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510(k) Data Aggregation
(26 days)
Intended for use in aesthetic and cosmetic applications requiring selective photothermolysis (photocoagulation or coagulation) and hemostasis of soft tissue in the medical special and plastic surgery, and dermatology.
The treatment of benign pigmented epidermal lesions including dyschromia. hyperpigmentation, melasma, and ephelides (freckles), lentigines, nevi, melasma, and cafe-au-lait macules.
The treatment of benign cutaneous vascular lesions including port wine stains, hemangiomas, facial, truncal and leg telangiectasias, rosacea, erythema of rosacea, angiomas, poikiloderma of Civatte, leg veins and venous malformations. Use on all skin types (Fitzpatrick I- VI).
The treatment of benign pigmented lesions including café -au-lait (macules), lentigines (senile and solar), freckles (ephelides), chloasma, nevi, nevus of Ota, and Becker's Nevi. • The treatment of other pigmented cutaneous lesions including verrucae, skin tags, keratosis, and plaques. • The treatment of benign cutaneous vascular lesions including port wine stains, hemangiomas, facial, truncal and leg telangiectasias, rosacea, angiomas and spider angiomas, poikiloderma of Civatte, leg veins and venous malformations. • Use on skin types (Fitzpatrick I-V).
The Advanced Fluorescence Technology (AFT) 650-950 nm handpiece (with and without contact-cooling) is indicated for: The treatment of tattoos, the treatment of moderate inflammatory acne vulgaris, the treatment of benign pigmented epidermal lesions including dyschromia, hyperpigmentation, melasma, and ephelides (freckles), lentigines, nevi, melasma, and cafe-au-lait, the treatment of cutaneous lesions including warts, scars and striae, the treatments vascular lesions including port wine stains, hemangiomas, facial, truncal and leg telangiectasias, rosacea, erythema of rosacea, angiomas and spider angiomas, poikiloderma of Civatte, leg veins and venous malformations. The removal of unwanted hair and to effect stable long-term or permanent hair reduction. Use on all skin types (Fitzpatrick I-VI), including tanned skin
Intended for use in aesthetic and cosmetic applications requiring selective photothermolysis (photocoagulation or coagulation) and hemostasis of soft tissue in the medical special and plastic surgery and dermatology The Advanced Fluorescence Technology (AFT) 420-950 nm Acne Module Applicator (with and without contact-cooling) is indicated for:
The treatment of moderate inflammatory acne vulgaris.
The treatment of benign pigmented epidermal lesions including dyschromia, hyperpigmentation, melasma, and ephelides (freckles).
The treatment of cutaneous lesions including warts, scars and striae.
The treatment of benign cutaneous vascular lesions including port wine stains hemangiomas, facial, truncal and leg telangiectasias, erythema of rosacea, angiomas and spider angiomas, poikiloderma of Civatte, leg veins and venous malformations.
Use on all skin types (Fitzpatrick I-VI).
Intended to emit energy in the infra-red spectrum to provide topical heating for the purpose of elevating the tissue temperature.
For the temporary relief of minor muscle pain and stiffness, the temporary relief of minor joint pain associated with arthritis, the temporary increase in local circulation where applied, and the relaxation of muscles; may also help muscle spasms, minor sprains and strains, and minor muscular back pain.
The Iris diode is intended for use for vascular lessons, spider naevi, teleangiectasis, red superficial veins o fthe legs and face, pigmented lesions (e.g. cafe-au-lait stains, lentigo), hemangiomas, port wine stains, rosacea.
The Alma Harmony is a Class II Medical Device that combines multiple technologies into one platform for use in dermatologic, aesthetic procedures and pain management 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 has 6 applicators that are attached to the console, which can be selected for use in treatment through the user interface.
There are 6 separate applicators. Each handpiece has its own indication for use.
