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The ECD01 model of ensoETM™ is indicated as follows:

The ensoETM™ is a thermal regulating device, intended to:

• 1. connect to a Gaymar Medi-Therm III Conductive Hyper/Hypothermia System or Stryker Altrix Precision Temperature Management System to control patient temperature.
• 2. connect to a Gaymar Medi-Therm III Conductive Hyper/Hypothermia System or Stryker Altrix Precision Temperature Management System to reduce the likelihood of ablation-related esophageal injury resulting from radiofrequency cardiac ablation procedures, and
• 3. provide gastric decompression and suctioning.
     The ECD02 model of ensoETM™ is indicated as follows:

The ensoETM™ is a thermal regulating device, intended to:

• 1. connect to a Gentherm/Cincinnati Sub-Zero Blanketrol II or Blanketrol III Hyper-Hypothermia System to control patient temperature.
• 2. connect to a Gentherm/Cincinnati Sub-Zero Blanketrol II or Blanketrol III Hyper-Hypothermia Systemto reduce the likelihood of ablation-related esophageal injury resulting from radiofrequency cardiac ablation procedures, and
• 3. provide gastric decompression and suctioning.

The ensoETM is a multi-lumen silicone tube that is placed in the esophagus in a manner similar to a standard orogastric tube. The primary function of the ensoETM™ is to connect to an external heat exchanger to either (1) cool or warm a patient or (2) cool the esophagus to reduce the likelihood of thermal injurv after radiofrequency (RF) cardiac ablation procedures.

The external heat exchanger circulates warmed or chilled water through the two outer lumens of the ensoETMTM. One outer lumen serves as the water inflow, while the other serves as the water outflow. The distal end of the ensoETM™ contains an opening between the two outer lumens, allowing the water to circulate back to the external heat exchanger without contacting the patient.

The central lumen of the ensoETM™ is open to the stomach to allow for gastric decompression and suction.

The ensoETM™ is primarily composed of standard medical-grade silicone. The ensoETMIM is a single-use, disposable, non-implantable device with an intended duration of use of 72 hours or less.

Here's an analysis of the acceptance criteria and the studies performed for the ensoETM™ device, based on the provided text:

Acceptance Criteria and Device Performance for ensoETM™

Note: The provided text details performance criteria for various non-clinical tests and outcomes of clinical studies. It doesn't explicitly state "acceptance criteria" in a singular, consolidated table for the overall device's effectiveness. Instead, the "acceptance criteria" are embedded within the description of each test or study objective. For the purpose of this response, I will synthesize these into a comprehensive table, drawing from the study descriptions.

The primary clinical acceptance criterion for the device's new indication (reducing ablation-related esophageal injury) is implied by the clinical trial results showing a reduction in esophageal lesions, although statistical significance was not always met in individual RCTs and the pooled analysis showed a non-significant reduction.

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Sizes and Data Provenance

Clinical Trial Data:

• Test set size:
  • Riverside: 6 patients (3 control, 3 ensoETM)
  • University of Pennsylvania (Penn): 44 patients completed (22 device, 22 control)
  • St. George's University Hospitals (St. George's): 120 patients underwent endoscopy (60 control, 60 ensoETM) from a total of 188 patients
  • Pooled Analysis: 166 patients (83 control, 83 ensoETM)
• Data provenance: Prospective, randomized controlled trials (RCTs). The specific countries are not explicitly named, but university hospitals suggest the US and potentially UK (St. George's University Hospitals).

Cross-sectional Study (Primary Analysis):

• Test set size: 25,186 patients (10,962 before cooling, 14,224 after cooling).
• Data provenance: Retrospective cohorts, from 25 hospital systems (30 separate hospitals). Countries are not specified.

Cross-sectional Study (Secondary Analysis):

• Test set size: 513 patients (253 before cooling, 260 after cooling).
• Data provenance: Retrospective review, a subset of the primary analysis, from two healthcare systems (three hospitals). Countries are not specified.

3. Number of Experts and Qualifications for Ground Truth

Clinical Trials (Esophageal Injury Ground Truth):

• Number of experts: Not explicitly stated, but endoscopy was performed by clinicians at each site. The "scoring methodology" (Table 1) suggests a classification system used by the endoscopists.
• Qualifications of experts: Implied to be medical professionals qualified to perform and interpret endoscopy findings, likely gastroenterologists or cardiologists with experience in post-ablation endoscopy. Specific years of experience are not mentioned.

Cross-sectional Study (AEF & AF Recurrence Ground Truth):

• Number of experts: Data were "extracted by site investigators" for the primary AEF endpoint, and "any of four electrophysiologists" for the secondary AF recurrence endpoint.
• Qualifications of experts: Site investigators and electrophysiologists, specialized in cardiac procedures and data record review.

4. Adjudication Method for the Test Set

The text does not explicitly describe a formal adjudication method (e.g., 2+1, 3+1) for the clinical trial or cross-sectional study ground truth establishment.

• For the clinical trials, it describes "scoring methodology for each of the sites and the common score which was used to combine the results," implying a standardized grading applied by the clinicians performing the endoscopy. It does not mention independent central review or consensus adjudication for the lesions.

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

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not conducted to evaluate how much human readers improve with AI vs. without AI assistance. The ensoETM™ is a physical medical device (temperature regulation device), not an AI-powered diagnostic or assistive tool for human readers/clinicians. Therefore, this type of study is not applicable.

6. Standalone (Algorithm Only) Performance

No, a standalone (algorithm only without human-in-the-loop performance) study was not conducted. The ensoETM™ is a physical device used during a medical procedure, not an algorithm.

7. Type of Ground Truth Used

• Clinical Trials (Esophageal Injury): Ground truth was established by expert assessment via endoscopy, using a defined injury grading scheme (e.g., Zargar grading, as seen in the Riverside study, and the common scoring scheme provided in Table 1).
• Cross-sectional Study (AEF & AF Recurrence): Ground truth was based on retrospective medical records review for reported AEFs and AF recurrence rates following PVI.

8. Sample Size for the Training Set

The document does not describe a "training set" in the context of an algorithm or AI development. The studies mentioned (bench, animal, clinical trials, cross-sectional) are for validation and evaluation of the physical device's safety and effectiveness.

9. How Ground Truth for the Training Set Was Established

As there was no "training set" in the AI/algorithm sense, this question is not applicable. The device's design and initial performance were likely informed by general medical knowledge, engineering principles, and previous versions of the device, but not through an explicit "training set" for ground truth establishment in this context.

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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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