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The Thera Vision Ultrasound Ablation System, ACOUSTx Applicators, and accessories are intended for the laparoscopic, intraoperative, and percutaneous coagulation and ablation of soft tissue. It is not indicated for ablation of prostate tissue.

The TheraVision System consists of the following subsystems:

• 4.1 Computer System: The computer system consists of a PC Compatible type computer running Microsoft Windows® Operating system.
• 4.2 Visualization Options: Visualization options include utilization with compatible, legally marketed imaging systems. Patient images may be imported in DICOM format from MRI, CT, US, Fluoroscopic X-Ray, and PET-CT scanners.
• 4.3 Software: A set of user interface and display modules allow user interaction and high-level control over the system, including power generation and safety monitoring. Top-level modules provide top level menu options and implement next-generation Microsoft Windows® display functionality.
• 4.4 Thermometry System: Temperature monitoring is accomplished using an optional multichannel type T patient isolated thermocouple data acquisition system.
• 4.5 RF Generation System: A Multichannel RF power generator system provides the RF enerqy needed drive the piezoelectric transducers for generation of sufficient ultrasound acoustic energy from the applicators to raise the temperature to therapeutic levels in the targeted tissue
• 4.6 Cooling System: Degassed sterile water is pumped through the ultrasound transducers in the applicators and provides ultrasound energy coupling to tissue and also provides a means for cooling the applicator.

ACOUSTx Applicators:
The ultrasound energy generated from ACOUSTx Applicators is absorbed during treatment producing thermal therapy within the targeted tissue region. The ACOUSTx Applicators are sterile and single-use and can be utilized with the TheraVision System and may contain up to four transducers each with angular insonation patterns of 360° or 180° for application of thermal therapy.

The provided FDA 510(k) summary (K150019) describes the TheraVision™ Ultrasound Ablation System and ACOUSTx™ Applicators. The submission aims to demonstrate substantial equivalence to predicate devices, focusing on the device's ability to create comparable ablation patterns.

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

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state "acceptance criteria" in a quantitative, pre-defined manner typical for clinical trials or formal performance goals. Instead, the performance is demonstrated by showing "comparable ablation patterns and times" to predicate devices. The implicit acceptance criterion is that the device should produce ablation dimensions within a range that is considered safe and effective, and comparable to legally marketed predicate devices.

• Liver: Penetration Depth: 1.4 - 3.4 cm, Pattern Length: 1.1 - 4.7 cm
• Muscle: Penetration Depth: 1.63 - 3.4 cm, Pattern Length: 1.2 - 4.7 cm
• Kidney: Penetration Depth: 1.5 - 2.7 cm, Pattern Length: 1.1 - 2.5 cm*

180° ACOUSTx Applicator:

• Liver: Penetration Depth: 1.9 - 2.8 cm, Pattern Length: 1.1 - 4.6 cm
• Muscle: Penetration Depth: 1.8 - 3.0 cm, Pattern Length: 1.1 - 4.6 cm
• Kidney: Penetration Depth: 1.6 - 2.7 cm, Pattern Length: 1.1 - 2.4 cm*

Comparison to Predicates:

• Sonatherm: penetration depth up to 3 cm (wedge-shaped pattern)
• Cool-tip™: ablation diameter 2.3 – 2.6 cm at lengths of 2.6 – 3.7 cm (ellipsoidal pattern)
• Valleylab: ablation diameter 1.8 - 3 cm at lengths of 3.9 - 5 cm (ellipsoidal pattern) |
  | Ablation times comparable to predicate devices. | The study involved different treatment times (3, 6, and 9 minutes) and concluded "comparable ablation patterns and times with respect to the three listed predicate devices." (Specific comparable times for predicates are not detailed here, but the range of times used demonstrates performance over an operational spectrum). |
  | Safety and efficacy for intended use and technology. | "Results from bench, animal, performance, and safety testing demonstrate the safety and efficacy of this device's intended use and technology." Compliance with IEC 60601-1, IEC 60601-1-2, IEC 61000-3-2, and IEC 61000-3-3. |

