(205 days)
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 Handpieces are indicated for:
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.
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 560-980nm 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, 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 spider 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 700-980m 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)
The RF MicroNeedling Handpiece is indicated for:
Use in dermatologic and general surgical procedures for electro-coagulation and hemostasis
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 user-friendly console that houses the power supply, the electronics, and the user interface. It then has 3 handpieces that are attached to the console, and through the user interface can be selected for use in the treatments.
There are 3 separate handpieces. Each handpiece has its own indication for use.
- Diode Laser Handpiece
- IPL Handpiece
- RF Microneedling Handpiece ●
The Diode Laser handpiece uses laser light in the 808nm wavelength for hair removal. The laser eliminates hair, employing a method knows as selective photothermolysis. This involves disabling hair regrowth mechanism by raising the temperature of the hair follicle high enough to irreversibly damage the follicle's germinative cells without damaging the epidermis and the surrounding tissue. The germinative root resides inside the follicle but is located to the outer follicles sheath. Therefore, the complete follicle volume must be heated above 70° C to accomplish permanent destruction of all stem cell.
Delivering a 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 Needle RF 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 handpieces 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. No handpieces or accessories are intended to be sterilized or disinfect by the end user. There are no components of the Darwin that are reusable.
This document, a 510(k) premarket notification for the Darwin device, primarily focuses on demonstrating substantial equivalence to predicate devices based on comparable technological characteristics and safety standards. It does not contain information about a study proving the device meets specific acceptance criteria related to its performance in terms of accuracy, sensitivity, or specificity, which would typically be seen for AI/ML-based medical devices.
The "Performance Data" section (VIII) describes electrical safety and electromagnetic compatibility testing, as well as thermal testing for the RF Microneedling handpiece. This type of performance data is focused on the device's physical and functional safety and effectiveness, rather than clinical efficacy or diagnostic accuracy as might be evaluated for an AI algorithm.
Therefore, I cannot provide the requested information for acceptance criteria and a study that proves the device meets those criteria in the context of an AI/ML algorithm's performance. The document describes a device that is intended for aesthetic and surgical procedures using laser, IPL, and RF microneedling technologies, not an AI or algorithm-driven device that would have metrics like sensitivity, specificity, or human reader improvement with AI assistance.
To directly answer your request based on the provided text, but noting the absence of AI/ML performance metrics:
-
A table of acceptance criteria and the reported device performance:
The document focuses on demonstrating substantial equivalence to predicate devices rather than listing specific, quantitative performance acceptance criteria for clinical outcomes like an AI/ML system would. The "Performance Data" section primarily addresses safety and functional performance testing.Acceptance Criteria (Inferred from testing) Reported Device Performance (Summary) IEC 60601-1 (Basic Safety & Essential Performance) Performed, demonstrating compliance. IEC 60601-1-2 (Electromagnetic Compatibility) Performed, demonstrating compliance. IEC 60601-2-22 (Laser Equipment Safety & Performance) Performed, demonstrating compliance. IEC 60601-2-2 (HF Surgical Equipment Safety & Performance) Performed, demonstrating compliance. RF Microneedling Thermal Performance Demonstrated "consistent formation of measurable thermal lesions for medium and highest energy level settings in the treatment of in vivo pig skin and in vitro liver and kidney tissues at a temperature close to physiological," leading to the conclusion that "treatment by this device at the appropriate testing settings will result in a desirable clinical treatment effect." -
Sample sized used for the test set and the data provenance:
- Sample Size: Not specified quantitatively for any human subjects or patients. For the thermal testing, "in vivo pig skin and in vitro liver and kidney tissues" were used, but specific numbers of subjects/samples are not provided.
- Data Provenance: Not applicable in the context of clinical patient data for AI validation. The testing described is laboratory/benchtop testing and animal model (pig skin) testing.
-
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
Not applicable. This device is not an AI/ML diagnostic or prognostic tool that requires expert-established ground truth from images or data. Ground truth in this context would relate to the physical effects of the device (e.g., thermal lesion formation), not interpretations by human experts. -
Adjudication method (e.g., 2+1, 3+1, none) for the test set:
Not applicable. This is not an AI/ML device requiring human annotation for ground truth establishment. -
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. The Darwin device is not an AI-assisted diagnostic or prognostic tool. No human-in-the-loop study comparing human performance with and without AI assistance was described. -
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Not applicable. This device does not feature a standalone algorithm that would be tested for its performance. -
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
For the thermal testing, the ground truth was the direct observation and measurement of thermal lesions in biological tissues (pig skin, liver, kidney). This is an objective physical outcome. -
The sample size for the training set:
Not applicable. This device is not an AI/ML system that undergoes a "training set" phase. -
How the ground truth for the training set was established:
Not applicable, as there is no training set for an AI/ML algorithm described in this submission.
§ 878.4810 Laser surgical instrument for use in general and plastic surgery and in dermatology.
(a)
Identification. (1) A carbon dioxide laser for use in general surgery and in dermatology is a laser device intended to cut, destroy, or remove tissue by light energy emitted by carbon dioxide.(2) An argon laser for use in dermatology is a laser device intended to destroy or coagulate tissue by light energy emitted by argon.
(b)
Classification. (1) Class II.(2) Class I for special laser gas mixtures used as a lasing medium for this class of lasers. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 878.9.