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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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Intended for use in the treatment of ocular pathology in both the posterior and anterior segments.

Intended for use in the posterior segment to perform retinal photocoagulation, panretinal photocoagulation, focal photocoagulation and grid photocoagulation for vascular and structural abnormalities of the retina and choroid including:

(532nm)

• proliferative and non-proliferative diabetic retinopathy
• macular edema
• choroidal neovascularization associated with wet age-related macular degeneration
• age-related macular degeneration
• lattice degeneration
• retinal tears and detachments

(577nm)

• proliferative and non-proliferative diabetic retinopathy
• macular edema
• choroidal neovascularization associated with wet age-related macular degeneration
• age-related macular degeneration
• lattice degeneration
• retinal tears and detachments

Intended for use in the treatment of ocular pathology in the anterior segment including:

(532 nm and 577nm)

• iridotomy
• trabeculoplasty

The Iridex PASCAL® (532 nm and 577 nm models) is an ophthalmic scanning laser system. PASCAL is an acronym for Pattern SCAn Laser. The system can perform single shot photocoagulation as is performed conventionally. In addition, the system is equipped with proprietary laser scanning technology that provides the user with the option to perform laser pattern scanning. This allows the user to place many laser treatment spots in a patient's eye rapidly by performing pattern scan laser photocoagulation. The system will scan user-selectable patterns of laser spots into a patient's eye.

The system includes a table for housing the laser module and associated electronics. A slit lamp is also integrated in the table enabling the interface to be at the base of the slit lamp, i.e., no external cabling. The table is smaller in size compared to prior versions to accommodate use in smaller rooms. In addition to single shot and pattern scanning the system also supports the use of a Laser Indirect Ophthalmoscope (LIO) with optical fiber port for connection of a LIO.

The system is available with either 532nm or 577nm laser emission.

This document is a 510(k) summary for the Iridex PASCAL® 532, Iridex PASCAL® 577, and Iridex PASCAL® (532 nm and 577 nm models) ophthalmic laser systems. It compares the subject device to a predicate device (PASCAL® Synthesis™ Ophthalmic Scanning Laser System) to establish substantial equivalence.

Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

Meet Iridex performance specifications pre- and post-conditioning testing. | PASS.
Test unit passed ISTA-3B conditioning and testing (Westpak testing)

Test unit passed Iridex performance testing Pre-and Post-conditioning (Iridex testing). |

2. Sample size used for the test set and the data provenance:

The document states that "Clinical testing was not required for this product change." This indicates that the performance data summarized above is based on non-clinical testing (e.g., bench testing, engineering validation). Therefore, there isn't a "test set" in the sense of a patient cohort. The testing was conducted on samples of the device itself.

• Sample size for test set: Not applicable for a clinical test set. The number of devices or components tested for each non-clinical verification is not specified, but it would typically be a statistically appropriate engineering sample size.
• Data provenance: The testing appears to be conducted by the manufacturer (Iridex testing) and potentially third-party labs (Westpak testing for shipping and packaging). The origin is thus manufacturer's internal testing and outsourced engineering testing. It is not retrospective or prospective clinical data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

This information is typically relevant for studies involving human interpretation or clinical outcomes. Since this submission relies on non-clinical engineering and safety standards, the concept of "ground truth established by experts" in this context is not directly applicable. The "ground truth" is the objective compliance with the specified international standards (e.g., IEC 60601 series, IEC 60825-1, IEC 62304) and the manufacturer's performance specifications. The experts involved would be the engineers and quality assurance personnel performing and overseeing these tests, and potentially external auditors or testing facility personnel. Their specific qualifications are not detailed but are presumed to be appropriate for conducting such technical verification.

4. Adjudication method for the test set:

Not applicable, as there is no clinical test set requiring expert adjudication of results. The testing involves objective measurements and comparisons against predefined criteria in relevant 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:

No. This device is an ophthalmic laser system, not an AI-powered diagnostic or assistive tool for human readers. Therefore, an MRMC comparative effectiveness study involving human readers and AI assistance is not relevant or mentioned.

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

Not applicable. This is a medical device (laser system), not an algorithm or AI. The tests performed are to confirm that the hardware and software components of the device meet safety and performance standards in a standalone operational capacity.

7. The type of ground truth used:

The "ground truth" used is defined by:

• International Standards: e.g., IEC 60601-1 (Electrical Safety), IEC 60601-1-2 (EMI/EMC), IEC 60601-1-6 (Usability), IEC 60601-2-22 (Laser Safety), IEC 60825-1 (Laser Safety), IEC 62304 (Software life-cycle processes).
• Manufacturer Performance Specifications: For shipping and packaging testing, "Iridex performance specifications" are used.

These standards and specifications serve as the objective criteria against which the device's performance is measured.

8. The sample size for the training set:

Not applicable. This is a physical medical device submission, not an AI/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 submission.

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The Iridex 810 Laser is indicated for retinal photocoagulation, laser trabeculoplasty, transscleral cyclophotocoagulation, transscleral retinal photocoagulation, and other diode laser treatments. The following are examples of applications for the Iridex 810 Laser.

