(135 days)
ESSENZ Patient Monitor is a modularly structured program package that is exclusively used with LivaNova 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 ESSENZ Patient Monitor is used to collect and view data generated during cardiopulmonary bypass surgery. It interfaces with LivaNova Heart-Lung machines to capture this data.
The ESSENZ Patient Monitor includes the following main components:
- Software: The data-recording software installed on the Perfusion System Monitor hardware; known as "ESSENZ Patient Monitor". It is used to save and process the collected data.
- Hardware: The Perfusion System Monitor. It is used to display and transfer the collected data.
- Hardware: A mast holder to mount the Perfusion System Monitor on a vertical mast of the respective LivaNova HLM.
This document describes the ESSENZ Patient Monitor, a device used with LivaNova Heart-Lung Machines to record, process, and evaluate perfusion data during cardiopulmonary bypass. The information provided is for a 510(k) premarket notification (K212003).
Here's an analysis of the acceptance criteria and supporting studies based on the provided text:
1. Table of Acceptance Criteria and the Reported Device Performance:
The document does not explicitly present a table of acceptance criteria with specific numerical targets. Instead, it states that the device was evaluated against recognized standards and through various non-clinical tests to demonstrate substantial equivalence to a predicate device (Sorin CONNECT, K170460). The general acceptance criterion is that the modified device is "as safe and effective" as the predicate.
For the purpose of this request, we can infer the categories of acceptance criteria from the performed tests and their general outcome:
| Acceptance Criteria Category (Inferred) | Reported Device Performance |
|---|---|
| Electrical Safety | Complies with IEC 60601-1 2005 A1:2012 (Medical electrical equipment - Part 1: General requirements for basic safety and essential performance). |
| Electromagnetic Compatibility (EMC) | Complies with IEC 60601-1-2 Edition 4.0 2014 (Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests). |
| Software Performance & Reliability | Software verification and validation conducted. Complies with IEC 62304 Edition 1.1 2015 (Medical device software - Software life cycle processes). |
| Usability & Human Factors | Human Factors testing conducted. Complies with IEC 60601-1-6 Edition 3.2 (Medical electrical equipment - Part 1-6: General requirements for basic safety and essential performance - Collateral standard: Usability) and IEC 62366-1 Edition 1.0 2015 (Medical devices — Part 1: Application of usability engineering to medical devices). |
| Risk Management | Complies with ISO 14971 Third Edition 2019 (Application of risk management to medical devices). |
| General Performance | Performance testing conducted. |
| Shipping & Durability | Performance testing of shipping containers conducted. |
| Substantial Equivalence | The modified ESSENZ Patient Monitor is determined to be as safe and effective as the cleared Sorin CONNECT, with the same intended use, indications, similar technological characteristics, and same principles of operation. |
2. Sample size used for the test set and the data provenance:
- Test Set Sample Size: The document does not specify a quantitative "test set sample size" in terms of patient data or specific number of tests. The testing described (Electrical Safety, EMC, Performance, Software V&V, Human Factors, Shipping) is related to hardware and software requirements, not clinical data sets in the typical sense of a diagnostic or therapeutic algorithm.
- Data Provenance: The tests conducted are non-clinical hardware and software verification and validation tests performed by the manufacturer, LivaNova Deutschland GmbH. The data provenance is internal to the manufacturer's testing processes. There is no mention of country of origin for a clinical data set because no clinical testing was performed or relied upon. The report states, "No animal testing was submitted to support the substantial equivalence of the modified device to the cleared Sorin CONNECT," and "No clinical testing was conducted in support of ESSENZ Patient Monitor."
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
This information is not applicable to the submitted document. The "ground truth" in this context refers to the compliance with engineering and regulatory standards established through non-clinical testing. These tests are evaluated against predefined specifications and industry standards, not against an expert-established clinical ground truth for a diagnostic outcome.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
This information is not applicable. Adjudication methods like 2+1 or 3+1 are typically used in clinical studies for interpretation of images or clinical outcomes, which were not part of this 510(k) submission for the given device. The testing was against engineering specifications and recognized standards.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
No MRMC study was conducted or is relevant to this device's submission. The ESSENZ Patient Monitor is a data management system for perfusion data during cardiopulmonary bypass; it is not an AI-assisted diagnostic tool that would involve human readers or image interpretation.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
The concept of "standalone performance" for an algorithm often applies to diagnostic or predictive AI. In this case, the "standalone performance" can be considered as the device's ability to accurately record, process, and evaluate perfusion data according to its specifications and in compliance with the relevant standards (IEC 60601-1, IEC 60601-1-2, IEC 62304, etc.) without human intervention in the data handling itself. The software verification and validation, along with performance testing, would cover this aspect. However, the device is explicitly used "with LivaNova Heart-Lung Machines" and the data can be "recorded automatically or entered manually," implying it is part of a larger system where human interaction remains.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
The "ground truth" for the non-clinical testing of the ESSENZ Patient Monitor is compliance with established engineering and safety standards (e.g., IEC 60601 series, IEC 62304, ISO 14971). The ground truth for its functional performance (data recording, processing, evaluation) would be derived from comparisons against expected computational and display outputs based on defined inputs, ensuring accuracy and reliability as specified in the device's design.
8. The sample size for the training set:
This information is not applicable. The ESSENZ Patient Monitor is a data management system, not a machine learning or AI model that requires a "training set." The software is re-engineered from a legacy version and verified/validated against specifications.
9. How the ground truth for the training set was established:
This information is 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).