*1 or 2 active transducers longitudinally

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

• Sample Size for Test Set: The document does not specify a precise numerical sample size for the in vivo testing (e.g., number of animals). It states that in vivo testing was performed "using a porcine model" and "three tissue types were treated: liver, muscle, and kidney." For ex vivo testing, the text mentions using "360° and 180° ACOUSTx Applicator models to apply thermal therapy to both chicken breast tissue and porcine tissue: liver, muscle, and kidney."
• Data Provenance:
  • Country of Origin: Not specified.
  • Retrospective or Prospective: Prospective, as the testing was conducted specifically to support the 510(k) submission. These are controlled laboratory and animal studies.

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

This section is not applicable. The measurements of ablation dimensions (penetration depth, pattern length) are objective physical measurements taken from the ablated tissue, not subjective expert interpretations requiring consensus. Therefore, no experts were used to establish a "ground truth" in the diagnostic sense.

4. Adjudication Method for the Test Set

Not applicable, as the data collection involved objective physical measurements, not subjective evaluations requiring adjudication.

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

No, an MRMC comparative effectiveness study was not done. This study focuses on the physical ablation properties of a device, not on diagnostic performance or human reader interpretation.

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

This device is an ablation system, not a diagnostic algorithm. The "standalone" performance in this context refers to the device's ability to produce specific thermal lesions. The in vivo and ex vivo testing conducted are effectively "standalone" performance tests of the device itself (without human interpretation of diagnostic output).

7. The Type of Ground Truth Used

The ground truth used was physical measurement of tissue ablation dimensions (penetration depth, pattern length) resulting from the device's operation. This is directly observable and measurable data from the treated tissue (ex vivo and in vivo).

8. The Sample Size for the Training Set

Not applicable. This device is a physical ablation system, not an AI or machine learning algorithm that requires a "training set" in the conventional sense. The device's operational parameters and design are based on engineering principles and preclinical testing, rather than data-driven learning from a large "training set."

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

Not applicable, as there is no "training set" for this type of device.

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The Sonatherm is indicated for the laparoscopic or intraoperative ablation of soft tissue from the ultrasound focal zone back to the surface of the targeted ablation area in General Surgery. The Sonatherm is not to be used for non-invasive ablation, i.e. leaving intervening tissue spared, and it is not indicated for the ablation of Prostate tissue.

The Sonatherm 600i is a modification of the previously cleared Sonatherm 600 (K 042096). The Sonatherm 600i uses the same HIFU transducer, with the same ultrasonic lesion generating power output as the Sonatherm 600.

The Sonatherm 600i operates in the same manner as the Sonatherm 600. The Sonatherm 600i operates by utilizing a focused ultrasound transducer positioned at the surface of the targeted ablation area to create a thermal lesion from the focal point of the transducer back to the surface of the targeted area in an open field or laparoscopic scenario.

The Sonatherm 600i incorporates three changes to the Sonatherm 600: a microprocessor controlled LCD user interface; a visually aided focal point targeting system; an integrated transducer positioning device

The microprocessor controlled LCD user interface incorporates a graphical interface that makes the operation of the device easier. The integrated positioning device allows the user to verify the positioning of the Sonatherm 600i probe over the intended target volume. This reduces the chance for operator error.

The Sonatherm 600i Ultrasonic Lesion Generating System, a modification of the previously cleared Sonatherm 600, was reviewed. This device generates thermal lesions for the laparoscopic or intraoperative ablation of soft tissue. The 510(k) summary provides details about its non-clinical testing.

Here's a breakdown of the acceptance criteria and study information:

1. Table of Acceptance Criteria and Reported Device Performance

The provided document doesn't explicitly state quantitative acceptance criteria or a specific table with "reported device performance" in the typical sense of a diagnostic device. However, it lists nonclinical tests performed to demonstrate substantial equivalence, which implicitly serve as the studies to meet underlying performance expectations for safety and effectiveness.

