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The AtriCure Isolator Synergy EnCompass Clamp and Guide System is intended to ablate cardiac tissue during surgery.

The Isolator Synergy EnCompass Clamp and Guide System (OLH, OSH, GPM100) is a single-use electrosurgical instrument offered in two configurations: standard length jaws (OSH), and long length jaws (OLH), each with an accessory Glidepath Magnetic Guide (GPM100). All Isolator devices are configured as vascular clamps and feature clamping jaws of various lengths and curvatures. The clamp features two pairs of opposing dual electrodes, an in-line handle with syringe-type actuation and button release mechanism. When activated, the generator delivers radiofrequency (RF) energy to the linear electrodes on the insulated jaws of the device. The Operator controls the application of this RF energy by pressing the Footswitch connected to the generator. The Guide is a single-use surgical accessory designed to facilitate the guidance of surgical instruments through tissue during cardiothoracic surgical procedures. The guide has a flexible, malleable shaft, and magnetic attachment ends that connect to the metal tip of the clamp jaws inside the jaw magnet cups.

The provided FDA 510(k) clearance letter and summary for the AtriCure Isolator® Synergy™ EnCompass Clamp and Guide System (K252056) describe modifications to an existing device, rather than a novel device requiring extensive clinical or AI-based performance studies. Therefore, the "acceptance criteria" and "study that proves the device meets the acceptance criteria" are focused on demonstrating substantial equivalence to a predicate device through bench testing and non-clinical performance evaluations, rather than establishing performance against specific diagnostic accuracy or clinical outcome metrics.

The document primarily focuses on ensuring the device modifications do not negatively impact the safety and effectiveness compared to the predicate device. As such, there is no mention of AI integration, MRMC studies, or extensive human reader performance evaluations typically associated with AI/CADe devices.

Here's the breakdown of the information as requested, tailored to what is provided in this specific 510(k) summary:

Acceptance Criteria and Study Proving Device Meets Acceptance Criteria for the AtriCure Isolator® Synergy™ EnCompass Clamp and Guide System (K252056)

The acceptance criteria and supporting studies for this device are designed to demonstrate substantial equivalence to its predicate device (Isolator® Synergy™ EnCompass Clamp (OLH, OSH) and Guide (GPM100) System, K210477) following minor design and manufacturing changes. The focus is on ensuring the updated device maintains the same safety and effectiveness profile.

1. Table of Acceptance Criteria and Reported Device Performance

Since this is a substantial equivalence submission for minor modifications, the "acceptance criteria" are implied by the specific performance tests conducted to show that the modified device performs similarly to the predicate and meets relevant safety standards. The reported device performance indicates that the device met these implicit criteria.

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

• Sample Size: The document does not specify exact numerical sample sizes for each test (e.g., number of clamps tested for mechanical properties, number of cadavers for usability). It refers to "bovine tissue" for ex vivo ablation and "cadaver lab" for usability. Given the nature of a 510(k) for minor device modifications, this level of detail regarding sample size for bench testing is typical.
• Data Provenance: The studies are primarily bench testing and laboratory-based non-clinical performance studies.
  • Ex vivo ablation: "bovine tissue"
  • Usability testing: "cadaver lab"
  • Biocompatibility: In vitro and some in vivo tests (implied by ISO 10993 standards, typically not human data unless specified).
  • Sterilization: Tests conducted at Steris Isomedix Operation (Spartanburg, SC).
  • Retrospective/Prospective: Not applicable as these are laboratory and bench studies for device changes, not clinical data from patients.
  • Country of Origin of Data: Not explicitly stated for all tests, but given the manufacturer (AtriCure, Inc., Ohio, USA) and sterilization vendor location (Spartanburg, SC, USA), the direct tests were likely conducted in the USA.

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

This type of information is generally not applicable to a 510(k) submission for minor device modifications based on bench and non-clinical testing. "Ground truth" in this context refers to established scientific and engineering principles, and performance standards (e.g., ISO, IEC). For the usability study, "participants" are mentioned, implying a group of users (likely surgeons or clinical personnel) who operated the device in a simulated environment, but their number and specific qualifications beyond being "users" are not detailed.

4. Adjudication Method for the Test Set

Not applicable. As these are technical, mechanical, and biological tests, "adjudication" in the sense of expert review for ambiguous cases (like in diagnostic image interpretation studies) is not relevant. The results are objective measurements against predefined acceptance criteria.

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

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This type of study is specifically designed for evaluating the impact of a diagnostic aid (e.g., AI in image interpretation) on human reader performance. The Isolator® Synergy™ EnCompass Clamp and Guide System is an electrosurgical instrument, not a diagnostic device, and the modifications are minor, so such a study would not be relevant or required.

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

Not applicable. This device does not incorporate an AI algorithm or software that operates independently to produce a diagnostic or analytical output. All testing pertains to the physical and functional performance of the medical device itself.

