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The VIVACE Electrosurgical System is intended for use in dermatologic and general surgical procedures for electrocoagulation and hemostasis, and the percutaneous treatment of facial wrinkles. This Vivace Electrosurgical System is intended for use with Skin Type I to Skin Type V.

The VIVACE Electrosurgical System is comprised of the following components: the system main body of the device which consists of the LCD touch screen control panel, the high frequency generating output section (main P.C.B board or RF Generator), and the power supply component, the Switching Power Supply (SMPS). The accessories to the device include the handpiece with disposable micro-need le cartridge (electrode) insertion, and foot switch. Radio frequency current (RF energy) is delivered from the RF Generator, through the handpiece and electrode tip into the target tissue. The hand piece being held at right angles, the tip is placed in light contact with the epidermis. As RF energy passes through the skin, it generates an electro thermal reaction, which is capable of coagulating (causing minor dermal damage) the tissue. The bi-polar RF energy is delivered between independent adjacent electrode pairs (total 36 needle electrode, 6 x 6 array insertion). The RF generator, hand piece are not disposable. Each disposable micro-needle cartridge (electrode) is supplied sterile and is for single patient use only and cannot be resterilized.

Here's a breakdown of the acceptance criteria and study information for the VIVACE Electrosurgical System based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size (Clinical Study): 31 participants were enrolled, with 28 subjects completing all three sessions and included in the final study analysis.
• Data Provenance: The study was a "31 patient US study," indicating the data was collected in the United States and was prospective as it involved tracking subjects over time after treatment.

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

• Number of Experts: Three, blinded, independent licensed physicians.
• Qualifications: "Licensed physicians" is the only qualification explicitly stated. No specific experience level (e.g., "radiologist with 10 years of experience") is provided.

4. Adjudication Method for the Test Set

• Adjudication Method: "By 2/3 evaluator agreement (≥ 1 point change) criteria." This means that for a subject to be considered to have improved, at least two out of the three blinded evaluators had to agree on at least a one-point improvement on the score.

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

• No, an MRMC comparative effectiveness study involving human readers with and without AI assistance was not reported in this summary. The study focused on the device's standalone clinical efficacy.

6. Standalone (Algorithm Only) Performance Study

• This device is an electrosurgical system, not an AI algorithm. Therefore, a standalone (algorithm only without human-in-the-loop performance) study in the context of AI is not applicable. The clinical study described evaluates the device's performance when used by clinicians.

7. Type of Ground Truth Used

• Clinical Ground Truth: Expert consensus of three blinded physicians using a validated clinical scoring methodology (9-point Fitzpatrick Wrinkle and Elastosis Scale).

8. Sample Size for the Training Set

• Not Applicable / Not Provided: This device is a medical instrument (electrosurgical system), not an AI algorithm that requires a training set in the typical sense. The summary describes a clinical study to validate the device's performance, not to train a predictive model.

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

• Not Applicable / Not Provided: As in point 8, this is not an AI algorithm with a training set. The "ground truth" (clinical outcomes) described in the performance section was established by expert evaluation.

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INTRAgen is intended for dermatologic and general surgical procedures for electro coagulation and hemostasis.

The INTRAgen uses the principle that coagulation of cellular tissue is caused using the heat generated by the load or contact resistance by carrying high frequency current to the body. Active electrodes of INTRAgen have 2 types according to effective area: model KT-07 (7 mm x 7 mm) and model KT-15 (15 mm x 15 mm). Electrical current flows through the tip of the electrode, through the target tissue and to the patient plate. The active electrodes are for single use. Patient contacting materials are PCB (Polychlorinated Biphenyl) and ABS (Acrylonitrile-Butadiene-Styrene Copolymer). The INTRAgen consists of the following components: INTRAgen (Main Frame), Active Accessory : Active Electrode(KT-07 (7 mm x 7 mm), KT-15 (15 mm x 15 mm)), Handpiece Hanger and Hand-piece, Miscellaneous Accessories : Foot Switch and Power Cable.

The provided document describes the INTRAgen, an electrosurgical cutting and coagulation device and its accessories. The document focuses on demonstrating its substantial equivalence to a predicate device (Thermage ThermaCool System) for dermatologic and general surgical procedures requiring electrocoagulation and hemostasis.

Here's the breakdown of the acceptance criteria and study information:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are not explicitly listed as a separate table but are implied by the types of tests performed and the statement "The INTRAgen met all the acceptance criteria." The performance is reported in the summary tables and discussed in the text.

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

• Test Set Sample Size:
  • Pre-clinical Study: "a porcine tissue model." The exact number of animals or tissue samples is not specified.
  • For Electrical Safety, Biocompatibility, Bench Data, and Sterilization, the "sample size" refers to the tested device units/materials. The document states "The tests were performed on the INTRAgen" and "The active electrodes... Biocompatibility test has been conducted..." without indicating the number of units.
• Data Provenance: The document does not specify the country of origin for the data collection, but the manufacturing company is based in Korea. The studies are described as "pre-clinical" and "bench tests", implying controlled laboratory settings rather than patient data.

