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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 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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This device is intended for use in dermatologic and general surgical procedures for electro-coagulation.

This device is an instrument used for tissue coagulation by means of high-frequency current. It consists of the main unit, Four handpieces, GP Cable, foot switch, LCD touchscreen, ground pad and power cable. The SILKRO has two operating modes: monopolar mode and bipolar mode.

The provided text does not contain information about acceptance criteria and reported device performance from a clinical study for the SILKRO device. Instead, it focuses on non-clinical tests and a comparison of technological characteristics with predicate devices to demonstrate substantial equivalence for regulatory clearance.

Specifically, the document lists:

• Non-clinical tests submitted (Section 7): These are primarily related to electrical safety, electromagnetic compatibility, usability, risk management, software validation, and biocompatibility, conducted according to various IEC and ISO standards.
• Ex vivo animal testing (Section 7): This was conducted to evaluate the thermal effect of the handpieces on tissue, observing depth and zone of coagulation and thermal damage.
• Biocompatibility testing (Section 8): Confirmed that materials met biocompatibility requirements for skin contact, following ISO 10993 standards.
• Sterilization and shelf-life testing (Section 9): Demonstrated a sterility assurance level and a three-year shelf-life through accelerated aging tests.

Therefore, I cannot provide the requested information for the following points as they are not present in the given text:

1. A table of acceptance criteria and the reported device performance.
2. Sample size used for the test set and the data provenance.
3. Number of experts used to establish the ground truth for the test set and their qualifications.
4. Adjudication method for the test set.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, or the effect size of how much human readers improve with AI vs without AI assistance.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.).
8. The sample size for the training set.
9. How the ground truth for the training set was established.

The document's conclusion (Section 11) states that "Results of performance testing demonstrated substantial equivalence of the subject device to the predicate," but it refers to the non-clinical tests mentioned earlier, not a clinical study involving human patients or a complex diagnostic performance evaluation.

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