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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.

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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.

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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.

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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.

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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.

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RetiCapture is a digital hand-held (portable) eye-fundus camera used to record digital photographs and video of fundus of the human eye and surrounding area.

RetiCapture is a hand-held digital ophthalmic camera that together with the optics modules used to capture digital images and video of fundus and surrounding area of the human eye. RetiCapture has an LED light source visible white light and infrared light. Light target LED's are used to eye position fixation during imaging. Image data is stored on the Flash memory card using 5 megapixel CMOS sensor and transferred to the PC by using USB connection. Device has rechargeable battery.

The provided text is a 510(k) Summary for the RetiCapture ophthalmic camera. It outlines the device's technical characteristics and its substantial equivalence to a predicate device. However, it does not contain information about acceptance criteria or a study proving the device meets those criteria, especially in the context of an AI/human-in-the-loop performance study.

The document focuses on:

• Device Description: A hand-held digital ophthalmic camera.
• Intended Use: To record digital photographs and video of the fundus of the human eye and surrounding area.
• Technical Characteristics: Comparison of specifications (FOV, Resolution, etc.) with a predicate device (MiiS Horus Scope DEC 100).
• Non-clinical tests: Performance according to various IEC and ISO standards related to safety, electromagnetic compatibility, photobiological safety, risk management, software validation, and ophthalmic instruments.

Therefore, I cannot provide the detailed information requested in the prompt based solely on the provided text. The requested information regarding acceptance criteria, study performance, sample sizes, expert ground truth, adjudication methods, MRMC studies, standalone algorithm performance, or training set details for AI models is not present in the given document.

The document only states that "Extensive software testing and validation have been conducted to ensure that RetiCapture performs to acceptable level, repeatedly and reliably referring to consensus standard IEC 62304:2006 and ISO 14971:2012." This refers to software engineering practices and risk management, not a clinical performance study with defined acceptance criteria for image quality or diagnostic accuracy.

To fulfill your request, I would need a different document that details the clinical or performance validation studies, including specific acceptance criteria and the results of those studies.

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The CuRAS Nd; Y AG laser system in indicated for : the incision, 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

1064nm Wavelength:

• Tattoo removal: dark ink (black, blue and brown)
• Removal of Nevus of Ota
• Removal or lightening of unwanted hair with or without adjuvant preparation.
• Treatment of Common Nevi
• Skin resurfacing procedures for the treatment of acne scars and wrinkle

The CuRAS Nd;YAG laser system is comprised of the following major components:

• 1. The main console unit
• 2. Delivery handpieces
• 3. Footswitch.
• 4. Accessories

The provided text is related to a 510(k) premarket notification for a medical device (CuRAS Nd:YAG Laser) and primarily focuses on its substantial equivalence to a predicate device. It details product specifications, intended use, and technical comparisons.

However, the document does not contain information regarding acceptance criteria, specific device performance metrics in the context of a study, sample sizes for test/training sets, data provenance, number or qualifications of experts for ground truth, adjudication methods, MRMC studies, standalone performance, or how ground truth was established for a training set.

The document explicitly states under "VIII. Clinical Data [21 CFR 807.92(b) (2)]":
"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."

Therefore, I cannot provide the requested information as it is not present in the given text. The document refers to compliance with safety standards (IEC 60601-series and IEC 60825-1) and software verification/validation, but these are general compliance requirements rather than specific performance studies with acceptance criteria as typically understood in the context of diagnostic or AI-driven device performance.

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SECRET RF 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 bipolar handpiece(Two type) with disposable 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 provided text describes a 510(k) summary for a medical device called "Secret RF". This document focuses on demonstrating substantial equivalence to a predicate device, "FRAXIS DUO_RF PART" (K160312), rather than providing detailed acceptance criteria and studies for independent device performance.

Therefore, many of the requested categories cannot be directly addressed from this document because it's a submission for substantial equivalence based on similar technology and intended use, not a clinical trial evaluating specific performance metrics against pre-defined acceptance criteria.

However, I can extract information related to the device's technical specifications and the non-clinical testing performed to establish safety and effectiveness for a 510(k) submission.

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

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

The document does not explicitly state acceptance criteria in terms of numerical performance metrics (e.g., sensitivity, specificity, accuracy). Instead, the "performance" demonstrated is that the device's technological characteristics and non-clinical test results are comparable or compliant with established standards, supporting its substantial equivalence to the predicate device.

