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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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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 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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The Cardioblate™ Gemini™ Surgical Ablation Device is intended to ablate cardiac tissue during cardiac surgery using radiofrequency energy. The system is indicated for use, under direct or endoscopic visualization, in surgical procedures, including minimally invasive surgical procedures.

The Cardioblate Gemini surgical ablation device (Model 49351), figure 1 below, is a handheld, single-use, bipolar, radio-frequency (RF) ablation device for use in cardiac surgery. It has a saline irrigation system to deliver fluid at the contact point between the tissue and electrode to cool the tissue during RF energy delivery. This device is intended for intermittent operation.

Model 49260 of the Cardioblate Gemini surgical ablation device is intended for use with Cardioblate 68000 Generator (figure 2), whereas Model 49351 is intended for use with the Valleylab™ FT10 Energy(figure 3), whereas model 49260 is intended for use with Cardioblate 68000 Generator(figure 3). The devices are provided sterile and nonpyrogenic, are disposable, and are for single use only. They are sterilized using ethylene oxide.

The Cardioblate Gemini-s is a bipolar electrode device that transmits radio frequency energy, generated by an external generator, between the two electrodes. The device has dual linear electrodes, 6.3 cm in length, with integral fluid delivery to the electrodes. The Gemini-s device is port accessible, intended for open or closed chest procedures to ablate tissue through resistive heating due to radiofrequency energy passing through tissue. The device is designed to reproduce the Cox-Maze lesion pattern by creating linear transmural lesions in both atria of the heart during cardiac procedures.

The Gemini-s surgical ablation device has a flexible neck design that provides the physician with the ability to access various anatomies utilizing a neck curve through the full range from 0 to 180-degree configuration.

Once the electrodes are correctly positioned, the parallel jaws lock by squeezing the handle. The electrodes have full contact with the tissue and the locking mechanism must be fully engaged to ensure accurate transmurality readings. Simultaneous with the actuation of the trigger and jaw closure is the opening of the (normally closed) fluid path to start the flow of saline. The device automatically shuts off the saline when the jaws are open and when the device is not in use.

The provided document is a 510(k) summary for the Medtronic Cardioblate Gemini-s 49260 and 49351 Surgical Ablation Devices. It states that the submission is a "Special 510(k) Notification" and that modifications were verified through "design verification testing." It also indicates that the "DFMECA file was updated along with the Risk Management File to reflect the current status and risk evaluations at the device and system level."

However, the document does not describe specific acceptance criteria and the study that proves the device meets those criteria, nor does it provide the detailed information requested in points 1-9 of your prompt.

The document focuses on demonstrating substantial equivalence to predicate devices (K121767 and K200514) based on having the same:

• intended use/indications for use
• contraindications
• operating principle
• energy type
• mechanism of action
• radiofrequency generator and delivery system
• patient contacting materials
• shelf life
• sterilization process
• dimensions
• performance
• irrigation
• electrical characteristics
• packaging configuration and materials

The only changes mentioned are "IFU updates (new warning and updated directions for use)." The document concludes that these changes "do not arise from different technological characteristics of the devices or raise different questions of safety and effectiveness."

Therefore, based solely on the provided text:

No information is available regarding specific acceptance criteria, reported device performance data, study design details (sample size, data provenance, expert involvement, adjudication), comparative effectiveness studies (MRMC), standalone performance, or training set details as requested. The document refers to "design verification testing" broadly, but does not provide any specifics about these tests, the criteria used, or the results obtained.

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

The CLAMP is a single-use electrosurgical instrument offered in two configurations: standard length jaws (OSH), and long length jaws (OLH). All Isolator devices are configured as vascular clamps and feature clamping jaws of various lengths and curvatures. The AtriCure Isolator clamps feature an in-line handle with syringe-type actuation and button release mechanisms. 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.

