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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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