(249 days)
The Medical Diode Laser Systems, include model: VELASⅡ-30A, GBOX-15AB, GBOX-20B, CHEESEⅡ-10B are intended to emit energy in the infrared spectrum to provide topical heating for the purpose of elevating tissue temperature for temporary relief of minor muscle and joint pain, muscle spasm, pain and stiffness associated with minor arthritis, promoting relaxation of muscle tissue, and to temporarily increase local blood circulation.
The Medical Diode Laser Systems, model: VELASⅡ-30B is intended to emit energy in the infrared spectrum to provide topical heating for the purpose of elevating tissue temperature for temporary relief of minor muscle and joint pain, muscle spasm, pain and stiffness associated with minor arthritis, promoting relaxation of muscle tissue, and to temporarily increase local blood circulation.
The Medical Diode Laser Systems, model: VELASⅡ-30B is also indicated for use for the temporary increase of clear nail in patients with onychomycosis (e.g., dermatophytes Trichophyton rubrum and T. mentagrophytes, and/or yeasts Candida albicans, etc.).
The "Medical Diode Laser Systems", include model: VELASⅡ-30B, VELASⅡ-30A, GBOX-15AB, GBOX-20B, CHEESEⅡ-10B which consist of three main components: Main device; Foot switch; Accessories.
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 810nm and/or 980nm+/-10nm (pilot beam: 650nm+/-10nm). 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 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 system by 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 provided FDA 510(k) clearance letter for the Gigaalaser Medical Diode Laser Systems does not contain a study that proves the device meets specific acceptance criteria related to its clinical efficacy. Instead, it demonstrates substantial equivalence to legally marketed predicate devices based on technological characteristics and safety standards.
The document focuses on non-clinical performance data (electrical safety, EMC, software V&V, mechanical/acoustic, animal, and clinical studies are noted as "not applicable" for this submission type) to argue that the proposed device is as safe and effective as its predicates.
Therefore, I cannot directly provide a table of acceptance criteria and reported device performance in the context of a clinical efficacy study, as such a study is explicitly stated as "not applicable" in this 510(k) submission. Similarly, details about sample size, expert ground truth, adjudication methods, MRMC studies, or standalone performance are not present because clinical efficacy testing was not required for this type of submission.
However, I can interpret the acceptance criteria in the context of a 510(k) submission as the requirements for demonstrating substantial equivalence to predicates, particularly regarding safety and technological characteristics. The "performance" reported is the demonstration that these criteria are met through compliance with recognized standards.
Here's an interpretation based on the provided document:
Overview of "Acceptance Criteria" for Substantial Equivalence and Device Performance (as demonstrated in the 510(k))
Within the context of a 510(k) submission, "acceptance criteria" are primarily established through demonstrating compliance with recognized performance standards and substantial equivalence to legally marketed predicate devices. The "study" proving this involves a comprehensive technical comparison and non-clinical testing.
The document explicitly states that clinical studies are "not applicable" for this 510(k) submission, meaning the acceptance criteria are focused on non-clinical performance and technological equivalence rather than empirical clinical efficacy data from a human trial.
1. Table of "Acceptance Criteria" (Substantial Equivalence) and "Reported Device Performance" (Demonstrated Compliance)
| Acceptance Criteria (Demonstration of Equivalence to Predicate) | Reported Device Performance (as summarized in the document) |
|---|---|
| Similar Indications for Use | Identical or Covered: All proposed device models (VELASⅡ-30A, GBOX-15AB, GBOX-20B, CHEESEⅡ-10B) share identical indications for general topical heating relief as their respective predicates. The VELASⅡ-30B also shares the onychomycosis indication with a co-predicate. |
| Similar Technological Characteristics (General) | Identical Diode Laser Technology: All models use the same diode laser technology (e.g., 980nm, 810nm, or combinations) as their respective predicates. |
| Similar Output Parameters (within clinical needs) | Within Predicate Scope: While some proposed device models show slight differences in output power, energy density, power density, spot diameter, operation mode (CW vs. pulse), pulse width, pulse repetition rate, transmission system, and aiming beam compared to their specific predicates, these differences are argued to be "slight" and "do not raise new types of questions regarding the safety and effectiveness" and are "within the scope of what predicate device claims" or "meet clinical needs." |
| Compliance with Electrical Safety Standards | Verified Conformity: Demonstrated compliance with IEC 60601-1:2005/AMD1:2012/AMD2:2020. |
| Compliance with Electromagnetic Compatibility (EMC) Standards | Verified Conformity: Demonstrated compliance with IEC 60601-1-2:2014+A1:2020. |
| Compliance with Laser Safety Standards | Verified Conformity: Demonstrated compliance with IEC 60825-1:2014. |
| Compliance with Usability Standards | Verified Conformity: Demonstrated compliance with IEC 60601-1-6:2010/AMD1:2013/AMD2:2020. |
| Compliance with Medical Laser Equipment Specific Standards | Verified Performance: Demonstrated compliance with IEC 60601-2-22:2019. |
| Software Verification & Validation | Conducted and Documented: Software testing conducted as per FDA guidance, with the software deemed a "moderate" level of concern. |
2. Sample Size Used for the Test Set and Data Provenance
This document does not describe a "test set" in the context of clinical data for efficacy. The "testing" referred to is primarily bench testing and compliance validation with international safety and performance standards. Therefore, concepts like sample size for a patient test set and data provenance (country of origin, retrospective/prospective) are not applicable as no clinical study for efficacy was performed or presented.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
Not applicable. As no clinical efficacy test set was used, there was no need for experts to establish ground truth on patient outcomes/diagnoses. The "ground truth" for the substantial equivalence argument relies on comparison to the published specifications and regulatory clearances of the predicate devices.
4. Adjudication Method for the Test Set
Not applicable, as no clinical test set requiring adjudication was used.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No. The document explicitly states "Clinical Studies: It is not applicable." Therefore, no MRMC study for human reader improvement with AI assistance was conducted or reported.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
No. This device is a laser system hardware, not an AI algorithm. Its performance is inherent to its physical output characteristics, not an algorithm's classification or detection performance.
7. The Type of Ground Truth Used
The "ground truth" for this 510(k) submission is primarily:
- Predicate Device Specifications: The established technical parameters and indications for use of the legally marketed predicate devices (K142078, K150138, K121363, K230047).
- Industry Standards: The requirements laid out in the cited IEC and other international standards for medical electrical equipment and laser safety.
8. The Sample Size for the Training Set
Not applicable. This is a hardware device, not a machine learning model that requires a training set of data.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no training set for this type of device.
§ 890.5500 Infrared lamp.
(a)
Identification. An infrared lamp is a device intended for medical purposes that emits energy at infrared frequencies (approximately 700 nanometers to 50,000 nanometers) to provide topical heating.(b)
Classification. Class II (special controls). The device, when it is an infrared therapeutic heating lamp, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 890.9.