(215 days)
The subject Lumenis M22 System has connection capability with the following available treatment handpieces, for multiapplication 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 400-1200nm (with 10 different filters) is indicated for:
- Benign epidermal lesions, including dyschromia, hyperpigmentation, melasma, ephelides (freckles) and tattoos
- Cutaneous lesions, including warts, scars and striae
- Benign cutaneous vascular lesions, including port wine stains, hemangiomas, facial, truncal and leg telangiectasias, erythema of rosacea, angiomas, poikiloderma of Civatte, leg veins and venous malformations
- Removal of unwanted hair from all skin types, and to effect stable long term, or permanent* hair reduction in skin types I-V through selective targeting of melanin in hair follicles
- Mild to moderate inflammatory Acne (Acne vulgaris)
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 treatment and clearance of superficial and deep telangiectasias) and reticular veins (0.1 - 4.0 mm. diameter) of the leg
- The removal of unwanted hair from all skin types, and to effect stable long term, or permanent* hair reduction in skin types I-V through selective targeting of melanin in hair follicles
- The non-ablative treatment of facial wrinkles
ResurFX module and handpiece. with wavelength of 1565 nm. is indicated for: - Use in dermatological procedures requiring fractional skin resurfacing and coaqulation of soft tissue
The Q-Switched Nd:YAG Laser Handpiece with a wavelength of 1064nm is indicated for: - Removal of dark tattoos
- 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 the completion of a treatment regime.
The ResurFX System with wavelength of 1565 nm. is indicated for use in dermatological procedures requiring fractional skin resurfacing and coagulation of soft tissue.
The subject Lumenis M22 System is a multi-application, multi-technology platform with four (4) available treatment handpieces:
- Universal 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 M22 System: - The Universal IPL handpiece has ten (10) 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, and a Narrow band filter of 525-585 nm. Further, the IPL handpiece has three (3) sapphire cool light guides available with sizes of: 15mm x 35mm, 8mm x 15 mm, 6mm diameter.
- The Multi-Spot Nd:YAG handpiece has four (4) different light guides/tips available in sizes of: 2mm x 4mm, 6 mm, 9 mm and 1.5 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 are available in four (4) different sizes of: 2, 2.5, 3.5, and 5 mm. The metal treatment tips are available in seven (7) different sizes of: 2, 2.5, 3.5, 4, 5, 6 and 8 mm.
The ResurFX System is an advanced computer-controlled laser emission system operating at a wavelength of 1565 nm, and is intended for Fractional Non-Ablative Skin Resurfacing application when using a dedicated handpiece.
The following accessories are provided with and/or may be purchased independently for the ResurFX System:
- Two (2) different treatment tips: SapphireCool and Precision tips.
- Footswitch.
The provided document is a 510(k) summary for the Lumenis M22 and ResurFX Systems, which are laser surgical instruments. It focuses on demonstrating substantial equivalence to predicate devices rather than proving a device meets specific clinical performance acceptance criteria through studies involving human-in-the-loop or standalone algorithm performance.
Therefore, many of the requested details about acceptance criteria, study types, sample sizes, expert involvement, and ground truth establishment are not present in this type of regulatory document. This document details engineering and performance bench testing to ensure the modified device functions as intended and safely, similar to its predicate.
Here's an analysis of the information that can be extracted from the document:
1. A table of acceptance criteria and the reported device performance:
The document doesn't present a table of specific clinical acceptance criteria with corresponding performance metrics like sensitivity, specificity, or accuracy for a diagnostic or AI-driven device. Instead, the "acceptance criteria" are implied by the performance bench testing ensuring the device meets safety and operational standards and functions as intended, similar to the predicate devices. The "reported device performance" is essentially that it passed these engineering and safety tests.
