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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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OTC: For minor wounds, ulcerations and burns, abraded skin, and irritated areas.

Professional: Intended in the management of:

• diabetic foot ulcers;
• leg ulcers (venous stasis ulcers, arterial ulcers and leg ulcers of mixed etiology);
• pressure ulcers/sores (partial and full thickness);
• 1st and 2nd degree partial thickness burns;
• grafted and donor sites and traumatic and surgical wounds.

Activon Tulle is a sterile wound care dressing for use in moist wound management. Activon Tulle is offered as 2x2 inch and 4x4 inch non-adherent knitted viscose primary dressing impregnated with 100% Manuka honey for effective wound treatment.

The provided text does not contain information about acceptance criteria or a study proving that the device (Activon Tulle) meets such criteria in terms of performance metrics like accuracy, sensitivity, or specificity.

Instead, the document is a 510(k) summary for a medical device (Activon Tulle) and its FDA clearance letter. It focuses on demonstrating substantial equivalence to an existing predicate device (Medihoney Dressings With Active Manuka Honey) for its intended use, rather than presenting a performance study against predefined acceptance criteria for the device's efficacy.

Here's a breakdown of what the document does include, and why it doesn't fit the requested format:

• Device Description and Intended Use: Clearly defines what Activon Tulle is and what types of wounds it is intended to manage.
• Technological Characteristics and Substantial Equivalence: Compares Activon Tulle's characteristics to its predicate device, highlighting similarities and minor differences (e.g., 100% Manuka honey in Activon Tulle vs. Manuka honey with calcium alginate in the predicate). This is the core of a 510(k) submission.
• Assessment of Performance Data and Safety: Mentions "Biocompatibility testing (cytotoxicity, sensitization and irritation) performed with Activon Tulle demonstrates that the dressing is safe for its intended use." This is about safety, not performance against clinical efficacy metrics.
• FDA Clearance Letter: Confirms that the FDA has reviewed the 510(k) submission and determined the device to be substantially equivalent to previously cleared devices.

Therefore, I cannot provide the requested table and study information because it is not present in the provided text. The document describes a regulatory submission pathway (510(k)) that focuses on substantial equivalence for market clearance, which typically does not require extensive clinical efficacy studies with predefined acceptance criteria as would be expected for novel or high-risk devices.

To summarize, for each of your requested points:

1. A table of acceptance criteria and the reported device performance: Not provided. The document focuses on substantial equivalence rather than performance metrics.
2. Sample sized used for the test set and the data provenance: Not provided. No clinical performance study data is included. Biocompatibility testing is mentioned, but no details on sample size or data provenance are given.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable/Not provided. No clinical performance study requiring expert ground truth is described.
4. Adjudication method (e.g., 2+1, 3+1, none) 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: Not applicable/Not provided. This device is a wound dressing, not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable/Not provided.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc): Not applicable/Not provided.
8. The sample size for the training set: Not applicable/Not provided.
9. How the ground truth for the training set was established: Not applicable/Not provided.

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