(55 days)
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.
| Acceptance Criteria Category (Implied by Standards) | Reported Device Performance |
|---|---|
| Design Standards | ISO 15004-2 met |
| Electrical Safety | IEC60601-2 met |
| General Medical Electrical Equipment | IEC60601-1 met |
| Laser Product Safety | IEC60825-1 met |
| Diagnostic and Surgical Laser Equipment | IEC60601-2-22 met |
| Usability Engineering Process | IEC60601-1-6 met |
| Application of Usability Engineering to Medical Devices | IEC62366 met |
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.
§ 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.