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This device indicated for use in dermatologic and general surgical procedures for electrocoagulation and hemostasis.

The DENSITY, DENZA, DENSITY Noir generates radiofrequency (RF) energy by means of high RF at 6.78MHz. 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. In detail, the main body uses the "reverse thermal gradient" principle to deliver RF energy, and thus, heat is generated and selective coagulation occurs while cooling the epidermis, resulting in denaturation and contraction of collagen fibers.

The devices are an RF (radiofrequency), software-controlled electrosurgical device used for electrocoagulation of soft tissue and hemostasis.

It consists of the following components:

• Electrosurgical Unit - Main body
• Handpiece
• electrode tips
• Neutral electrode pad and neutral electrode pad cable, cleared under K201685
• Foot switch
• Power cord

This document is a 510(k) clearance letter for an electrosurgical device, not a study report for an AI device. As such, most of the requested information regarding AI device acceptance criteria, study details, and performance metrics (like effect sizes for AI assistance, standalone performance, training sets, etc.) is not present in the provided text.

The device described, "DENSITY; DENZA; DENSITY Noir," is an electrosurgical cutting and coagulation device. The clearance is based on substantial equivalence to a predicate device (K230663), implying that its performance is expected to be similar to legally marketed devices based on established standards and non-clinical testing.

Here's a breakdown of the information that can be extracted from the provided text, along with an explanation of why other requested information is not available:

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

The document does not explicitly state "acceptance criteria" for performance that would be found in a typical AI device study (e.g., sensitivity, specificity, AUC thresholds). Instead, the acceptance is based on demonstrating substantial equivalence to a predicate device through adherence to recognized standards and non-clinical performance testing.

Acceptance Criteria (Implied by Substantial Equivalence and Standards Adherence):

• IEC 60601-1:2005, IEC 60601-1:2005/AMD1:2012, IEC 60601-1:2005/AMD2:2020 (Basic safety and essential performance)
• IEC 60601-1-2:2014 (Electromagnetic disturbances)
• IEC 60601-2-2 (HF surgical equipment particular requirements)
• IEC 60601-1-6:2013 (Usability) |
  | Software | Software verified and validated to a moderate level of concern, adhering to software lifecycle processes. | Evaluated according to IEC 62304:2006. |
  | Usability/Human Factors | Application of usability engineering to medical devices. | Evaluated in accordance with IEC 62366:2008 based on Human Factor Engineering. |
  | Biocompatibility | Materials in contact with patients are biocompatible. | Documented in reference to ISO 10993-1:2009, ISO 10993-5:2009, and 10993-10:2010. |
  | Bench Testing Performance | Device operates safely and within predefined design specifications, demonstrating intended function for electrocoagulation and hemostasis. | Bench testing conducted to assure safe operation and adherence to design specifications. |
  | Ex Vivo Thermal Testing | Performance in tissue coagulation and hemostasis, particularly regarding thermal effects. | Ex Vivo testing conducted on three types of tissue under GLP Thermal testing in accordance with FDA guidance "Premarket Notification (510(k)) Submissions for Electrosurgical Devices for General Surgery". |
  | Risk Management | Risks identified, analyzed, and controlled. | Risk analysis conducted based on ISO 14971:2019. |
  | Substantial Equivalence | Device is as safe and effective as a legally marketed predicate device, with no new questions of safety or effectiveness raised by differences. | Compared to predicate device K230663. All key parameters (output energy type, user interface, operating frequency, max power, electrode tip types, temperature range, impedance, coolant solution, communication) were found to be substantially equivalent. Minor differences in electrode tip styles and number of tips were deemed not to affect performance or safety. |

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

This information is not provided as this letter describes non-clinical testing for an electrosurgical device, not a clinical study or AI performance evaluation. The "test set" here refers to the materials and conditions used for bench and ex-vivo testing. The document states:

• "Ex Vivo testing conducted on three types of tissue". No specific sample size (e.g., number of tissue samples) or provenance is mentioned beyond "under GLP Thermal testing."

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 applicable/not provided. Ground truth for an AI device is typically established by expert interpretation of medical images or data. For an electrosurgical device, performance is evaluated against engineering specifications, recognized safety standards, and physiological responses during ex-vivo testing, not by expert interpretation generating a "ground truth" in the same sense as an AI diagnostic.

