(280 days)
The R:GEN Laser System is indicated for use by an opthalmic physician to produce a wound to the Retinal Pigmented Epithelium (RPE) of the retina of the eye, via focal laser treatment of Clinically Significant Macular Edema (CSME)
The R:GEN Laser System is a surgical laser instrument for use by ophthalmic physicians for performing selective retinal therapy (SRT) for treatment of Clinically Significant Macular Edema (CSME) which is a condition secondary to Diabetic Retinopathy. It is designed for use in a clinic or outpatient facility, or in Retinal Specialist's practice.
The R:GEN Laser System is a Q-switched Nd: YLF (Neodymium-doped Yttrium Lithium Fluoride) laser with an emission wavelength of 527 nm (produced by second-harmonic generation). The R:GEN Laser System consists of a main laser, an optical fiber, delivery system including slit lamp, and a footswitch. The graphic user interface (GUI) screen of the control panel is equipped with an LCD (liquid crystal display) touch screen so that operators can easily adjust parameters for optimal settings. The software included provides all the functions, which are necessary to use the device.
The GUI screen of the control panel allows the operator to set the treatment parameters, such as the laser energy for each patient. The GUI screen of the control panel also displays useful information about the system during operation. During operation of the R:GEN Laser System, all system functions are continuously monitored internally by a micro-controller and displayed to the operator.
The provided text describes a 510(k) premarket notification for the R:GEN Laser System, which is indicated for the treatment of Clinically Significant Macular Edema (CSME). The document aims to demonstrate substantial equivalence to a legally marketed predicate device, the Ellex 2RT Laser System.
Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:
Summary of Acceptance Criteria and Device Performance:
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Bench Testing: Accuracy of laser spot diameter, pulse duration, and energy in laser exposure mode. Compliance with ISO 13485:2003, AAMI / ANSI ES 60601-1:2005/(R)2012 and A1:2012, IEC 60601-2-22 Third Edition 2007-05, and IEC 60825-1 Edition 2.0 2007-03. | The R:GEN Laser System bench testing meets all device specifications and complies with all applicable standards. |
| Animal Testing (Objective): Evaluate retinal effects of Selective Retina Therapy (SRT) in two animal models (in vivo mice and ex vivo porcine) and demonstrate effectiveness in selectively destroying RPE cells without collateral damage to neural retina or choroid, with the goal of inducing RPE cell regeneration. | Two animal studies (in vivo mice and ex vivo porcine) were conducted in full compliance with GLPs, to evaluate retinal effects of SRT and demonstrate effectiveness in selectively destroying RPE cells without collateral damage to neural retina or choroid with the goal of inducing RPE cell regeneration. (No specific quantitative performance metrics are provided in the summary of these studies). |
| Clinical Testing (Safety): No severe loss of vision (e.g., >2 ETDRS lines or ≥15 letters), no scotomatous changes, no treatment-related complications or adverse events. | Study 1 (Korean subjects): No eyes experienced severe loss of vision (>2 ETDRS lines) at 6-month follow-up. No scotomatous changes in macular sensitivity within the central 10° over 6 months. No treatment-related complications or adverse events. |
| Study 2 (Caucasian subjects): No severe loss of vision (≥15 letters). No complications or adverse events noted during or after treatment, and no patients reported adverse effects or pain during laser application. | |
| Clinical Testing (Effectiveness - Visual Acuity): Improvement or stability in visual acuity. | Study 1 (Korean subjects): Mean visual acuity improved significantly from 0.35 logMAR to 0.23 logMAR (p=0.002) at 6 months. 29.4% gained ≥2 ETDRS lines, 41.2% gained 1-2 ETDRS lines, 17.6% remained stable (1 ETDRS lines. |
| Study 2 (Caucasian subjects): Mean BCVA improved from 43.7 letters to 46.1 letters (p=0.02) at 6 months. BCVA improved (>5 letters) or remained stable (±5 letters) in 84% of eyes. 13% improved by ≥10 letters, while 16% lost more than 5 letters. | |
| Clinical Testing (Effectiveness - Anatomical/Functional): Changes in central macular thickness (CMT), maximum macular thickness (MMT), macular sensitivity, hard exudates, leakage in fundus fluorescein angiography (FFA). | Study 1 (Korean subjects): No significant change in CMT (p>0.05). MMT decreased from 465.8 ± 87.4 um to 434.3 ± 83.9 um (p=0.006). Mean macular sensitivity increased from 20.8 ± 3.4 dB to 22.5 ± 3.5 dB (p=0.02). |
| Study 2 (Caucasian subjects): Overall retinal thickness, hard exudates, and leakage in FFA did not change significantly (p>0.05). Improvement of BCVA correlated with a reduction of hard exudates (p=0.01) and central retinal thickness (p=0.01). |
Detailed Information on the Study:
2. Sample size used for the test set and the data provenance:
- Study 1: 23 eyes of 21 Korean subjects with clinically significant DME. Data provenance: Republic of Korea (implied by "Korean subjects"). The study design implies it was a prospective follow-up study for 6 months.
