(82 days)
1064 nm Indications for Use: Coagulation and hemostasis of benign vascular lesions such as, but not limited to-telangiectasia and rosacea. Removal of unwanted hair, for the stable long term, or permanent hair reduction through selective targeting of melanin in hair follicles, and for the treatment for pseudofolliculitis barbae (PFB). The Profile 1064 Laser Systems and Accessories are indicated for use on all skin types (Fitzpatrick I-VI), including tanned skin. The Profile 1064 Laser Systems and Accessories are indicated for the treatment of facial wrinkles. Incision/excision and cutting, vaporization, ablation, coagulation/hemostasis of soft tissue in the performance of surgical applications. All soft tissue is included, such as skin, cutaneous tissue, subcutaneous tissue, striated and smooth tissue, muscle, cartilage meniscus, mucous membrane, lymph vessels and nodes, organs and glands. It is further indicated for laser assisted lipolysis.
1320 nm Indications for Use: It is indicated for the treatment of fine lines and wrinkles. It is also indicated for the treatment of back acne, atrophic acne scars and mild to moderate inflammatory acne vulgaris. Profile Multi-Platform System with fiber delivery is indicated for the treatment of reflux of great and small saphenous veins associated with varicose veins and varicosities, and for treatment of incompetence and reflux of superficial veins in the lower extremity.
2940 nm Indications for Use; Skin resurfacing and treatment of wrinkles.
Pulsed Light (300-1400 nm) Indications for Use: The Profile Multi-Platform Systems and Accessories are indicated for use in surgical, aesthetic and cosmetic applications requiring selective photothermolysis (photocoagulation or coagulation) and hemostasis of soft tissue in the medical specialties of general and plastic surgery and dermatology. It is intended for use for: The treatment of benign pigmented lesions including dyschromia, hyperpigmentation, melasma, ephelides (freckles); (515nm LP filter, 560nm LP filter) The treatment of benign cutaneous 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; (560nm LP filter, 590nm LP filter) The removal of unwanted hair from all skin types, and to effect stable long-term, or permanent, hair reduction: (590nm LP filter, 640nm LP filter, 695nm LP filter) Treatment of facial wrinkles, treatment of fine lines and wrinkles; and (590nm LP filter, 640nm LP filter, 695nm LP filter, 800nm LP filter) Topical heating for the purpose of elevating tissue temperature for the temporary relief of minor muscle and joint 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. In addition, it may also help muscle spasms, minor sprains and strains, and minor muscular back pain. (800nm LP filter)
The Profile Multi-Platform System is a modular, multi-wavelength laser/light system. The system uses scanning and focusing optics to deliver a pattern of thermal energy to the treatment site. The system consists of control console which houses the power supply, cooling system, fiber optic delivery system and/or articulated arm delivery system with handpiece and/or scanner.
This submission (K070388) is for the Sciton Profile Multi-Platform System, a modular, multi-wavelength laser/light system. It is a 510(k) submission, meaning the device is seeking clearance based on substantial equivalence to existing legally marketed predicate devices, rather than requiring new clinical studies to prove safety and effectiveness from scratch.
Therefore, the document does not contain explicit acceptance criteria and a study demonstrating the device meets those criteria in the way one might expect for a novel device or a device claiming superior performance. Instead, the "acceptance criteria" are implied by the substantial equivalence determination process, where the device must demonstrate comparable performance and safety characteristics to established predicates.
Here's an analysis of the provided information in the context of a substantial equivalence submission:
1. Table of Acceptance Criteria and Reported Device Performance
As this is a substantial equivalence submission, there are no explicit "acceptance criteria" for performance metrics like sensitivity, specificity, or accuracy that a diagnostic AI device would typically have. The "performance" is demonstrated by asserting that the device shares the same intended use, similar design features, and functional features as the predicate devices.
| Acceptance Criterion (Implied by Substantial Equivalence) | Reported Device Performance (as stated in the submission) |
|---|---|
| Intended Use Equivalence: Device's intended uses are substantially the same as predicate devices. | 1064 nm Indications: Coagulation and hemostasis of benign vascular lesions; hair removal for all skin types (Fitzpatrick I-VI), including tanned skin, and treatment for pseudofolliculitis barbae (PFB); treatment of facial wrinkles; incision/excision, cutting, vaporization, ablation, coagulation/hemostasis of soft tissue; laser assisted lipolysis. |
| 1320 nm Indications: Treatment of fine lines and wrinkles; back acne, atrophic acne scars, and mild to moderate inflammatory acne vulgaris; treatment of reflux of great and small saphenous veins associated with varicose veins and varicosities, and for incompetence and reflux of superficial veins in the lower extremity. | |
| 2940 nm Indications: Skin resurfacing and treatment of wrinkles. | |
| Pulsed Light (300-1400 nm) Indications: Surgical, aesthetic, and cosmetic applications requiring selective photothermolysis and hemostasis of soft tissue for: benign pigmented lesions; benign cutaneous vascular lesions; removal of unwanted hair from all skin types for stable long-term or permanent hair reduction; treatment of facial wrinkles, fine lines and wrinkles; topical heating for temporary relief of minor muscle/joint pain and stiffness, minor joint pain associated with arthritis, temporary increase in local circulation, muscle relaxation, muscle spasms, minor sprains/strains, and minor muscular back pain. | |
| Technological Characteristics Equivalence: Device design and functional features are similar to predicate devices. | The Profile Multi-Platform System shares "similar design features (including wavelength, laser/light medium and delivery systems, power supply, cooling and control system), functional features (including power output, repetition rate, energy, spot size and fluence)" with its predicate devices. |
| Safety and Effectiveness Equivalence: Risks and benefits are comparable to predicate devices. | "The indications for use are based upon the indications for use for predicate systems. Technologically, the Profile Multi-Platform System is substantially equivalent to the listed predicate devices. Therefore, the risks and benefits for the Profile Multi-Platform System are comparable to the predicate devices." |
2. Sample Size Used for the Test Set and Data Provenance
This is a physical medical device submission (laser/light system), not an AI/software device that requires a test set of data for performance evaluation. Therefore, there is no "test set" in the context of an algorithm's performance on a dataset. The device's performance is established through equivalence to predicate devices, which implies that the predicate devices have already demonstrated safety and effectiveness through their own clinical use and/or studies.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
Not applicable. As described in point 2, there is no "test set" or ground truth establishment in the context of evaluating an algorithm's performance.
4. Adjudication Method for the Test Set
Not applicable. There is no test set in the context of evaluating an algorithm's performance.
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. The Sciton Profile Multi-Platform System is a laser/light system, not an AI software intended to assist human readers (e.g., radiologists interpreting images). Therefore, an MRMC study comparing human reader performance with and without AI assistance is not relevant.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was Done
Not applicable. This is a physical laser/light system, not an AI algorithm.
7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)
Not applicable. There is no "ground truth" in the context of evaluating an AI algorithm's performance. The basis for safety and effectiveness is substantial equivalence to legally marketed predicate devices, which would have had their own evidence for safety and effectiveness, potentially including clinical outcomes data.
8. The Sample Size for the Training Set
Not applicable. This is a physical medical device, not an AI algorithm that requires a training set.
9. How the Ground Truth for the Training Set Was Established
Not applicable. This is a physical medical 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.