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The Isolator ™ Transpolar™ pen is a device intended to ablate cardiac tissue during cardiac surgery using radiofrequency energy.

The Isolator Transpolar pen is a sterile, single use, electrosurgery device to be used in conjunction with an electrosurgical generator for the delivery of radiofrequency current.

This document is a 510(k) summary for the AtriCure Isolator™ Transpolar™ pen, a device intended to ablate cardiac tissue during cardiac surgery using radiofrequency energy. The submission aims to establish substantial equivalence to predicate devices rather than present a study proving the device meets specific performance acceptance criteria. Therefore, most of the requested information regarding acceptance criteria and a study to prove they are met is not available in the provided text.

Here's a breakdown of what can and cannot be provided based on the input:

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

Not available in the provided text. The submission focuses on substantial equivalence based on function, materials, and intended use, not on specific performance metrics with acceptance criteria.

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

Not available. The document states "Appropriate product testing was conducted to evaluate conformance to product specification and substantial equivalence to predicate devices." However, no details on test protocols, sample sizes, or data provenance are provided. This is typical for a 510(k) summary relying on substantial equivalence to predicate devices, where extensive clinical trials or performance testing against specific acceptance criteria might not be required if the device is sufficiently similar to existing legally marketed devices.

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. No "test set" in the context of expert-adjudicated ground truth is mentioned or implied. The focus is on technical conformity and comparison to predicate devices, not on a clinical performance study with expert evaluation.

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

Not applicable. See point 3.

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 device is an electrosurgical pen, not an AI-powered diagnostic tool. MRMC studies are used for evaluating diagnostic performance of imaging systems or AI algorithms with human readers.

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

Not applicable. This is not an algorithm or AI device.

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

Not applicable. No ground truth in this context is established as the submission relies on substantial equivalence rather than a clinical performance study with diagnostic endpoints.

8. The sample size for the training set

Not applicable. 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. This is not an AI/ML device.

Summary of Substantial Equivalence Information Provided:

The provided documents primarily serve as a 510(k) summary for regulatory clearance, focusing on demonstrating substantial equivalence to legally marketed predicate devices, rather than presenting a detailed study with specific performance acceptance criteria for a novel device.

• Predicate Devices: The Isolator™ Transpolar™ pen is deemed substantially equivalent to the Medtronic Cardioblate Pen (K013392), the Tissue Link Bipolar Sealer 2.3 (Bipolar Floating Ball) device (K032132), and the AtriCure Bipolar System (K020919).
• Basis for Substantial Equivalence: The submission states that the Isolator™ Transpolar™ pen is substantially equivalent in its:
  • Indications for use.
  • Basic overall function.
  • Materials used.
• Testing: "Appropriate product testing was conducted to evaluate conformance to product specification and substantial equivalence to predicate devices." This included biocompatibility testing in accordance with ISO 10993-1. However, specific details of these "product specifications" or the results are not provided in this summary.

In essence, the "study" proving the device meets its requirements is the demonstration that it is sufficiently similar to already cleared devices, making it "substantially equivalent." This type of submission does not typically include detailed performance acceptance criteria or a clinical study in the way might be expected for novel devices or AI algorithms.

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The Epicor Medical UltraCinch is intended for the ablation of cardiac tissue during cardiac surgery.

The items in the UltraCinch Accessory Pack are intended for use in the ablation of cardiac tissue during cardiac surgery.

Epicor Medical UltraCinch Tissue Ablation Device and Accessories

This document is a 510(k) premarket notification for the Epicor Medical UltraCinch Tissue Ablation Device and Accessories. It focuses on demonstrating substantial equivalence to previously marketed devices rather than establishing novel safety and effectiveness criteria through specific performance goals and studies.

Therefore, the requested information regarding acceptance criteria, study details, sample sizes, expert involvement, and ground truth types cannot be fully provided from the given text. This type of submission relies on showing that the new device is as safe and effective as existing legally marketed predicate devices, often by demonstrating similar technological characteristics and performance in standard tests, rather than setting and meeting new, specific quantitative acceptance criteria for a novel clinical outcome.

However, based on the provided text, here's what can be extracted and inferred:

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

The document does not specify quantitative acceptance criteria in terms of performance metrics (e.g., specific percentages, measurements, or clinical outcomes) that the device must meet. Instead, it states that "Results of in vitro testing, in vivo testing, and human clinical studies demonstrate that the Epicor Medical UltraCinch tissue ablation device and accessories are safe and effective for their intended use."

The device performance is generally reported as:

• "safe and effective for their intended use."
• "meet the requirements of ISO 10993-1." (for biocompatibility)

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

• Sample Size for Test Set: Not specified in the provided text. The document mentions "clinical studies" but does not give details about their size or structure.
• Data Provenance: Not explicitly stated. The document refers to "in vitro testing, in vivo testing, and human clinical studies." These could be retrospective or prospective, and the country of origin is not mentioned.

