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The Thermal Angel™ model 200 Blood/Fluid Warmer is Indicated for the warming of blood, blood products and intravenous fluids prior to administration. It is intended to be used by healthcare professionals in clinical and field environments.

Thermal Angel™ model 200 Blood and Fluid Warmer is an in-line, intravenous blood and fluid warmer. Thermal Angel™ is indicated for use whenever introduction of normothermic, parenteral (intravenous or irrigation) fluids are desired or indicated, whether in field or clinical settings.

The Thermal Angel™ model 200 Blood/Fluid Warmer consists of a single unit that is placed The Themal Angel - The set and a standard IV extension set. Thermal Angel™ is designed to warm blood, blood products and intravenous fluics at flow rates of up to and including 200 ml/min. Thermal Angel™ will deliver temperatures of 38°C (100.4°F). While the temperature will drop immediately after making major changes in flow rate, it will drop only a few degrees and return smoothly and within seconds, to 38℃ (100.4°F).

Thermal Angel's™ fluid path is sterile and nonpyrogenic, and the entire warming unit is disposable after use. Thermal Angel™ is battery operated, powered by a 12V DC system. Blood, blood and intravenous fluids travel through stainless steel tubing which is surrounded by a heating blanket and heated by electrical resistance. The temperature of the device is accurately controlled by the device's electronics. The electrical requirements are designed in accordance with UL 2601 and CSA 601.

Here's an analysis of the provided text regarding the Thermal Angel™ model 200 Blood/Fluid Warmer, structured to address your questions.

Important Note: The provided text is a 510(k) Summary and correspondence from the FDA. It describes the device and its intended use, and states that laboratory evaluations were conducted. However, it does not include the detailed results of a study with acceptance criteria and specific performance metrics in the format requested. The document primarily focuses on establishing "substantial equivalence" to predicate devices. Therefore, many of your specific questions regarding acceptance criteria and detailed study performance cannot be answered from the provided text.

Acceptance Criteria and Device Performance

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

Based on the provided text, the primary performance criteria explicitly stated are:

Study that Proves Device Meets Acceptance Criteria:

The document states, "Laboratory evaluations have been conducted to evaluate the hemolytic effect of the Thermal Angel™ model 200 Blood/Fluid Warmer during flow, stop flow, and high flow rates. Hemolysis was shown to be none or not clinically significant."

For the temperature and flow rate performance, the document describes the design: "Thermal Angel™ is designed to warm blood, blood products and intravenous fluids at flow rates of up to and including 200 ml/min. Thermal Angel™ will deliver temperatures of 38°C (100.4°F)." It also states, "While the temperature will drop immediately after making major changes in flow rate, it will drop only a few degrees and return smoothly and within seconds, to 38℃ (100.4°F)." This suggests these performance characteristics were verified during product development and testing, typical of a Class II device submission, but the specific study details (e.g., number of test runs, data collected, statistical analysis) are not provided in this summary.

Additional Study Details:

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

The text mentions "Laboratory evaluations" for hemolysis. It does not specify the sample size for these evaluations, nor does it provide details on data provenance (country of origin, retrospective/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)

Not applicable and not provided. This device is a fluid warmer, not an AI/diagnostic device that typically requires expert-established ground truth for a test set in the way a medical image analysis device would. The "ground truth" for its performance would be objective measurements (temperature, flow, hemolysis assays).

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

Not applicable and not provided. (See explanation for #3).

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

Not applicable. This is not an AI/diagnostic device, and no MRMC study or AI assistance is mentioned.

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

Not applicable. This is not an algorithm-based device. The device's performance is standalone in the sense that the device itself performs the heating function.

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

For temperature performance and flow rates, the ground truth would be physical measurements of temperature and flow. For hemolysis, the ground truth would typically be laboratory assays for free hemoglobin.

8. The sample size for the training set

Not applicable. This device does not use a "training set" in the context of machine learning or AI. Its design and performance are based on engineering principles and physical testing.

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

Not applicable. (See explanation for #8).

