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The POTENZA is intended for use in dermatologic and general surgical procedures for electrocoagulation and hemostasis.

The POTENZA is an RF (radiofrequency), software-controlled electrosurgical device used for electrocoagulation of soft tissue and hemostasis. The POTENZA consists of the following components: Electrosurgical Unit - Main body, Two different handpieces ( motor and AC), Six different electrode tips for the motor handpiece and three needle tips for the AC handpiece; provided as single use, sterile products, Neutral electrode pad and neutral electrode pad cable, cleared under K092761, Handpiece stand, Foot switch, Power cord. The POTENZA generates radiofrequency (RF) energy by means of high RF at 1MHz or 2MHz. The RF energy is delivered through the skin into the target tissue via a handpiece equipped with an electrode tip. As the RF energy passes through the tissue, it generates an electrothermal reaction which is capable of coagulating the tissue. The POTENZA has two operating modes: monopolar mode and bipolar mode.

This looks like a 510(k) summary for a medical device. Based on the provided text, the device in question is the "POTENZA," an RF electrosurgical device. However, the document does NOT contain information about acceptance criteria or a study proving the device meets those criteria in the way you've outlined for AI/CADe devices (i.e., sensitivity, specificity, reader studies, etc.).

This document describes the regulatory process for establishing substantial equivalence to a predicate device, which primarily relies on demonstrating that the new device has similar technological characteristics and performs comparably to devices already on the market. The performance data presented here are primarily engineering bench tests, electrical safety, biocompatibility, and software validation. These are standard tests for electrosurgical devices to ensure safety and functionality, not to evaluate diagnostic performance or AI algorithm effectiveness.

Therefore, many of the specific questions you've asked, particularly those related to AI/CADe system validation (sample sizes for test sets, data provenance, ground truth establishment, expert adjudication, MRMC studies, standalone performance), are not applicable to the information provided in this 510(k) summary for an electrosurgical device.

Here's a breakdown of what can be extracted, and why other parts are not present:

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

The document does not explicitly state "acceptance criteria" in the format of a clinical performance metric (like sensitivity or specificity) with a target value. Instead, the acceptance criteria are implicitly met by passing various engineering and biocompatibility tests.

Regarding the specific questions about AI/CADe validation:

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

   • Not applicable. This device is an electrosurgical unit, not an AI/CADe system that analyzes data like images. The "test set" here refers to physical components and the device itself undergoing engineering and biological safety tests.

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. Ground truth, in the context of AI/CADe, involves expert interpretation of data. For this electrosurgical device, "ground truth" relates to objective physical and biological properties measured by standardized tests (e.g., cytotoxicity assays, electrical measurements).

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

   • Not applicable. Adjudication is for resolving discrepancies in expert interpretations of data. This is not performed for physical device 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.

   • Not applicable. This is not an AI-assisted diagnostic device.

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

   • Not applicable. This is not an AI algorithm. Its performance is evaluated as a standalone electrosurgical unit through bench and safety tests.

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

   • The "ground truth" for the tests performed are highly standardized scientific and engineering measurements. For example, for biocompatibility, the ground truth is whether specific biological responses (e.g., cell death, irritation) occur above a predefined threshold according to the specified ISO standards. For electrical safety, the ground truth is whether the device parameters (e.g., leakage current, output power) fall within the limits set by IEC standards.

8. The sample size for the training set.

   • Not applicable. There is no AI training set for this electrosurgical device.

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

   • Not applicable. There is no AI training set or associated ground truth.

In summary, the provided document is a 510(k) summary for an electrosurgical device, detailing its regulatory pathway to market based on substantial equivalence. It focuses on safety and fundamental performance characteristics through engineering and biocompatibility testing, not on the diagnostic accuracy or AI performance metrics you've requested.

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Secret RF Smartcure applicator is intended for use in dermatologic and general surgical procedures for electro-coagulation and hemostasis

Secret RF's High Frequency(=Radio Frequency) includes the system main body, a handpices with singleuse micro-needle type electrodes, footswitch and an LCD touch screen control panel.

The HF energy is delivered to the target tissue using a handpiece and disposable tip(micro needle electrode tip), the tip being placed in light contact with the epidermis and the handpiece being held at right angles to the target tissue. As the HF energy passes through the skin, it generates an electro thermal reaction, which is capable of coagulating the tissue. Using the micro needle tip, the Secret RF system creates heat within the target dermal tissue via micro-needles inserted from the tip.