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

• Pre-clinical Study:
  • Number of Experts: Not specified.
  • Qualifications: "Histology evaluation" and "immune histochemical and PCR studies" would imply evaluation by qualified scientists or pathologists. However, specific qualifications (e.g., "radiologist with X years of experience") are not provided.
• For other tests (Electrical Safety, Biocompatibility, Bench Data, Sterilization), ground truth is established by meeting recognized standards (e.g., IEC, ISO) and internal specifications, which are assessed by qualified engineers/testers rather than external domain experts in the clinical sense.

4. Adjudication Method for the Test Set

• No adjudication method is described. For the pre-clinical study, the evaluation was stated as "histologically and by RT-PCR," implying objective lab analyses rather than expert consensus requiring adjudication.

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

• No MRMC comparative effectiveness study was done. This device is an electrosurgical unit, not an AI-assisted diagnostic or therapeutic tool that involves human readers interpreting data. The study primarily focuses on the device's technical specifications and biological effects in a pre-clinical model.

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

• This question is not applicable. The INTRAgen is a hardware electrosurgical device, not an algorithm or AI. Its performance is inherent to its physical operation, not an algorithm's output.

7. The Type of Ground Truth Used

• Pre-clinical Trial: The ground truth was based on objective biological markers and histological evaluations:
  • Histological evaluation of wound healing response.
  • Immune histochemical and PCR studies for neocollagenesis and neoelastogenesis.
• Other Tests: Ground truth was based on established industry standards (IEC, ISO), internal engineering specifications, and measurement accuracy.

8. The Sample Size for the Training Set

• Not applicable. This device does not involve an AI algorithm that requires a training set. The "training set" concept is relevant for machine learning models, not for traditional medical devices like electrosurgical units.

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

• Not applicable. As a traditional medical device, there is no training set for which ground truth would be established.

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The Intensif Applicator is intended for use in Dermatologic and General Surgical procedures for electrocoagulation and hemostasis.

EndyMed's Intensif Applicator is a treatment handpiece to be attached to the FDA cleared EndyMed Imagine TC Skin Treatment System (K08346) (EndyMed Pro). The Intensif Applicator has a custom grid array of micro electrodes that is used to deliver the energy into the tissue. The Intensif Applicator tip emits bipolar RF energy that flows between electrodes to create thermal heating of the tissue for hemostasis and coagulation. The Intensif Applicator consists of: . Disposable treatment element (tip) . RF electrodes on a disposable tip . Operation trigger.

Here's a breakdown of the acceptance criteria and study information for the Intensif Applicator, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Study Information

This device did not involve a clinical study with human subjects. The supporting studies are entirely preclinical and ex vivo.

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

• Test Set Sample Size: Not specified. The document mentions "a few Ex Vivo laboratory studies and Ex Vivo animal studies tests" but does not quantify the number of samples or animals used.
• Data Provenance: The studies were "Ex Vivo laboratory studies and Ex Vivo animal studies tests." The location where these studies were performed is not explicitly stated, but the company is based in Israel. This is a preclinical type of data.

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

• This information is not applicable as the studies were preclinical (ex vivo laboratory and animal) and did not involve human interpretation or expert evaluation to establish ground truth in the context of clinical outcomes. The "ground truth" was based on measurable physical and biological effects in the lab.

4. Adjudication Method for the Test Set

• Not applicable. There was no human expert adjudication of a test set as the studies were preclinical.

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, a Multi Reader Multi Case (MRMC) comparative effectiveness study was not performed. This device is not an AI-assisted diagnostic tool; it's an electrosurgical applicator.

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

• While the device itself operates without human intervention post-activation, this question is typically relevant for diagnostic algorithms or AI. For this medical device, the "standalone" performance refers to its ability to achieve its intended physical effect (electrocoagulation and hemostasis) as demonstrated in the ex vivo studies. It is not an "algorithm only" type of device.

7. The Type of Ground Truth Used

• The "ground truth" for this device's performance was established through measurable physical and biological effects in ex vivo laboratory settings and animal tissues. This included:
  • Evaluating thermal and biological effects.
  • Measuring power control and accuracy.
  • Testing safety features functionality.
  • Validating needle depth.

8. The Sample Size for the Training Set

• Not applicable. This device is a medical device for electrocoagulation and hemostasis, not an AI/machine learning algorithm requiring a "training set" of data in the conventional sense. Its design and performance are based on engineering principles and physical testing.

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

• Not applicable, as there was no "training set" in the context of AI/machine learning for this device.

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The Glow by EndyMed is a noninvasive device intended for use in Dermatologic and General Surgical procedures. The TC applicator is indicated for mild to moderate facial wrinkles and rhytides. The FSR applicator is indicated for Dermatological procedures requiring ablation and resurfacing of the skin.