7. The Type of Ground Truth Used

The "ground truth" for the performance tests conducted is based on:

• Regulatory Standards: Compliance with recognized standards like ISO 10993 (Biocompatibility), IEC 60601 (Electrical Safety), and ANSI/AAMI/ISO 11135 (Sterilization).
• Engineering Specifications: Predetermined design life, mechanical limits (e.g., force, jaw aperture), and functional requirements for the device.
• Established Medical Practice: The ability to create "transmural lesions" in tissue (ex vivo), reflecting the intended therapeutic effect.
• Predicate Device Performance: The underlying "ground truth" for demonstrating substantial equivalence is often the proven safety and effectiveness of the legally marketed predicate device. The new device must perform in a "substantially equivalent manner" in relevant aspects.

8. The Sample Size for the Training Set

Not applicable. This device is a physical electrosurgical clamp and guide system, not an AI/ML-driven software device that requires a "training set" of data.

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

Not applicable, for the same reason as point 8.

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AtriCure's cryoICE® cryoXT™ cryoablation probes are intended for use to temporarily block pain by ablating peripheral nerves performed by freezing target tissues, creating an inflammatory response (cryonecrosis).

The cryoICE® cryoXT™ probe is a sterile, single-use device designed to enable cryoablation of target nerves by allowing surgeons to surround exposed peripheral nerves with its blunt prong-shaped distal tip, and in conjunction with an AtriCure cryoICE BOX (ACM), temporarily freeze the tissue in contact with the probe tip by circulating a cryogenic agent, nitrous oxide, through the device. cryoXT is offered in one single probe length of approximately 11" (28 cm) long. The device has a flexible tubeset that consists of a gas supply tube and exhaust tube, a handle, a malleable probe which is covered by an insulating sheath and has a prong-shaped distal tip at the distal end.

The provided FDA 510(k) Clearance Letter for the cryoICE cryoXT cryoablation probe focuses on demonstrating substantial equivalence to predicate devices through comparisons of technological characteristics and non-clinical bench testing. However, it does not contain information about clinical studies with human subjects, AI/algorithm performance, ground truth establishment, or human reader performance. Therefore, I cannot fully address all points in your request.

Based on the provided document, here's the information that can be extracted:

1. Table of Acceptance Criteria and Reported Device Performance

The document describes several non-clinical bench tests performed to demonstrate performance. The acceptance criteria are stated as being "predetermined" and the device "met the predetermined acceptance criteria." However, specific quantitative acceptance criteria values and the reported quantitative performance data are not provided in this summary. Instead, a qualitative statement of meeting the criteria is given.

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

The document describes non-clinical bench testing. Therefore, there is no "test set" in the context of human data or image data. The "samples" would be individual cryoablation probes or components tested in a lab setting. The document does not specify the number of units/samples used for each of the listed bench tests.

Data Provenance: The data is from non-clinical bench testing conducted by the manufacturer, AtriCure, Inc., based in Mason, Ohio, USA. The document does not indicate if it's retrospective or prospective, as this distinction typically applies to clinical data.

3. Number of Experts Used to Establish Ground Truth and Qualifications

Not applicable. This device clearance is based on non-clinical bench testing and demonstration of substantial equivalence to existing predicate devices. It does not involve interpretation of medical images or diagnostic performance where expert ground truth would be established.

4. Adjudication Method for the Test Set

Not applicable. As stated above, this is non-clinical bench testing, not a study requiring adjudication of human data or expert interpretations.

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

No. The document describes non-clinical bench testing and comparison of technological characteristics to predicate devices. There is no mention of a human-in-the-loop study or MRMC study.

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

No. This is a physical medical device (cryoablation probe), not an AI/algorithm.

7. The Type of Ground Truth Used

For the non-clinical bench tests, "ground truth" would be established by the engineering specifications and performance targets derived from the predicate devices and general safety/performance standards for cryosurgical devices. For example, the "Iceball Performance Test" would likely have a ground truth of a specific iceball size or temperature profile, which is determined by engineering and clinical requirements of the device's function. The results are compared against these predetermined specifications.

8. The Sample Size for the Training Set

Not applicable. This a physical device, and the clearance is based on substantial equivalence and non-clinical bench testing. There is no "training set" in the context of AI or machine learning.

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

Not applicable. As above, no training set is involved.

Summary of what the document does provide regarding acceptance criteria and proof:

The document focuses on demonstrating substantial equivalence of the new cryoICE cryoXT cryoablation probe to its predicate devices (CRYO2 and CRYOS) through a comparative analysis of technological characteristics and a series of non-clinical bench tests.

• Acceptance Criteria Approach: The acceptance criteria for the bench tests were "predetermined," and the device "met the predetermined acceptance criteria ensuring substantial equivalence." The specific quantitative values for these criteria are not disclosed in this summary.
• Proof: The "study" proving the device meets the criteria consists of the successful completion of the following non-clinical bench tests: Cryogenic Performance Test, Iceball Performance Test, Mechanical Reliability Test, Pressure Cycle Withstand Test, Drop Test, Dimensional Verification Test, Biocompatibility Test, and Sterility Test.
• Conclusion: The tests demonstrated equivalence in performance and did not raise any new safety issues, leading to the conclusion that the device is substantially equivalent in fundamental design, technology, function, materials, packaging, sterilization, operating principle, and intended use to the previously cleared predicate devices.

