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510(k) Data Aggregation
(68 days)
GluSeal® 90 liquid adhesive bandage is intended to cover minor cuts, scrapes, burns, and minor irritations of the skin and help protect them from infection.
The GluSeal® 90 is a formulated compound of the cyanoacrylate series. The compound, which exists in monomeric form in the plastic containers, polymerizes extremely rapidly in the presence of anions, especially of hydroxyl ions [in the presence of water]. It has the ability to adhere to moist living tissues. It demonstrates a favorable tissue response and reveals no toxic or foreign body reaction in humans.
This document describes the GluSeal® 90 liquid adhesive bandage, a device intended to cover minor cuts, scrapes, burns, and minor irritations of the skin and help protect them from infection. The primary study presented is a performance testing comparison to predicate devices, focusing on demonstrating substantial equivalence rather than a detailed clinical trial with acceptance criteria for specific performance metrics.
Here's an analysis of the provided information based on your requested points:
1. Table of Acceptance Criteria and Reported Device Performance
The provided document does not explicitly state quantitative acceptance criteria for the GluSeal® 90, as it primarily focuses on demonstrating substantial equivalence to predicate devices through performance testing. Instead, the "acceptance criteria" can be inferred as achieving similar performance or being comparable to the predicate devices in the described tests.
| Performance Test Category | Acceptance Criteria (Inferred) | GluSeal® 90 Reported Performance |
|---|---|---|
| Hydrolytic Byproducts | Similar degradation products and formaldehyde levels to predicate Indermil samples. | "No other significant degradation products were produced." "Produced similar levels of formaldehyde as found in the Indermil samples." |
| Thermal Effects | Similar exotherm profile to predicate Indermil during polymerization. | "Had very little exotherm of the adhesive." "Performed similarly to the control article Indermil during these tests." |
| Adhesive Strength Properties | Similar properties to predicate Indermil commercial tissue adhesive. | "Appears to have similar properties to the Indermil commercial tissue adhesive." |
| Biocompatibility | Product is safe for its intended use per ANSI/AAMI/ISO 10993. | "Confirmed that the product is safe for its intended use." |
| Mechanical and Performance Tests | Equivalence to predicated devices. | "Demonstrating equivalence to the predicated devices." |
2. Sample Size for Test Set and Data Provenance
The document does not specify the exact sample sizes used for the "Hydrolytic Byproducts Analyses," "Thermal Effects Study," and "Adhesive Strength Properties Study." It implicitly compares GluSeal® 90 to "Indermil samples" (for hydrolytic and thermal effects) and "Indermil commercial tissue adhesive" (for adhesive strength), but the number of samples for each is not given.
The data provenance is not explicitly stated regarding country of origin, but it is a regulatory submission to the US FDA from a Canadian applicant (GluStitch, Inc., Delta, British Columbia, Canada). The studies appear to be retrospective in the sense that they were conducted for this premarket notification rather than as part of a continuous, ongoing monitoring process.
3. Number of Experts and Qualifications
The document does not mention the number of experts used to establish ground truth or their qualifications for the performance tests described. These appear to be laboratory-based tests rather than expert-reviewed clinical outcomes.
4. Adjudication Method
No adjudication method is mentioned as the studies are laboratory-based performance tests rather than clinical evaluations requiring expert consensus.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No multi-reader multi-case (MRMC) comparative effectiveness study is mentioned. This is not applicable as the device is a liquid adhesive bandage, not an AI-assisted diagnostic tool.
6. Standalone Performance Study
Yes, standalone performance studies were done. The "Performance Testing" section describes three distinct studies evaluating the GluSeal® 90 independently and in comparison to a control (Indermil):
- Hydrolytic Byproducts Analyses: Evaluated degradation products and formaldehyde levels.
- Thermal Effects Study: Assessed exotherm during polymerization.
- Adhesive Strength Properties Study: Compared adhesive properties.
Additionally, biocompatibility testing was performed in accordance with ANSI/AAMI/ISO 10993, which is a standalone evaluation of the device's biological safety.
7. Type of Ground Truth Used
The ground truth for these performance tests is based on laboratory measurements and established scientific methods for analyzing chemical composition (degradation products, formaldehyde), thermal properties (exotherm), and physical properties (adhesive strength). For biocompatibility, the ground truth is adherence to the ANSI/AAMI/ISO 10993 standard, which relies on a battery of biological tests.
8. Sample Size for Training Set
No training set is mentioned. This device is a physical product (liquid bandage), not an AI algorithm that requires training data.
9. How Ground Truth for Training Set Was Established
Not applicable as there is no training set for an AI algorithm.
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