(95 days)
ResScan is intended to augment the standard follow-up care of patients by providing transfer of machine and therapeutic information, including the ability to remotely change settings. It is intended to be used by Clinicians in conjunction with ResMed compatible flow generators, using ResMed's proprietary communications protocol.
The performance and functional characteristics of ResScan includes all the user friendly features of the predicate device. ResScan allows the clinician to: Download and view patient and machine data from ResMed flow generators, Store patient details, Set machine parameters (Using Removal Media or PC direct connection), Create and print reports, Uses Removal Media or PC direct connection as the interface between the flow generator and ResScan, Support for Data Card Reader. Summary of additional features from the ResScan (K050775): ResMed compatible flow generators include, S8 series flow generators (73 BZD), VPAP Bilevel devices (73 MNS) and Stellar (73 MNT). Display/reporting of additional modes such as S, ST, ASV, iVAPS & PAC. Additional Windows Vista (64 bit) and Windows 7 (32 & 64 bit), and added support for remote settings via removable media - SD cards and USB sticks. Added support for display of alarm events. Added the capability to generate patient compliance reports based on US CMS guidelines both on a per patient basis and across all patient data.
This document describes the regulatory submission for the ResScan device, an adjunct to patient care that allows clinicians to transfer machine and therapeutic information and remotely change settings on ResMed compatible flow generators.
Here's an analysis of the acceptance criteria and study information:
1. Table of Acceptance Criteria and Reported Device Performance
The provided document does not explicitly present a table of acceptance criteria with corresponding performance metrics in a quantitative format for the ResScan device. Instead, it describes a more general approach to verification.
| Acceptance Criteria Category | Description/Reported Performance |
|---|---|
| Functional Verification | End-to-end testing confirmed that settings were successfully transferred between the flow generator and ResScan, and data captured by the flow generator was sent to ResScan. All tests confirmed the product met the predetermined acceptance criteria. |
| Design Input Specifications | Performance testing of ResScan has been conducted using End bench testing methodology to demonstrate that the modified ResScan performs to design input specifications. ResScan device met the predetermined pass/fail criteria as defined in the ResScan System Verification Report. |
| Safety and Effectiveness | The modified ResScan has not altered the safety and effectiveness when used for patient compliance management as an adjunct with ResMed flow generators. The inclusion of new features was assessed within the risk analysis, and no additional safety risks were found. |
| Regulatory Compliance | Complies with FDA Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices (May 11, 2005) and FDA Off-the-Shelf Software Use in Medical Devices (September 9, 1999). |
| Substantial Equivalence | Demonstrated substantial equivalence to the predicate device (ResScan, K050775) based on similar intended use, same operating principle, same technologies, and same manufacturing process. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: Not explicitly stated. The document refers to "End bench testing methodology" and "testing activities" performed as a result of risk analysis and design requirements. This suggests a rigorous internal testing process, but the specific number of test cases or "samples" is not quantified.
- Data Provenance: The testing appears to be internal "bench testing" and "Verification activities" conducted by ResMed Ltd, Australia. There is no mention of external data, clinical data, or country of origin for a specific "test set" in the context of patient data.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
- The document describes a "Non-Clinical Testing" approach involving "predetermined pass/fail criteria" and "design input specifications." This implies that the ground truth for testing was established by the design and engineering teams at ResMed based on the device's functional requirements.
- The document does not mention the use of external "experts" (e.g., radiologists, clinicians) to establish ground truth for a test set, as this was not a clinical study involving interpretation of patient data. The ground truth was based on the device's technical specifications and expected performance.
4. Adjudication Method for the Test Set
- An adjudication method is not applicable or mentioned. The testing described is verification testing against predetermined design inputs and pass/fail criteria, not a study involving human reviewers assessing output and requiring a consensus mechanism.
5. Multi Reader Multi Case (MRMC) Comparative Effectiveness Study
- No MRMC study was done. The document explicitly states: "Clinical testing was not deemed necessary as identified in the Risk Analysis, as ResScan only obtains patient and machine information from therapeutic devices for which clinical trials have already been conducted, or compared with previous predicate comparison test results. Accordingly no clinical testing is required." Therefore, there is no effect size reported for human readers improving with AI vs. without AI assistance.
6. Standalone Performance Study (Algorithm Only Without Human-in-the-Loop)
- Yes, a standalone performance study was done for the device's functionality. The described "End bench testing methodology" and "Verification activities" represent a standalone evaluation of the ResScan software's ability to:
- Successfully transfer settings between flow generators and ResScan.
- Receive data captured by the flow generator.
- Perform to design input specifications.
- Meet predetermined pass/fail criteria.
- The "algorithm" here refers to the software's functionality in handling data transfer and settings, rather than an AI-driven interpretive algorithm.
7. Type of Ground Truth Used
- The ground truth used for the non-clinical testing was design input specifications and predetermined pass/fail criteria. This refers to the functional requirements and expected behavior of the software, not clinical outcomes, pathology, or expert consensus on patient data.
8. Sample Size for the Training Set
- The concept of a "training set" is not applicable here. ResScan is a software device for data transfer and settings management, not a machine learning or AI algorithm that requires a training set in the conventional sense. The development likely involved standard software engineering practices (coding, unit testing, integration testing, system testing) rather than data-driven machine learning model training.
9. How the Ground Truth for the Training Set Was Established
- Not applicable, as there was no training set for a machine learning model. The "ground truth" for the device's development and verification was its design specifications and functional requirements as established by ResMed's engineering and product development teams.
§ 868.5895 Continuous ventilator.
(a)
Identification. A continuous ventilator (respirator) is a device intended to mechanically control or assist patient breathing by delivering a predetermined percentage of oxygen in the breathing gas. Adult, pediatric, and neonatal ventilators are included in this generic type of device.(b)
Classification. Class II (performance standards).