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DERMABOND™ PRINEO™ System is intended for topical application only to hold closed easily approximated skin edges of wounds from surgical incisions, including punctures from minimally invasive surgery, and simple, thoroughly cleansed, trauma-induced lacerations. DERMABOND™ PRINEO™ System should be used in conjunction with, but not in place of, deep dermal stitches. Additionally, the adjunct wound closure device component maintains temporary skin edge alignment along the length of the wound during application of the liquid adhesive.

DERMABOND™ PRINEO™ Skin Closure System is a sterile, liquid topical skin adhesive containing a monomeric (2-octyl cyanoacrylate) formulation and colorant D & C Violet No. 2. It is provided in a single-use applicator packaged in a rigid blister. The applicator is composed of a crushable glass ampule contained within a pen applicator with an attached applicator tip. As applied to skin, the liquid topical skin adhesive is slightly more viscous than water and polymerizes within minutes. In vitro studies have shown that DERMABOND PRINEO System acts as a barrier to microbial penetration as long as the adhesive film remains intact. Clinical studies were not conducted to demonstrate microbial barrier properties.

DERMABOND PRINEO also incorporates a self-adhering mesh that is applied to the approximated skin edges to provide temporary skin edge alignment of incisions up to 20 cm in length until the liquid topical skin adhesive is applied to achieve skin closure.

This is a 510(k) premarket notification for a medical device (DERMABOND™ PRINEO™ Skin Closure System) applying for clearance from the FDA. This document primarily focuses on establishing substantial equivalence to a predicate device, rather than presenting a de novo study with detailed acceptance criteria and performance data.

Therefore, the requested information regarding acceptance criteria, study details, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, and ground truth establishment for a new device cannot be fully extracted from this document in the manner typically expected for a new device submission.

Here's a breakdown of why and what can be extracted:

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

• Not Applicable in the traditional sense. This document explicitly states: "This section is not applicable, as both nonclinical testing are not necessary to support substantial equivalence since there have been no changes to the technological characteristics of the devices, including the adhesive formulation, design, material and performance; this change is only to reduce adhesive volume for subject device."
• Since there were no new non-clinical or clinical studies conducted to demonstrate performance against new acceptance criteria, such a table cannot be created from this document. The submission is based on the premise that the modified device (reduced adhesive volume) performs equivalently to the predicate, which has already met its acceptance criteria.

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

• Not Applicable. No new test set data is presented for performance evaluation because no new studies were deemed necessary. The assessment hinges on the predicate device's existing data and the argument that a reduced adhesive volume does not alter the fundamental safety or effectiveness.

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)

• Not Applicable. No new test set requiring expert ground truth establishment was conducted.

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

• Not Applicable. No new test set requiring adjudication was conducted.

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

• Not Applicable. This device is a physical medical device (skin closure system), not an AI-powered diagnostic or interpretive tool. Therefore, MRMC studies involving human "readers" or AI assistance are irrelevant to this submission.

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

• Not Applicable. As above, this is not an algorithm-based device.

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

• Not Applicable. No new ground truth for performance evaluation was established for this submission. The "ground truth" for demonstrating substantial equivalence relies on the established performance and safety of the predicate device.

8. The sample size for the training set

• Not Applicable. This document does not pertain to the development of a predictive model or AI, so there is no "training set."

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

• Not Applicable. As above, there is no training set.

Summary based on the provided document:

The core of this 510(k) submission is to demonstrate substantial equivalence of the modified DERMABOND™ PRINEO™ Skin Closure System (with reduced adhesive volume) to its predicate device (K133864).

The document explicitly states that non-clinical and clinical testing were not necessary to support substantial equivalence because "there have been no changes to the technological characteristics of the devices, including the adhesive formulation, design, material and performance; this change is only to reduce adhesive volume for subject device."

Therefore, the "proof" that the device meets acceptance criteria implicitly relies on:

• The predicate device (K133864) having already met its acceptance criteria through its original clearance.
• The argument that a reduction in adhesive volume does not compromise the fundamental safety and effectiveness of the device, given that all other technological characteristics, materials, design, intended use, and manufacturing processes remain identical to the cleared predicate.

