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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 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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For Adult Patients
AtriCure's Cryo2 cryo2 cryoablation probes are sterile, single use devices intended for use in the cryosurgical treatment of cardiac arrhythmias by freezing target tissues, creating an inflammatory response (cryonecrosis) that blocks the electrical conduction pathway.
The Cryo2 cryolCE cryo-ablation probes are also intended for use to temporarily block pain by ablating peripheral nerves.
For Adolescent Patients
The Cryo2 cryolCE cryo-ablation probes are intended for use to temporarily block pain by ablating intercostal nerves under direct visualization1 in adolescent patients of at least 12 years of age.
1 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.
For Adult Patients
AtriCure's cryolCE cryoSPHERE cryoablation probes are sterile, single use devices intended for use performed by freezing target tissues, creating an inflammatory response (cryonecrosis) for blocking pain by temporarily ablating peripheral nerves.
For Adolescent Patients
The cryolCE cryoSPHERE cryo-ablation probes are intended for use to temporarily block pain by ablating intercostal nerves under direct visualization1 in adolescent patients of at least 12 years of age.
1 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 cryosurgical handpiece, or cryo-ablation probe, utilized in the AtriCure Cryosurgical System is a hand held, single use, cryosurgical instrument intended for the cryosurgical treatment of cardiac surgery; it is also intended for use in blocking pain by temporarily ablatinq peripheral nerves. The cryosurgical handpiece uilizes a high-pressure cryogen (nitrous oxide, N20) to freeze target tissues, creating an inflammatory response, and ultimately, cryonerosis. The cryosurgical handpiece provides below -40°C, the temperature at which intracellular ice formation occurs which is considered lethal to cells. When high pressure nitous oxide is supplied to the cryprobe via the AtriCure Cryo Module, rapid cooling is achieved via the Joule-Thompson effect. The end effector, or cryolip, of the probe is malleable to allow access to varying anatomy and anatomical sites.
The cryo-ablation probes are comprised of a cryotip end effector, shaft, handle, thermocouple, inlet tube, and exhaust tube. The cryotip consists of an aluminum boiler and three infices distributed throughout the cryotip internally to provide uniform cooling. The 4-mm diameter, cryotip is malleable throughout its 10-cm length. A supplied forming tool can be cryotip into the desired form. The cryolip is attached to an insulated rigid shaft that allows the surgeon to adjust the exposed cryolip up to 10 cm in therapeutic length. A thermocouple is affixed to the proximal external surface of the temperatures on the console. The handle is attached to the shaft. Inlet and exhaust tubes and thermocouple wire pass through the handle and connect to the AtriCure Cryo Module (ACM).
The cryoICE PROBE is a sterile, single-use cryosurgical instrument.
The form tool facilitates bending of the malleable tip.
This PROBE was designed for treatment of cardieving controlled temperatures down to -50° to -70°C; it can also be used to temporarily block pain by ablating peripheral nerves in adolescent patients of at least 12 years of aqe.
The cryolCE cryoSPHERE cryoablation (CRYOS/CRYOS-L) probe is a single use cryablation of peripheral nerves by allowing a surgeon to insert the probe through an incision to reach the probe tip on the target site, and in conjunction with an AtriCure Cryo Module (ACM), temporarily freeze the tissue in by circulating a cryogenic agent, nitrous oxide, through the device. The CRYOS probe is offered in two probe length configurations: approximately 11" and 18" long. The probe is malleable and is capable of being bent by the end user. At the distal end, the CRYOS device features an 8 mm diameter ball tip shaped probe.
The PROBE is a single-use device offered in two configurations: standard length probe shaft (CRYOS), and extended length probe shaft (CRYOS-L). The probe shaft is malleable and supports forming by the supplied TOOL. The PROBE features a spherical 8mm cryoablation tip.

This document is a 510(k) summary for AtriCure CryoICE cryo-ablation probes (Cryo2, CryoS, CryoS-L). It focuses on the expanded indication for use in adolescent patients aged 12 and above for temporary pain unique to its use in intercostal nerves under direct visualization.