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

• Non-Clinical Testing (IEC Standards): Not applicable for "sample size" in the conventional sense of a clinical test set. These are engineering and electrical safety tests typically performed on a device unit.
• Animal Testing: Micropig models were used. The document does not specify the number of animals (sample size).
• Data Provenance: The document implies these tests were conducted by the manufacturer or accredited labs for the purpose of the 510(k) submission. No country of origin for the "test set" data is explicitly stated beyond the manufacturer being in Korea. The animal study results are not presented in a way that would indicate retrospective or prospective, but animal studies for regulatory submissions are typically prospective.

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

This is not applicable to the non-clinical and animal testing described. Ground truth in a clinical context (e.g., expert consensus on image interpretation) is not part of this 510(k) summary, which focuses on device safety and technical equivalence. The animal study generated histological data, which would typically be analyzed by veterinary pathologists, but this detail and the number of experts are not provided.

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

This is not applicable. Adjudication methods are typically used in clinical studies involving interpretation of data by multiple human readers, which is not described here.

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 a 510(k) submission for a non-AI electrosurgical device, not an AI-powered diagnostic or assistive tool.

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

Not applicable. This device is an electrosurgical tool, not an algorithm. Its performance is directly tied to its physical and electrical characteristics and how it interacts with tissue.

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

• For Non-Clinical Testing (IEC standards): "Ground truth" is compliance with the defined parameters and limits of the specific international standards (e.g., electrical safety, EMC).
• For Animal Testing: The ground truth for evaluating tissue effects was histological data obtained from micropig models, presumably interpreted by pathologists.

8. The sample size for the training set

Not applicable. This is not an AI/machine learning device that requires a training set.

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

Not applicable. There is no training set for this device.

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• 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 FRAXIS DUO is intended for use in dermatologic and general surgical procedures for electro-coagulation and hemostasis

FRAXIS DUO is a combination of two separate systems: CO2 laser and HF electrosurgical system. The Laser and High Frequency(=Radio frequency) can not be used simultaneously. FRAXIS DUO's CO2 laser includes the system main body, different handpieces(Fractional type, Non-fractional type), footswitch and an LCD Touch screen control panel. FRAXIS DUO's CO2 laser utilize a CO2 RF tube to generate a laser beam with a wavelength of 10,600nm and use different handpiece(Fractional type, Non-fractional type) for different indications for use. The physician can optimize the effect for different applications by controlling the power of the laser pulse and using a different handpiece. The laser are supplied with different handpieces depending upon the device configuration. FRAXIS DUO's High Frequency(=Radio Frequency) includes the system main body, a Bipolar handpiece equipped with disposable micro-needle electrodes, footswitch and an LCD touch screen control panel. The HF energy is delivered using disposable micro-needle electrodes.

The provided text describes the FRAXIS DUO device and its predicates, but it does not contain acceptance criteria for device performance or a study demonstrating that the device meets such criteria.

Instead, the document details a substantial equivalence determination by the FDA for the FRAXIS DUO to legally marketed predicate devices. This determination is based on a comparison of technological characteristics, indications for use, and performance data. The performance data provided is primarily non-clinical and animal testing to demonstrate safety and similar tissue effects to the predicate devices.

Here's a breakdown of the requested information based on the provided text, highlighting what is present and what is missing:

1. Table of Acceptance Criteria and Reported Device Performance:

The document does not provide a specific table of acceptance criteria with quantitative metrics and their corresponding reported device performance values for the FRAXIS DUO. Instead, it relies on demonstrating comparable performance and safety to predicate devices through a series of tests.

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

• Sample Size for Test Set: Not explicitly stated in terms of a specific number of cases or individuals for a clinical test set. The "test set" here refers to animal models for safety and histological evaluation.
  • Laser Part Animal Testing: "In vivo animal testing using micropig models was also conducted..." (Number of micropigs not specified).
  • HF Electrosurgical Part Animal Testing: "In vivo animal testing using micropig models was also conducted..." (Number of micropigs not specified).
• Data Provenance: The animal studies were "In vivo animal testing using micropig models." The country of origin of the data is not specified, but the manufacturer is ILOODA CO LTD. from South Korea. The studies are prospective in nature, as they involve conducting tests on live animals to gather data.

