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The BioTrend oxygen saturation and hematocrit system measures percent oxygen saturation and hematocrit of the blood in the extracorporeal circuit. The extracorporeal circuit is used for, but is not limited to, cardiopulmonary bypass, closedchest support, and limb perfusion.

The Medtronic Tri-optic Measurement Cell is a sterile, single-use cell used with the BioTrend Oxygen Saturation and Hematocrit System. This 510(k) premarket notification was submitted to add Balance Biosurface to the disposable cell as update the labeling information for all Tri-optic Measurement Cell versions. The disposable cell is coated on its blood contacting surfaces with Balance Biosurface. Previously cleared disposable cells are also available in uncoated form, and with Carmeda BioActive Surface coating or Trillium Biosurface coating.

The provided document is a 510(k) premarket notification for a medical device called the "Tri-optic Measurement Cell with Balance Biosurface," a cardiopulmonary bypass in-line blood gas monitor. The notification aims to demonstrate substantial equivalence to previously cleared predicate devices.

Based on the information provided, here's a breakdown of the acceptance criteria and the study details:

1. Table of Acceptance Criteria and Reported Device Performance:

Note: The document does not explicitly state numerical acceptance criteria for "Pass" results (e.g., a specific percentage for accuracy, or a specific limit for leaching). The "Pass" indicates the device met the internal Medtronic requirements for these tests.

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

• Sample Size: Not explicitly stated. The document refers to "bench testing" but does not provide numbers of units tested for each specific test (Coverage, Leaching, Accuracy).
• Data Provenance: Bench testing. No information on country of origin. The testing is described as occurring prior to submission (February 11, 2014) and is therefore retrospective in nature for the submission.

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

Not applicable. This device is a measurement cell, and the testing described (coverage, leaching, accuracy of flow rate reading) does not involve expert interpretation or diagnosis of images/data for ground truth establishment in the way an AI diagnostic device would.

4. Adjudication Method for the Test Set:

Not applicable. As noted above, this testing does not involve human expert adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:

No, an MRMC study was not done. The device is an in-line blood gas monitor, not a diagnostic imaging AI tool that would typically involve human readers.

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

Yes, the described "bench testing" represents standalone performance of the physical device components (measurement cell and its coating) as they relate to its function in reading flow rate and ensuring coating integrity. The "algorithm" here implies the underlying technology that reads oxygen saturation and hematocrit, which is considered unchanged from the predicate device.

7. The Type of Ground Truth Used:

• For Coverage and Leaching testing: The ground truth would be based on validated analytical or chemical methods to confirm the presence, uniformity, and adhesion of the coating.
• For Accuracy testing (related to not interfering with the accuracy of reading the flow rate): The ground truth would likely be established through standard metrology or a reference method for flow rate measurement, against which the device's reading (or its lack of interference) is compared. The document implies the "BioTrend instrument" itself provides the reading, and the test is to ensure the coating doesn't degrade this established accuracy.

8. The Sample Size for the Training Set:

Not applicable. This device is not an AI/ML algorithm that requires a "training set" in the conventional sense. The "training" for such a device would be its initial design, engineering, and calibration processes, which are not detailed here.

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

Not applicable, as there is no specific "training set" in the context of an AI/ML algorithm.

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The Trillium™ Tri-optic Measurement Cell is intended for use in the BioTrend oxygen saturation and hematocrit system.

Indications for Use:

The BioTrend oxygen saturation and hematocrit system measures percent The Blor rond oxygen saturation in the extracorporeal circuit. The extracorporeal circuit is used for, but is not limited to, cardiopulmonary bypass, closed chest support and limb perfusion.

The Trillium™ Tri-optic Measurement Cell is a single-use insert designed to be used in the BioTrend Qxygen Saturation and Hematocrit System (K954501). The BioTrend Oxygen Saturation and Hematocrit System measures oxygen saturation and hematocrit by using dual wavelength photometric techniques. The Tri-optic Measurement Cell is an in-line, full flow, sterile and non-pyrogenic fluid path disposable device. The device accommodates the transmission of the light-emitting signal into the blood path and collection of the backscattered light signal.

The provided document is a 510(k) premarket notification for a medical device called the Trillium™ Tri-optic Measurement Cell. This particular submission is a "SPECIAL 510(k)," meaning it's for a modification to an already legally marketed device. The modification involves coating the blood contact surfaces with Trillium™. The document primarily focuses on demonstrating substantial equivalence to predicate devices rather than providing detailed acceptance criteria and a study report with specific performance metrics.

Therefore, much of the requested information (like a table of acceptance criteria, specific device performance, sample sizes for test/training sets with provenance, number and qualifications of experts, adjudication methods, MRMC studies, standalone performance, and detailed ground truth establishment) is not explicitly available in the provided text.

However, based on what is available, here's a breakdown:

1. Table of Acceptance Criteria and Reported Device Performance:

The document does not provide a quantitative table of acceptance criteria or specific reported device performance metrics in numerical form. Instead, it states that the device was evaluated for its Coating Characteristics, Physical Characteristics, and Performance Characteristics during "in vitro bench testing." The conclusion drawn from these tests is:

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

• Sample Size: Not specified. The document only mentions "in vitro bench testing."
• Data Provenance: The studies were "in vitro bench testing," implying laboratory-based testing. No information on country of origin or whether it was retrospective/prospective is provided.

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

Not applicable or not specified. Since the testing was "in vitro bench testing" and focused on physical and performance characteristics, human expert ground truth as typically understood in diagnostic studies (e.g., radiologists interpreting images) is not relevant here. The ground truth would be based on validated laboratory measurement methods.

4. Adjudication Method for the Test Set:

Not applicable or not specified.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done:

No. An MRMC study is typically for evaluating diagnostic interpretative performance, which is not the focus of this device's evaluation based on the provided text.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:

The device itself is an "in-line, full flow, sterile and non-pyrogenic fluid path disposable device" designed to be used with a BioTrend Oxygen Saturation and Hematocrit System. It's a component, not a standalone diagnostic algorithm. Therefore, the concept of "standalone performance" in the context of an algorithm does not directly apply here. The "performance data" mentioned refers to the physical and functional performance of the device component.

7. The Type of Ground Truth Used:

The ground truth for the "in vitro bench testing" would be based on objective measurements and validated laboratory standards for coating, physical, and performance characteristics (e.g., material analysis, flow dynamics measurements, optical properties, stability testing etc.). The document indicates "acceptable scientific methods" exist for assessing these characteristics.

8. The Sample Size for the Training Set:

Not applicable. This is a physical device modification, not a machine learning algorithm that requires a "training set" in the conventional sense.

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

Not applicable for the same reason as point 8.

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