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

The document does not explicitly present a table of acceptance criteria with numerical targets. Instead, it states that clinical evidence demonstrated the use of the cryoablation probes in adolescent patients (≥ 12 years) for intercostal nerve ablation was "as safe and effective" as its use in adults. The evaluation was based on the following endpoints, implying these were the performance areas assessed:

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

The document states that AtriCure partnered with the UCSF Stanford Pediatric Device Consortium (PDC) to evaluate clinical evidence, which comprised clinical publications. The exact sample size from these publications is not specified in this summary. The data provenance (country of origin, retrospective/prospective nature) is also not explicitly stated in this summary.

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 510(k) summary. The evaluation relies on published clinical evidence rather than a dedicated expert panel for ground truth establishment within this specific submission.

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

This information is not provided in the 510(k) summary. Given that the evidence is based on clinical publications, any adjudication would have been part of the original studies, and details are not reiterated here.

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

A multi-reader multi-case (MRMC) comparative effectiveness study was not performed as this device is a physical medical instrument (cryoablation probe) and not an AI-assisted diagnostic or interpretative tool. Therefore, the concept of human readers improving with AI assistance is not applicable here.

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

This question is not applicable as the device is a physical cryoablation probe and not an algorithm.

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

The "ground truth" for the comparison of safety and effectiveness was based on outcomes data from the clinical publications. Specifically, it assessed "intraoperative or post-operative complications," "adverse events observed," and specific post-ablation conditions like "cryoablation associated numbness," "neuropathic pain," "chest wall numbness," and "post-operative pneumothorax." The comparison was against the known safety and effectiveness in adult patients.

8. The sample size for the training set

This document describes a premarket notification (510(k)) for a medical device and relies on existing clinical evidence. There is no "training set" in the context of machine learning for this type of device submission. The clinical evidence used for assessment is analogous to a validation set.

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

As there is no "training set" in the context of machine learning for this device, this question is not applicable. The clinical evidence used for evaluation was derived from existing clinical publications, where the "ground truth" (e.g., presence of complications, pain levels) would have been established within those individual studies.

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The AtriClip LAA Exclusion System is indicated for the occlusion 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 guide. When closed, the Clip applies uniform pressure over the length of the Clip to ensure consistent, reproducible, and secure occlusion of the left atrial appendage (LAA). The clip is then deployed and is left as a permanent implant. The Clip is available in the following lengths to accommodate different sizes of LAA: 35 mm, 40 mm, 45 mm, and 50 mm.

The Clip Appliers are disposable devices with a handle, shaft, suture anchors, and deployment end-effector containing the Clip.

Here's a breakdown of the acceptance criteria and study information for the AtriClip LAA Exclusion System based on the provided document:

Acceptance Criteria and Device Performance

The document does not explicitly state formal "acceptance criteria" as a pass/fail threshold. Instead, it presents performance results from clinical studies and a published literature review, which serve as evidence of the device's safety and effectiveness. The "reported device performance" in the table below is derived from these stated clinical outcomes.

Study Information

The information provided describes a combination of clinical study data and a published literature review.

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

• Total Patients Evaluated (Clinical Evidence): 129 patients
• LAA occlusion directly following Clip deployment: 129 patients
• LAA exclusion post-operatively (3-12 months): 58 patients
• Data Provenance: The document emphasizes "clinical evidence based on the multiple IDE clinical studies and published clinical literature." This suggests a combination of prospective data from AtriCure-sponsored IDE studies (e.g., IDE Stroke, Hybrid DEEP, Staged DEEP) and data from retrospective or prospective studies included in the literature review. The country of origin is not specified but is implicitly the US for the IDE studies.

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

• This information is not provided in the document. The studies refer to "LAA occlusion" and "LAA exclusion" as outcomes, but do not specify how these were determined (e.g., by human experts, imaging interpretation, etc.) nor the qualifications of those involved in assessing these outcomes.

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

• This information is not provided in the document.

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 comparative effectiveness study was not done. The device being reviewed is an implantable clip, not an AI-powered diagnostic or assistive tool for human readers. Therefore, the concept of "human readers improve with AI vs without AI assistance" is not applicable.

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

• Not applicable. The AtriClip LAA Exclusion System is a medical device (an implantable clip and applier), not an algorithm or AI system. Its performance is evaluated through its physical function in occluding the LAA in vivo.

