(75 days)
Browser is a software program that is used by a HCP (Healthcare Professional) to view, analyze, and edit patient data gathered with a SmartMonitor® Infant Apnea Monitor.
Information that is collected includes patient information, equipment parameters, compliance logs, patient events, equipment events, and waveforms.
The data is downloaded to a PC, either by direct connection to the monitor or by modem. The data can also be retrieved from a computer file or memory disk such as a floppy or card.
The software allows the user to review and manipulate event information, produce reports, save changes, and forward data via e-mail.
Browser is a Windows 95 software program used for reviewing events recorded by a Healthdyne Technologies SmartMonitor. Browser allows the operator to observe the time and duration of physiological events such as apnea, bradycardia, tachycardia and oxygen desaturation. The operator can also observe the waveforms associated with these events. These events and waveforms are downloaded from the monitor using a directly connected cable or via a modem.
The document provided describes a software program named "Browser" (Model 4500E), which is intended to be used by Healthcare Professionals to view, analyze, and edit patient data gathered with a SmartMonitor® Infant Apnea Monitor. It does not contain detailed acceptance criteria or a comprehensive study report with specific performance metrics as typically seen for medical devices with diagnostic or treatment functions.
Based on the provided text, here's a breakdown of the information requested:
1. Table of Acceptance Criteria and Reported Device Performance:
The document does not specify quantitative acceptance criteria. Instead, it focuses on functional equivalence to a predicate device.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Functional Equivalence to Predicate Device (Healthdyne Technologies 9500E software): The software should perform the same essential user features as the predicate device. | "Both allow the user to observe physiological events and equipment events and both allow the user to view waveforms associated with events." |
| Functionality, Safety, and Effectiveness: The software should operate as intended, be safe for its intended use, and be effective in fulfilling its purpose. | "The cumulative test results demonstrated the functionality and safety and effectiveness of the Browser software..." |
| Ability to view, analyze, and edit patient data from SmartMonitor® Infant Apnea Monitor. | "Browser is a software program which is used by Intended Use: Healthcare Professionals to view, analyze and edit patient data gathered with a SmartMonitor® Infant Apnea Monitor." |
| Ability to observe time and duration of physiological events (apnea, bradycardia, tachycardia, oxygen desaturation). | "Browser allows the operator to observe the time and duration of physiological events such as apnea, bradycardia, tachycardia and oxygen desaturation." |
| Ability to observe waveforms associated with events. | "The operator can also observe the waveforms associated with these events." |
| Data download capability (direct connection or modem). | "These events and waveforms are downloaded from the monitor using a directly connected cable or via a modem." |
| No change in source code from predicate. | "...Browser is a completely new program that shares no source code with the 9500E." (This is a design choice, not a performance metric, but relevant to its equivalence claim). |
2. Sample Size Used for the Test Set and Data Provenance:
- Sample Size: The document mentions "actual patient data" and "simulated patient data" were used for testing. However, it does not specify the number of patient datasets or cases used in the test set.
- Data Provenance: The document does not specify the country of origin of the data. It implies both retrospective (historical patient data) and simulated data were used.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications:
The document does not mention the use of experts to establish ground truth for the test set. The comparison was primarily between the output of the new software and the predicate software, using "actual patient data" and "simulated patient data." There is no indication of independent expert review for ground truth.
4. Adjudication Method for the Test Set:
Not applicable. There is no mention of an adjudication method as ground truth was not established by multiple experts in a consensus manner. The comparison was between the output of two software programs.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done:
No, an MRMC comparative effectiveness study was not done. This device is a software tool for data review, not an AI diagnostic aid that assists human readers in interpreting images or data for making clinical decisions. The comparison was between two software programs.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study Was Done:
Yes, a form of standalone performance was assessed. The "Non-Clinical Testing" involved:
- "System level and module/integration level testing to verify all the defined software requirements." This implicitly refers to the algorithm's functional performance.
- A "clinical comparison of actual patient data was performed by comparing reports generated by the predicate 9500E software and the Browser software." This compares the output of the new software with the predicate software, essentially evaluating the algorithm's output without human intervention during the comparison step itself.
7. The Type of Ground Truth Used:
The "ground truth" for the test set was effectively the output of the predicate device (Healthdyne Technologies 9500E software) when processing "actual patient data." The new Browser software's output was compared against the 9500E's output to demonstrate "substantial equivalence." Simulated patient data was also used, where the "ground truth" would be the known parameters of the simulated data.
8. The Sample Size for the Training Set:
Not applicable. This is a software program for viewing and analyzing data, not a machine learning or AI model that requires a training set in the conventional sense. The "Browser" is described as a "completely new program that shares no source code with the 9500E," indicating it was developed through traditional software engineering rather than machine learning.
9. How the Ground Truth for the Training Set Was Established:
Not applicable, as there was no training set in the context of machine learning. The software was developed and tested against its defined requirements and against the functionality of the predicate device.
§ 868.2375 Breathing frequency monitor.
(a)
Identification. A breathing (ventilatory) frequency monitor is a device intended to measure or monitor a patient's respiratory rate. The device may provide an audible or visible alarm when the respiratory rate, averaged over time, is outside operator settable alarm limits. This device does not include the apnea monitor classified in § 868.2377.(b)
Classification. Class II (performance standards).