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The intended use of the Belmont® buddy lite™ Fluid Warmer is to warm blood, blood products, and intravenous solution prior to administration. It is intended to be used by healthcare professionals in clinical environments to prevent hypothermia.

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The provided text is a 510(k) premarket notification letter from the FDA to Belmont Instrument Corporation for their device, The Belmont® buddy lite™ Fluid Warmer. This type of document does not contain the detailed information requested regarding acceptance criteria, study design parameters (sample sizes, data provenance, expert details, adjudication methods), multi-reader multi-case studies, standalone performance, or ground truth establishment for AI/ML-based medical devices.

The letter is a regulatory approval document confirming that the device is substantially equivalent to legally marketed predicate devices for its stated indications for use (warming blood, blood products, and intravenous solutions prior to administration to prevent hypothermia). It discusses regulatory compliance and general controls but does not present clinical study results or technical performance data in the format requested for an AI/ML device.

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

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The intended use of the Belmont® buddy lite™ Fluid Warmer is to warm blood, blood products, and intravenous solution prior to administration. It is intended to be used by healthcare professionals in clinical environments to prevent hypothermia.

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The provided document is a 510(k) clearance letter from the FDA for a medical device called "The Belmont® buddy lite™ Fluid Warmer." This document does not describe or include information about a study that proves the device meets acceptance criteria in the manner requested, which typically refers to performance studies for software, AI, or diagnostic devices.

Instead, this letter is a regulatory approval based on the device's "substantial equivalence" to a predicate device. It confirms that the device meets certain regulatory requirements for marketing.

Therefore, I cannot extract the requested information regarding acceptance criteria, study details, sample sizes, expert qualifications, or ground truth as those elements are not part of this type of FDA clearance document for a medical fluid warming device.

The information on this document focuses on:

• Device Name: The Belmont® buddy lite™ Fluid Warmer
• Regulation Number/Name: 21 CFR 864.9205, Blood and Plasma Warming Device
• Regulatory Class: II
• Product Code: BSB
• Indications For Use: To warm blood, blood products, and intravenous solution prior to administration by healthcare professionals in clinical environments to prevent hypothermia.
• Basis of Approval: Substantial equivalence to legally marketed predicate devices.

The questions in the prompt are more relevant to the evaluation of AI/ML-based medical devices or diagnostic tools, which involve detailed performance studies with quantitative metrics, ground truth establishment, and often human reader studies. This document pertains to a physical fluid warming device.

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buddy plus™ Fluid Warmer intended use is for warming blood, blood products and intravenous solution prior to administration. It is intended to be used by healthcare professionals in clinical environments to prevent hypothermia.

The Belmont buddy plus™ Fluid Warmer is a portable in-line blood and fluid warmer. It consists of three components, a heater unit, a power module which powers the heater unit and displays alarm and status messages, and a single-use disposable heat exchanger set. The power module also contains a built-in battery pack which automatically switches over to the battery operation when the AC power is disconnected. When the power is restored, the system reverts to AC power automatically, the battery charger is activated, and the battery is charged. The heating technology used is resistive heating of two plates within the heater unit. The buddy plus™ Fluid Warmer warms intra-venous fluids, including blood and blood products, to physiological temperature, and monitors fluid temperature. It also senses lack of IV fluid flow, or empty set, and a number of internal fault conditions including over-heating, loss of electrical connection to the heater, and failure to heat. The device stops heating and alarms if an alarm or fault condition occurs. The system provides the user with alarm, alarm message, temperature, and other operating information via a bright alphanumeric display. The sterile disposable set is placed in-line between a standard IV line at its input and a user-supplied cannula or IV infusion set at its output. The input can come from a gravity fed IV line with roller clamp and drip chamber, external to the device and not supplied by Belmont Instrument Corp. The device is intended for low applications where the flow rate is 6 liter/hour (100 ml/min) or less.

The Belmont buddy plus™ Fluid Warmer is a nonelectromagnetic blood or fluid warming device intended for warming blood, blood products, and intravenous solutions to physiological temperature prior to administration. It is designed for use by healthcare professionals in clinical environments to prevent hypothermia, specifically for applications where the flow rate is 6 liters/hour (100 ml/min) or less.

Here's a breakdown of the acceptance criteria and the study information presented:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size and Data Provenance for Test Set

• Sample Size: The document does not specify a numerical sample size for the "nonclinical tests." It only states that "the following tests were carried out."
• Data Provenance: Not specified, but the testing was conducted by Belmont Instrument Corporation, presumably in-house or through a contracted laboratory to demonstrate performance. The testing is implied to be prospective, as it was done to "verify performance" for K062774.

