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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.

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.

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The Iridex® Laser Console (532 model) are solid state lasers that are used to deliver laser energy in either continuous wave pulse (CW-pulse® mode, for ophthalmic applications (532 and 577 models) and for Ear, Nose, and Throat (Otolaryngology) applications (532 model only).

Iridex® 532 Laser

The Iridex® 532 Laser is indicated for use in soft and fibrous tissue, including osseous tissue incision, excision, coagulation, vaporization, ablation and vessel hemostasis in the medical specialties of, ear, nose and throat (ENT)/otolaryngology, and ophthalmology as follows:

Ophthalmology

Indicated for retinal photocoagulation, laser trabeculoplasty, iridoplasty including:

• · Retinal photocoagulation (RPC) for the treatment of
  • o Diabetic retinopathy, including:
    • Nonproliferative retinopathy
    • Macular edema
    • Proliferative retinopathy
  • o Retinal tears and detachments
  • o Lattice degeneration
  • o Age-related macular degeneration (AMD)
  • o Retinopathy of prematurity
  • o Sub-retinal (choroidal) neovascularization
  • o Central and branch retinal vein occlusion
• · Laser trabeculoplasty, iridotomy, iridoplasty for the treatment of glaucoma, including
  • o Primary open angle/Closed angle

Ear, Nose, and Throat (ENT)/Otolaryngology

Otosclerotic Hearing loss and/or diseases of the inner ear:

• · Stapedectomy
• · Stapedotomy
• · Myringotomies
• · Lysis of Adhesions
• · Control of Bleeding
• · Removal of Acoustic Neuromas
• · Soft tissue Adhesion in Micro/Macro Otologic Procedures

Iridex® 577 Laser

The Iridex® 577 Laser is indicated for use in soft and fibrous tissue, including osseous tissue incision, excision, coagulation, vaporization, ablation and vessel hemostasis in the medical specialty of ophthalmology as follows:

Ophthalmology

Indicated for use in photocoagulation of both anterior and posterior segments including:

• · Retinal photocoagulation, panretinal photocoagulation and intravitreal endophotocoagulation of vascular and structural abnormalities of the retina and choroid including: o Proliferative and nonproliferative diabetic retinopathy o Choroidal neovascularization o Branch retinal vein occlusion o Age-related macular degeneration (AMD) o Retinal tears and detachments o Retinopathy of prematurity · Iridotomy, iridectomy and trabeculoplasty in angle closure glaucoma and open angle glaucoma

The Iridex 532/577 Laser consoles are solid state lasers that are used to deliver laser energy in continuous wave and MicroPulse® for ophthalmic applications and (for 532 only) ear, nose, and throat (ENT) / otolaryngology applications. The Iridex® 532 Laser delivers a 532 nm wavelength (green) laser emission, and the Iridex® 577 Laser delivers a 577mm wavelength (true-yellow) laser emission.

The Iridex 532 Laser and the Iridex 577 Laser systems are comprised of a laser console with footswitch and an optical fiber delivery device. Each laser console model contains two laser diodes as follows:

• Iridex 532 Laser: 532 nm for Treatment and 650 nm for Aiming beam ●
• Iridex 577 Laser: 577 nm for Treatment and 650 nm for Aiming beam ●

imaging optics, power supply, control electronics, and software/embedded firmware (with microprocessor). Lasing can only be initiated from the footswitch.

Optical fiber Delivery Devices are provided separately.

The provided text describes a 510(k) summary for the Iridex® Laser, demonstrating substantial equivalence to a predicate device. The information primarily focuses on non-clinical performance data rather than a detailed clinical study involving human readers and AI assistance.

Based on the provided document, here's a breakdown of the acceptance criteria and the study that proves the device meets them:

Acceptance Criteria and Reported Device Performance

The study primarily evaluates the safety and performance of the Iridex® Laser against established standards and internal specifications, not a comparative effectiveness study with human readers and AI. Thus, the performance is measured against technical and safety benchmarks.

1. Table of Acceptance Criteria and the Reported Device Performance

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

The document explicitly states: "Clinical testing was not required for this product change." This indicates that the regulatory submission relies on non-clinical performance and safety data, as well as a comparison to a predicate device. Therefore, there is no test set of clinical images or patient data as would be used in an AI/imaging device. The "test set" here refers to the units of the device itself and its components undergoing engineering validation.

The provenance of this data is from internal Iridex testing and external test houses (e.g., Westpak testing for shipping/packaging). The data is prospective in the sense that the tests were conducted specifically for this regulatory submission on the subject devices.

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

Given that this is a non-clinical device performance and safety study, not a diagnostic AI study, there were no clinical experts (e.g., radiologists) involved in establishing ground truth for a test set of images. The ground truth for the device's technical performance (e.g., power output accuracy, pulse duration) would be established by calibrated measurement equipment and engineering standards, not human expert consensus.

4. Adjudication Method for the Test Set

Not applicable. Since there's no clinical test set requiring image interpretation or diagnosis, there's no need for an adjudication method (like 2+1 or 3+1 consensus) for ground truth establishment. Technical performance metrics are typically measured against established engineering tolerances directly.

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, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This device is a laser system for treatment, not an AI or diagnostic imaging device. The submission focuses on demonstrating substantial equivalence to a predicate laser device based on technical specifications and safety standards, not on improving human reader performance with AI assistance. Therefore, there is no effect size related to AI improvement for human readers.

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

Not applicable. This device is a therapeutic laser system, not an algorithm, and does not operate as a "standalone" diagnostic or AI tool. Its performance is intrinsic to its hardware and embedded software controlling laser emission.

7. The Type of Ground Truth Used

The "ground truth" for this device's performance is based on:

• International Electrotechnical Commission (IEC) Standards: For electrical, laser, EMI/EMC safety, usability, and software lifecycle processes (e.g., IEC 60601-1, IEC 60601-2-22, IEC 60825-1, IEC 60601-1-2, IEC 60601-1-6, IEC 62304).
• ISTA Standards: For shipping and packaging integrity (ISTA 3A).
• Internal Iridex Performance Specifications: For parameters like treatment beam power output, pulse duration/interval, and aiming beam power output.

This is a technical and engineering ground truth, established through calibrated measurements and adherence to recognized industry standards, rather than clinical consensus or pathology findings.

8. The Sample Size for the Training Set

Not applicable. This is a medical device, not an AI model requiring 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 an AI model.

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The "CHERYLAS-15N and CHERYLAS-20N" are indicated for the treatment of reflux of the saphenous veins associated with varicose veins and varicosities.

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 1470mm. It features impact structure, high efficiency and long lifetime. Generally the beam shall be shamed as the big beam divergence of the laser from the diode. When the coaxiality of laser and fiber meet the requirements, the laser beam can be coupled efficiently into the fiber.

The block diagram shows how the diode laser system works. 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 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 system can test and calibrate power by the calibration and feedback unit.

The provided document is a 510(k) premarket notification for a medical device (Medical Diode Laser Systems) and primarily focuses on proving substantial equivalence to a predicate device based on technical characteristics and adherence to safety standards. It explicitly states "Clinical data: Not applicable." Therefore, the document does not contain the information requested regarding acceptance criteria and a study proving a device meets those criteria, specifically concerning performance metrics like sensitivity, specificity, or the improvement of human readers with AI assistance.

The information provided pertains to the device's technical specifications, intended use, and comparison to a predicate device, focusing on safety and technological equivalence rather than AI/algorithm performance.

To answer your request, the document would need to include details about a clinical study or a robust non-clinical performance study with specific metrics, a test set, ground truth establishment, and statistical analysis, which is absent.

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