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

• The ground truth appears to be based on clinical outcomes data from the clinical studies. For "LAA occlusion directly following Clip deployment," this would likely be immediate intraoperative assessment (visual or imaging). For "LAA exclusion post-operatively," this would typically involve follow-up imaging (e.g., transesophageal echocardiography) to confirm the complete closure or exclusion of the LAA.

8. The sample size for the training set:

• This information is not applicable/not provided as the device is not an AI/ML model that requires a training set in the conventional sense. The "training" for such a device would be its design, manufacturing, and preclinical testing phases.

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

• This information is not applicable/not provided for the same reason as above.

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The Isolator linear pen is a sterile, single use electro surgery device intended to ablate cardiac tissue during 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, 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™ linear pen System is comprised of the AtriCure® Ablation and Sensing Unit (ASU), Isolator™ linear pen (Pen), Footswitch, ASU Source Switch(ASB). The Pen is a single patient use electrosurgical instrument designed for use only with the ASU and ASB. The Pen is used to ablate cardiac tissues and as a surgical pacing and mapping tool. When the Pen is connected to the ASU, the ASU provides the bipolar radiofrequency (RF) energy flowing between both electrodes of the Pen. The Operator controls the application of this RF energy by pressing the Footswitch. When the Pen is connected to an auxiliary pace, sense, or stimulation device; the Pen is designed to provide temporary pacing or monitoring.

This document is a 510(k) premarket notification for a medical device called the "Isolator Multifunctional Linear Pen." It describes the device, its intended use, and its equivalence to a predicate device. However, it does not contain the acceptance criteria or a study demonstrating the device meets specific performance criteria in the way that would typically be presented for an AI/ML medical device.

The document focuses on demonstrating substantial equivalence to an existing predicate device (K130521) for regulatory clearance. This means the manufacturer is asserting that the new device is as safe and effective as a legally marketed device, not necessarily that it meets novel, quantifiable performance metrics against a specific clinical condition using AI/ML.

Here's what can be extracted from the document, and what is missing based on your request:

What can be found in the document:

• Device Name: Isolator Multifunctional Linear Pen
• Intended Use:
  • To ablate cardiac tissue during cardiac surgery using radiofrequency (RF) energy when connected directly to the ASU or ASB in Ablation mode.
  • 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.
• Regulatory Status: Class II medical device, Product Code OCL (Electrosurgical Cutting and Coagulation Device and Accessories).
• Predicate Device: Isolator Multifunctional Linear Pen (cleared via 510(k) K130521 on April 05, 2013).
• Comparison to Predicate Device:
  • Same intended use
  • Same operating principle
  • No changes in operating principle or performance specifications
  • Same sterilization parameters
• Performance Data (Non-clinical Bench Testing and Biocompatibility):
  • Reliability Testing (details not provided)
  • Biocompatibility Testing (in accordance with ISO 10993-1, included Cytotoxicity, Sensitization, Irritation, Systemic Toxicity, Material Mediated Pyrogen). This testing was done to assess risks of a modification to the PET material.

What is MISSING based on your request (and why):

This document is a 510(k) summary for a hardware electrosurgical device, not an AI/ML algorithm. Therefore, many of the requested elements for AI/ML device evaluation are not applicable or detailed:

1. A table of acceptance criteria and the reported device performance: Not provided in the context of specific, quantifiable clinical or AI performance metrics. The "performance data" section states "Testing determined that the Isolator Multifunctional Linear Pen conformed to design controls and product specifications," which is a general statement of compliance, not specific performance metrics.
2. Sample sized used for the test set and the data provenance: Not applicable as there's no "test set" in the context of an AI/ML algorithm evaluating data. The performance claims rely on the substantial equivalence to the predicate device and general non-clinical bench testing.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable.
4. Adjudication method for the test set: Not applicable.
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.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc): Not applicable.
8. The sample size for the training set: Not applicable.
9. How the ground truth for the training set was established: Not applicable.

In summary, this document demonstrates regulatory clearance for a traditional medical device based on substantial equivalence and general safety/performance testing, not the type of detailed AI/ML performance evaluation you've described.

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