CONDITION: Diabetic Retinopathy (Nonproliferative Retinopathy, Macular Edema, Proliferative Retinopathy), Glaucoma (Primary Open Angle, Closed Angle, Refractory Glaucoma (recalcitrant/uncontrolled)), Retinal Tears, Detachments, and Holes, Lattice Degeneration, Age-Related Macular Degeneration (AMD), Intra-Ocular Tumors (Choroidal Hemangioma, Choroidal Melanoma, Retinoblastoma), Retinopathy of Prematurity, Sub-Retinal (choroidal) Neovascularization, Central and Branch Retinal Vein Occlusion

TREATMENT: Panretinal Photocoagulation (PRP); Focal and Grid Laser Treatments, Laser Trabeculoplasty; Iridotomy; Transscleral Cyclophotocoagulation (TSCPC), Transscleral Retinal Photocoagulation (TSRPC); Focal and Grid Laser Treatments, Focal and Grid Laser Treatments, Focal and Grid Laser Treatments, Focal and Grid Laser Treatments, PRP; TSRPC; Focal and Grid Laser Treatments, Focal and Grid Laser Treatments, PRP; Focal and Grid Laser Treatments

The Iridex 810 Laser system is comprised of a laser console with footswitch and an optical fiber delivery device. The laser console contains two laser diodes (810 mm 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 is a 510(k) summary for the Iridex 810 Laser System. It focuses on demonstrating substantial equivalence to a predicate device, primarily through non-clinical performance testing related to electrical safety, laser safety, electromagnetic compatibility, usability, and software.

Crucially, this document does not describe a study involving human readers or AI assistance assessing the device's performance in diagnosing or treating conditions. It's about the safety and fundamental performance of a laser device, not an AI diagnostic tool.

Therefore, I cannot provide information on many of the requested points, such as:

• Sample size for the test set and data provenance: Not applicable, as this is a physical device safety and performance evaluation, not a diagnostic accuracy study.
• Number of experts used to establish ground truth & qualifications: Not applicable.
• Adjudication method for the test set: Not applicable.
• Multi-Reader Multi-Case (MRMC) comparative effectiveness study: Not applicable. This is not an AI-assisted diagnostic device.
• Stand-alone (algorithm only without human-in-the-loop performance) study: Not applicable.
• Type of ground truth used (expert consensus, pathology, outcomes data, etc.): Ground truth here refers to engineering and safety standards, not clinical diagnostic accuracy.
• Sample size for the training set: Not applicable, as this is not an AI/machine learning device being trained.
• How the ground truth for the training set was established: Not applicable.

However, I can extract information related to the acceptance criteria and the summary of non-clinical performance data for the Iridex 810 Laser System as presented in the document:

1. Table of Acceptance Criteria and Reported Device Performance

Meet internal Iridex performance specifications pre- and post-conditioning testing. | PASS. All 5 units passed pre and post ISTA-3A testing (Westpak testing) and Pre-and Post-conditioning Testing (Iridex testing). |

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

• For "Shipping and Packaging Testing," the sample size was 5 units.
• For other non-clinical tests (Electrical Safety, Laser Safety, EMI/EMC, Usability, Software), the specific sample size is not explicitly stated within this summary. However, these are typically engineering verification tests performed on a limited number of test units to confirm compliance with international standards.
• Data Provenance: The document does not specify the country of origin for the test data but indicates that the testing was performed internally by Iridex ("Iridex testing") and by a third-party lab ("Westpak testing" for packaging). These are non-clinical engineering tests, not patient studies, so "retrospective or prospective" doesn't directly apply in the clinical sense.

Study Proving Device Meets Acceptance Criteria:

The study that proves the device meets the acceptance criteria is the non-clinical performance testing conducted by the manufacturer, Iridex Corporation, and sometimes by accredited third-party testing laboratories. The summary states:

• "The following table summarizes nonclinical testing relevant to the Iridex 810 Laser System (Console and Compatible Delivery Devices) in accordance with the requirements of the design control regulations and established quality assurance procedures."
• "Other than the packaging testing, which is updated to current ISTA 3A guidelines, Verification and Validation method(s) and results are unchanged from those data submitted in K202760; and those data continue to apply to the SUBJECT device."
• "Clinical testing was not required for this product change."

This indicates that the "study" demonstrating performance is a series of engineering verification and validation tests against established international standards for medical devices and lasers.

In summary, this document is for a laser device intended for ophthalmic treatments (e.g., retinal photocoagulation). The "acceptance criteria" and "study" described pertain to the device's fundamental safety, electrical performance, laser output characteristics, usability, and software quality, as per relevant international standards, rather than clinical diagnostic accuracy or AI performance improvements.

Ask a specific question about this device

The Iridex 810 Laser is indicated for retinal photocoagulation, transscleral cyclophotocoagulation, transscleral retinal photocoagulation, and other diode laser treatments. The following are examples of applications for the Iridex 810 Laser.

