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For use in dermatology: incision, excision, ablation, and vaporization with hemostasis of soft tissue, Treatment of back acne Treatment of atrophic acne scars Treatment of facial wrinkles Treatment of mild to moderate acne vulgaris Treatment of Sebaceous Hyperplasia

NOABLE LASER is a laser surgical instrument used during treatment where the laser 1450nm wavelength generated from the diode laser module. It can be used for incision, destruction and removal of skin tissue by illuminating a 1450 nm wavelength laser on the skin tissue.

Based on state-of-the-art diode laser technology, the system offers many advantages, including the combination of the effective wavelengths, excellent pulse characteristics, and unique dynamic cooling device (DCD) and compact instrument. Laser is sent out through the diode laser module equipped inside the Main body to oscillate the laser and the user uses the touch LCD in the Main body and hand-piece to set the output parameters while controlling laser radiation through the foot switch and hand-piece switch. At this point, a coolant is sprayed from the end of the hand- piece to protect skin from the heat generated by the radiated laser, resulting in a reduction in skin irritation and pain.

The provided document is a 510(k) Premarket Notification from the FDA for a medical device called "NOABLE LASER." This document focuses on demonstrating substantial equivalence to a predicate device, rather than providing detailed acceptance criteria and a study report as would be found in a clinical trial. As such, information regarding clinical effectiveness directly linked to numerical acceptance criteria for specific medical conditions is not present.

However, based on the non-clinical testing section, we can infer some "acceptance criteria" related to device performance, safety, and equivalence to established standards.

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

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

Since this is a 510(k) submission and not a clinical study report with specific performance metrics for clinical efficacy, the "acceptance criteria" are primarily based on meeting recognized industry standards and demonstrating similar technological characteristics to the predicate device. Direct numerical performance metrics for clinical outcomes (e.g., reduction in acne lesion count) are not provided in this document.

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

The document primarily describes non-clinical testing. For the biocompatibility tests (cytotoxicity, sensitization, irritation) and the accuracy tests, the "sample size" would refer to the number of test materials, cells, or animals used. However, this specific sample size is not explicitly stated in the provided text.

• Data Provenance: The document does not specify the country of origin for the non-clinical testing data. The manufacturer is based in South Korea, but the testing could have been conducted anywhere. The testing is non-clinical, implying a prospective test design for evaluation against standards.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This is not applicable as the document describes non-clinical engineering and safety testing, not human-read clinical data. "Ground truth" in this context would be defined by the technical standards themselves (e.g., IEC, ISO) and the measurements obtained from the device.

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

This is not applicable as the document describes non-clinical testing and not a study requiring reader adjudication of clinical outcomes.

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 is not applicable. The "NOABLE LASER" is a laser surgical instrument, described as an energy-based device, not an AI-powered diagnostic or assistive tool for human readers. Therefore, an MRMC study comparing human readers with and without AI assistance is not relevant to this device.

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

This is not applicable. The device is a physical laser instrument, not an algorithm. Its operation involves a human operator (physician/dermatologist).

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

For the non-clinical tests described:

• Biocompatibility: The "ground truth" is defined by the toxicological responses of cells or tissues as measured against the criteria established in ISO 10993 standards.
• Electrical Safety, EMC, Laser Safety, Particular Performance: The "ground truth" is adherence to the specifications and limits defined by the IEC standards (IEC 60601-1, IEC 60601-1-2, IEC 60825-1, IEC 60601-2-22).
• Accuracy Testing: The "ground truth" is the specified nominal values and their acceptable tolerance ranges for energy output and laser radiation range.

8. The sample size for the training set

This is not applicable as the device is a laser surgical instrument and not an AI/machine learning algorithm requiring a "training set."

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

This is not applicable for the same reason as above.

