Search Results

For polyester and polypropylene LSI SOLUTIONS® Suture Quick Load® Products: general soft tissue approximation and/or ligation.

For polyglycolic acid (PGA) and polydioxanone (PDS) LSI SOLUTIONS® Suture Quick Load® Products: general soft tissue approximation and/or ligation, including use in ophthalmic procedures, but not for use in cardiovascular and neurological procedures.

The LSI SOLUTIONS® Suture Quick Load® Products, like the predicates, are intended for the approximation of soft tissue by passing ligature through said soft tissue. The LSI SOLUTIONS® Suture Quick Load® Products have Ferrule attachments, similar to needle attachments, that facilitate the use of the suture with the LSI SOLUTIONS® SEW-RIGHT® family and PLACE-RIGHT® family of suture placement device products.

This 510(k) premarket notification for the LSI SOLUTIONS® Suture Quick Load® Products does not contain a study demonstrating device performance against acceptance criteria.

Instead, it relies on a substantial equivalence determination to legally marketed predicate devices. This means that LSI SOLUTIONS, Inc. is claiming their device is as safe and effective as existing, approved devices, and therefore does not require new, extensive clinical trials or performance studies to prove its efficacy from scratch.

Here's why the requested information cannot be found in this document:

• Acceptance Criteria & Reported Performance: There are no specific acceptance criteria for performance (e.g., tensile strength thresholds, knot security metrics) described in this document, nor are there reported results of a study designed to measure these. The document focuses on comparing the intended use and technological characteristics of the new device to predicate devices.
• Sample Size, Data Provenance, Experts, Adjudication: These details would typically be part of a formal study report, which is not included here.
• MRMC, Standalone Performance: These refer to types of studies (often for AI/image analysis devices) that are not relevant to a surgical suture product.
• Ground Truth: For a physical medical device like a suture, "ground truth" would be established through a combination of manufacturing specifications, material testing standards, and established clinical performance of similar devices. This document doesn't detail how these were specifically established for this device's premarket notification, beyond asserting its similarity to predicates.
• Training Set Sample Size & Ground Truth (for training): Again, these concepts apply more to machine learning or AI-based devices and are not relevant to a surgical suture.

Summary of what is provided regarding device performance and its path to market:

The document serves as a 510(k) Premarket Notification, which specifically aims to demonstrate substantial equivalence to existing legally marketed predicate devices.

The "study" that proves the device meets acceptance criteria (in the context of a 510(k)) is the comparison to predicate devices, asserting that its technological characteristics and intended use are similar enough that it raises no new questions of safety or effectiveness.

1. Table of Acceptance Criteria and Reported Device Performance:

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

• Not Applicable: This document does not describe a "test set" in the context of a performance study with a specific sample size. The substantial equivalence relies on a comparison of device characteristics and intended use to existing devices.

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

• Not Applicable: "Ground truth" for a surgical suture is typically established through material science testing and clinical experience with equivalent devices, not through expert review of a "test set" as might be done for diagnostic imaging.
• The FDA, through its review process, acts as the ultimate "expert" in determining substantial equivalence based on the provided documentation and existing regulatory standards.

4. Adjudication method for the test set:

• Not Applicable: No test set or adjudication method is described. The FDA's review process itself can be seen as an adjudication on the substantial equivalence claim.

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: This is a surgical suture, not a diagnostic or AI-assisted device. MRMC studies are not relevant.

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

• No: This is a surgical suture, not an algorithm-based device.

7. The type of ground truth used:

• Predicate Device Equivalence: The "ground truth" for the new device's safety and effectiveness is established by its demonstrated substantial equivalence to legally marketed predicate devices (e.g., Deknatel™ Tevdek® II, Deklene® II, Surgisorb, Mono-Dox). This implies that the predicate devices have already established their safety and effectiveness through their own regulatory pathways and market history.
• The document states: "The LSI SOLUTIONS® Suture Quick Load® Products, like the predicates, are intended for the approximation of soft tissue by passing ligature through said soft tissue." This statement forms the basis of the equivalence argument.
• The regulation classifications (e.g., 21 CFR 878.5000 for nonabsorbable polyester surgical suture) further define the expected performance and safety standards for this product type.

8. The sample size for the training set:

• Not Applicable: This document does not describe a "training set" in the context of machine learning.

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

• Not Applicable: See point 8.

Ask a specific question about this device