In a situation like this, the "acceptance criteria" are effectively met by demonstrating that the changes are minor and do not affect the established performance characteristics of the predicate device. No new study data is presented to prove independent performance against new acceptance criteria.

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DERMABOND™ PRINEO™ System is intended for topical application only to hold closed easily approximated skin edges of wounds from surgical incisions, including punctures from minimally invasive surgery, and simple, thoroughly cleansed, trauma-induced lacerations. DERMABOND™ PRINEO™ System should be used in conjunction with, but not in place of, deep dermal stitches. Additionally, the adjunct wound closure device component maintains temporary skin edge alignment along the length of the wound during application of the liquid adhesive.

DERMABOND™ PRINEO™ Skin Closure System is a sterile, liquid topical skin adhesive containing a monomeric (2-octylcyanoacrylate) formulation and the colorant D & C Violet No. 2. It is provided in a single-use applicator packaged in a rigid blister. The applicator is composed of a crushable glass ampule contained within a pen applicator with an attached applicator tip. As applied to skin, the liquid adhesive is slightly more viscous than water and polymerizes within minutes. In vitro studies have shown that DERMABOND™ PRINEO™ System acts as a barrier to microbial penetration as long as the adhesive film remains intact. Clinical studies were not conducted to demonstrate microbial barrier properties.

DERMABOND™ PRINEOTM System also incorporates 2 self-adhering meshes that are applied to the approximated skin edges to provide temporary skin edge alignment of incisions up to 40 cm in length until the liquid adhesive is applied to achieve skin closure.

The provided text describes a 510(k) premarket notification for a medical device, the Dermabond Prineo Skin Closure System. It focuses on demonstrating substantial equivalence to a previously cleared predicate device, rather than proving the device meets specific acceptance criteria through a clinical study involving human-in-the-loop performance, expert ground truth establishment, or MRMC studies.

Therefore, many of the requested elements for describing "acceptance criteria and the study that proves the device meets the acceptance criteria" are not present in this document. This submission relies on non-clinical design verification and comparison to a predicate device.

Here's an attempt to extract relevant information and note what is not available based on the provided text:

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

The document lists various tests performed to demonstrate safety and effectiveness for the Dermabond Prineo Skin Closure System (42cm) and its substantial equivalence to the predicate device (22cm). However, it does not provide specific quantitative acceptance criteria or detailed numerical results for each test. Instead, it states that "No new safety or performance issues were raised during the testing." and "The additional size meets the same requirements as the current FDA cleared K133864 device."

Here's a table of the types of tests performed, as listed in the document. The "Reported Device Performance" column reflects the general statement provided in the document.

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

• Sample Size for Test Set: The document mentions a "14 day Porcine Effectiveness Study" and various bench tests. However, it does not specify the sample sizes for these tests.
• Data Provenance: Not specified. The studies were non-clinical design verification.

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

• Not Applicable. This document describes a 510(k) submission based on non-clinical testing and substantial equivalence, not a clinical study involving experts establishing ground truth for a test set.

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

• Not Applicable. As above, this was not a clinical study with image interpretation requiring adjudication.

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

• Not Applicable. This device is a skin closure system, not an AI-assisted diagnostic tool. An MRMC study is not relevant to this type of device or this submission.

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

• Not Applicable. This is a physical medical device, not an algorithm.

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

• For the non-clinical tests, the "ground truth" would be established by the engineering specifications, material properties, and biological compatibility standards (e.g., ISO 10993). For the porcine effectiveness study, the "effectiveness" would be assessed based on observed outcomes relevant to wound closure. However, specific definitions and methodologies for establishing this "ground truth" (e.g., how "effectiveness" was quantified and assessed in the porcine study) are not detailed in this document.

8. The sample size for the training set

• Not Applicable. This device is not an AI/machine learning algorithm that requires a training set. The submission focuses on non-clinical "design verification."

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

• Not Applicable. (See point 8).

