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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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