Search Results

The Eagle device is a prescription device intended to coagulate or cut tissue of the eye, orbit, or surrounding skin by a laser beam. The Eagle device has the same intended use as the predicate device. The Eagle device has the following Indications for Use (IFU) statement:

The Eagle device is indicated for use in selective laser trabeculoplasty (SLT).

The Eagle device is a Q-switched, 532 nm-wavelength, frequency-doubled Nd:YAG laser that is intended for use in performing selective laser trabeculoplasty. The laser spots produced by the Eagle device have a 400 um spot size, a 3 ns pulse duration, and a 50-Hz pulse repetition rate. The sequence of laser spots consists of 120 spots in a predefined circumferential elliptical pattern delivered at a pre-defined pulse energy level. The spots are delivered through the limbus to the trabecular meshwork in a non-contact fashion, without the need for the use of a contact gonioscopy lens. The device automatically locates the treatment location. The treatment location may be adjusted slightly by the operator. Once confirmed by the operator, the device then automatically applies the laser treatment sequence to the limbal region of the eye, while the eye tracker compensates for any eye movement. The default energy setting is 1.8 mJ/pulse.

Here's an analysis of the provided text regarding the acceptance criteria and study proving the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance

The provided text does not explicitly list "acceptance criteria" for the device's performance in the typical sense of numerical thresholds for a specific metric that must be met. Instead, it describes a non-inferiority study where the Eagle device (subject device) is compared to a conventional SLT device (predicate). The implicit acceptance criteria appear to be the demonstration of non-inferiority in effectiveness (IOP reduction) and a comparable safety profile to the predicate device.

Implicit Acceptance Criteria and Reported Device Performance

• Eagle: 5.48 ± 0.52 mmHg reduction
• Conventional SLT: 6.29 ± 0.53 mmHg reduction
  Difference (SLT - Eagle): -0.80 mmHg (95% Cl -2.28, 0.68). The study concluded that the Eagle device demonstrated acceptable effectiveness comparable to conventional SLT. |
  | Safety (Adverse Events) | Primary Safety Outcome: Rate of ocular adverse events (AEs) in the Eagle treatment group at or prior to 12 months should be comparable to the conventional SLT group. | Overall Safety Profile:
• Serious Ocular SAEs (0-6 months): 1 in Eagle (0%) vs 1 in conventional SLT (1.1%) (subluxation of pre-existing IOL deemed related to conventional SLT).
• Serious Ocular SAEs (6-12 months): 1 in Eagle (1.0%) (acute optic neuropathy, non-glaucomatous) vs 0 in conventional SLT.
• Most Common Non-Serious AE (0-6 months): Punctate subconjunctival hemorrhage (20.8% in Eagle vs 1.1% in conventional SLT) - resolved without sequelae.
• Cataract progression (0-6 months): 3.1% in Eagle vs 1.1% in conventional SLT.
• Overall, comparable safety profile to the conventional SLT device, with some differences in types and frequencies of non-serious AEs. |
  | SLIT Lamp Examination (AC Cells & Flare) | Changes in anterior chamber cells and flare from screening should be minimal and comparable between groups. | AC Cells (Increase +0.5 or more):
• Post Procedure: Eagle 31.3% vs SLT 20.9%
• 1 Day: Eagle 18.9% vs SLT 12.1%
• Rapid reduction over time, with negligible increases beyond 1 month for both groups.
  AC Flare (Increase +0.5 or more):
• Post Procedure: Eagle 20.8% vs SLT 16.5%
• 1 Day: Eagle 11.6% vs SLT 7.7%
• Rapid reduction over time, with negligible increases beyond 1 month for both groups. |

2. Sample Size Used for the Test Set and Data Provenance

• Sample Size for Test Set:
  • Randomized Participants (ITT Population): 196 participants (99 to Eagle, 97 to conventional SLT)
  • Participants Underwent Assigned Procedure: 187 participants (96 Eagle, 91 conventional SLT)
  • Modified Per Protocol (mPP) Population: 152 participants (77 Eagle, 75 conventional SLT)
• Data Provenance: Prospective, multi-center, randomized, controlled trial. The specific countries of origin for the data are not explicitly stated, but it's a multi-center study.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

This was a clinical trial involving patients, not an AI review of images needing expert consensus for ground truth. The "ground truth" for effectiveness was objective physiological measurements (Intraocular Pressure reduction) and for safety, it was the occurrence of adverse events monitored by clinical investigators. Therefore, standard expert-based ground truth establishment (e.g., from radiologists) is not applicable here. Clinicians at the 14 sites would have assessed patients, but "experts" for ground truth in the AI sense are not mentioned.

4. Adjudication Method for the Test Set

This was a clinical trial with objective measures and adverse event reporting. Therefore, an adjudication method like "2+1" for discrepancies in expert readings (common in AI imaging studies) is not directly applicable. Clinical trial protocols typically have methods for reporting, verifying, and adjudicating adverse events and protocol deviations, but this isn't detailed in the provided summary.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done

No, an MRMC comparative effectiveness study was not done. The study directly compared two laser devices (Eagle vs. conventional SLT) in a randomized controlled trial on human patients, measuring clinical outcomes (IOP reduction and adverse events), not human reader performance with or without AI assistance.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

No, a standalone algorithm-only performance study was not conducted in the traditional sense of evaluating an AI's diagnostic accuracy. The Eagle device is a laser system that automatically locates treatment areas and applies laser sequences, with the operator able to make slight adjustments and confirm. The study evaluates the device's clinical performance when used by an operator, not a purely autonomous AI algorithm against a manual process.

7. The Type of Ground Truth Used

The ground truth used in this clinical study was based on:

• Effectiveness: Objective physiological measurement of unmedicated Intraocular Pressure (IOP).
• Safety: Clinical observation and reporting of ocular adverse events (AEs).

8. The Sample Size for the Training Set

The provided document describes a clinical validation study for the Eagle device, which is a medical device (laser system), not an AI algorithm that requires a separate training set. Therefore, there is no "training set" in the context of machine learning. The clinical trial directly evaluated the device's performance in patients.

9. How the Ground Truth for the Training Set Was Established

As there is no "training set" for an AI algorithm, this question is not applicable. The device itself is the subject of the clinical investigation, with its internal automation being part of its design.

Ask a specific question about this device