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The EsoCool catheter is a thermal regulating device intended to connect to a Gentherm Blanketrol III Hyper-Hypothermia System to control the patient temperature.

The EsoCool Thermal Regulation Catheter is a dual lumen tube that is placed in the esophagus. The two lumens are connected to an external heater cooler to allow for circulation of cold or warm fluid in a closed loop system. Heater cooler control is used to modulate the fluid temperature and control of patient's temperature. The EsoCool catheter is made of polyurethane with barium sulfate for radiopacity. The EsoCool catheter is a single-use, disposable, non-implantable device with an intended duration of use of 24 hours or less.

The provided text describes the regulatory clearance of a medical device, the EsoCool Thermal Regulation Catheter, and mentions non-clinical testing performed. However, it does not detail specific acceptance criteria, reported device performance metrics in a tabular format, or information about separate test sets, experts, or ground truth establishment as typically associated with AI/ML device evaluations. The device appears to be a hardware device, not an AI/ML algorithm requiring such specific performance validation.

Therefore, many of the requested fields cannot be populated from the provided document.

Here's a breakdown of what can be gleaned:

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

The document lists types of bench and animal testing performed but does not provide specific quantitative acceptance criteria or corresponding reported device performance values. It only states that testing was done to "confirm conformance to the special controls per 21 CFR 870.5910" and that "non-clinical testing demonstrate that the device is safe and as effective as the legally marked predicate device."

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

• Sample size for bench testing: Not specified.
• Sample size for animal testing: Not specified, only refers to a "porcine animal model."
• Data provenance: The testing was "non-clinical," involving bench and animal studies. No information about country of origin is provided.

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, as this is a hardware device undergoing non-clinical bench and animal testing, not an AI/ML algorithm requiring expert ground truth for interpretation tasks.

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

Not applicable for this type of non-clinical device 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, as this is a hardware device, not an AI/ML system designed to assist human readers.

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

Not applicable, as this is a hardware device, not an AI/ML algorithm.

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

For the animal studies, the "ground truth" would be established through direct physiological measurements (temperature profiles) and histological analysis ("Gross and light microscopy assessment of the esophagus") to determine esophageal injury.

8. The sample size for the training set

Not applicable, as this is not an AI/ML device that requires a training set.

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

Not applicable, as this is not an AI/ML device that requires a training set.

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Model # ECD05-A:
The EnsoETM is a thermal regulating device, intended to:

• · connect to a Cincinnati Sub-Zero Norm-O-Temp Hyperthermia System to raise or maintain a patient's temperature,
  · allow enteral administration of fluids, and
  · provide gastric decompression and suctioning.

Model # ECD06-A
The EnsoETM is a thermal regulating device, intended to:
· connect to a Cincinnati Sub-Zero Norm-O-Temp Hyperthermia System to raise or maintain a patient's temperature, and
· provide gastric decompression and suctioning.

The EnsoETM is a multi-lumen silicone tube that is placed in the esophagus in a similar manner to a standard orogastric tube to raise or maintain a patient's temperature, while simultaneously maintaining access to the stomach to allow gastric decompression, drainage, and enteral administration of fluids, thereby maintaining the functionality of the standard orogastric tube. Raising or maintaining patient temperature is achieved by connecting the device to an external heat exchanger. Two lumens connect to the exchanger. A third central lumen connects to wall standard gastric decompression or, in some models, an enteral administration system to allow enteral administration of fluids. The device is made of standard medical-grade silicone. It is a single-use, disposable, non-implantable device with a duration of use of 72 hours or less.

The provided text is a 510(k) premarket notification for a medical device called EnsoETM. It describes the device's indications for use, technological characteristics, and non-clinical performance testing. However, it does not contain information about acceptance criteria, a specific study that proves the device meets these criteria, or details regarding the methodologies for establishing ground truth, MRMC studies, or training sets typical of studies for AI/ML-based medical devices.

