Search Results

The SurgiLight 1470 Diode Laser System (Model: Halo) is indicated for use in surgical applications requiring the vaporization, incision, excision, ablation, cutting and hemostasis, or coagulation of soft tissue in conjunction with endoscopic equipment for medical specialist including: Urology, Thoracic Surgery, Plastic Surgery and Dermatology, General Surgery, Ophthalmology, Orthopedics, Podiatry, Arthroscopy, Spinal Surgery, Gynecology, Pulmonary Surgery, Neurosurgery, Gastroenterology, Head/neck/ENT and Radiology, Oral Surgery and Dental procedures, Endovascular coagulation and endovenous occlusion of the greater saphenous vein in patients with superficial vein reflux.

The SurgiLight 1470 Diode Laser System (model: Halo) incorporates a 1470nm wavelength Gallium Arsenide (GaAs) diode laser for producing its therapeutic effects. The device also incorporates a red (650nm) aiming beam diode to indicate the area to be irradiated by the laser beam. The device is composed of the main unit, footswitch, a power cord and remote interlock components. The device incorporates an LCD touchscreen for the device user to set output parameters and for control of the device. The device transmits the laser output via optical fibers with SMA905 connectors.

This document is a 510(k) clearance letter for the SurgiLight 1470 Diode Laser System (Model:Halo). It states that the device is substantially equivalent to legally marketed predicate devices.

Important Note: The provided document is a 510(k) clearance letter for a laser surgical instrument. These types of devices typically demonstrate substantial equivalence through performance testing against recognized consensus standards and comparison of technological characteristics to predicate devices. They do not involve AI-based image analysis or diagnostic capabilities that would require the kind of complex study design (e.g., MRMC studies, human reader improvement metrics, expert consensus ground truth for image data) described in your request.

Therefore, many of the specific criteria related to AI performance studies (e.g., sample size for test sets, number of experts for ground truth, MRMC studies, standalone AI performance) are not applicable to this type of medical device clearance.

Here's an analysis based on the information provided in the 510(k) document, addressing your questions where applicable and noting when information is not pertinent to this device type:

Acceptance Criteria and Device Performance for SurgiLight 1470 Diode Laser System (Model:Halo)

Based on the 510(k) summary, the "acceptance criteria" are primarily demonstrated through compliance with recognized international standards for medical electrical equipment and a comparison of technical specifications to legally marketed predicate devices. The "study" proving the device meets these criteria is the non-clinical testing performed.

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are implicitly defined by the compliance with the listed standards and the demonstrated substantial equivalence to predicate devices in key technical specifications.

2. Sample Size Used for the Test Set and the Data Provenance

• Not Applicable in the traditional sense of a clinical or image-based test set. For a laser surgical instrument, "testing" refers to bench testing and compliance with electrical, safety, and performance standards. There is no "test set" of patient data or images.
• The data provenance would be from internal laboratory testing conducted by Micro-Energy Medical Technology Co., Ltd. for product verification and validation. It is retrospective in the sense that the results are used to support the 510(k) submission.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts

• Not Applicable. This device does not use AI or diagnostic imaging where expert-established ground truth on a test set of clinical images would be necessary. Performance is evaluated against engineering specifications and industry standards.

4. Adjudication Method for the Test Set

• Not Applicable. There is no "test set" of clinical cases requiring adjudication by human experts.

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

• No, an MRMC comparative effectiveness study was not done. This is a laser surgical instrument, not an AI-assisted diagnostic imaging device. Therefore, the concept of human reader improvement with AI assistance is not relevant.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

• Not Applicable. This is a hardware medical device (laser system), not a standalone AI algorithm.

7. The type of ground truth used

• For this device, the "ground truth" is defined by:
  • Engineering Specifications: The device's output power, wavelength, pulse parameters, etc., must meet its design specifications.
  • Consensus Standards: Compliance with the requirements outlined in IEC 60601-1, IEC 60601-1-2, IEC 60601-2-22, and IEC 60825-1 serves as the ground truth for safety and essential performance.
  • Predicate Device Characteristics: The functional and technological characteristics are compared to those of legally marketed predicate devices to establish substantial equivalence.

8. The sample size for the training set

• Not Applicable. This device does not involve machine learning algorithms requiring a training set of data.

9. How the ground truth for the training set was established

• Not Applicable. See point 8.

In summary, the provided 510(k) clearance describes a laser surgical device, not an AI-powered diagnostic tool. The acceptance criteria and supporting studies focus on demonstrating device safety, performance, and substantial equivalence to existing devices through compliance with recognized standards and technical characteristic comparisons, rather than clinical efficacy studies involving patient data or AI algorithm validation.

Ask a specific question about this device