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The AtriClip LAA Exclusion System is indicated for the exclusion of the heart's left atrial appendage, performed under direct visualization and in conjunction with other cardiac surgical procedures.

Direct visualization, in this context, requires that the surgeon is able to see the heart directly, with or without assistance from a camera, endoscope, etc., or other appropriate viewing technologies.

The AtriClip PRO-Mini LAA Exclusion System consists of a single use, sterile, self-closing, implantable Clip (AtriClip Mini) preloaded on a Single Use Clip Applier along with a Selection Guide. When closed, the Clip applies uniform pressure over the length of the Clip to ensure consistent, reproducible, and secure exclusion of the left atrial appendage (LAA). The Clip is then deployed and is left as a permanent implant, and excludes the LAA, resulting in electrical isolation of the LAA. The Clip is available in the following lengths to accommodate different sizes of LAA: 35 mm, 40 mm, 45 mm, and 50 mm. The PRO-Mini device is a disposable device with a handle, leftright and up/down articulation knobs, articulation lock, deployment tab, shaft, suture anchors, and end effector containing the AtriClip Mini.

This document outlines the FDA's clearance for the AtriClip PRO-Mini LAA Exclusion System (PROM) based on its substantial equivalence to previously cleared predicate devices. The information provided primarily focuses on the device's technical characteristics and the non-clinical bench testing performed to demonstrate this equivalence. It does not describe a study involving algorithms, AI, human readers, or clinical performance metrics that would typically have acceptance criteria like sensitivity, specificity, or AUC when evaluating diagnostic or prognostic devices.

Therefore, many of the requested sections (2-6, 8-9) are not applicable or cannot be extracted from this document as they pertain to clinical or AI/algorithm-based studies, which are not described here.

Here's the information that can be extracted or inferred from the provided text, focusing on the device's substantial equivalence through bench testing:

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

Based on the provided text, the acceptance criteria are generalized as demonstrating "equivalence in performance" and not raising "any new issues of safety." The reported performance is that the device "met the predetermined acceptance criteria." Specific quantitative acceptance criteria are not detailed in this document, nor are specific quantitative performance results.

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

This information is not provided in the document. The document refers to "bench testing," which implies laboratory-based tests rather than patient data.

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)

This information is not provided as the study is non-clinical bench testing, not a study requiring expert clinical interpretation for ground truth establishment.

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

This information is not provided as the study is non-clinical bench testing, and adjudication methods are typically used for expert clinical review of cases.

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, a multi-reader multi-case (MRMC) comparative effectiveness study was not done and is not described in this document. This document pertains to the clearance of a physical medical device (implantable clip system) based on non-clinical bench testing, not an AI or imaging device involving human readers.

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

Not Applicable. This document describes a physical medical device, not an algorithm or AI system.

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

For the non-clinical bench testing, "ground truth" would likely be established by engineering specifications, material standards, and validated testing methodologies to measure mechanical properties, reliability, and tissue interaction. The document doesn't explicitly state the methodology for establishing this "ground truth" for each bench test, but it is implied by the nature of such testing.

8. The sample size for the training set

Not Applicable. This document describes the clearance of a physical medical device based on non-clinical bench testing, not an AI or algorithm-based device that would require a training set.

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

Not Applicable. As no training set is described or implied, the establishment of its ground truth is not relevant.

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The AtriCure cryolCE BOX is a non-sterile, reusable medical device which delivers cryogenic energy, namely nitrous oxide, to AtriCure's cryo-ablation PROBES.

The AtriCure cryolCE BOX (ACM) is an electro-mechanical cryogenic surgical system that delivers a Nitrous Oxide (№0) cryo-genic energy source to a PROBE to create lines of ablation through tissue. The ACM includes single use PROBES (not part of this submission), Component and Accessories. The ACM provides controlled lesion forming temperature that is below -40°C (-40°F).

In addition to the Activation Button on the front panel of the ACM, an accessory Footswitch can also be used to activate and terminate the cryo ablation cycle.

The ACM is designed to operate only with AtriCure's PROBES. Refer to the AtriCure's PROBE Instruction for Use for detailed use and description.

The provided text is a 510(k) summary for the AtriCure cryoICE BOX (ACM) and does not contain detailed information about specific acceptance criteria or a study proving that the device meets those criteria.

However, based on the limited information available in the "V. Performance Data" section, here's what can be extracted and then what cannot be answered from the provided text:

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

The document provides a general statement in "V. Performance Data": "The AtriCure cryoICE BOX device met the predetermined acceptance criteria ensuring substantial equivalence to the previously cleared AtriCure Cryo Module."

It does not provide a specific table of acceptance criteria or detailed reported device performance. It only states that the device met the criteria.

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

This information is not provided in the document. The "Performance Data" section indicates "bench testing was conducted," but no details on sample size, data provenance, or whether it was retrospective or prospective are given.

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)

This information is not provided in the document. The device is a "Cryosurgical Unit And Accessories" and the testing mentioned is "bench testing," which typically does not involve expert-established ground truth in the context of medical image analysis or diagnostic performance.

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

This information is not provided in the document. Adjudication methods are relevant for studies involving human interpretation or subjective assessments, which are not described here for this device's performance testing.

