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The Single Use RF electrode (Needle Type) is a monopolar electrosurgical electrode indicated for coagulation of soft tissue when it used in conjunction with compatible radio frequency electrosurgical device.

Single Use RF Electrode (Needle Type) consists of conductive electrode part, insulation coated part and conductive post part. There are several models (Models: GA-B, GA-C, GA-I, GA-S, GA-W3A, GA-F3A, GA-IL, GA-SL, GA-W3B, GA-F1A) according to the total size and needle electrode part size. The conductive post of electrode is inserted into the head of the intended handpiece to receive the radio frequency current and delivers the current to a target tissue for coagulation in electrosurgical procedure. This device is a monopolar RF electrosurgical electrode used in conjunction with radio frequency electrosurgical device and a neutral electrode plate which complies with IEC 60601-1 and IEC 60601-2-2. It is intended to be used exclusively with the ESU cleared in K160469, Model: AGNES.

The provided document is a 510(k) summary for a medical device called "Single Use RF electrode (Needle Type)". This type of document is a premarket notification to the FDA to demonstrate that the device is substantially equivalent to a legally marketed predicate device.

Therefore, it describes tests performed to show safety and effectiveness compared to a predicate device, rather than explicit "acceptance criteria" and a "study that proves the device meets the acceptance criteria" in the sense of demonstrating a novel performance claim with specific thresholds.

The studies conducted are primarily focused on ensuring the new device is as safe and effective as existing, legally marketed devices.

Here's an analysis of the information, formatted to address your specific points where applicable, and highlighting what's not present in a 510(k) summary:

1. Table of Acceptance Criteria and Reported Device Performance

As a 510(k) summary, specific numerical "acceptance criteria" and "reported device performance" for novel claims are generally not detailed. Instead, the document states that tests were performed and results "met the requirements" or "supported the safety and effectiveness." The primary acceptance criterion for a 510(k) is "substantial equivalence" to a predicate device, meaning it's as safe and effective.

Here's a summary of the tests performed and their general outcomes:

2. Destroyed sebaceous glands, reduced inflammatory cells, papule, and pustule (rabbit ear model). | 1. Penetration depth "relatively accurate," distinct coagulation.
3. Sebaceous glands destroyed, inflammation and lesions "greatly reduced," considered "valid method to prevent reoccurrence." |

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

• Nonclinical/Benchtop Tests: Sample sizes are not reported in this summary. These tests are typically performed on a limited number of device units.
• Animal Study:
  • One part of the animal study used mini pigs to check penetration depth. The number of mini pigs is not specified.
  • Another part used a rabbit ear model to assess acne treatment. The number of rabbits is not specified.
• Data Provenance: The document does not explicitly state the country of origin for the non-clinical or animal study data beyond the applicant/submitter being based in South Korea. The animal study appears to be prospective in nature, as it describes inducing acne in rabbits and then treating them.

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

• Nonclinical/Benchtop Tests: For these types of tests, "ground truth" is typically established by recognized standards and engineering specifications rather than expert interpretation of images or other subjective data. No experts are mentioned in this context.
• Animal Study - Macroscopic Assessment: A dermatologist performed macroscopic assessment. The number and specific qualifications (e.g., years of experience) of the dermatologist(s) are not specified. Their role was to assess "damage and safety on the skin surface and inside the corium."
• Animal Study - Histological Assessment: This involved standard pathology techniques (hematoxylin & eosin staining). While a pathologist would interpret these, the document does not specify the number or qualifications of experts for histological interpretation.
• No "ground truth" in the typical sense of human expert consensus for a diagnostic AI study is found here, as this is not an AI diagnostic device.

4. Adjudication Method for the Test Set

• Not applicable in the context of this 510(k) submission. Adjudication methods (like 2+1, 3+1) are typically used for establishing ground truth in clinical studies involving interpretation by multiple readers, especially for AI diagnostic devices. This document is about an electrosurgical electrode and its safety/performance through bench and animal testing.

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

• No MRMC comparative effectiveness study was done. This document pertains to an electrosurgical electrode, not an AI-assisted diagnostic or therapeutic device 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

• Not applicable. This device is a physical electrosurgical electrode, not an algorithm.

7. The Type of Ground Truth Used

• Nonclinical/Benchtop Tests: Ground truth is implicitly based on recognized international and national standards (e.g., IEC, ISO, ASTM) and the device's engineering specifications.
• Animal Study - Macroscopic Assessment: Ground truth for macroscopic assessment was a dermatologist's visual assessment and measurements using a camera and a folliscope magnifying glass, and a 3D measuring instrument (PRIMOS Pico).
• Animal Study - Histological Assessment: Ground truth was established by histological analysis (hematoxylin & eosin staining) of tissue samples.

8. The Sample Size for the Training Set

• Not applicable. This device is a physical electrosurgical electrode, not a machine learning or AI algorithm that requires a training set. The "training set" concept is irrelevant here.

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

• Not applicable. As established in point 8, there is no training set for this device.

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AGNES is indicated for use in dermatological and general surgical procedures for electrocoagulation and hemostasis.

AGNES is a RF electrosurgical device. It consists of LCD screen, radiofrequency generator and SMPS. The accessories are a hand-piece, Single use RF electrodes (needle type). Disposable neutral electrode pad and a footswitch.

