(15 days)
Indications for Use for Fitzpatrick skin types (I to VI)
- The removal of unwanted hair and to effect stable long-term or permanent hair reduction. Permanent hair reduction is defined as a long-term stable reduction in the number of hairs re-growing after a treatment regimen.
- The treatment of moderate inflammatory acne vulgaris.
- The treatment of benign pigmented epidermal lesions including dyschromia. hyperpigmentation, melasma, 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.
The integrated thermal cooling is indicated for use in cooling the epidermis at the treatment site prior to, during, and after treatment in general aesthetic dermatologic and plastic surgery procedures. - Reduce pain during and/or with light treatment (via partial anesthesia from cooling)
- Reduce discomfort during and/or associated with light treatment
- Minimize thermal injury, including thermal necrosis, to non-target skin and skin structures during and/or associated with light treatment, thus reducing possible complications such as scabbing, scarring, hyper - and/or hypopigmentation
- Allow the use of higher light fluences for light or laser treatments (such as for hair removal and the treatment of vascular or pigmented lesions)
- Reduce potential side effects of light or laser treatments (such as for hair removal and the treatment of vascular or pigmented lesions)
The Accelawave is an Intense Pulsed Light-based medical device utilizing xenon flash lamp technology to illuminate the dermis to offer light based therapies as listed in the indications of use. The Accelawave emits light at 420nm to 1200nm via a 15mm x 45mm treatment area at a repetition rate equal to or less than 0.5Hz (operator selective). Light is delivered to the skin surface while a water-cooled heat transfer network cools the contacting surfaces and the epidermis.
This 510(k) summary for the Accelawave System does not contain the detailed information typically found in a study proving a device meets acceptance criteria. A 510(k) submission primarily demonstrates substantial equivalence to a predicate device, rather than providing extensive clinical trial data with specific performance metrics and statistical analyses.
Therefore, many of the requested elements (acceptance criteria, reported device performance, sample sizes for test/training sets, ground truth establishment, expert qualifications, adjudication methods, MRMC studies, standalone performance) are not present in the provided document.
However, based on the information given, here's what can be extracted and what is missing:
Acceptance Criteria and Study to Prove Device Meets Criteria
The provided 510(k) summary for the Accelawave System focuses on demonstrating substantial equivalence to legally marketed predicate devices, rather than on providing a detailed study proving specific performance acceptance criteria for a novel algorithm or diagnostic device. As such, the document does not present explicit acceptance criteria for diagnostic performance metrics (e.g., sensitivity, specificity, accuracy) and a study designed to meet those.
Instead, the "acceptance criteria" can be inferred as fulfilling the requirements for substantial equivalence to the predicate devices (Chromogenex K053324, Sciton K032460, Lumenis K020839) in terms of:
- Technological characteristics
- Performance (as demonstrated by similar output spectrum, output pulse characteristics, and treatment parameters)
- Intended use
- Indications for use
- Operator interface
- Safety (including compliance with European Medical Directive 93/42/EEC and voluntary standard UL60601-1:1996 for electrical safety).
The "study" that proves the device meets these (implied) acceptance criteria is the overall demonstration within the 510(k) submission that the Accelawave System is substantially equivalent to the identified predicate devices. This typically involves technical comparisons, safety testing, and a discussion of similar indications and mechanisms of action.
1. Table of Acceptance Criteria and Reported Device Performance
As noted, explicit, quantifiable acceptance criteria and device performance metrics (like sensitivity, specificity, etc.) are not provided in this type of submission. The document states that the Accelawave System is "substantially equivalent in terms of technological characteristics, performance, intended use, indications for use and operator interface" to its predicates.
| Acceptance Criteria (Inferred from 510(k) requirements for substantial equivalence) | Reported Device Performance (as demonstrated for substantial equivalence) |
|---|---|
| Technological Characteristics: Similar to predicates | Output Spectrum Characteristics: Similar to predicates |
| Output Pulse Characteristics: Similar to, and programmable like, predicates | |
| Treatment Parameters: Similar to, and programmable like, predicates | |
| Performance: Safe and effective for indications, similar to predicates | Device complies with European Medical Directive 93/42/EEC |
| Will comply with UL60601-1:1996 when marketed in the U.S. | |
| Intended Use: Similar to predicates | IPL-based medical device using xenon flash lamp for light-based therapies |
| Indications for Use: Similar to predicates | Indications listed for various skin conditions and cooling functions |
| Operator Interface: Similar to predicates | Not explicitly detailed, but implied by substantial equivalence |
| Safety: Minimize side effects, manage thermal injury | Integrated thermal cooling to reduce pain, discomfort, and thermal injury |
| Potential side effects (red patches, blistering) are disclosed and managed |
2. Sample Size Used for the Test Set and Data Provenance
Not applicable or Not provided. This 510(k) summary for an Intense Pulsed Light (IPL) system does not include clinical efficacy studies with specific "test sets" or data provenance in the way a diagnostic AI device would. The demonstration of safety and effectiveness relies on comparison to predicate devices and adherence to safety standards.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
Not applicable or Not provided. As there is no clinical "test set" and ground truth establishment in the context of diagnostic accuracy, this information is not present. The document refers to "Indications for Use for Fitzpatrick skin types (I to VI)" which are general classifications rather than expert-established ground truths for a specific study.
4. Adjudication Method for the Test Set
Not applicable or Not provided. No adjudication method is mentioned as there's no diagnostic test set requiring such.
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
No. An MRMC study is not applicable and was not done. This device is an IPL system for therapeutic applications (hair removal, acne, pigmented lesions, vascular lesions, etc.), not a diagnostic imaging device with human readers or AI assistance in interpretation.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
No. This device is a physical therapeutic system, not a standalone algorithm. Its performance is intrinsically "with human-in-the-loop" as it is operated by a healthcare professional.
7. The Type of Ground Truth Used
Not applicable or Not provided in the context of diagnostic performance. For the therapeutic claims, the "ground truth" would implicitly be the clinical outcomes experienced by patients treated with the device, compared to outcomes from predicate devices or established treatment protocols. However, no specific study data or ground truth definition for clinical outcomes is detailed here.
8. The Sample Size for the Training Set
Not applicable or Not provided. There is no "training set" in the context of this IPL device's development as it is not an AI/ML algorithm.
9. How the Ground Truth for the Training Set was Established
Not applicable or Not provided. Not relevant for this type of device 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.