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

This information is not applicable/not provided. Adjudication methods are used in studies involving human interpretation or labeling, especially for AI algorithm ground truth establishment. This is not relevant for the type of non-clinical testing described.

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 applicable/not provided. An MRMC study is relevant for evaluating the impact of AI assistance on human performance, typically in diagnostic imaging. The device in question is a standalone electrosurgical instrument and does not involve AI assistance for human readers.

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

This information is not applicable/not provided. This device is a manual electrosurgical instrument, not an AI algorithm. Therefore, "standalone algorithm performance" is not relevant.

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

For the non-clinical testing:

• Bench testing: Ground truth is defined by the device's technical specifications and engineering design (e.g., power output within tolerance, correct operating frequency).
• Ex Vivo testing: Ground truth would be the expected physiological effect (e.g., desired thermal coagulation) confirmed through histological examination or other scientific methods in the tissue samples. This is implied by "Ex Vivo testing conducted... under GLP Thermal testing."

8. The sample size for the training set

This information is not applicable/not provided. This device is an electrosurgical instrument, not an AI system that requires a "training set."

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

This information is not applicable/not provided for the same reason as point 8.

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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 generates radiofrequency (RF) energy by means of high RF at IMHz 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.

The provided text is a 510(k) Summary for the POTENZA device, which is an electrosurgical cutting and coagulation device. The document primarily focuses on demonstrating substantial equivalence to a predicate device (also named POTENZA, K201685) rather than presenting a study to prove acceptance criteria for a new device.

The "acceptance criteria and reported device performance" in this context refer to the performance standards and test results that show the modified device is substantially equivalent to the previously cleared predicate device.

Here's an analysis of the provided information, framed to address your request as best as the document allows:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state "acceptance criteria" in the traditional sense of a performance study. Instead, it details various tests performed to demonstrate that the changes made to the device (new electrode tips) do not raise new questions of safety or effectiveness and that the device continues to conform to applicable standards. The "reported device performance" are the results of these tests, which consistently show "Pass."

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

• Sample Size: The document does not specify exact sample sizes for each test (e.g., number of devices tested for electrical safety, number of tissue samples for ex vivo testing). For biocompatibility, it states "four newly added electrode tips" were tested, but not the number of samples for each biological test. For ex-vivo testing, it mentions "three types of tissue Liver, Kidney and Muscle," but not the quantity of each.
• Data Provenance: The tests were conducted by Jeisys Medical Inc., the manufacturer. The data is retrospective in the sense that it was generated for this regulatory submission. Country of origin for the data is implied to be South Korea, where Jeisys Medical Inc. is based. The tests were laboratory (bench) and ex-vivo animal tissue tests.

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

Not applicable. This submission relies on performance against recognized standards and technical specifications for electrosurgical devices, rather than human expert-established ground truth for a diagnostic AI algorithm. The device is a physical instrument, not an AI or diagnostic software.

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

Not applicable. Adjudication methods are typically used in studies involving human interpretation or subjective assessments, often in diagnostic contexts. The tests described are objective, physical, electrical, and biological performance tests against defined standards.

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 electrosurgical tool, not an AI-assisted diagnostic or interpretation system. Therefore, an MRMC study or evaluation of human reader improvement with AI assistance is irrelevant to this submission.

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 through bench testing and ex-vivo studies.

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

The "ground truth" for the tests performed consists of:

• Specified limits/ranges within recognized consensus standards (e.g., ISO 10993 series, IEC 60601 series).
• The device's own predefined design specifications for parameters like output accuracy, frequency, power, impedance, needle depth, motor speed, etc.
• The expected biological responses for biocompatibility (e.g., no cytotoxicity, no sensitization).
• Expected thermal effects consistent with electrocoagulation and hemostasis in ex-vivo tissue.

8. The sample size for the training set

Not applicable. No AI/machine learning model is described, so there is no training set.

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

Not applicable. As there is no training set mentioned, the establishment of its ground truth is not relevant.

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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 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. The NEW POTENZA consists of the following components: Electrosurgical Unit - Main body, handpieces (Predicate Device have Motor, AC handpieces), electrode tips for the handpiece – Add three non-invasive tips connect to S handpiece, Neutral electrode pad and neutral electrode pad cable, cleared under K201685, Handpiece stand, Foot switch, Power cord.