CONDITION: Diabetic Retinopathy (Nonproliferative Retinopathy, Macular Edema, Proliferative Retinopathy), Glaucoma (Primary Open Angle, Closed Angle, Refractory Glaucoma (recalcitrant/uncontrolled)), Retinal Tears, Detachments, and Holes, Lattice Degeneration, Age-Related Macular Degeneration (AMD), Intra-Ocular Tumors (Choroidal Hemangioma, Choroidal Melanoma, Retinoblastoma), Retinopathy of Prematurity, Sub-Retinal (choroidal) Neovascularization, Central and Branch Retinal Vein Occlusion.

TREATMENT: Panretinal Photocoagulation (PRP); Focal and Grid Laser Treatments, Laser Trabeculoplasty; Iridotomy; Transscleral Cyclophotocoagulation (TSCPC), Transscleral Retinal Photocoagulation (TSRPC); Focal and Grid Laser Treatments, PRP; Focal and Grid Laser Treatments, Focal and Grid Laser Treatments, Focal and Grid Laser Treatments, PRP; TSRPC; Focal and Grid Laser Treatments, Focal and Grid Laser Treatments, PRP; Focal and Grid Laser Treatments.

The Iridex 810 Laser system is comprised of a laser console with footswitch and an optical fiber delivery device. The laser console contains two laser diodes (810 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 the Iridex 810 Laser, focusing on its substantial equivalence to a predicate device (OcuLight SL/SLx, Model # 13030 (K020374)). The information provided is for regulatory clearance (510(k)) and primarily addresses engineering and safety verification rather than clinical performance studies typically associated with AI/software devices. Therefore, many of the requested categories related to clinical study design (e.g., sample size for test set, number of experts, adjudication method, MRMC studies, ground truth establishment for training set) are not applicable or not explicitly detailed in this document.

Here's the information extracted and organized as requested:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size Used for the Test Set and Data Provenance
The studies described are engineering verification tests, not clinical performance studies with patient data. Therefore, the concept of a "test set" from patient data, country of origin, or retrospective/prospective nature is not applicable here. The "test set" effectively refers to the device and its components undergoing prescribed electrical, mechanical, and safety tests.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
Not applicable. Ground truth, in the context of this device's verification, is established via engineering standards and specifications (e.g., IEC standards for electrical and laser safety, software lifecycle processes) and internal product release specifications. The "experts" would be the engineers and technicians performing and verifying these tests against the defined standards.

4. Adjudication Method for the Test Set
Not applicable, as this is not a clinical study involving human assessment of data.

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 MRMC study was conducted. This device is an ophthalmic laser system, not an AI-powered diagnostic or assistive tool 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 laser system and does not involve AI algorithms for standalone performance measurement.

7. The Type of Ground Truth Used
The ground truth used for these verification studies are established engineering and medical device safety standards (e.g., IEC 60601-1, IEC 60601-2-22, IEC 60825-1, IEC 60601-1-2, IEC 60601-1-6, IEC 62304) and the manufacturer's internal product release specifications.

8. The Sample Size for the Training Set
Not applicable. This device does not use machine learning algorithms that require a training set.

9. How the Ground Truth for the Training Set was Established
Not applicable, as there is no training set for this device.

Ask a specific question about this device

The Iridex TruFocus LIO Premiere Laser Indirect Ophthalmoscope with the Family of Iridex® IQ Laser Systems (IQ 532 [532nm], IQ 577 [577mm], IQ 630-670 [630mm-670mm], IQ 810 [810nm]), hand pieces & accessories that are used with them to deliver laser energy in either CW-pulse™ or LongPulse™ mode. Intended for soft and fibrous tissue, including osseous tissue incision, coagulation, vaporization, ablation and vessel hemostasis in the medical specialties of, dermatology, ear, nose and throat (ENT)/ otolaryngology, and ophthalmology as follows:

532 nm:

• Dermatology:
• · Pigmented Skin Lesions
• · Vascular Lesions

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

Ophthalmology:

Indicated for retinal photocoagulation, laser trabeculoplasty, iridoplasty including:

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

577nm

Dermatology:

• · Treatment of Vascular and pigmented lesions
  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 :

• Proliferative and nonproliferative diabetic retinopathy;
• Choroidal neovascularization;
• Branch retinal vein occlusion;
• Age-related macular degeneration
• Retinal tears and detachments
• Retinopathy of prematurity
• · Iridotomy, iridectomy and trabeculoplasty in angle closure glaucoma and open angle glaucoma

630 - 670nm

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:
• Proliferative and non-proliferative diabetic retinopathy;
• Choroidal neovascularization:
• Branch retinal vein occlusion;
• Age-related macular degeneration
• Retinal tears and detachments
• Retinopathy of prematurity
• · Iridotomy, iridectomy and trabeculoplasty in angle glaucoma and open angle glaucoma

810nm

Ophthalmology:

Indicated for retinal photocoagulation, laser trabeculoplasty, transscleral cyclophotocoagulation, transscleral retinal photocoagulation, iridotomy, including the following examples:

• · Retinal photocoagulation for the treatment of:
• · Diabetic retinopathy, including:
• Nonproliferative retinopathy
• Macular edema
• Proliferative retinopathy
• · Retinal Tears, Detachments and Holes
• · Lattice degeneration
• · Age-related macular degeneration (AMD) with choroidal neovascularization (CNV)
• · Retinopathy of prematurity
• · Sub-retinal (choroidal) neovascularization
• · Central and Branch Retinal Vein Occlusion
• · Laser trabeculoplasty, Iridotomy, Transscleral Cyclophotocoagulation (TSCPC) for the treatment of glaucoma, including:
• Primary open angle
• Closed angle
• Refractory Glaucoma (recalcitrant/uncontrolled)

