Search Results

The Secret MAX DEEPLUS MENU and SMARTCURE MENU are intended use in dermatologic and general surgical procedures for electro-coagulation and hemostasis.

The WAVPLUS MENU is intended for the treatment of the following medical condition; using the handpiece for delivery of non-thermal RF energy combined with massage;

· Relief of minor muscle aches and pain, relief of muscle spasm

· Temporary improvement of local blood circulation

· Temporary reduction in the appearance of cellulite

Not Found

I am sorry, but the provided text does not contain any information about acceptance criteria or a study that proves a device meets those criteria. The document is an FDA 510(k) clearance letter for the "Secret MAX Multi-platform RF System", outlining its regulatory status and intended use. It does not include details about device performance metrics, study designs, sample sizes, expert qualifications, or ground truth establishment.

Ask a specific question about this device

The SUPER VELOCE and Accessories are indicated for use in surgical, aesthetic, and cosmetic applications requiring selective photothermalysis (photocoagulation) and hemostasis of soft tissue in the medical specialties of general and plastic surgery and dermatology.

• · Mild to moderate inflammatory and pustular inflammatory acne vulgaris.(420nm filter, 560mm filter) · The treatment of benign pigmented lesions including dyschromia, hyperpigmentation, melasma, ephelides (freckles) (515nm filter, 560nm filter)
  · The treatment of cutaneous lesions including warts, scars and striae; (515nm filter)
  · The treatment of benign cutaneous vascular lesions, including port wine stains, hemangiomas, facial, truncal and leg telangiectasias, rosacea, erythema of rosacea, angiomas, poikiloderma of Civate, leg veins and venous malformations; (560nm filter, 590nm filter)
  · The removal of unwanted hair from all skin types, and to effect stable long-term, or permanent, hair reduction(590mm filter, 640nm filter, 695nm filter)
  · Topical heating for the purpose of elevating tissue temperary relief of minor muscle and joint pain and stiffness, the temporary relief of min associated with arthritis, the temporary increase in local circulation where applied, and the relaxation of muscles. In addition, it may also help muscle spasms, and strains, and minor muscular back pain. (800nm filter)
  The integral thermo-electric cooler is incoaling the epidermis at the treatment site prior to, during and after light or laser treatment in general surgery, plastic surgery and dermatology to:
  · Reduce pain during and/or associated with light or laser treatment (via partial anesthesia from cooling);
  · Reduce discomfort during and/or associated with light or laser treatment:
  · Minimize thermal injury, including thermal necrosis, to non-target skin and skin structures during and/or associated with light or laser treatment, thus reducing possible complications such as scabbing, scarring, hyper- and/or hypopigmentation;
  • Allow the use of higher light or laser fluences for light or laser treatments (such as for hair reatment of vascular or pigmented lesions): and
  · Reduce potential side effects of light or laser treatments (such as for hair removal and the treatment of vascular or pigmented lesions)

Not Found

This document (K241699) is an FDA 510(k) clearance letter for the "Super Veloce" device. It outlines the regulatory classification and general controls applicable to the device, but it does not contain information about acceptance criteria or a study that proves the device meets those criteria.

510(k) clearances typically do not include detailed performance study results or acceptance criteria within the clearance letter itself. Instead, the manufacturer submits this information to the FDA as part of their 510(k) application, and the FDA evaluates it to determine substantial equivalence. The clearance letter only states that the device has been determined to be "substantially equivalent" to legally marketed predicate devices.

Therefore, I cannot provide the requested information based on the provided text. The document focuses on regulatory approval, not on the specific performance study details of the device.

Ask a specific question about this device

CO2 LASER Part: Fractional mode is indicated only for ablative skin resurfacing. Non-fractional mode is indicated for incision, excision, ablation, vaporization and coagulation of body soft tissues including intraoral tissues, in medical specialties including aesthetic (dermatology and plastic surgery), otorhinolaryngology (ENT), gynecology, neurosurgery, dental and oral surgery and genitourinary surgery.

HF electrosurgical Part : The Secret Pro is intended for use in dermatologic and general surgical procedures for electro coaqulation and hemostasis

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

Not Found

The provided documents are FDA 510(k) clearance letters for the "Secret Pro" device. These letters indicate the administrative correction of a previous letter and the initial clearance for the device. However, they do not contain any information regarding acceptance criteria, device performance, a study to prove acceptance criteria, sample sizes, data provenance, expert qualifications, ground truth establishment, or any details about standalone performance or comparative effectiveness studies.