This 510(k) summary describes a device (POTENZA) that is substantially equivalent to a previously cleared predicate device. The key changes are the addition of a new S handpiece and three new non-invasive electrode tips. The provided text primarily focuses on demonstrating the safety and effectiveness of these additions through non-clinical testing rather than complex AI performance studies. As such, many of the requested points regarding AI acceptance criteria, MRMC studies, and large-scale data sets are not directly applicable or available in this specific document.

However, based on the provided text, we can describe the acceptance criteria and study that proves the device meets them as they relate to the changes in the device.

1. Table of Acceptance Criteria and Reported Device Performance

For the specific changes (new S handpiece and non-invasive tips), the acceptance criteria are generally focused on safety and functionality demonstrating equivalence to the predicate device.

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DENSITY indicated for use in dermatologic and general surgical procedures for electrocoagulation and hemostasis.

The DENSITY generates radiofrequency (RF) energy by means of high RF at 6.78MHz. 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. In detail, the main body uses the "reverse thermal gradient" principle to deliver RF energy, and thus, heat is generated and selective coaqulation occurs while cooling the epidermis, resulting in denaturation and contraction of collagen fibers.

The DENSITY is an RF (radiofrequency), software-controlled electrosurgical device used for electrocoagulation of soft tissue and hemostasis.

The DENSITY consists of the following components:
•Electrosurgical Unit - Main body
•Handpiece
•6 different electrode tips
•Neutral electrode pad and neutral electrode pad cable, cleared under K201685
•Foot switch
•Power cord

This document is a 510(k) Premarket Notification for the medical device "DENSITY", an electrosurgical unit for dermatologic and general surgical procedures. It seeks substantial equivalence to a predicate device, the Thermage FLX System.

Based on the provided text, the device DENSITY is an electrosurgical cutting and coagulation device. The document does not describe an AI/ML medical device or provide information on acceptance criteria and studies related to AI/ML performance metrics such as accuracy, precision, recall, or human reader improvement with AI assistance. Instead, it focuses on demonstrating substantial equivalence based on technical characteristics and safety standards for an electrosurgical device.

Therefore, many of the requested items related to AI/ML device performance and testing (e.g., acceptance criteria for AI, sample sizes for AI test sets, expert ground truth, MRMC studies, standalone AI performance) are not applicable or cannot be extracted from this document.

However, I can extract the information pertinent to the device's substantial equivalence and non-clinical performance data.

Here's a breakdown of the available information:

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

The document does not specify "acceptance criteria" in terms of performance metrics like sensitivity or specificity for a diagnostic/AI device. Instead, "acceptance" appears to be based on demonstrating substantial equivalence to a predicate device through conformity to recognized standards and comparable technical specifications.

Here's a table summarizing the comparison with the predicate device (Thermage FLX System K170758), which serves as the basis for demonstrating equivalence in performance and safety for this type of device:

• I-Tip II(Around eye), F-Tip II(Face): 2ea
• B-Tip(Body), B-Tip(Body)II: 4ea | - EYE Tip 0.25: 1ea
• TOTAL Tip 3.0: 1ea
• NEW TOTAL TIP 4.0: 1ea
• BODY TIP 16.0: 4ea |
  | Coolant Control Parameters | Type of gas: 1234ze; Method of gas control: Handpiece solenoid control operation; Mouth valve specifications: 12V; Solenoid valve specifications: 1.8V 24.8 BAR | Type of gas: 1234ze; Method of gas control: Handpiece solenoid control operation; Mouth valve specifications: 12V; Solenoid valve specifications: 1.8V 24.8 BAR |

Key takeaway on performance: The document states: "There are no significant differences between DENSITY and the predicate devices (K170758) that would adversely affect the use of the product. It is substantially equivalent to this device in design, function, and technical characteristics." "Any minor differences in the human interface and accessories design do not raise any new types of safety and effectiveness issues, as verified by performance testing."

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

• Test Set Sample Size: "No clinical performance testing was performed." The evaluation relies on non-clinical performance data and comparison to the predicate device's established safety and effectiveness.
• Data Provenance: Not applicable as no clinical test set data was used.

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

• Not applicable as no clinical test set requiring expert ground truth was performed for this 510(k) submission.

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

• Not applicable as no clinical test set requiring adjudication was performed.

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/ML device, and no MRMC study was conducted.

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

• Not applicable. This is not an AI/ML device.

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

• Not applicable as no clinical ground truth was established for this submission. The "ground truth" for demonstrating substantial equivalence is based on established technical standards and the performance of the predicate device.

