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Essenz HLM is intended to be used during cardiopulmonary bypass for procedures lasting six (6) hours or less.

Essenz ILBM is indicated for supplementary, in-line monitoring of the extracorporeal arterial oxygen partial pressure, venous oxygen saturation, venous hematocrit/hemoglobin, and arterial and venous temperature during cardiopulmonary bypass procedures up to six (6) hours.

Essenz HLM is a modular heart-lung machine. The device consists of a central console base for support, positioning mobility and power supply, roller and centrifugal pumps, user interface displays, controls, clamps and sensors for the monitoring of extracorporeal perfusion.

The Essenz HLM is configurable to user needs with different system components. The main configurable and optional system components consist of: Console, Cockpit, Control Units/ Console Control Units, Pumps, Bubble sensor, Level sensor, Temperature sensor, Pressure sensor, Flow Sensor, Manual Venous Occluder, Venous Clamp, Arterial Clamp, EP-Pack/ Power Pack, Cabinet (Enclosure), Mast.

Essenz ILBM is used for in-line continuous monitoring of patient's blood parameters during procedures requiring extracorporeal circulation when used with a compatible heart-lung machine.

Provided in-line measured parameters of Essenz ILBM are: In the Venous line: Haematocrit / Haemoqlobin (Hct/Hb), Venous blood oxygen saturation (sO2), Venous blood temperature (venT). In the Arterial line: Arterial blood oxygen partial pressure (pO2), Arterial blood temperature (artT).

The duration of application is limited to 6 hours of continuous use.

Essenz ILBM consists of the following components / disposables: B-Capta Venous and Arterial Sensors, Essenz ILBM Sensor Module, B-Capta Venous and Arterial Reference Element Holders, B-Capta disposable Venous and Arterial Cuvettes.

The B-Capta venous sensor is an optical sensor which measures hematocrit/hemoglobin and oxygen saturation using an optical reflectance technology when connected to its dedicated disposable cuvette. Infrared technology is used to measure the temperature of the venous blood.

The B-Capta arterial sensor is an optical sensor which measures, partial pressure of oxygen using an optical fluorescence technology when connected to its dedicated disposable cuvette. Infrared technology is used to measure the temperature of the arterial blood.

Both sensors are functionally connected to the compatible heart-lung machine. Data are displayed on the graphical user interface of the compatible heart-lung machine.

The provided document is a 510(k) premarket notification for two devices, Essenz HLM and Essenz ILBM, and focuses on demonstrating their substantial equivalence to predicate devices rather than proving performance against specific acceptance criteria through a clinical study.

Therefore, the document does not contain the detailed information to answer most of your questions regarding acceptance criteria, study design, sample sizes, expert qualifications, or ground truth establishment as it would for a device undergoing de novo review or requiring clinical trials for efficacy.

Here's a breakdown of what can be answered based on the provided text, and what cannot:

1. A table of acceptance criteria and the reported device performance

• Cannot be provided. The document states "No clinical testing was conducted in support of the Essenz HLM and Essenz ILBM as the technological characteristics and indications for use are equivalent to those of the predicate devices." Instead, the submission relies on non-clinical testing (electrical safety, EMC, performance testing, software verification and validation) to demonstrate substantial equivalence to the predicate devices, implying that their performance is similar to already cleared devices. No specific performance metrics or acceptance criteria are detailed in this summary.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Cannot be provided. No clinical test set data is described. The non-clinical testing does not typically refer to "sample size" in the same way a clinical study would (e.g., number of patients or cases).

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

• Cannot be provided. Since no clinical test set requiring expert ground truth establishment was conducted, this information is not available.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

• Cannot be provided. No clinical test set requiring adjudication is described.

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

• Cannot be provided. The devices (Heart-Lung Machine and Extracorporeal Blood-Gas Monitor) are not AI-assisted devices that would involve human readers or MRMC studies.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done

• Partially applicable, but for different device types. The devices described (Essenz HLM and Essenz ILBM) are medical devices, not AI algorithms. Their "standalone performance" is assessed through the non-clinical testing mentioned (electrical safety, EMC, performance testing, software V&V) rather than solely as an algorithm. The document explicitly states "No clinical testing was conducted."

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

• Cannot be provided. As no clinical studies demanding ground truth were performed, this information is not present. For non-clinical tests, "ground truth" would be defined by engineering specifications, reference measurements, and standard testing methodologies.

8. The sample size for the training set

• Cannot be provided. These are not machine learning/AI devices where a "training set" would be applicable in the context of clinical data.

9. How the ground truth for the training set was established

• Cannot be provided. See answer to #8.

In summary, the provided FDA 510(k) summary focuses on demonstrating substantial equivalence through non-clinical testing (electrical safety, EMC, performance testing, software verification and validation) rather than presenting results from a clinical study with detailed acceptance criteria and ground truth validation.

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Essenz HLM is intended to be used during cardiopulmonary bypass for procedures lasting six (6) hours or less.

Essenz HLM is a modular heart-lung machine like its primary predicate Stöckert S5 System. The device consists of a central console base for support, positioning mobility and power supply, roller and centrifuqal pumps, user interface displays, controls, clamps and sensors for the monitoring of extracorporeal perfusion. The Essenz HLM is configurable to user needs with different system components. The main configurable and optional system components consist of: Console, Cockpit, Control Units/ Console Control Units, Pumps, Bubble sensor, Level sensor, Temperature sensor, Pressure sensor, Flow Sensor, Manual Venous Occluder, Electrical venous occluder (EVO), Arterial Clamp/ Electric Remote Control, EP-Pack/ Power Pack, Cabinet (Enclosure), Mast.

This FDA 510(k) summary for the Essenz HLM heart-lung machine does not contain information on acceptance criteria for device performance or a study proving that the device meets those criteria. In fact, it explicitly states "CLINICAL TESTING: None required" and "ANIMAL TESTING: None required."

The document details non-clinical testing for verification and validation, but these tests are against recognized standards for electrical safety, EMC, software, human factors, and mechanical performance, rather than specific, quantified device performance acceptance criteria.

Therefore, I cannot provide the requested information from the provided text.

Here's why the document doesn't contain the requested information in the typical format for AI/ML device evaluations:

• Device Type: The Essenz HLM is a hardware medical device (a heart-lung machine console) used for cardiopulmonary bypass. The questions you've asked (acceptance criteria, study design, sample size, ground truth, expert consensus, MRMC studies, standalone performance) are highly relevant to AI/Machine Learning (AI/ML) driven medical devices, especially those involved in diagnostic or predictive tasks where performance metrics like sensitivity, specificity, or AUC are critical and need to be validated against expert ground truth.
• Regulatory Pathway: This is a 510(k) submission, which demonstrates substantial equivalence to a predicate device. For hardware devices like this, substantial equivalence is often established through detailed comparisons of technological characteristics, materials, and non-clinical performance (electrical safety, EMC, mechanical testing, software verification) against recognized standards, rather than clinical efficacy studies on patient outcomes or AI model performance.
• Focus of the Document: The document focuses on demonstrating that the Essenz HLM is as safe and effective as its predicate through engineering verification and validation testing, not through a study evaluating its diagnostic accuracy or predictive capability.

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