(28 days)
The ENDOTINE Ribbon™ is indicated for use in subperiosteal midface suspension surgery to fixate the cheek subdermis in an elevated position.
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.
The provided text is a 510(k) summary for the ENDOTINE Ribbon™, a medical device. This document focuses on demonstrating substantial equivalence to a predicate device rather than presenting a detailed study with specific acceptance criteria and performance metrics for the device itself. Therefore, many of the requested details about a study proving acceptance criteria are not available in this particular document.
Here's a breakdown of the available information:
1. Table of Acceptance Criteria and Reported Device Performance
This document does not provide a table of acceptance criteria or specific reported device performance metrics in the way that would be found in a clinical study report. The 510(k) process for this device relies on demonstrating substantial equivalence to a previously cleared predicate device, rather than proving performance against specific quantitative criteria. The statement, "The Modified Device meets all internal functional performance requirements," is the closest the document comes to mentioning performance.
2. Sample Size Used for the Test Set and Data Provenance
This information is not available in the provided 510(k) summary. The submission is a regulatory filing for market clearance based on substantial equivalence, not a report of a new clinical study with a test set of data.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts
This information is not available in the provided 510(k) summary. Given the absence of a distinct test set and associated ground truth establishment process, this detail is not relevant to this submission.
4. Adjudication Method for the Test Set
This information is not available in the provided 510(k) summary.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance
This information is not available and is not applicable to this device. The ENDOTINE Ribbon™ is a bioabsorbable surgical implant for soft tissue fixation, not an AI-powered diagnostic or assistive tool. Therefore, a study comparing human reader performance with and without AI assistance would not be relevant.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done
This information is not available and is not applicable to this device. As mentioned, this is a physical implant, not an algorithm or AI system.
7. The Type of Ground Truth Used
This information is not available in the provided 510(k) summary.
8. The Sample Size for the Training Set
This information is not available in the provided 510(k) summary. This device is not an AI/ML product that would require a training set in the conventional sense.
9. How the Ground Truth for the Training Set Was Established
This information is not available in the provided 510(k) summary. This is not an AI/ML product.
Summary of Device and Regulatory Context based on the provided text:
The ENDOTINE Ribbon™ is a bioabsorbable implant pre-loaded on an insertion tool, intended for subperiosteal midface suspension surgery to fixate the cheek subdermis in an elevated position.
The manufacturer, Coapt Systems, Inc., sought 510(k) clearance by demonstrating substantial equivalence to their previously marketed device, the ENDOTINE Midface™ ST 4.5 Device (K032698).
The core of the submission states: "Based on the design, materials, fundamental technology, intended use, and performance specifications, Coapt Systems believes the proposed ENDOTINE Ribbon™ is substantially equivalent to the unmodified predicate device... Therefore, safety and effectiveness are reasonably assured, justifying 510(k) clearance for commercial sale."
The FDA's letter confirms that they "have determined the device is substantially equivalent... to legally marketed predicate devices." This means the regulatory body accepted the manufacturer's claim of equivalence, implying that the safety and effectiveness of the ENDOTINE Ribbon™ are considered comparable to a device already on the market, rather than requiring a new, independent study to establish specific acceptance criteria and performance against those criteria.
§ 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.