The letters primarily focus on:

• Notifying the applicant of an administrative change.
• Confirming the device's substantial equivalence to predicate devices.
• Listing the device's indications for use.
• Reminding the applicant of regulatory requirements (e.g., general controls, quality system regulation, adverse event reporting).

Therefore, I cannot provide the requested information based on the provided text. To answer your questions, details from a specific study report (e.g., a clinical validation study or performance testing report) would be needed, which are not present in these FDA clearance documents.

Ask a specific question about this device

The PENTO Nd: YAG and Alexandrite laser system in indicated for : the incision, ablation, vaporization of soft tissues for general dermatologic and general surgical procedures for coagulation and hemostasis.

755nm Wavelength:

• Temporary hair reduction.
• Stable long-term or permanent reduction through selective targeting of melanin in hair follicles.
• Permanent hair reduction is defined as long-term stable reduction in the number of hairs regrowing after a treatment regime.
• Permanent hair reduction is defined as the long-term, stable reduction in the number of hairs regrowing when measured at 6, 9, and 12 months after the completion of a treatment regime.
• On all skin types (Fitzpatrick I- VI) including tanned skin.
• Treatment of benign pigmented lesions. Treatment of wrinkles.
• The photocoagulation of dermatological vascular lesions (such as port-wine stains, hemangiomas, telangiectasias).

1064nm Wavelength:

• Removal of unwanted hair, for stable long term or permanent hair reduction and for treatment of PFB.
• Permanent hair reduction is defined as the long-term, stable reduction in the number of hairs regrowing when measured at 6, 9, and 12 months after the completion of a treatment regime.
• The lasers are indicated on all skin types Fitzpatrick I- VI including tanned skin.
• Photocoagulation and hemostasis of pigmented and vascular lesions such as but not limited to port wine stains. hemangioma, warts, telangiectasia, rosacea, venus lake, leg veins and spider veins.
• Coagulation and hemostasis of soft tissue.
• Benign pigmented lesions such as, but not limited to, lentigos (age spots), solar lentigos (sun spots), cafe au lait macules, seborrheic keratosis, nevi, chloasma, verrucae, skin tags, keratosis, tattoos (significant reduction in the intensity of black and/or blue-black tattoos) and plaques.
• The laser is indicated for pigmented lesion size, for patients with lesions that would potentially benefit from aggressive treatment, and for patients with lesions that have not responded to other laser treatments.
• Reduction of red pigmentation in hypertrophic and keloid scars where vascularity is an integral part of the scar.
• Treatment of wrinkles.
• Temporary increase of clear nail in patients with onychomycosis (e.g., dermatophyton rubrum and T. mentagrophytes, and/or yeast Candida Albicans, etc.

The PENTO Nd: YAG and Alexandrite laser system in indicated for : the incision, ablation, vaporization of soft tissues for general dermatologic and general surgical procedures for coagulation and hemostasis.

755nm Wavelength:

• Temporary hair reduction.
• Stable long-term or permanent reduction through selective targeting of melanin in hair follicles.
• Permanent hair reduction is defined as long-term stable reduction in the number of hairs regrowing after a treatment regime.
• Permanent hair reduction is defined as the long-term, stable reduction in the number of hairs regrowing when measured at 6, 9, and 12 months after the completion of a treatment regime.
• On all skin types (Fitzpatrick I- VI) including tanned skin.
• Treatment of benign pigmented lesions. Treatment of wrinkles.
• The photocoagulation of dermatological vascular lesions (such as port-wine stains, hemangiomas, telangiectasias).

1064nm Wavelength:

• Removal of unwanted hair, for stable long term or permanent hair reduction and for treatment of PFB.
• Permanent hair reduction is defined as the long-term, stable reduction in the number of hairs regrowing when measured at 6, 9, and 12 months after the completion of a treatment regime.
• The lasers are indicated on all skin types Fitzpatrick I- VI including tanned skin.
• Photocoagulation and hemostasis of pigmented and vascular lesions such as but not limited to port wine stains. hemangioma, warts, telangiectasia, rosacea, venus lake, leg veins and spider veins.
• Coagulation and hemostasis of soft tissue.
• Benign pigmented lesions such as, but not limited to, lentigos (age spots), solar lentigos (sun spots), cafe au lait macules, seborrheic keratosis, nevi, chloasma, verrucae, skin tags, keratosis, tattoos (significant reduction in the intensity of black and/or blue-black tattoos) and plaques.
• The laser is indicated for pigmented lesion size, for patients with lesions that would potentially benefit from aggressive treatment, and for patients with lesions that have not responded to other laser treatments.
• Reduction of red pigmentation in hypertrophic and keloid scars where vascularity is an integral part of the scar.
• Treatment of wrinkles.
• Temporary increase of clear nail in patients with onychomycosis (e.g., dermatophyton rubrum and T. mentagrophytes, and/or yeast Candida Albicans, etc.

