(85 days)
The Alma Q laser is intended for use in aesthetic and surgical applications requiring the ablation, excision, incision, and photothermolysis (photocoagulation or coagulation) of soft tissue in the medical specialties of dermatology, general and plastic surgery.
a) LP1064nm
- For the coagulation and hemostasis of benign vascular lesions such as, but not limited to, port wine stains, hemangiomas, warts, telangiectasia, rosacea, venus lake, leg veins, and spider veins.
- The Alma Q laser system is also indicated for the treatment of wrinkles.
- The Alma Q is also indicated for the removal of unwanted hair and for the treatment of pseudofolliculitis barbae (PFB).
- The Alma Q laser system is indicated for use on all skin types (Fitzpatrick IVI), including tanned skin.
- The intended use of the integral cooling system in the Alma O laser handpiece is to provide cooling of the skin prior to laser treatment, for the reduction of pain during laser treatment, to allow for the use of higher fluences for laser treatments such as hair removal and vascular lesions, and to reduce the potential side effects of laser treatments.
b) OS 532nm
- Tattoo removal
-Red inks
-Blue and light blue inks
-Green inks - Treatment of benign vascular lesions
-Telangiectasias
-Spider angiomas
-Cherry angiomas
-Spider nevi - Treatment of benign pigmented lesions
-Cafe-au-lait birthmarks solar lentigines
-Solar lentigines
-Becker's nevi
-Freckles
-Nevus spilus
-Nevus of ota - Incision, excision, ablation, and vaporization of soft tissue in general dermatology
c) QS 1064nm
The Alma Q laser treatment system is intended for use:
For the removal or lightening of unwanted facial or body hair.
For skin resurfacing (ablation of epidermal skin layers) in dermatology and aesthetic surgery,
Benign dermal pigmented lesions (dermal melanocytosis); and
For tattoo removal (dark and blue inks).
The subject device, Alma Q Laser incorporates a flash lamp pumped Nd:Yag laser. The radiation emitted by this device has the ideal 1064nm wavelength. It also incorporates a built-in frequency conversion technology to obtain the 532nm (green) wavelength. The laser system is operated with an articulated arm system for transmitting the laser radiation with different size tips. Alma Q can operate in Q-switching mode and produce 1064nm wavelength beam. This beam can also be efficiently converted into 532nm wavelength beam using a KTP crystal. This laser can also operate in long-pulsed mode at 1064nm wavelength. The system is intended to be used in user facilities such as hospitals, physicians' offices and medical spas.
The material that could contact the patient during device use is aluminum with limited-duration surface contact with intact skin. The device is re-usable and non-sterile; instructions for cleaning its components between uses are provided in the labeling.
The provided document is a 510(k) Premarket Notification for the Alma Q Laser, a medical device. This type of FDA submission seeks to demonstrate that a new device is "substantially equivalent" to a legally marketed predicate device, meaning it is as safe and effective.
The document does not include data from a study designed to prove the device meets specific performance acceptance criteria for clinical efficacy. Instead, it relies on a comparison to predicate devices and non-clinical performance testing to establish substantial equivalence. Therefore, I cannot provide a table of acceptance criteria and reported device performance from a clinical study, nor specific details about expert-established ground truth or MRMC studies, as these types of studies were not deemed necessary for this particular submission.
Here's what the document states regarding performance and the justification for not conducting clinical studies:
- No Clinical Studies Deemed Needed: "Based on the similarities in the safety and effectiveness profiles of the subject and predicate devices, no animal or clinical studies were deemed needed to support this submission." (Page 12)
- Reliance on Substantial Equivalence: The primary method for proving the device's safety and effectiveness is by demonstrating its substantial equivalence to previously cleared predicate devices (Mydon and Naturalase). The submission details the technological characteristics and indications for use of the Alma Q Laser and compares them to the predicate devices.
- Non-Clinical Performance Testing: "In all instances, the Alma Q Laser functioned as intended and the results observed were as expected." (Page 12). This refers to non-clinical performance testing, likely related to engineering specifications, safety standards, and functional verification, to ensure the device performs according to its design. The document lists several IEC standards that were likely used for this testing (e.g., IEC 60601-1 for electrical safety, IEC 60825-1 for laser safety).
In summary, this document does not contain the information required to populate a table of acceptance criteria and reported device performance from a clinical study, as no such clinical study was conducted or required for this 510(k) submission.
Therefore, I will reiterate the key points from the provided text that explain why no such study details are available:
- No Clinical/Animal Studies: The submission explicitly states that "no animal or clinical studies were deemed needed to support this submission" due to the device's similarities to predicate devices in safety and effectiveness profiles.
- Method of Proof: The method of proof for this device's safety and effectiveness is
Substantial Equivalenceto predicate devices. - Performance Testing: Refers to
Non-clinical performance testing(e.g., electrical safety, laser safety, software verification and validation, biocompatibility) which ensured the device functioned as intended and met expected results.
Because the request specifically asks for information that is not present in the provided text (i.e., acceptance criteria and performance from a clinical study), I cannot fulfill all parts of your request based solely on this document.
§ 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.