The document discusses the EnsoETM, which is an esophageal thermal regulation device, not an AI/ML diagnostic or image-analysis device. The "performance testing" mentioned refers to engineering tests, specifically "coolant lumen flow rate," to demonstrate compatibility with a heat exchanger, not clinical performance in terms of diagnostic accuracy or reader improvement.

Therefore, I cannot extract the information required by your prompt regarding acceptance criteria and study details for an AI/ML device from this document. The prompt's requirements (e.g., sample size for test set, data provenance, number of experts for ground truth, MRMC studies, standalone performance, training set details) are relevant to the evaluation of AI/ML software as a medical device, which is not what this 510(k) pertains to.

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Model # ECD03-A:

The EnsoETM is a thermal regulating device, intended to:

· connect to a Gaymar Medi-Therm III Conductive HyperHypothermia System or Stryker Altrix Precision Temperature Management System to control patient temperature,

· allow enteral administration of fluids,

· and provide gastric decompression and suctioning.

Model # ECD04-A:

The EnsoETM is a thermal regulating device, intended to:

· connect to a Cincinnati Sub-Zero Blanketrol III Hyper-Hypothermia System to control patient temperature.

· allow enteral administration of fluids,

· and provide gastric decompression and suctioning.

The EnsoETM is a multi-lumen silicone tube that is placed in the esophagus in a similar manner to a standard orogastric tube to control a patient's temperature, while simultaneously maintaining access to the stomach to allow gastric decompression, drainage, and enteral administration of fluids, thereby maintaining the functionality of the standard orogastric tube. Modulation and control of patient temperature is achieved by connecting the device to an external heat exchanger. Two lumens connect to the external heat exchanger. A third central lumen connects to wall suction to allow standard gastric decompression or an enteral administration system to allow enteral administration of fluids. The device is made of standard medical-grade silicone. It is a single-use, disposable, non-implantable device with a duration of use of 72 hours or less.

The provided text describes a 510(k) premarket notification for a medical device called EnsoETM, a thermal regulating device. The purpose of the submission (K180244) is to extend the duration of use for two models, ECD03-A and ECD04-A, from 36 hours to 72 hours.

However, the document explicitly states: "No additional performance testing was conducted." This means there is no new study described within this document that "proves the device meets the acceptance criteria" for the extended duration of use.

The submission claims substantial equivalence based on existing data and the fact that the subject devices are identical to predicate devices (K172029) except for the change in duration of use, and identical to reference devices (K172493) with the same 72-hour duration of use, except for gastric lumen connector and the indication for enteral administration of fluids.

Therefore, I cannot provide the requested information about acceptance criteria and a study that proves the device meets them, as the document states no new performance testing was conducted for this particular 510(k) submission.

The tables for acceptance criteria and device performance, as well as details about sample sizes, ground truth establishment, expert adjudication, MRMC studies, or standalone performance, are not present because no new performance testing was performed and reported in this specific submission for the extended duration of use. The substantial equivalence is based on comparisons to previously cleared devices and their existing performance data.

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Model # ECD03-A:
The EnsoETM is a thermal regulating device, intended to:
• connect to a Gaymar Medi-Therm III Conductive Hyper/Hypothermia System or Stryker Altrix Precision Temperature Management System to control patient temperature,
• allow enteral administration of fluids,
• and provide gastric decompression and suctioning.

Model # ECD04-A:
The EnsoETM is a thermal regulating device, intended to:
• connect to a Cincinnati Sub-Zero Blanketrol II or Blanketrol III Hyper-Hypothermia System to control patient temperature,
• allow enteral administration of fluids,
• and provide gastric decompression and suctioning.

The EnsoETM is a multi-lumen silicone tube that is placed in the esophagus in a similar manner to a standard orogastric tube to control a patient's temperature, while simultaneously maintaining access to the stomach to allow gastric decompression, drainage, and enteral administration of fluids, thereby maintaining the functionality of the standard orogastric tube. Modulation and control of patient temperature is achieved by connecting the device to an external heat exchanger. Two lumens connect to the external heat exchanger. A third central lumen connects to wall suction to allow standard gastric decompression or an enteral administration system to allow enteral administration of fluids. The device is made of standard medical-grade silicone. It is a single-use, disposable, non-implantable device with an intended duration of use of 36 hours or less.