Here's an analysis of the provided text regarding acceptance criteria and supporting studies, formatted as per your request:

Based on the provided FDA 510(k) summary for the AtriCure Isolator® Synergy™ EnCompass Clamp (OLH, OSH) and Guide (GPM100) System (K210477), the device described is an electrosurgical cutting and coagulation device, not an AI/ML-based diagnostic device. Therefore, many of the typical acceptance criteria and study aspects you've asked about (like sensitivity, specificity, human-in-the-loop performance, expert ground truth for image data, MRMC studies, effect size of AI assistance, training set details) are not applicable or not provided in this type of submission for this medical device.

This submission focuses on demonstrating substantial equivalence to a predicate device through non-clinical performance testing. The "acceptance criteria" here refer to the pre-established benchmarks for these engineering and performance tests, rather than clinical efficacy metrics for a diagnostic algorithm.

Here's a breakdown of the available information:

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

The document states: "The Isolator Synergy EnCompass Clamp (OLH, OSH) and Guide (GPM100) met the predetermined acceptance criteria ensuring substantial equivalence to the previously cleared Isolator Synergy Dual Electrode Clamp (EMR2/EML2)." However, the specific numerical acceptance criteria for each test and the precise reported device performance against those criteria are not detailed in this summary. The summary only lists the types of tests performed.

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

• Sample Size for Test Set: Not specified for any of the individual tests. This type of detail is typically found in the full test reports, not the 510(k) summary.
• Data Provenance: The tests are "bench testing" and "Ex vivo Ablation Comparison Testing," and a "GLP Animal Study." This indicates laboratory and animal testing, not human patient data. Therefore, country of origin is not applicable in the same way as with clinical data. The studies are prospective in nature, as they involve testing the new device.

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. This device is an electrosurgical clamp, not a diagnostic imaging device requiring expert interpretation for ground truth. Ground truth for these engineering tests would be established through physical measurements, chemical analyses, and biological observations (in the animal study/biocompatibility).

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

Not applicable. This concept pertains to resolving discrepancies in expert interpretations, which is not relevant for the type of testing performed for this device.

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 a surgical instrument, not an AI-assisted diagnostic tool.

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

Not applicable. This is not an AI algorithm.

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

The "ground truth" for this type of device is established through:

• Engineering specifications and measurements (e.g., clamp force, electrical resistance, temperature).
• Ex vivo and in vivo (animal study) observations of ablation lesion quality and tissue response.
• Standardized biocompatibility tests to assess material interactions with biological systems.
• Accelerated aging for shelf life.

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.

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The AtriCure Isolator® Synergy™ Surgical Ablation System is intended to ablate cardiac tissue during surgery.

The AtriCure Isolator Synergy Surgical Ablation System is comprised of the Ablation and Sensing Unit (ASU), AtriCure Switch Matrix (ASB), an AtriCure Isolator Synergy device, and a footswitch. The AtriCure Isolator Synergy device is a single-patient use, electrosurgical instrument designed for use only with the ASU.

The AtriCure Isolator Synergy clamp is used for cardiac tissue ablation. 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.

All AtriCure Isolator Synerqy devices are configured as vascular clamps and feature clamping jaws of various lengths, curvatures and apertures; rounded jaw tips, and cables that plugs into the ASB switch matrix and ASU RF generator.

The AtriCure Isolator Synergy Clamps features two pairs of opposing dual electrodes, an in-line handle with syringetype grip handle/ actuation and button release mechanisms.

There is a Glidepath™ Tape Guide that is a single-patient use, detachable, surgical device the guidance of surgical instruments through soft tissue during general surgical procedures. The Guide is package with ISOLATOR devices that have the Attachment Tip.

The Glidepath Tape Instrument Guide is a single-patient use, surgical device designed to facilitate the guidance of surgical instruments through soft tissue during general surgical procedures.

The provided document is a 510(k) summary for the AtriCure Isolator® Synergy™ Surgical Ablation System, which describes modifications to an existing device. It focuses on demonstrating substantial equivalence to a predicate device rather than presenting a de novo study with acceptance criteria for a new device's performance.

