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GluStitch® Twist Tissue Adhesive is intended for the topical skin incisions and trauma-induced lacerations in areas of low skin tension that are simple, thoroughly-cleansed, and have easily approximated skin edges. GluStitch® Twist may be used in conjunction with, but not in place of, deep dermal stitches.

GluStitch Twist Tissue Adhesive is a sterile, topical tissue adhesive containing n-butyl-2-cyanoacrylate. GluStitch Twist Tissue Adhesive is supplied in a single patient use, twist-and-use ampoule that contains at least 0.5g of liquid tissue adhesive.

This document describes the GluStitch® Twist Tissue Adhesive and its performance testing. Below is an analysis of the provided text to extract the requested information regarding acceptance criteria and the study proving the device meets them.

1. A table of acceptance criteria and the reported device performance

The document does not explicitly state acceptance criteria in a quantitative format for most of the performance tests. Instead, it focuses on demonstrating substantial equivalence to the predicate device, Indermil® Tissue Adhesive. The reported performance is primarily in terms of "substantially equivalent" for various characteristics.

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

The document mentions an "in vivo assessment of incision closure was conducted in swine," but it does not specify the sample size (number of swine or number of incisions) used for this study.
The provenance of this data is a GLP (Good Laboratory Practices) study, indicating a prospective study design conducted under controlled conditions. The country of origin for the study is not explicitly stated.

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 information is not provided in the document. The in vivo study evaluated "histopathologic evidence," implying pathological assessment, but details about the number and qualifications of the experts (e.g., pathologists) who interpreted these findings are absent.

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

This information is not provided in the document.

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 device is a tissue adhesive, not an AI-assisted diagnostic tool for human readers. Therefore, an MRMC study comparing human reader performance 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. The device is a physical tissue adhesive, not a software algorithm. Its performance is evaluated through direct physical and biological testing, not through algorithmic performance.

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

For the in vivo assessment, the ground truth was established through histopathologic evidence in swine, which is a form of pathology. The study also evaluated the incidence of chemical burn and infection as safety outcomes.

8. The sample size for the training set

This is not applicable. The device is a physical product, not a machine learning model that requires a training set.

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

This is not applicable for the same reason as point 8.

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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.

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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PeriAcryl® 90, PeriAcry18 80, PeriAcry1 70, and PeriAcry16 60 are indicated to be used as an adjunct to temporarily assist in securing periodontal dressings.

The Family of PeriAcryl® is a formulated compound of the cyanoacrylate series. It is available in 90/10 butyl/octyl, 80/20, butyl/octyl, 70/30 butyl/octyl and 60/40 butyl/octyl formulations depending on the dentist's preference. 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 submission for KO71484 is for a medical device (PeriAcryl®), not an AI/ML device. Therefore, the requested information regarding acceptance criteria, study details, and AI/ML specific metrics (like MRMC studies, standalone performance, training sets, etc.) is not applicable to this document.

The document describes the device as a formulated compound of the cyanoacrylate series, indicated as an adjunct to temporarily assist in securing periodontal dressings. The substantial equivalency information states that the device has the same intended use and technological characteristics as predicate devices and does not contain new ingredients raising additional safety and effectiveness concerns.

Therefore, I cannot provide a table of acceptance criteria or details of a study proving the device meets those criteria, as these concepts are inherent to the evaluation of AI/ML software performance, which is not the subject of this 510(k) summary.

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GluSeal™ liquid adhesive bandage is intended to cover minor cuts, scrapes, burns, and minor irritations of the skin and help protect them from infection.

GluSeal™ is monomeric 2 octyl cyanoacrylate. This 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).

GluSeal™ will be packaged in three different ways ranging from a multiuse bottle containing 5 ml cyanoacrylate; a multiuse vial containing 1 ml cyanoacrylate, and a kit containing 12 x 0.2 ml disposable applicators. Each of the multiuse kits will contain application pipettes and administration dishes or administration trays.

The provided text is a 510(k) summary for the medical device GluSeal™, a liquid adhesive bandage. It details the device's characteristics and its substantial equivalence to a predicate device, but it does not contain any information regarding specific acceptance criteria, study data, or clinical trials to prove device performance.