The provided FDA document is a 510(k) clearance letter for the PENTO Nd:YAG and Alexandrite laser system. It describes the device's intended use and substantial equivalence to a predicate device, but does not contain information about acceptance criteria, device performance studies, sample sizes, expert qualifications, or ground truth establishment related to an AI/ML component.

Therefore, I cannot extract the requested information based on the input document. The document focuses on the regulatory clearance of a physical laser system, not on an algorithm's performance.

Ask a specific question about this device

The MTX-C1 is intended for the following medical condition; using three types of handpieces for delivery of non-thermal RF combined with massage:

• · Relief of minor muscle aches and pain, relief of muscle spasm
• Temporary improvement of local blood circulation
• · Temporary reduction in the appearance of cellulite

The MTX-C1 main unit is a RF(Radio-frequency) energy generator employed for a variety of aesthetic applications. The Main unit output is set and monitored via touchscreen and controlled by a footswitch.
The main unit can be used with 3 different types of handpieces for treatment.
The system consists of ;

1. Main unit
2. 3 type treatment handpiece
3. Footswitch

• 4. Touch screen(User interface)
     The three treatment handpieces differ in size and configuration and are indicated for the treatment of various size areas.
     The operator can adjust treatment parameters such as the power level and treatment time from the user interface on the Main Unit.
     The handpiece is applied with a rubbing/massaging technique and the applicator should be moved continuously on the skin.

This document is a 510(k) summary for the MTX-C1 device, seeking a substantial equivalence determination to a predicate device (Venus Legacy CX). It primarily focuses on demonstrating equivalence through comparison of technological characteristics and adherence to safety standards, rather than proving diagnostic performance against a specific set of acceptance criteria in a clinical study.

Therefore, the requested information regarding acceptance criteria and a study proving device performance (including sample sizes, expert ground truth, adjudication, MRMC studies, standalone performance, and ground truth establishment for training and test sets) is not present in this document.

The document details the following about the device and its testing:

• Device Name: MTX-C1
• Intended Use: Relief of minor muscle aches and pain, relief of muscle spasm; temporary improvement of local blood circulation; temporary reduction in the appearance of cellulite.
• Predicate Device: Venus Legacy CX (K143554)
• Testing Performed:
  • Biocompatibility testing: Patient contact components and materials tested and validated according to ISO10993-1.
  • Non-Clinical testing (Safety Standards):
    • IEC 60601-1 (General requirements for basic safety and essential performance)
    • IEC 60601-1-2 (Electromagnetic compatibility)
    • IEC 60601-2-2 (Particular requirements for high frequency surgical equipment and accessories)
  • Performance bench testing: The three handpieces of MTX-C1 were tested to achieve superficial skin temperature (40 - 45°C) and maintain it for the required therapy time. This demonstrated that the device "can achieve therapeutic parameters substantially equivalent to the currently cleared predicate device for the intended use."

The document states that "The technological differences... do not alter the device's core technology or performance and have been addressed by the manufacturer through the applicable safety standards... and through non-clinical performance bench testing (Skin temperature)." This strongly suggests that a clinical performance study with human subjects, as would be typical for an AI/CAD device, was not required or conducted for this 510(k) submission, as the substantial equivalence was established through technical and safety testing.

In summary, none of the specific criteria related to clinical study design, ground truth establishment, or human/AI performance metrics (points 1-9 in your request) can be extracted from this document, as it outlines a 510(k) submission primarily based on technological equivalence and adherence to safety standards for an electrosurgical device, not a diagnostic AI algorithm.

Ask a specific question about this device

The Reepot laser system is indicated for the incision, ablation, vaporization of soft tissues for general dermatology, dermatologic and general surgical procedures for coagulation and hemostasis.

532nm Wavelength :

• Tattoo removal: light ink (red, tan, purple, orange, skyblue, green)
• Removal of Epidermal Pigmented Lesions
• Removal of Minor Vascular Lesions including but not limited to telangiectasias
• Treatment of Lentigines
• Treatment of Cafe-Au-Lait
• Treatment of Seborrheic Keratoses
• Treatment of Post Inflammatory Hyper-Pigmentation
• Treatment of Becker's Nevi, Freckles and Nevi Spilus

The reepot Nd;Y AG laser system is comprised of the following major components:

• 1. Laser system console
• 2. LCD control panel
• 3. VSLS handpieces (included camera and LCD display)
• 4. Footswitch.
• 5. Accessories

This document is a 510(k) premarket notification for a laser surgical instrument, the reepot Nd:YAG laser system. It focuses on demonstrating substantial equivalence to a predicate device, not on presenting novel performance data for acceptance criteria against a specific medical condition. Therefore, the detailed information requested regarding clinical effectiveness studies, such as the use of test sets, expert adjudication, MRMC studies, or standalone algorithm performance, is not available in this document.