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 information is not provided in the document. A MRMC study is relevant for assessing diagnostic performance, especially of AI/CAD systems that assist human readers. This device is a cryosurgical unit, not an AI or diagnostic imaging device, so such a study would not typically be applicable.

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

This information is not provided in the document. This concept is typically relevant for AI/algorithm performance. The device is hardware (a cryosurgical unit), and its performance would be assessed through functional bench tests, not as an "algorithm only" product.

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

This information is not provided in the document beyond the general statement that "predetermined acceptance criteria" were met during "bench testing." For a cryosurgical unit, "ground truth" would generally involve objective measurements against engineering specifications (e.g., temperature achieved, power output, flow rates) rather than clinical ground truth like pathology or outcomes data, which are more applicable to diagnostic or therapeutic devices where a direct clinical outcome is being measured against a gold standard.

8. The sample size for the training set

This information is not provided in the document. This is only relevant for machine learning or AI models, which is not applicable to the AtriCure cryoICE BOX as described.

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

This information is not provided in the document for the same reason as point 8.

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The AtriCure Isolator Synergy EnCapture Clamp is intended to ablate cardiac tissue during surgery.

The AtriCure Isolator Synergy EnCapture Clamp (referred to hereafter as CLAMP) is a single patient use electrosurgical instrument designed for use with an AtriCure RF GENERATOR. The CLAMP is used for cardiac tissue ablation. When activated, the GENERATOR delivers radiofrequency (RF) energy to the linear electrodes on the insulated jaws of the device. The Operator controls the application of this RF energy by pressing the Footswitch. The CLAMP features two pairs of opposing dual electrodes, an in-line handle with syringe-type actuation and button release mechanism. The device outer and ablative faces of the distal jaw segments have textured surfaces to increase the engagement between the jaw face and the cardiac tissue. The CLAMP is compatible with the Gidepath Tape Instrument (hereafter known as GUIDE), that is designed to attach to the fixed jaw of the CLAMP with a half turn attachment end connection. The GUIDE is a single-patient, optional component designed to facilitate the guidance of the CLAMP around target tissue during general surgical procedures.

The provided text describes a 510(k) premarket notification for the AtriCure Isolator Synergy EnCapture Ablation System (EMH). It primarily focuses on demonstrating substantial equivalence to a predicate device (Isolator Synergy Surgical Ablation System, K211311) rather than presenting a study proving a device meets specific acceptance criteria based on human expert performance in image analysis or similar tasks.

Therefore, many of the requested details about acceptance criteria for AI/image analysis devices, sample sizes for test sets, expert ground truth establishment, MRMC studies, and training sets are not applicable to this document. This document details the clearance of a surgical ablation system, which is a physical device used to ablate cardiac tissue during surgery, not a software or AI-driven diagnostic/image analysis tool.

However, I can extract and present the relevant performance data and "acceptance criteria" (in the context of substantial equivalence) as described in the provided text.

Here's an analysis of the provided text in relation to your request:

Acceptance Criteria and Study Proving Device Meets Acceptance Criteria

Context: The device in question is the "AtriCure Isolator Synergy EnCapture Ablation System (EMH)," an electrosurgical instrument for cardiac tissue ablation. The regulatory submission is a 510(k), which aims to demonstrate "substantial equivalence" to a legally marketed predicate device, not necessarily to prove absolute performance against a predefined clinical metric as one might for a novel AI diagnostic. The "acceptance criteria" here therefore relate to demonstrating this substantial equivalence through various performance tests.

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

The document doesn't provide a direct table of "acceptance criteria" with numerical performance targets in the way one would for an AI diagnostic (e.g., AUC > 0.9). Instead, it presents various non-clinical and animal studies conducted to demonstrate that the new device performs "substantially equivalent" to its predicate. The acceptance for these tests is implicitly that the device performs comparably to the predicate and raises no new safety or effectiveness concerns.

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

• In Vivo GLP Animal Study: 12 pigs were used.
  • 6 pigs for the subject device (Isolator Synergy EnCapture Ablation System EMH).
  • 6 pigs for the predicate device (Isolator Synergy Surgical Ablation System EMR2/EML2).
• Data Provenance: The study was a GLP (Good Laboratory Practice) animal study. No information about country of origin, or retrospective/prospective human data is relevant as this is an animal study for a physical device.

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

• Not Applicable. This is a physical surgical device, not an AI/image analysis product requiring human expert interpretation for ground truth. The "ground truth" in the animal study would be the physiological and pathological outcomes measured directly from the animals (e.g., "conduction block" and "macroscopic and microscopic analysis").

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

• Not Applicable. As per 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 is not an AI-assisted diagnostic device. No MRMC study was performed because the device does not involve human readers interpreting cases/images.

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:

• For the In Vivo GLP Animal Study: The ground truth was based on direct physiological outcomes (evidence of conduction block) and histopathology (macroscopic and microscopic analysis of tissue) post-ablation from the animal subjects. For the other tests (mechanical, biocompatibility, electrical safety), the "ground truth" is adherence to established engineering and safety standards.

8. The sample size for the training set:

• Not Applicable. This is a physical device, not an AI algorithm. There is no concept of a "training set" in the context of this regulatory submission.