The Iridex TruFocus LIO Premiere Laser Indirect Ophthalmoscope is a light combination and reflection viewing system used with the Iridex IQ/GL/SL/TX laser system families. The LIO combines a laser treatment beam from an Iridex laser source with the illumination beam of a Heine binocular indirect ophthalmoscope into a mixed optical beam used by a physician with a handheld ophthalmic examination (condensing) lens to enter a patient's pupil and to collect and view reflections by a patient's retina returned through the same pupil. It provides a portable alternative to patients who cannot be examined or treated with a fixed slit lamp adapter. The LIO is supplied non-sterile and is intended for reuse and worn on the physician's head to view and treat the patient's retina. The device can be used to evaluate and treat patients of all ages, including infants, in an office, operating room and ambulatory surgical center setting.

The provided text describes a 510(k) premarket notification for the Iridex TruFocus LIO Premiere Laser Indirect Ophthalmoscope. It primarily focuses on demonstrating substantial equivalence to a predicate device rather than detailing extensive clinical performance studies for a novel AI/software-driven medical device. Therefore, much of the requested information regarding AI model performance, ground truth establishment, training sets, and expert adjudication cannot be extracted from this document, as it pertains to a different type of device and regulatory pathway.

This document describes hardware modifications to an existing device and updates to its operating manual. The performance data presented is "simulated use" validation testing for the physical device, not an AI or software algorithm.

However, I can provide the information that is present in the document.

1. A table of acceptance criteria and the reported device performance

The document does not present acceptance criteria in a formal table with reported device performance in the manner typically seen for clinical effectiveness of a new AI/software feature. Instead, it describes a "simulated use" validation test.

2. Sample size used for the test set and the data provenance

• Sample size for the test set: 25 modified TruFocus LIO Premiere devices.
• Data provenance: Not directly applicable in the sense of patient data. The "test set" consists of the physical devices themselves undergoing simulated use. The testing was conducted as part of a 510(k) submission, implying it was contemporary to the submission date (August 3, 2018). It is not specified if the testing was retrospective or prospective in relation to patient treatment, as it was a simulated use test of the device's functionality. The country of origin of the data (testing location) is not specified.

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 and not provided. The "ground truth" for this simulated use test was whether the device could be properly operated and aligned physically according to its design specifications using the updated manual, not a clinical diagnosis or outcome. The validation involved verifying the physical alignment and functionality of the device, likely a pass/fail assessment based on engineering specifications, rather than an expert clinical determination. The risk assessment was performed by a "qualified cross-functional team," but their role was in assessing risks, not establishing a clinical ground truth for a test set.

4. Adjudication method for the test set

Not applicable and not provided. The test was a simulated use validation, which likely involved a technical assessment of physical alignment and function, not a consensus-based adjudication of clinical findings.

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. This document does not mention an MRMC study or any AI component. The device is a laser indirect ophthalmoscope, a hardware device, not an AI-assisted diagnostic tool.

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

No. This is a hardware device, not an algorithm.

7. The type of ground truth used

The "ground truth" was the physical functionality and alignment of the device as per its design specifications when operated by a user following the updated manual. This is a technical/engineering ground truth based on the device's intended operation, not a clinical "expert consensus" or "pathology/outcomes data."

8. The sample size for the training set

Not applicable. This device does not involve a training set for an AI algorithm.

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

Not applicable. There is no AI algorithm with a distinct training set described in this document.

Ask a specific question about this device

The Iridex TruFocus LIO Premiere Laser Indirect Ophthalmoscope with the Family of Iridex® IQ Laser Systems (IQ 532 [532nm], IQ 577 [577nm], IQ 630-670 [630nm-670nm], IQ 810 [810nm]), hand pieces & accessories that are used with them to deliver laser energy in either CW-pulse, M or LongPulse TM mode. Intended for soft and fibrous tissue, including osseous tissue incision, coagulation, vaporization, ablation and vessel hemostasis in the medical specialties of, dermatology, ear, nose and throat (ENT)/ otolaryngology, and ophthalmology as follows:

532 nm:

Dermatology:

• · Pigmented Skin Lesions
• · Vascular Lesions

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

Ophthalmology:
Indicated for retinal photocoagulation, laser trabeculoplasty, iridotomy, iridoplasty including:

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

577nm

Dermatology:

• · Treatment of Vascular and pigmented lesions
  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 :

• Proliferative and nonproliferative diabetic retinopathy;
• Choroidal neovascularization;
• Branch retinal vein occlusion;
• Age-related macular degeneration
• Retinal tears and detachments
• Retinopathy of prematurity
• · Iridotomy, iridectomy and trabeculoplasty in angle closure glaucoma and open angle glaucoma

630 - 670nm

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:

