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The Diode Laser is intended for use in dermatologic and general surgical procedures.

The Standard Mode is intended for hair removal, permanent hair reduction.

The FHR Mode is intended for hair removal, permanent hair reduction.

The diode laser system is intended for use on all skin types (Fitzpatrick skin types I-VI), including tanned skin.

The diode laser is a surgical device intended for use in dermatologic and general surgical procedure. It utilizes a semiconductor diode with invisible infrared radiation as a laser source (808 nm). The laser power is delivered to the treatment area via a laser handpiece. The emission laser is activated by a footswitch.

The diode laser emits 808nm wavelength laser which is absorbed by melanin and at the same time greatly reduce the absorption by water and haematoglobin. The laser beam penetrates through epidermis into dermis and absorbed by melanin in hair and hair follicle, producing laser photothermal effect, conducting the energy from hair section to hair toot, rising temperature of melanin and decomposing it, thus reaching effect of hair removal.

During treatment, the Sapphire in handpiece assures reliable and constant cooling result for skin surface with the maximum comfort and safety. When the laser system starts to release energy, skin cooling system works automatically. The cooling system reduces the temperature of treatment area and increase treatment comfort.

The proposed device includes power supply system, central control system, cooling system, laser deliver system and safety feature.

The cover material of the proposed device is ABS (Acrylonitrile Butadiene Styrene) plastic. The patient contact components in laser handpiece include supporting plate which is made of stainless steel and crystal which is made of sapphire.

The provided document describes a 510(k) submission for a Diode Laser (model DLH-06) intended for dermatologic and general surgical procedures, specifically hair removal and permanent hair reduction.

Here's an analysis of the provided information concerning acceptance criteria and the supporting study:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present "acceptance criteria" for the device's clinical efficacy (e.g., specific percentage of hair reduction deemed acceptable). Instead, it relies on demonstrating substantial equivalence to a predicate device. The performance is assessed through bench tests to meet design specifications and compliance with relevant standards.

However, we can infer some "performance characteristics" from the device specifications and the comparison to the predicate device.

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

The document describes bench tests to verify design specifications and compliance with standards. It does not describe a clinical study with a "test set" of patients. Therefore, information on sample size for a test set, country of origin, or retrospective/prospective nature of a clinical study is not available in this document. The data provenance is from laboratory/engineering bench tests.

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

Since no clinical study with a patient "test set" is described, there is no information regarding experts used for establishing ground truth or their qualifications. The "ground truth" here is defined by the technical specifications and adherence to international safety and performance standards for laser devices.

4. Adjudication Method for the Test Set

As no clinical study or test set involving human subjects is described, there is no information on an adjudication method.

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

No MRMC comparative effectiveness study is mentioned or implied. The focus of this submission is on demonstrating substantial equivalence through technical specifications and compliance with standards, not on comparing human reader performance with and without AI assistance. This device is a laser system, not an AI-assisted diagnostic tool.

6. Standalone (i.e., algorithm only without human-in-the-loop performance) Study

This concept is not applicable to the device described. The device is a laser system, not an algorithm, and its operation involves a human operator. The document describes bench tests of the device itself.

7. Type of Ground Truth Used

The "ground truth" for this submission is based on:

• Engineering Specifications: The design parameters of the device (wavelength, fluence, spot size, etc.).
• International Standards: Compliance with recognized safety and performance standards for medical electrical equipment and laser products (e.g., IEC 60601 series, IEC 60825-1, ISO 10993 series).
• Predicate Device Characteristics: The established safety and effectiveness characteristics of the legally marketed predicate device (Alma Lasers Modified Diode Laser Module with SHR Treatment Mode). Substantial equivalence is the primary ground for approval.

8. Sample Size for the Training Set

Since no clinical study (and thus no "training set" of patient data for an algorithm) is described, there is no information on the sample size for a training set.

