(204 days)
· The DEKA LOTUS 590nm pulsed light handpiece is indicated for permanent hair removal. 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 DEKA LOTUS 500G pulsed light handpiece is intended for treatment of benion pigmented lesions, including lentigines, nevi, melasma, and cafe-au-lait; and treatment of benign vascular lesions, including port wine stains, hemangiomas, telangiectasias, rosacea, facial and leg veins.
· The DEKA LOTUS RF handpiece is indicated for use in dermatologic and general surgical procedures for the non-invasive treatment of mild to moderate facial wrinkles and rhytides.
The DEKA Lotus is a device provided with two pulsed light handpieces and a RF handpiece. The two pulsed light handpieces have a built-in cooled waveguide which differ in emission spectrum, connected to the main unit through a flexible multifunctional cable. The handpiece uses a linear Xenon flashlamp, emitting a broad spectrum of electromagnetic radiation (light) when energized. The RF handpiece produces a particular electric current at 1MHz that induces a molecular oscillation on the cells, raising their temperature locally. The RF current flows through the special electrodes, forming a homogeneous heat area.
This document is a 510(k) Summary for the DEKA LOTUS device, which is an intense pulsed light and radiofrequency (RF) system. It focuses on demonstrating substantial equivalence to legally marketed predicate devices rather than proving specific performance metrics against pre-defined acceptance criteria for a novel AI/software component in a diagnostic context.
Therefore, the information required to answer your specific questions about acceptance criteria, ground truth, sample sizes for training/testing, expert adjudication, and MRMC studies is not present in this document. This is because the DEKA LOTUS is a medical device (pulsed light and RF system), and the 510(k) submission primarily relies on demonstrating equivalence to existing devices through non-clinical performance data (electrical safety, EMC) and comparisons of technical specifications and indications for use, rather than clinical performance studies involving AI algorithms.
Here's a breakdown of why this information is missing and what is provided:
Why the requested information is absent:
- Nature of the Device: The DEKA LOTUS is a physical medical device (laser/light/RF system), not an AI/software-based diagnostic tool. Its performance is assessed through its physical characteristics and safety, not through diagnostic accuracy or interpretation of images/data by an algorithm.
- 510(k) Pathway: The 510(k) substantial equivalence pathway typically does not require extensive clinical trials or performance studies if the device is similar enough to existing ones. It focuses on comparing the new device to predicates in terms of indications for use, technological characteristics, and safety/EMC.
- No AI/Software Component for Interpretation: There's no mention of a software component that interprets medical images, diagnoses conditions, or assists human readers in a diagnostic task. The software validation mentioned refers to the general control software for the device's operation, not an AI for diagnostic purposes.
What information is provided in the document (and how it relates to your questions, or why it doesn't):
-
A table of acceptance criteria and the reported device performance:
- Acceptance Criteria: Not explicitly stated in the context of device performance metrics for an AI. The "acceptance criteria" here are implicitly met by demonstrating substantial equivalence to the predicate devices through identical or similar technical specifications and parameters (e.g., fluence, pulse duration, frequency for light/RF) and demonstrating compliance with safety standards (IEC 60601 series).
- Reported Device Performance: The document provides comparative tables showing the technical specifications of the DEKA LOTUS against its predicate devices (Quanta Chrome, Palomar Icon, Pollogen Legend+™ System) for pulsed light (590nm, 500G) and RF handpieces. Examples include:
- Pulsed Light (590nm): Fluence (Up to 25 J/cm² - identical to predicate), Spot Size (20x17 mm vs. predicates' 48x13 mm/25x13mm - difference noted as not affecting safety/effectiveness), Pulse Duration (Up to 40 ms - identical), Repetition Rate (3 Hz max. - identical).
- Pulsed Light (500G): Fluence (Up to 80 J/cm² - identical), Spot Size (17x20 mm vs. predicate's 10x15 mm - difference noted as not affecting safety/effectiveness), Pulse Duration (1-100 ms - identical).
- RF Handpiece: Frequency (1 MHz - identical), Waveform (Sinusoidal - identical), Maximum output power (50W or 15W - identical).
- Safety and EMC testing: The document states that electrical safety and electromagnetic compatibility (EMC) testing were conducted according to ANSI AAMI ES60601-1 and IEC 60601-1-2. There were also tests according to IEC 60601-2-57 for non-laser light source equipment. This implies these standards' requirements serve as "acceptance criteria" for basic safety and performance, which were met.
-
Sample sizes used for the test set and the data provenance: Not applicable. This refers to an AI/software's performance test set. The document mentions non-clinical testing (electrical safety, EMC, thermal profiles) but these don't involve test "samples" in the sense of patient data for a diagnostic algorithm. No clinical data or test sets are described.
-
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. This relates to ground truth for diagnostic AI.
-
Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable. This relates to ground truth for diagnostic AI.
-
If a multi-reader multi-case (MRMC) comparative effectiveness study was done: No. The document explicitly states "Clinical Performance Data: None." This type of study (MRMC) is relevant for assessing human reader performance with and without AI assistance, which is not the purpose of this submission for a light/RF device.
-
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. There is no diagnostic algorithm to perform in a standalone manner.
-
The type of ground truth used: Not applicable. Ground truth typically refers to validated diagnostic labels for training/testing AI models.
-
The sample size for the training set: Not applicable. There is no AI model being trained on patient data.
-
How the ground truth for the training set was established: Not applicable. There is no AI model being trained on patient data.
In summary, this 510(k) submission for the DEKA LOTUS device demonstrates substantial equivalence based on the device's technical specifications and compliance with relevant safety and performance standards for physical medical devices, rather than a clinical performance study of an AI-powered diagnostic tool.
§ 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.