(119 days)
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.
| Test Category | Specific Test Type | Acceptance Criteria (Not Explicitly Stated) | Reported Device Performance (Summary) |
|---|---|---|---|
| Biocompatibility/In vivoTesting | Irritation (Intracutaneous Reactivity) | (Presumed to meet ISO 10993-1:2009 standards) | Conforms to requirements; no new safety/performance issues |
| Irritation (Modified ISO Skin) | (Presumed to meet ISO 10993-1:2009 standards) | Conforms to requirements; no new safety/performance issues | |
| Sensitization (ISO Guinea Pig Maximization) | (Presumed to meet ISO 10993-1:2009 standards) | Conforms to requirements; no new safety/performance issues | |
| 14 day Porcine Effectiveness Study | (Details of effectiveness criteria not provided) | Conforms to requirements; no new safety/performance issues | |
| Bench Testing | Creep Strength | (Details of criteria not provided) | Conforms to requirements; no new safety/performance issues |
| Peel Strength- mesh only (N/cm) | (Details of criteria not provided) | Conforms to requirements; no new safety/performance issues | |
| Peel adhesion Strength-Mesh with adhesive (N/cm) | (Details of criteria not provided) | Conforms to requirements; no new safety/performance issues | |
| Wound/Tissue holding Strength (Ibf) | (Details of criteria not provided) | Conforms to requirements; no new safety/performance issues | |
| Set Time (Seconds) | (Details of criteria not provided) | Conforms to requirements; no new safety/performance issues | |
| Set Temperature (°C) | (Details of criteria not provided) | Conforms to requirements; no new safety/performance issues |
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.
§ 878.4011 Tissue adhesive with adjunct wound closure device for topical approximation of skin.
(a)
Identification. A tissue adhesive with adjunct wound closure device intended for the topical approximation of skin is a device indicated 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. It may 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 wound during application of the liquid adhesive.(b)
Classification. Class II (special controls). The special control for this device is FDA's “Guidance for Industry and FDA Staff; Class II Special Controls Guidance Document: Tissue Adhesive with Adjunct Wound Closure Device Intended for the Topical Approximation of Skin.” See § 878.1(e) for the availability of this guidance document.