- Iris VL / PL is an IPL handpiece operating in the wavelength range of 540nm-950nm ●
- Iris Dye VL and Dye SVL is an IPL handpiece operating in the wavelength range of ● 500nm-600nm
- Iris SHR is an IPL handpiece that operates in the wavelength range of 650nm-950nm
- Iris Acne is an IPL handpiece operating in the wavelength range of 420nm 950nm ●
- Iris NIR is near infrared with a wavelength of 1300nm ●
- Iris Diode is a 520nm diode laser.
The provided text is a 510(k) Premarket Notification from the FDA regarding Alma Lasers, Inc.'s Alma Harmony device. This document focuses on demonstrating substantial equivalence to existing legally marketed devices, rather than proving that the device meets specific performance-based acceptance criteria through a clinical study.
Therefore, the document does not contain the information requested for acceptance criteria and a study proving the device meets them, particularly regarding AI-assisted performance, reader studies, or detailed performance metrics. The crucial sentence in Section VIII states: "Based on the similarities in the safety and effectiveness profiles of the subject and the predicate, no clinical studies were deemed needed to support this submission."
This means the submission relies on bench testing, software verification/validation, and comparison to predicate devices to demonstrate safety and effectiveness, rather than a clinical trial with acceptance criteria for performance.
Therefore, I cannot populate the requested information regarding acceptance criteria, study data, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, or ground truth establishment relevant to an AI/performance study, as this information is not present in the provided document.
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(89 days)
The Aurora DS is indicated for the removal of unwanted hair from skin types I-VI, and to effect stable long-term, or permanent, hair reduction.
The Aurora DS is a device indicated for the removal of unwanted hair from skin types I-VI, and to effect stable longterm, or permanent, hair reduction. The Aurora DS treatment is based on the principle of selective (electromagnetic) thermolysis. According to this principle, parameters of optical and RF energy (spectrum, exposure duration and energy density) are chosen and optimized to selectively damage to the hair follicle without damaging the surrounding tissues.
This 510(k) summary does not contain the detailed information necessary to complete all sections of your request, particularly regarding specific acceptance criteria values, sample sizes, and expert qualifications for performance studies.
This is common for older 510(k) submissions, which often presented less granular data than more recent ones require. Instead, it focuses on demonstrating substantial equivalence to predicate devices.
However, I will extract and infer information where possible based on the provided text.
Acceptance Criteria and Reported Device Performance
The document does not explicitly state numerical acceptance criteria for hair removal or reduction beyond indicating the device should "effect stable long-term, or permanent, hair reduction." It relies on substantial equivalence to predicate devices, implying that its performance is expected to be comparable.
| Performance Metric | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Hair Removal/Reduction | Not explicitly stated (implied comparable to predicate devices for "stable long-term, or permanent hair reduction") | Indicated for "removal of unwanted hair from skin types I-VI, and to effect stable long-term, or permanent, hair reduction." Performance is deemed substantially equivalent to predicate devices. |
Study Details
Given the context of a 510(k) submission primarily focused on substantial equivalence to predicate devices, detailed clinical study methodologies are not provided in this summary. The summary highlights that "Based upon an analysis of the overall performance characteristic for the device, Syneron Medical Ltd. believes that no significant differences present." This general statement suggests that any studies conducted were likely aimed at demonstrating this equivalence rather than establishing de novo performance metrics against specific criteria.
- Sample Size used for the test set and the data provenance:
- Sample Size: Not specified in the provided summary.
- Data Provenance: Not specified (e.g., country of origin, retrospective/prospective).
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not specified.
- Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not specified.
- 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 device is a hair removal system, not an AI-assisted diagnostic tool.
- If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Not applicable as this is a device for hair removal, not an algorithm. Performance is inherent to the device's design and mechanism.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Not explicitly stated. For hair removal devices, ground truth for efficacy would typically involve quantitative hair counts or subjective photographic assessments by clinicians and/or patients over time.
- The sample size for the training set:
- Not applicable, as this is a medical device for hair removal, not an AI/machine learning algorithm with a training set.
- How the ground truth for the training set was established:
- Not applicable.
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