Therefore, many of the requested details about acceptance criteria, specific performance metrics, and study designs (like MRMC or standalone) are not explicitly present in the provided text as it pertains to showing the device meets new acceptance criteria. Instead, the document discusses how the modified device meets the same requirements for safety and efficacy as the predicate device.

Here's an attempt to answer the questions based on the information available:

Acceptance Criteria and Device Performance Study for AtriCure Isolator® Synergy™ Surgical Ablation System (K211311)

The submission K211311 describes modifications to the AtriCure Isolator Synergy Clamps, specifically an alternate end effector design change to an overmold configuration. The core claim is that the modified device remains substantially equivalent to the predicate device (cleared per K110117) and meets the same requirements for safety and efficacy. Therefore, the "acceptance criteria" can be inferred as maintaining the performance characteristics of the predicate device.

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size and Data Provenance for Test Set:

The document states, "Performance testing confirmed that the Isolator Synergy Clamps meets the same requirements for safety and efficacy as the predicate Isolator Synergy Clamp." It also mentions, "the previously submitted bench and animal data remain valid for the AtriCure Isolator Synergy clamps."

• Sample Size: Not explicitly stated for specific performance tests on the modified device. The testing conducted was to confirm the modified clamps meet the same requirements as the predicate device.
• Data Provenance: Not specified, but likely proprietary internal testing data given the nature of a 510(k) submission for device modification. The reference to "previously submitted bench and animal data" suggests a combination of laboratory and animal studies, which would be prospective in nature. Country of origin is not specified.

3. Number of Experts and Qualifications for Ground Truth:

Not applicable. This is a technical device modification submission, not a study involving expert human reader interpretation of images or data to establish ground truth. The ground truth for performance characteristics (e.g., transmurality, lesion width) would be established through direct physical measurements during bench and animal testing.

4. Adjudication Method for Test Set:

Not applicable. The "test set" performance is evaluated against engineering and biological criteria (e.g., lesion characteristics, biocompatibility), not through human reader adjudication.

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

No, an MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic or screening devices where human reader performance is a key metric. This submission concerns a surgical ablation system.

6. Standalone (Algorithm Only) Performance:

Not applicable. The device is a physical electrosurgical instrument; it does not involve algorithms or AI that would have standalone performance in the context of this submission. The clamp itself has no software.

7. Type of Ground Truth Used:

The ground truth for the performance claims (e.g., transmurality, lesion width, biocompatibility) would be based on:

• Direct Physical and Biological Measurements: During bench testing and animal studies. For instance, lesion transmurality would be confirmed through histological analysis in animal models.
• Standardized Testing Protocols: Results from tests against ISO and IEC standards (e.g., ISO 10993 for biocompatibility) serve as the ground truth for those specific aspects.

8. Sample Size for the Training Set:

Not applicable. This device is not an AI/ML algorithm that requires a training set. The clinical application and underlying technology (RF ablation) are well-established.

9. How Ground Truth for Training Set Was Established:

Not applicable, as there is no training set for an AI/ML algorithm.

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The Cardioblate Gemini-s surgical ablation device is intended to ablate cardiac tissue during cardiac surgery using radiofrequency (RF) energy. The system is indicated for use, under direct or endoscopic visualization, in surgical procedures, including minimally invasive surgical procedures.

The Cardioblate Gemini-s surgical ablation device (Model 49351) is a hand-held, single-use, bipolar, radio-frequency (RF) ablation device for use in cardiac surgery. It has a saline irrigation system to deliver fluid at the contact point between the tissue and electrode to cool the tissue during RF energy delivery. This device is intended for intermittent operation.

The proposed Cardioblate Gemini-s device is intended for use with the Valleylab™ FT10 Energy Platform (VLFT10GEN) with software version 3.0.0 or higher.

The devices are provided sterile and nonpyrogenic, are disposable, and are for single use only. They are sterilized using ethylene oxide.