The provided text is a U.S. FDA 510(k) Premarket Notification document for the EnsoETM device. This document describes a medical device, its intended use, and the non-clinical performance testing conducted to demonstrate its substantial equivalence to previously cleared predicate devices.

The request asks for information relevant to the acceptance criteria and study that proves a device meets the acceptance criteria, specifically in the context of an AI/human-in-the-loop study. However, the provided document does not describe an AI/human-in-the-loop study, nor does it discuss ground truth establishment for such a study, nor does it mention AI or machine learning in any context.

The "acceptance criteria" and "device performance" described in the document relate to non-clinical performance testing of a physical medical device (EnsoETM), an esophageal thermal regulation device with capabilities for enteral fluid administration and gastric decompression. The testing described focuses on the device's physical properties, such as tensile strength, burst strength, leakage, flow rate, resistance to vacuum, and connector properties, to ensure it functions as intended and safely when used with external temperature management systems.

Therefore, I cannot fulfill the request as it pertains to AI-related acceptance criteria, MRMC studies, ground truth establishment, or training set details because this information is not present in the provided text.

I can, however, extract the acceptance criteria and demonstrated performance for the physical device's non-clinical testing as described in the document:

Based on the provided FDA 510(k) document for the EnsoETM device, here is a summary of the non-clinical performance testing and conclusions related to meeting acceptance criteria:

The "acceptance criteria" in this context are the successful demonstration that the subject devices (EnsoETM models ECD03-A and ECD04-A) meet performance requirements and are substantially equivalent to the predicate devices (EnsoETM models ECD01-A and ECD02-A), particularly with the new ENFit connector for enteral administration. The "study" refers to a series of non-clinical, laboratory-based performance tests.

1. Table of Acceptance Criteria and Reported Device Performance:

The document states that "Non-clinical performance testing was conducted to demonstrate the technological characteristics of the subject devices are substantially equivalent to the predicate devices." For each test, the "Discussion" implicitly serves as the reported device performance demonstrating that the acceptance criteria (i.e., suitability, ability to withstand pressures, prevention of leakage, capability for flow, etc.) were met.

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

The document concerns non-clinical, laboratory-based performance testing of a physical device. It does not provide specific sample sizes (e.g., number of devices tested for each parameter) or data provenance in terms of country of origin or retrospective/prospective nature, as these are typically not reported for such engineering tests in a 510(k) summary. The tests are implicit to be conducted under controlled laboratory conditions to demonstrate device performance characteristics.

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

This information is not applicable as the document describes non-clinical engineering performance testing of a physical device, not an AI or diagnostic imaging study requiring expert labeling or ground truth establishment.

4. Adjudication Method for the Test Set:

This information is not applicable as the document describes non-clinical engineering performance testing.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done:

No, an MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic devices that involve human interpretation of medical images, often with AI assistance, which is not the subject of this 510(k).

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

No, a standalone algorithm performance study was not done. This device is a physical medical device, not an algorithm.

7. The type of Ground Truth used:

This information is not applicable as the document describes non-clinical engineering performance testing. The "ground truth" for these tests would be the established engineering standards, specifications, and physical laws against which the device's performance is measured (e.g., the specified burst pressure a lumen must withstand, or the dimensional requirements of an ISO standard).

8. The sample size for the training set:

This information is not applicable as the document describes non-clinical engineering performance testing, not an AI or machine learning study.

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

This information is not applicable as the document describes non-clinical engineering performance testing, not an AI or machine learning study.

Conclusion from the document regarding meeting acceptance criteria:

The "Conclusion" section of the document states: "The results of all performance testing demonstrate the subject devices have technological characteristics that do not raise new questions of safety or effectiveness when compared to the predicate devices. Therefore, the subject devices are substantially equivalent to the predicate devices." This directly indicates that the device met the non-clinical acceptance criteria established for substantial equivalence.

