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RO handpiece, AGNES (F) RF handpiece and AGNES (B) RF handpiece of RFMagik are intended for use in dermatologic and general surgical procedures for electrocoagulation and hemostasis.

RFMagik is a medical device combined with RF current, to function as an electrosurgical device for use in dermatology and general surgical procedures. It is possible to select and change modes, parameters, outputs, etc. using the panel on the main body. It consists of the main device, LCD screen, two handpieces, single use electrodes, electrode pad, NE pad cable, food switch.

There are three handpieces. RO handpiece, AGNES (F) RF handpiece and AGNES (B) RF handpiece that delivers RF energy through the disposable electrode in the handpiece.

This document is an FDA 510(k) clearance letter for an RF Electrosurgical Device (RFMagik). It states that the device is substantially equivalent to legally marketed predicate devices.

However, the provided document does NOT contain information about acceptance criteria, device performance results, sample sizes, expert ground truth establishment, or clinical study details. The section on "Clinical Testing" explicitly states: "Clinical testing is not a requirement and has not been performed."

The document focuses on:

• Regulatory details: Device classification, product codes, indications for use.
• Technological comparison: Detailed comparison of the subject device (RFMagik) with a primary predicate device (RFMagik Lite) and a reference device (AGNES). This comparison highlights similarities and differences in handpieces, electrodes, output power, etc., and explains why these differences do not affect substantial equivalence.
• Non-clinical testing: Biocompatibility, sterility, shelf-life, and performance bench testing. An "Ex Vivo Study" was conducted on tissue types (liver, skin, muscle) for thermal testing.

Therefore, I cannot fulfill your request for a table of acceptance criteria, device performance, sample sizes for the test set, data provenance, number/qualifications of experts, adjudication methods, MRMC study details, standalone performance, type of ground truth, training set sample size, or how training ground truth was established. This information is typically found in specific study reports or sections of a 510(k) submission that go beyond what is published in the clearance letter itself.

The document indicates that the substantial equivalence was primarily demonstrated through bench testing and comparison to predicate devices, rather than clinical trials or extensive human-in-the-loop performance studies.

Summary of what CANNOT be provided from the given document:

1. Table of acceptance criteria and reported device performance: Not present.
2. Sample size for the test set and data provenance: No clinical test set. Ex vivo study mentioned, but specific sample sizes are not detailed.
3. Number of experts and qualifications for ground truth: Not applicable as no clinical study with expert ground truth review was performed.
4. Adjudication method for the test set: Not applicable.
5. MRMC comparative effectiveness study: Not conducted.
6. Standalone (algorithm only) performance: Not applicable as this is a physical electrosurgical device, not an AI algorithm.
7. Type of ground truth used: Not applicable for a clinical study. Ex vivo study used physical tissue, but no "ground truth" akin to medical image labeling.
8. Sample size for the training set: Not applicable as there is no mention of an AI/ML algorithm requiring a training set.
9. How ground truth for the training set was established: Not applicable.

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RO handpiece and AGNES RF handpiece of RFMagik Lite are intended for use in dermatologic and general surgical procedures for electrocoagulation and hemostasis.

RFMagik Lite is a medical device combined with RF current, to function as an electrosurgical device for use in dermatology and general surgical procedures. It is possible to select and change modes, parameters, outputs, etc. using the panel on the main body. It consists of the main device, LCD screen, two handpieces, single use electrodes, electrode pad, NE pad cable, food switch. There are two handpieces. RO handpiece and AGNES RF handpiece that delivers RF energy through the disposable electrode in the handpiece.

The provided FDA 510(k) clearance letter for RFMagik Lite does not contain information about specific acceptance criteria or a study that directly proves the device meets such criteria in terms of clinical performance or effectiveness. The document primarily focuses on demonstrating substantial equivalence to predicate devices through non-clinical testing (electrical, EMC, biocompatibility, sterility, shelf life, and performance bench testing) and an ex vivo study.

