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The Radiant Medical Reprieve® Endovascular Temperature Therapy System is a thermal regulating device intended to induce, maintain, and reverse mild hypothermia in neurosurgical patients in surgery and in recovery/intensive care.

The Reprieve System consists of a single-use, heparin-coated, central venous catheter; a single-use, heat exchange cassette; an integrated temperature probe; and an external controller. The Controller unit has a user interface to select operating parameters and is connected to the Catheter via the Cassette and extension lines. The catheter is designed for placement in the inferior vena cava via the femoral vein using a 12 Fr hemostatic introducer sheath.

The provided text is a 510(k) summary for the Radiant Medical Reprieve® Endovascular Temperature Therapy System. It describes the device, its intended use, and claims substantial equivalence to predicate devices. However, the document does not contain the detailed information required to describe acceptance criteria, a specific study proving those criteria were met, or the specifics of such a study for an AI/ML device.

The "Performance Test" section states: "The Reprieve Endovascular Temperature Therapy System has been tested for system performance substantially equivalent to the predicate devices. In addition the Catheter has been tested for functionality in accordance to BS EN ISO 10555, for biocompatibility in accordance to ISO 10993, and for sterility in accordance to ISO 11137. The controller has been tested for electrical safety in accordance to IEC 60601."

This statement indicates that the device met established international standards for medical devices and demonstrated substantial equivalence to predicate devices, but this is a regulatory compliance statement and not a detailed account of an AI/ML clinical validation study. The Reprieve® Endovascular Temperature Therapy System is a hardware-based thermal regulating device, not an AI/ML-powered diagnostic or therapeutic system. Therefore, the concepts of "acceptance criteria" and "study that proves the device meets the acceptance criteria" in the context of an AI/ML algorithm (e.g., sample size for test sets, data provenance, number of experts for ground truth, adjudication methods, MRMC studies, standalone performance, training set details) are not applicable to this device as described.

To answer your request based only on the provided text, I can only state what is present, which is the system was tested for substantial equivalence and adherence to specific international standards, not against AI/ML performance metrics.

Therefore, I cannot provide the requested table and detailed information because the provided document describes a hardware medical device, not an AI/ML algorithm, and thus does not contain the information relevant to AI/ML acceptance criteria and study designs.

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The Reprieve Endovascular Temperature Therapy System is a thermal regulating system intended to achieve and/or maintain normothermia in cardiac surgery patients in surgery and in recovery/intensive care, and for use in fever reduction, as an adjunct to other antipyretic therapy, in patients with cerebral infarction and intracerebral hemorrhage who require access to the central venous circulation and who are intubated and sedated.

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This document is a 510(k) premarket notification letter from the FDA regarding the Reprieve® Endovascular Temperature Therapy System. It does not contain information about the acceptance criteria or results of a study proving the device meets those criteria.

Therefore, I cannot fulfill the request to provide:

1. A table of acceptance criteria and reported device performance.
2. Sample size used for the test set and data provenance.
3. Number of experts and their qualifications for ground truth.
4. Adjudication method.
5. MRMC comparative effectiveness study results.
6. Standalone algorithm performance.
7. Type of ground truth used.
8. Sample size for the training set.
9. How ground truth for the training set was established.

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The Radiant Medical Reprieve® Endovascular Temperature Therapy System is indicated for use in cardiac surgery patients to achieve and/or maintain normothermia during surgery and recovery/intensive care.

The Reprieve System consists of a single-use, heparin-coated, central venous catheter; a single-use, heat exchange cassette; an integrated temperature probe; and an external controller. The Controller unit has a user interface to select operating parameters and is connected to the Catheter via the Cassette and extension lines. The catheter is designed for placement in the inferior vena cava via the femoral vein using a 12 Fr hemostatic introducer sheath.

The provided document is a 510(k) summary for the Reprieve® Endovascular Temperature Therapy System. It describes the device, its intended use, and its equivalence to a predicate device. However, it does not include detailed acceptance criteria or a study proving the device meets specific performance metrics in the way your request outlines (e.g., sensitivity, specificity, or performance against a set of statistical targets for a diagnostic device).

This document focuses on establishing substantial equivalence based on technological characteristics and the successful completion of general performance and safety tests, rather than a clinical trial demonstrating specific performance outcomes against a predefined set of acceptance criteria for diagnostic accuracy.

Here's a breakdown based on the information available and what is missing:

1. Table of Acceptance Criteria and Reported Device Performance

This information is not present in the provided 510(k) summary. The document states:
"The Reprieve Endovascular Temperature Therapy System has been tested for system performance." and "Based upon the successful completion of performance verification tests and the comparison to the predicate devices, the Radiant Medical Reprieve Endovascular Temperature Therapy System performs with safety and effectiveness equivalent to the predicate device."