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Model #ECD01-A:

The EnsoETM is a thermal regulating device, intended to:

· connect to a Gaymar Medi-Therm III Conductive Hyper/Hypothermia System or Stryker Altrix Precision Temperature Management System to control patient temperature,

· and provide gastric decompression and suctioning.

Model # ECD02-A

The EnsoETM is a thermal regulating device, intended to:

· connect to a Cincinnati Sub-Zero Blanketrol III Hyper-Hypothermia System to control patient temperature,

· and provide gastric decompression and suctioning.

The EnsoETM is a multi-lumen silicone tube that is placed in the esophagus in a similar manner to a standard orogastric tube to modulate a patient's temperature, while simultaneously maintaining access to the stomach to allow gastric decompression and drainage, thereby maintaining the functionality of the standard orogastric tube. Modulation and control of patient temperature is achieved by connecting the EnsoETM to an external heat exchanger. Two lumens connect to the external heat exchanger. A third central lumen connects to wall suction and is used for standard gastric decompression. The EnsoETM is made of standard medical-grade silicone. It is a single-use, disposable, non-implantable device with an intended duration of use of 72 hours or less.

The provided document is a 510(k) summary for the EnsoETM device, focusing on an increase in the intended duration of use from 36 hours to 72 hours. This is an important distinction. The core function and safety of the device for its initial duration have already been established in previous 510(k) submissions (K170009 and K152450).

Therefore, the "acceptance criteria" and "study that proves the device meets the acceptance criteria" in this context are specifically related to the extended duration of use, rather than the initial performance of the device as a thermal regulating and gastric decompression tool.

Based on the provided text, here is the information:

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

The document does not explicitly state quantitative acceptance criteria for safety and effectiveness related to the extended duration of use. Instead, it refers to demonstrating that the device is "safe and effective" for 72 hours through a retrospective analysis of real-world human use data.

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

• Sample Size: 18 patients
• Data Provenance:
  • Country of Origin: Not specified in the provided text.
  • Retrospective or Prospective: Retrospective analysis of real-world human use data.

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

The document does not specify the number of experts or their qualifications used to establish ground truth for this retrospective analysis. Given it's a safety and effectiveness assessment for extended use, the "ground truth" would likely be based on clinical outcomes observed in the patients (e.g., lack of adverse events, continued functionality). This is not explicitly defined in terms of expert consensus for image or data interpretation, as might be the case for an AI-based diagnostic device.

4. Adjudication method for the test set

Not applicable/not specified. This type of study (retrospective analysis of real-world use) for device duration extension doesn't typically involve an "adjudication method" in the sense of reconciling expert opinions on specific data points, as would be common in diagnostic imaging studies. The "ground truth" is derived directly from the observed clinical data.

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

No. This study is not an MRMC comparative effectiveness study. The device is a physical medical device (esophageal thermal regulation device), not an imaging AI or diagnostic tool that assists human readers.

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

Not applicable. This is a physical medical device, not an algorithm. Therefore, "standalone performance" in the context of an algorithm is not relevant. The device operates with human connection to an external heat exchanger and human placement.

7. The type of ground truth used

The ground truth was based on real-world human use data, likely encompassing clinical outcomes, adverse event reporting, and potentially device performance metrics (e.g., sustained temperature control, continued gastric decompression) collected during the extended use period in those 18 patients. It is not expert consensus, pathology, or specific outcomes data in the sense of a disease diagnosis, but rather the observed clinical reality of the device's performance over an extended duration.

8. The sample size for the training set

Not applicable. This is a physical device, and the study described is a retrospective analysis for an extended duration of use. There is no "training set" in the context of machine learning or AI algorithm development. The "training" of the device itself would have occurred during its prior development and manufacturing, and its initial clearance was based on different studies.

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

Not applicable. As explained above, there is no "training set" in the context of this 510(k) submission.

