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The Barkey S-Line blood / fluid warming system is intended to deliver warm blood, blood products, and liquids to adult and pediatric patients. It delivers the fluid via intravenous (IV) administration in hospitals and clinical settings where warmed intravenous fluids are required.

The Barkey S-line is a blood and infusion fluid warmer. The infused fluid flows through a standard IV set. The IV line is inserted into a groove in a warming sleeve, referred to as the Sline. The warming sleeve is made of silicon with embedded heating wires. There is no direct contact between the heat exchanging tube and the fluids. The fluid only contacts the off-the-shelf 510(k) I.V. extension set. There is no software / firmware in the device. The S-line operates on 100 - 240 VAC. 50/60 Hz powering an IEC 60601-1 compliant internal power supply. The set temperature is set to 39 ℃ which is not user selectable. The fluid is warmed to approximately 39 ℃ as it travels a path through the heating sleeve. The temperature is constantly monitored and adjusted. The temperature is measured at the end of the extension set, where it leaves the heated sleeve prior to delivery to the patient. The S-line unit weighs approximately 1.3 kg and is equipped with a knob clamp at the back of the devices for attachment to an I.V. pole, the S-line may also be clamped to a bedrail. Independent overtemperature protector monitors the temperature in the warming section. In case of a fault, there is a second overtemperature safety feature which if a temperature of 43°C +/- 1°C is reached, the warming section's heater is switched off, the luminous ring in the display and control panel shows yellow and an acoustic alarm sounds.

The provided text is a 510(k) Premarket Notification for the Barkey S-Line blood/fluid warming system. This document is a submission to the FDA demonstrating that a new medical device is substantially equivalent to a legally marketed predicate device.

Crucially, this document does not describe a clinical study or a study proving the device meets acceptance criteria in the context of typical AI/ML medical device performance studies. Instead, it describes non-clinical testing (electrical/EMC and performance testing) to demonstrate the device's basic functionality and safety, and compares its specifications to a predicate device to establish substantial equivalence.

Therefore, many of the requested items (e.g., sample size for test set, number of experts, MRMC study, ground truth for training set) are not applicable to the type of device and submission described in this document. The Barkey S-Line device is a fluid warmer, not a diagnostic AI/ML system that would typically undergo such a rigorous performance validation involving human experts and clinical datasets.

However, I can extract the "acceptance criteria" in a broad sense from the non-clinical testing sections and the comparison to the predicate.

Non-Applicable Information for this Device/Submission Type:

• Sample sized used for the test set and the data provenance: Not a clinical study involving a test set of patient data.
• Number of experts used to establish the ground truth: Not applicable, no ground truth based on expert review of medical images/data.
• Qualifications of those experts: Not applicable.
• Adjudication method for the test set: Not applicable.
• If a multi-reader multi-case (MRMC) comparative effectiveness study was done: No, this is not an AI/ML diagnostic device requiring an MRMC study.
• Effect size of how much human readers improve with AI vs without AI assistance: Not applicable.
• If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable, as there's no complex algorithm. The "electronics" section explicitly states "No microprocessor" and "The temperature regulation is realized by hardware comparator circuit."
• The type of ground truth used: Not applicable in the sense of clinical ground truth (e.g., pathology, expert consensus). The "ground truth" here is the physical measurement of temperature and electrical properties against specified ranges.
• The sample size for the training set: Not applicable; there is no machine learning model requiring a training set.
• How the ground truth for the training set was established: Not applicable.

Acceptance Criteria and Reported Device "Performance" (as per the non-clinical testing and comparison):

Based on the nature of this 510(k) submission for a fluid warmer, the "acceptance criteria" are derived from relevant electrical/safety standards and the device's ability to maintain a target temperature within specified limits, similar to the predicate device.

