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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.

Ask a specific question about this device