The Cardioblate Gemini-s is a bipolar electrode device that transmits radio frequency energy, generated by an external generator, between the two electrodes. The device has dual linear electrodes, 6.3 cm in length, with integral fluid delivery to the electrodes. The Gemini-s device is port accessible, intended for open or closed chest procedures to ablate tissue through resistive heating due to radiofrequency energy passing through tissue. The device is designed to reproduce the Cox-Maze lesion pattern by creating linear transmural lesions in both atria of the heart during cardiac procedures.

The Gemini-s surgical ablation device has a flexible neck design that provides the physician with the ability to access various anatomies utilizing a neck curve through the full range from 0 to 180-degree configuration.

Once the electrodes are correctly positioned, the parallel jaws lock by squeezing the handle. The electrodes have full contact with the tissue and the locking mechanism must be fully engaged to ensure accurate transmurality readings. Simultaneous with the actuation of the trigger and jaw closure is the opening of the (normally closed) fluid path to start the flow of saline. The device automatically shuts off the saline when the jaws are open and when the device is not in use.

The provided document is a 510(k) summary for the Medtronic Cardioblate Gemini-s Surgical Ablation Device. This document focuses on demonstrating substantial equivalence to a predicate device, rather than proving the device meets specific performance acceptance criteria for an AI/ML-enabled diagnostic device.

Therefore, the information required to answer your specific questions about acceptance criteria, study design, ground truth establishment, sample sizes for training/test sets, expert adjudication, and MRMC studies is not present in this document. This submission is for an electrosurgical device, not an AI software.

However, I can extract and structure the information that is available regarding performance testing to show what kind of "acceptance criteria" and "study" were relevant for this type of device based on its nature.

Based on the provided Medtronic 510(k) Summary for the Cardioblate Gemini-s Surgical Ablation Device (K200514), here's what can be inferred about its "acceptance criteria" and "study" for regulatory approval:

Core Principle for Approval: The primary "acceptance criterion" for this Class II device, as outlined in the 510(k) process, is demonstrating substantial equivalence to a legally marketed predicate device (K121767 Cardioblate Gemini-s Surgical Ablation Device, Model 49260). This means the device must perform as safely and effectively as the predicate, and any differences must not raise new questions of safety or effectiveness.

1. Table of Acceptance Criteria and Reported Device Performance (Inferred)

Since this is a substantial equivalence submission for an electrosurgical device, the "acceptance criteria" are not reported as quantitative metrics like sensitivity/specificity for a diagnostic AI. Instead, they are related to compliance with relevant standards and demonstrating comparable performance to the predicate.

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

• Sample Size: Not explicitly stated as a number of "cases" or "patients" in the context of an AI test set. For the benchtop lesion verification, the "sample size" would likely refer to the number of ablation attempts or tissue samples tested. This number is not provided.
• Data Provenance: The studies were non-clinical performance tests (mechanical, electrical, EMC, benchtop lesion verification, usability). They were not based on patient data in the sense of retrospective or prospective clinical studies. The "data" comes from engineering and benchtop laboratory testing.

3. Number of Experts and Qualifications for Ground Truth:

• Not Applicable: This type of submission relies on engineering and laboratory testing against established standards and predicate device performance, not expert human image interpretation to establish ground truth for an AI algorithm. Therefore, there's no mention of experts or their qualifications for ground truth establishment in this context.

4. Adjudication Method for the Test Set:

• Not Applicable: There is no "test set" in the sense of a dataset requiring human adjudication for ground truth for an AI algorithm.

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

• No: An MRMC study is relevant for evaluating the impact of an AI algorithm on human reader performance. This device is an electrosurgical tool, not an AI diagnostic, so an MRMC study was not performed or necessary.

6. If a Standalone (Algorithm Only) Performance Study was Done:

• Not Applicable: This is an electrosurgical device, not an AI algorithm. The performance studies evaluate the physical device's specifications and capabilities.

7. The Type of Ground Truth Used:

• Engineering Standards and Predicate Performance: The "ground truth" for this device's performance is compliance with established international standards (IEC 60601 series) for medical electrical equipment, and demonstrably equivalent performance to the predicate device in terms of mechanical function, electrical safety, EMC, and the ability to create lesions in a soft tissue model.

