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The Habib EUS RFA 6700 is indicated for coagulation and ablation of soft tissue when used in conjunction with compatible radio frequency generator.

The Habib EUS RFA 6700 is a catheter that is delivered during an EUS procedure, through 19 Gauge (G) endoscopic needles. The subject device is monopolar configuration and thus, must be used in conjunction with patient grounding pad. RF energy is produced by connecting the catheter to a compatible RF generator via accessory cable. When attached to a generator, RF current is emitted from the exposed portion of the electrode and this current translates into ion agitation within the surrounding tissue, which is converted by friction into heat and induces cellular death by means of coagulation necrosis.

The provided text describes a 510(k) submission for the Habib EUS RFA 6700 device, asserting its substantial equivalence to a predicate device (K150029). The submission outlines various performance, biocompatibility, and electrical tests conducted to demonstrate that the device meets required specifications.

Here's the information extracted and organized as requested:

1. Table of Acceptance Criteria and Reported Device Performance

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

The document does not explicitly state the sample size for any of the performance tests. The tests appear to be laboratory-based bench tests and biocompatibility tests, rather than clinical studies with patient data. Therefore, details regarding country of origin or retrospective/prospective nature of patient data are not applicable.

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

This information is not applicable. The evaluations described are primarily engineering and biocompatibility tests, not interpretations of clinical data requiring expert consensus or ground truth establishment in that context.

4. Adjudication Method for the Test Set

This information is not applicable as the tests are objective engineering and biological assessments, not subjective interpretations requiring 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

An MRMC comparative effectiveness study was not done. This device is an electrosurgical tool, not an AI-powered diagnostic or assistive technology for human readers.

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

This information is not applicable. The device is a physical electrosurgical catheter and not a standalone algorithm.

7. The Type of Ground Truth Used

The "ground truth" for the tests performed can be considered the established scientific and engineering standards outlined by the various ISO and IEC standards cited (e.g., ISO 10993 for biocompatibility, IEC 60601 for electrical safety). The performance bench tests would have had internal engineering specifications as their "ground truth."

8. The Sample Size for the Training Set

This information is not applicable as the device is not an AI algorithm that requires a training set.

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

This information is not applicable as the device is not an AI algorithm that requires a training set.

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The Habib EUS RFA 6700 is indicated for coagulation of soft tissue when used in conjunction with compatible radio frequency generator.

The Habib EUS RFA 6700 is a catheter that is delivered during an EUS procedure, through 19 or 22 Gauge (G) endoscopic needles. The Habib EUS RFA 6700 is monopolar configuration and thus, must be used in conjunction with patient grounding pad. RF energy is produced by connecting the catheter to a compatible RF generator via an accessory cable. When attached to a generator, RF current is emitted from the exposed portion of the electrode and this current translates into ion agitation within the surrounding tissue, which is converted by friction into heat and induces cellular death by mans of coagulation necrosis.

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

This document is a 510(k) Pre-Market Notification for a medical device called "Habib EUS RFA 6700." The purpose of a 510(k) submission is to demonstrate that a new device is "substantially equivalent" to a legally marketed predicate device, meaning it's as safe and effective. As such, the "acceptance criteria" here are generally to demonstrate substantial equivalence through meeting performance, biocompatibility, and electrical safety standards comparable to the predicate devices. The "study" refers to the pre-clinical (bench) testing performed to show this.

1. Table of Acceptance Criteria and Reported Device Performance

The document doesn't explicitly list "acceptance criteria" in a quantitative, pass/fail table for all performance tests. Instead, it states that the device "met the required specifications" and "performance clearly demonstrate that the Habib EUS RFA 6700 is safe and effective." The performance tests listed are qualitative descriptions of the tests performed.

However, we can infer some "acceptance criteria" for the device based on the tests conducted and the need to demonstrate substantial equivalence:

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

The document details a series of "Performance bench testing," "biocompatibility testing," and "electrical testing." However, it does not provide specific sample sizes (number of devices or tests performed) for these tests. It only lists the types of tests conducted.

For data provenance (country of origin, retrospective/prospective), the tests appear to be pre-clinical bench tests. This kind of testing generally occurs in a lab setting, likely where the device is manufactured or tested, which is EMcision Ltd. in the United Kingdom based on the submitter's address. It is not clinical data (retrospective or prospective from human subjects).

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

This information is not provided in the document. For pre-clinical bench testing, "ground truth" isn't typically established by clinical experts in the same way it would be for diagnostic AI. Instead, the "ground truth" for these tests would be the established scientific and engineering principles of the test methods (e.g., a pulling test measures force until failure, a biocompatibility test assesses cellular response). The personnel performing these tests would be engineers, lab technicians, and scientists qualified in their respective fields (materials science, electrical engineering, biology, etc.), but their specific number and qualifications are not mentioned.

4. Adjudication Method for the Test Set

This information is not applicable and therefore not provided since the studies described are pre-clinical bench tests, not studies requiring expert adjudication of clinical outcomes or images. Adjudication methods like "2+1" or "3+1" are typical for clinical studies or studies involving human readers and ground truth establishment from multiple experts.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, If So, What Was the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance

This information is not provided and not applicable. The document describes the pre-clinical validation of a physical medical device (an electrosurgical electrode), not an AI algorithm. Therefore, no MRMC study, human reader improvement with AI, or effect size is discussed.

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

This information is not provided and not applicable. The "Habib EUS RFA 6700" is a physical medical device. It is not an algorithm, and therefore, standalone algorithm performance is not relevant to this submission.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)

For the performance and electrical bench tests, the "ground truth" is defined by the validated test methods and specifications themselves. For example:

• Functional tests: Adherence to physical properties (e.g., dimensions, strength, flexibility), consistent activation, and effective tissue coagulation as determined by engineering and material science principles.
• Biocompatibility tests: Adherence to biological safety standards as defined by ISO 10993 series and evaluated in laboratory settings (e.g., cell cultures for cytotoxicity, animal models for implantation).
• Electrical/EMC tests: Conformance to published international and national safety standards for medical electrical equipment (e.g., IEC 60601-1, IEC 60601-2-2, various EN standards for EMC).

There is no "expert consensus" or "pathology/outcomes data" ground truth in the context of these pre-clinical tests.

8. The Sample Size for the Training Set

This information is not provided and not applicable. The "Habib EUS RFA 6700" is a physical medical device, not an AI model or algorithm that requires a training set.

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

This information is not provided and not applicable, as there is no training set for a physical medical device.

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