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The Esophageal Cooling Device is a thermal regulating device, intended to:

• connect to a Gaymar Medi-Therm III Conductive Hyper/Hypothermia System or Stryker Altrix Precision Temperature Management System to control patient temperature, and
• provide gastric decompression and suctioning.

The Esophageal Cooling Device is a multi-lumen silicone tube that is placed in the esophagus in a similar manner to a standard orogastric tube to modulate a patient's temperature, while simultaneously maintaining access to the stomach to allow gastric decompression and drainage and maintain the functionality of the standard orogastric tube. Modulation and control of patient temperature is achieved by connecting the Esophageal Cooling Device to an external heat exchanger. Two lumens connect to the exchanger. A third central lumen connects to wall suction and is used for standard gastric decompression. The Esophageal Cooling Device is made of standard medical-grade silicone. It is a single-use, disposable, non-implantable device with an intended duration of use of 36 hours or less.

This document is a 510(k) premarket notification for the Esophageal Cooling Device (ECD), seeking to expand its indications for use to include compatibility with an additional external heat exchanger, the Stryker Altrix Precision Temperature Management System.

Here's a breakdown of the requested information based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state formal acceptance criteria with numerical targets. Instead, the non-clinical performance testing focuses on demonstrating an aspect suitable for maintaining thermal transfer capabilities.

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

• Sample Size: Not specified for the "Flow rate" test. The entire document refers to a single device (Esophageal Cooling Device model ECD01-A).
• Data Provenance: The testing was non-clinical performance testing. The provenance (country of origin, retrospective/prospective) is not specified, but typically non-clinical tests are conducted in a laboratory setting by the manufacturer.

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

Not applicable. This was a non-clinical performance test, likely involving engineering or technical personnel, not medical experts establishing ground truth in a clinical context.

4. Adjudication Method for the Test Set

Not applicable. This was a non-clinical performance test.

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 document describes a medical device, not an AI or imaging diagnostic tool that would typically involve human readers.

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

Not applicable. This document describes a medical device, not an algorithm. The testing focused on the device's physical performance (flow rate) in conjunction with an external system.

7. The Type of Ground Truth Used

The ground truth for the non-clinical performance testing was based on the physical properties and engineering specifications of the device and the associated external heat exchanger, specifically the objective measurement of "flow rate." It's an objective measurement rather than expert consensus, pathology, or outcomes data.

8. The Sample Size for the Training Set

Not applicable. This device does not involve a "training set" in the context of an algorithm or machine learning.

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

Not applicable as there is no training set for this type of device.

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Model #: ECD01-A:
The Esophageal Cooling Device is a thermal regulating device, intended to:

• connect to a Gaymar Medi-Therm III Conductive Hyper/Hypothermia System to control patient temperature, and
• provide gastric decompression and suctioning.

Model #: ECD02-A:
The Esophageal Cooling Device is a thermal regulating device, intended to:

• connect to a Cincinnati Sub-Zero Blanketrol II or Blanketrol III Hyper-Hypothermia System to control patient
  temperature, and
• provide gastric decompression and suctioning.

The Esophageal Cooling Device (ECD) is a multi-lumen silicone tube that is placed in the esophagus in a similar manner to a standard orogastric tube to modulate a patient's temperature, while simultaneously maintaining access to the stomach to allow gastric decompression and drainage and maintain the functionality of the standard orogastric tube. Modulation and control of patient temperature is achieved by connecting the ECD to an external heat exchanger. Two lumens connect to the external heat exchanger. A third central lumen connects to wall suction and is used for standard gastric decompression. The ECD is made of standard medical-grade silicone. It is a single-use, disposable, nonimplantable device.

The provided text is a 510(k) summary for the Esophageal Cooling Device (ECD). It details the device's characteristics, indications for use, and a comparison to a predicate device, along with a list of non-clinical performance tests. However, this document does not describe acceptance criteria for a device's performance in terms of metrics like sensitivity, specificity, accuracy, or any performance targets against a ground truth.