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

As there is no training set mentioned in the context of an algorithm or clinical study, this information is not applicable. The "ground truth" for the device's development and testing involved adherence to technical specifications, manufacturing standards, and regulatory requirements, as assessed through bench testing and comparison to a predicate device.

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APOLLO V+ Medical Platform / APOLLO IV+ Medical Platform / Nice Station Light Based Platform, the three models have the same intended use. They can be used in dermatology, cosmetic medicine, and other surgical applications according to the different handpieces.

The specific indications should reference to the indications of each handpiece.

1. Er:YAG laser handpiece:

• Incision, excision, ablation, vaporization of soft tissue .
• The non-ablative treatment of facial wrinkles -

2. Long Pulse Nd:YAG Laser Handpiece:

• Removal of unwanted hair, for stable long term or permanent hair reduction and for treatment . of PFB.
• 3. Q-Switch Nd:YAG Laser Handpiece: Tattoo Removal: Dark Ink: (Black & Blue) Nevus of Ota Skin resurfacing procedures for the treatment of acne scars and wrinkles
• 4. IPL Handpiece:

The Intense Pulsed Light wavelengths are 515-1200 nm

HR (Hair Removal): 650-1200 nm

The removal of unwanted hair from skin types I-V, and to effect stable long-term, or permanent, hair reduction in skin types I-V through selective targeting of melanin in hair follicles

SR (Skin Remove): 570-1200nm

The treatment of benign pigmente (epidermal and cutaneous) lesions, such as warts.

VR (Vascular and Pigmented Lesion Removal): 515-1200nm

The treatment of benign vascular lesions including port wine stains, hemangiomas, facial, truncal and leg telangiectasias, rosacea, melasma, angiomas and spider anglormas, polkiloderma of civate; leg veins, and venous malformations.

APOLLO V+ Medical Platform / APOLLO IV+ Medical Platform / Nice Station Light. Based Platform, the three models have the same modules and handpieces. The equipment configuration is the only difference among the three models.

APOLLO V+ Medical Platform is a modular multifunction device. The equipment can be used in dermatology, cosmetic medicine and other surgical according to the different handpieces. The APOLLO V+ Medical Platform has three laser handpieces of Er: YAG laser, Long Pulse Nd: YAG Laser, and Q-Switch Nd: YAG Laser, and one IPL handpiece.

APOLLO IV+ Medical Platform is a modular multifunction device. The equipment can be used in dermatology, cosmetic medicine and other surgical according to the different handpieces. The APOLLO IV+ Medical Platform has three laser handpieces of Er: YAG laser, Long Pulse Nd: YAG Laser, and Q-Switch Nd:YAG Laser, and one IPL handpiece. There is one difference between APOLLO IV+ Medical Platform and APOLLO V+ Medical Platform, it is "desktop" style for APOLLO IV+ Medical Platform, and a standard case, with wheels to allow easy movement on the floor, for APOLLO V+ Medical Platform.

Nice Station Light Based Platform is a modular multifunction device. The equipment can be used in dermatology, cosmetic medicine and other surgical according to the different handpieces. The Nice Station Light Based Platform has three laser handpieces of Er:YAG laser, Long Pulse Nd:YAG Laser, and Q-Switch Nd: YAG Laser, and one IPL handpiece. The Nice Station Light Based Platform has a standard case, with wheels to allow easy movement on the floor. The difference between Nice Station Light Based Platform and APOLLO V+ Medical Platform is the appearance.

The user can activate laser emission, IPL emission by means of a footswitch.

