(429 days)
The intended use of the "CHARISMA" is:
-Dermatological procedures requiring coagulation of soft tissue and skin resurfacing procedures. further indicated for treatment of benign pigmented lesions, such as, but not limited to lentigines (age spots), solar lentigos (sun spots), melasma, dyschromia, and for treatment of facial wrinkles and fine lines.
-Incision, excision, ablation, vaporization, hemostasis and/or coagulation of soft tissue
-Endovascular coagulation and endovenous occlusion of the greatest saphenous vein in patients with superficial vein reflux
-Further indicated for laser assisted lipolysis.
The intended use of the "REGAL" is:
-Incision, excision, ablation, vaporization, hemostasis and/or coagulation of soft tissue
-Endovascular coagulation and endovenous occlusion of the greatest saphenous vein in patients with superficial vein reflux
-Further indicated for laser assisted lipolysis.
Diode laser is a kind of laser with semiconductor as working material. It consists of working material, cavity resonator and power source. The diode laser for this unit is GaAlAs diode bar, and the wavelength is 1470nm. It features impact structure, high efficiency and long lifetime. Generally, the beam shall be emitted as the big beam divergence of the laser from the diode. With the GIGAA'S unique fiber-coupling technology, the laser beam can be coupled efficiently into the fiber. MCU (Micro Controller Unit) is the control center of system. MCU controls the drive board and temperature system by changing operating current. The operating power supply is the power source of the whole system, it supplies power for MCU, diode laser module by DC-DC conversion module and temp-control circuit. MCU controls the drive current of diode laser module by adjusting the DC-DC module and current-control circuit. The MCU has three external input sources: footswitch, remote interlock connector and information input from the touch units, it has one external output unit: display terminal. The diode laser module provides laser power output by fiber with optical fiber coupling system.
The document provided is a 510(k) premarket notification for two medical diode laser systems, CHARISMA and REGAL. It aims to demonstrate substantial equivalence to legally marketed predicate devices, not to prove the device meets specific acceptance criteria through a clinical study. Therefore, much of the requested information regarding acceptance criteria, study design, sample sizes, expert involvement, and ground truth cannot be extracted from this document in the typical sense of a clinical performance study for an AI/software device.
However, I can provide information on the non-clinical tests performed to demonstrate safety and performance equivalence, as these serve as the "acceptance criteria" for this type of submission.
Here's a breakdown of the available information:
1. Table of Acceptance Criteria and Reported Device Performance
For this 510(k) submission, the "acceptance criteria" are compliance with established electrical safety, EMC, and laser safety standards, as well as satisfactory software verification and validation. The "reported device performance" is the demonstration of compliance through non-clinical testing.
| Acceptance Criteria Category | Specific Acceptance Criteria (Standard & Version) | Reported Device Performance (Compliance Status) |
|---|---|---|
| Electrical Safety | IEC60601-1: 2005/(R)2012 | Conformity verified |
| Electromagnetic Compatibility (EMC) | IEC60601-1-2: 2014-02 | Conformity verified |
| Laser Safety | IEC 60825-1: 2007-03 | Conformity verified |
| Laser Equipment Performance | IEC 60601-2-22: 2012-10 | Performance verified |
| Software Verification and Validation | FDA's "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices" (Moderate Level of Concern) | Testing conducted and documentation provided, demonstrating compliance |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: Not applicable. The testing described is non-clinical, involving the physical device and its software being tested against engineering and safety standards, rather than a "test set" of patient data or samples.
- Data Provenance: Not applicable. The testing involves the device itself and its components, not patient data.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
Not applicable. This is a non-clinical submission. Ground truth, in the context of clinical studies for AI/software, refers to definitive diagnoses or measurements. Here, the "ground truth" is compliance with international safety and performance standards. The "experts" involved would be the engineers and quality assurance personnel conducting and verifying the tests, but their specific number and qualifications are not detailed in this document.
4. Adjudication Method for the Test Set
Not applicable. There is no "adjudication method" in the sense of resolving discrepancies in expert opinions on patient data. Compliance with standards is typically determined by objective measurements and verification protocols.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. The document explicitly states under "VIII Clinical Testing" that it "is not applicable." This type of study is usually performed for diagnostic AI devices where human performance with and without AI assistance is being compared.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done
No, a standalone performance study in the context of AI/software algorithm only was not done. The device is a physical medical laser system, and the non-clinical tests assess the safety and performance of the hardware and integrated software, not a standalone algorithm.
7. The Type of Ground Truth Used
As this is a non-clinical submission, the "ground truth" is compliance with recognized international safety and performance standards (IEC 60601-1, IEC 60601-1-2, IEC 60825-1, IEC 60601-2-22) and FDA guidance for software. These standards define the acceptable limits and behaviors for medical electrical equipment, laser products, and software.
8. The Sample Size for the Training Set
Not applicable. This document describes a medical device's safety and performance testing for regulatory clearance, not the development or training of an AI algorithm. Therefore, there is no "training set" in the context of machine learning.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no training set mentioned or implied in this regulatory submission.
§ 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.