Instead, the "acceptance criteria" can be inferred as the successful completion of various engineering and safety tests, and the "study" is the non-clinical performance testing conducted by the manufacturer. These tests are primarily to demonstrate that the device is safe, functions as intended, and is substantially equivalent to a previously cleared device.

Therefore, many of the requested fields cannot be directly answered from the given input, as the document focuses on regulatory clearance for a physical medical device, not a diagnostic or AI-driven system that would typically undergo studies with performance metrics against a ground truth.

Here's an attempt to answer the questions based on the provided text, while acknowledging its limitations for certain categories:

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

Since this document describes a physical medical device (Esophageal Cooling Device) and the "studies" are non-clinical engineering and safety tests, the acceptance criteria are generalized to "suitability for intended use" rather than specific numerical performance metrics typically seen for diagnostic devices or AI systems.

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 does not specify sample sizes (e.g., number of devices tested) for the non-clinical performance tests. These are typically engineering tests, likely involving a small number of physical samples from manufacturing lots. Data provenance in terms of country of origin or retrospective/prospective is not applicable as these are laboratory/benchtop tests, not human studies.

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 not an imaging or diagnostic device that requires expert ground truth establishment for a test set. The "ground truth" here is based on engineering specifications and existing regulatory standards for medical device safety and performance.

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

Not applicable. This concept applies to studies where expert opinions (e.g., medical image interpretations) are being adjudicated. For engineering tests of a physical device, results are typically determined by measurement against established standards, not expert consensus or 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 not an AI-assisted diagnostic device, nor is it a device that involves "human readers."

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

Not applicable. This is a physical medical device, not an algorithm.

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

For biocompatibility, the ground truth is established by ISO 10993 standards (e.g., cell viability for cytotoxicity, irritation scores for irritation). For mechanical tests (tensile, burst, strength, leakage, vacuum, flow rate), the ground truth is established by industry-accepted engineering standards and internal specifications derived from the device's intended use and comparison to the predicate device. The ultimate "ground truth" for regulatory clearance is "substantial equivalence" to the predicate device in terms of safety and effectiveness.

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 algorithms. Its design and manufacturing are based on established engineering principles and prior device models.

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

Not applicable, as there is no "training set." The design and testing are based on engineering principles and regulatory guidances relevant to medical devices.

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The Esophageal Cooling Device is a thermal regulating device, intended to:

• · connect to a Gaymar Medi-Therm III Conductive Hyper/Hypothermia System to control patient temperature, and
• · provide gastric decompression and suctioning.

The Esophageal Cooling Device (ECD) is a silicone tube with three lumens that is placed in the esophagus (Figure 1). The intended function of the device is to control a patient's temperature. while simultaneously maintaining access to the stomach to allow gastric decompression and drainage. Modulation and control of patient temperature is intended to be achieved by connecting the ECD to an external heat exchanger and circulating temperaturecontrolled fluid (distilled water). Two lumens (the cooling lumens) connect to the external heat exchanger and are in contact with the esophageal tissues. A third central lumen connects to wall suction and is used for standard gastric decompression. A web supports the inner gastric lumen and separates the cooling lumens.

The ECD is made of standard medical-grade silicone. It is a single-use, disposable, nonimplantable device with a stated intended duration of use of 36 hours or less.

The ECD is intended to be used in conjunction with the Gaymar Medi-Therm III Conductive Hyper/Hypothermia System (cleared under K100585) with the following operating specifications:

• · Dead Head Pressure: Maximum 9 psi (62 kPa)
• Flow: Minimum 16 gallons/h (60.6 L/hr)
• · Water Temperature Control Range: 4°C 42°C

The Gaymar System supplies temperature-controlled water through a connector hose to the ECD. An accessory probe interfaces between the Gaymar System and the patient to sense patient temperature, which is displayed on the Gavmar System's control panel. The Gaymar device controls water temperature by mixing hot and cold water using hot and cold solenoid valves under microprocessor control and includes a circulating pump, heater, and refrigeration system.

