(25 days)
For central monitoring of multiple adult, pediatric, and neonatal patients; and where the clinician decides to monitor cardiac arrhythmia of adult, pediatric, and neonatal patients and/or ST segment of adult patients to gain information for treatment, to monitor adequacy of treatment, or to exclude causes of symptoms.
M3290A IntelliVue Information Center Software Release E.1 (for DataBase Server with Alert Data Export). The modification is a change that provides different alert data export via the hospital LAN.
The provided text (K031403) describes a 510(k) summary for a software release, not a study presenting "acceptance criteria and the study that proves the device meets the acceptance criteria" in the traditional sense of a clinical performance study with specific metrics like sensitivity, specificity, etc.
The submission is for a minor modification to an existing device (M3290A IntelliVue Information Center Software Release E.1), specifically a change in how alert data is exported. The primary claim for regulatory approval is substantial equivalence to a legally marketed predicate device.
Therefore, many of the requested categories for acceptance criteria and study details cannot be directly extracted from this document, as a comprehensive performance study with quantified acceptance criteria and statistical analysis of device performance against ground truth is not detailed in this summary.
Here's an attempt to answer the questions based only on the provided text, highlighting where information is absent:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Software functionality meets specified requirements. | "web software interface functionality meets all reliability requirements and performance claims." |
| Reliability and performance claims are met. | "web software interface functionality meets all reliability requirements and performance claims." (Repeated in text) |
| Substantial equivalence to the predicate device. | "Test results showed substantial equivalence." |
| Performance, functionality, and reliability characteristics are established. | "Verification, validation, and testing activities establish the performance, functionality, and reliability characteristics of the new device..." |
| Pass/Fail criteria for testing match predicate device specifications. | "Pass/Fail criteria were based on the specifications cleared for the predicate device." |
2. Sample size used for the test set and the data provenance
- Sample Size (Test Set): Not specified in the provided text.
- Data Provenance: Not specified. The document only mentions "system level tests, integration tests, environmental tests, and safety testing from hazard analysis." It does not indicate if patient data was used, its origin, or if it was retrospective or prospective.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Number of Experts: Not specified.
- Qualifications of Experts: Not specified.
- Rationale: This type of information is typically part of a clinical validation study, which is not detailed in this 510(k) summary. The submission focuses on technical changes and substantial equivalence.
4. Adjudication method for the test set
- Adjudication Method: Not specified.
- Rationale: Adjudication methods are relevant for studies establishing ground truth for diagnostic devices, which is not the focus of this submission.
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
- MRMC Study: No, an MRMC comparative effectiveness study was not done or is not reported in this summary.
- Rationale: This device is a software release for an information center, primarily affecting data export, not a diagnostic AI tool for image interpretation that would typically undergo MRMC studies.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- Standalone Performance Study: No, a standalone algorithm-only performance study (in the context of diagnostic accuracy, for example) was not done or is not reported.
- Rationale: The device is described as an "Information Center Software" for "central monitoring" and "alert data export." Its function is to process and export physiological monitoring data rather than performing a standalone diagnostic task that would typically have an "algorithm only" performance metric. The testing mentioned (system, integration, environmental) refers to the software's operational characteristics and reliability, not its diagnostic accuracy in a standalone mode.
7. The type of ground truth used
- Type of Ground Truth: Not explicitly stated as "ground truth" in terms of reference standard patient outcomes or pathology. The "ground truth" for this submission appears to be the specifications and performance of the legally marketed predicate device.
- Rationale: The submission states, "Pass/Fail criteria were based on the specifications cleared for the predicate device and test results showed substantial equivalence." This implies that the 'truth' against which the new device was evaluated was its ability to perform equivalently to the existing, cleared device's established specifications.
8. The sample size for the training set
- Sample Size (Training Set): Not applicable and not specified.
- Rationale: This device is not described as utilizing machine learning or AI that would require a "training set" in the context of diagnostic algorithm development. The software is a release for an existing information center.
9. How the ground truth for the training set was established
- Ground Truth (Training Set): Not applicable and not specified.
- Rationale: As mentioned above, a "training set" and associated ground truth establishment are not relevant to the type of device and submission described here.
§ 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.