The document primarily addresses safety and technical equivalence, rather than clinical performance acceptance criteria.

However, I can extract the relevant information that is available:

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

The document doesn't provide specific quantitative "acceptance criteria" in terms of clinical efficacy or diagnostic accuracy. Instead, it demonstrates technical performance and safety compliance by comparing its specifications to a predicate device and adhering to recognized standards.

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

• Not Applicable. No clinical test set data is presented in this 510(k) submission. The submission states, "Based on the similarities in the safety and effectiveness profiles of the subject, reference, and primary predicate devices, no animal or clinical studies were deemed needed to support this submission."

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

• Not Applicable. No clinical test set and thus no ground truth established by experts is mentioned.

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

• Not Applicable. No clinical test set is mentioned.

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 a laser surgical instrument, not an AI-powered diagnostic or assistive tool. No MRMC study was conducted or is relevant to this submission.

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

• Not Applicable. This device is a laser surgical instrument, not an algorithm.

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

• Not Applicable. As no clinical studies were performed for this submission, no ground truth data from such studies is provided. The "ground truth" for this submission revolves around demonstrating that the device's technical specifications and intended use are substantially equivalent to a legally marketed predicate device, and that it adheres to relevant safety standards (IEC 60601-1, IEC 60601-1-2, IEC 60601-2-22, IEC 60825-1).

8. The sample size for the training set:

• Not Applicable. This submission is for a physical medical device (laser system), not a machine learning or AI model that requires a training set.

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

• Not Applicable. No training set for an AI/ML model is involved.

Ask a specific question about this device

The Secret Duo 1540 nm laser handpiece is indicated for use in dermatological procedures requiring the coagulation of soft tissue, as well as for skin resurfacing procedures.

Secret Duo Laser

I am sorry, but the provided text is a 510(k) clearance letter from the FDA for a device called "Secret Duo". It contains regulatory information, indications for use, and contact details, but it does not include any information about the acceptance criteria or a study that proves the device meets those criteria.

Therefore, I cannot answer your request with the information provided.

Ask a specific question about this device

ACUTRON is intended for use in dermatologic and general surgical procedures for electro-coagulation and hemostasis

ACUTRON is High Frequency(=Radio Frequency, RF) includes the system main body, a handpieces with single-use micro-needle type electrodes, footswitch and an LCD touch screen control panel. The RF energy is delivered to the target tissue using a handpiece and disposable tip(micro needle electrode tip), the tip being placed in light contact with the epidermis and the handpiece being held at right angles to the target tissue. As the RF energy passes through the skin, it generates an electro thermal reaction, which is capable of coagulating the tissue. Using the micro needle tip, the ACUTRON creates heat within the target dermal tissue via micro-needles inserted from the tip. The ACUTRON is consists of ; 1) Main unit 2) Smartcure handpiece(FDA cleared K182355) 3) Monopolar type micro-needle electrodes(FDA cleared K182355)

The provided text is a 510(k) summary for the ACUTRON device, an electrosurgical cutting and coagulation device. The document focuses on demonstrating substantial equivalence to predicate devices rather than providing details of new clinical or standalone performance studies with specific acceptance criteria and detailed performance metrics.

Therefore, many of the requested details about acceptance criteria, specific device performance, sample sizes for test/training sets, expert qualifications, adjudication methods, MRMC studies, and standalone performance studies are not available in the provided text.

Here's a breakdown of what can be extracted and what information is missing based on your request:

1. Table of acceptance criteria and the reported device performance

This information is not provided in the document. The 510(k) summary asserts substantial equivalence based on technical specifications and leveraging performance data from predicate devices, rather than presenting new acceptance criteria and a study demonstrating performance against those criteria.

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

Not applicable/Not provided. No new "test set" in the context of a clinical performance study (e.g., diagnostic accuracy) is described. The performance data is primarily "leveraged" from predicate devices and non-clinical testing.

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

Not applicable/Not provided. As no new clinical performance study with a test set requiring expert ground truth establishment is detailed, this information is absent.

4. Adjudication method for the test set

Not applicable/Not provided.

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. The device is an electrosurgical unit, not an AI-powered diagnostic tool. Therefore, an MRMC study comparing human readers with and without AI assistance is not relevant and was not performed.