This indicates that some performance tests were conducted to demonstrate safety and effectiveness, but the specific acceptance criteria (e.g., target temperature range, heating/cooling rates, or a numerical accuracy metric) and the quantitative results against those criteria are not detailed in this summary. Instead, it relies on demonstrating equivalence to a predicate device.

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

This information is not present. The 510(k) summary refers to "performance verification tests" but does not specify the sample size, type (e.g., in-vitro, ex-vivo, clinical), or data provenance (country, retrospective/prospective) of any test sets used.

3. Number of Experts Used to Establish Ground Truth and Qualifications

This information is not applicable/not present. The device is a thermal regulating system, not a diagnostic device that requires expert interpretation to establish a "ground truth" for a test set in the way a diagnostic AI would. The performance tests would likely focus on objective measurements of temperature regulation, safety, and functionality according to engineering standards.

4. Adjudication Method for the Test Set

This information is not applicable/not present for the same reasons as #3.

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

No, a MRMC study was not done. This type of study is relevant for diagnostic devices where human readers interpret images or data, and the AI's impact on their performance is being evaluated. The Reprieve® System is a thermal regulating therapy device.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

Yes, this type of "standalone" evaluation aligns with the "Performance Test" section. The document states: "The Reprieve System has been tested for system performance." and details various tests for the catheter (BS EN ISO 10555), biocompatibility (ISO 10993), sterility (ISO 11137), and electrical safety of the controller (IEC 60601). These are all standalone engineering and safety tests of the device itself. The clinical performance related to achieving normothermia would also be considered a standalone function of the device's ability to heat/cool the patient.

7. The Type of Ground Truth Used

For a thermal regulating system, the "ground truth" for performance tests would involve objective, measurable physical parameters, such as:

• Temperature measurements: Verifying the device can achieve and maintain target temperatures within specified tolerances using calibrated thermometers.
• Flow rates and pressure measurements: Ensuring fluid circulation within the system meets specifications.
• Safety parameters: Confirming the device operates without adverse events (e.g., overheating, electrical hazards).
• Biocompatibility: Testing materials for biological safety rather than clinical outcomes directly.

The document refers to adherence to international standards (e.g., ISO 10555, ISO 10993, IEC 60601), which inherently define the "ground truth" or acceptable performance against which the device is tested.

8. The Sample Size for the Training Set

This information is not applicable/not present. The Reprieve® System is a hardware medical device with embedded control logic, not an AI/ML algorithm that undergoes a training phase with a distinct training dataset in the sense of modern deep learning models. Its design and performance are based on established engineering principles and validation testing, not statistical learning from a clinical dataset (training set).

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

This information is not applicable/not present for the same reasons as #8.

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The Radiant Medical Endocatheter Temperature Probe is indicated for use with the SetPoint/Reprieve Endovascular Temperature Management System to measure core body temperature.

The Endocatheter Temperature Probe consists of a sheath containing two thermistors on separate and independent circuits. This Probe is intended for placement into the inferior vena cava through the guidewire lumen of the catheter. The outer sheath is Pebax and has a soft, straight Pebax tip. The Endocatheter Probe is heparin-coated for hemocompatibility. The intended use is to measure a patient's core body temperature via venous blood temperature. The Endocatheter Probe is for single use only. It is provided sterile and packaged in a Tyvek/polyethylene pouch. Sterilization is by gamma irradiation.

Here's an analysis of the provided text regarding the Endocatheter Temperature Probe, structured to address your specific questions about acceptance criteria and the supporting study:

The provided document does not contain a detailed study report with specific acceptance criteria or performance metrics typical of clinical trials for efficacy. Instead, it describes a 510(k) premarket notification which focuses on demonstrating substantial equivalence to a predicate device, rather than proving novel clinical effectiveness or setting new performance benchmarks.

Therefore, many of your specific questions cannot be fully answered from this document. However, I will extract what is available and indicate when information is not present.

Acceptance Criteria and Study Details for the Endocatheter Temperature Probe (K042388):

The submission primarily relies on demonstrating that the device is substantially equivalent to a legally marketed predicate device (Radiant Medical Endovascular Temperature Probe, K024327). This means the "acceptance criteria" are largely centered on meeting existing standards and showing comparable functionality and safety to the predicate, rather than achieving specific quantitative performance targets against a clinical gold standard.