APOLLO V+ Medical Platform / APOLLO IV+ Medical Platform / Nice Station Light Based Platform includes:

a) Power supply
The system provides energy for the operation of equipment.

b) Control system
The system controls the cooling system, Laser emission and delivery system and safety features according the setting parameter which is set by user via the user interface.

c) User interface
User sets treatment parameter via the user interface.

d) Cooling system,
The cooling system consists of whole device cooling and IPL handpiece skin cooling.

e) Laser emission and delivery system

f) Safety features
The safety features are used to ensure the equipments is operated properly, such as key switch, -- emergency stop switch and interlock control unit.

g) Many handpiece types

• Er: YAG handpiece, 2940 nm wavelength t
• . Long Pulse Nd: YAG laser handpiece, 1064 nm wavelength
• . Q-Switch Nd: YAG laser handpiece, 1064 nm wavelength
• IPL handpiece. 650-1200nm wavelengths in RH filter, 570-1200nm wavelengths in SR filter, 515-1200 nm wavelengths in VR filter.

All of the housing of handpieces are made of ABS (Acrylonitrile Butadiene Stryene), These handpieces can be removed by the user and interchanged.

The principle of generation and treatment of energy sources

There are three kinds of energy sources, laser energy, IPL energy

The principle of generation and treatment of laser energy .
In laser handpiece, there is one optical cavity containing the laser crystal (such as Er. Y AG crystal,

Nd:YAG crystal). The laser beam is activated by means of the use of Xenon lamps.
This beam is directed to the treatment zone by means of a laser viewfinder. When the laser beam contacts human tissue, the energy in the beam is absorbed, resulting in a very rapidly, highly localized temperature increase to the target tissue. The instantaneous temperature increase (thermal effect) causes the cells change of target tissue to achieve laser treatment effect.

The principle of generation and treatment of IPL energy
In IPL module, the IPL (Intense Pulsed Light) which is activated by means of the use of Xenon lamp is directed to the treatment zone via the sapphire in selectable wavelengths. The IPL works on the principle of selective photothermolysis. That is, causing thermal damage to target tissue by using light of appropriate wavelength. The IPL is different from lasers in that it has many wavelengths in each pulse of light instead of just one wavelength. There are three filtered light guide for the selection of the wavelengths range.

The provided text describes a medical device, the APOLLO V+ Medical Platform and its variants, and seeks to establish its substantial equivalence to predicate devices through non-clinical testing. However, the document does not contain information about acceptance criteria or a study proving the device meets acceptance criteria in the manner typically understood for AI/ML-based medical devices.

The document is a 510(k) summary for a laser and IPL platform, which is a hardware-based device, not an AI/ML software. Therefore, the questions related to clinical performance metrics like sensitivity, specificity, reader studies, ground truth establishment, sample sizes for test/training sets, and expert consensus for AI/ML algorithms are not applicable to the content provided.

The text focuses on hardware safety, performance specifications, and biocompatibility, comparing the new device to existing predicate devices to demonstrate "Substantial Equivalence" for regulatory approval.

Here's a breakdown of what is available and why the requested information isn't present:

1. Table of Acceptance Criteria and Reported Device Performance:

• Acceptance Criteria (Implicit from testing): The non-clinical tests were conducted to verify that the proposed device met "all design specifications" and was "Substantially Equivalent (SE) to the predicate device." Implicit acceptance criteria are compliance with various international standards for medical electrical equipment safety, laser product safety, electromagnetic compatibility, and biocompatibility.
• Reported Device Performance:
  • Same output energy, pulse width, repetition rate, and spot size as the predicate device for laser and IPL handpieces.
  • Compliance with IEC 60825-1: 2007 (Safety of laser products).
  • Compliance with IEC 60601-2-22: 1995 (Safety of diagnostic and therapeutic laser equipment).
  • Compliance with IEC 60601-1:1988+A1:1991+A2:1995 (General requirements for safety).
  • Compliance with IEC60601-1-2:2001+A1:2004 (Electromagnetic compatibility).
  • Compliance with ISO 10993-5:2009 (Biocompatibility - Vitro cytotoxicity).
  • Compliance with ISO 10993-10:2002 (Biocompatibility - Irritation and delay-type hypersensitivity).
  • The focusing device (viewfinder) was tested for biocompatibility and deemed not to raise safety and effectiveness problems.
  • The IPL handpiece cooling method, while different from the predicate, complies with IEC 60601-1 and achieves equivalent cooling.
  • Power calibration and disinfection methods are proven safe and effective via test reports.