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

The provided 510(k) summary does not specify a "test set" in the context of human data or a machine learning model. The studies described are non-clinical engineering and performance tests (e.g., targeting accuracy, thermal mapping). Therefore, information on sample size for a "test set" or data provenance (country of origin, retrospective/prospective) for patient data is not applicable as no clinical studies were performed, and the non-clinical tests would involve physical measurements and simulations, not patient data.

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

This information is not applicable. Since the studies involved non-clinical performance evaluations of a medical device (e.g., measuring power output, thermal profiles), the "ground truth" was established by engineering specifications, physical measurements, and comparison to the predicate device's known performance. No human experts were involved in establishing "ground truth" for patient data in this context.

4. Adjudication Method for the Test Set

This information is not applicable. As there was no test set of patient data requiring expert review, no adjudication method was used.

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. The 510(k) summary explicitly states: "No clinical testing is required because product did not change HIFU power output or type. Note: clinical data was also not required to clear the original device." Therefore, there is no effect size of human readers improving with or without AI assistance, as AI is not mentioned and clinical studies were not performed.

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

This information is not applicable. The Sonatherm 600i is a physical medical device (ultrasonic lesion generating system), not an algorithm or an AI-powered system. Therefore, standalone algorithm performance is not relevant.

7. The Type of Ground Truth Used

For the non-clinical tests, the "ground truth" was established through:

• Engineering specifications and design parameters: For acoustic power output.
• Physical measurements and objective testing: For targeting accuracy and thermal mapping.
• Validation against established performance standards: To demonstrate equivalent performance to the predicate device.

8. The Sample Size for the Training Set

This information is not applicable. As the device is a physical medical instrument and not an AI/machine learning model, there is no "training set."

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

This information is not applicable. There was no training set for an AI/machine learning model.

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The Ultrazonix Spine Minimal-Invasive Disc System is intended for use by professional medical personnel for coagulation and decompression of intervertebral disc material to treat symptomatic patients with annular disruption of contained herniated lumbar discs. The safety and efficacy of this device has not been established in the thoracic and cervical intervertebral regions of the spine and should not be used in those regions.

The Ultrazonix Spine Minimal-Invasive Disc System is intended for use by professional medical personnel for coagulation and decompression of intervertebral disc material to treat symptomatic patients with annular disruption of contained herniated lumbar discs. The safety and efficacy of this device has not been established in the thoraci and cervical intervertebral regions of the spine and should not be used in those negions. The Ultrazonix Spine Minimal-Invasive Disc System is comprised of a non-disposable Control Unit, and a sterile, single-use Probe Kit. These two major component parts are described as follows: a) Non disposable Control Unit This contains a power supply, a high frequency-generator, an amplifier, an independent safety system and a user interface with an alphanumerical display and a key pad and a foot-operated switch. The probe and a foot-operated switch are connected to the Control Unit. High frequency induced ultrasound is emitted from the probe and controlled by means of the foot-operated switch. b) Sterile, single-use Probe Kit, consisting of A blunt 500 mm long stainless steel Guide Pin with a diameter of 2 mm. The Guide Pin is used as a pathfinder to navigate towards the spinal disk under fluoroscopic guidance. A 5.3 mm Dilator which is used to prepare a canal for the Introducer. It has a conical front which ensures as little harm as possible is done to adjacent tissue and blood vessels A 6 mm Introducer which is a thin walled, approximately 180 mm long tube with a handle to be used as a guide for the Probe. It is placed over the Dilator and when the desired position against the disk is reached the Guide Pin and the Dilator are removed and The ultrasonic Probe is inserted into the Introducer. It consists of a thin shaft with a piezo ceramic transducer placed at the front /tip.

The provided text describes a 510(k) premarket notification for the Ultrazonix Spine Minimal-Invasive Disc System.

Here's an analysis of the acceptance criteria and study information based on the provided document:

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

The document does not explicitly state quantitative acceptance criteria in terms of specific performance metrics for the device’s efficacy (e.g., a certain percentage of disc decompression or coagulation effectiveness). Instead, the acceptance is based on demonstrating "substantial equivalence" to predicate devices. The performance data section refers to "in vitro and animal study evaluations" and "current clinical experiences" showing the device "functions as intended" and is "safe and efficient in coagulation and decompression of disc tissue."