8. The Sample Size for the Training Set:

• Not Applicable: This is not an AI/ML device, so there is no "training set."

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

• Not Applicable: As there is no training set for an AI/ML model, this question does not apply.

In summary: The provided document is a 510(k) submission for a physical medical device (an electrosurgical ablation device) seeking clearance based on substantial equivalence to a predicate. The "acceptance criteria" and "studies" described primarily involve engineering and benchtop testing to demonstrate compliance with standards and comparable performance to the existing predicate device, rather than the rigorous clinical validation methodology (including AI-specific elements like ground truth establishment, expert adjudication, and MRMC studies) that would be required for an AI/ML software as a medical device (SaMD).

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The EPi-Sense Guided Coagulation System with VisiTrax is intended for the coagulation of cardiac tissue using Radiofrequency (RF) energy using thoracoscopic, and laparoscopic surgical techniques.

The EPi-Sense Guided Coagulation System with VisiTrax may be used for temporary cardiac signal sensing and recording during surgery when connected to an external recording device.

The EPi-Sense Guided Coagulation System flexible, cooled electrode device, with a suction stabilizer feature, transmits radiofrequency (RF) energy from an Electrosurgical RF Generator (nonsterile, re-useable) connected through an Instrument Cable (sterile). The device is designed to produce local tissue heating which results in coagulation of cardiac tissue. A temporary sensing electrode feature may be used with an off-the-shelf electrogram recording system with the use of an additional instrument cable (non-sterile).

The Subtle Cannula is a sterile, single-use access tool used to introduce the EPi-Sense probe into the chest cavity. The cannula is a 30 cm or 40 cm long device with a large central lumen to accommodate both the EPi-Sense probe and a commercially available laparoscope for visualization. The cannula is comprised of a distal tip, a shaft with a textured grip at the proximal end, a vacuum line and an integrated quidewire.

The Sensing Cable is a reusable, non-sterile cable that provides connection for the sensing electrodes of the EPi-Sense probe to a commercially available external electrogram recording system.

The Subtle Cannula and Sensing Cable are accessories to the EPi-Sense Guided Coagulation System.

Here's an analysis of the provided text regarding the acceptance criteria and study for the EPi-Sense Guided Coagulation System with VisiTrax:

Summary of Device and Changes:

The device in question is the EPi-Sense Guided Coagulation System with VisiTrax. The submission (K193162) is for modifications to two accessories: the Sensing Cable and the Subtle Cannula. The core EPi-Sense system itself (and its intended use) remains unchanged from its previously cleared version (K142084).

Acceptance Criteria and Device Performance (Based on the provided text):

The document states that the modified devices met "the new and existing predetermined acceptance criteria." However, it does not explicitly list the specific acceptance criteria or the reported device performance metrics in a quantitative manner. Instead, it refers to general categories of testing and compliance.

Since specific criteria and metrics are not provided in the text, a table can only indicate the categories of testing performed and the general outcome.

Detailed Study Information:

Based on the provided text, the study conducted was a design verification and validation testing for modifications made to existing accessories (Sensing Cable and Subtle Cannula) of a previously cleared device. It was not a standalone performance study of the entire system or a multi-reader, multi-case comparative effectiveness study.

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

   • Sample Size: Not explicitly stated. The document mentions "Mechanical design verification testing" but does not quantify the number of units or tests performed.
   • Data Provenance: The study was internal, conducted "per AtriCure's Quality System." There is no mention of country of origin for data or whether it was retrospective or prospective in the sense of patient data. This appears to be engineering verification testing rather than clinical study data.

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 technical design verification study, not a clinical study involving expert interpretation of data or images. Ground truth, in this context, would be engineering specifications and standards, not clinical consensus.

3. Adjudication method for the test set:

   • Not applicable for this type of technical verification testing.