• Proliferative and non-proliferative diabetic retinopathy;
• Choroidal neovascularization:
• Branch retinal vein occlusion;
• Age-related macular degeneration
• Retinal tears and detachments
• Retinopathy of prematurity
• · Iridotomy, iridectomy and trabeculoplasty in angle glaucoma and open angle glaucoma

810nm

Ophthalmology:
Indicated for retinal photocoagulation, laser trabeculoplasty, transscleral cyclophotocoagulation, transscleral retinal photocoagulation, iridotomy, including the following examples:

• Retinal photocoagulation for the treatment of:

• Diabetic retinopathy, including:

• Nonproliferative retinopathy
  Macular edema
  Proliferative retinopathy

• Retinal Tears, Detachments and Holes

• Lattice degeneration

• Age-related macular degeneration (AMD) with choroidal neovascularization (CNV)

• Retinopathy of prematurity

• Sub-retinal (choroidal) neovascularization

• Central and Branch Retinal Vein Occlusion

• Laser trabeculoplasty, Iridotomy, Transscleral Cyclophotocoagulation (TSCPC) for the treatment of glaucoma, including:

• Primary open angle

• Closed angle

• Refractory Glaucoma (recalcitrant/uncontrolled)

Iridex TruFocus LIO Premiere with the Family of Iridex® IQ Laser Systems (IQ 532 [532nm], IQ 577 [577nm], IQ 630-670 [630mm-670mm], and IQ 810 [810mm]), hand pieces, delivery devices & accessories is a delivery accessory used with the Iridex family of IQ laser systems (IQ532, IQ577, and IQ810). Iridex TruFocus LIO Premiere and the Family of Iridex® IO Laser Systems (10 532 1532nm), 10 577 [577mm], IQ 630-670 [630nm-670mm], IQ 810 [810nm]), hand pieces, delivery devices & accessories is a headmounted diagnostic indirect ophthalmoscope which is used with a handheld lens to view and perform laser treatments on a patient's retina. It allows binocular visualization of the peripheral retina not easily viewed at the slit lamp and can be used to evaluate and treat patients, including infants, while they are in a supine position. The LIO is a laser delivery device used to perform transpupillary laser photocoagulation during noninvasive ocular surgical procedures. The LIO is supplied non-sterile and is intended for reuse. Variants of the device may relate to the style of headband, laser wavelength to be delivered, and the device to laser connector (i.e. RFID).

The provided document is a 510(k) premarket notification for a medical device: the Iridex TruFocus LIO Premiere with the Family of Iridex® IQ Laser Systems. This document is a regulatory submission to the FDA, not a study report designed to prove the device meets acceptance criteria through clinical performance.

The focus of a 510(k) submission is to demonstrate "substantial equivalence" to a legally marketed predicate device, primarily by comparing technological characteristics and intended use. The "acceptance criteria" and "study" described in the prompt are typically associated with performance studies for novel devices or significant modifications, often involving clinical trials or rigorous analytical validation. This document does not describe such studies for proving performance in the context of AI/ML, human readers, or image analysis.

Therefore, most of the requested information regarding acceptance criteria, sample sizes, expert ground truth, adjudication, MRMC studies, standalone algorithm performance, and training data is not present in this 510(k) submission.

However, I can extract the following information which partially relates to your request:

1. Table of acceptance criteria and reported device performance:

The document states that the device's safety and effectiveness are proven by testing to various ISO and IEC standards. These standards implicitly contain acceptance criteria for the electrical, optical, and mechanical safety and performance of the laser system and ophthalmoscope. The "reported device performance" is the statement that the device meets these standards.

2. Sample size used for the test set and the data provenance:

• Sample Size: Not applicable/not mentioned. This 510(k) submission relies on demonstrating substantial equivalence through a comparison of technological characteristics and adherence to recognized safety standards, not a specific performance study on a "test set" of patient data for AI/ML.
• Data Provenance: Not applicable. No patient data or clinical imagery test sets are described.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

• Not applicable. This is not a study involving expert validation of a diagnostic output. The "ground truth" for this type of device (a laser surgical instrument) is its adherence to engineering and safety specifications and intended function.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

• Not applicable. No test set requiring expert adjudication is described.

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. This device is a laser indirect ophthalmoscope and laser delivery system, not an AI/ML diagnostic or image assistance device. Therefore, no MRMC study or AI assistance is relevant here.

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

• Not applicable. This device does not feature a standalone algorithm in the sense of AI/ML for diagnosis or image analysis.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

• The "ground truth" for this device's submission is based on engineering specifications, performance standards (e.g., laser power output accuracy, beam stability, optical clarity, electrical safety), and comparison to a legally marketed predicate device. There is no biological or clinical "ground truth" data (like pathology or outcomes) discussed in this substantial equivalence determination beyond the general safety and effectiveness of the device type for its intended use.

8. The sample size for the training set:

• Not applicable. This document does not describe the development or validation of an AI/ML model, so there is no "training set."

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

• Not applicable. See point 8.

