(23 days)
The ENDOTINE Ribbon™ is indicated for use in elevation and fixation of tissues in the temporal region, midface, lower face/jowl to the deep temporal fascia and the neck to the mastoid fascia during cosmetic procedures.
The ENDOTINE Ribbon™ consists of a bioabsorbable implant pre-loaded on an insertion tool. The device implant is a soft tissue fixation platform. The insertion tool and implant are sterilized together.
Here's an analysis of the provided text regarding the ENDOTINE Ribbon™ device, specifically focusing on the requested information.
It's important to note that this document is a 510(k) summary for a Special 510(k) Premarket Notification. Special 510(k)s are typically used for modifications to a manufacturer's own legally marketed device where the modifications do not affect the intended use or alter the fundamental scientific technology of the device. This usually means that extensive new clinical studies or detailed performance data comparing the new device to the predicate are not provided in the 510(k) summary itself, as the substantial equivalence is often based on the previous clearance and controlled design changes.
Therefore, much of the requested information regarding detailed study design, sample sizes for test/training sets, expert qualifications, and specific acceptance criteria with device performance results are not present in this type of summary. The primary claim here is substantial equivalence to a predicate device already on the market (K051415), which is also an ENDOTINE Ribbon™ from the same company.
Acceptance Criteria and Study to Prove the Device Meets Acceptance Criteria
1. Table of acceptance criteria and the reported device performance:
This 510(k) summary does not include a table of specific acceptance criteria or detailed reported device performance. The document states:
- "The Subject Device meets all internal functional performance requirements."
- "Based on the design, materials, fundamental technology, intended use, and performance specifications, Coapt Systems believes the proposed ENDOTINE Ribbon™ is substantially equivalent to the predicate device, the ENDOTINE Ribbon™ Device, currently marketed under the Federal Food, Drug and Cosmetic Act."
For a Special 510(k) like this, specific acceptance criteria and performance data are usually not provided in the summary. The "acceptance criteria" are generally that the modified device performs comparably to the predicate device and meets established internal design controls and functional requirements, which are often not explicitly detailed in the public 510(k) summary. The comparison is primarily focused on demonstrating that the modifications do not raise new questions of safety or effectiveness.
2. Sample size used for the test set and the data provenance:
- Sample Size for Test Set: Not specified in the provided document.
- Data Provenance: Not specified. Given the nature of a Special 510(k) for a modification, any testing would likely be internal (e.g., benchtop, mechanical, or limited animal/cadaver studies) rather than a full clinical trial. The document doesn't mention clinical data used specifically for "testing" this modified device, relying instead on substantial equivalence to the previously cleared predicate.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable/Not specified. This document does not describe a clinical study where experts established ground truth for a test set.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not applicable/Not specified. This document does not describe a clinical study with an adjudication method.
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 an absorbable surgical suture/fixation platform, not an AI-assisted diagnostic or imaging device. Therefore, MRMC studies and AI-related metrics are irrelevant here.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- Not applicable. This is not an algorithmic device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- Not applicable/Not specified. The assessment of this device for substantial equivalence relies on design, materials, manufacturing processes, fundamental technology, intended use, and performance specifications compared to its predicate. There isn't a "ground truth" in the diagnostic sense.
8. The sample size for the training set:
- Not applicable/Not specified. There is no mention of a "training set" as this is not an AI/machine learning device.
9. How the ground truth for the training set was established:
- Not applicable/Not specified.
Summary of Device and Approval Process based on the provided text:
- Device Name: ENDOTINE Ribbon™
- Manufacturer: Coapt Systems, Inc.
- Submission Type: Special 510(k) Premarket Notification (K060828)
- Submission Date: March 22, 2006
- Clearance Date: April 19, 2006
- Classification Name: Absorbable Surgical Suture
- Regulation Number: 21 CFR 878.4493
- Intended Use: Elevation and fixation of tissues in the temporal region, midface, lower face/jowl to the deep temporal fascia and the neck to the mastoid fascia during cosmetic procedures.
- Predicate Device: ENDOTINE Ribbon™ (K051415) by Coapt Systems, Inc.
- Basis for Clearance: Substantial equivalence to the predicate device, stating "no significant new issues of safety or effectiveness have been raised" and that the "Subject Device meets all internal functional performance requirements." This implies that while specific details aren't provided, internal company testing and analysis demonstrated that the modifications did not negatively impact the safety and effectiveness relative to the cleared predicate.
§ 878.4493 Absorbable poly(glycolide/l-lactide) surgical suture.
(a)
Identification. An absorbable poly(glycolide/l-lactide) surgical suture (PGL suture) is an absorbable sterile, flexible strand as prepared and synthesized from homopolymers of glycolide and copolymers made from 90 percent glycolide and 10 percent l-lactide, and is indicated for use in soft tissue approximation. A PGL suture meets United States Pharmacopeia (U.S.P.) requirements as described in the U.S.P. “Monograph for Absorbable Surgical Sutures;” it may be monofilament or multifilament (braided) in form; it may be uncoated or coated; and it may be undyed or dyed with an FDA-approved color additive. Also, the suture may be provided with or without a standard needle attached.(b)
Classification. Class II (special controls). The special control for this device is FDA's “Class II Special Controls Guidance Document: Surgical Sutures; Guidance for Industry and FDA.” See § 878.1(e) for the availability of this guidance document.