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The DCS Lacrimal Stent is a sterile, single-use lacrimal stent. The DCS Lacrimal Stent is a hollow flexible silicone lacrimal stent designed to be positioned distally in the paranasal cavities and proximally at the medial fornix conjuntival reflection. It is composed of a medical grade silicone tube with an internal diameter of 1.0 mm and with a total length of 15.5 mm.

AI/ML Overview

The presented document, K113316, is a Premarket Notification [510(k)] Summary for the DCS Lacrimal Stent. This type of submission is for demonstrating substantial equivalence to a legally marketed predicate device, rather than proving safety and effectiveness through clinical trials with defined acceptance criteria and statistical performance metrics. Therefore, explicit "acceptance criteria" and a "study that proves the device meets the acceptance criteria" in the format of a clinical trial with statistical performance endpoints are not applicable in this 510(k) summary.

Instead, the submission focuses on demonstrating that the DCS Lacrimal Stent is substantially equivalent to existing predicate devices based on:

Intended Use: The DCS Lacrimal Stent's intended use is compared to that of predicate devices.
Technological Characteristics: Key device attributes like material, dimensions, and sterilization methods are compared.
Performance Testing (Bench and Cadaver): Verification of physical properties relevant to the device's function.
Biocompatibility: Confirmation that the material is suitable for its intended prolonged contact.

The document does not describe a clinical study with a test set, ground truth, experts, or statistical performance data for the device.

Here's an breakdown based on the information provided and what is typical for a 510(k) submission:

1. Table of Acceptance Criteria and Reported Device Performance

As this is a 510(k) summary for substantial equivalence, formal "acceptance criteria" with a "reported device performance" are not presented as they would be in a clinical trial. Instead, the submission argues for equivalence based on technological characteristics and functional testing.

Acceptance Criteria (Demonstrated Equivalence through)	Reported Device Performance (Summary of Findings)
Intended Use Equivalence: The DCS Lacrimal Stent is intended for use during repair of the lacrimal system for intubation and bypass to canalicular pathologies, which aligns with the general intent of predicate lacrimal stents.	The intended use is deemed substantially equivalent to predicate devices, particularly Gunther-Weiss (Jones Tubes) and broadly with FCI Ophthalmics and Eagle Vision stents.
Technological Characteristics Equivalence: Material, dimensions (outer diameter, punctum collar diameter, length), and packaging/sterilization are comparable or do not raise new safety/effectiveness concerns.	Material: Medical Grade Silicone Tubing (similar to other modern stents).
Dimensions: Stent outer diameter (1.5mm to 2.25mm), Punctum collar diameter (2.5mm by 6.0mm), Stent length (15.5mm) are within the range or comparable to predicates, with differences attributed to design for intra- vs. extra-ductal intubation.
Packaging/Sterility: Tyvek Pouch; Radiation Sterilized for Single Use Only, achieving SAL of 10^-6, comparable to modern sterile medical devices.
Performance Testing: Adequate tensile strength and internal flow profile for intubation and fluid drainage.	Verified by bench and cadaver testing to have adequate tensile strength and internal flow profile for intubation of the nasal punctum and lacrimal anatomy to facilitate tear fluid drainage. Specific numerical values or detailed test results are not provided in this summary.
Biocompatibility: Medical grade silicone is suitable for prolonged contact, externally communicating with tissue.	Successfully tested according to ISO 10993, demonstrating suitability for intended use and substantial equivalence to predicate devices, raising no new safety questions.
Sterilization: Radiation sterilization to a Sterility Assurance Level (SAL) of 10^-6 per ANSI/AAMI/ISO 11137-2.	Device is labeled sterile, single-use, and radiation sterilized by a validated process to SAL of 10^-6.

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

This information is not provided in the 510(k) summary. The performance testing mentions "bench and cadaver testing," but does not specify sample sizes for these tests, nor the data provenance in terms of country of origin or whether it was retrospective or prospective.

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

This information is not provided. The 510(k) summary refers to internal performance testing (bench and cadaver) and biocompatibility studies. There is no mention of a test set requiring expert-established ground truth in the context a clinical study.

4. Adjudication Method for the Test Set

This information is not applicable/not provided as there is no described test set requiring expert adjudication in this 510(k) summary.

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. The DCS Lacrimal Stent is a physical medical device, not an AI-based diagnostic tool. Therefore, an MRMC study or AI assistance is not relevant to this submission.

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

This is not applicable. The DCS Lacrimal Stent is a physical medical device, not an algorithm, so standalone performance in this context is not relevant.

7. The Type of Ground Truth Used

For the performance testing (bench and cadaver), the "ground truth" would implicitly be the established engineering and physiological standards for tensile strength, flow dynamics, and material biocompatibility, rather than expert consensus, pathology, or outcomes data from a clinical trial. The specific metrics and how they were evaluated clinically for "ground truth" are not detailed in this summary.

8. The Sample Size for the Training Set

This is not applicable/not provided. The device is a physical stent and does not involve AI or machine learning, thus no training set in that context.

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

This is not applicable/not provided for the reasons stated in point 8.

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