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The Family of IRIDEX® IQ Laser Systems (IQ 532 [532nm], IQ 630-670 [630nm-670mm], IQ 810 [810mm] [IRIDEX Cyclo G6 Laser System]) and the hand pieces & accessories that are used with them to deliver laser energy in either CW-pulse, MicroPulse™ mode. Intended for soft and fibrous tissue, including osseous tissue incision, excision, coagulation, vaporization, ablation and vessel hemostasis in the medical specialties of, dermatology, ear, nose and throat (ENT)/ otolaryngology, and ophthalmology as follows:

810nm (The IRIDEX Cyclo G6 Laser System)

Ophthalmology:

The IRIDEX® Cyclo G6™ Laser System and Probe Delivery Devices (G-Probe Illuminate, & MicroPulse® P3) are used to deliver laser energy in either CW-Pulse (CW) or MicroPulse (uP) treatment mode and indicated for the treatment of Glaucoma:

MicroPulse P3 Device: For the treatment of Glaucoma including: • Primary Open-Angle • Closed-Angle • Refractory. Treatment (Intended Use): Transscleral Cyclophotocoagulation (TSCPC) of the ciliary processes. Mode: μP

G-Probe & G-Probe Illuminate: For the treatment of Glaucoma including: • Primary Open-Angle • Closed-Angle • Refractory. Treatment (Intended Use): Transscleral cyclophotocoagulation (TSCPC) of the ciliary processes. Mode: CW

The Iridex Cyclo G6 is an 810nm (diode) ophthalmic laser comprised of the following main components:

• Main console containing the major electrical components, including:
  • Control Panel including control knobs (power, interval, duration or software assigned function), treat/standby button, and display;
  • Two delivery device fiber-optic connector ports (only one active at a time);
  • LIO illumination connection;
  • Smart key port for detecting/operating safety filters and/or accessory identification;
  • Emergency stop switch;
  • Key switch;
  • Connector ports for the footswitch, remote control, and power cord;
• A treatment Footswitch (either wired, wireless, or wireless with PowerAdjust);
• A Wired Remote Control that duplicates the control panel;
• Delivery Accessories including G-Probe and MicroPulse P3 probe Handpieces, and the G-Probe Illuminate
• Optional Cart/Stand

The laser system automatically enters the "Standby" mode after it is turned on and completes its internal "selftest". Laser emission is not possible until the user attaches the proper delivery device, selects the desired treatment settings, verifies eye safety filter status, places the system into "Ready", and depresses the footswitch.

The system has a primary display screen (power, interval, duration, pulse mode, aiming beam brightness, illumination brightness, treatment/standby toggle, counter reset) and additional screens for ancillary options (system volume, display contrast/brightness, preset selection (user defined/generated), aiming beam settings).

The user may adjust power, treatment duration, treatment interval, type of laser output mode (CW-pulse, MicroPulse), aiming beam brightness, illumination brightness, and reset the laser shot counter. Additionally, for some delivery devices the user may optionally select the on/off operation of the countdown timer on the display screen as well as the on/off function of the voice countdown.

The G-Probe Illuminate that is the subject of this 510(k) is a handheld fiber optic delivery device. It is intended to be used to perform transscleral cyclophotocoagulation of the ciliary processes. It is differentiated from the G-Probe described in earlier submissions by the incorporation of two additional optical fibers to provide white light transillumination of the optic globe. Such transillumination can aid probe placement by revealing the location of internal ocular structures such as the ciliary processes. The incorporation of this transillumination function into a multifunction probe offers the user similar functionality as a separate handheld transilluminator, with a more convenient setup that requires fewer hands or assistants to operate. It is provided as a sterile, single-use device.

The provided document is a 510(k) Premarket Notification for the Iridex Cyclo G6 Laser System and G-Probe Illuminate. This submission focuses on demonstrating substantial equivalence to a predicate device rather than presenting a performance study with acceptance criteria in the manner one might find for a novel AI/software medical device.

Therefore, the typical acceptance criteria and study design for "device performance" in terms of accuracy, sensitivity, or specificity against a ground truth (e.g., for an AI diagnostic algorithm) are not applicable or present in this document. Instead, the document discusses the equivalence of the proposed device to a legally marketed predicate device based on technical characteristics and safety testing.

Here's a breakdown of the requested information based on the provided document:

1. A table of acceptance criteria and the reported device performance

As this is a 510(k) demonstrating substantial equivalence for a physical laser system and its probe (with an added illumination feature), there are no "acceptance criteria" presented in the measurable performance metrics typical for an AI/diagnostic software. Instead, the "performance" is demonstrated through successful completion of various engineering, sterility, and biocompatibility tests, and the "acceptance criterion" is essentially demonstrating that the modified device (Iridex Cyclo G6 Laser System with G-Probe Illuminate) performs safely and effectively at least as well as the predicate device.

The study that "proves" the device meets acceptance criteria is the sum of the conformance to various standards and the comparison of technological characteristics to the predicate.