In Summary:

The provided FDA document is a 510(k) clearance letter for a medical device (Dermabond Prineo Skin Closure System). It outlines the device details and the basis for its substantial equivalence to a predicate device. The "study that proves the device meets the acceptance criteria" in this context refers to a series of non-clinical design verification tests (biocompatibility and bench testing) and a 14-day porcine effectiveness study. The document asserts these tests provide "reasonable assurance that the proposed device has been designed and tested to assure conformance to the requirements for its intended use" and that "No new safety or performance issues were raised during the testing." It does not provide the granular details of acceptance criteria, specific numerical results, sample sizes for all tests, or the methodology for ground truth establishment that would be present in a submission for an AI/ML-based diagnostic device or a comprehensive clinical trial report.

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DERMABOND™ PRINEO™ System is intended for topical application only to hold closed easily approximated skin edges of wounds from surgical incisions, including punctures from minimally invasive surgery, and simple, thoroughly cleansed, trauma-induced lacerations. DERMABOND™ PRINEO™ System should be used in conjunction with, but not in place of, deep dermal stitches. Additionally, the adjunct wound closure device component maintains temporary skin edge alignment along the length of the wound during application of the liquid adhesive.

DERMABOND™ PRINEO™ Skin Closure System is a sterile, liquid topical skin adhesive containing a monomeric (2-octyl cyanoacrylate) formulation and the colorant D & C Violet No. 2. It is provided in a single-use applicator packaged in a rigid blister. The applicator is composed of a crushable glass ampule contained within a pen applicator with attached applicator tip. As applied to skin, the liquid adhesive is slightly more viscous than water and polymerizes within minutes. In vitro studies have shown that DERMABOND™ PRINEO™ System acts as a barrier to microbial penetration as long as the liquid adhesive film remains intact. Clinical studies were not conducted to demonstrate microbial barrier properties.

DERMABOND™ PRINEO™ System also incorporates a self-adhering mesh that is applied to the approximated skin edges to provide temporary skin edge alignment until the liquid adhesive is applied to achieve skin closure.

This document is a 510(k) premarket notification for the DERMABOND™ PRINEO™ Skin Closure System, seeking clearance for a new revision of the device's labeling. The document explicitly states that the device itself has not changed in any material, construction, specification, manufacturing, or sterilization process. Therefore, it does not contain a study demonstrating new device performance against acceptance criteria.

The submission claims substantial equivalence to previously cleared DERMABOND™ PRINEO™ devices (K082289/DEN090005 and K133864). Since the device itself is identical to a previously cleared predicate and the changes are only to labeling (adding a contraindication and other clarifications), no new performance data or studies are presented in this document to demonstrate the device meets acceptance criteria. The document relies on the substantial equivalence of the unchanged device to the predicate device.

Therefore, I cannot provide the requested information from this document, as the core of the submission is about labeling changes to an already cleared and unchanged device, not a new study proving performance against acceptance criteria for the device itself.

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DERMABOND PRINEO Skin Closure System is intended for topical application only to hold closed easily approximated skin edges of wounds from surgical incisions, including punctures from minimally invasive surgery, and simple, thoroughly cleansed, traumainduced lacerations. DERMABOND PRINEO should be used in conjunction with, but not in place of, deep dermal stitches. Additionally, the adjunct wound closure component maintains temporary skin edge alignment along the length of the wound during application of the liquid adhesive.

DERMABOND™ PRINEO™ Skin Closure System is a sterile, liquid topical skin adhesive containing a monomeric (2-octyl cyanoacrylate) formulation and colorant D & C Violet No. 2. It is provided in a single-use applicator packaged in a rigid blister. The applicator is composed of a crushable glass ampule contained within a pen applicator with an attached applicator tip. As applied to skin, the liquid topical skin adhesive is slightly more viscous than water and polymerizes within minutes. In vitro studies have shown that DERMABOND PRINEO acts as a barrier to microbial penetration as long as the liquid topical skin adhesive film remains intact. Clinical studies were not conducted to demonstrate microbial barrier properties.

