(79 days)
The Forma System and Forma Light System** are indicated for use in aesthetic applications in dermatology. The Forma System and Forma Light System** have 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 Forma System and Forma Light System** with the Intense Pulsed Light (IPL) Handpieces (10 different Applicators) with a spectrum of 430-1100nm are indicated for:
HR*, F-HR*, B-HR* Applicators (650-1100nm):
· 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.
HR, F-HR, B-HR Applicators (590-1100nm):
· Removal of unwanted hair from skin types I-IV, and to effect stable long term, or permanent hair reduction* in skin types I-IV through selective targeting of melanin in hair follicles.
SR, F-SR, B-SR Applicators (530-1100nm):
- · Benign epidermal lesions, including dyschromia, hyperpigmentation, ephelides (freckles)
- · Cutaneous lesions, including striae
· 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. F-AC Applicator (430-1100nm):
· Mild to moderate inflammatory Acne (Acne vulgaris)
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The Forma System with the ST Handpiece (Radio Frequency) is indicated for the treatment of relief of minor muscle aches and pain, relief of muscle spasm, temporary improvement of local blood circulation.
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The Forma System with the PLG Handpiece (Microdermabrasion Applicator) is indicated for skin dermabrasion.
The Forma System is a multi-application, multi-technology platform, intended for noninvasive aesthetic applications utilizing Radio Frequency (RF) and Intense Pulsed Light (IPL) technologies.
The system platform includes an AC/DC power supply unit, an RF Generator, a CPU main card and user interface including a LCD display and touch screen module. In addition to the system platform, the Forma System is provided with 12 applicators according to the following technology related sub-categories:
- . ST Applicator (Radiofrequency) for the treatment of relief of minor muscle aches and pain, relief of muscle spasm, temporary improvement of local blood circulation.
- Ten Intense Pulsed Light (IPL) Applicators divided into four sub-categories: o
- o HR*, F-HR* & B-HR* (650-1100nm) Applicators for hair removal treatments (skin types I-V).
- HR, F-HR & B-HR (590-1100nm) Applicators for hair removal o treatments (skin types I-IV).
- o SR, F-SR & B-SR (530-1100nm) Applicators for the treatment of pigmented and vascular lesions.
- o F-AC (430-1100nm) Applicator for acne treatments.
- PLG Applicator (Diamond ring) is indicated for skin dermabrasion. ●
The operator chooses and monitors the mode and intensity of the treatment from a digital control panel located on the front panel of the Forma System. The Forma System has three applicator ports; one for IPL based applicators, one for RF applicator and one for the skin dermabrasion applicator. The ports must be simultaneously connected with all there applicators for the system to operate.
The Forma Light System is a model of the Forma System employing only IPL technology.
The provided document is a 510(k) summary for the Forma System and Forma Light System, which are multi-application, multi-technology platforms for aesthetic applications in dermatology. The device uses Radio Frequency (RF) and Intense Pulsed Light (IPL) technologies.
Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:
1. A table of acceptance criteria and the reported device performance:
The document doesn't explicitly state "acceptance criteria" in a quantitative, performance-metric sense. Instead, it details adherence to recognized consensus standards and performance testing to verify design requirement specifications, ensuring safety and effectiveness compared to predicate devices. The "acceptance criteria" can therefore be inferred as compliance with these standards and functional performance as designed.
| Acceptance Criteria (Inferred from compliance and design verification) | Reported Device Performance (from "Non-Clinical Performance Data") |
|---|---|
| Safety and Essential Performance Standards: | |
| - AAMI/ANSI 60601-1 (2012) | - The Forma System and Forma Light System comply with this standard. |
| - IEC 60601-1-2 (Edition 3.0, 2007) | - The Forma System and Forma Light System comply with this standard for Electromagnetic Compatibility. |
| - IEC 60601-2-57 (Edition 2.0, 2011) (for non-laser light source) | - The Forma System and Forma Light System comply with this standard for Basic Safety And Essential Performance of Non-Laser Light Source Equipment. |
| - IEC 60601-2-2 (Edition 5.0, 2009) (Forma System only, for RF) | - The Forma System complies with this standard for Basic Safety And Essential Performance of High Frequency Surgery Equipment. |
| Functional Verification (Design Requirement Specifications): | |
| - Full system operation and user procedures | - Comprehensive software-system test plan and results report covers full system test. Includes operation and user procedures, programs, firmware functionality, hardware interfaces, performance, load test, download procedure, integrity, recovery, and usability. |
| - ST Applicator RF output power accuracy | - Bench tests demonstrated that the ST Applicator performs according to the design requirement specifications and is substantially equivalent to the predicate device. Bench tests evaluated device RF output power accuracy compared with design requirements and predicate device specifications. |
| - ST Applicator tissue temperature profile (safety and effectiveness) | - Tissue temperature profile testing showed a safe and effective tissue heating profile achieved with the Forma System ST Applicator. |
| - Consistency and accuracy of RF and IPL power outputs | - Performance tests included bench testing to evaluate the consistency and accuracy of the RF and IPL power outputs. These tests demonstrated that minor differences meet system requirements and do not raise new safety or effectiveness concerns. |
| Substantial Equivalence: | |
| - Similar indications for use and technological characteristics to predicates | - The Forma System and Forma Light System are found substantially equivalent to the Viora Reaction (K090221) and Lumenis M22 System (K142860) due to similar indications for use, technological characteristics, functionality, mechanism of operation, performance specifications, monitoring features, safety features, compliance with safety standards, and patient contact materials. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document explicitly states "Clinical Performance Data: Not Applicable" and focuses solely on "Non-Clinical Performance Data." Therefore, there is no patient-based "test set" for which sample size or data provenance would be relevant in the context of clinical studies. The testing described is bench testing, software validation, and electrical/mechanical safety testing.
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, as no clinical test set or ground truth established by experts is described in this non-clinical submission. The "ground truth" for the non-clinical tests would have been the design specifications and recognized international safety standards.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable, as there is no clinical test set or human interpretation requiring adjudication.
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 device is an aesthetic medical device (IPL and RF platform), not an AI-driven diagnostic or assistive tool for human readers. No MRMC study was conducted or is relevant to this submission.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This device does not involve an "algorithm" in the sense of AI or image analysis. It is a physical medical device that delivers energy. Its "standalone performance" is assessed through its compliance with safety standards and its ability to consistently output energy as designed, which was evaluated via the non-clinical performance and bench tests.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For the non-clinical performance data, the "ground truth" was:
- Design requirements/specifications: For evaluating the output power accuracy of the ST Applicator and the overall system functionality.
- Recognized consensus standards: AAMI/ANSI 60601-1, IEC 60601-1-2, IEC 60601-2-57, and IEC 60601-2-2, which define the safety and essential performance requirements for medical electrical equipment, including specific types of energy-delivering devices.
- Predicate device specifications: Used for comparison to demonstrate substantial equivalence, particularly for RF output power accuracy and overall technological characteristics.
8. The sample size for the training set
Not applicable. There is no mention of machine learning or an "AI" component that would require a training set. The device is a hardware-based system.
9. How the ground truth for the training set was established
Not applicable, as no training set for a machine learning model is mentioned.
§ 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.