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

• Not Applicable. As per point 8.

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The EPi-Ease™ Epicardial Access System is intended to access the epicardial surface of the heart via a subxiphoid approach.

EPi-Ease is composed of a radiopaque blunt distal tip, a distal suction port designed to draw pericardial tissue into the device, a hollow 22-gauge Tuohy needle that enables puncture of the pericardium internal to the device, and a lumen to allow for insertion of an endoscope to provide direct visualization during blunt dissection, needle puncture, and guidewire delivery. The distal suction port connects to the device handle and terminates in a standard luer connection. The needle connects to the handle and terminates in a needle actuator, which enables extension, and rotation of the encased needle a limited distance within the distal tip and provides a port for insertion of a commercially available guidewire. After puncture, the device allows passage of a standard, commercially available .014" guidewire. An additional flushing port is available using the 3-way stopcock.

The provided text describes the regulatory clearance of a medical device, the EPi-Ease™ Epicardial Access System (EAS), by the FDA. However, it does not contain information about a study involving an AI/Machine Learning algorithm or human readers. The document focuses on the mechanical and design verification and validation of a physical medical device (an epicardial access system) in comparison to a predicate device, as required for a 510(k) submission.

Therefore, I cannot provide the requested information regarding:

• A table of acceptance criteria and reported device performance related to an AI/ML study.
• Sample sizes, data provenance, number/qualifications of experts, or adjudication methods for an AI/ML test set.
• MRMC comparative effectiveness study, effect size, or standalone AI performance.
• Ground truth type, training set sample size, or how ground truth for the training set was established in the context of an AI/ML study.

The document lists "Performance Data" which refers to bench testing conducted on the physical device to ensure mechanical integrity, biocompatibility, shelf-life, etc., demonstrating substantial equivalence to a predicate device. This is a common requirement for physical medical devices and is distinct from studies required for AI/ML-driven devices.

Here's an interpretation of the "acceptance criteria" and "study" mentioned in the document for the physical device:

Acceptance Criteria and Study for the EPi-Ease™ Epicardial Access System (EAS)

The document states: "The EPi-Ease device met the predetermined acceptance criteria ensuring substantial equivalence to the predicate." The "study" here refers to the a series of bench tests, not an AI/ML performance study.

1. Table of Acceptance Criteria and Reported Device Performance (for the physical device):

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

• This information (specific sample sizes for each bench test) is not provided in the document.
• Data provenance: The testing was performed as part of the device's regulatory submission, likely at the manufacturer's facility or approved test labs. This is not "data provenance" in the sense of patient data for an AI/ML model.

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

• This is not applicable as the document describes bench testing of a physical device, not an AI/ML model requiring expert consensus for ground truth. The "ground truth" for these tests are objective measurements and established standards (e.g., ISO, ASTM).

4. Adjudication method for the test set:

• This is not applicable for the bench testing described. Test results are determined by meeting pre-specified engineering and performance specifications.

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, an MRMC study was not done. This device is a physical medical instrument, not an AI-assisted diagnostic tool.

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

• No, this is not applicable. The device is a physical instrument, not an algorithm.

7. The type of ground truth used:

• The ground truth for the bench tests are engineering specifications, material standards (e.g., ISO, ASTM), and functional performance criteria established for medical devices of this type, ensuring safety and effectiveness.

8. The sample size for the training set:

• This is not applicable. The document describes a physical device, not an AI/ML model that undergoes training.

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

• This is not applicable. There is no "training set" in the context of this device's development as described.

In summary, the provided document is a 510(k) clearance letter for a physical medical device, not an AI/Machine Learning product. Therefore, the specific questions related to AI/ML model testing and validation cannot be answered from the given text.

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The AtriClip® LAA Exclusion System is indicated for the exclusion of the heart's left atrial appendage, performed under direct visualization and in conjunction with other cardiac surgical procedures.

Direct visualization, in this context, requires that the surgeon is able to see the heart directly, with or without assistance from a camera, endoscope, etc., or other appropriate viewing technologies.

The AtriClip LAA Exclusion System consists of a single use, sterile, self-closing, implantable Clip preloaded on a Single Use Clip Applier along with a selection quide. When closed, the Clip applies uniform pressure over the length of the Clip to ensure consistent, reproducible, and secure exclusion of the left atrial appendage (LAA). The Clip is then deployed and is left as a permanent implant and excludes the LAA resulting in electrical isolation of the LAA. Preclinical animal studies (Kamohara 2005,2006) demonstrate that complete exclusion with the Clip also results in acute and chronic electrical isolation of the LAA. A human clinical study (Starck 2012) has demonstrated acute electrical isolation. Chronic electrical isolation has not been evaluated in human clinical studies. The Clip is available in the following lengths to accommodate difference sizes of LAA: 35 mm, 40 mm, 45 mm, and 50 mm. The Clip Appliers are disposable devices with a handle, shaft, suture anchors, articulation controls, and deployment loop/jaws which contain the Clip.

