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The esolution® Esophageal Retractor is indicated for use in patients undergoing percutaneous cardiac catheter ablation of atrial fibrillation to deviate the esophagus away from the ablation energy source and to reduce the risk of ablation-related esophageal injury.

The esolution® Esophageal Retractor is a sterile mechanical deviation device for esophageal protection during cardiac ablation procedures. This device is placed in the lumen of the esophagus to reduce the likelihood of esophageal injury or a specific adverse event during cardiac ablation procedures. The device uses mechanical means to deviate the esophagus away from the source of ablation energy. The esolution® Esophageal Retractor contains two main components: an Outer Sheath, which is placed in the esophagus prior to the initiation of the therapeutic ablation procedure and a Mechanical Deflection Device that is inserted into the Outer Sheath once the Outer Sheath has been positioned in the esophagus for the indicated atrial fibrillation ablation therapeutic care. The purpose of this 510(k) is to capture the modifications made to the esolution® Esophageal Retractor required for manufacturability including changes to materials and design.

This document is a 510(k) premarket notification summary for a medical device called the "esolution® Esophageal Retractor (Gen 2.1)". The purpose of the 510(k) submission is to demonstrate that the modified device (Gen 2.1) is substantially equivalent to a previously cleared predicate device (esolution®, DEN230006).

Acceptance Criteria and Device Performance for (esolution® Esophageal Retractor (Gen 2.1))

The document focuses on non-clinical performance data to establish substantial equivalence, primarily comparing the modified device to its predicate. The acceptance criteria are essentially the performance characteristics demonstrated by the predicate device and reproduced by the subject device.

Here's the breakdown of the acceptance criteria and reported device performance based on the provided text:

Analysis of the Study Proving Device Acceptance:

Based on the provided document, the study conducted to prove the device meets acceptance criteria is a non-clinical performance testing intended to demonstrate substantial equivalence to a predicate device.

1. Sample Size used for the test set and the data provenance:

   • Sample Size: The document does not specify the exact sample size for each non-clinical test (e.g., number of units tested for tensile strength or deflection). It broadly states, "The esolution® (Gen 2.1) was tested for biocompatibility, tensile strength, deflection, and vacuum leak."
   • Data Provenance: The data is generated from "non-clinical performance testing," which implies laboratory or bench testing. The country of origin is not explicitly stated, but the submission is to the U.S. FDA, suggesting the testing was either conducted in the U.S. or at a facility whose data is accepted by the FDA for U.S. market approval. It is inherently prospective for the Gen 2.1 device, as the testing was performed to support this specific regulatory submission.

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

   • This type of non-clinical testing (biocompatibility, mechanical performance) does not typically involve human experts in the way clinical studies for AI algorithms do for ground truth establishment. The "ground truth" here is objective physical measurements and adherence to established engineering and biocompatibility standards (e.g., ISO 10993-1, specified mechanical strengths). Therefore, there is no mention of experts establishing ground truth in the context of diagnostic performance.

3. Adjudication method for the test set:

   • Not applicable as this is non-clinical mechanical and material testing, not a diagnostic or clinical study requiring adjudication of expert interpretations.

4. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

   • No, a multi-reader multi-case (MRMC) comparative effectiveness study was not conducted or described. This type of study is relevant for AI-powered diagnostic devices where human readers (e.g., radiologists) might be assisted by AI. The esolution® Esophageal Retractor is a mechanical device, not an AI diagnostic tool.

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

   • Not applicable. This device is a mechanical medical device, not a software algorithm. The "performance" here refers to its physical and material properties, not an algorithm's output.

6. The type of ground truth used:

   • The "ground truth" for the non-clinical tests are engineering specifications, material science standards (e.g., ISO), and predefined performance thresholds (e.g., minimum tensile strength of 15N, deflection of 0.7 lbf). These are objective, measurable outcomes rather than expert consensus, pathology, or clinical outcomes data.

7. The sample size for the training set:

   • Not applicable. This device does not involve a "training set" in the context of machine learning or AI. It is a manufactured mechanical device.

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

   • Not applicable, as there is no training set mentioned or implied for this type of device.

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The esolution® Esophageal Retractor is indicated for use in patients undergoing percutaneous cardiac catheter ablation of atrial fibrillation to deviate the esophagus away from the ablation energy source and to reduce the risk of ablation-related esophageal injury.

The esolution® Esophageal Retractor is a catheter-based device designed to displace the esophagus away from the source of ablation energy during percutaneous cardiac catheter ablation procedures and to reduce the risk of ablation energy-induced esophageal injury. The esolution® Esophageal Retractor uses both mechanical force and vacuum suction to grasp the esophagus and deflect it away from the posterior wall of the left atrium in both left and right directions. The device comprises three components: (1) outer sheath, (2) inner mechanical displacement plates, and (3) handle and control knob. The distal end of the outer sheath features two eyelets for attaching a temperature probe (a temperature probe is not required for use of the esolution® Esophageal Retractor).

Here's a summary of the acceptance criteria and the study that proves the device meets them, based on the provided text:

Acceptance Criteria and Device Performance for esolution® Esophageal Retractor

1. Table of Acceptance Criteria and Reported Device Performance

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

The primary clinical effectiveness study (EASY AF Study) enrolled 120 randomized subjects who received study treatment and were followed up. Of these, 118 subjects (65 Control and 53 esolution) underwent endoscopy.
The study was a prospective, randomized, controlled, single-blinded multicenter study. The text mentions a "small pilot OUS clinical trial" and "12 medical centers" for the pivotal IDE trial, indicating multi-country (outside US) and US data provenance.