1. Table of Acceptance Criteria and Reported Device Performance

Given the nature of a 510(k) summary, specific numerical acceptance criteria for performance (e.g., accuracy +/- X degrees with Y% confidence) and corresponding reported device performance values are not explicitly stated in this document in a tabular format. The "acceptance criteria" are implied by the performance tests conducted and the comparison to the predicate device.

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

• Sample Size for the Test Set: Not specified. The document mentions "performance verification tests" but does not detail the number of units tested or if any human subject testing was part of this verification.
• Data Provenance: The tests were conducted internally by Radiant Medical, Inc. The document does not specify country of origin for any human data (if collected) or indicate if the study was retrospective or prospective. It implies bench testing and potentially in vitro or animal studies for biocompatibility.

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

Not applicable/Not specified. This type of information (expert review for ground truth) is typically relevant for diagnostic imaging devices or devices where subjective expert assessment is critical. For a temperature probe, "ground truth" would likely be established against a highly accurate reference thermometer in a controlled environment, not via expert consensus.

4. Adjudication Method for the Test Set

Not applicable/Not specified. Adjudication methods (like 2+1 or 3+1) are used to resolve discrepancies in expert interpretations, which is not relevant for a device like a temperature probe that measures a biophysical parameter.

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

No, a MRMC comparative effectiveness study was not done. This type of study is typically for diagnostic devices where human readers interpret medical images or data. The Endocatheter Temperature Probe is a measurement device.

6. Standalone Performance Study (Algorithm only without human-in-the-loop)

Yes, in essence, standalone performance testing was done. The "Performance Test" section states: "The Endocatheter Temperature Probe has been tested for functionality in accordance with BS EN ISO 10555 and for biocompatibility in accordance to ISO 10993." These are standards for catheter functionality and biocompatibility, implying the device's technical performance was assessed on its own. Specific numerical results are not provided in this summary.

7. Type of Ground Truth Used

The type of ground truth used would have been against reference standards for temperature measurement (e.g., highly accurate laboratory thermometers) for functionality testing, and standard laboratory methods for assessing material biocompatibility. It would not typically involve "expert consensus," "pathology," or "outcomes data" in the traditional sense for a device like this during premarket submission.

8. Sample Size for the Training Set

Not applicable. This device is a largely electromechanical temperature probe, not an AI or machine learning algorithm. Therefore, there is no "training set" in the context of data science. The device's design and manufacturing processes are validated, not "trained."

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

Not applicable, as there is no training set.

Summary Takeaway:

This document is a 510(k) summary for a temperature probe. The primary goal of a 510(k) is to demonstrate substantial equivalence to a predicate device, focusing on safety and effectiveness without requiring new clinical trials to prove efficacy. Therefore, the details requested about clinical study designs, expert reviews, and AI-related metrics are largely absent, as they are not typically part of a 510(k) submission for this class of device. The "studies" mentioned are performance verification tests against established national/international standards (BS EN ISO 10555, ISO 10993).

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The SetPoint® Endovascular Temperature Probe is indicated for use with the SetPoint Endovascular Temperature Management System to measure core body temperature.

The SetPoint Endovascular Temperature Probe consists of a sheath containing two 400-series equivalent thermistors on separate and independent circuits. This Probe is intended for endovascular placement similar to other venous catheters with temperature measurement capability, including the Arrow International Inc. Multi-Lumen Central Venous Catheter (K904404). The outer sheath is Pebax and has a soft, straight Pebax tip. The Endovascular Probe is heparin-coated for hemocompatibility. It is compatible with a 4 Fr. introducer with Touhy-Borst hemostasis valve. The intended use is to measure a patient's core body temperature via venous blood temperature. The Endovascular Probe is for single use only. It is provided sterile and packaged in a polyethylene/Tyvek pouch. Sterilization is by gamma irradiation.

Here's a breakdown of the acceptance criteria and study information for the Radiant Medical SetPoint Endovascular Temperature Probe based on the provided document:

This document is a 510(k) summary, which typically focuses on demonstrating substantial equivalence to a predicate device rather than comprehensive de novo clinical outcome studies. Therefore, the information regarding in-depth clinical studies, expert-based ground truth, and specific acceptance criteria as might be seen for AI/ML devices, is limited.

Acceptance Criteria and Device Performance

Note: The document states the device "performs with similar safety and effectiveness" to predicate devices, but it does not define explicit numerical acceptance criteria or provide specific numerical results for the probe's temperature measurement accuracy, precision, or other performance characteristics.