This document is a 510(k) premarket notification from the FDA, which focuses on demonstrating substantial equivalence of a modified medical device to a previously cleared predicate device. It explicitly states that no performance data was generated for the modified device as the changes were deemed not to significantly alter the device's design, performance, or intended use. Therefore, the document does not describe acceptance criteria for a new study or present results from such a study for the modified AtriClip LAA Exclusion System.

It states: "The proposed changes do not include any change to design or performance specifications of the AtriClip LAA Exclusion System. Additionally, the proposed changes did not modify the intended use, therefore the previously submitted bench and animal data remain valid for the AtriClip LAA Exclusion System."

This means that the substantial equivalence determination relies on the performance data of the predicate device (K210293), not new data from the modified device in this submission (K233407).

Therefore, I cannot provide the requested information about acceptance criteria or a study proving the modified device meets these criteria, as this document asserts no such new study was performed for K233407.

The document does not contain any of the following information:

• A table of acceptance criteria and reported device performance for the modified device.
• Sample size used for a test set or data provenance for a new study.
• Number of experts or their qualifications for establishing ground truth for a new study.
• Adjudication method for a new study.
• Information about a multi-reader multi-case (MRMC) comparative effectiveness study for the modified device.
• Information about a standalone performance study for the modified device.
• Type of ground truth used for a new study.
• Sample size for a training set (as no new AI/software component is mentioned).
• How ground truth for a training set was established (as no new AI/software component is mentioned).

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FOR ADULT PATIENTS
AtriCure's cryolCE cryoSPHERE+ and cryoSPHERE MAX cryoablation probes are intended for use to temporarily block pain by ablating peripheral nerves performed by freezing target tissues, creating an inflammatory response (cryonecrosis).

FOR ADOLESCENT PATIENTS
The cryolCE cryoSPHERE+ and cryoSPHERE MAX cryo-ablation probes are intended for use to temporarily block pain by ablating intercostal nerves under direct visualization* in adolescent patients of at least 12 years of age.

*Direct visualization, in this context, requires that the surgeon is able to see the targeted tissue for cryoablation directly or with assistance from a camera, endoscope or other similar optical technology.

The cryolCE cryoSPHERE+ and cryolCE cryoSPHERE MAX cryoablation probes are sterile, single use devices that achieve cryoablation of peripheral nerves by allowing a surgeon to insert the probe through an incision to reach the target tissue, place the probe tip on the target site, and in conjunction with an AtriCure Cryo Module (ACM), temporarily freeze the tissue in contact with the probe tip by circulating a cryogenic agent, nitrous oxide, through the device. The cryolCE cryoSPHERE+ and cryolCE cryoSPHERE MAX device is offered in two probe length configurations: approximately 11" and 17" long. At the distal end, the ryoICE cryoSPHERE+ and cryoICE cryoSPHERE MAX probe features an 8mm or 10mm diameter ball tip shape for each length configuration. The flexible region of the probe is malleable and is capable of being bent by the end user using an included forming tool.

The provided text is an FDA 510(k) clearance letter for the AtriCure cryoICE cryoSPHERE+ and cryoSPHERE MAX cryoablation probes. This document primarily focuses on demonstrating substantial equivalence to a predicate device rather than presenting a detailed study proving the device meets specific acceptance criteria. As such, information regarding many of the requested points (like sample size for test sets, number of experts for ground truth, MRMC studies, or training set details) is not present.

However, I can extract the available information regarding acceptance criteria and the type of study conducted to support the equivalence claim.

Acceptance Criteria and Reported Device Performance

The document states that the acceptance criteria were predetermined, and the device met these criteria, ensuring substantial equivalence. While specific numerical acceptance criteria are not detailed in the provided text, the criteria implicitly refer to demonstrating equivalence in performance, features, and safety compared to the predicate device.

Study Details Based on Provided Information:

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

   • Sample Size: Not specified. The document only lists "Reliability Testing," "Transit," "Shelf-life," "Cryogen Performance/Thermal Insulation," "Mechanical testing," "Biocompatibility," "Sterility," and "EMC" as types of tests.
   • Data Provenance: Not specified, but these are typically bench tests performed in a laboratory setting by the manufacturer. These are non-clinical bench testing.

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

   • Not applicable. This was a non-clinical bench testing study, not a clinical study involving experts defining a medical ground truth for diagnostic accuracy.

3. Adjudication method for the test set:

   • Not applicable. This was a non-clinical bench testing study.

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. This device is a cryoablation probe (surgical instrument), not an AI diagnostic tool. Therefore, MRMC studies and AI assistance metrics are not relevant to this submission.

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

   • No. This is a medical device, not a software algorithm.

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

   • For the non-clinical bench tests, the "ground truth" would be established engineering specifications, performance standards, material properties, and regulatory requirements (e.g., sterilization efficacy, biocompatibility standards).

7. The sample size for the training set:

   • Not applicable. This is a medical device, not an AI/ML algorithm requiring a training set.

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

   • Not applicable. This information is not relevant to this device type.

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The Isolator linear pen is a sterile, single use electrosurgery device intended to ablate cardiac tissue during cardiac surgery using radiofrequency (RF) energy when connected directly to the ASU/ASB or MAG in Ablation mode.