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. The document explicitly states, "No changes were made in operating principle, or specifications of performance" for the core device. The testing focused on demonstrating that the modifications to the accessories did not negatively impact mechanical performance or system compatibility, and that the device still complied with a relevant electrical safety standard (IEC 60601-2-2). There is no mention of AI, human readers, or clinical effectiveness studies in this submission.

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

   • Yes, in the sense that the testing was focused on the components themselves, independent of direct clinical human-in-the-loop interaction for performance evaluation. However, it's not an "algorithm-only" study as the device is a physical electrosurgical system, not a software algorithm in the typical sense of AI/ML. The "standalone" here refers to the device being tested against specifications.

6. The type of ground truth used:

   • Engineering specifications, design controls, and recognized standards (e.g., IEC 60601-2-2). The goal was to demonstrate conformance to these predefined technical requirements and equivalency to the previously cleared predicate device's mechanical and system compatibility characteristics.

7. The sample size for the training set:

   • Not applicable. This was design verification for hardware modifications, not an AI/ML model for which a "training set" would typically be used.

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

   • Not applicable, as there was no training set in the context of an AI/ML algorithm.

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The Isolator Transpolar Pen is a sterile, single use electro surgery device intended to ablate cardiac surgery using radiofrequency (RF) energy when connected directly to the ASU Source Switch in Ablation mode. When the Pen is connected to the ASU Source Switch in Auxiliary mode, it may be used for temporary cardiac sensing, recording, stimulation, and temporary pacing during the evaluation of cardiac arrhythmias.

The Isolator linear pen is a sterile, single use electro surgery device intended to ablate cardiac surgery using radiofrequency (RF) energy when connected directly to the ASU or ASB in Ablation mode. The Isolator linear pen may be used for temporary cardiac pacing, recording, and stimulation during the evaluation of cardiac arrhythmias during surgery when connected to a temporary external cardiac pacemaker or recording device.

The Isolator Multifunctional Linear Pen (MLP1) utilizes radiofrequency (RF) energy from the RF generator (ASU) 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 Multifunctional 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 Pens (MAX1, MAX5; hereafter MAX devices) are 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 a re-usable ablation and sensing unit (ASU). When a 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 provided text is a 510(k) Premarket Notification from the FDA regarding two electrosurgical devices, the Isolator Transpolar Pen (MAX) and the Isolator Multifunctional Linear Pen (MLP1). This document primarily focuses on a proposed material change (an alternate resin for electrode separation) for these devices and demonstrates their substantial equivalence to previously cleared versions.

However, the provided document does not contain the information requested regarding acceptance criteria and the study that proves the device meets specific performance criteria. Specifically, it lacks:

• A table of acceptance criteria and reported device performance.
• Sample sizes used for a test set or training set.
• Data provenance (country of origin, retrospective/prospective).
• Number and qualifications of experts for ground truth establishment.
• Adjudication methods.
• Details of multi-reader multi-case (MRMC) comparative effectiveness studies or effect sizes.
• Standalone algorithm performance.
• The type of ground truth used (expert consensus, pathology, outcomes data, etc.) beyond general statements of "verification and validation testing."
• How ground truth was established for training or test sets.

The document states: "The Isolator Linear and Transpolar Pen devices met the predetermined acceptance criteria ensuring substantial equivalence to the previously cleared K163408 MLP1 device, and K061593 MAX device. No new safety or performance issues were raising during testing." This indicates that some performance testing was done against predetermined criteria, but the specifics of those criteria and the study results are not detailed in this publicly available 510(k) summary.

In summary, based on the provided text alone, it is not possible to answer the detailed questions about acceptance criteria and the specific study proving the device meets those criteria, as these details are not present in this document. The document focuses on demonstrating substantial equivalence primarily due to a material change, rather than providing a comprehensive performance study that would typically be required for a novel AI/software-based device.

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For models 60SF2, 60SF3, and 60SF7:
The Cardioblate CryoFlex surgical ablation system is intended for minimally invasive cardiac surgical procedures, including the treatment of cardiac arrhythmias. The Cardioblate CryoFlex 7 cm, 10 cm, and 10-S probes and the Surgical Ablation Console freeze target tissue and block the electrical conduction pathways by creating an inflammatory response and cryonecrosis.

