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The Prismacomfort blood warmer is used to warm the return blood flow line in order to replace heat loss to the atmosphere and effluent flow during a Prismaflex® treatment.

The Prismacomfort blood warmer consists of one controller and one sleeve warmer. The controller (Barkey autocontrol 3XPT) controls the sleeve warmer (Barkey autoline XPT 4R) and displays alarm and status messages. The Prismacomfort blood warmer warms the returning blood flow line by means of a silicon tube heat exchanger (applied part Barkey autoline XPT 4R) which covers the blood return flow line of the Gambro Prismaflex® system completely. The heat is transferred by the contact of the resistance heating system Barkey autoline XPT 4R to the inserted blood return line. The complete enclosure of the returning blood flow line to be warmed ensures that there are no temperature losses to the surroundings. The warmth produced by the sleeve warmer is therefore transferred to the return blood flow at maximum efficiency. The device is intended for the Prismaflex® System and may be used with any of the Prismaflex® system therapy choices, when heat loss may cause undesirable cooling of the patient.

This document is a 510(k) premarket notification for the Barkey Prismacomfort blood warmer, submitted to the FDA. It mainly focuses on demonstrating substantial equivalence to a predicate device, the Stihler prismaflo. As such, the document does not contain the detailed information typically found in a study proving a device meets specific acceptance criteria for performance endpoints beyond basic safety and functional verification against established standards and predicate device characteristics.

Here's an analysis of the provided text in relation to your request:

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

The document does not provide a table with quantitative acceptance criteria (e.g., specific alarm thresholds, temperature ranges, or flow rates) and a direct comparison of the device's performance against these criteria as part of a formal study outcome. Instead, it states that the device:

• Complies with safety standards: DIN EN 60601-1, DIN EN 60601-1-2, UL 2601-1/10.97, CAN/CSA-C22.2 No. 601.1-M90, ASTM F 2172-02. This is a form of acceptance criteria (compliance with standards) but not specific performance metrics.
• "Verify the ability of the system to prevent cooling down of blood return lines on Gambro Prismaflex CRRT system." This is a functional goal, not a quantifiable acceptance criterion with a reported performance value.
• "Verify the ability of the system to protect the patient and to detect and alarm at unsafe operating conditions." Again, a general safety goal, not a specific performance metric against a numerical threshold.

The "reported device performance" is summarized by asserting that the device is "substantially equivalent in safety and effectiveness" to the predicate device, Stihler prismaflo, and "capable of heating blood return flow line on Gambro Prismaflex® system" while "giving efficient heat to keep the blood return flow on Gambro Prismaflex® Systems warm." This is a qualitative statement of performance rather than quantitative data.

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

The document mentions "tests were carried out" to verify the device's ability to prevent cooling and protect patients. However, it does not specify any sample size for a test set (e.g., number of units tested, number of simulated runs). The data provenance is implied to be from internal testing by the submitter (Barkey GmbH & Co. KG, Germany). It does not specify if the tests were retrospective or prospective, but typically verification and validation tests for medical devices are prospective.

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)

This section is not applicable to this type of device and submission. The "ground truth" for a blood warmer would typically be objective physical measurements (temperature, flow, alarm activation) against engineering specifications and regulatory standards, not expert clinical consensus or interpretation as would be the case for diagnostic imaging.

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

This is not applicable. Adjudication methods like 2+1 (two experts agree, a third resolves disagreement) are used when expert consensus is required for ground truth, typically in subjective diagnostic interpretation. For objective device performance testing, adjudication is generally not employed in this manner.

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

This is not applicable. An MRMC study is relevant for diagnostic devices involving human interpretation (e.g., radiologists reading images) and the impact of AI algorithms on their performance. The Prismacomfort blood warmer is a therapeutic/supportive device.

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

This is not applicable in the context of an "algorithm only" device. The Prismacomfort blood warmer is a physical device, and its performance is inherently standalone (i.e., it performs its function without requiring a human to directly "interpret" its output in a diagnostic sense for each use, beyond setting it up and monitoring it). The non-clinical tests assess the device's inherent performance.

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

The "ground truth" for this device's testing is based on engineering specifications, established safety standards (e.g., DIN EN 60601-1), and the performance characteristics of the legally marketed predicate device (Stihler prismaflo). It involves objective measurements (e.g., temperature control, alarm activation) and verification of compliance with these standards and functional requirements.

8. The sample size for the training set

This is not applicable. Blood warming devices generally do not involve machine learning or AI algorithms that require "training sets" in the conventional sense. The device's operation is based on established thermodynamic and electronic control principles.

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

This is not applicable as there is no training set for this device.

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