3. Number of Experts and their Qualifications for Ground Truth of Test Set

This type of information is not applicable to this device. The Belmont buddy plus™ Fluid Warmer is a medical device for warming fluids, and its performance and safety are typically evaluated through engineering and functional tests against established physical and safety criteria, rather than through expert consensus on qualitative assessments or diagnostic interpretation. Therefore, there are no "experts" establishing a "ground truth" in the diagnostic sense.

4. Adjudication Method for the Test Set

Not applicable for this type of device testing. Adjudication methods like 2+1 or 3+1 are used in studies involving human interpretation (e.g., image analysis) where ambiguous cases require expert resolution. The nonclinical tests described for the fluid warmer are objective, measurable performance criteria.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No, an MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic devices that involve human interpretation and aims to assess the impact of AI assistance on human performance. The Belmont buddy plus™ Fluid Warmer is a therapeutic/supportive care device, not a diagnostic one involving human readers.

6. Standalone (Algorithm Only) Performance Study

Yes, a standalone study was performed in the sense that the device's technical specifications and functional capabilities were tested independently to verify its performance against design requirements. The "nonclinical tests" fall under this category, evaluating the device's ability to warm fluids and its safety features directly.

7. Type of Ground Truth Used

The "ground truth" for this device's performance is established by objective engineering specifications and safety standards. For example:

• Physiological temperature: This is a defined temperature range (e.g., 37°C ± a certain tolerance). The device's ability to achieve and maintain this temperature is measured directly.
• Alarm conditions: These are defined fault conditions, and the "ground truth" is whether the device accurately detects them and triggers the appropriate alarm.

8. Sample Size for the Training Set

This information is not applicable. The Belmont buddy plus™ Fluid Warmer is not an AI/ML-driven device that requires a training set. Its design and operation are based on conventional engineering principles of resistive heating and electronic control, not machine learning algorithms.

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

This information is not applicable for the reasons stated in point 8.

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buddy™ Fluid Warmer intended use is for warming blood, blood products and intravenous solution prior to administration. It is intended to be used by healthcare professionals in clinical environments to prevent hypothermia.

The Belmont buddy™ Fluid Warmer is a portable in-line blood and fluid warmer. It consists of three components, a heater unit, a power module and a disposable set. The power module powers the heater unit and displays alarm and status messages, and a disposable set which is placed in the heater unit and through which the fluid flows. The heating technology used is resistive heating of two plates within the heater unit. The buddy™ Fluid Warmer warms intra-venous fluids, including blood and blood products, to physiological temperature, and monitors fluid temperature. It also senses lack of flow, or empty set, and a number of internal fault conditions such as electrical connection to the heater, and failure to heat. The device stops heating and alarms if an alarm or fault condition occurs. The device provides the user with alarm, alarm message, temperature, and other operating information via a bright alphanumeric display. The sterile disposable set is placed in-line between a standard IV line at its input and a standard IV infusion set at its output. The input can come from a bag or supplied via a standard clamp and drip chamber, external to the device and not supplied by Belmont Instrument Corp. The device is intended for low flow applications where the flow rate is 6 liter/hour (100 ml/min) or less. This premarket application describes a modification to the disposable set.

The provided document is a 510(k) Premarket Notification for the Belmont buddy™ Fluid Warmer. It describes modifications to an existing device and claims substantial equivalence to its predicate device. However, it does not contain detailed acceptance criteria, specific performance metrics, or a formal study design that would allow for a comprehensive table of acceptance criteria and reported device performance.

The document states that "In order to verify performance of the Belmont buddy™ Fluid Warmer in support of substantial equivalence, the following tests were carried out: a. Verify the ability of the system to warm cold fluids to physiological temperature. b. Verify the ability of the system to protect the patient and to detect and alarm at unsafe or ineffective operating conditions." It concludes that "Both systems perform as intended according to the specifications of the device." However, it does not explicitly list these specifications or the quantitative results of the verification tests.

Therefore, I cannot provide a table of acceptance criteria and reported device performance with numerical values, nor can I answer many of the specific questions about sample size, ground truth, or MRMC studies, as this information is not present in the provided text.

