(142 days)
LED Light Therapy Device use of the red, blue, Yellow and infrared regions of the spectrum is intended to emit energy to treat dermatological conditions.
The red light (633±10mm wavelength) is generally indicated to treatment of superficial, benign vascular, and pigmented lesions.
The blue light (417±10 nm wavelength) is generally indicated to treat dermatological conditions and specifically indicated to treat moderate inflammatory acne vulgaris.
The Yellow light (599±10nm wavelength) is generally indicated to treat dermatological conditions and specifically indicated for treatment of periorbital wrinkles and rhytides.
The infrared light (835±15nm wavelength) is generally use for the temporary relief of minor muscle and joint pain. arthritis and musele spasm; relieving stiffness; promoting the relaxation of muscle tissue; and to temporarily increase local blood circulation where applied.
The LED Light Therapy Device uses specific wavelengths of light, produced by LEDs (Light emitting diodes), to manage aesthetic conditions. The device produces light in the red light region of the spectrum (633±10nm), in the blue light regions of the light spectrum (417±10mm), yellow light area (590 ± 10nm) and infrared light region of light spectrum (835±15nm).
The LED Light Therapy Device instrument is equipped with two irradiators. The RBY irradiator has five panels, each of which emits three different colors of light sources (red light, blue light, yellow light); RBI irradiator has five panels, each panel emits three different colors of light sources (red light, blue light, infrared light).
The instrument is mainly composed of a main frame, an irradiator, and a lifting stand.
Based on the provided text, the document is a 510(k) Premarket Notification from the FDA regarding an LED Light Therapy Device (KN-7000L). It focuses on establishing substantial equivalence to previously cleared predicate devices, primarily through comparison of technical specifications and non-clinical testing.
Therefore, the document does NOT contain information regarding clinical studies, acceptance criteria for an AI/device performance, expert ground truth establishment, or multi-reader multi-case studies. The device in question is an LED light therapy device, not an AI-powered diagnostic or assistive device that would typically undergo such rigorous performance evaluation against patient data.
The document details the device's technical specifications and confirms compliance with electrical safety, electromagnetic compatibility, and photobiological safety standards.
As a result, I cannot provide the requested information for the following points as they are not present in the provided text:
- A table of acceptance criteria and the reported device performance: No performance metrics beyond technical specifications (wavelength, irradiance, etc.) and compliance with safety standards are mentioned.
- Sample sizes used for the test set and the data provenance: No clinical test sets or data provenance (country, retrospective/prospective) are discussed. The "test set" here refers to non-clinical tests (e.g., electrical, photobiological).
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable, as there's no ground truth established for clinical performance.
- Adjudication method for the test set: Not applicable.
- If a multi-reader multi-case (MRMC) comparative effectiveness study was done: No MRMC study was conducted or mentioned. This type of study is typical for AI devices assisting human readers in diagnostic tasks, which is not the function of this LED light therapy device.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable, as there is no AI algorithm.
- The type of ground truth used: Not applicable.
- The sample size for the training set: Not applicable, as this is not an AI/machine learning device.
- How the ground truth for the training set was established: Not applicable.
However, I can extract the following information that is relevant to the type of acceptance criteria and "study" conducted for this device, which focuses on non-clinical performance and substantial equivalence:
1. Table of "Acceptance Criteria" (Non-Clinical Performance) and Reported Device Performance
For this type of device, "acceptance criteria" primarily relate to meeting established safety and performance standards rather than clinical efficacy metrics derived from patient data. The manufacturer asserts substantial equivalence based on these comparisons and non-clinical testing.