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Incision, excision, ablation, vaporization of soft tissue for general dermatology (1064 mm) Tattoo Removal: Dark ink (blue and black) (1064 nm) Tattoo Removal: light ink (red, sky blue, green) (532 nm) telangiectasias (532 nm) spider nevi (532 nm) solar lentiginos, senile lentiginos, becker's nevi, freckles (532 nm) nevus of ota (1064 nm)

The ACTIVO is based on the Nd:YAG(1064nm) and KTP Nd: YAG(532nm) laser technology. It is indicated for the incision, ablation, vaporization of soft tissues for general dermatology. Three basic elements of operations are as follows: 1) A Nd:YAG crystal is used as a gain medium which produces a laser beam. 2) A resonator then amplifies the beam. 3) A lamp that contains Xe gas is used, as a pumping light source. The lamp requires a high-pressure power source device for operation. When the electric energy generated from the high-pressure power source is induced into the electrode of the lamp, it converts into light energy(1064nm). This converted light energy pumps the Nd: YAG crystal - a gain medium - and the light exhausted from the crystal is amplified into a specific wavelength light(532nm). As it passes between the resonant gases, laser beam radiates to an output unit. The regulation of laser output and repetition rate can be set by the user via GUI (Graphic User Interface) and controlled by microprocessor, which interfaces with the power supply.

This FDA 510(k) summary is for the ACTIVO laser surgical instrument. It relies on non-clinical testing for substantial equivalence, as no clinical testing was performed or required. Therefore, the device does not have acceptance criteria defined by an effectiveness study that proves its performance against clinical endpoints. Instead, its acceptance criteria are based on meeting design specifications and demonstrating substantial equivalence to a predicate device through non-clinical performance and safety standards.

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

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

Since this filing is based on substantial equivalence through non-clinical testing, the "acceptance criteria" are the standards and design specifications met by the device, and the "reported device performance" is that it successfully met these standards.

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

• Sample Size for Test Set: Not applicable. No clinical test set involving human or animal subjects was used as the submission relies solely on non-clinical testing and comparison to a predicate device.
• Data Provenance: Not applicable for clinical data. For non-clinical testing, the tests were conducted at facilities presumably in the country of manufacture or a certified testing laboratory, but this specific detail is not provided. The device manufacturer is DAEJU MEDITECH ENGINEERING CO., LTD. in Seoul, Republic of Korea.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)

• Not applicable. There was no clinical test set requiring expert ground truth establishment. The document refers to compliance with international standards and internal verification for non-clinical aspects.

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

• Not applicable. No clinical test set requiring adjudication was used.

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. No MRMC study was conducted. This device is a laser surgical instrument, not an AI-assisted diagnostic or treatment planning system that would involve human readers.

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

• Not applicable. This is a physical medical device (laser surgical instrument), not a standalone algorithm.

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

• Not applicable for clinical ground truth. For non-clinical testing, the "ground truth" equivalent would be the established specifications and parameter tolerances of the device, and the established limits and requirements of the referenced international standards (e.g., IEC 60601-1, ISO 10993).

8. The sample size for the training set

• Not applicable. This device is a physical laser instrument, not an AI/ML-based device that requires a training set.

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

• Not applicable. No training set was used.

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The AROMA GRAND 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.

The subject device. AROMA GRAND is a surgical device, which is intended for hair removal, permanent hair reduction on all skin tvpes (Fitzpatrick skin type I-VI).

It utilizes a semiconductor diode as a laser source (808nm). The laser power is delivered to the treatment area via a laser hand-piece. The emission laser is activated by a footswitch.

The provided text describes information about a 510(k) submission for a medical device called "AROMA GRAND". However, it does not contain any information regarding acceptance criteria or a study that proves the device meets those acceptance criteria in the context of clinical performance or diagnostic accuracy.

The document focuses on demonstrating substantial equivalence to a predicate device (VIKINI DIODE LASER SYSTEM) through non-clinical testing, primarily related to electrical safety, EMC, particular performance testing (likely referring to laser output specifications), and software verification.