8. The sample size for the training set:

• Not applicable as this is not an AI/ML device.

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

• Not applicable as this is not an AI/ML device.

Summary of Device Acceptance (for this traditional medical device):

The acceptance of the DENSITY device for marketing is based on demonstrating substantial equivalence to an already legally marketed predicate device (Thermage FLX System K170758). This is achieved through:

• Non-clinical performance data:
  • Evaluation against recognized consensus standards for electrical medical equipment such as IEC 60601-1 (basic safety and essential performance), IEC 60601-1-2 (electromagnetic disturbances), IEC 60601-2-2 (high frequency surgical equipment), IEC 60601-1-6 (usability).
  • Software verification and validation in accordance withIEC 62304 (moderate level of concern) and IEC 62366 (usability engineering/Human Factor Engineering).
  • Biocompatibility testing documented according to ISO 10993 standards.
  • Risk analysis conducted based on ISO 14971.
• Comparison of technical characteristics: As detailed in the table above, demonstrating analogous specifications (e.g., operating frequency, max power, temperature range, impedance, coolant type) to the predicate device.

The document explicitly states: "No clinical performance testing was performed." This means the device's safety and effectiveness for its intended use were demonstrated through the non-clinical testing and the comparison to a legally marketed predicate, rather than through clinical trials with human subjects.

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The SmoothCool HR System is indicated for hair removal (permanent hair reduction).

The SmoothCool HR System is an Intense Pulsed Light (IPL) system used hair removal (Permanent hair reduction) in the area of dermatology. The system consists of a console containing the power unit and control electronics with control and display panel including software. Applicators/hand pieces are connected to the system in order to generate light energy for treatment in the waveband 420-950 nm. Four different hand pieces are attached with the system.

The provided text describes a 510(k) premarket notification for the "SmoothCool HR System," an Intense Pulsed Light (IPL) system for hair removal. However, it does not contain any information regarding acceptance criteria, device performance metrics, or any study involving a test set, expert adjudication, or AI assistance. The document focuses on establishing substantial equivalence to a predicate device based on technical characteristics and modifications (adding more filters).

Therefore, I cannot provide the requested information about acceptance criteria and the study proving the device meets them from the given text. The text only mentions "risk analysis and verification/validation tests" and lists "Energy Output Test" and "Button Operation Test" as performed, but does not provide specific criteria, results, or study details.

Here's what I can extract from the provided text, highlighting the absence of the requested information:

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

   • Information not provided. The document states that "risk analysis and verification/validation tests per modification" were performed, and "the test results support that the modifications do not raise a question in safety and performance." However, no specific acceptance criteria or performance metrics are detailed.

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

   • Information not provided. There is no mention of a test set, sample sizes, or data provenance (e.g., country of origin, retrospective/prospective study design).

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

   • Information not provided. No experts or ground truth establishment for a test set are mentioned.

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

   • Information not provided. No adjudication method is mentioned as a test set or clinical study is not described.

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:

   • Information not provided. This device is an IPL system for hair removal; it is not an AI-assisted diagnostic or imaging device, so an MRMC study with human readers and AI assistance would not be relevant.

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

   • Information not provided. This device is a physical IPL system, not an algorithm.

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

   • Information not provided. Ground truth is not discussed as no clinical study or diagnostic performance evaluation is described.

8. The sample size for the training set:

   • Information not provided. Training sets are not relevant for this type of device and the information provided.

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

   • Information not provided. Ground truth for a training set is not relevant here.

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The SmoothCool HR System is indicated for hair removal (permanent hair reduction).

SmoothCool HR System is an Intense Pulsed Light (IPL) system used for hair removal (permanent hair reduction) in the area of dermatology. The system consists of a console containing the power unit and control electronics with control and display panel including software. Applicators/hand pieces are connected to the system in order to generate light energy for treatment. Four different hand pieces are offered with the system.

The provided document is a 510(k) summary for the SmoothCool HR System, which is an Intense Pulsed Light (IPL) system for hair removal. It aims to demonstrate substantial equivalence to predicate devices, not to describe the acceptance criteria and study that proves the device meets those criteria in the way typically associated with AI/ML-based medical devices or diagnostic devices involving performance metrics like sensitivity, specificity, or AUC.

Therefore, the specific information requested in the prompt (e.g., acceptance criteria table, sample size for test set, number of experts, adjudication method, MRMC study, standalone performance, ground truth type, training set sample size, how ground truth was established for training set) is not present in this document.