1. Table of Acceptance Criteria and Reported Device Performance

• 1.7 ml/min, 37°C
• 25 ml/min, 29°C
• 100 ml/min – N/A
  (Compared to predicate's performance at max 41°C: 1.7 ml/min, 37°C; 25 ml/min, 37.5°C; 100 ml/min, 36°C). Despite differences in specific performance values for flow rates, these are typically considered sufficient for the stated indications when compared for substantial equivalence. The document doesn't explicitly state the thresholds for "acceptable" performance for each flow rate but implied sufficiency. |
  | Ingress Protection (Water/Particulate): Adequate protection against ingress of foreign objects and water. | IPX2 (compared to predicate's IPX4). Deemed "adequate ingress protection" given the device's design and intended use. |
  | Protection Against Electric Shock: Classification of protection against electric shock. | Type BF (Similar to predicate). |
  | Alarm Functionality: Timely and appropriate audible/visual alerts for fault conditions (e.g., overtemperature). | Audible and Visual alarms for "Overtemperature" and "Fault" conditions. (Similar to predicate's Audible and Visual alarms for Low temp (42.0C)). |
  | Compatibility with Accessories: Proper function with specified IV sets. | "Used with user supplied FDA cleared IV sets" from Biegler (K954769), which are cleared for use with fluid warmers. (Similar to predicate). |
  | Dimensions: Appropriate physical size for intended use (implied, not a direct safety/performance criterion but part of equivalence). | 90 x 60 x 160 mm ("Dimensions not critical" compared to predicate's 228 x 278 x 132mm, as long as it functions). |
  | Operational Power Requirements: Compatibility with standard hospital power supply. | 100 - 240 VAC, 50/60 Hz (Similar to predicate's 110/220 VAC). |
  | Indications for Use, Patient Population, Environments of Use: Alignment with the predicate device and appropriate for intended context. | "Similar" in all these aspects to the predicate device. |
  | Fundamental Warming Methodology & Principle of Operation: Maintain a similar, safe approach to fluid warming. | "Similar technology of heat exchanger." The difference (heating within the controller vs. heating the line) "does not raise different risk concerns." |
  | Fluid Contact Materials: (Crucial for patient safety) Ensuring no hazardous materials in contact with fluids or that proper clearances exist for compatible accessories. | "The subject device has no fluid contacting materials" as it heats the IV line, which is an FDA-cleared accessory. (Predicate uses accessory extension sets that contact fluid). This is a design difference but deemed safe and equivalent. |

2. Sample Size and Data Provenance:

• Sample Size: This document does not specify a "sample size" in the context of clinical data for an AI/ML device. The "testing" involves internal non-clinical validation of the device's physical and electrical properties. The number of units tested for electrical safety, temperature accuracy, or flow rate performance is not explicitly stated but would be part of a quality management system.
• Data Provenance: Not applicable in the context of clinical data. The performance claims are based on non-clinical testing performed internally by the manufacturer (Barkey GmbH & Co. KG), presumably in Germany given their address. The testing reports (e.g., electrical, performance testing) would be available internally.

3. Number of Experts and Qualifications:

• Not applicable. This device does not rely on expert interpretation of medical data for its function or validation for regulatory submission. The "experts" involved would be engineers and quality assurance personnel performing the non-clinical tests.

4. Adjudication Method:

• Not applicable.

5. MRMC Comparative Effectiveness Study:

• No. This type of study is for evaluating the impact of AI on human reader performance, which is not relevant for a fluid warming device.

6. Standalone Performance:

• Yes, in a very literal sense. The device's performance in heating fluids and its safety features (e.g., overtemperature cutoff, alarms) are evaluated as a standalone product against engineering specifications and relevant standards. There is no AI/ML component or complex algorithm, it's a hardware-based direct warming device.

7. Type of Ground Truth Used:

• The "ground truth" for this device's performance relies on physical measurements against engineering specifications and regulatory standards. For example:
  • Temperature: Measured temperature must fall within a specified range (e.g., 39°C +/- tolerance) and safety cutoffs (e.g., 43°C +/- 1°C).
  • Electrical Safety: Electrical parameters (e.g., leakage current, insulation resistance) must meet the limits specified by IEC 60601-1.
  • Flow Rate vs. Temperature: Measured output fluid temperature at various input fluid temperatures and flow rates.
• This is not "expert consensus," "pathology," or "outcomes data."

8. Sample Size for the Training Set:

• Not applicable. There is no training set as there is no machine learning component. The device's temperature regulation is achieved through a "hardware comparator circuit" rather than a software algorithm.

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

• Not applicable.

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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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