Here's a breakdown of why I cannot answer most of your questions based on the provided text:

• No clinical performance acceptance criteria: The document does not define specific clinical performance metrics (e.g., sensitivity, specificity, accuracy for a diagnostic device; or hair reduction percentage, lesion clearance rate for a therapeutic device) or set acceptance criteria for them.
• No clinical study to prove acceptance criteria: Because no clinical performance acceptance criteria are mentioned, there is no corresponding study described to prove these criteria were met.
• "Not applicable" for Clinical Testing: The document explicitly states "Clinical Testing: Not applicable," which further confirms the absence of a clinical study testing the device's efficacy/performance in human subjects for its intended use.

Therefore, I can only address the questions where relevant information is found in the text, primarily focusing on the non-clinical testing.

Here's an analysis of what information is available:

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

   • Clinical Performance: Not applicable/Not provided. The document does not define specific clinical performance acceptance criteria for its indications (hair removal, permanent hair reduction, treatment of benign vascular and pigmented lesions) nor report clinical performance against such criteria.

   • Non-Clinical Performance (General Safety and Technical Standards): The document reports compliance with several international standards. These standards implicitly contain acceptance criteria for the respective tests.

     Acceptance Criteria (Implied by Standard Compliance)	Reported Device Performance
     Biocompatibility:
     - Cytotoxicity standards (ISO 10993-1)	Conducted and reported
     - Sensitization standards (ISO 10993-1)	Conducted and reported
     Electrical Safety:
     - AAMI/ANSI/ES 60601-1:2005(R) 2012 and A1:2012	Complies with standard
     Electromagnetic Compatibility (EMC):
     - EN 60601-1-2:2015	Complies with standard
     Laser Safety:
     - IEC 60825-1:2014	Complies with standard
     Particular Laser Performance:
     - IEC 60601-2-22:2012	Complies with standard
     Software Verification & Validation:
     - FDA Guidance for Software in Medical Devices	Conducted and provided
     Accuracy Testing (Energy Output & Spot Size):
     - Does not deviate from tolerance/fixed value	Tested and complies

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

   • For Non-Clinical Testing: The document does not specify sample sizes (e.g., number of devices tested) for the non-clinical tests.
   • For Clinical/Performance Testing: "Clinical Testing: Not applicable." Therefore, no test set, sample size, or data provenance for clinical performance is provided.

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

   • For Clinical/Performance Testing: "Clinical Testing: Not applicable." Thus, no experts were used to establish ground truth for a clinical test set.
   • For Non-Clinical Testing: Not specified. Standard compliance is typically verified by testing laboratories.

4. Adjudication method for the test set

   • For Clinical/Performance Testing: "Clinical Testing: Not applicable." No adjudication method described.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

   • This is not an AI-assisted device. The AROMA GRAND is a laser surgical instrument. Therefore, an MRMC comparative effectiveness study regarding "human readers improving with AI" is not relevant and was not performed/described. "Clinical Testing: Not applicable."

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

   • This device is not an algorithm; it is a physical laser device. Standalone algorithm performance is not applicable. "Clinical Testing: Not applicable."

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

   • For Non-Clinical Testing: The "ground truth" for the non-clinical tests is established by the requirements and specifications of the respective international standards (e.g., specific thresholds for electromagnetic emissions, safety limits for laser output, pass/fail criteria for biocompatibility).
   • For Clinical/Performance Testing: "Clinical Testing: Not applicable." No ground truth for clinical outcomes is discussed.

8. The sample size for the training set

   • For Non-Clinical Testing: Not applicable. Non-clinical tests do not typically involve "training sets" in the machine learning sense.
   • For Clinical/Performance Testing: "Clinical Testing: Not applicable."

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

   • For Non-Clinical Testing: Not applicable.
   • For Clinical/Performance Testing: "Clinical Testing: Not applicable."

In summary, the provided FDA 510(k) letter and summary describe a device that is cleared based on substantial equivalence to a predicate device, supported by extensive non-clinical testing demonstrating compliance with safety and performance standards, but without any clinical performance studies on human subjects.

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