(30 days)
The subject Stellar M22 has connection capability with the following available treatment handpieces, for multi-application treatment options. All handpieces are designed for aesthetic and dermatological skin procedure applications, as follows:
- The Intense Pulsed Light (IPL) handpiece with a spectrum of 400-1200 nm (with 9 different filters) is indicated for:
- Benign epidermal lesions, including dyschromia, hyperpigmentation, melasma, and o ephelides (freckles)
- Cutaneous lesions, including warts, scars and striae O
- Benign cutaneous vascular lesions, including port wine stains, hemoangiomas, facial, O truncal and leg telangiectasias, erythema of rosacea, angiomas and spider angiomas, poikiloderma of Civatte, leg veins and venous malformations
- Removal of unwanted hair and to effect stable long term, or permanent* hair O reduction in skin types I-V through selective targeting of melanin in hair follicles
- Mild to moderate inflammatory Acne (Acne vulgaris) o
- The Nd:YAG Laser handpiece with a wavelength of 1064 nm (Multi-Spot Nd:YAG) is ● indicated for:
- The coagulation and hemostasis of vascular lesions and soft tissue, including the O treatment and clearance of superficial and deep telangiectasias (venulectasias) and reticular veins (0.1-4.0 mm. diameter) of the leg
- The removal of unwanted hair and to effect table long term, or permanent* hair O reduction in skin types I-V through selective targeting of melanin in hair follicles
- The non-ablative treatment of facial wrinkles o
- . ResurFX module and handpiece, with wavelength of 1565 nm, is indicated for:
- Use in dermatological procedures requiring fractional skin resurfacing and O
coagulation of soft tissue
- Use in dermatological procedures requiring fractional skin resurfacing and O
The Q-Switched Nd:YAG Laser Handpiece with a wavelength of 1064 nm is indicated ● for:
- Removal of dark tattoos O
- o Treatment of pigmented lesions
*Note
Permanent hair reduction is defined as long-term, stable reduction in the number of hairs regrowing when measured at 6, 9, and 12 months after completion of treatment regime.
The subject Stellar M22 for Intense Pulsed Light (IPL) and Laser System is a multi-application, multitechnology platform with four (4) available treatment handpieces:
- Stellar Intense Pulsed Light (IPL) handpiece; ●
- . Multi-Spot Nd:YAG laser handpiece;
- ResurFX non-ablative laser handpiece: ●
- Q-Switched Nd:YAG laser handpiece. ●
The following accessories are provided with and/or may be purchased independently for each of the four (4) available treatment handpieces of the Stellar M22 for Intense Pulsed Light (IPL) and Laser Systems:
- The Stellar IPL handpiece has nine (9) different filters available: Cut-off filters of 515, . 560, 590,615, 640, 695 and 755 nm, Notch Filters of 400-600 & 800-1200 nm and 530-650& 900-1200 nm. Further, the IPL handpiece has three (3) Sapphire Cool LightGuides available with sizes of: 15mm x 35mm, 8mm x 15 mm, 6 mm diameter.
- The Multi-Spot Nd:YAG handpiece has three (3) different LightGuides available in sizes . of: 2mm x 4mm, 6 mm, and 9 mm.
- The ResurFX handpiece has two (2) different treatment tips available: SapphireCool and Precision tips
- . The Q-Switched Nd:YAG handpiece has both disposable and gold plated metal treatment tips available. The disposable treatment tips and metal treatment tips are available in seven (7) different sizes of: 2, 2.5, 3.5, 4, 5, 6 and 8 mm.
The provided text is a 510(k) summary for the Stellar M22 for Intense Pulsed Light (IPL) and Laser system. This document outlines the device's intended use, technological characteristics, and compares it to a predicate device (M22 System, K170060) to establish substantial equivalence.
However, the summary does not include specific acceptance criteria or details of a study that proves the device meets those criteria in a quantitative sense as often seen in clinical performance studies with specific endpoints. Instead, it describes "Performance Data" in the context of design verification, compliance with standards, and software validation to demonstrate that modifications to the device do not raise new questions of safety or effectiveness compared to the predicate device.
Therefore, many of the requested items (e.g., sample size for test set, number of experts for ground truth, MRMC study, standalone performance) are not detailed in this type of regulatory submission, as it focuses on demonstrating substantial equivalence rather than proving a specific diagnostic accuracy or treatment efficacy de novo.
Below is a summary based on the information provided, with "N/A" for information not present in the document.
1. A table of acceptance criteria and the reported device performance
The document does not explicitly present acceptance criteria in a quantitative table format that measures specific performance metrics against a defined threshold. Instead, it focuses on demonstrating that the Stellar M22 device's modifications do not introduce new safety or effectiveness concerns compared to its predicate. The "reported device performance" is framed in terms of functional verification and compliance with standards.
| Acceptance Criteria Category | Reported Device Performance/Compliance |
|---|---|
| Design Verification & Validation | Tests performed to validate modifications to the device (specifics not detailed) |
| Risk Analysis | Compliance with ISO 14971 |
| Electrical Safety | Compliance with IEC 60601-1 |
| Electromagnetic Compatibility (EMC) | Compliance with IEC 60601-1-2 |
| IPL Compatibility | Compliance with IEC 60601-2-57 |
| Software Verification & Validation | Tests performed (specifics not detailed) |
| Technological Characteristics Equivalence | The device's technological characteristics (wavelength, pulse duration, maximum fluence, etc.) are substantially equivalent to the predicate, with minor modifications not raising new safety/effectiveness questions (see detailed comparison table in the source text). |
2. Sample size used for the test set and the data provenance
N/A - The document describes general performance data related to engineering verification and validation, and compliance with standards. It does not refer to a clinical "test set" with a specific sample size of patients or images for diagnostic or therapeutic performance evaluation. The data provenance is also not specified in terms of country of origin or retrospective/prospective nature, as this is not a clinical study report.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
N/A - No clinical "test set" requiring ground truth established by experts is described in this regulatory submission for substantial equivalence.
4. Adjudication method for the test set
N/A - No clinical "test set" or adjudication method is described.
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
N/A - This document does not describe an MRMC comparative effectiveness study or involve AI assistance for human readers. The device is a laser and IPL system for dermatological procedures, not an AI-powered diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
N/A - This device is a medical instrument (laser and IPL system), not an algorithm or AI system. Therefore, standalone algorithm performance is not applicable.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
N/A - As there is no clinical "test set" for performance evaluation in the context of diagnostic accuracy or treatment efficacy against a reference standard, the concept of ground truth in that sense is not detailed. The performance data focuses on engineering and safety compliance.
8. The sample size for the training set
N/A - The document does not describe a "training set" in the context of machine learning or AI algorithms.
9. How the ground truth for the training set was established
N/A - Not applicable, as there is no mention of an AI training set or related ground truth.
§ 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.