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

No. The ACUTRON is a medical device (electrosurgical unit), not a software algorithm. Therefore, "standalone performance" in the context of an algorithm is not applicable. The document describes non-clinical testing of the device itself (electrical and mechanical safety, EMC).

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

Not applicable/Not provided for a new clinical study. For the animal testing and biocompatibility, the assumption is that established scientific methods and reference standards would be used, but specific "ground truth" for a performance endpoint is not detailed. The document mentions "Ex-vivo histology testing for ACUTRON handpieces is being leveraged from the Smartcure Applicator handpieces, the predicate device." This implies histology was used as a reference for the predicate, but specific details for ACUTRON are not given beyond leveraging.

8. The sample size for the training set

Not applicable/Not provided. This device is hardware for electrosurgery, not an AI/ML algorithm that requires a "training set."

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

Not applicable/Not provided.

Summary of available information related to performance/testing:

The document focuses on demonstrating substantial equivalence to existing predicate devices (Secret RF Smartcure applicator K182355 and Secret RF K170325). The performance data cited is primarily in the form of non-clinical testing and leveraging existing data from the predicate devices.

Non-clinical testing performed for ACUTRON:

• Biocompatibility testing: Leveraged from the predicate device as patient contact components and materials are identical.
• IEC 60601-1: 2005, AMD 1: 2012: General Requirements for basic safety and essential performance of Medical Electrical Equipment. (The requirements were fulfilled).
• IEC 60601-1-2: 2014: General Requirements for basic safety and essential performance (collateral standards: electromagnetic compatibility). (The requirements were fulfilled).
• IEC 60601-2-2: 2017: Particular requirements for the basic safety and essential performance of high-frequency surgical equipment and high-frequency surgical accessories. (The requirements were fulfilled).
• Animal testing: Ex-vivo histology testing for ACUTRON handpieces is being leveraged from the Smartcure Applicator handpieces (predicate device).

Conclusion from the document:

The manufacturer concludes that "There are no significant differences between ACUTRON and the predicate device and the reference device. The proposed device does not raise any additional questions regarding safety and effectiveness. ACUTRON has the same indication of use and shares the same technological characteristics as the predicate devices." This substantial equivalence argument is based on the shared technical specifications and leveraging the performance and safety data of the predicate devices.

Ask a specific question about this device

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

Not Found

I am sorry, but the provided text does not contain the information necessary to describe the acceptance criteria and the study that proves the device meets those criteria, as requested by your detailed prompt.

The document is an FDA 510(k) clearance letter for the "Secret Duo" device. It primarily states that the device has been determined to be substantially equivalent to legally marketed predicate devices for its stated indications for use (electro-coagulation and hemostasis in dermatologic and general surgical procedures).

Here's a breakdown of what is in the text versus what is missing based on your prompt:

What is in the text:

• Device Name: Secret Duo (and Secret Duo RF Smartcure applicator)
• Regulation Number: 21 CFR 878.4810
• Regulation Name: Laser Surgical Instrument For Use In General And Plastic Surgery And In Dermatology
• Regulatory Class: Class II
• Product Code: GEX, GEI
• Indications for Use: "for electro-coagulation and hemostasis."
• 510(k) Number: K202043

What is NOT in the text (and is required by your prompt):

1. A table of acceptance criteria and the reported device performance: This document does not detail any specific performance metrics or acceptance criteria for the device itself, beyond its substantial equivalence determination.
2. Sample sizes used for the test set and the data provenance: There is no mention of any study, test data, or sample sizes.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: No mention of experts or ground truth establishment.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: No mention of any test set or 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 device is a surgical instrument (laser/RF), not an AI-assisted diagnostic tool for human readers. Therefore, an MRMC study comparing human reader performance with and without AI assistance would not be applicable or described for this type of device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: This pertains to AI algorithms. The Secret Duo is hardware.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): No ground truth is discussed.
8. The sample size for the training set: No training sets are mentioned, as this is not an AI/software device in the context of the prompt's focus.
9. How the ground truth for the training set was established: Not applicable for the same reasons as above.

In summary, the provided document is a regulatory clearance letter, not a detailed study report that would contain the requested information about device performance, study methodology, or ground truth establishment.

Ask a specific question about this device

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

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

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

The Secret RF is consists of ;

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

The Secret RF Smartcure Applicator consists of :

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

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

The document focuses on:

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

Therefore, I cannot fulfill your request for:

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

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

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

Study Description (as reported in the document):

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

1. Biocompatibility Testing:

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

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

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

3. Animal Testing:

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

Missing Information:

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

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

Ask a specific question about this device