Here's a breakdown of what can be inferred or directly stated from the document, and where information is missing:

1. Table of Acceptance Criteria and Reported Device Performance

• Acceptance Criteria (Inferred from testing goals):
  • Ability to warm cold fluids to physiological temperature.
  • Ability to protect the patient and to detect and alarm at unsafe or ineffective operating conditions.
• Reported Device Performance:
  • The document states that the device "performs as intended according to the specifications of the device" and is "capable of heating blood products or intravenous fluids to physiological temperature." No specific numerical performance values (e.g., target temperature range, alarm thresholds, accuracy) are provided in this summary.

2. Sample size(s) used for the test set and the data provenance

• Sample Size for Test Set: Not specified.
• Data Provenance: Not specified (e.g., country of origin, retrospective/prospective). The tests were carried out by the manufacturer to verify performance.

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

• Number of Experts: Not applicable. The "ground truth" here would be the device's ability to meet its engineering and functional specifications, which would be assessed through objective testing and measurement, not expert interpretation of outputs in the clinical sense.
• Qualifications of Experts: Not applicable.

4. Adjudication method for the test set

• Adjudication Method: Not applicable. Performance was verified against device specifications and functional requirements through testing, not through expert adjudication of an output or diagnosis.

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

• MRMC Study: No, an MRMC comparative effectiveness study was not done. This device is a fluid warmer, not a diagnostic AI system that would assist human readers in interpreting data.

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

• Standalone Performance Study: Yes, in a sense. The described "verification tests" would evaluate the device's ability to perform its warming and safety functions independently, without a human "in-the-loop" influencing its core operational performance. However, this is not an "algorithm-only" performance in the context of AI, but rather a functional device performance.

7. The type of ground truth used

• Type of Ground Truth: The "ground truth" for this device's performance would be engineering specifications and functional requirements related to temperature regulation, alarm conditions, and fluid flow detection, verified through objective measurements and testing. This is not "expert consensus, pathology, or outcomes data" in the typical medical imaging/AI context.

8. The sample size for the training set

• Sample Size for Training Set: Not applicable. This device is a hardware fluid warmer with embedded controls, not a machine learning or AI system that requires a "training set" in the conventional sense. Its "training" would be its design, calibration, and manufacturing processes.

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

• How Ground Truth for Training Set Established: Not applicable, as there is no "training set" for this type of device. The specifications and functional requirements are established through engineering design, regulatory standards, and intended use.

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The Microheater intended use is for warming blood, blood products and intravenous solution prior to administration. It is intended to be used by healthcare professionals in clinical environments to prevent hypothermia. The system is not meant for the infusion of drugs, or platelet or granulocyte suspensions.

The Belmont Microheater is a portable in-line blood and fluid warmer. It consists of three components, a heater unit, a power module which powers the heater unit and displays alarm and status messages, and a single-use disposable heat exchanger set. The heating technology used is resistive heating of two plates within the heater unit. The Microheater warms intra-venous fluids, including blood and blood products, to physiological temperature, and monitors fluid temperature. It also senses lack of IV fluid flow, or empty cartridge, and a number of internal fault conditions including over-heating, loss of electrical connection to the heater, and failure to heat. The device stops heating and alarms if an alarm or fault condition occurs. The system provides the user with alarm, alarm message, temperature, and other operating information via a bright alphanumeric display. The sterile disposable set is placed in-line between a standard IV line at its input and a user-supplied cannula or IV infusion set at its output. The input can come from a gravity fed IV line with roller clamp and drip chamber, external to the device and not supplied by Belmont Instrument Corp. The Microheater is not meant to be used with pressurized infusers. The device is intended for low applications where the flow rate is 6 liter/hour (100 ml/min) or less.

This document is a 510(k) premarket notification for the Belmont Microheater, a blood and fluid warmer. The provided text describes the device, its intended use, and a summary of nonclinical tests performed to support its substantial equivalence to a predicate device. However, it does not provide the detailed acceptance criteria and study results in the format requested.

Specifically, the document states:

• "11. Summary of Nonclinical Tests and Results" lists two verification tests:
  • "Verify the ability of the system to warm cold fluids to physiological temperature."
  • "Verify the ability of the system to detect and alarm at unsafe or ineffective operating conditions."
• It also states: "In order to verify performance of the Belmont Microheater in support of substantial equivalence, the following tests were carried out."
• Under "12. Conclusion," it mentions: "Both systems have the same intended use, and are capable of heating blood products or intravenous fluids prior to administration to physiological temperature. Both systems have an independent fail-safe circuit which stops heating and alarms if the system overheats."