Here's a breakdown of the requested information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

No specific acceptance criteria in terms of clinical performance metrics (e.g., success rates, complication rates, or comparative outcomes) are mentioned in the document for the RFMagik Lite. The "performance testing" referenced is primarily bench testing to ensure the device operates safely within design specifications. The acceptance criteria for the non-clinical tests are implicit in the adherence to recognized standards.

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

The document does not specify a "test set" in the context of clinical or human subject data. The testing mentioned is non-clinical (bench, ex vivo). For the ex vivo study, the number of tissue types used was three (liver, skin, and muscle), but the specific number of samples or specimens within each tissue type is not provided.

The provenance of this ex vivo data would be laboratory-based, focusing on tissue samples rather than human subjects. The country of origin for the ex vivo study is not explicitly stated, but the submission is from a South Korean company.

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

Since there is no mention of a clinical "test set" or human subject data, there is no information about experts establishing ground truth for such a set. The ex vivo study would likely involve experts in histology or pathology for evaluating thermal effects, but their number and qualifications are not detailed.

4. Adjudication Method for the Test Set

Not applicable, as there is no described clinical "test set" requiring adjudication.

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

Not applicable. The RFMagik Lite is an electrosurgical device for cutting and coagulation, not an AI-assisted diagnostic or imaging device that would typically undergo an MRMC study comparing human reader performance with or without AI assistance.

6. If a Standalone (i.e., Algorithm Only Without Human-in-the-Loop Performance) Was Done

Not applicable. The RFMagik Lite is a physical electrosurgical device, not a standalone algorithm.

7. The Type of Ground Truth Used

For the non-clinical testing, the "ground truth" is defined by the adherence to and successful completion of recognized consensus standards (e.g., AAMI ES60601-1, IEC60601-2-2 for electrical safety, ISO 10993 for biocompatibility). For the ex vivo study, the "ground truth" would likely be the observed thermal effects on the tested tissues, assessed against predetermined safety or efficacy thresholds (though these thresholds are not explicitly stated in the document).

8. The Sample Size for the Training Set

Not applicable. This device is not an AI/ML algorithm that requires a training set.

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

Not applicable, as there is no training set for an AI/ML algorithm.

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

The AGNES MEDICAL CO.,LTD PlazMagik is an electro-surgical device for use in dermatological applications. The effect of the device is achieved by heating the outer layer of the skin to that part or all or the epidermis becomes non-viable and there is controlled damage to the underlying dermis.

The PlazMagik system consists of a system console, footswitch, Two type of handpiece and tip guide.

This document describes the regulatory clearance for the PlazMagik electrosurgical device. It outlines the safety and performance testing conducted to demonstrate substantial equivalence to a predicate device, but it does not include acceptance criteria or a study proving that specific performance metrics are met against those criteria.

Here's a breakdown of the information provided, and what is missing based on your request:

1. Table of Acceptance Criteria and Reported Device Performance:

• Missing from the document. The document lists various tests performed (Biocompatibility, Electrical Safety, Software Verification, Bench Testing, Ex Vivo Study), but it does not provide specific acceptance criteria for these tests nor does it report the precise performance metrics of the PlazMagik device against such criteria. For example, for "Output Energy" in bench testing, it states "Tested parameters included: Output Energy" but doesn't provide what the acceptable range for output energy was or what the device's actual output energy was.

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

• Biocompatibility: Not specified.
• Electrical Safety & EMC: Not specified.
• Software Verification and Validation: Not specified.
• Bench Testing: Not specified.
• Ex Vivo Study:
  • Sample Size: "Ex Vivo testing conducted on three types of tissue - Liver, skin and Muscle." The number of samples within each tissue type is not specified.
  • Data Provenance: Not explicitly stated, but Ex Vivo studies are generally conducted in a laboratory setting. It's not retrospective or prospective in the clinical trial sense.

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

• Not applicable. The document describes non-clinical testing. There is no mention of human-established ground truth or experts for these tests.