- Study 2: 39 eyes of 39 Caucasian subjects with previously untreated non-ischemic DME. Data provenance: Not explicitly stated, but "Caucasian subjects" suggests a Western population (e.g., North America, Europe). The study design implies it was a prospective follow-up study for 6 months.
- Animal Studies: In vivo mice and ex vivo porcine models. No specific sample sizes for these animal studies are provided in the summary.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- The document does not explicitly state the number of experts or their qualifications used to establish ground truth for the clinical test sets.
- However, the indication states the device is for use by an "ophthalmic physician," and treatments were for "Clinically Significant Macular Edema (CSME) according to ETDRS criteria." This implies that the diagnosis and assessment of improvement (e.g., visual acuity, macular thickness) were performed by qualified ophthalmic professionals following established clinical guidelines (like ETDRS criteria). The evaluation of outcomes (logMAR, ETDRS lines, CMT, MMT, macular sensitivity) would have been based on standard ophthalmological measurements, which serve as the implicit "ground truth" in clinical trials.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- The document does not mention any specific adjudication method (e.g., 2+1, 3+1 consensus) for the clinical study outcomes. It seems the clinical data (visual acuity, OCT measurements, etc.) were collected and analyzed directly based on standard clinical protocols.
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 comparative effectiveness study was done. This device is a laser system for treatment, not an AI-based diagnostic or assistive software. The clinical studies evaluated the direct effectiveness of the laser treatment itself. Therefore, the concept of "human readers improving with AI vs without AI assistance" is not applicable here.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. The R:GEN Laser System is a physical medical device (laser) used by an ophthalmic physician, not a standalone algorithm. Its performance is intrinsically tied to human operation and clinical assessment.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Clinical Outcomes Data: The ground truth for the clinical studies was based on objective and subjective clinical outcomes data, including:
- Visual Acuity: Measured by logMAR and ETDRS letters/lines.
- Anatomical Measurements: Central Macular Thickness (CMT), Maximum Macular Thickness (MMT) typically measured via Optical Coherence Tomography (OCT).
- Functional Measurements: Macular sensitivity (presumably microperimetry).
- Clinical Observations: Assessment of hard exudates and leakage in Fundus Fluorescein Angiography (FFA).
- Safety Endpoints: Absence of severe vision loss, scotomatous changes, or adverse events.
- These are considered standard clinical endpoints for evaluating the effectiveness and safety of treatments for macular edema.
8. The sample size for the training set:
- The document describes performance data for the R:GEN Laser System, a hardware device. There is no mention of a "training set" in the context of device performance as this is not an AI/machine learning device that requires a training phase.
- The animal studies could be considered a form of "pre-clinical training" or optimization for the laser's physical parameters/treatment protocols, although the term "training set" is not used. For clinical studies, there isn't a separate training set; the studies described are the efficacy trials.
9. How the ground truth for the training set was established:
- Not applicable. As a non-AI/ML device, there is no "training set" in the conventional sense that requires establishing ground truth for machine learning algorithms. The development and refinement of the laser system's parameters would have been guided by engineering principles, pre-clinical research (animal studies), and possibly preliminary human trials, rather than a formally labeled "training set."
§ 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.