This summary indicates that tests were performed to verify performance against certain implicit criteria (e.g., reaching physiological temperature, detecting and alarming unsafe conditions, implementing a fail-safe circuit). However, the document does not explicitly define specific numerical acceptance criteria (e.g., a target temperature range, alarm thresholds), nor does it present the reported device performance data against such criteria in a table format.

Therefore, many of the requested details cannot be extracted from the provided text.

Here is what can be inferred or stated as "not provided" based on the document:

1. Table of Acceptance Criteria and Reported Device Performance:

Note: The document provides a summary of tests and a conclusion of capability, but not the specific numerical acceptance criteria (e.g., "target temperature of 37 ± 1°C") or the detailed performance results that demonstrate meeting these criteria (e.g., "average temperature achieved was 37.2°C with a standard deviation of 0.5°C").

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

• Sample Size: Not specified. The document states "the following tests were carried out" but does not give the number of trials, units tested, or data points collected for these nonclinical tests.
• Data Provenance: The tests were "carried out" by Belmont Instrument Corporation. It's an internal company study for regulatory submission. It's prospective in the sense that the testing was performed specifically for this submission. Country of origin not explicitly stated for the testing, but the company is based in Billerica, MA, USA.

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

• Not Applicable. This device is a fluid warmer, and the described tests are nonclinical performance validations (e.g., heating to a certain temperature, alarm function). The "ground truth" for these tests would be objective measurements (e.g., temperature probes, electrical sensors), not expert interpretation.

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

• Not Applicable. As mentioned above, the tests are objective performance validations, not subjective interpretations requiring adjudication.

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 a hardware device (fluid warmer), not an AI-assisted diagnostic or imaging device used by human readers.

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

• Not Applicable. This is a hardware device. The "standalone" performance would be its ability to warm fluids and alarm, which is implicitly what the nonclinical tests addressed, but the term "standalone" typically refers to AI algorithm performance without human intervention. The device operates autonomously to achieve its intended function (warming fluids) and has an "independent fail-safe circuit."

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

• For the performance tests (warming, alarming): The "ground truth" would be objective physical measurements (e.g., temperature readings from calibrated sensors, verification of alarm activation under specific faulty conditions).
• For compliance with standards: The ground truth is successful adherence to the requirements outlined in the referenced standards (e.g., ethylene oxide sterilization efficacy, biological compatibility, electrical safety requirements).

8. The sample size for the training set:

• Not Applicable. This is a hardware device, not a machine learning or AI model that requires a training set. The device's operational parameters and safety features are designed and engineered, not "trained" on data.

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

• Not Applicable. (See #8).

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Indications for Use:

• 1. Warming transfusions, infusions, fluids.
• 2. Warming blood infusions and return blood flow.

Not Found

I am sorry, but the provided text is a 510(k) clearance letter for a medical device called "ASTOFLO," a blood and infusion warmer. It outlines the FDA's determination of substantial equivalence to a predicate device and provides information on regulatory responsibilities.

The document does not contain any information about acceptance criteria, device performance studies, sample sizes, ground truth establishment, or multi-reader multi-case studies. Therefore, I cannot extract the requested information from this text.

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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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Warm return blood flow

Not Found

I'm sorry, but this document does not contain the information requested. The document appears to be an FDA 510(k) clearance letter for a device called "Prismatherm II." It indicates that the device has been found substantially equivalent to a predicate device and can be marketed.

However, the letter does not include any details about acceptance criteria, device performance studies, sample sizes, expert qualifications, adjudication methods, or ground truth establishment. These details would typically be found in the 510(k) submission itself, not directly in the clearance letter provided here.

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Gentle heating of all transfusions and infusions close to the patient -Warm return blood flow

Astotherm Plus, Astotubes, Astoline

I am sorry, but the provided text from the FDA 510(k) notification for the "Astotherm Plus, Astotubes, Astoline" devices does not contain the detailed information necessary to answer your request about acceptance criteria and a study proving device performance.

The document is a general clearance letter stating that the device is "substantially equivalent" to previously marketed devices and lists its "Indications for Use." It does not include:

1. A table of acceptance criteria and reported device performance.
2. Sample sizes or data provenance for a test set.
3. Number or qualifications of experts for ground truth.
4. Adjudication method.
5. Information on any multi-reader multi-case (MRMC) comparative effectiveness study or effect size.
6. Details about a standalone (algorithm only) performance study.
7. Type of ground truth used (e.g., pathology, outcomes data).
8. Sample size for the training set.
9. How ground truth for the training set was established.

This type of information would typically be found in detailed premarket submission documents, clinical trial reports, or performance testing summaries, which are not present in this specific clearance letter.

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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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