(240 days)
The TattooStar Effect Y laser is indicated for incision, excision, ablation and vaporization of soft tissue in general dermatology and the removal of tattoos, pigmented lesions, vascular lesions and unwanted hair and skin resurfacing procedures. Depending on the wavelength selected, the indications are as follows: Removal of black and blue tattoo color 1064 nm: . Removal of unwanted hair Skin resurfacing 532 nm: Removal of pigmented lesions (including but not limited to lentigo benigna, hyperpigmented burn and boil scar, naevus Ota / Ito, freckles, Becker naevi, Café-au-lait spots) Removal of red tattoo color Removal of minor vascular lesions Removal of sky blue tattoo color 585 nm: The Asclepion Pulsed Light of the TattooStar Effect Y is intended for permanent hair reduction, treatment of vascular lesions, pigmented lesions and inflammatory acne. Depending on the different filters, the indications are as follows: 400 - 750 nm: Acne 500 - 1200 nm: Hair removal of blond hair, skin type I-II Vascular lesions, skin type I-II 550 - 1200 nm: Hair removal of brown and black hair, skin type I-II Hair removal of blond, brown and black hair, skin type III Vascular lesions, skin type III-IV Pigmented lesions, skin type I-IV 650 - 1200 nm: Hair removal of black hair, skin type IV The Radiofrequency is intended for dermatologic and general surgical procedures for non-invasive treatment of wrinkles and rhytids. The Acoustic Wave is intended for the activation of connective tissue.
The TattooStar Effect Y is a pulsed Nd:YAG solid state laser emitting wavelengths of 1064nm and 532nm. The beam can be converted to 585nm by means of an optional dye handpiece. The laser system can optionally be equipped with a pulsed light module (APL), a radiofrequency module (RF) and an acoustic wave module (AW).
The provided 510(k) summary for the Asclepion Laser Technologies GmbH TattooStar Effect Y does not contain typical acceptance criteria tables or detailed study results for device performance as would be found in a clinical trial report.
Instead, the submission primarily focuses on establishing "substantial equivalence" to predicate devices, which is common for 510(k) clearances. This means the manufacturer largely relies on the safety and effectiveness of previously cleared devices with similar technology and intended uses, rather than conducting extensive new clinical studies with defined acceptance criteria for the new device.
Here's an analysis based on the information provided, highlighting what is present and what is absent from the request:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not explicitly defined in terms of quantitative metrics (e.g., specific percentages of lesion clearance, wrinkle reduction metrics, etc.) | The device is deemed "safe and effective" for its stated indications based on substantial equivalence to predicate devices. |
| For Radiofrequency (RF) module: "In vivo study for the removal of wrinkles by means of Radiofrequency." (No specific performance data or success criteria provided for this study). |
Explanation: The documentation states the TattooStar Effect Y is "another safe and effective device" and details its intended uses and specific indications for different wavelengths and modules. However, it does not present quantifiable acceptance criteria (e.g., "The device must achieve X% clearance of red tattoo pigment in Y% of patients") or provide detailed performance data against such criteria. The "safety and effectiveness" argument is primarily built on the substantial equivalence to predicate devices, not on meeting specific, pre-defined performance thresholds for the TattooStar Effect Y itself in a dedicated study (except for the mention of the RF study, which lacks details).
2. Sample Size Used for the Test Set and Data Provenance
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Test Set Sample Size:
- For the Radiofrequency (RF) module's "in vivo study for the removal of wrinkles": Not specified. The document simply states "In vivo study" without providing any details about the number of subjects or cases included.
- For other indications (tattoos, pigmented lesions, hair removal, etc.): Not applicable. No dedicated, new "test set" or clinical study with a specified sample size is described for these indications for the TattooStar Effect Y device. The substantial equivalence argument relies on the performance of predicate devices.
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Data Provenance (Country of Origin, Retrospective/Prospective):
- For the RF module's "in vivo study": Not specified. There is no information about the country where this study was conducted or whether it was retrospective or prospective.
- For other indications: The basis for claiming safety and effectiveness for other indications is the substantial equivalence to predicate devices (Spectra K071451, K103455; Dermablate Effect K081541; Aluma K051214; Ellipse Flex PPT K052688). The original clinical data for these predicate devices would have their own provenance, but it's not provided for the TattooStar Effect Y submission.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Experts
- Not applicable / Not specified.
- For the described "in vivo study for the removal of wrinkles," there is no mention of external experts being used to establish a ground truth. Clinical studies for device efficacy typically measure changes directly (e.g., depth of wrinkles, objective scores) rather than requiring expert consensus on a "ground truth" in the way an AI diagnostic algorithm might.
- For the overall device, the "ground truth" for safety and effectiveness is implicitly established by the regulatory clearance of the predicate devices.
4. Adjudication Method for the Test Set
- Not applicable / Not specified.
- Given the nature of the "in vivo study" for wrinkles (likely direct measurement or physician assessment of change), a multi-reader adjudication method as described (e.g., 2+1) is not typically used for this type of clinical outcome.
- No other "test set" requiring adjudication or expert consensus is mentioned.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- No, an MRMC comparative effectiveness study was not done.
- This type of study is usually conducted for AI-powered diagnostic or decision support tools to assess how AI assistance impacts human reader performance. The TattooStar Effect Y is a laser device for medical procedures, not a diagnostic imaging tool with an AI component in the sense of image interpretation.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
- Not applicable.
- This concept is relevant for AI algorithms. The TattooStar Effect Y is a physical medical device. While it may have internal software controlling laser parameters, it is not an "algorithm" in the context of standalone performance evaluation for diagnostic or interpretative tasks.
7. Type of Ground Truth Used
- For the "in vivo study for the removal of wrinkles": Likely clinical assessment (e.g., physician's global aesthetic improvement scale, objective wrinkle measurement techniques) of the treated area. The document doesn't provide details, but this is the typical "ground truth" for studies on aesthetic improvements.
- For other indications: The "ground truth" for the overall device's safety and effectiveness for its stated indications is based on the established performance and safety profiles of the predicate devices cleared by regulatory bodies.
8. Sample Size for the Training Set
- Not applicable. The TattooStar Effect Y is a physical medical device, not an AI algorithm that requires a "training set" in the machine learning sense. Any manufacturing, calibration, or internal software development wouldn't be referred to as a "training set."
9. How the Ground Truth for the Training Set Was Established
- Not applicable. As established in point 8, there is no "training set" in the context of this device.
§ 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.