Search Results

The MonoStent™ Monocanalicular Stent, the EagleVision® Lacrimal Intubation Set, and the EagleVision® K Type Lacrimal Intubation Set are lacrimal stents and their delivery systems. They are intended for use in lacrimal system reconstruction. This includes, but is not limited to, treatment of: epiphora in infants or adults; canalicular pathologies such as stenosis; obstruction or laceration; and conditions requiring dacryocystorhinostomy (conventional or laser); or imperforation of the nasolacrimal duct in an infant.

The MonoStent™ Monocanalicular Stent, the EagleVision® Lacrimal Intubation Set, and the EagleVision® K Type Lacrimal Intubation Set are lacrimal stents and delivery systems.
The MonoStent™ Monocanalicular Stents consist of a length of silicone tubing, with a silicone punctum pluq molded perpendicularly onto one end of the tubing. A stainless steel stylet is provided with the stent to assist in the insertion of the silicone tubing.
The EagleVision® Lacrimal Intubation Set is comprised of stents for use in monocanalicular and bicanalicular intubation procedures. The stents are made of medical grade silicone tubing that is attached to malleable stainless steel probes. The intubation set allows for probing and stenting as a one step procedure.
The EagleVision® K Type Lacrimal Intubation Set is comprised of stents for use in monocanalicular and bicanalicular intubation procedures. The stents are made of silicone probes attached with a silicone rod.

The provided document is a 510(k) summary for medical devices (Eagle Vision Lacrimal Stents and Intubation Sets). This type of submission relies on demonstrating substantial equivalence to previously cleared predicate devices, rather than comprehensive de novo clinical studies with specific performance metrics and acceptance criteria in the way envisioned by the request.

Therefore, the acceptance criteria and study detailed in the request do not directly apply to this specific submission. There is no mention of a standalone algorithm or a multi-reader multi-case study for this type of medical device as it's a physical product, not an AI/software device.

However, I can extract the information relevant to a substantial equivalence determination, which serves as the "study" demonstrating it meets "acceptance criteria" for regulatory clearance.

Here's how the information maps to your request, with significant caveats due to the nature of a 510(k) for a physical device:

Acceptance Criteria and Reported Device Performance (as demonstrated by Substantial Equivalence to Predicate Devices)

• MonoStent™ Monocanalicular Stent: "[consist of] a length of silicone tubing, with a silicone punctum pluq molded perpendicularly onto one end of the tubing. A stainless steel stylet is provided with the stent to assist in the insertion of the silicone tubing."
• EagleVision® Lacrimal Intubation Set: "[comprised of] stents for use in monocanalicular and bicanalicular intubation procedures. The stents are made of medical grade silicone tubing that is attached to malleable stainless steel probes. The intubation set allows for probing and stenting as a one step procedure."
• EagleVision® K Type Lacrimal Intubation Set: "[comprised of] stents for use in monocanalicular and bicanalicular intubation procedures. The stents are made of silicone probes attached with a silicone rod."
  The document asserts: "The devices have similar designs and technological characteristics" to the predicate devices, specifically mentioning the use of medical grade silicone tubing and similar delivery mechanisms (stylet, malleable probes, silicone rods). Detailed technical specifications of the predicate devices are not provided in this summary, but the claim of similarity is central to the substantial equivalence argument. |
  | Similar Principles of Operation | Same Principles: Implied through the similar indications for use and technological characteristics (i.e., stenting to maintain patency in the lacrimal system). |
  | Safety and Effectiveness | Demonstrated through the assertion that "Descriptive characteristics were sufficient for assurance of equivalence" and a "comprehensive literature and MDR review was conducted to demonstrate that the [new devices] are substantially equivalent to the [predicate devices]." This implies that the new devices are considered acceptably safe and effective because their design, materials, and intended use are similar to devices already on the market deemed safe and effective. |

Study Details (as applicable to a 510(k) Substantial Equivalence Determination)

For this 510(k) submission, the "study" is a comparative analysis against predicate devices to demonstrate substantial equivalence, rather than a clinical trial with performance metrics.

1. Sample size used for the test set and the data provenance:

   • Test Set Sample Size: Not applicable in the context of a traditional performance study. The "test set" here refers to the characteristics of the new device itself, which are compared against the predicate devices. There is no patient sample size mentioned or required for this type of submission focused on substantial equivalence of physical devices.
   • Data Provenance: The data provenance is from the design specifications and manufacturing materials of the new devices, and a "comprehensive literature and MDR review" of the predicate devices. This is retrospective in terms of reviewing existing data and regulatory clearances.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

   • Number of Experts: Not applicable. The "ground truth" for a 510(k) comparison is essentially the regulatory clearance and performance history of the predicate devices.
   • Qualifications of Experts: The experts involved are the product development team at Eagle Vision, Inc., who performed the design analysis and comparison, and the FDA reviewers (Division of Ophthalmic and Ear, Nose and Throat Devices) who ultimately determine substantial equivalence.

3. Adjudication method for the test set:

   • Adjudication Method: Not applicable. There is no "test set" requiring adjudication in the sense of clinical outcome assessment. The comparison against predicate devices is a regulatory and technical assessment.

4. 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:

   • MRMC Study: No. This is a physical lacrimal stent and intubation set, not an AI/software device. Therefore, no MRMC study, human readers, or AI assistance is involved.

5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

   • Standalone Performance: No. This is not an algorithm or AI device.

6. The type of ground truth used:

   • Ground Truth: The "ground truth" used for determining substantial equivalence relies on the established regulatory clearances (K-numbers) and the known performance and safety data of the predicate devices (EV™ Monocanalicular Stent - K883233, Lacrimal Intubation Set & DCR Set - K990672, and Ritleng Bicanaliculus Intubation Set - K955671). The assertion is that these predicate devices are safe and effective, and because the new devices are substantially equivalent, they are also safe and effective.

7. The sample size for the training set:

   • Training Set Sample Size: Not applicable. There is no concept of a "training set" for physical medical devices in this context, nor for an AI algorithm.

8. How the ground truth for the training set was established:

   • Training Set Ground Truth: Not applicable for the same reasons as above.

Ask a specific question about this device