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

This information is not provided in the text. As this is a 510(k) submission focused on substantial equivalence, the "ground truth" (in the sense of a diagnostic or predictive AI model) is not the primary focus. The "ground truth" for the device's function would be the physical effect of ablation, which is assessed through the "in vivo testing" and "human clinical studies" mentioned in a general sense.

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

This information is not provided in the text.

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:

This is not applicable to this device. The Epicor Medical UltraCinch is a tissue ablation device, not an AI software or diagnostic imaging system that would involve human readers interpreting cases with or without AI assistance.

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

This is not applicable to this device. As explained above, this is a physical medical device for cardiac tissue ablation, not an algorithm or AI system.

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

For this type of device, the "ground truth" would likely relate to:

• Successful ablation: Confirmation of tissue destruction/modification.
• Clinical outcomes: Reduction of arrhythmias or other target conditions.
• Safety metrics: Absence of adverse events.

However, the specific methods for establishing this ground truth (e.g., pathology reports from ablated tissue, electrophysiological mapping results, long-term patient follow-up, etc.) are not detailed in the provided text.

8. The sample size for the training set:

This is not applicable as this is a physical medical device, not an AI/ML model that requires a training set. The "studies" mentioned would be for device validation, not model training.

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

This is not applicable as this is a physical medical device, not an AI/ML model that requires a training set.

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The SurgiFrost® 10 cm Cryosurgical Device plus FrostByte™ Clamp and Cryosurgical Console is intended for minimally invasive cardiac surgical procedures, including the treatment of cardiac arrhythmias. The SurgiFrost® 10 cm Cryosurgical Device plus FrostByte™ Clamp and Cryosurgical Console freezes the target tissue and blocks the electrical conduction pathways by creating an inflammatory response and cryonecrosis.

The SurgiFrost® 10 cm Cryosurgical Device plus FrostByte™ Clamp and Cryosurgical Console are intended for minimally invasive cardiac surgical procedures, including the treatment of cardiac arrhythmias. The SurgiFrost® 10 cm Cryosurgical Device plus FrostByte™ Clamp and Cryosurgical Console freezes the target tissue and blocks the electrical conduction pathways by creating an inflammatory response or cryonecrosis. The SurgiFrost® 10 cm Cryosurgical Device used with or without the FrostByte™ Clamp, Cryosurgical Console and accessories act together as a System. The system is composed of the following components: Cryosurgical Control Panel and Power Cord, Cryosurgical Console, Tank Carrier, Gas Tank Regulator and Wrench, Gas Hose, SurgiFrost® Cryosurgical Device (Single Use), FrostByte™ Clamp (Single Use), Footswitch (optional). The SurgiFrost® Cryosurgical System consists of a compact, easy-to-operate Cryosurgical Console and associated accessories that include SurgiFrost® 10 cm Cryosurgical Probe to deliver cold temperatures to the targeted tissue. The control console operates off standard 120/230 VAC (60/50 Hz) wall power and utilizes inert argon gas. The Cryosurgical Console controls a single-use, disposable SurgiFrost® Cryosurgical Probe.

The provided 510(k) summary for the CryoCath Technologies Inc. SurgiFrost® 10 cm Cryosurgical Device plus FrostByte™ Clamp and Cryosurgical Console does not contain information regarding detailed acceptance criteria or a specific study proving the device meets distinct performance thresholds.

Instead, the document states that the device is "substantially equivalent to the predicate devices based on intended use, design, materials, technological, and operational characteristics." It also mentions "Performance Testing" but provides no details about the tests performed, their results, or the acceptance criteria used.

Therefore, I cannot populate the requested table or provide the detailed information about sample sizes, ground truth establishment, expert qualifications, or MRMC studies.

Here's an analysis based on the provided text, indicating what information is not present:

1. Table of Acceptance Criteria and Reported Device Performance:

Explanation: The 510(k) summary focuses on demonstrating substantial equivalence to predicate devices rather than providing specific performance metrics against pre-defined acceptance criteria for this particular device. It doesn't detail performance endpoints such as temperature reach, cryoablation zone size, success rate of blocking electrical conduction, or any other quantifiable metrics.

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

• Sample Size for Test Set: Not mentioned.
• Data Provenance: Not mentioned.

Explanation: The document does not describe any specific "test set" or a study involving human subjects or data where performance was measured. The claim of "substantial equivalence" is typically supported by bench testing, non-clinical studies, and comparisons to the known performance of predicate devices, but the details of such tests are not provided in this summary.

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

• Number of Experts: Not mentioned.
• Qualifications of Experts: Not mentioned.

Explanation: Since no specific test set requiring expert ground truth is described, this information is absent. The regulatory approval process for these types of devices through 510(k) relies heavily on demonstrating similarity to already approved devices, rather than establishing new clinical effectiveness data requiring expert review of outcomes.

4. Adjudication Method for the Test Set:

• Adjudication Method: Not applicable/Not mentioned.

Explanation: Without a described test set requiring human assessment or outcome review, an adjudication method is not relevant or not detailed in this summary.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done:

• MRMC Study: Not mentioned.
• Effect Size of Human Reader Improvement with AI vs. without AI: Not applicable (as no AI component is described).