The EndyMed Glow is a non-invasive unit consists of a user interface, programmable logic controller (PLC), an RF power module, internal electronics, and treatment handpieces. The user interface allows the selection of treatment parameters by pressing on the treatment buttons; A LCD screen displays the current treatment settings. The PLC is a specially configured computer that provides the operational and safety functions of the system. The system is connected to one or two out of 2 TC handpieces with different size electrode areas for different treatment sites, or to a FSR handpiece. The RF power module provides RF energy to the handpiece, producing a sinusoidal signal at 1MHz frequency.

The provided text is a 510(k) Summary for the "Glow by EndyMed" device. This document is a premarket notification to the FDA to demonstrate that the device is substantially equivalent to a legally marketed predicate device. It does not contain information about a clinical study designed to prove the device meets specific acceptance criteria.

The document primarily focuses on:

• Device Description and Intended Use: Describing what the device is and what it's used for.
• Predicate Devices: Identifying previously cleared devices to which "Glow by EndyMed" claims substantial equivalence.
• Performance Standards: Stating compliance with general safety and EMC standards for medical electrical equipment.
• Technological Characteristics Comparison with Predicates: Asserting that the device has the same technological characteristics as the predicate devices.

Therefore, the requested information regarding acceptance criteria, device performance, sample sizes, ground truth establishment, expert qualifications, adjudication methods, and MRMC studies cannot be extracted from this document as such studies are not described.

The document states:

• "The Glow by EndyMed has the same technological characteristics (i.e., design, material, chemical composition, energy source) as the predicate devices."
• "The TC applicator has exactly the same RF technology characteristics as the EndyMed Imagine TC Skin Treatment System (K0834610) and the FSR applicator has the same fractional RF technology as the EndyMed Fractional Skin Resurfacing (FSR) Applicator (K101510)."

This indicates that the primary "proof" of meeting acceptance criteria for a 510(k) submission like this is typically through demonstrating substantial equivalence to already cleared devices, rather than through new clinical performance studies with defined acceptance criteria for a novel device. The implicit acceptance criteria are that the device performs as safely and effectively as the predicate devices.

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The Fractional Skin Resurfacing (FSR) Applicator is intended for dermatological procedures requiring ablation and resurfacing of the skin

EndyMed's Fractional Skin Resurfacing (FSR) Applicator is a treatment handpiece to be attached to the FDA cleared EndyMed Imagine TC Skin Treatment System (K08346). The FSR Applicator tip emits bipolar RF energy that flows between electrodes to create micro-ablation points on the skin, forming superficial ablation with a volumetric non ablative heating effect in the dermis.

The provided text describes the EndyMed Fractional Skin Resurfacing (FSR) Applicator and its 510(k) submission. However, it does not contain the specific details required to fully address your request regarding acceptance criteria and a detailed study.

The document states that a "performance testing" was conducted and its results "clearly indicate that the Fractional Skin Resurfacing (FSR) Applicator offers a non-invasive, effective, safe device for skin resurfacing." It also claims the device "is as safe, as effective, and performs at least as safely and effectively as the legally marketed device" (predicate devices).

Here's a breakdown based on the information provided, highlighting what is missing:

1. Table of acceptance criteria and the reported device performance:

Missing Information: The document does not explicitly state specific quantitative or qualitative acceptance criteria (e.g., minimum percentage improvement in skin texture, reduction in wrinkles, safety endpoint thresholds). It only provides a general statement about the device's performance relative to safety and efficacy.

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

Missing Information: The document states "a performance testing" was conducted but does not provide any details on:

• The sample size of participants or data points used in the test set.
• The country of origin for the data.
• Whether the study was retrospective or prospective.

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):

Missing Information: The document mentions "performance testing" but does not describe how ground truth was established, nor does it refer to any experts involved in this process or their qualifications.

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

Missing Information: There is no information provided about any adjudication method used for establishing ground truth or evaluating the test results.

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 (Based on available information): This device is an applicator for dermatological procedures (physical treatment), not an AI-assisted diagnostic device that would involve human readers interpreting results with or without AI. Therefore, an MRMC study related to AI assistance for human readers is not relevant in this context.

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

Not Applicable (Based on available information): Similar to point 5, this is a physical treatment device, not an algorithm. Standalone performance (algorithm-only) is not applicable here. The device's performance inherently involves a human operator.

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

Missing Information: The document does not specify the type of ground truth used for evaluating the device's performance. Given it's a skin resurfacing device, potential ground truths could include clinical assessment scores (e.g., wrinkle scales, skin texture scores), photographic assessment, or potentially histological changes, but none are mentioned.

8. The sample size for the training set:

Missing Information: As the device is not an AI algorithm, there is no "training set" in the conventional sense. The "performance testing" described is likely a clinical trial or study on human subjects, not an algorithm training process.

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

Missing Information: As there is no AI algorithm training set, this question is not applicable.

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