Therefore, I cannot provide the requested information in the format you described. The document primarily focuses on regulatory approval based on equivalence to a previously cleared device (CLOSURE Medical Corporation's LIQUIDERM™) rather than a de novo study with acceptance criteria and performance metrics.

Specifically, the document states:

• "The intended use and chemical structure of the GluStitch, Inc.'s GluSeal™ and CLOSURE Medical Corporation's LIQUIDDERM™ are equivalent." This is the core argument for its clearance, implying that since the predicate device was deemed safe and effective for its intended use, a device with equivalent characteristics will also be safe and effective.

To provide the information you asked for, a different type of document, such as a clinical study report or a detailed test report, would be necessary.

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GluSite is indicated for use as dental cement for bonding dental materials such as crowns, caps, and pins, or temporarily attaching a fiber to the surface of the tooth in a procedure to treat periodontal disease.

GluSite (2-octyl cynoacrylate) is a clear colorless, free-flowing liquid monomer packaged in a glass multiple-use vials. Upon contact with weak bases, GluSite polymerizes to form a strong adhesive bond. Depending on the availability of moisture, this could take up to one minute.

Here's an analysis of the provided text regarding the acceptance criteria and study for the GluSite device:

This document ([K013446](https://510k.innolitics.com/search/K013446)) is a 510(k) summary for a medical device seeking market premarket clearance. It is not a detailed study report, but rather a summary to establish substantial equivalence to a predicate device. Therefore, much of the requested information regarding detailed study design (sample sizes for training/test sets, expert qualifications, adjudication, MRMC studies, standalone performance, ground truth details) is not present in this document.

1. Table of Acceptance Criteria and Reported Device Performance:

The document doesn't explicitly state quantitative "acceptance criteria" through a table of targets that the device had to meet. Instead, the core of the evaluation for a 510(k) is demonstrating substantial equivalence to a predicate device. The "performance" is reported as equivalent to the predicate.

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

• Sample Size for Test Set: Not specified in the provided text.
• Data Provenance: Not specified. It's common for 510(k) submissions to include bench testing or in-vitro tests, but the document doesn't detail the type or origin of this data. It only states "test results."

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 in the document. For a medical device like dental cement, "ground truth" would typically refer to objective measurements of physical properties (e.g., bond strength, setting time, solubility) rather than expert interpretation of images.

4. Adjudication method for the test set:

This information is not provided and is generally not applicable to the type of performance testing expected for a dental cement (which focuses on objective physical properties rather than subjective interpretations).

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:

• MRMC Study: No, an MRMC study was not conducted (and would not be relevant) for this device.
• Effect size of human readers with/without AI assistance: This is not applicable as GluSite is a dental cement, not an AI-powered diagnostic or assistive device for human readers.

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

• Standalone Performance Test: Not applicable in the context of an "algorithm only" device. However, the "test results" mentioned imply a standalone performance evaluation of the cement's physical properties. The document states "test results demonstrates that the two devices are equivalent in performance," which suggests direct comparison of the substance itself without a human-in-the-loop component.

7. The type of ground truth used:

The document implies that the ground truth for performance comparison was based on objective, measurable physical and chemical properties of the dental cement, such as those related to its claim of being equivalent to the predicate in "chemical composition" and "performance." For dental cements, these typically include properties like:

• Bond strength
• Setting time
• Solubility
• Film thickness
• Radiopacity
• Biocompatibility

8. The sample size for the training set:

Not applicable and not provided. As a physical dental cement, there is no "training set" in the machine learning sense. The device's performance is inherent to its material properties, not learned from data.

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

Not applicable and not provided. There is no training set for this type of device.

Summary of Key Takeaways from the document:

The provided 510(k) summary for GluSite focuses on establishing substantial equivalence to the predicate device, Octyldent®, based on:

• Equivalent intended use
• Equivalent chemical composition (both are 2-octyl cyanoacrylate)
• Undisclosed "test results" demonstrating equivalent performance.

The document does not delve into the detailed methodology of these "test results" regarding sample sizes, expert involvement, or adjudication methods, as its purpose is a high-level regulatory summary for equivalence.

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