• Sufficiency of pre-clinical data: Data gathered was deemed "sufficient" to qualify the system as "safe and efficient in coagulation and decompression of disc tissue."
• Current clinical experiences: Also showed the product is "safe in coagulation and decompression of lumbar discs."
• Technological Characteristics: The device is considered "the same" as the predicate for coagulation and decompression of disc material to treat symptomatic patients with annular disruption of contained herniated lumbar discs. Any differences "do not raise new questions of safety and effectiveness." |

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 does not provide details on the sample size for human test subjects or the provenance (country, retrospective/prospective nature) of the "current clinical experiences" mentioned. It only refers to "in vitro and animal study evaluations" and "current clinical experiences."

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This information is not provided in the document. The type of study described (pre-clinical and clinical experience for safety and efficacy) does not typically involve independent experts establishing ground truth in the same way an AI diagnostic device study would.

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

This was not an AI diagnostic device. Therefore, an MRMC comparative effectiveness study involving human readers' improvement with AI assistance would not be applicable, and no such study is mentioned. The device described is a surgical tool.

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

This was not an AI diagnostic device, so a standalone algorithm performance study is not applicable. The device itself is a standalone medical tool for performing a procedure, and its performance was assessed through in vitro, animal, and clinical experiences.

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

The document implicitly uses physiological outcomes (demonstrated coagulation and decompression of disc tissue) and patient safety and efficacy from "current clinical experiences" as the ground truth indicators. The "in vitro and animal study evaluations" would also assess direct physical effects of the device on tissue.

8. The sample size for the training set

This is not an AI/ML device, so there is no "training set." The device's design and operational parameters would be developed through engineering and experimental testing, not machine learning training.

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

As it is not an AI/ML device, there is no training set or ground truth established for one.

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The Sonatherm is indicated for the laparoscopic or intraoperative ablation of soft tissue from the ultrasound focal zone back to the surface of the targeted treatment area in General Surgery.

Sonatherm 600 Ultrasonic Lesion Generating System is comprised of a generator, which feeds a 3 to 5 MHz electrical signal to one or more piezoelectric crystals mounted in a hand-held handpiece; the crystals then vibrate at the same frequency. A Coupling Fluid Recirculation System is provided to provide a temperature stabilized coupling/coolant fluid surrounding the Transducer crystal(s). The fluid is contained by a flexible membrane surrounding the transducer head. A user interface provides Input Controls and Output Readouts for Operator.

In operation, the Transducer Membrane is placed against the organ to be treated. When the unit is engaged, the transducer will vibrate, create acoustic waves in the coupling fluid that then couples to the organ tissue and propagates into it. The waves converge to a focal point that concentrates the energy within a finite tissue volume. As the temperature of the tissue rises above the ablation point, the tissue necroses. The treatment head is moved under Operator control to treat a preselected volume of tissue from the focal point back to the surface of the organ.

The Misonix Inc. Sonatherm 600 Ultrasonic Lesion Generating System is an ultrasonic surgical system designed for the laparoscopic or intraoperative ablation of soft tissue. The provided document is a 510(k) summary and FDA clearance letter, which focuses on demonstrating substantial equivalence to predicate devices rather than directly presenting acceptance criteria and a detailed study report in the way a clinical trial might. Therefore, the information typically found in acceptance criteria and study design for AI/CADe devices, such as sensitivity, specificity, or reader performance, is not directly applicable or available in this document.

However, based on the provided text, we can infer the "acceptance criteria" were related to safety and engineering performance, and the "study" involved non-clinical tests to demonstrate that the device met these engineering and safety standards and was substantially equivalent to existing devices.

Here's an interpretation of the available information:

1. Table of Acceptance Criteria and Reported Device Performance

The document lists "Voluntary Standards" and "Non-Clinical Tests for Determination of Substantial Equivalence." These effectively serve as the acceptance criteria and the methods used to demonstrate performance for pre-market notification (510k) of this type of medical device.

