(33 days)
Sorin CONNECT is a modularly structured program package that is exclusively used with Sorin/Stöckert heart lung machines. The system allows detailed recording of perfusion data during cardiopulmonary bypass as well as the processing and evaluation of this data. The data may be recorded automatically or entered manually.
The Sorin CONNECT is aiming to capture, display and store numerical or other perfusion related information entered by the user or captured from Stocket/Sorin Heart Lung Machine and from any compatible external device via a serial cable connection to the HLM interface. The capture of the data is performed automatically from the HLM via a serial cable communication or via RFID while simultaneously allowing for simple, manual user inputs The Sorin CONNECT Data Management System includes a hardware unit (the Personal Computer, hereinafter referred to as Datapad II, and the RFID card/reader hereinafter identified as Heartlink) and the software only product. The Sorin CONNECT software can be embedded into Datapad II (Online version hereinafter identified as Connect recorder) or available also on a server computer (server version hereinafter identified as Connect Manager). The Datapad II with embedded Connect Recorder allows for collection of all data that occur during an operation in order to generate a complete case record; its database store data in trend, event, calculation and it is possible to display on the monitor tabular trends or to view measurement trend graphs, with different measurements combined in each graph, to help the perfusionist in identify changes in the patient's physiological condition. The Connect Manager is a central database application in which all case records are stored and processed; in this case it is possible to consolidate data from different Connect Recorders on one central server computer. The application stores and manages data for documentation, reporting, analysis and export after the clinical case has been done: data are stored in a specific database and it is possible to display on the server workstation tabular trends, measurement trend graphs as well as statistical analysis and document them on a printer. The two different Sorin CONNECT applications have access to their own, independent database and data transfer among the databases takes place using either an USB memory stick or a network (Ethernet) connection: - HLM32.DBS is the database on the server computer. This database contains all case records that are already closed. - ONLINE32.DBS is the database on each of the online computers. This database contains the current case record(s) data. The Sorin CONNECT, through actuators, software and control mechanisms, performs the data collection, storage and management as requested by the operator through the user interface. Operating modes include automatic collection of data and manual insertion of data via keyboard The supported medical devices for Sorin CONNECT are the Stöckert/Sorin Heartlung machines SC (K982014), S3 (950990), S5 (K071318) and C5 (K093882).
The provided text outlines the acceptance criteria and the study conducted for the Sorin CONNECT Data Management System to demonstrate its substantial equivalence to predicate devices, rather than a study proving the device meets specific performance criteria in a clinical setting.
The study described is primarily focused on non-clinical bench testing for safety and performance specifications, and a comparison of technological characteristics with predicate devices to establish substantial equivalence for regulatory purposes.
Here's an analysis based on the provided information:
1. Table of Acceptance Criteria and Reported Device Performance:
The document doesn't present a table with specific, quantifiable acceptance criteria (e.g., accuracy, sensitivity, specificity) for device performance in the way one might expect for a diagnostic or therapeutic AI device. Instead, the "acceptance criteria" are implied by the standards and characteristics listed in the comparison table with predicate devices and the scope of the non-clinical tests.
