and reliability requirements.
| Acceptance Criteria (Inferred from documentation) | Reported Device Performance |
|---|---|
| Performance, functionality, and reliability consistent with predicate device. | "Verification, validation, and testing activities were conducted to establish the performance, functionality, and reliability characteristics of the new device with respect to the predicate. Testing involved system level tests, integration tests, environmental tests, and safety testing from hazard analysis. Pass/Fail criteria were based on the specifications cleared for the predicate device and test results showed substantial equivalence." |
| Remote Access Services (RAS) functionality meets performance and reliability requirements. | "Additionally, a Network Test Plan was performed in connection with Remote Access Services functionality under a variety of conditions and configurations. The results show that RAS functionality met all performance and reliability requirements and the testing passed." |
| Expansion of Remote Services Access for on-line troubleshooting while monitoring. | This capability was successfully implemented and its functionality met requirements per the Network Test Plan. |
| Enhanced standalone and networking capabilities. | These enhancements were verified and validated through a range of testing activities, demonstrating substantial equivalence to the predicate device. |
| Upgraded hardware and operating system environments. | The upgraded environments were incorporated, and the device's functionality and performance were confirmed through testing to remain equivalent to the predicate. |
II. Sample Size Used for the Test Set and Data Provenance
The document does not specify a "test set" in the context of clinical data for performance evaluation (e.g., patient cases with diagnoses). The testing described is primarily software and system-level functional testing.
- Sample Size: Not applicable in the traditional sense of patient samples. The testing involved "system level tests, integration tests, environmental tests, and safety testing." The "Network Test Plan" for Remote Access Services was performed "under a variety of conditions and configurations," but specific numbers are not given.
- Data Provenance: Not applicable, as this was not a clinical study involving patient data. This was technical system testing.
III. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
- Number of Experts: Not applicable. The "ground truth" for this type of software/system testing would be the predefined functional specifications and expected outputs of the software and hardware system.
- Qualifications of Experts: If any "experts" were involved, they would likely be software engineers, quality assurance testers, and regulatory affairs personnel responsible for verifying compliance with specifications. Their specific qualifications are not listed.
IV. Adjudication Method for the Test Set
- Adjudication Method: Not applicable. The testing primarily involved verifying system functionality against predefined technical specifications, rather than adjudicating clinical interpretations. "Pass/Fail criteria were based on the specifications cleared for the predicate device."
V. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
- MRMC Study: No, an MRMC comparative effectiveness study was not done. The document describes technical verification and validation against a predicate device's specifications, not a study comparing human reader performance with and without AI assistance for tasks like arrhythmia detection or ST segment analysis.
VI. If a Standalone (algorithm only without human-in-the-loop performance) was done
- Standalone Performance: The core function of the "Viridia Information Software" is to provide information for monitoring. While the software has "standalone" capabilities (as described in point 4 of the 510(k) summary), the document does not present quantitative performance metrics (e.g., sensitivity, specificity for arrhythmia detection) as a "standalone algorithm" in isolation from a human observer. The validation focuses on the software's functionality within the existing monitoring system.
VII. The Type of Ground Truth Used
- Type of Ground Truth: The ground truth for this device's validation was primarily predefined technical specifications (functionality, performance, reliability requirements) derived from the predicate device and internal engineering standards. For the Remote Access Services, the successful operation "under a variety of conditions and configurations" against its specific requirements served as its ground truth.
VIII. The Sample Size for the Training Set
- Sample Size for Training Set: Not applicable. This document describes a software update for an existing monitoring system, not the development of a novel machine learning algorithm that would require a "training set" of data.
IX. How the Ground Truth for the Training Set was Established
- Ground Truth for Training Set: Not applicable, as no training set for a machine learning algorithm is mentioned or implied.
§ 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.