• Product Code: General & Plastic Surgery
• Regulation: GEX, 21 CFR 878.4810
• Intended Use: Treatment of Glaucoma (Primary Open-Angle, Closed-Angle, Refractory)
• Indications for Use: Transscleral cyclophotocoagulation (TSCPC) of the ciliary processes
• Wavelength: 810nm - Infrared (IR) Diode
• Aiming Beam: 630-670 nm - red (nominal) – variable intensity from 0 to

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The Family of IR.IDEX® IQ Laser Systems (IQ 532 [532nm], IQ 630-670 [630mm-670m], IQ 810 [810nm] [IRIDEX Cyclo G6 Laser System]) and the hand pieces & accessories that are used with them to deliver laser energy in either CW-pulse, MicroPulse TM or LongPulse TM mode. Intended for soft and fibrous tissue, including osseous tissue incision, excision, coagulation, vaporization, ablation and vessel hemostasis in the medical specialties of, dematology, ear, nose and throat (ENT)/ otolaryngology, and ophthalmology as follows:

810nm (IRIDEX Cyclo G6 Laser System)

Ophthalmology:

The IRIDEX® Cyclo G6 Laser System and Probe Delivery Devices (G-Probe & MicroPulse P3) are used to deliver laser energy in either CW-Pulse (CW) or MicroPulse™ (uP) treatment mode and indicated for the treatment of Glaucoma:

MicroPulse P3 Device: For the treatment of Glaucoma including: • Primary Open-Angle • Closed-Angle • Refractory. Treatment: Transscleral cyclophotocoagulation (TSCPC) of the ciliary processes. Mode: uP

G-Probe: For the treatment of Glaucoma including: • Primary Open-Angle • Closed-Angle • Refractory. Treatment: Transscleral cyclophotocoagulation (TSCPC) of the ciliary processes. Mode: CW

The Iridex Cyclo G6 is comprised of the following main components:

• Main console containing the major electrical components, including:
  • Control Panel including control knobs (power, interval, duration or software assigned function), treat/standby button, and display;
  • Two delivery device fiber-optic connector ports (only one active at a time);
  • LIO illumination connection;
  • Smart key port for detecting/operating safety filters and/or accessory identification:
  • Emergency stop switch:
  • Key switch;
  • Connector ports for the footswitch, remote control, and power cord;
  • A treatment Footswitch (either wired, wireless, or wireless with PowerAdjust);
  • A Wired Remote Control that duplicates the control panel;
  • Delivery Accessories including G-Probeand MicroPulse P3 probe Handpieces. Microscope Adapters, and Laser Indirect Ophthalmoscopes (these are not used with the Cyclo G6 but are available for use with the other members of the laser family).
  • Optional Cart/Stand

This document is a 510(k) premarket notification for the Iridex Cyclo G6 laser system. It asserts substantial equivalence to a predicate device (K071687 Family of Iridex IQ Laser Systems), rather than providing detailed acceptance criteria and a study to prove meeting those criteria in the context of a new diagnostic or AI-based device.

Therefore, many of the requested elements (acceptance criteria table, sample sizes, ground truth establishment, expert qualifications, adjudication methods, MRMC studies, standalone performance) are not applicable or not present in this type of FDA submission.

However, I can extract information related to the device's technical specifications and the basis for its safety and effectiveness claims.

Acceptance Criteria and Reported Device Performance (Table)

Since this is a submission for substantial equivalence based on technological characteristics and indications for use being identical or very similar to a predicate device, specific performance metrics with acceptance criteria as typically seen for novel diagnostic devices are not provided. Instead, the "performance" here relates to the device's physical and functional attributes matching the predicate.

Study Information (Based on the provided document)

1. Sample size used for the test set and the data provenance:

   • Not Applicable. This submission explicitly states: "No clinical data was needed for these indications. They are identical to those on K071687." Therefore, there was no separate "test set" of patient data used to evaluate the device's clinical performance as part of this 510(k). The evaluation relies on the known performance and safety of the predicate device and the new device's comparable technical specifications.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

   • Not Applicable. As no clinical data/test set was used for this submission, there was no need for experts to establish ground truth for a test set.

3. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

   • Not Applicable. No test set was used.

4. 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. This device is a laser surgical instrument, not an AI-assisted diagnostic or image analysis tool. Therefore, an MRMC study related to human reader improvement with or without AI assistance is not relevant to this submission.

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

   • No. This is a hardware laser system, not an algorithm.

6. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

   • Not Applicable. No new clinical ground truth was established for this submission. The "ground truth" for demonstrating substantial equivalence was the established safety and effectiveness of the existing predicate device, backed by its technical specifications and historical clinical use.

7. The sample size for the training set:

   • Not Applicable. This is a laser hardware system, not a machine learning algorithm requiring a training set.

8. How the ground truth for the training set was established:

   • Not Applicable. No training set was used.

Summary of the Study:

The "study" in this context is a bench testing and engineering comparison against the predicate device, K071687. The submission explicitly states:

• "No clinical data was needed for these indications. They are identical to those on K071687."
• "The technological characteristics of the Iridex Cyclo G6 laser are substantially equivalent to those of the predicate device."
• "The review of the indications for use and technical characteristics provided demonstrates that the Iridex Cyclo G6 Laser is substantially equivalent to the predicate device and is safe and effective for use for the various indications for use stated."
• "The software changes that are the subject of this 510(k) were verified and validated in accordance with the Iridex design control procedures."

