(158 days)
The LEDA System with the Applicator LEDA SCR 585 yellow is indicated for the treatment of periorbital wrinkles and rhytides.
The LEDA System with the Applicator LEDA SCR 635 red is indicated for the treatment of superficial, benign vascular and pigmented lesions.
The LEDA System with the Applicators LEDA EPI 808 and LEDA EPI 980 is indicated for hair removal and permanent hair reduction defined as the stable, long-term reduction in hair counts at 6, 9, or 12 months following a treatment regime.
The system is composed of a table-top base unit that includes the power supply, software and cooling system. Different applicators containing the light sources can be plugged into the base unit. The device is controlled by a touch-screen graphic user interface. There are three kinds of applicators each of which is available with several wavelengths. For details see the following section.
The LEDA is a device designed for dermatological use. Depending on the applicator selected wavelength in the range of 550-1,000 nm are produced either by Light Emitting Diodes (LED) or Diode Lasers. For each applicator and thus each wavelength there is a specific set of medical indications.
The provided text is a 510(k) Summary for a medical device called LEDA. It primarily focuses on demonstrating substantial equivalence to predicate devices rather than presenting a study proving the device meets specific acceptance criteria with quantifiable performance metrics.
However, I can extract information related to the device's indications for use and the basis for its substantial equivalence claim.
Here's an analysis based on the provided text, structured to address your questions where possible:
1. Table of Acceptance Criteria and Reported Device Performance
The provided document does not contain a table of acceptance criteria with quantifiable performance metrics that a study aimed to prove. Instead, the submission relies on demonstrating substantial equivalence to already cleared predicate devices. The "performance" being reported is the similarity in technological characteristics and intended use.
Therefore, I cannot create such a table directly from this document. The "criteria" are implicitly met if the device's technology and indications are sufficiently similar to approved predicates, implying comparable safety and efficacy.
2. Sample Size Used for the Test Set and Data Provenance
The document does not describe a specific clinical study with a test set of patients or data. The submission relies on a comparison of device specifications and indications for use with established predicate devices.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
As there is no clinical test set described, there is no information about experts used to establish ground truth. The submission hinges on the regulatory agency's assessment of substantial equivalence based on technical specifications and established indications of predicate devices.
4. Adjudication Method for the Test Set
Not applicable, as no clinical test set is described.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not conducted or reported in this 510(k) summary. The submission's focus is on demonstrating substantial equivalence through technological comparison rather than a human-in-the-loop performance study.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
This refers to a device that is inherently an algorithm-only device, such as AI-based diagnostic software. The LEDA device is a physical light-based therapeutic device. Therefore, the concept of a "standalone" algorithm-only performance test is not applicable in this context. The performance is inherent to the physical device's operation.
7. The Type of Ground Truth Used
The "ground truth" implicitly used in this 510(k) submission is the established safety and effectiveness of the predicate devices based on their prior regulatory clearance. The LEDA device aims to demonstrate that it is sufficiently similar to these predicates that it shares their established safety and efficacy profiles. There is no new ground truth established via pathology, outcomes data, or expert consensus specifically for the LEDA device in this document.
8. The Sample Size for the Training Set
Not applicable, as this is a traditional medical device submission for a light-based therapy device, not an AI/machine learning device that would require a training set.
9. How the Ground Truth for the Training Set was Established
Not applicable, as there is no training set mentioned or implied.
§ 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.