Here's an analysis of the provided text regarding the acceptance criteria and supporting studies for the AGNES device.

It's important to note that the provided document is a 510(k) Summary, which establishes substantial equivalence to a predicate device. It demonstrates that the new device is as safe and effective as a legally marketed device and does not necessarily involve establishing new acceptance criteria or conducting a comprehensive "study that proves the device meets the acceptance criteria" in the same way a PMA (Premarket Approval) submission would. Instead, the focus is on showing equivalence through comparing specifications, adherence to recognized standards, and preclinical/animal testing to address differences.

Therefore, some of the requested information (like human reader MRMC studies or specific acceptance criteria for a novel AI algorithm's performance) is not applicable or present in this type of FDA submission.

Acceptance Criteria and Device Performance for AGNES (K160469)

The "acceptance criteria" for this 510(k) submission are primarily rooted in demonstrating that the AGNES device is substantially equivalent to its predicate devices (HR-5000 and INTRAcel Premium Fractional RF Micro Needle System) and that any differences do not raise new questions of safety or effectiveness. This is achieved by conforming to recognized electrical safety and performance standards, and, for specific functional aspects, through preclinical and animal studies.

The document does not present a table of quantitative acceptance criteria for its overall performance and compare it to reported device performance in a clinical efficacy context. Instead, it demonstrates compliance with safety and engineering standards and addresses the biological effects of its differences through testing.

1. Table of Acceptance Criteria and Reported Device Performance

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

• Engineering/Safety Tests (Electrical, Biocompatibility, Sterility): The document refers to compliance with recognized standards (IEC, ISO, ASTM). These standards typically define the sample sizes and procedures for testing components and the overall device. For example, biocompatibility tests (ISO 10993) would involve specific numbers of cell cultures, animals, or material samples. The exact sample sizes for each specific engineering test are not detailed in this 510(k) summary but are inherent to the standard methods. Data provenance is implied to be laboratory testing by the manufacturer or accredited labs.
• Animal Study: The study used "mini pigs" for penetration depth and coagulation assessment, and a "rabbit's ear model" for acne treatment. Specific numbers of animals are not provided in the summary. The provenance is preclinical testing, likely conducted by or for the manufacturer.

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

• Engineering/Safety Tests: "Experts" in this context are the qualified personnel in test laboratories who perform and interpret the results of the standard tests (e.g., electrical engineers for IEC 60601, toxicologists/biologists for ISO 10993, microbiologists for sterility tests). Their specific number and qualifications are not detailed in the summary but are presumed to meet the requirements of the standards.
• Animal Study (Macroscopic Assessment): A "dermatologist" performed macroscopic assessment on damage and safety. The number of dermatologists and their specific years of experience are not specified.
• Animal Study (Histological Assessment): The histological assessments would typically be performed by a veterinary pathologist or a pathologist with experience in animal tissue, but their number and specific qualifications are not detailed.

4. Adjudication Method for the Test Set

• Engineering/Safety Tests: Adjudication is generally not applicable in the same way as clinical imaging studies. Compliance is determined by whether the device's performance meets the quantitative thresholds defined by each standard (e.g., leakage current within limits, tensile strength exceeding a value).
• Animal Study:
  • Macroscopic Assessment: A "dermatologist" assessed damage and safety. It's unclear if this was a single dermatologist, or if a consensus/adjudication process was used if multiple assessors were involved.
  • Microscopic Assessment: The histological assessment involves objective staining and observation. While interpretation requires expertise, a formal adjudication process between multiple experts for "ground truth" establishment in this specific context is not mentioned.

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

• No, an MRMC comparative effectiveness study was not explicitly mentioned or performed as part of this 510(k) submission. This type of study is more common for diagnostic devices (e.g., AI for radiology reading) to compare human performance with and without AI assistance. The AGNES device is a therapeutic electrosurgical device; its primary function is to perform a physical action (electrocoagulation and hemostasis) and treat conditions like acne, not to provide diagnostic readings. The "effectiveness" is shown through its functional performance and biological effect, not by improving human reader interpretation.

6. Standalone (Algorithm Only Without Human-in-the-Loop) Performance

• Not applicable. The AGNES device is a physical electrosurgical device operated by a human. It is not an AI algorithm designed to operate autonomously or provide outputs without human interaction.

7. Type of Ground Truth Used

• Engineering/Safety Tests: The "ground truth" is defined by the objective pass/fail criteria established by the international and national standards (IEC, ISO, ASTM).
• Animal Study: The "ground truth" for the animal study was based on:
  • Clinical Assessment (Photo Assessment): Macroscopic observations by a dermatologist and photographic evidence.
  • Histological Pathology Analyses: Microscopic examination of tissue samples stained with hematoxylin & eosin, assessing sebaceous gland destruction, inflammatory cells, etc. This is considered objective biological evidence.
  • 3D Measuring Instrument (PRIMOS Pico): For assessing reduction of acne lesions, providing quantitative data.

8. Sample Size for the Training Set

• Not applicable / Not disclosed. This is a medical device approval that primarily relies on engineering specifications, safety standards, and preclinical (animal) performance, not machine learning or AI models that require a "training set" in the conventional sense. The device itself is designed and tested, not "trained" on data.

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

• Not applicable. As there is no "training set" in the AI/machine learning sense, no ground truth was established for it.

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