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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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