(72 days)
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.
| Acceptance Criteria (Inferred from Test Design) | Reported Device Performance |
|---|---|
| The user could properly align and operate the device (e.g., the illumination and aiming/treatment beams would pass through the 20-diopter condensing lens and concentrically enter the simulated pupil plane using a pupil size of 6 mm in diameter, and achieve proper alignment of the internal illumination and aiming/treatment beam mirrors as well as illumination and aiming beam travel within the binocular field of view by using the adjustment control knobs) when following the updated operator manual. | "All units passed the simulated use test." This indicates that for all tested devices, the users were able to properly align and operate the device according to the updated manual and observe the expected beam alignments and travel. |
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.
§ 878.4810 Laser surgical instrument for use in general and plastic surgery and in dermatology.
(a)
Identification. (1) A carbon dioxide laser for use in general surgery and in dermatology is a laser device intended to cut, destroy, or remove tissue by light energy emitted by carbon dioxide.(2) An argon laser for use in dermatology is a laser device intended to destroy or coagulate tissue by light energy emitted by argon.
(b)
Classification. (1) Class II.(2) Class I for special laser gas mixtures used as a lasing medium for this class of lasers. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 878.9.