For model 60CM1:
The Cardioblate CryoFlex Surgical Ablation System is intended for minimally invasive cardiac surgical procedures, including the treatment of cardiac arrhythmias. The Cardioblate CryoFlex Clamp and Surgical Ablation Probe and the Surgical Ablation Console freeze target tissue and block the electrical conduction pathways by creating an inflammatory response and cryonecrosis.

The Medtronic Cardioblate™ CryoFlex™ Surgical Ablation System is an argon based cryosurgical system intended for minimally invasive cardiac surgical procedures, including the treatment of cardiac arrhythmias. The Cardioblate™ CryoFlex™ 7 cm, 10 cm, and 10-S probes, the Cardioblate™ CryoFlex™ clamp, and the Cardioblate™ CryoFlex™ Ablation Console freeze target tissue and block the electrical conduction pathways by creating an inflammatory response and cryonecrosis. The system utilizes an argon-based cryogen for fast, controlled freezing.

The Cardioblate™ CryoFlex™ clamp and surgical ablation probes are single use, disposable cryoablation probes that are designed for use with the Cardioblate™ CryoFlex™ surgical ablation system. The probes include integrated thermocouple for monitoring temperature at the ablation segment. The clamp and surgical ablation probes are supplied sterile and cannot be reused or re-sterilized.

The probe's shaft and ablation segment are made of specially heat-treated stainless steel. The shaft is designed with enough malleability that the surgeon can shape it, while still maintaining enough stiffness to ensure its stability in the operating field.

The malleable ablation segment has a bellows configuration, which provides kink resistance and thermal performance. A moveable insulative sleeve on the shaft allows the surgeon to vary the size of the ablation zone.

The probe has a 3-m (10 ft) connection hose which is to be handed out of the sterile field to an operating room nurse for connection to the control panel.

This document is a 510(k) premarket notification for the Cardioblate CryoFlex Surgical Ablation System. It focuses on demonstrating substantial equivalence to a previously cleared predicate device (K123733), specifically regarding an updated connector design. As such, it does not describe a clinical study to establish performance against acceptance criteria in the context of disease diagnosis or treatment effectiveness. Instead, the "study" described is a comparison of device characteristics to establish substantial equivalence.

Here's an analysis based on the provided text, addressing your points where possible:

1. Table of Acceptance Criteria and Reported Device Performance

As this submission is for a modification (updated connector design) to a previously cleared device, the "acceptance criteria" are based on demonstrating that the modified device maintains the same fundamental characteristics and performance as the predicate. The performance is reported in terms of substantial equivalence.

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

No test set in the traditional sense of patient data is described. The "test" is a comparison of the modified device's technical specifications and functionality to the predicate device. The provenance of this comparison data is from the manufacturer, Medtronic, Inc.

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

Not applicable. There is no "ground truth" related to disease diagnosis or treatment outcome established by experts in this submission. The ground truth for the comparison is the existing design and performance of the predicate device, against which the modified device is assessed.

4. Adjudication Method for the Test Set

Not applicable. There's no clinical trial or expert review of cases described to require an adjudication method. The assessment is a direct comparison of engineering and design characteristics.

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

Not applicable. This is a 510(k) submission for a device modification, not an AI-based diagnostic or therapeutic aid requiring MRMC studies to assess human reader improvement.

6. Standalone (Algorithm Only) Performance

Not applicable. This device is a surgical ablation system, not an algorithm.

7. Type of Ground Truth Used

The "ground truth" implicitly used for this submission is the established performance and safety profile of the legally marketed predicate device (K123733). The submission aims to demonstrate that the modified device's characteristics are "substantially equivalent" to this existing ground truth.

8. Sample Size for the Training Set

Not applicable. This is a hardware modification submission, not an AI algorithm development. There is no concept of a "training set" in this context.

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 establishment for it.

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