1. Sample size used for the test set and the data provenance

• Sample Size: Not explicitly stated for specific performance tests. The document mentions tests for functionality and biocompatibility, but not the number of probes or samples used in these tests.
• Data Provenance: Not specified (e.g., country of origin, retrospective/prospective). These were likely bench and lab tests, not human subject clinical trials with specific patient data provenance.

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

• This type of information is not applicable to the regulatory submission for this device. The tests mentioned (functionality, biocompatibility, electrical safety) are typically engineering and laboratory-based assessments, not dependent on expert consensus or clinical interpretation for ground truth.

3. Adjudication method for the test set

• Not applicable. As the tests described are engineering and laboratory tests, an adjudication method as would be applied to subjective clinical assessments is not relevant.

4. 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

• No. This is not an AI/ML device, and no MRMC comparative effectiveness study was performed or described. This type of study is specifically for evaluating the impact of AI on human interpretation.

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

• No. This is a hardware device (temperature probe), not an algorithm. Standalone performance as defined for AI algorithms is not applicable.

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

• The ground truth for functionality would have been established by reference standards or highly accurate calibrated measurement devices (e.g., a known temperature bath for temperature accuracy, or standard test blocks for mechanical properties).
• For biocompatibility, the ground truth is established by adherence to ISO 10993 standards and their specified chemical/biological assays, rather than expert consensus on clinical images or pathology.

7. The sample size for the training set

• Not applicable. This is a traditional medical device (temperature probe) and does not involve AI/ML algorithms or a "training set" in the context of machine learning.

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

• Not applicable. As there is no training set for an AI/ML algorithm, this question is not relevant.

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The intended use of the SetPoint® System is to raise, lower, and/or maintain blood temperature. The SetPoint® System is indicated for use in cardiac surgery patients to achieve and/or maintain normothermia during surgery and recovery/intensive carc.

The SetPoint System is used to raise, lower, and/or maintain blood temperature. It consists of a single-use, heparin-coated, central venous catheter; a single-use, heat exchange cassette; an external controller; and associated accessories. The Controller unit has a user interface to select operating parameters and is connected to the Catheter via insulated lines. The catheter is designed for placement in the inforior vena cava via the femoral vein using a 10 Fr hemostatic introducer sheath. The Cassette is an integral part to the Catheter and an interface to the Controller.

The provided text is a 510(k) Summary of Safety and Effectiveness document for the SetPoint® Endovascular Temperature Management System. It describes the device, its intended use, and states that performance tests were conducted. However, the document does not contain acceptance criteria or specific details of the study that proves the device meets those criteria.

It only states:

• "The SetPoint® Endovascular Temperature Management System has been tested for system performance."
• "In addition the Catheter has been tested for functionality in accordance to the BS EN ISO 10555, for biocompatibility in accordance to ISO 10993."
• "The controller has been tested for electrical safety in accordance to EN 60601."
• "Based upon the successful performance tests and the comparison to the predicate devices, the SetPoint® Endovascular Temperature Management System consisting performs with similar safety and effectiveness."

Therefore, I cannot provide the requested information for acceptance criteria and the detailed study because it is not present in the provided text.

Based on the information provided, here's what can be answered:

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

• Not Available. The document states that performance tests were conducted and "successful," but does not list specific acceptance criteria or the numerical results of those tests.

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

• Not Available. The document mentions "performance tests" but does not specify the sample size used, the origin of the data, or whether the study was retrospective or 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. This device is a thermal management system, not an imaging or diagnostic device that typically relies on expert ground truth for classification or diagnosis. The "performance tests" would likely involve objective measurements rather than expert review.

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

• Not Applicable. Same as above, adjudication methods are typically used for diagnostic or classification tasks with expert review, which is not relevant for this type of device performance testing.

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-assisted diagnostic or imaging device, so an MRMC comparative effectiveness study involving human readers and AI assistance is not relevant.

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

• Not Applicable. This is a medical device for temperature management, not an algorithm, so "standalone" performance in the context of an algorithm is not relevant. The "system performance" tests would be considered the standalone performance of the device itself.

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

• Not Available/Not Applicable (for ground truth as in diagnostic context). For a thermal management system, "ground truth" would likely refer to objective measurement standards for temperature control, flow rates, electrical safety, and biocompatibility. The document refers to standards like BS EN ISO 10555, ISO 10993, and EN 60601, which define the methods and criteria for these objective measurements.

8. The sample size for the training set

• Not Applicable. This document describes a medical device, not a machine learning algorithm that requires a training set.

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

• Not Applicable. As this is not a machine learning algorithm, there is no training set or associated ground truth establishment process in this context.

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