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The Diode Laser Handpiece is indicated for: The hair removal single (HRS) and hair removal moving (HRM) mode are intended for permanent reduction in hair regrowth defined as 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. Use on all skin types (Fitzpatrick I-VI) including tanned skin. The IPL Handpiece has various filters to create different wavelengths. The various wavelengths are broken down by wavelength and applicable indication for use: Intended for use in aesthetic applications requiring selective photothermolysis (photocoagulation or coagulation) and hemostasis of soft tissue in the medical specialties of general and plastic surgery, and dermatology. The IPL handpiece is indicated for: Indication for Use for the 430-980nm wavelength . Benign pigmented epidermal and cutaneous lesions including dyschromia, hyperpigmentation, melasma, Ephelides (freckles), and striae. • Benign cutaneous vascular lesions, including port wine stains, hemangiomas, facial and truncal telangiectasias, angiomas, and poikiloderma of Civatte. · For use on Fitzpatrick skin types (I-V) Indication for use for the 515-980mm wavelength . Benign pigmented epidermal and cutaneous lesions including dyschromia, hyperpigmentation, melasma, Ephelides (freckles), and striae. • Benign cutaneous vascular lesions, including port wine stains, hemangiomas, facial and truncal telangiectasias, angiomas, poikiloderma of Civate and Lentigines. • For use on Fitzpatrick skin types (I-V) Indication for use for the 560-980mm wavelength • Benign pigmented epidermal and cutaneous lesions including dyschromia, hyperpigmentation, melasma, Ephelides (freckles), and striae. • Benign cutaneous vascular lesions, including port wine stains, hemangiomas, facial and truncal telangiectasias, angiomas, poikiloderma of Civate and Lentigines. • The removal of unwanted hair to effect stable long-term or permanent hair reduction • For use on Fitzpatrick skin types (I-V) Indication for use for the 585-980mm wavelength • Benign pigmented epidermal and cutaneous lesions including dyschromia, hyperpigmentation, melasma, Ephelides (freckles), and striae. • Benign cutaneous vascular lesions, including port wine stains, hemangiomas, facial and truncal telangiectasias, angiomas, and poikiloderma of Civatte. • The removal of unwanted hair to effect stable long-term or permanent hair reduction • For use on Fitzpatrick skin types Indication for use for the 640-980mm wavelength . Benign pigmented epidermal and cutaneous lesions including dyschromia, hyperpigmentation, melasma, Ephelides (freckles), and striae. • Benign cutaneous vascular lesions, including port wine stains, hemangiomas, facial and truncal telangiectasias, angiomas, and poikiloderma of Civatte. • The removal of unwanted hair to effect stable long-term or permanent hair reduction • For use on Fitzpatrick skin types (I-V) Indication for use for the 700-980nm wavelength • The removal of unwanted hair and to effect stable long-term or permanent hair reduction. Permanent reduction in hair regrowth 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 regime • For use on Fitzpatrick skin types (I-V) RF Microneedling Handpiece The RF MicroNeedling Handpiece is indicated for use in dermatologic and general surgical procedures for electrocoagulation and hemostasis Thermal RF Handpiece The Thermal RF Handpiece is indicated for heating for the purpose of elevating tissue temperature for selected medical conditions such as temporary relief of pain, muscle spasms, and increase in local circulation.

