(27 days)
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
- o Diabetic retinopathy, including:
- · 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
| Verification/Validation Method(s) | Acceptance Criteria | Summary of Results |
|---|---|---|
| Testing to External Standards | ||
| IEC 60601-1 Electrical Safety | Meet applicable clauses of IEC 60601-1 | PASS. Device meets requirements of applicable clauses of IEC 60601-1. |
| IEC 60601-2-22 Laser Safety | Meet all applicable IEC 60601-2-22 test items except for EMC, Biocompatibility | PASS. Device meets requirements of applicable clauses of IEC 60601-2-22. |
| IEC 60825-1 Laser Safety | Meet applicable IEC 60825-1 requirements | PASS. Device meets IEC 60825-1 Requirements. |
| IEC 60601-1-2 EMI/EMC | Meet IEC 60601-1-2 Requirements | PASS. The unit met the requirements of applicable clauses of IEC 60601-1-2. |
| IEC 60601-1-6 (Usability) | Meet the requirements of the applicable clauses IEC 60601-1-6 | PASS. Device meets requirements of applicable clauses of IEC 60601-1-6. |
| IEC 62304, Medical device software, Software life-cycle processes | Software lifecycle processes and activities meet requirements of applicable clauses of IEC 62304 | PASS. Software lifecycle processes and activities meet IEC 62304 Requirements. |
| Shipping and Packaging Testing | Meet ISTA 3A Testing and Acceptance Requirements for: Preconditioning, Atmospheric Conditioning, Shock Test, Random Vibration With and Without Top Load, Random Vibration Under Low Pressure - Truck Portion, Random Vibration Under Low Pressure - Air Portion, Shock Test. Meet internal Iridex performance specifications pre- and post-conditioning testing. | PASS. The test unit passed pre and post ISTA-3A testing (Westpak testing) and Pre-and Post-conditioning testing to specification (Iridex testing). |
| Testing to Iridex Internal Specifications | ||
| Treatment Beam Power Output (Measured at 50, 250, 500, 1000, and 2000 mW for both models; 2500 mW for Iridex 532 model only) | Measured Power Output is Power Setting ±20% | PASS |
| Pulse Duration/Interval (MicroPulse Mode) (Measured various combinations of Pulse Duration and Interval settings throughout and beyond claimed range) | Measured Pulse Duration/Interval is Pulse Duration/Interval Setting ±10% | PASS |
| Pulse Duration/Interval (Continuous-Wave Mode) (Measured various combinations of Pulse Duration and Interval settings throughout and beyond claimed range) | Measured Pulse Duration/Interval is Pulse Duration/Interval Setting ±10% | PASS |
| Aiming Beam Power Output (Measured at 0 mW and 0.7 mW setting) | Measured Power Output observable throughout specified power range, ±0.2 mW nominal | PASS |
| Software Verification/Validation (Software development and V&V consistent with IEC 62304; V&V tasks performed at each stage, revisited, or new tasks initiated until acceptance/passing criteria achieved) | Each module within each of the five following Software V&V Domains must pass: 1) Product Info Domain, 2) Essential (Basic) Function Domain, 3) Setting Domain, 4) Specials Domain, 5) Accessories Domain | QUALIFIED. Each module within the five Software V&V Domains passed: 1) Product Info Domain, 2) Essential (Basic) Function Domain, 3) Setting Domain, 4) Specials Domain, 5) Safety Domain. The software performance meets the requirements of the software requirements specification. |
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.
§ 886.4390 Ophthalmic laser.
(a)
Identification. An ophthalmic laser is an AC-powered device intended to coagulate or cut tissue of the eye, orbit, or surrounding skin by a laser beam.(b)
Classification. Class II.