4. Adjudication Method for the Test Set:

• Not applicable. The document describes non-clinical testing. There is no mention of an adjudication method as would be used in a clinical study with human readers/assessors.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size:

• No, an MRMC study was not done. The document explicitly states: "Clinical testing is not a requirement and has not been performed."

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done:

• Not applicable. This device is an electrosurgical cutting and coagulation device, not an AI/algorithm-based diagnostic or therapeutic software. The "Software Verification and Validation Testing" refers to the control software within the device, not a standalone AI algorithm for medical image analysis or similar.

7. The Type of Ground Truth Used:

• Biocompatibility: Based on compliance with ISO standards (e.g., cell viability, presence/absence of irritation).
• Electrical Safety & EMC: Based on compliance with IEC standards (e.g., meeting specified limits for electrical leakage, electromagnetic emissions/immunity).
• Software Verification and Validation: Based on meeting design specifications and requirements.
• Bench Testing: Based on predefined design specifications (e.g., output energy within a certain range, tip integrity after use).
• Ex Vivo Study: Based on GLP Thermal testing in accordance with FDA guidance, likely assessing tissue effects (e.g., coagulation depth, thermal spread) against expected outcomes or safety limits.

8. The Sample Size for the Training Set:

• Not applicable. This device is hardware with embedded control software; it does not involve machine learning or a "training set" in the context of AI.

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

• Not applicable. (See point 8).

Summary of what is present vs. missing:

The document provides evidence of various non-clinical tests conducted to support the safety and substantial equivalence of the PlazMagik device. It lists the types of tests and the standards followed, and generally reports "Pass" for biocompatibility and indicates that electrical safety/EMC and software testing were "conducted" and "shows that the device is safe and meets requirement." However, it does not provide the specific quantitative acceptance criteria or the measured performance values that would allow for a direct comparison in a table as requested. It also explicitly states that no clinical (human) testing was performed, which means no human reader studies, ground truth experts, or training sets in the AI context were involved.

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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 footswitch, a hand-piece, single use RF electrodes and FDA cleared Disposable neutral electrode pad (K102372).

The provided text describes a 510(k) summary for the AGNES RF electrosurgical device. It primarily focuses on demonstrating substantial equivalence to a predicate device, particularly for newly added electrode models. However, it does not explicitly detail acceptance criteria or a comprehensive study proving the device meets specific performance thresholds in a clinical or AI-assisted context.

The document is a K223805 510(k) submission for an electrosurgical cutting and coagulation device. The key information is about the device's technical specifications and the comparison of the subject device (AGNES with additional electrode models) to its predicate device (AGNES with a previously cleared electrode model).

Based on the provided text, a robust study proving the device meets acceptance criteria, especially in the context of an AI/human-in-the-loop diagnostic accuracy study, is NOT present. The document describes a bench testing and an animal testing study to demonstrate the safety and effectiveness of the device as an electrosurgical tool, but not a study designed to evaluate diagnostic performance or human reader improvement with AI assistance.

Therefore, many of the requested sections regarding acceptance criteria and performance in a diagnostic or AI-assisted context cannot be directly answered from the provided text.

Here's an analysis of what CAN be extracted or inferred from the document regarding its performance in the context of a 510(k) submission, and what cannot:

1. Table of Acceptance Criteria and Reported Device Performance:

The document doesn't provide a typical "acceptance criteria" table for diagnostic performance metrics (e.g., sensitivity, specificity, AUC). Instead, the "acceptance criteria" can be inferred from the comparison table demonstrating substantial equivalence to the predicate device and the results of the bench and animal testing.