The Darwin is a Class II Medical Device that combines multiple technologies into one platform for use in dermatologic and aesthetic procedures. The system is comprised of a micro-processor-controlled and userfriendly console that houses the power supply, the electronics and the user interface. It has 4 handpieces that are attached to the console, which can be selected for use in treatment through the user interface. There are 4 separate handpieces. Each handpiece has its own indication for use. - . Diode Laser Handpiece - IPL Handpiece - RF Microneedling Handpiece . - Thermal RF The Diode Laser handpiece uses laser light in the 808nm wavelength for hair removal. The laser removes hair, employing a method knows as selective photothermolysis. This involves raising the temperature of the hair follicle without damaging the epidermis and the surrounding tissue. Delivering pulsed light using a coherent light source of 808nm wavelength, the diode laser handpiece is intended for hair removal and permanent hair reduction on skin types (Fitzpatrick skin types I - V). The user can choose from two modes: hair removal shot (HRS) and hair removal moving (HRM) when using the Diode laser handpiece. The IPL Handpiece produces light pulses with a specific duration, intensity, and spectral distribution allowing for a controlled and confined energy delivery into tissue. IPL use in dermatology relies on the basis that certain targets for energy absorption (chromophores) are capable of absorbing energy from this broad spectrum of light wavelength (absorptive band) without exclusively being targeted by their highest absorption peak. The IPL Handpiece has various filters to create different wavelengths. The handpiece is Intended for use in aesthetic and cosmetic applications requiring selective photothermolysis (photocoagulation or coagulation) and hemostasis of soft tissue in the medical specialties of general and plastic surgery, and dermatology. Each wavelength has its own indications for use, which are listed in the tables below. Filters for the non-invasive IPL handpiece include 430nm, 515nm, 560nm, 585, 640nm, and 700nm. The user can select two treatment modes: ST (Skin Type) and HR (Hair Removal) when using the IPL handpiece. The RF Microneedling handpiece operates using sterile, single-use, multi-needle tips (10 pin and 25 pin) and is intended for use in dermatologic and general surgical procedures for electro-coagulation and hemostasis. The RF Microneedling handpiece generates radiofrequency (RF) energy by means of bipolar RF at 2 MHz. The RF handpiece penetrates micro needles directly into the skin and delivers high frequency energy. This energy flows through the electrode to the tissue and uses heat generated by load or contact resistance to induce coagulation. The RF energy is delivered through the skin into the target tissue via a handpiece equipped with an electrode tip. As the RF energy passes through the tissue, it generates an electrothermal reaction which is capable of coagulating the tissue. The RF Microneedling Handpiece has a single use sterile disposable cartridge. This is the only sterile component on the device. The RF Microneedling handpieces are not intended to be sterilized or disinfected by the end user. The Thermal RF Handpiece is indicated for heating for the purpose of elevating tissue temperature for selected medical conditions such as temporary relief of pain, muscle spasms, and increase in local circulation.

The provided document is a 510(k) summary for the Darwin device, which includes several handpieces (Diode Laser, IPL, RF Microneedling, Thermal RF). The submission aims to demonstrate substantial equivalence to legally marketed predicate devices.

Here's an analysis of the acceptance criteria and supporting study 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" for performance in the typical sense of a target value. Instead, it demonstrates performance by showing technical specifications that are either identical or considered similar/a subset of predicate devices. The entire document is essentially a comparison study against predicate devices to establish substantial equivalence.

Therefore, the "acceptance criteria" are implicitly met by demonstrating these technical equivalences.

Study that proves the device meets the acceptance criteria:

The provided text focuses on demonstrating substantial equivalence to predicate devices rather than reporting on a de novo clinical trial with specific performance metrics and their achievement. The "study" here is a comparison to legally marketed predicate devices based on their indications for use and technical specifications.

The document lists the following performance data provided in support of the substantial equivalence determination:

• IEC 60601-1: General Requirements for basic safety and essential performance of medical electrical equipment.
• IEC 60601-1-2: General Requirements for basic safety and essential performance: electromagnetic compatibility.
• IEC 60601-2-22: Particular requirements for basic safety and essential performance of surgical, cosmetic, therapeutic, and diagnostic laser equipment.
• IEC 60601-2-2: Particular requirements for the basic safety and essential performance of high-frequency surgical equipment and high-frequency surgical accessories.
• ISO 10993-1: Biological Evaluation of Medical Devices.

These are international consensus standards related to electrical safety, electromagnetic compatibility, and biocompatibility, which verify the device's fundamental safety and performance aspects. The successful completion of these tests demonstrates that the Darwin device meets recognized safety and effectiveness benchmarks, aligning with the performance of its predicate devices.

2. Sample size used for the test set and the data provenance:
The document does not describe a test set or test subjects in the context of a clinical performance study. The evaluation relies on comparison to predicate devices and adherence to international safety standards. Therefore, information regarding "sample size" for a comparative clinical test set or data provenance (country of origin, retrospective/prospective) is not applicable or provided here.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
This information is not applicable or provided. The ground truth is established by the existing regulatory clearance of the predicate devices and the technical specifications required to meet IEC and ISO standards.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
This information is not applicable or provided. There is no described "test set" in the context of human interpretation or diagnostic evaluation that would require an adjudication method.

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 information is not applicable or provided. The Darwin device is not described as an AI-assisted diagnostic tool for human readers. It is a physical device for dermatologic and surgical procedures.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
This information is not applicable or provided. As mentioned, the Darwin device is a physical therapeutic/surgical instrument, not a diagnostic algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
The "ground truth" in this context is established by:

• Regulatory Clearance of Predicate Devices: The FDA has already determined the predicate devices to be safe and effective for their stated indications.
• International Consensus Standards: Adherence to standards like IEC 60601-1, IEC 60601-1-2, IEC 60601-2-22, IEC 60601-2-2, and ISO 10993-1 provides the ground truth for electrical safety, electromagnetic compatibility, and biocompatibility.

8. The sample size for the training set:
This information is not applicable or provided. There is no mention of an AI model or training set in this submission.

9. How the ground truth for the training set was established:
This information is not applicable or provided for the same reason as above.

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