FDA 510(k) Search - By Innolitics (SaMD and AI Experts)

The RITLENG®+ is a self-retaining nasal bicanalicular intubation for the lacrimal ducts. It consists of a silicone tube with two larger diameter portions, connected at each extremity with a PEEK thread guide. Each thread guide has a wide diameter part and a narrow diameter part. The silicone tube may be coated with polyvinylpyrrolidone (PVP) to improve its wettability. The central body of the intubation displays a marking intended for the intubation placement between the lacrimal puncta.

AI/ML Overview

The provided document is a 510(k) Premarket Notification from the FDA for a medical device called RITLENG®+ and RITLENG®+ PVP. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than providing extensive clinical study data with acceptance criteria for device performance in the same way one might describe a novel diagnostic AI algorithm.

Therefore, the information about acceptance criteria and a study proving the device meets them needs to be interpreted within the context of a 510(k) submission, where the "study" is primarily a non-clinical comparison and testing against established specifications and predicate device characteristics.

Here's the breakdown based on the provided text:

Description of Acceptance Criteria and the Study that Proves the Device Meets the Acceptance Criteria:

The RITLENG®+ device is a bicanalicular lacrimal stent. For a 510(k) submission, the "acceptance criteria" are predominantly related to the device's technical specifications, safety, and functionality being comparable to a predicate device, as well as meeting relevant standards. The "study" refers to the non-clinical tests performed to demonstrate this equivalence and performance.

1. Table of Acceptance Criteria and the Reported Device Performance:

Acceptance Criteria Category	Specific Criteria (Implicitly Derived)	Reported Device Performance
Intended Use	Identical to predicate device	"RITLENG®+ is substantially equivalent to the RITLENG® Intubation as both devices have the identical intended use and intubation method, with similar indications for use statements."
Material Biocompatibility	Meets ISO 10993 standards and comparable to predicate device material	"The implant part of both devices is made from the identical grade silicone... The biocompatibility of the device is supported by cytotoxicity testing per ISO 10993-5, three sets of chemical characterization testing ... per ISO 10993-18, and toxicological risk assessment." Also supported by "biocompatibility information of the materials used in the subject device to the materials used in the cleared predicate."
Sterilization	Achieves SAL 10-6 via Ethylene Oxide (EO)	"Both devices are packaged in a double Tyvek pouch and sterilized by Ethylene Oxide to a sterility level of SAL 10-6." "Ethylene oxide sterilization specifications... were performed to the applicable standards."
Wettability (Optional Feature)	Comparable to predicate device's coated option	"The silicone tube of both devices may be coated with polyvinylpyrrolidone (PVP) to improve its wettability."
Physical Design/Functionality	Meets established specifications for new features (self-retaining) and overall function	"RITLENG®+ has been designed and tested to the applicable standards. All nonclinical test results met the established specifications for the device." "The results from non-clinical testing demonstrate RITLENG®+ meets the established specifications for the device..."
Packaging & Shelf-Life	Meets applicable standards	"package integrity studies, and stability studies were performed to the applicable standards; and the test results support the shelf-life and storage conditions for the device."
Manufacturing Quality Control	In-process and final product controls assure manufacturing within specifications	"In-process controls and final product quality controls, including finished product release testing and inspection, assure that RITLENG®+ is manufactured within specifications."

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

This document does not describe a "test set" in the context of clinical data for an AI/diagnostic device. The "tests" mentioned are non-clinical bench tests (e.g., cytotoxicity, chemical characterization, sterilization efficacy, material testing, package integrity, stability studies). Therefore, terms like "sample size," "data provenance," "country of origin," and "retrospective/prospective" are not applicable in the way they would be for a clinical study on human subjects or an AI product's performance. The "samples" for testing would be units of the device itself or its constituent materials. The provenance of this physical testing data is from the manufacturer (FCI SAS) and the testing laboratories they contracted.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This is not applicable. The ground truth for non-clinical tests is based on scientific and engineering standards and validated test methodologies, not expert consensus in a medical diagnostic sense. For example, "ground truth" for cytotoxicity is determined by cell viability assays against established thresholds, not by a panel of experts.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This is not applicable as there is no "test set" requiring expert adjudication in the context of this 510(k) submission.

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

This is not applicable. This is a conventional medical device (lacrimal stent), not an AI-powered diagnostic tool. Therefore, an MRMC study comparing human readers with and without AI assistance was not performed.

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

This is not applicable. This is a conventional medical device.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

The "ground truth" for this device's evaluation is primarily based on established engineering and material science standards (e.g., ISO 10993 for biocompatibility), validated test methods, and comparison to the characteristics of the predicate device. For instance:

Biocompatibility: Results of cytotoxicity, chemical characterization tests against established safety thresholds.
Sterility: Absence of microorganisms to a sterility assurance level (SAL) of 10^-6, confirmed by validated sterilization processes.
Physical Properties: Measurement of dimensions, material strength, etc., against predefined specifications.
Intended Use: Direct comparison of the stated indications for use with the predicate device.

8. The sample size for the training set

This is not applicable. This is a conventional medical device, not an AI product that requires a "training set."

9. How the ground truth for the training set was established

This is not applicable.

Summary

Regulation Number and Section

N/A