This document focuses on regulatory equivalence for a hardware device (IPL system) based on updated components and technical characteristics rather than a software algorithm's performance against clinical endpoints or expert consensus. The "tests" mentioned are for energy output and electrical safety/EMC, which are standard for such physical devices, not performance evaluation against clinical outcomes or a ground truth as would be relevant for devices that interpret data or diagnose conditions.

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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.

The provided text describes the 510(k) premarket notification for the POTENZA device, specifically for the addition of four new electrode tips. The document details the performance data collected to demonstrate that the expanded device meets acceptance criteria and is substantially equivalent to its predicate.

Here's a breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance

The document provides tables of acceptance criteria and results for biocompatibility and sterilization residual testing. Other tests mention conformance to specified standards as their acceptance criteria.

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

The document does not explicitly state sample sizes for specific tests with numerical values like "N=X". For biocompatibility testing, it mentions "the electrode tips were tested as shown in Table 1," implying a sufficient sample was used for each test type according to the standard. Similarly, for bench testing, it states "Jeisys conducted bench testing to assure that the four new electrode pins operate safely and within the predefined design specifications," suggesting testing was performed on the new electrode tips.

The data provenance is from Jeisys Medical, Inc. (South Korea), as the submitter is based in Seoul, Korea. The studies are retrospective in the sense that they are conducted by the manufacturer for the specific purpose of demonstrating substantial equivalence to a predicate device, rather than actively collecting new clinical data on human patients in a prospective manner.

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 document. The studies described are primarily in vitro (biocompatibility, sterilization), in silico (software), and benchtop engineering tests, not studies that require expert-established ground truth from clinical images or patient data.

4. Adjudication Method (e.g., 2+1, 3+1, none) for the Test Set

This information is not applicable and not provided. Adjudication methods are typically used in clinical studies or studies involving expert review of data (e.g., medical images). The tests described here are technical performance tests, not clinical evaluations 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

This information is not provided and not applicable. The device is an electrosurgical cutting and coagulation device, not an AI-powered diagnostic or assistive tool for human readers. No MRMC study was conducted.

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

This information is not applicable. The POTENZA is a hardware device with associated software, not a standalone algorithm/AI for diagnostic interpretation. Its performance is evaluated through its physical and electrical characteristics as well as its software's functionality. The bench testing and electrical safety tests demonstrate the device's standalone performance.

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

The ground truth for the various tests is based on recognized consensus standards and predefined design specifications. For example:

• Biocompatibility: Standards like ISO 10993 and USP provide the "ground truth" for acceptable biological response.
• Electrical Safety & EMC: IEC 60601 series standards define the ground truth for safe electrical operation and electromagnetic compatibility.
• Software Verification: FDA guidance provides the framework for acceptable software validation.
• Bench Testing: The device's own predefined design specifications, safety mechanisms, and performance ranges (e.g., needle depth range of the predicate device) serve as the ground truth.
• Sterilization & Shelf-life: ISO standards (e.g., 10993-7, 11135), ASTM standards (e.g., F1980-16, F1929-15), and USP standards provide the ground truth for acceptable sterilization residuals, sterility assurance level, and packaging integrity.

8. The Sample Size for the Training Set

This information is not provided and not applicable. The described tests are for device validation and verification, not for training an AI or machine learning model.

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

This information is not provided and not applicable. No training set for an AI/ML model is mentioned or relevant to this device's submission.

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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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INTRAcel RF Microneedle System is indicated for use in dermatological and general surgical procedures for electrocoagulation, hemostasis and the percutaneous fractional treatment of the skin in monopolar and bipolar mode.

The INTRAcel RF Microneedle System comprises of two primary components; an RF Generator with User Interface Software and a disposable Electrode Insertion Device with an integrated cable.

Here's an analysis of the provided text regarding the acceptance criteria and supporting studies for the INTRAcel RF Microneedle System:

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 a "test set" in the context of clinical images or patient data that would require sample sizes and data provenance like country of origin or retrospective/prospective nature. The studies described are primarily non-clinical, focusing on device performance, electrical safety, biocompatibility, and software validation.

• Animal Performance Testing (Wound Healing): The "study was conducted to see the wound healing response following FRM treatment for both human and porcine skin." While human skin is mentioned, the detailed procedural description (biopsy time points, H&E, HSP47, RT-PCR) is for "Micro-pig covering 10 weeks." The specific number of human or porcine subjects is not provided. The study appears to be prospective as it involves active treatment and observation over time.