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

An Endoscopy Adjudication Committee (EAC) was used to review endoscopy images and establish the ground truth for ablation lesions and other findings.
The specific number of experts on the EAC and their detailed qualifications (e.g., number of years of experience) are not explicitly stated in the provided text.

4. Adjudication Method for the Test Set

The text states: "Images reviewed by EAC." It also says, "The Clinical Events Committee, who blindly adjudicated each adverse event." This implies a blinded independent adjudication process for both endoscopy findings and adverse events. The specific format (e.g., 2+1, 3+1) is not specified, but the involvement of an EAC and blinding suggests a robust consensus process.

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

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not explicitly described in the provided text. The study compares the device's performance against a control group (standard therapy without the device), not specifically how human readers improve with AI assistance. The esolution® Esophageal Retractor is a mechanical device, not an AI-assisted diagnostic tool for image interpretation.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

Not applicable. The esolution® Esophageal Retractor is a mechanical medical device, not an algorithm or software. Therefore, standalone algorithm performance is not relevant to this submission.

7. Type of Ground Truth Used

For the clinical study, the primary ground truth was ablation-related esophageal lesions noted on post-ablation esophageal endoscopy, characterized using the Kansas City Classification. This was adjudicated by an EAC.
For animal studies, ground truth involved gross and microscopic architecture of the esophagus.

8. Sample Size for the Training Set

Not applicable. This is a hardware medical device, not a machine learning algorithm that requires a training set. The clinical study investigated the direct effect of the device on patient outcomes rather than training an algorithm.

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

Not applicable, as there is no training set for this mechanical device.

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In Radiation Therapy, it is often necessary to create irregularly shaped fields to contour to the charing In Nation Therapy, It is often nobsoad fields can be achieved by supplementing the shaping the shaping desired treatment shape. Integral shaped that system with tertiary beam blocks. These Beam Blocks are used to further collimate and contour the treatment field.

This device is intended to be used in Radiation Therapy for creating irregularly shaping treatment fields.

This looks like a 510(k) premarket notification for a medical device. The document states that the device is "substantially equivalent" to a predicate device, meaning it doesn't introduce new safety or effectiveness issues. The following information is not available in the provided text:

• Acceptance criteria and reported device performance (no specific performance metrics or testing results are provided)
• Sample size for the test set or data provenance
• Number and qualifications of experts for ground truth
• Adjudication method
• Multi-reader multi-case (MRMC) comparative effectiveness study results
• Standalone algorithm performance
• Type of ground truth used
• Sample size for the training set
• Method for establishing ground truth for the training set

This type of submission focuses on demonstrating equivalence to an existing device rather than presenting detailed performance studies against specific acceptance criteria.

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In Radiation Therapy, it is often necessary to create irregularly shaped fields to contour to the desired treatment shape. Irregular shaped fields for electron beam cases can be achieved by supplementing the shaping ability of the treatment machine's electron collimation system with tertiary beam blocks. These Beam Blocks are inserted into the ends of the electron cones. The electron beam blocks are created from low melting point lead alloy that is poured in a molten state into a pre-cut Styrofoam form. When the molten lead alloy cools it creates a hard, lead shield custom shaped for the desired form.

This device is intended to be used in Radiation Therapy for creating irregularly shaped treatment fields in electron beam therapy. The electron beam block is mounted in the end of an electron cone and is not in contact with the patient at any time when in use. The electron beam blocks are created from low melting point lead alloy that is poured in a molten state into a pre-cut Styrofoam form. When the molten lead alloy cools it creates a hard, lead shield custom shaped for the desired form.

1. Acceptance Criteria and Reported Device Performance:

   The provided document is a 510(k) premarket notification for an "Electron Beam Field Shaping System" (K973953). This type of submission relies on demonstrating substantial equivalence to a legally marketed predicate device, rather than establishing specific performance acceptance criteria and then proving the device meets them through studies with defined metrics.

   Therefore, there is no table of acceptance criteria and reported device performance in the document as it would be found in a De Novo or PMA application. Instead, the "performance" described is in terms of similarity to the predicate device.

   The key statement regarding performance is:
   "This device is similar in design, construction, materials, intended use and performance characteristics to the predicate devices. No new issues of safety or effectiveness are introduced by using this device."

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

   No formal "test set" with a defined sample size for performance evaluation is mentioned. The submission focuses on demonstrating substantial equivalence through design and material similarity, and intended use, rather than presenting a study with a test set of data.

3. Number of Experts and Qualifications for Ground Truth:

   Not applicable. Since no formal performance study with a test set and ground truth establishment is described, there's no mention of experts or their qualifications for this purpose.

4. Adjudication Method:

   Not applicable. As no independent test set or ground truth establishment is described, there is no mention of an adjudication method.

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

   No MRMC comparative effectiveness study was conducted or reported. This submission is for a physical device (beam shaping blocks) used in radiation therapy, not an AI software system that would typically undergo such a study to evaluate human reader improvement with AI assistance.

6. Standalone Performance (Algorithm Only without Human-in-the-Loop):

   Not applicable. This device is a passive physical component in a radiation therapy system, not an algorithm or AI system. Its function is to create irregularly shaped treatment fields, and it's used in conjunction with a treatment machine and human operators.

7. Type of Ground Truth Used:

   Not applicable. The concept of "ground truth" (e.g., expert consensus, pathology, outcomes data) is not relevant to this 510(k) submission, which focuses on device design and functionality rather than diagnostic or prognostic accuracy.

8. Sample Size for the Training Set:

   Not applicable. This is not an AI or machine learning device, so there is no "training set" in the conventional sense.

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

   Not applicable. As there is no training set mentioned, there is no ground truth established for it.

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