The Secret RF is consists of ;

• 1. Secret RF main unit (FDA cleared K170325)
• 2. Bipolar type handpieces with Bipolar type micro-needle electrodes (FDA cleared K170325)
• 3. Secret RF Smartcure applicator

The Secret RF Smartcure Applicator consists of :

• Smartcure handpiece
• Monopolar type micro-needle electrodes (MTR-AC-01 , MTR-AC-04, MTR-AC-27G, K3i)

The provided text describes a 510(k) premarket notification for the "Secret RF Smartcure Applicator" and details its substantial equivalence to predicate devices, but it does not contain information on acceptance criteria and a study proving the device meets those criteria in the context of clinical performance or effectiveness data (e.g., sensitivity, specificity, accuracy).

The document focuses on:

• Regulatory Clearance: Affirming that the device is substantially equivalent to legally marketed predicate devices for dermatologic and general surgical procedures for electro-coagulation and hemostasis.
• Technical Specifications: Comparing the proposed device's technical characteristics (e.g., frequency, max power, RF duration, electrode type) with a predicate device (SecretRF K170325) and two reference devices (AGNES K160469, EVRF K112334).
• Performance Data (Non-Clinical/Pre-Clinical): Listing performed tests, which are primarily related to safety, electrical compatibility, and basic functionality:
  • Biocompatibility testing (ISO10993-1;2009)
  • Electrical safety and essential performance (IEC 60601-1, IEC 60601-1-2, IEC 60601-2-2: 2009)
  • Animal testing (micropig models for histological data on ablation and thermal damage depth and zone at various post-treatment intervals and intensities).

Therefore, I cannot fulfill your request for:

1. A table of acceptance criteria and reported device performance related to clinical outcomes or diagnostic accuracy, as this information is not present. The "performance data" listed refers to design verification and validation testing for safety and basic function, not clinical efficacy or diagnostic performance metrics.
2. Sample size used for the test set and data provenance: Not mentioned, as no clinical effectiveness study is described.
3. Number of experts and their qualifications for ground truth: Not applicable, as no ground truth for labeling or diagnosing clinical conditions is discussed.
4. Adjudication method for the test set: Not applicable.
5. Multi-reader multi-case (MRMC) comparative effectiveness study: Not conducted or reported. The document explicitly states the device's substantial equivalence is based on similarities to predicate devices and performance testing related to safety and functionality.
6. Standalone performance (algorithm only): Not applicable, as this is a physical medical device, not an AI algorithm.
7. Type of ground truth used: Not applicable in the context of clinical performance data. The animal study used histological data as an endpoint for depth and zone of ablation/thermal damage.
8. Sample size for the training set: Not applicable, as this is not an AI/machine learning device.
9. How ground truth for the training set was established: Not applicable.

However, based on the provided text, I can infer a type of "acceptance criteria" related to regulatory compliance and safety, and report the "performance" in terms of meeting these standards.

Inferred Acceptance Criteria and Reported Performance (based on regulatory and safety compliance):

Study Description (as reported in the document):

The document references several types of studies performed as part of the 510(k) submission, primarily for demonstrating safety and substantial equivalence, rather than clinical efficacy or diagnostic performance.

1. Biocompatibility Testing:

   • Description: Testing of patient contact components and materials.
   • Standard: ISO 10993-1:2009.
   • Data Provenance: Not specified, but generally performed in a lab setting.
   • Sample Size: Not specified (refers to materials, not patients).
   • Ground Truth: Adherence to the ISO standard.

2. Non-Clinical (Engineering/Safety) Testing:

   • Description: Evaluation of the device's electrical safety, essential performance, and electromagnetic compatibility.
   • Standards: IEC 60601-1, IEC 60601-1-2, IEC 60601-2-2: 2009.
   • Data Provenance: Not specified, but generally performed in a lab setting.
   • Sample Size: Not specified (typically tests on a device unit).
   • Ground Truth: Compliance with the respective IEC standards.

3. Animal Testing:

   • Description: In vivo study to obtain histological data on depth and zone of ablation and thermal damage.
   • Species: Micropig models.
   • Purpose: To assess immediate, 7-day, and 14-day post-treatment effects.
   • Data Provenance: Animal study. Country of origin not specified.
   • Sample Size: Not specified (number of micropigs or treatment sites).
   • Ground Truth: Histological analysis of tissue samples.
   • Experts: Not specified, but typically includes pathologists.
   • Adjudication: Not specified.

Missing Information:

Crucially, the document explicitly states this is a substantial equivalence determination for a medical device. For such submissions, extensive clinical efficacy studies with predefined acceptance criteria for patient outcomes (like those you’d expect for an AI diagnostic device's sensitivity/specificity or a pharmaceutical drug's effectiveness) are often NOT required if the device is sufficiently similar to legally marketed predicate devices. The focus is on ensuring basic safety and functional equivalence.

Therefore, the requested details related to clinical performance metrics, ground truth establishment for a diagnostic output, training sets, or human-AI comparative effectiveness studies are not present in this regulatory summary because they were likely not part of the 510(k) submission for this type of device.

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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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