(25 days)
The HP M2331A CareVue 9000 is a clinical information system intended for use in data collection, storage, and management with independent bedside devices, and ancillary systems that are connected either directly or through networks. It is indicated for use by health care providers whenever there is a need for generation of a patient record and computation of drug dosage.
The Hewlett-Packard M2331A CareVue 9000 Clinical Information Management System. The modification is primarily a software based change that expands access to more information data bases. Also, improvements were made to upgrade the hardware and operating system environments.
The provided text is a 510(k) summary for the Hewlett-Packard M2331A CareVue 9000 Clinical Information Management System, seeking clearance from the FDA in 1999. This document is focused on demonstrating substantial equivalence to previously cleared devices rather than providing detailed performance studies with acceptance criteria in the manner one might expect for a new diagnostic or AI-powered medical device today.
Therefore, much of the requested information regarding specific acceptance criteria, detailed study designs, expert involvement, and ground truth establishment is not present in this document.
Here's an analysis based on the available information:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Pass/Fail criteria based on specifications cleared for predicate devices. | "Testing involved system level tests, integration tests, and safety testing from risk analysis. Pass/Fail criteria were based on the specifications cleared for the predicate devices and test results showed substantial equivalence." The document implies that all tests met these internal "pass/fail" or "specifications." |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: Not specified.
- Data Provenance: Not specified. The summary refers to "system level tests, integration tests, and safety testing from risk analysis," which typically involve internal testing and possibly simulated data rather than patient data from a specific country or collected retrospectively/prospectively.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
- Number of Experts: Not specified.
- Qualifications of Experts: Not specified. Given the nature of a Clinical Information Management System (CIMS), "experts" might have been clinicians or IT professionals evaluating system functionality and data integrity rather than medical diagnosticians establishing ground truth for disease detection, which is not the primary function of this device.
4. Adjudication Method for the Test Set
- Adjudication Method: Not specified.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
- MRMC Study: No, an MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic devices where human readers interpret medical images or data. The CareVue 9000 is a Clinical Information Management System for data collection, storage, and management, not a diagnostic interpretation tool in itself.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done
- Standalone Performance: Not explicitly stated or in the context of an "algorithm only" performance as understood in AI/ML devices today. The device is a system with software, and its "performance" would be evaluated in terms of its functionality (e.g., data accuracy, accessibility, computational correctness for drug dosages), not standalone diagnostic accuracy.
7. The Type of Ground Truth Used
- Type of Ground Truth: Not explicitly stated as "ground truth" in the modern sense (e.g., pathology, clinical outcomes). For a CIMS, the "ground truth" for its performance would likely relate to:
- Data Integrity: Whether data is accurately collected, stored, and retrieved.
- Functional Correctness: Whether computations (e.g., drug dosages) are performed correctly.
- System Reliability: Whether the system operates as intended without errors or crashes.
- This would be verified against system specifications and known correct computations/data.
8. The Sample Size for the Training Set
- Sample Size for Training Set: Not applicable/not specified. The CareVue 9000 is a rule-based or procedural software system, not an AI/machine learning device that requires a "training set" in the modern sense. Its development would involve software engineering and testing against requirements, not data-driven model training.
9. How the Ground Truth for the Training Set Was Established
- Establishment of Ground Truth for Training Set: Not applicable/not specified, as there is no "training set" in the context of this device.
Summary of Device and Study Context for K992636:
The K992636 submission for the Hewlett-Packard M2331A CareVue 9000 Clinical Information Management System is a premarket notification for a software-based change that expanded access to more information databases and upgraded hardware/operating systems. Its primary function is for data collection, storage, management of patient records, and computation of drug dosages.
The review process for this type of device in 1999 primarily relied on demonstrating substantial equivalence to existing predicate devices. This means the key argument was that the new device had the same intended use, technological characteristics, and performed safely and effectively as its predecessors. The "study" mentioned is general "Verification, validation, and testing activities" that included system-level tests, integration tests, and safety testing aligned with risk analysis. The acceptance criteria were based on the specifications of the predicate devices. This is a very different submission and review context compared to what would be required for a novel AI-powered diagnostic device today, which would necessitate rigorous clinical studies with detailed methodologies for ground truth, expert adjudication, and statistical performance metrics.
§ 870.2450 Medical cathode-ray tube display.
(a)
Identification. A medical cathode-ray tube display is a device designed primarily to display selected biological signals. This device often incorporates special display features unique to a specific biological signal.(b)
Classification. Class II (performance standards).