The Isolator linear pen may be used for temporary cardiac pacing, sensing, recording, and stimulation during the evaluation of cardiac arrhythmias during surgery when connected to a temporary external cardiac pacemaker or recording device.

The Isolator Transpolar Pen is a sterile, single use electrosurgery device intended to ablate cardiac tissue during cardiac surgery using radiofrequency (RF) energy. The Isolator Transpolar Pen may be used for temporary cardiac pacing, sensing, recording, and stimulation during the evaluation of cardiac arrhythmias during surgery when connected to a temporary external cardiac pacemaker or recording device.

The Coolrail® linear pen is a sterile, single use electrosurgery device intended to ablate cardiac tissue during cardiac surgery using radiofrequency (RF) energy.

The AtriCure Bipolar (Transpolar) System is intended to ablate cardiac tissue during surgery.

The AtriCure Isolator Synergy EnCompass Clamp and Guide System is intended to ablate cardiac tissue during surgery.

The AtriCure Bipolar (Transpolar) System is intended to ablate cardiac tissue during surgery.

The Isolator Linear Pen (MLP1) utilizes radiofrequency (RF) energy from a RF generator to create lines of ablation on cardiac tissue. The MLP1 device is comprised of an end effector, shaft, handle, and cable. This end effector consists of one pair of ablation electrodes separated with insulating material, with the electrodes used for the pacing and sensing functions. When the Isolator linear pen is connected to an external cardiac pacemaker or recording device, it may be used for temporary cardiac sensing, recording, stimulation, and temporary pacing during the evaluation of cardiac arrhythmias.

The Isolator Transpolar Pen (MAX1, MAX5) is a hand-held, single use bipolar surgical instrument intended for the ablation of cardiac tissue and for use by trained surgeons only. It is composed of a handpiece with a bipolar electrode configuration at its distal end with integral cable and is powered by a radiofrequency (RF) generator. When the Transpolar pen is connected to an external cardiac pacemaker or recording device, it may be used for temporary cardiac sensing, recording, stimulation, and temporary pacing during the evaluation of cardiac arrhythmias.

The Coolrail Linear Pen (MCR1) is a hand-held, single use surgical instrument intended for the ablation of cardiac tissues during cardiac surgery. The pen utilizes bipolar energy generated by a radiofrequency (RF) generator. The Coolrail linear pen is designed with internally cooled electrodes to reduce thermal heating allowing for the energy to traverse deeper and more consistently into the target tissue. The ASU delivers bipolar RF energy, which flows between the internally cooled electrodes of the Coolrail linear pen. The Operator controls the application of energy by pressing the footswitch.

The Isolator Synergy Clamps (EMR2, EML2) are single-patient use, electrosurgical instruments designed for use with a radiofrequency (RF) generator and are indicated to ablate cardiac tissue. When activated, the ASU delivers radiofrequency (RF) energy to the linear electrodes on the insulated jaws of the AtriCure Isolator Synergy Clamp. The Operator controls the application of this RF energy by pressing the Footswitch. The AtriCure Isolator Synergy Clamps feature two pairs of opposing dual electrodes, an in-line handle with syringe-type grip handle/ actuation and button release mechanisms.

The Isolator Synergy EnCompass Clamps (OLH, OSH) are a single-use electrosurgical instrument offered in two configurations: standard length jaws (OSH), and long length jaws (OLH). The AtriCure Isolator clamps feature an in-line handle with syringe-type actuation and button release mechanisms. The clamps utilize bipolar energy generated from a radiofrequency (RF) generator.

The Isolator Synergy Access Clamp (EMT1) is a handheld, single use, bipolar radiofrequency (RF) surgical instrument intended for the ablation of cardiac tissue. EMT1 is part of the AtriCure Bipolar (Transpolar) System which includes an accessory instrument guide (Glidepath Tape). The EMT1 clamp is connected via an integral cable to a radiofrequency (RF) generator.

The ASU/ASB Generator is the original RF energy source for the cleared handpieces listed above. The ASU/ASB Generator will continue to be available for use and is unchanged from the original clearances.

The Multifunctional Ablation Generator (MAG) is an alternate RF energy source to the currently cleared ASU/ASB generator for each handpiece system above. The MAG RF generator is a portable reusable device that produces and delivers monopolar and bipolar RF energy at 460 kHz. It provides a pass-thru to an external sense and pace system (feature relates to the Pen devices). The MAG consists of several circuit boards, power supplies, a power entry module, a footswitch interface, and an LCD display with an integrated touchscreen. Like the ASU/ASB generator, the main function of the MAG is to deliver and control of voltage and current output to the selected handpiece. Upon reaching a predetermined threshold (voltage and/or current relationship or a preset time), the RF generator will provide visual and audible indications to signal the end of the ablation cycle and decrease the energy level until RF is stopped or the time limit is reached. A footswitch and a Start-Stop button on the touchscreen are included in the system to start and stop RF ablation. The output of the MAG generator is designed to be equivalent to the ASU/ASB generator when connected to each handpiece listed above.

This looks like a 510(k) summary for a medical device called the AtriCure RF Pen and Clamp Handpieces, which are electrosurgical devices intended to ablate cardiac tissue. The summary is primarily aimed at demonstrating substantial equivalence to previously cleared predicate devices, with the main change being the addition of an alternative radiofrequency (RF) generator, the Multifunctional Ablation Generator (MAG).