DERMABOND PRINEO also incorporates a self-adhering mesh that is applied to the approximated skin edges to provide temporary skin edge alignment of incisions up to 20 cm in length until the liquid topical skin adhesive is applied to achieve skin closure.

The provided text describes the DERMABOND™ PRINEO™ Skin Closure System, a topical skin adhesive. However, it does not contain a typical acceptance criteria table with performance metrics that would be applicable to an AI/ML device or diagnostic tools in the requested format. Instead, it details the regulatory submission and the overall safety and effectiveness assessment for a medical device.

Therefore, many of the requested sections related to traditional diagnostic performance studies (like sample sizes for test/training sets, expert ground truth, MRMC studies, standalone performance, and ground truth establishment methods) are not explicitly present in the provided documentation for this specific device. The information focuses on bench testing, biocompatibility, and substantial equivalence to a predicate device, rather than diagnostic accuracy or AI performance.

Here's an attempt to extract and interpret the information based on the provided text, primarily focusing on the type of study conducted for this specific medical device rather than an AI/ML diagnostic:

Acceptance Criteria and Study for DERMABOND™ PRINEO™ Skin Closure System

Given that this is a 510(k) summary for a topical skin adhesive, the "acceptance criteria" and "study" are framed around demonstrating substantial equivalence to a predicate device and ensuring the safety and effectiveness of the new size variant (up to 20 cm incision length) through nonclinical design verification and biocompatibility testing. There are no explicit performance metrics in the format of "acceptance criteria" with numerical targets and "reported device performance" against those targets as would be expected for a diagnostic device. Instead, the "acceptance criteria" can be inferred as successful completion of various bench and in-vivo tests, demonstrating equivalence and meeting established safety standards.

1. Table of Acceptance Criteria and Reported Device Performance

As explicit numerical acceptance criteria were not listed, this table reflects the types of tests performed and the general outcome of demonstrating conformance and substantial equivalence.

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

• Test Set Sample Size: The document does not specify exact sample sizes for each bench test (e.g., number of tensile strength tests, number of peel tests). For the "14 day Porcine Effectiveness Study," the sample size is not stated.
• Data Provenance: The studies are described as "nonclinical design verification" and "in vivo" (porcine model). These are likely conducted internally by Ethicon or contract labs. The "Biocompatibility/In vivo" tests are standard regulatory tests. There is no information regarding country of origin for the data (other than Ethicon being a US company) or whether it was retrospective or prospective in the sense of human clinical trials. The porcine study would be prospective in its design.

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

This section is not applicable (N/A) as the submission details bench and animal (porcine) studies, not studies involving human expert interpretation for ground truth, which is typical for AI/ML diagnostic devices. The "ground truth" for these tests would be the measured physical properties or biological responses against established material and biological safety standards.

4. Adjudication Method for the Test Set

N/A. This is not a human interpretation study requiring adjudication. The results of the physical and biological tests are objective measurements.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done, What was the Effect Size of How Much Human Readers Improve with AI vs without AI Assistance

N/A. This device is a topical skin adhesive, not an AI/ML diagnostic tool, and therefore, an MRMC study comparing human reader performance with and without AI assistance is not relevant or applicable.

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

N/A. This device is not an algorithm or AI. It is a physical medical device.

7. The Type of Ground Truth Used

The "ground truth" for this device's testing is best described as:

• Physical and Mechanical Measurement Standards: For tests like Peel, Tensile Strength, Viscosity, Creep, etc., the ground truth corresponds to accepted engineering and material science standards and specifications for performance.
• Biological Safety Standards: For Biocompatibility tests (Cytotoxicity, Irritation, Sensitization, etc.), the ground truth relies on established ISO 10993 standards for biological evaluation of medical devices.
• Animal Model Observations: For the "14 day Porcine Effectiveness Study," the ground truth would be direct observation of wound approximation and healing in the animal model, assessed by researchers or veterinarians against clinical endpoints (e.g., wound integrity, closure success).

8. The Sample Size for the Training Set

N/A. This device does not involve a "training set" in the context of AI/ML or a diagnostic model that learns from data.

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

N/A. As there is no training set, this question is not applicable.

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