| Device Feature/Aspect | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|
| IPL Handpiece | ||
| Wavelength | Same as predicate (400-1200 nm) | Same (400-1200 nm) |
| Pulse Duration (msec) | Same as predicate | Same |
| Operational Wavelengths (Filters) | Addition of new filters (Vascular Filter, KTP filter) without compromising safety/efficacy | Integrated new filters, functioning as intended |
| Spot sizes (cm²) | Addition of new 6mm round size without compromising safety/efficacy | Integrated new 6mm round size, functioning as intended |
| Max Fluence | Up to 35 J/cm², or 56 J/cm² supported by K020839 for tip size | Up to 35 or 56 J/cm², upon tip size; expected fluence with new filters/guides showed lower fluence than previously cleared devices. |
| Pulse Rate [Hz] | Same as predicate (Up to 1 Hz) | Same |
| Multiple Sequential Pulsing | Addition of AOPT mode with varying fluence per pulse, without compromising safety/efficacy | AOPT mode integrated, functioning as intended |
| Multi-Spot Nd:YAG Handpiece | ||
| Operational Wavelengths | Same as predicate (1064 nm) | Same |
| Spot sizes (mm) | Same as predicate | Same |
| Max Fluence | Same as predicate (Up to 600 J/cm²) | Same |
| Pulse Rate [Hz] | Same as predicate (Up to 1 Hz) | Same |
| Multiple Sequential Pulsing | Same as predicate | Same |
| ResurFX Handpiece (M22 System & Standalone) | ||
| Operational Wavelengths | Same as predicate (1565nm) | Same |
| Max Energy | Up to 70mJ per micro-beam; or up to 40mJ supported for new tip | Up to 40 or 70mJ per micro-beam, upon tip; expected fluence with new scan shapes/Precision tip showed same or lower fluence than previously cleared devices. |
| Type of laser | Same as predicate (Er:Glass Fiber-laser with scanner) | Same |
| Tip treatment width | Addition of 18mm Precision Tip | Integrated new 18mm Precision Tip, functioning as intended |
| Scanning shapes | Addition of "vertical line" and "vertical rectangle" without compromising safety/efficacy | Integrated new scanning shapes, functioning as intended |
| Scanner | Same as predicate (Dual axis scanner) | Same |
| Q-Switched Nd:YAG Handpiece | ||
| Operational Wavelengths | Same as predicate (1064 nm) | Same |
| Spot sizes (mm, diameter) | Addition of 4mm and 8mm sizes without compromising safety/efficacy | Integrated new 4mm and 8mm sizes, functioning as intended; expected fluence with new tips showed lower fluence than previously cleared device. |
| Max Fluence | Same as predicate (Up to 14 J/cm²) | Same |
| Pulse Duration(nsec) | Same as predicate (6-8) | Same |
| Pulse Rate [Hz] | Same as predicate (0.5-5.0) | Same |
| General | ||
| Risk Analysis | Compliance with ISO 14971 | Performed |
| Electrical Safety & EMC | Conformance with IEC 60601-1, IEC 60601-1-2 | Passed |
| IPL Compatibility | Conformance with IEC 60601-2-57 | Passed |
| Software Changes | Validated to work as intended | Validated |
| Handpiece Accessories/Features | Validated to work as intended | Validated |
| ResurFX Environmental Testing | Ability to withstand variant operation, storage, and transportation conditions | Passed |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
Not applicable. This is a 510(k) for a device modification, focusing on engineering verification and validation (V&V) and safety testing. There is no "test set" in the context of clinical data for an AI algorithm. The V&V activities involve testing the physical device and its components.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
Not applicable. No "ground truth" was established by clinical experts for a test set, as this is not a study of an AI or diagnostic device's clinical performance.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. No clinical test set requiring adjudication was used.
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
Not applicable. This document is not about an AI-assisted diagnostic device, but rather a laser surgical instrument. Therefore, no MRMC study was conducted or reported.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This device does not have a standalone algorithm in the sense of a diagnostic or image interpretation AI. Its "standalone" characteristic refers to the ResurFX system being made available as a separate unit rather than just a module of the M22. This is a hardware device for treatment, not an algorithm for analysis.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Not applicable. The ground truth for this device's performance is its physical and electrical specifications, and its ability to function safely and effectively within those parameters as demonstrated by engineering bench testing and compliance with recognized standards.
8. The sample size for the training set
Not applicable. This is not an AI/ML device that requires a training set.
9. How the ground truth for the training set was established
Not applicable.
§ 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.