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Thermal Angel™ is an in-line intravenous fluid and blood warmer. Thermal Angel™ is indicated for use whenever parenteral introduction of normothermic fluids are desired or indicated, whether in field or clinical settings.

The Thermal Angel™ 200 Blood/Fluid Warmer consists of a single unit that is placed in-line between a standard IV drip set and a standard IV extension set. Thermal Angel™ is designed to warm blood, blood products and intravenous liquids at flow rates of up to and including 200 ml/min. Thermal Angel™ will deliver temperatures at 38°C. While the temperature will drop immediately after making major changes in flow rate, it will drop only a few degrees and return smoothly, and within seconds, to 38°C. Thermal Angel's™ fluid path is sterile and the entire unit is disposable after use. Blood, blood products or intravenous fluids travel through stainless steel tubing which is surrounded by a heating blanket and heated by means of electrical resistance. The temperature of the device is accurately controlled by the device's electronics. The electrical requirements are designed in accordance with UL 2601 and CSA 601.

The provided document is a 510(k) summary for the Thermal Angel™ 200 Blood/Fluid Warmer. It primarily focuses on demonstrating substantial equivalence to predicate devices based on technological characteristics and intended use. It does not contain information about a study that assesses performance against acceptance criteria in the format typically used for AI/ML device evaluations.

Therefore, I cannot provide a table of acceptance criteria and reported device performance, nor details about a study evaluating AI/ML performance.

However, I can extract information related to the device's technical specifications and general claims of achieving certain performance.

Here's an analysis based on the provided document, addressing the points where information is available or noting its absence:

1. Table of Acceptance Criteria and Reported Device Performance:

The document doesn't explicitly define "acceptance criteria" for a study in the context of device performance as one might expect for an AI/ML device (e.g., target sensitivity, specificity). Instead, it focuses on demonstrating that its technological characteristics are comparable to predicate devices and that certain output parameters are achieved.

2. Sample size used for the test set and the data provenance:

• Not applicable. This document describes a medical device (blood/fluid warmer), not an AI/ML system, and therefore does not refer to test sets for algorithm evaluation.
• The document mentions "studies will be conducted" regarding hemolytic effect, but details of these studies (sample size, data provenance) are not included in this 510(k) summary; only the intent is stated.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

• Not applicable. This information pertains to AI/ML model development, which is not the subject of this 510(k) submission.

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

• Not applicable. No such test set or adjudication process is mentioned for this type of device.

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:

• Not applicable. This device is a physical warmer and does not involve human readers or AI assistance in interpretation.

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

• Not applicable. There is no algorithm component described for this device.

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

• Not applicable in the context of AI/ML evaluation. For a physical device like a warmer, "ground truth" would refer to direct measurements of physical parameters (e.g., actual fluid temperature, flow rate, assessment of hemolysis in laboratory tests). The document only states the desired outcomes for these physical parameters (e.g., 38°C delivery temperature, none or not clinically significant hemolysis).

8. The sample size for the training set:

• Not applicable. No AI/ML training set is referenced.

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

• Not applicable. No AI/ML training set is referenced.

Summary of what the document does provide:

• Predicate Devices: The device is being compared to existing, legally marketed blood/fluid warmers (Augustine Medical Bair Hugger™, Level 1 Technologies, Inc. Hotline™, Baxter Thermacyl™).
• Technological Equivalence: The document primarily uses a comparison chart to demonstrate that the Thermal Angel™ 200 has similar technological characteristics (heating method, temperature control, alarms) to these predicate devices.
• Intended Use Equivalence: The intended use is stated to be the same as currently marketed devices.
• Future Studies Mentioned: It notes that nonclinical studies to evaluate the hemolytic effect will be conducted prior to marketing, with the acceptance criterion being "none or not clinically significant hemolysis." However, the results of these studies are not included in this summary.

In conclusion, this 510(k) summary is for a physical medical device and is primarily based on demonstrating substantial equivalence to predicate devices through a comparison of technical specifications and intended use, rather than a clinical performance study with defined acceptance criteria and statistical outcomes for an AI/ML component.

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