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

• Test Set (for performance validation of the electrosurgical function):
  • Bench Testing: Not explicitly stated as a "sample size" of devices, but implies testing of the subject device and its new accessories against electrical safety and performance standards (IEC 60601-2-2:2017).
  • Animal Testing: Tissues from 3 mini pigs were used for thermal tissue spread experiment (skin, liver, kidney, femoral muscle). Skin from 1 mini pig was used for histopathological analysis. This is not a "test set" in the context of an AI/diagnostic study, but for evaluating the physical tissue effects of the electrosurgical device.
• Data Provenance: The studies were conducted by AGNES Medical Co., Ltd, based in Korea. The provenance of the specific test data for the animal study is "mini pig tissues." It would be considered prospective for the device's validation.

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

• This question is not applicable to the provided document. The document describes a medical device (electrosurgical unit), not a diagnostic AI system requiring expert consensus for ground truth establishment. The "ground truth" in this context relates to the physical and biological effects of the electrosurgical energy, evaluated through standard engineering tests and pre-clinical animal studies. Histopathological analysis for the animal study would typically involve a veterinary pathologist, but their number and specific qualifications are not detailed.

4. Adjudication Method for the Test Set:

• Not applicable in the context of diagnostic AI. For the animal study, the evaluation methods were "Thermal imaging area analysis, the maximum temperature, the time to reach basal temperature, and histopathological analysis." Adjudication among human readers is not relevant here.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done and the effect size of how much human readers improve with AI vs without AI assistance:

• No, an MRMC study was NOT done. This type of study is relevant for diagnostic AI devices where human readers interpret medical images. The AGNES device is an electrosurgical cutting and coagulation device, not an image interpretation or diagnostic AI tool.

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

• Not applicable. The AGNES device is not an algorithm or AI system. It's a hardware medical device used by a human operator. Its performance is inherent in its electrosurgical capabilities, not in an independent software algorithm.

7. The Type of Ground Truth Used:

• Bench Testing: Engineering measurements against established performance standards (e.g., output power, frequency, safety parameters).
• Animal Testing: Direct measurement of physical effects on biological tissues (thermal imaging, temperature readings, histopathological analysis). This is a form of direct biophysical ground truth.

8. The Sample Size for the Training Set:

• Not applicable. The AGNES device is not an AI/ML device, so there is no "training set" in the context of machine learning. Its design and efficacy are based on established electrosurgical principles and engineering/biological validation, not on learned patterns from a dataset.

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

• Not applicable, as there is no training set.

In summary: The provided 510(k) summary focuses on demonstrating the substantial equivalence of an electrosurgical device, particularly regarding the addition of new electrode models, to its predicate. The "studies" mentioned (bench and animal testing) are for validating the physical and biological safety and performance of the electrosurgical function, not for evaluating diagnostic accuracy or AI-assisted human performance, which are the typical contexts for the detailed questions about acceptance criteria and ground truth in your prompt.

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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 footswitch, a hand-piece, single use needle type RF electrodes and FDA cleared Disposable neutral electrode pad (K102372).

This document, K203013, is a 510(k) summary for a medical device called AGNES, an RF electrosurgical device. It's a submission to the FDA to demonstrate substantial equivalence to a previously cleared device (K192728).

The document details changes made to the device and the testing performed to ensure safety and effectiveness. However, it does not contain any information regarding acceptance criteria or a study proving the device meets those criteria in the context of human clinical performance or AI algorithm performance. This is because K203013 is for an electrosurgical device, not an AI or imaging device that would typically have performance metrics like sensitivity, specificity, or reader improvement.

The tests performed are primarily bench tests, animal studies, and biocompatibility tests related to the physical changes made to the device (e.g., power input, connector color, and a new type of RF electrode). Therefore, I cannot fulfill your request for information on acceptance criteria and a study proving performance in the way you've outlined for an AI/imaging device.

To directly address your specific points, based on the provided document:

1. A table of acceptance criteria and the reported device performance: This document does not provide a table of acceptance criteria for clinical performance (e.g., sensitivity, specificity, accuracy) because it's not evaluating an AI or diagnostic imaging device in that manner. The "performance" discussed relates to electrical safety, electromagnetic compatibility, and thermal effects, for which the acceptance is successful compliance with recognized standards.

