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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.

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.

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The TheraSense Inc. FreeStyle™ Connect Data Management System is intended for use in home and clinical settings to aid people with diabetes and their healthcare professionals in the review, analysis and evaluation of glucose test results to support an effective diabetes management program.

The FreeStyle™ Connect Data Management System is an optional data management software accessory for use with the FreeStyle™ Blood Glucose Monitoring System. The FreeStyle™ Connect Data Management System permits the transfer of data from the FreeStyle™ Blood Glucose Meter to a personal computer for enhanced data management capability.

Here's an analysis of the provided text regarding the acceptance criteria and study information for the TheraSense FreeStyle™ Connect Data Management System:

Summary of Acceptance Criteria and Study Information for TheraSense FreeStyle™ Connect Data Management System

The provided document is a 510(k) summary for a medical device and, as such, focuses on demonstrating substantial equivalence to a predicate device rather than detailing specific clinical trial results with acceptance criteria in the manner one might find for a novel diagnostic algorithm.

The core of the "study" described here is software verification and validation testing, confirming that the data management system functions as intended and meets specified performance requirements.

1. Table of Acceptance Criteria and Reported Device Performance

Given the nature of the device (data management software) and the document (510(k) summary), the "acceptance criteria" are related to software functionality and safety rather than a diagnostic performance metric like sensitivity or specificity. The reported performance is adherence to these software development and testing standards.

2. Sample Size Used for the Test Set and Data Provenance

The document does not specify a "test set" in the context of patient data or clinical accuracy. The testing described is software verification and validation. Therefore:

• Sample Size for Test Set: Not applicable in the traditional sense of a clinical test set. The validation would involve various software testing scenarios, test cases, and simulated data, but not a specific "sample size" of patient data for accuracy measurement.
• Data Provenance: Not applicable. The validation focuses on the software's functionality, data transfer, storage, display, and analysis capabilities rather than the origin of clinical data used for accuracy assessment.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

• Number of Experts: Not applicable. For software verification and validation, the "ground truth" is defined by the software specifications, functional requirements, and relevant regulatory guidance. Software engineers, quality assurance personnel, and potentially medical device experts (to interpret regulatory requirements) would be involved in the design and review of these tests.
• Qualifications of Experts: Not explicitly stated, but typically involves software developers, quality assurance engineers, and regulatory affairs specialists.

4. Adjudication Method for the Test Set

• Adjudication Method: Not applicable. Software verification and validation results are typically determined by comparing the software's output/behavior against predefined expected outcomes based on the software specifications. There is no mention of a human adjudication process for test results in the document.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

• MRMC Study: No, an MRMC comparative effectiveness study was not performed or described. This type of study is typically done for diagnostic imaging devices where human readers interpret results with or without AI assistance. The FreeStyle™ Connect Data Management System is data management software, not a diagnostic imaging AI.
• Effect Size of Human Readers Improve with AI vs. Without AI: Not applicable, as no such study was conducted. The software aims to "aid people with diabetes and their healthcare professionals in the review, analysis and evaluation of glucose test results," implying an improvement in data management and insight, but not through an AI diagnostic assistance paradigm.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

• Standalone Study: Yes, in essence, the software verification and validation described is a "standalone" evaluation of the algorithm's (software's) functionality. It demonstrates that the software itself performs its intended data management tasks (transfer, storage, display, analysis) correctly according to its specifications, independent of a specific human-in-the-loop diagnostic interpretation. However, its intended use is to "aid" human users, so its ultimate value is realized with human interaction. The validation focuses on the technical correctness of the software's operations.

7. Type of Ground Truth Used

• Type of Ground Truth: The ground truth used for software verification and validation is primarily software specifications, functional requirements, and regulatory guidance. The software's output and behavior are compared against these documented requirements to confirm correct operation. For data-handling aspects, the ground truth would be the original data from the FreeStyle™ Blood Glucose Meter.

8. Sample Size for the Training Set

• Sample Size for Training Set: Not applicable. The FreeStyle™ Connect Data Management System is a rule-based software that processes and displays data. It is not an AI/ML model that requires a "training set" in the machine learning sense.

9. How the Ground Truth for the Training Set Was Established

• How Ground Truth for Training Set Was Established: Not applicable, as there is no training set for this type of software.

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