3. Number of Experts Used to Establish Ground Truth and Qualifications

This information is not provided in the document. The studies detailed are technical (electrical, biocompatibility, software) or animal studies for wound healing, which do not typically involve human expert adjudication for ground truth establishing in the sense of medical image interpretation.

4. Adjudication Method for the Test Set

This information is not applicable/provided for the types of studies performed (technical bench testing, software validation, animal studies). There's no indication of a test set requiring adjudication in the context of expert consensus.

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

A MRMC comparative effectiveness study was not performed or reported in this document. The device is an electrocoagulation and microneedling system; therefore, its performance is assessed directly through physical and electrical properties, biological safety, and tissue response, rather than as an aid to human interpretation like an AI diagnostic tool.

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

This concept is not applicable to the INTRAcel RF Microneedle System in the way it's usually applied to AI diagnostic algorithms. The device itself is an active treatment device, not a diagnostic algorithm. The software validation mentioned is for the control and functionality of the device, implying a "standalone" software performance in terms of controlling the hardware as intended, rather than interpreting medical data.

7. Type of Ground Truth Used

• For Electrical Safety & EMC: Ground truth would be defined by the specifications and pass/fail criteria of the referenced international standards (IEC 60601 series).
• For Performance Testing: Ground truth would be defined by the device's design specifications and expected functional outputs (e.g., specific power output, tip count accuracy).
• For Biocompatibility Testing: Ground truth is established by the results of standardized biological tests (cytotoxicity, sensitization, intracutaneous reactivity) against acceptance criteria for biocompatible materials.
• For Sterilization & Shelf Life: Ground truth is established by the ability to achieve sterility (e.g., meeting sterility assurance levels) and maintain device integrity/functionality over time via accelerated aging.
• For Software Verification & Validation: Ground truth is the established "Software Design Specifications" — the software's ability to operate the device as programmed and safely (per the "moderate" level of concern).
• For Animal Performance Testing (Wound Healing): Ground truth is established through histological examination (H&E, HSP47 stain) and molecular analysis (RT-PCR for mRNA changes in collagen, HSPs, MMPs) of biopsied tissue, documenting physiological wound healing responses at different time points and energy levels.

8. Sample Size for the Training Set

This information is not provided and is specifically irrelevant as the document describes a physical medical device, not an AI/ML algorithm that requires a training set of data. The software mentioned handles device control, not predictive modeling or classification.

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

This information is not applicable as there is no "training set" in the context of an AI/ML model for this device.

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The LIPOcel delivers High Intensity Focused Ultrasound (HIFU) energy that can disrupt the Subcutaneous Adipose Tissue (SAT) to provide a non-invasive approach to achieve a desired aesthetic effect. The LIPOcel is specifically indicated for non-invasive waist circumference reduction.

LIPOcel, the Subject Device, is a medical device indicated for non-invasive waist circumference reduction. It consists of a control unit, Touch LCD monitor, power supply unit, and driver unit for irradiation and for setting parameters after the main power and key switch is turned on. The ultrasound energy that is generated from the pulse generator operates the HIFU transducer, and is irradiated from the cartridge when the footswitch or the finger switch on the handpiece is pressed in the READY state and the energy is delivered into the target tissue. HIFU energy is irradiated based on linear scanning method through the hand-piece depending on irradiation energy, irradiation spacing and irradiation distance, that are set in advance by the user. The Subject Device's L13 Cartridge uses the focused ultrasound energy to focus from the transducer onto the fat layer at a depth of 13mm from the surface of the skin. As a result, tissue temperature rises over 55°C and thermal coagulation occurs. Using thermal effects generated by the HIFU transducer, cellular disruption of the subcutaneous adipose tissue occurs. This thermal coagulation results in the contraction of the collagen and subsequently results in destruction of the adipose tissue. The destroyed adipose tissue is cleared via an inflammatory response.

Here's an analysis of the provided text to extract the acceptance criteria and study details:

1. Table of Acceptance Criteria and Reported Device Performance:

The document describes the device's performance in terms of waist circumference reduction. It does not explicitly state pre-defined acceptance criteria in a quantitative format for the primary effectiveness endpoint (waist circumference reduction). However, it reports the study outcome, which implicitly serves as the performance achieved.

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