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

• Number of Experts: Not explicitly stated.
• Qualifications of Experts: The histological evaluations were performed to assess "depth and zone of ablation and thermal damage." It is implied that qualified personnel (e.g., veterinary pathologists or dermatopathologists) conducted these evaluations, but their specific qualifications (e.g., "radiologist with 10 years of experience") are not mentioned.

4. Adjudication Method for the Test Set:

• Adjudication Method: Not described. The text mentions "Histologic evaluation was done by H&E for immediately after procedure" and that "Histologically, both FRAXIS DUO and predicate device created tissue coagulation in the dermis and show similar coagulated pattern." This implies a single assessment for each sample, rather than a multi-reader adjudication process.

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

• No, an MRMC comparative effectiveness study was not done. The document focuses on non-clinical and animal testing for safety and technological equivalence, not on human reader performance or improvements with AI assistance. The device is a physical instrument, not an AI diagnostic tool.

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

• Not applicable. The FRAXIS DUO is a laser and electrosurgical instrument for therapeutic use, not an algorithm, so a standalone algorithm performance study is irrelevant to this device.

7. Type of Ground Truth Used:

• For the animal studies, the "ground truth" was established through histological evaluation (H&E staining) of tissue samples from the micropigs, assessing the "depth and zone of ablation and thermal damage." This is a form of pathology-based ground truth for observable tissue effects.

8. Sample Size for the Training Set:

• Not applicable. This device is a therapeutic medical instrument, not a machine learning or AI model that requires a training set. The performance data is based on engineering tests and animal studies.

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

• Not applicable, as there is no training set for this device.

Summary regarding "Acceptance Criteria and Study":

The document details the FDA's 510(k) clearance process based on substantial equivalence to predicate devices. This means the FRAXIS DUO demonstrated that it is as safe and effective as existing legally marketed devices.

The "study" that supports this is a combination of:

• Biocompatibility testing (ISO10993-1;2009 for patient contact materials).
• Non-clinical testing for electrical safety (IEC 60601-1, IEC 60601-1-2) and laser safety (EN 60825-1, EN 60601-2-22).
• In vivo animal testing using micropig models to histologically evaluate the depth and zone of ablation and thermal damage immediately, 7 days, and 14 days post-treatment for both the CO2 laser part and the HF electrosurgical part. An additional preclinical test compared 2MHz and 1MHz high-frequency characteristics on tissue.

The "acceptance criteria" were implicitly met by demonstrating that the device fulfilled the requirements of the specified standards and that the animal study results showed the fractional and non-fractional modes were "safe for use and effective" and produced "similar coagulated pattern[s]" to the predicate device in histological evaluations. There were no explicit numerical cut-offs or performance targets presented as "acceptance criteria" in this summary.

Ask a specific question about this device

The VIKINI DIODE LASER SYSTEM is indicated for hair removal, permanent hair reduction and for the treatment of benign vascular and pigmented lesions.

Permanent hair reduction is defined as the long-term, stable reduction in the number of hairs re-growing when measured at 6, 9, and 12 months after the completion of a treatment regimen.

Not Found

The provided document, a 510(k) premarket notification letter for the VIKINI DIODE LASER SYSTEM, does not contain details about specific acceptance criteria or an internal study demonstrating how the device meets those criteria.

This document is an FDA clearance letter, which means the FDA has determined that the VIKINI DIODE LASER SYSTEM is substantially equivalent to legally marketed predicate devices. This determination is based on the information provided by the manufacturer in their 510(k) submission, which would have included data to support the device's safety and effectiveness. However, the clearance letter itself does not typically detail the specific studies performed or the acceptance criteria used within those studies.

To answer your request, one would typically need to review the actual 510(k) submission document (which is not provided here) that ILOODA Company, Ltd. submitted to the FDA for the VIKINI DIODE LASER SYSTEM. This submission would contain the detailed studies, acceptance criteria, and performance data.

Based solely on the provided text, I can only state the 'Indications for Use', which serve as the broad performance goals for the device:

• Hair removal
• Permanent hair reduction (defined as the long-term, stable reduction in the number of hairs re-growing when measured at 6, 9, and 12 months after the completion of a treatment regimen)
• Treatment of benign vascular lesions
• Treatment of pigmented lesions

Therefore, I cannot provide the requested information regarding:

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
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, or its effect size
6. If a standalone performance test was done
7. The type of ground truth used
8. The sample size for the training set
9. How the ground truth for the training set was established

In summary, the provided document is a regulatory clearance letter, not the technical study report itself.

Ask a specific question about this device