| Parameter/Characteristic (Implied Acceptance Criteria) | Reported Performance/Comparison (Sorin CONNECT) |
|---|---|
| Intended Use Equivalence | Equivalent to TLink; limited to cardiac surgery intervention compared to IntelliVue. |
| Modular Division | Equivalent to both IntelliVue and TLink; all systems have an SW application for PC/server and an online application for data collection monitor (also a PC). |
| User Interface | Equivalent to both IntelliVue and TLink (touch screen, standard keyboard/mouse). |
| Data Source | Equivalent to IntelliVue (manual, automatic, RFID, calculations); difference with TLink is RFID vs. barcode scanner. |
| Data Management | Identical to both IntelliVue and TLink (operator can overrule and modify data). |
| Data Storage | Equivalent to both IntelliVue and TLink (relational database, PC embedded or central server). |
| Data Transfer/Backup | Equivalent to TLink (portable storage, network, WLAN); difference with IntelliVue which also uses telemetry. |
| Data Output | Equivalent to TLink (numerical, graphical, statistical); difference with IntelliVue which also outputs wave pulse. |
| Fundamental Scientific Technology | Equivalent to IntelliVue and TLink (Microsoft .NET framework, WLAN module). |
| Availability | Identical to IntelliVue and TLink (standalone SW embedded in PC or LAN). |
| Materials (Hardware/Firmware) | Equivalent to IntelliVue and TLink (PC, Microsoft Windows XP/Windows). |
| Sterilization/Shelf Life | Identical to IntelliVue and TLink (not sterile). |
| Biocompatibility | Identical to IntelliVue and TLink (no blood contacting parts). |
| EMC (Emissions) | Identical to IntelliVue (Group 1 Class A per CISPR 11); TLink data not available. |
| Electromagnetic Compatibility & Electrical Safety | Identical to IntelliVue (UL 60601-1, IEC 60601-1-2 testing); TLink data not available. |
| Compliance with Performance Specifications | Performance testing conducted to verify and stress PC server/client specifications and simulate various real deployment scenarios. Confirmed performance of software with compatible devices. |
| Electrical Testing | Compliant (details not specified). |
| Electromagnetic Compatibility Testing | Compliant (details not specified, but references IEC 60601-1-2). |
| Software Compliance | Compliant with IEC 62304 and FDA Guidance for Off-the-Shelf software. |
| Cybersecurity | Compliant with FDA Guidance for networked medical devices. |
| Usability | Compliant with IEC 62366. |
| Health Information Technology | Compliant with ANSI HL 7 V2.5-2003. |
| Risk Management | Compliant with ISO 14971. |
| Wireless Technology | Compliant with FDA guidance for radio frequency wireless technology. |
2. Sample Size for the Test Set and Data Provenance:
The document mentions "performance testing... simulating various scenarios of real customer deployment in the hospital" but does not specify a numerical sample size for this testing. It implies a simulated environment rather than actual patient data. There is no information regarding country of origin or whether the data was retrospective or prospective, as it appears to be a systems/software validation rather than a clinical data study.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:
Not applicable. This device is a data management system, not a diagnostic device requiring expert interpretation of medical images or measurements to establish a "ground truth" for a test set. The validation is against technical specifications and predicate device characteristics.
4. Adjudication Method for the Test Set:
Not applicable. As described above, there's no clinical "ground truth" or expert review process detailed for this type of software system validation.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
No, an MRMC study was not done. This type of study is relevant for diagnostic devices where human readers interpret cases, and the AI's impact on their performance is evaluated. The Sorin CONNECT is a data management system, not an AI-powered diagnostic tool.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study:
Yes, a form of "standalone" evaluation was performed in the sense that the software's performance was tested against its specifications and predicate device characteristics in simulated environments, independent of active human clinical decision-making during the test. The "performance testing" described directly assesses the system's functionality.
7. Type of Ground Truth Used:
The "ground truth" for this device's validation is adherence to:
- Predicate Device Characteristics: The comparison table explicitly uses the characteristics of the IntelliVue Clinical Information Portfolio and TLink Data Management System as a benchmark for substantial equivalence.
- Technical Standards and Regulations: Compliance with various international and national standards (e.g., IEC 62304 for software, ISO 14971 for risk management, FDA guidances for cybersecurity and off-the-shelf software, electrical safety, EMC).
- Internal Performance Specifications: The testing aimed to "verify and stress the PC server and client specifications" and confirm performance.
8. Sample Size for the Training Set:
Not applicable. The Sorin CONNECT Data Management System described is not an AI/ML device that requires a training set in the conventional sense for learning patterns from data. It's a software system for data capture, display, and storage.
9. How the Ground Truth for the Training Set Was Established:
Not applicable, as there is no training set for this device.
§ 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).