(138 days)
The IntelliVue GuardianSoftware is intended for use by healthcare providers whenever there is a need for generation of a patient record.
The IntelliVue GuardianSoftware is indicated for use in the collection, storage and management of data from Philips specified measurements and Philips Patient Monitors that are connected through networks.
The IntelliVue GuardianSoftware (866009) is a Clinical Information Management System. It collects and manages vital signs data acquired from the Philips specified measurements and Philips Patient Monitors. The IntelliVue GuardianSoftware provides review, reporting, clinical documentation, remote viewing, operating, interfacing, storage, printing and predictive trend analytics, meaning trending, notification, calculations and clinical advisories including EWS deterioration status. The IntelliVue GuardianSoftware is a software only product. It is intended to be installed on customer supplied compatible off-the shelf information technology equipment that meet the technical requirements as specified by Philips.
The provided text primarily details an FDA 510(k) submission for the Philips IntelliVue GuardianSoftware and an administrative change letter. It does not contain an elaborative study description with acceptance criteria and its proof for device performance in the requested format.
However, based on the general information provided in the 510(k) summary, I can extract and infer some information, but it will not be a complete answer to all your specific questions:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state quantitative acceptance criteria or detailed device performance metrics in a table format. It broadly states:
| Acceptance Criteria (Inferred) | Reported Device Performance (Inferred) |
|---|---|
| Performance, functionality, and reliability characteristics met | All test results showed substantial equivalence to the predicate device. |
| Compliance with hazard analysis pass/fail criteria | All specified pass/fail criteria have been met. The test results confirmed the effectiveness of the implemented design risk mitigation measures. |
| Meeting safety and reliability requirements and performance claims | The Philips IntelliVue GuardianSoftware (SW Rev.D.0) meets all safety and reliability requirements and performance claims. |
2. Sample size used for the test set and the data provenance
- Sample Size for Test Set: Not specified. The document only mentions "software testing on integration level (functional testing and regression testing) and software testing on system level (hazard analysis testing and dedicated software performance testing)." It does not indicate the number of patient records or data points used in these tests.
- Data Provenance: Not specified. It does not mention the country of origin of the data or whether the data was retrospective or prospective.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not specified. The document does not describe the establishment of a "ground truth" for the test set using human experts. The testing appears to be functional and performance-based against specifications, not clinical outcomes evaluated by experts.
4. Adjudication method for the test set
Not specified. Since no expert ground truth establishment is mentioned, there's no mention of an adjudication method.
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
No. The document describes the Philips IntelliVue GuardianSoftware as a Clinical Information Management System for collecting, storing, and managing vital signs data, and providing review, reporting, clinical documentation, remote viewing, operating, interfacing, storage, printing, and predictive trend analytics. It is not an AI-assisted diagnostic device, and therefore, an MRMC comparative effectiveness study comparing human readers with and without AI assistance is not applicable to this device and was not mentioned.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
Yes, implicitly. The testing described is for the software itself, independently verifying its performance, functionality, and reliability according to specifications and safety standards. The device is a "software only product" and its testing would inherently be standalone.
7. The type of ground truth used
For the software verification and validation, the "ground truth" would be the pre-defined specifications, requirements, and safety standards (e.g., ANSI/AAMI/IEC 62304:2006). The software was tested to ensure it met these established criteria. It does not involve medical ground truth like pathology, expert consensus on images, or outcomes data.
8. The sample size for the training set
Not applicable/Not specified. This device is described as a "Clinical Information Management System" that handles data collection, storage, and management, including predictive trend analytics and clinical advisories. While "predictive trend analytics" could potentially involve machine learning, the document does not elaborate on the specific algorithms used or if a training set, characteristic of machine learning models, was employed or is relevant to its substantial equivalence claim. The focus here is on the functionality and safety of the data management software itself.
9. How the ground truth for the training set was established
Not applicable/Not specified, for the same reasons as #8. If predictive trend analytics involve trained models (which is not explicitly stated but hinted at), the method for establishing ground truth for such a training set is not described. The document emphasizes testing against a predicate device's cleared specifications and general software safety standards.
§ 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).