The document relies on the inherent safety and efficacy already established for the predicate device due to the identical indications for use and substantially equivalent technical characteristics of the Iridex Cyclo G6. The "proof" is the detailed comparison of specifications, demonstrating that the new device performs identically to a legally marketed device.

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The VariLite Laser System is intended for use in dermatological applications:

The 532 nm wavelength delivered with VariLite handpieces, DioLite 532 handpieces, and the ScanLite Scanner is indicated for:

• the treatment of vascular lesions including:
  • Telangiectasia
  • Cherry Angiomas
  • Leg Veins
  • Neovascularization
  • Spider Angiomas
  • Port Wine Stains
  • Roscea
  • Venous Lakes
• the treatment of benign pigmented lesions including:
  • Lentigines
  • Freckles
  • Dermatosis Papulosis Nigra
  • Poikloderma of Civatte
  • Café- au- lait Stains
  • Melasma
• the treatment of cutaneous lesions including:
  • Verruca
  • Keratoses
  • Skin Tags
• the treatment of moderate inflammatory acne vulgaris.

The 940 nm wavelength delivered with VariLite handpieces is indicated for:

• the treatment of vascular lesions including:
  • Telangiectasia
  • Cherry Angiomas
  • Leg Veins
  • Neovascularization
  • Spider Angiomas
  • Port Wine Stains
  • Roscea
  • Venous Lakes
• the treatment of benign pigmented lesions including:
  • Lentigines
  • Freckles
  • Dermatosis Papulosis Nigra
  • Poikloderma of Civatte
  • Café- au- lait Stains
  • Melasma
• hair removal.

The VariLite is a dual wavelength medical diode laser source that delivers laser light at either 532 nm or 940 nm. Its main components are a laser console, footswitch, and a variety of fiber optic handpiece delivery devices, including manual handpieces and the ScanLite Scanner, which are all considered part of the VariLite Laser System. The VariLite console is also intended to be compatible with other delivery devices that have been the subject of previous 510(k) applications. These devices include DioLite 532 handpieces (K964074).

The provided text is a 510(k) summary for the IRIDEX VariLite Laser System, which is a premarket notification for a medical device in the United States. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving clinical effectiveness through extensive clinical trials with acceptance criteria and statistical analyses.

Therefore, many of the requested elements for acceptance criteria and study design are not applicable in this context. The document explicitly states "Clinical performance Data: None."

Here's a breakdown of the information as it relates to your request:

1. A table of acceptance criteria and the reported device performance

• Not Applicable. The 510(k) summary does not define specific clinical acceptance criteria or report a "performance" in the way a clinical trial would (e.g., sensitivity, specificity, accuracy). The submission relies on demonstrating substantial equivalence to existing predicate devices, meaning it has the same intended use, similar technological characteristics, and raises no new questions of safety or effectiveness. Performance is inferred from the safety and effectiveness profile of the predicate devices.

2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)

• Not Applicable. No clinical "test set" of patients was used as part of this 510(k) submission. Non-clinical performance data relied on "applicable consensus and voluntary standards" (e.g., electrical safety, electromagnetic compatibility), as indicated by a Declaration of Conformity.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

• Not Applicable. No clinical test set requiring ground truth establishment by experts was part of this submission.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set

• Not Applicable. No clinical test set was used.

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

• Not Applicable. This is a laser system for dermatological treatment, not an AI-assisted diagnostic or interpretative device. Therefore, MRMC studies and AI-related effectiveness are not relevant.

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

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

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

• Not Applicable. No clinical ground truth was established for this submission. The "ground truth" for showing substantial equivalence essentially lies in the established safety and effectiveness of the predicate devices.

8. The sample size for the training set

• Not Applicable. There is no "training set" in the context of this device. The device is not learning from data in the way an AI or diagnostic algorithm would.

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

• Not Applicable. See point 8.

Summary of Device Acceptance (as per 510(k) process):

The VariLite Laser System was accepted by the FDA based on a demonstration of substantial equivalence to existing, legally marketed predicate devices. This means the FDA concluded that the device is as safe and effective as the predicate devices, has the same intended use, and generally the same technological characteristics.

The "study" or evidence provided to meet this "acceptance criteria" (substantial equivalence) consists of:

• Predicate Device Comparison: Detailed comparison of the VariLite Laser System's intended use, indications for use, and technological characteristics (wavelengths, delivery methods) to four predicate devices:
  • IRIDEX Corporation DioLite 532 (K964074)
  • Laserscope Aura (K951034 / K024206)
  • Nidek, Inc. Prima KTP (K973828)
  • Dornier MedTech Medilas D SkinPulse S (K003993)
• Non-Clinical Performance Data: A "Declaration of Conformity" indicating that the device meets "applicable consensus and voluntary standards." This typically covers aspects like electrical safety, electromagnetic compatibility, and laser safety standards (e.g., IEC 60601-1, IEC 60825-1).
• Absence of Clinical Data: Explicitly stated as "None," meaning no new clinical trials were conducted by the manufacturer for this specific 510(k) submission to demonstrate effectiveness or safety. The safety and effectiveness are inferred from the predicate devices.

The FDA's letter (K041930) confirms that the device was found "substantially equivalent" and thus permitted to market, based on the information provided in the 510(k) submission.

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