Here's a summary of the acceptance criteria and the study information for the Esophageal Cooling Device, structured as requested:

Acceptance Criteria and Device Performance

Study Details for Esophageal Cooling Device

1. Sample Size and Data Provenance

• Test Set (Bench/Animal):
  • Bench Testing: The document does not specify a precise sample size (N) for each individual bench test, but refers to "final manufactured product" exposed to worst-case conditions.
  • Animal Study: 5 female domestic swine (61-70 kg).
  • Data Provenance: The animal study was published in "Resuscitation 2013; 8; p. 1619-1624" by Kulstad et al. The country of origin for the animal study is not explicitly stated in the provided text, but it's a published research study. The study was prospective in nature, involving experimental temperature modification in the animals.
• Test Set (Clinical Data Summaries):
  • Sample Size: 16 patient summaries.
  • Data Provenance: Obtained from centers outside the United States where the device is commercially available. These were summaries of therapeutic cooling, maintenance, and rewarming, making them retrospective clinical observations rather than a formal prospective clinical trial.

2. Number of Experts and Qualifications for Ground Truth (Clinical Data)

• Number of Experts: Not applicable/not specified for establishing ground truth in a formal sense. The clinical data provided consists of summaries from various centers where the device was in use. The "truth" in these summaries relates to observed temperature control and absence of reported adverse events, presumably documented by the healthcare professionals at those institutions.
• Qualifications of Experts: Not specified. The summaries were from "healthcare professionals with training in the use of orogastric tubes and the use of the Gaymar Medi-Therm III Conductive Hyper/Hypothermia System," as noted in the device limitations for general use.

3. Adjudication Method for the Test Set (Clinical Data)

• Adjudication Method: None explicitly stated. The document refers to "clinical data summaries," "reports," and "feedback from centers," implying a collection of independently generated clinical observations rather than a centralized, adjudicated test set.

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

• Was it done? No. This type of study is typically associated with diagnostic AI tools where human readers interpret cases with and without AI assistance to measure improvement. The Esophageal Cooling Device is a hardware device for therapeutic temperature management, not an interpretive diagnostic tool.
• Effect Size of Human Readers' Improvement: Not applicable, as no such study was performed or is relevant for this device.

5. Standalone Performance Study (Algorithm only)

• Was it done? Yes, a form of standalone performance was done for the device itself through the extensive bench testing and the animal study.
  • Bench Testing: Demonstrated the device's functional performance (mechanical integrity, thermal transfer, compatibility with the external system, material strength, leakage, vacuum resistance, etc.) in a controlled environment without direct human intervention beyond setting up the tests.
  • Animal Study: Evaluated the device's ability to induce, maintain, and reverse therapeutic hypothermia, as well as its safety profile (esophageal tissue integrity, gastric suctioning) in a physiological system. While humans operated the external heat exchanger, the performance measured was of the device itself and its interaction with the biological system.

6. Type of Ground Truth Used

• Bench Testing: Engineering specifications, physical measurements, and industry standards (e.g., ISO, ASTM, pre-defined thresholds for force, pressure, temperature, flow rates).
• Animal Study:
  • Tissue integrity: Pathology (gross pathological and histological analysis by a veterinary pathologist at necropsy).
  • Temperature control: Direct measurements of swine body temperature and external heat exchanger settings.
  • Gastric suctioning: Quantifiable volume of gastric fluids collected.
• Clinical Data Summaries: Physician observations, patient temperature charts, and reported adverse events/device malfunctions from clinical practice, which can be considered a form of outcomes data or reported clinical experience.

7. Sample Size for the Training Set

• Training Set: Not applicable. The document describes pre-market testing and clinical observations for a new medical device, not a machine learning algorithm that requires a "training set." The device itself is not an AI/ML algorithm. The "training" for the device would be its iterative design, engineering, and manufacturing process based on established principles, not data.

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

• Ground Truth for Training Set: Not applicable, as there is no algorithms with a training set for this device.

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