Here's an analysis of the provided information concerning acceptance criteria and study data:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are not explicitly stated as numerical targets for performance metrics. Instead, the entire submission hinges on demonstrating equivalence to predicate devices. The "reported device performance" is the finding that the system with the MAG generator is "equivalent" to the system with the predicate ASU/ASB generator.

The tables (Table 2 to Table 7) list various technological characteristics for each specific device (Isolator Synergy Clamps EMR2 & EML2, Isolator Synergy Access System EMT1, EnCompass OLH/OSH, Isolator Transpolar Pen MAX1/5, and Multifunctional Linear Pen MLP1, Coolrail Linear Pen MCR1). For almost all features, the comparison is "Same," meaning the proposed device/system feature is identical to the current/predicate device.

The key "acceptance criteria" here implicitly are:

• Identical Intended Use: The proposed device must have the same intended use as the predicate device (verified in row 3 of each table, with minor language adjustments noted as "Equivalent - Adjusted language to align with AtriCure's other RF devices" but indicating no change in core intent).
• Equivalent RF Generator Performance: The MAG generator must demonstrate equivalent RF energy output, algorithms, frequency, and duration to the ASU/ASB generator (verified in rows 13-15 or 14-17 of each table, marked as "Equivalent" for the generator itself, and "Same" for algorithm, frequency, and duration).
• No Change in Handpiece Design: The single-use handpieces themselves must be unchanged from the predicate systems.
• Conformance to Standards: The device must meet recognized electrical safety and EMC standards (IEC 60601-1, IEC 60601-1-2, IEC 60601-2-2).
• Packaging, Sterilization, Biocompatibility: These aspects must remain the same and meet relevant standards (ISO 10993 for biocompatibility, 10-6 SAL for sterility assurance).
• System Performance Equivalence: Bench testing and ex-vivo lesion equivalency testing must confirm that system performance with the MAG generator is equivalent to performance with the ASU/ASB generator.

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

The document does not specify a numerical sample size for "test sets" in the traditional sense of clinical or statistically powered performance studies. The testing described is primarily bench testing and ex-vivo lesion equivalency testing.

• Sample Size: Not explicitly stated as a number of devices or data points from a large population. It mentions "System testing with each handpiece" which implies a representative number of each device type was tested.
• Data Provenance: The data provenance is from "Bench testing" and "ex-vivo lesion equivalency testing." This indicates the testing was done in a laboratory setting, likely on animal tissue or synthetic models, not human subjects. There is no mention of country of origin for the data, but given the company is US-based and seeking FDA clearance, the testing would generally align with US regulatory expectations and likely performed in the US or by a recognized international testing facility. The data is retrospective in the sense that it's performed to support a pre-market notification, not a prospective clinical trial.

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

This information is not provided in the document. For bench and ex-vivo testing, "ground truth" might be established by direct physical measurements or comparisons to established baselines, rather than expert interpretation of complex data like medical images. Therefore, the concept of "experts establishing ground truth" in the clinical sense is not directly applicable here.

4. Adjudication Method for the Test Set

This information is not provided and is generally not applicable to the type of bench and ex-vivo performance testing described. Adjudication methods (like 2+1 or 3+1) are typically used in studies involving human interpretation or subjective assessments where multiple experts need to agree on a "ground truth" diagnosis or outcome.

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

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study is critical for evaluating the impact of AI or new technologies on human reader performance, typically in diagnostic imaging. The device described is an electrosurgical device, and the focus of this submission is on the equivalence of a new power generator, not on changing human diagnostic performance.

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

The specific context of "standalone algorithm performance" as it relates to AI is not directly applicable here. The "algorithm" referenced (Algorithm G, B, C, L in the tables) refers to the proprietary algorithms within the RF generator controlling power output based on tissue impedance.

However, the bench testing and ex-vivo lesion equivalency testing essentially represent standalone performance of the device's ability to ablate tissue. These tests evaluate the device's technical capabilities (e.g., power output characteristics, lesion depth/quality) without human intervention beyond operating the device according to its instructions. The equivalence was demonstrated by comparing the MAG generator's performance in these standalone bench tests to the ASU/ASB generator's performance.

7. The Type of Ground Truth Used

For the bench and ex-vivo testing, the "ground truth" would be established through direct physical measurement and characterization of the ablations. This could involve:

• Physical measurements: Lesion dimensions (depth, width), temperature profiles.
• Histopathology: For ex-vivo tissue, microscopic examination to confirm lesion extent and cellular changes (though not explicitly stated, this is standard for lesion equivalency).
• Electrical measurements: Characterizing RF power output, frequency, and current delivery under various load conditions.

8. The Sample Size for the Training Set

This information is not applicable as the document describes an electrosurgical device system, not an AI/machine learning algorithm that requires a "training set" in the computational sense. The "proprietary algorithm which senses tissue impedance" within the generator would have been developed and refined through engineering processes and testing, not a machine learning training paradigm of external data.

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

This information is not applicable for the same reasons as point 8.

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