(148 days)
The modified MSq Family of Lovely Light/Laser System and Delivery Devices and Accessories are indicated for a variety of aesthetic and surgical applications in the medical specialties of general and plastic surgery and dermatology, endoscopic/ laparoscopic general surgery, gastroenterology, gynecology, otorhinolaryngology (ENT), neurosurgery, oculoplastics, orthopedics, pulmonary/thoracic surgery and urology.
The Lovely System models (Aria and Harmony) are intended for use in aesthetic, cosmetic, and surgical applications requiring the ablation, vaporization, excision, incision, and photothermolysis (photocoagulation or coagulation) of soft tissue in the medical specialties of dermatology, general and plastic surgery, endoscopic/ laparoscopic general surgery, gastroenterology, gynecology, otorhinolaryngology (ENT), neurosurgery, oculoplastics, oral surgery, ophthalmology (skin around the eyes), orthopedics, pulmonary/thoracic surgery, and urology for surgical and aesthetic applications.
Specific indications for different wavelengths and models are listed for Dermatology and Plastic Surgery, General Surgery, Genitourinary, Gynecology, Oral/Maxillofacial, Otorhinolaryngology/ Head and Neck (ENT), Ophthalmology, and Podiatry.
The modified MSq Family of Lovely Light/Laser System and Delivery Devices and Accessories are comprised of the following main components:
- A system console that includes the control display, software and control electronics, keyswitch, emergency stop, cooling system, optics bench;
- Footswitch;
- Variety of handpieces and attachment accessories.
The provided document is a 510(k) summary for a medical device (Modified MSq Family of Lovely Light/Laser Systems). It describes the device's indications for use and states its substantial equivalence to predicate devices. However, it does not contain information about acceptance criteria, specific device performance data from a study, sample sizes for test or training sets, ground truth establishment, expert qualifications, adjudication methods, or MRMC studies.
510(k) summaries primarily focus on demonstrating substantial equivalence to legally marketed predicate devices, rather than presenting detailed clinical trial results with predefined acceptance criteria and performance metrics in the same way a PMA (Premarket Approval) application would. The summary argues for substantial equivalence based on identical indications for use, and similar design features, and functional features to predicate devices.
Therefore, I cannot fulfill your request for:
- A table of acceptance criteria and the reported device performance: This information is not present in the provided text.
- Sample size used for the test set and the data provenance: This information is not present.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: This information is not present.
- Adjudication method for the test set: This information is not present.
- 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: This is a laser system, not an AI diagnostic device, so an MRMC study in this context would not be relevant and is not mentioned.
- If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: This is a laser system, not an algorithm.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc.): This information is not present, as detailed studies with ground truth are not described.
- The sample size for the training set: This information is not present.
- How the ground truth for the training set was established: This information is not present.
The document's "Safety and Effectiveness Information" section simply states: "The review of the indications for use and technical characteristics provided to demonstrate that the modified MSq Family of Lovely Light/Laser System and Delivery Devices and Accessories are substantially equivalent to the predicate devices." This indicates that the safety and effectiveness were primarily demonstrated through comparison to already approved devices and their established safety profiles, rather than through a new, independent performance study with specific acceptance criteria that would be outlined in this type of summary.
§ 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.