Search Results

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.

Ask a specific question about this device

The PROXISURE™ Suturing Device, ETHIBOND™ Suture Cartridge, and Coated VICRYL™ Suture Cartridge are indicated for suturing in minimally invasive surgeries. Applications are for the placement of interrupted or running stitches in soft tissue.

The PROXISURE™ Suturing Device and ETHIBOND™ Suture Cartridge are indicated for suturing in minimally invasive surgeries. Applications are for the placement of interrupted or running stitches in soft tissue.

The PROXISURE™ Suturing Device and Coated VICRYL™ Suture Cartridge are indicated for suturing in minimally invasive surgeries. Applications are for the placement of interrupted or running stitches in soft tissue.

The PROXISURE™ Suturing System is composed of a reusable PROXISURE™ Suturing Device and single-use, sterile Suture Cartridges that are used for placement of interrupted or running stitches in soft tissue. The Suturing Device has a stationary shaft that has an articulating and rotating end effector. The device is reusable and must be cleaned and sterilized by the end user per the cleaning, disinfection, and sterilization instructions provided in the Instructions for Use before and between uses. A Suture Cartridge is loaded at the distal tip of the end effector which contains the needle and suture for use during the surgical procedures.

The PROXISURE ™ Suture Cartridges are designed for use with the PROXISURE™ Suturing Device and are available with two types of sutures in three sizes each. The suture material is commercially available Coated VICRYL™ and ETHIBOND EXCEL™ sutures. ETHIBOND™ Suture is dyed green with D&C Green #6 (Color Index No. 61565) to enhance visibility in the surgical field. ETHIBOND Suture complies with the requirements of the European Pharmacopoeia (Ph. Eur.) for sterile poly(ethylene terephthalate) Suture and the United States Pharmacopoeia (USP) for Non-Absorbable Surgical Sutures. Coated VICRYL™ Sutures that come with the Suture Cartridge are dyed by adding D+C violet #2 (Color Index number: 60725) during polymerization. Coated VICRYL™ Suture complies with the requirements of the European Pharmacopoeia (Ph. Eur.) and the United States Pharmacopoeia (USP) for Sterile Synthetic Absorbable Braided Sutures, except for an occasional slight oversize in the gauges for the suture cartridge. The PROXISURE™ Suturing Device and the Suture Cartridges are packaged separately and will be available for assembly prior to use at the surgical site.

This document is a 510(k) Pre-market Notification from the FDA for the PROXISURE Suturing Device and its associated Suture Cartridges. It focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study for meeting acceptance criteria for a novel AI or diagnostic device. Therefore, much of the requested information regarding acceptance criteria, study design, ground truth, and expert involvement is not applicable or cannot be extracted from this type of regulatory document.

However, I can provide information based on the performance data presented in the summary, which states that bench testing was performed to verify the performance of the subject device meets the definition of substantial equivalence to the predicate device and the device will perform as intended.

Here's a breakdown of what can and cannot be answered from the provided text:

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

Explanation: The document does not provide specific quantitative acceptance criteria or detailed quantitative results. Instead, it states that
Bench testing was performed to verify the performance of the subject device meets the definition of substantial equivalence to the predicate device and the device will perform as intended.
This implies that the acceptance criteria were based on demonstrating comparable performance to the predicate device in these specific areas.

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: Not specified. The document only mentions "bench testing."
• Data Provenance: Not specified, but generally, bench testing is conducted in a laboratory setting, not typically tied to a specific country of origin in the same way clinical data would be. It is not retrospective or prospective clinical data.

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 question is not applicable to this document. The "ground truth" concept is more relevant for diagnostic or AI devices where a definitive expert-determined label or outcome is needed. For mechanical device bench testing, "ground truth" is typically defined by engineering specifications and objective measurements, not subjective expert assessment of an outcome in the same way.

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

• This question is not applicable to this document. Adjudication methods are used in studies involving human interpretation or clinical outcomes where discrepancies need to be resolved. Bench testing of a mechanical device does not typically involve such 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

• No, an MRMC comparative effectiveness study was not done. This type of study is specifically for evaluating the impact of AI on human reader performance, which is not relevant to a mechanical suturing device.

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

• This question is not applicable to this document. This refers to the standalone performance of an AI algorithm. The PROXISURE Suturing Device is a mechanical device, not an AI or algorithm. The "bench testing" described is for the mechanical function of the device, which is its standalone performance.

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

• Type of Ground Truth: For the bench testing described, the "ground truth" would be established by engineering specifications, material science properties, and objective physical measurements against predefined performance standards or in comparison to the predicate device's measured performance. It is not based on expert consensus, pathology, or outcomes data in the clinical sense.

8. The sample size for the training set

• Not applicable. This device is a mechanical suturing device, not an AI or machine learning model that requires a "training set."

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

• Not applicable. As above, there is no "training set" for this type of device.

Ask a specific question about this device