The document concludes that "Based upon an analysis of the operating characteristic specifications, Output of Engineering Tests, FMEA Analysis and Voluntary Consensus Standard Investigations, Misonix, Inc. has concluded that the Misonix Inc. Sonatherm 600 Ultrasonic Lesion Generating System is substantially equivalent" to the predicate devices. This implies that the device successfully met the criteria in all the listed tests and analyses.

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

• Sample Size for Test Set: Not applicable in the context of this device and report. The tests conducted were non-clinical engineering and performance characterization tests, not studies on a "test set" of patient data.
• Data Provenance: Not applicable. The tests were conducted internally by the manufacturer (Misonix, Inc.) through "Output of Engineering Tests," "FMEA Analysis," and investigations into "Voluntary Consensus Standard."

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

Not applicable. Ground truth, in the sense of expert consensus on patient data, is not mentioned as part of the 510(k) submission for this device, which relies heavily on engineering and performance testing against established standards and comparison to predicate devices. The "ground truth" here would be the physical properties and performance parameters measured in a lab setting.

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

Not applicable. There was no "test set" of patient cases requiring expert adjudication.

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

Not applicable. This device is an ultrasonic lesion generating system, not an AI/CADe diagnostic tool that would involve human readers or image interpretation. Therefore, an MRMC study or assessment of human reader improvement with AI assistance is not relevant to this submission.

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

Not applicable. There is no algorithm for diagnostic interpretation in this device. The device itself performs the therapeutic function, with operator control. The document explicitly states: "There is no software associated with this product."

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

The "ground truth" for the non-clinical tests would have been engineering specifications, physical measurements, and compliance with recognized voluntary standards. For example, for "Focal Length Accuracy Measurements," the ground truth would be the accurately measured focal length of the device compared to its design specification. For "In Vitro Targeting Accuracy Measurements," the ground truth would be the actual ablated tissue volume/shape in an in vitro model compared to the intended or predicted ablation.

8. The sample size for the training set

Not applicable. As noted, there is no software or AI component that would require a training set.

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

Not applicable. No training set exists.

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

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

Epicor Medical UltraCinch Tissue Ablation Device and Accessories

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

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

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

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

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

The device performance is generally reported as:

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

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

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

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

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

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

This information is not provided in the text.

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

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

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

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

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

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

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

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

8. The sample size for the training set:

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

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

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

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The Epicor Medical Ablation System (the UltraWand Ablation Device, Ablation Control System, and Connecting Cable) is Intended for the ablation of cardiac tissue during cardiac surgery.

Epicor Medical Ablation System, including the UltraWand Ablation Device, Ablation Control System, and Connecting Cable

The provided text is a 510(k) premarket notification letter and summary for the Epicor Medical Ablation System. It confirms that the device is "substantially equivalent" to legally marketed predicate devices, meaning it has similar indications for use and safety/effectiveness. However, the document does not contain the specific acceptance criteria or details of a study that proves the device meets those criteria in the format of AI/ML evaluation as requested.

The document states:

• "Results of in vitro and in vivo testing demonstrate that the Epicor Medical Ablation System is safe and effective for its intended use."
• "The materials used in the Epicor Medical Ablation System meet the requirements of ISO 10993-1."
• "Based on the intended use, product, performance and biocompatibility information provided in this notification, the subject device has been shown to be substantially equivalent to the currently marketed predicate devices."

This is a general statement of compliance and substantial equivalence, not a detailed report of acceptance criteria and the performance against them with numerical metrics, expert adjudication, or sample size specifics as typically found in an AI/ML device submission. The FDA 510(k) pathway often relies on demonstrating substantial equivalence to existing devices rather than entirely novel performance criteria.

Therefore, I cannot extract the specific information requested about acceptance criteria, study details, sample sizes, expert qualifications, or ground truth establishment relevant to an AI/ML device because this information is not present in the provided text. The device described, the "Epicor Medical Ablation System," is an electrosurgical cutting and coagulation device, not an AI/ML diagnostic or predictive tool.

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