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The device is a modularly structured program package that is exclusively used with Sorin/Stockert 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 used to collect and view data generated during cardiopulmonary bypass surgery. It interfaces with Sorin Heart-Lung machines to capture this data.

The Sorin CONNECT includes the following main components:

• The Datapad display monitor. It's used to display the collected data.
• The data recording software installed on the Datapad; known as "CONNECT Recorder". . lt's used to save the collected data.
• The PC software for reviewing data; known as "CONNECT Manager". It's used to view ● the recorded data and manually enter additional data including clinician's comments.
• . An RFID card reader used to transfer the data from the Heartlink card to the Datapad.
• . A pole mounting system (holder) to attach the Datapad to an IV pole.

The provided text is a 510(k) summary for the Sorin CONNECT, a data management system for heart-lung machines. It focuses on demonstrating substantial equivalence to a predicate device and outlines hardware and software updates. However, it does not contain information regarding acceptance criteria and a study proving the device meets those criteria, as typically found in clinical performance studies of AI/ML devices.

Specifically, the document states:

• NON CLINICAL TEST RESULTS: Electrical safety (IEC 60601-1) and electromagnetic compatibility (IEC 60601-1-2) were determined.
• IN VITRO TEST RESULTS: "Verification, validation, and testing activities, were conducted to demonstrate compliance to the product's specifications and compliance to safety and effectiveness requirements."

This implies that the testing performed for this 510(k) submission was primarily focused on hardware updates, software compatibility, and meeting electrical and EMC standards, rather than evaluating the performance of an AI/ML algorithm against a predefined set of diagnostic or predictive acceptance criteria.

Therefore, for your specific request regarding acceptance criteria and a study proving the device meets them, the following information is not present in the provided text:

1. Table of acceptance criteria and reported device performance: Not available. The document refers to "product's specifications" and "safety and effectiveness requirements" in a general sense, but no specific performance metrics or acceptance thresholds are listed.
2. Sample size used for the test set and data provenance: No test set involving patient data or clinical outcomes is described. The "testing activities" refer to non-clinical and in-vitro testing for compliance.
3. Number of experts used to establish the ground truth and qualifications: Not applicable, as there's no clinical performance evaluation involving expert consensus on patient data.
4. Adjudication method: Not applicable.
5. Multi Reader Multi Case (MRMC) comparative effectiveness study: Not applicable.
6. Standalone (algorithm only) performance: Not applicable, as it's a data management system hardware/software update, not an AI/ML algorithm.
7. Type of ground truth used: Not applicable.
8. Sample size for the training set: Not applicable, as no AI/ML model training is described.
9. How the ground truth for the training set was established: Not applicable.

In summary, the provided document describes a 510(k) submission for updates to a medical device focused on data management (Sorin CONNECT), demonstrating substantial equivalence through non-clinical and in-vitro testing for hardware/software functionality, electrical safety, and EMC. It does not provide the kind of performance data, acceptance criteria, or study details typically associated with AI/ML device evaluations.

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