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

• Not applicable as this is a hardware device. The "test set" would be the device itself and its components undergoing bench testing according to engineering standards. There is no patient data involved in this type of submission for demonstrating substantial equivalence.

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

• Not applicable. Ground truth as typically defined for AI/ML validation (e.g., expert consensus on medical images) is not relevant here. The "ground truth" is adherence to engineering and safety standards.

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

• Not applicable. This concept pertains to resolving discrepancies in expert interpretations for establishing ground truth in clinical studies, which is not part of this technical hardware submission.

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 hardware device; no AI component or human-in-the-loop performance study is described.

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

• Not applicable. There is no algorithm described in the context of standalone performance.

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

• Not applicable. The "ground truth" for this device is its adherence to specified engineering parameters and its compliance with recognized international safety and performance standards.

8. The sample size for the training set:

• Not applicable. There is no AI/ML model for which a training set would be required.

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

• Not applicable.

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The equipment is used for human tissue vaporization. coagulation in dermatology and plastic surgery, general surgery, gynecology, podiatry, dental and otorhinolaryngology,
The equipment is used for human tissue vaporization in dermatology and plastic surgery, general surgery, gynecology, podiatry, dental and otorhinolaryngology,

Trixel CO2 Laser is a carbon dioxide laser used in medical and aesthetic industry for treatment of such skin conditions as fine and coarse wrinkles, scars of various origin, uneven pigmentation and dilated pores. Due to the CO2 laser's high absorption of water, its high-energy beam of laser light interacts with the skin's surface causing the upper layer to peel off and use photothermolysis to stimulate deep cell regeneration and then achieve the target of skin improvement.
The equipment is mainly used for human tissue vaporization, coagulation and exposure to achieve the purpose of treatment.

The provided text does not contain information about acceptance criteria or a study that proves the device meets specific acceptance criteria. The document is a 510(k) summary for a CO2 Laser, focusing on demonstrating substantial equivalence to a predicate device rather than providing a performance study against predefined acceptance criteria.

The summary outlines:

• Device Identification and Intended Use: The proposed device (Trixel CO2 Laser/Trixel II CO2 Laser) is intended for human tissue vaporization and coagulation in various surgical specialties.
• Predicate Device Identification: The predicate device is the CO2 LASER SYSTEM (K101555) from ADVANCED TECHNOLOGY LASER CO., LTD.
• Device Description: Details the components of both Trixel CO2 Laser models.
• Non-Clinical Test Conclusion: States that bench tests were conducted to verify the proposed device met design specifications and was substantially equivalent. It lists compliance with several IEC standards (IEC 60825-1: 2007, IEC 60601-2-22: 2007, IEC 60601-1:1988+A1:1991+A2:1995, IEC60601-1-2:2001+A1:2004). These standards relate to laser safety, medical electrical equipment safety, and electromagnetic compatibility.
• Substantial Equivalence Conclusion: Compares the proposed device to the predicate device, highlighting similarities in product code, regulation number, class, maximum power, work mode, wavelength, mode structure, spot size, and pulse setting. It addresses minor differences (intended use, light arm, aiming beam, cooling system, power input) with analyses concluding they do not introduce safety or effectiveness problems.

Therefore, I cannot extract the requested information regarding acceptance criteria, device performance tables, sample sizes, ground truth establishment, expert qualifications, adjudication methods, MRMC studies, or standalone performance studies from the provided text. The document focuses on regulatory compliance through substantial equivalence, which primarily involves comparing the new device to an existing legally marketed device based on technical specifications and safety standards, rather than conducting new clinical performance trials with specific acceptance criteria.

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