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

   • Bench Testing (Electrical Safety, EMC): These tests are typically performed on a sample of the manufactured device and new accessories. Sample size is not specified but would follow standard engineering testing practices for medical devices, often a small number of units.
   • Biocompatibility Testing: Tested on materials of manufacture and the final device. Sample size not specified.
   • Animal Testing: Conducted on tissues from 3 mini pigs for thermal tissue damage/spread, and skin from 1 mini pig for histopathological analysis.
   • Data Provenance: Not explicitly stated for specific test data, but the submitter is Agnes Medical CO., LTD in South Korea.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. The "ground truth" for this device's performance is established by compliance with engineering and biological safety standards (e.g., IEC standards, ISO standards for biocompatibility), not through expert consensus on diagnostic interpretations. For the animal study, histopathological analysis would be performed by a qualified pathologist, but the number and qualifications are not specified.

4. Adjudication method for the test set: Not applicable. There's no human interpretation or diagnostic decision-making being assessed by multiple readers that would require adjudication.

5. If a multi-reader, multi-case (MRMC) comparative effectiveness study was done: No. This is not an AI or diagnostic imaging device; therefore, an MRMC study is not relevant.

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:

   • Bench Testing: Engineering specifications and compliance with international standards (e.g., IEC 60601-1, IEC 60601-2-2, IEC 60601-1-2).
   • Biocompatibility: Compliance with ISO 10993 series standards.
   • Animal Testing: Histopathological analysis of tissue and thermal imaging measurements.

8. The sample size for the training set: Not applicable. This document does not describe an AI/ML device that requires a training set.

9. How the ground truth for the training set was established: Not applicable.

In summary, the provided document pertains to the regulatory clearance of an electrosurgical device based on engineering and biological safety standards, not an AI or diagnostic imaging device involving clinical performance metrics and reader studies.

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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 footswitch, a hand-piece, FDA cleared Single use needle type RF electrodes (K171707) and FDA cleared Disposable neutral electrode pad (K102372).

The provided text is a 510(k) summary for the AGNES RF electrosurgical device. It outlines changes made to an existing device (K160469) and asserts substantial equivalence to meet FDA requirements. However, this document does not contain the acceptance criteria or a study proving device performance against such criteria for a diagnostic or AI-driven device.

This 510(k) summary focuses on demonstrating that modifications made to an existing RF electrosurgical device (AGNES) do not negatively impact its safety and effectiveness compared to the predicate device. It primarily covers design changes, software changes, and performance testing related to international standards for electrosurgical equipment.

Therefore, I cannot provide the requested information from the given text as it is not present. The document focuses on regulatory compliance for modifications to an electrosurgical device, not on diagnostic performance or AI model validation studies.

Here's why the requested information cannot be extracted:

• Acceptance Criteria & Reported Performance: There are no specific acceptance criteria for a diagnostic device or AI system in this document. The "performance" discussed relates to the electrosurgical unit's output power levels, operating time, and compliance with general safety standards for electrosurgical devices (e.g., IEC 60601-2-2).
• Sample Size & Data Provenance (Test Set): No test set for an AI model or diagnostic performance is mentioned. The "tests" performed are for hardware changes and software validation of the electrosurgical unit.
• Number of Experts & Qualifications (Ground Truth): Not applicable, as there's no diagnostic ground truth being established or evaluated.
• Adjudication Method: Not applicable.
• Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study: Not applicable.
• Standalone Performance: The "standalone" performance mentioned refers to the electrosurgical unit functioning by itself, not an AI algorithm.
• Type of Ground Truth: Not applicable; there is no diagnostic ground truth.
• Sample Size (Training Set): Not applicable; no AI model training is mentioned.
• Ground Truth for Training Set: Not applicable.

In summary, the provided FDA 510(k) notification is for a physical medical device (an electrosurgical unit) and its modifications, not for a diagnostic device or AI system that would have the types of performance studies and acceptance criteria you're asking about.

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