(88 days)
HS-890A 980mm Diode Laser Therapy Device is intended for use in surgical application requiring the vaporization , incision, excision, ablation, cutting and hemostasis or coagulation of soft tissue. Such as vascular lesions and dental procedure.
The Diode Laser Therapy Device is a desktop device which utilizes a semiconductor diode with invisible infrared radiation as a laser source (980nm). The laser power is delivered to the treatment via a delivery system. The proposed device includes power supply system, delivery system, control system, cooling system and laser system.
The provided document is a 510(k) summary for a medical device called the "980nm Diode Laser Therapy Device." This document details the device's characteristics, its intended use, and its comparison to a predicate device for the purpose of demonstrating substantial equivalence. It is important to note that the document does not describe acceptance criteria and a study proving a device meets those criteria in the context of an AI/machine learning-based device. Instead, it outlines the regulatory approval process for a traditional medical laser device.
Therefore, many of the requested items (e.g., sample size for test set, expert qualifications for ground truth, MRMC study, training set information) are not applicable to the content of this document.
However, I can extract the information that is available:
1. A table of acceptance criteria and the reported device performance:
The document does not present acceptance criteria in a table format with reported device performance in the way one would for an AI/ML device evaluating statistical metrics (e.g., sensitivity, specificity). Instead, the acceptance criteria are implicitly the adherence to established performance standards for medical laser devices, and the reported device performance is its successful compliance with these standards.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Compliance with Electrical Safety standard IEC 60601-1 | Device complies with IEC 60601-1: 2005+corr.1:2006+Corr.2.2007+A1:2012 |
| Compliance with Electromagnetic Compatibility standard IEC 60601-1-2 | Device complies with IEC 60601-1-2:2014 |
| Compliance with Laser Safety standard IEC 60825-1 | Device complies with IEC 60825-1:2014 |
| Compliance with Particular Requirements for Laser Equipment standard IEC 60601-2-22 | Device complies with IEC 60601-2-22:2007(third edition) +A1:2012 |
| Device functions as intended within its specifications (e.g., wavelength, power output, pulse width, operation mode, delivery system, aiming beam, laser class, operation interface, power supply, dimensions, weight, safety classification, software) | Device specifications (e.g., 980nm±10nm wavelength, 1-30W output power, 5~400ms pulse width, etc.) are listed and compared to the predicate device, implying performance within these stated parameters. The "Non-Clinical Testing" section states that tests were performed to "verify that the proposed device met all design specification" and "The test result demonstrated that the proposed device complies with the following standards." |
| Substantial Equivalence to Predicate Device (K151890) | Concluded: "Base on the performance testing and validation studies that the subject device is substantially equivalent to the predicate device." |
2. Sample sized used for the test set and the data provenance:
This information is not applicable. The device is a physical laser therapy device, not an AI/ML algorithm that processes data. Testing involved engineering and safety compliance rather than data analysis.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
This information is not applicable. Ground truth, in the context of this device, would refer to the physical and electrical safety standards outlined, which are established by recognized regulatory and standardization bodies.
4. Adjudication method for the test set:
This information is not applicable. Adjudication methods like 2+1 or 3+1 are typically used in clinical review of imaging or complex diagnoses for AI/ML performance evaluation. The testing here is for compliance with technical standards.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
This information is not applicable. This is not an AI-assisted device, and no human reader studies are mentioned.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
This information is not applicable. The device is a standalone physical laser system, not an algorithm.
7. The type of ground truth used:
The "ground truth" for this device's acceptance is its compliance with established international and national standards for medical electrical equipment and laser safety. These include:
- IEC 60601-1 (General requirements for basic safety and essential performance)
- IEC 60601-1-2 (Electromagnetic disturbances)
- IEC 60825-1 (Safety of Laser products - Equipment classification and requirements)
- IEC 60601-2-22 (Particular requirements for the safety and essential performance of surgical, cosmetic, therapeutic and diagnostic laser equipment)
The document explicitly states that "The test result demonstrated that the proposed device complies with the following standards."
8. The sample size for the training set:
Not applicable, as this is not an AI/ML device.
9. How the ground truth for the training set was established:
Not applicable, as this is not an AI/ML device.
§ 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.