| Feature / Criterion | Acceptance "Criterion" (via Predicate Comparison & Standards Compliance) | Reported Device Performance (KN-7000L) |
|---|---|---|
| Product Code | Same as predicate (GEX) | GEX |
| Indications for Use | Same or substantially equivalent to predicate devices for treating dermatological conditions (superficial, benign vascular, pigmented lesions, moderate inflammatory acne vulgaris, periorbital wrinkles/rhytides, temporary relief of minor muscle/joint pain, arthritis, muscle spasm, stiffness, muscle tissue relaxation, increased local blood circulation). | Same as predicates, encompassing red (633±10nm), blue (417±10nm), yellow (599±10nm), and infrared (835±15nm) regions for dermatological conditions and pain relief. |
| Wavelength(s) | Within ranges of predicate devices. | RBY irradiator: Red (633±10nm), Blue (417±10nm), Yellow (590±10nm). RBI irradiator: Red (633±10nm), Blue (417±10nm), Infrared (835±15nm). (Considered "basically the same" or "substantially equivalent" to predicates K190938 and K200104 despite minor numerical differences). |
| Maximum Power Density (mW/cm²) | Within size ranges of predicate devices. | Red: 20-96 mW/cm²; Blue: 10-120 mW/cm²; Yellow: 5-35 mW/cm²; Infrared: ≤ 70 mW/cm². Combined: Red/IR: 166 mW/cm², Blue/IR: 190 mW/cm². (Considered "substantially equivalent" as within predicate ranges). |
| Standard Dose (Joules) | Within size ranges of predicate devices. | Red: 155 J/cm²; Blue: 144 J/cm²; Yellow: 42 J/cm²; IR: 84 J/cm². Combined: Red/IR: 199 J/cm², Blue/IR: 228 J/cm². (Considered "substantially equivalent" as within predicate ranges). |
| Effective Irradiation Area (CM²) | Within size ranges of predicate devices. | 900 cm² ±10% (Considered "substantially equivalent" compared to predicate ranges of 500-1008 cm²). |
| Electrical Safety | Compliance with IEC 60601-1, IEC 60601-1-2. | Tested and meets IEC 60601-1: 2005+A1:2012, IEC 60601-1-2:2014. |
| Photobiological Safety | Compliance with IEC 62471. | Tested and complies with IEC 62471:2006 (incorporating ANSI IESNA RP 27.1, 27.2, 27.3). |
| Electromagnetic Compatibility (EMC) | Compliance with IEC 60601-1-2. | Tested and meets IEC 60601-1-2:2014. (Note: IEC 60601-2-57:2011 is also listed as an EMC test, but it is actually a particular standard for non-laser light sources for therapeutic and diagnostic use, which includes EMC aspects). |
| Software Verification & Validation | Documentation consistent with moderate level of concern, software requirements met, hazards mitigated. | Software documentation consistent with moderate level of concern submitted. System validation testing demonstrated all software requirement specifications met and hazards mitigated. |
| Additional Main Performance Indicators (e.g., power supply, noise, timing) | Met for the device, and within acceptable ranges for medical devices of this type. | Power supply: AC 100-240V±10%, 50/60 Hz±2%; Input power: 600VA; Working noise: ≤ 60dB (A); Timer error: ≤ ±2% of set value; Continuous working time ≤ 99min. Functions include manual stop, replaceable irradiator, preset treatments, calibration, time/dose modes, continuous/pulse output. |
Summary of "Study" Proving Compliance:
The "study" in this context is a non-clinical testing and comparison study aiming to demonstrate substantial equivalence (SE) to predicate devices by verifying the new device shares fundamental technological characteristics and performs comparably in terms of safety and technical specifications.
- Type of "Study": Non-clinical performance testing and comparative analysis to predicate devices.
- Purpose: To demonstrate substantial equivalence (SE) for 510(k) clearance, indicating the device is as safe and effective as a legally marketed predicate device.
- Ground Truth: The "ground truth" for this regulatory submission is adherence to recognized medical device standards (IEC 60601-1, IEC 60601-1-2, IEC 60601-2-57, IEC 62471) and the established performance characteristics of the predicate devices. The device's measured technical specifications (e.g., wavelength, irradiance, power) were compared against these standards and predicate parameters.
- Data Provenance/Sample Size: Not applicable in the traditional sense of patient data. The "sample size" refers to the tested units of the KN-7000L device undergoing the specified non-clinical tests. The data provenance is from the manufacturer's internal testing. The document does not specify the exact number of units tested, but it is implied that the testing performed on the device samples confirmed compliance.
- Expert involvement for Ground Truth, Adjudication, MRMC, Standalone AI, Training Set: These concepts are not applicable to the non-clinical testing and substantial equivalence demonstration for a light therapy device. There is no AI component, and no human diagnostic performance is being evaluated.
§ 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.