Explanation: This device is a cryosurgical system, not an AI-powered diagnostic or assistive tool. Therefore, an MRMC study comparing human reader performance with and without AI assistance is not relevant to this submission.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done:

• Standalone Performance: Not applicable.

Explanation: As this is a physical medical device (cryosurgical system), the concept of "standalone (algorithm only)" performance does not apply. The device's performance is inherently linked to its physical operation and use by a clinician.

7. The Type of Ground Truth Used:

• Type of Ground Truth: Not mentioned.

Explanation: Because no specific "test set" with performance outcomes is detailed, the type of ground truth used to evaluate performance is not discussed. For cryosurgical devices, ground truth for effectiveness would typically involve histological confirmation of cryonecrosis, electrophysiological evidence of conduction block, or clinical outcomes, but these are not specified as part of a formal performance study in this summary.

8. The Sample Size for the Training Set:

• Sample Size for Training Set: Not applicable/Not mentioned.

Explanation: As this is not an AI/ML device, the concept of a "training set" is not relevant.

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

• Ground Truth Establishment for Training Set: Not applicable/Not mentioned.

Explanation: As this is not an AI/ML device, the concept of establishing ground truth for a "training set" is not relevant.

Summary of the Document's Approach:

The provided 510(k) summary document focuses on establishing substantial equivalence to already legally marketed predicate devices. This regulatory pathway typically involves demonstrating that the new device has the same intended use, similar technological characteristics, and does not raise new questions of safety or effectiveness compared to the predicate. It does not generally require extensive new clinical effectiveness studies with explicit acceptance criteria and performance statistics for the new device, unless significant technological differences or new intended uses are introduced. The statement "The differences between the CryoCath devices are minor and raise no new issues of safety or effectiveness" reinforces this approach.

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The Cardima Ablation System is intended to ablate cardiac tissue during cardiac surgery using radiofrequency energy

Cardima® Ablation System

The provided text does not contain detailed information about specific acceptance criteria and a study proving the device meets them in the format requested. The document is a 510(k) summary for the Cardima Ablation System, which primarily focuses on demonstrating substantial equivalence to predicate devices for regulatory clearance.

Here's a breakdown of what can be extracted and what information is missing based on your request:

1. Table of Acceptance Criteria and Reported Device Performance

Based on the provided text, specific numerical acceptance criteria and detailed device performance metrics are NOT available. The document only states:

Missing Information:

The summary does not provide quantitative acceptance criteria (e.g., specific thresholds for ablation depth, temperature, lesion size, or success rates) or detailed performance data (e.g., actual measured ablation parameters, complication rates, success rates in a clinical context). The statement "safe and effective" is a high-level conclusion, not a detailed performance metric.

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

• Sample Size for Test Set: Not specified. The document mentions "in-vitro testing" but does not provide details on the number of samples, devices, or tests performed.
• Data Provenance: The testing appears to be in-vitro, meaning conducted in a controlled laboratory environment rather than on live subjects. The country of origin of the data is not specified, but the applicant (Cardima, Inc.) is based in Fremont, CA, USA, suggesting the testing was likely conducted in the US.

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

• Not Applicable / Not Specified. For in-vitro testing of an ablation system, "ground truth" would typically be established by physical measurements (e.g., using calipers, thermometers, oscilloscopes, or histological analysis of tissue models) rather than expert interpretation of images or clinical data. There is no mention of human experts establishing ground truth for the in-vitro performance tests described.

4. Adjudication Method for the Test Set

• Not Applicable / Not Specified. Since the ground truth for in-vitro tests is typically objective measurement, an adjudication method for human expert disagreements would not be relevant or mentioned.

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

• No. An MRMC study is relevant for diagnostic imaging devices where human readers interpret medical images. This device is an ablation system, and the reported testing is primarily in-vitro performance, not related to image interpretation by humans. No mention of such a study is made.

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

• Not Applicable / Not Specified. This device is a manual-use surgical tool, not an AI algorithm. "Standalone performance" in this context refers to the device operating as intended without human intervention for automated tasks. While the device itself operates "standalone" in delivering energy, the concept of "algorithm only" or "human-in-the-loop" performance doesn't apply as it's not an AI-driven diagnostic or automated system. The reported in-vitro testing can be considered an evaluation of the device's standalone physical performance parameters.

7. The Type of Ground Truth Used

• Physical/Objective Measurements: For "in-vitro testing," the ground truth would have been established through objective measurements of physical parameters such as temperature, energy delivery, lesion size, depth, or electrical characteristics in tissue models or non-biological materials. The specific type of measurements or the gold standard used for these measurements is not detailed in the summary.

8. The Sample Size for the Training Set

• Not Applicable / Not Specified. This device is an electrosurgical ablation system, not an AI/machine learning device that requires a "training set." Therefore, there is no training set in the context of AI.

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

• Not Applicable / Not Specified. As there's no training set for an AI algorithm, this question is not relevant to the provided document.

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