(13 days)
The Magma Spark Pro system intended use is for non-invasive aesthetic and cosmetic treatments.
The Magma Spark Pro system has connection capability with the following available treatment hand pieces, for multiapplication treatment options. All hand pieces are designed for aesthetic and dermatological skin procedure applications, as follows:
· Magma Spark Pro system with ALD/LLD Laser hand piece is indicated for:
o Hair removal
- o Permanent hair reduction * in skin type I-VI
o Pseudofolliculitis Barbae (PFB)
· Magma Spark Pro system with Intense Pulsed Light (IPL) Hand pieces (5 different Applicators) with a spectrum of 430-1100nm is intended for:
o Magma Spark Pro system with L-650 (650-1100nm) IPL hand piece is indicated for:
" 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.
" Benign epidermal lesions, including dyschromia, hyperpigmentation
o Magma Spark Pro system with S-590 (590-1100nm) IPL hand piece is indicated for:
▪ Removal of unwanted hair from all skin types, and to effect stable long term, or permanent hair recuction * in skin types I-IV through selective targeting of melanin in hair follicles.
· Benign epidermal lesions, including dyschromia, hyperpigmentation, melasma and ephelides (freckles)
· 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, venous malformations.
o Magma Spark Pro system with L-530 (530-1100nm) IPL hand piece is indicated for:
· Benign epidermal lesions, including dyschromia, hyperpigmentation, ephelides (freckles)
- · 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 and spider angiomas, poikiloderma of Civatte, leg veins and venous malformations.
o Magma Spark Pro system with S-530 (530-1100nm) IPL hand piece is indicated for:
· Mild to moderate inflammatory Acne (Acne vulgaris)
· Benign epidermal lesions, including dyschromia, hyperpigmentation, ephelides (freckles)
- · 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 and spider angiomas, poikiloderma of Civatte, leg veins and venous malformations
o Magma Spark Pro system with S-430 (430-1100nm) IPL hand piece is indicated for:
= Mild to moderate inflammatory Acne (Acne vulgaris)
Note * Permanent hair reduction is defined as the 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 Magma Spark Pro device is a computerized, multi-application, compatible system platform designed to provide laser and intense pulsed light (IPL) optical energies for noninvasive aesthetic dermatology procedures.
The Magma Spark Pro is a relatively small tabletop device (portable version is also available). The device is compatible with two diode laser applicators (ALD and LLD) at nominal 808 nm wavelength and five IPL applicators: S-430, S-530, S-590, L-530 and L-650 at a wavelength range of 430-1100 nm. The system platform includes an AC/DC safety approved power supply, a CPU board, a Laser driver board, a charging board, a simmer board, an LCD display, Wires connectors and control components (inlet with On/Off switch and fuses, Emergency button), footswitch panel, water based cooling system for IPL and Laser applicators cooling and a touch screen module. The operator of Magma Spark Pro chooses and monitors the mode and intensity of the treatment from a digital control panel on the front of the device. Melanin meter is provided as an accessory tool for skin type determination.
The provided document is a 510(k) summary for the Magma Spark Pro device. It details various aspects of the device, including its intended use, specifications, and comparison to predicate devices, but it does not contain a study that proves the device meets specific acceptance criteria in terms of clinical performance or diagnostic accuracy.
Instead, the document states: "Therefore, apart to the performance testing conducted in adherence with the aforementioned recognized consensus standards, no additional testing was performed to sustain device safety and effectiveness." and "Clinical Performance Data: Not Applicable."
This implies that the device's safety and effectiveness for its stated indications for use are established through adherence to recognized consensus standards and by demonstrating substantial equivalence to previously cleared predicate devices, rather than through new clinical performance studies with specific acceptance criteria.
Therefore, many of the requested sections about acceptance criteria, clinical studies, sample sizes, ground truth, experts, and adjudication methods are not applicable based on the provided text.
Here's a breakdown of what can be extracted based on the document:
1. A table of acceptance criteria and the reported device performance
No explicit acceptance criteria or reported device performance in terms of clinical outcomes (e.g., hair reduction percentage, lesion clearance rate) are provided. The "performance" discussed in the document refers to technical specifications and adherence to safety standards.
| Acceptance Criteria (Explicit Clinical Performance) | Reported Device Performance |
|---|---|
| Not Applicable (No explicit clinical performance acceptance criteria stated in the document) | Not Applicable (No clinical performance data reported in the document) |
The document does mention compliance with several performance standards (e.g., IEC 60601-1 for basic safety, IEC 60825-1 for laser product safety), which are technical and safety-related, not clinical efficacy or diagnostic accuracy criteria.
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, as no clinical performance study with a test set is described.
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 performance study with a test set and ground truth established by experts is described.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable, as no clinical performance study with a test set requiring adjudication 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
Not applicable. The device is a laser/IPL system for aesthetic treatments, not an AI or diagnostic imaging device that would involve human readers or MRMC studies.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
Not applicable. The device is a physical medical device, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Not applicable, as no clinical performance study requiring ground truth is described. The approval is based on substantial equivalence to predicate devices and adherence to technical safety standards.
8. The sample size for the training set
Not applicable, as no machine learning or AI algorithm requiring a training set is described.
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.