(22 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 an insertion tool/cover and a bioabsorbable implant. The device implant consists of fixation tines attached to an anchoring leash. This device along with its insertion tools are supplied sterile for single use only.
Here's an analysis of the provided text regarding the ENDOTINE Ribbon™ device, structured to address your specific questions.
1. Table of Acceptance Criteria and Reported Device Performance
The provided 510(k) summary does not explicitly state specific, quantifiable acceptance criteria in terms of numerical thresholds for device performance. Instead, it relies on a qualitative assessment of "substantial equivalence" to predicate devices and adherence to general standards.
However, based on the text, we can infer the broad performance and safety "criteria" that were considered met.
| Acceptance Criteria (Inferred) | Reported Device Performance |
|---|---|
| Safety and Effectiveness (General) | "The ENDOTINE Ribbon™ Device is safe and appropriate for the intended use." |
| "No new issues of safety or effectiveness were raised for the ENDOTINE Ribbon™ Device." | |
| "Therefore, safety and effectiveness are reasonably assured, justifying 510(k) clearance for commercial sale." | |
| Similarity to Predicate Devices | "Its similarity to the predicate devices." |
| "The ENDOTINE Ribbon™ is substantially equivalent in design, materials and fundamental scientific technology to the ENDOTINE Ribbon™." (This appears to be a typo in the original document, likely meaning "to predicate devices") | |
| "The technological characteristics of the ENDOTINE Ribbon™ are similar to many absorbable, implantable general, orthopedic and plastic surgery devices legally distributed by other manufacturers." | |
| "Any differences between the ENDOTINE Ribbon™ and the predicate devices are minor and do not raise issues regarding safety or effectiveness." | |
| Exceeding User Specifications and USP Standards | "A design pathway that included extensive cadaver modeling and evaluations which exceeded user specifications and USP Standards for absorbable surgical sutures." |
| Fulfilling Device Requirements (User Specifications) | "The ENDOTINE Ribbon™ performance data meet the applicable standards and fulfill the device requirements as defined in the user specifications." |
| Indications for Use Substantiation | "The 'Indication Statement' for the ENDOTINE Ribbon™ is substantiated by the results of the performance evaluations and comparison testing to the predicate devices." |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify a numerical sample size for a formal "test set" in the context of controlled clinical trials or efficacy studies. The performance evaluations mentioned are described as:
- "Extensive cadaver modeling and evaluations."
- "Comparison testing to the predicate devices."
The provenance of this data (e.g., country of origin, retrospective/prospective) is not detailed. The phrase "cadaver modeling and evaluations" suggests laboratory-based testing rather than live human studies, and it appears to be a preclinical evaluation.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
The document mentions:
- "Feedback and user observation from several leading surgeons."
It does not specify the exact number of surgeons or their detailed qualifications (e.g., specific years of experience, subspecialty). These "experts" appear to have provided qualitative feedback rather than establishing a formal "ground truth" for a statistical test set.
4. Adjudication Method for the Test Set
No formal adjudication method (e.g., 2+1, 3+1) is described for a test set. The expert involvement appears to be in the form of "feedback and user observation," suggesting a more informal process rather than a structured adjudication panel for establishing ground truth on a specific dataset.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
No MCRM comparative effectiveness study was done or reported in this document. The submission is a 510(k) for substantial equivalence, which primarily relies on comparing the new device to existing predicate devices based on design, materials, and intended use, along with some performance testing. It does not involve assessing the improvement of human readers with AI assistance, as AI is not a component of this device.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
The ENDOTINE Ribbon™ is a medical device (bioabsorbable implant with insertion tool) and does not contain any AI algorithms. Therefore, a standalone algorithm performance study is not applicable and was not performed.
7. The Type of Ground Truth Used
The concept of "ground truth" in the context of a diagnostic or AI algorithm study is not directly applicable here. For this device, "truth" is established by:
- Demonstrating substantial equivalence to legally marketed predicate devices.
- Meeting "user specifications" and "USP Standards for absorbable surgical sutures" (likely referring to material properties, strength, absorption rate, etc.).
- "Extensive cadaver modeling and evaluations" for mechanical performance and design validation.
- "Feedback and user observation from several leading surgeons" confirming usability and perceived performance.
Essentially, the "ground truth" is inferred from these various forms of evidence aligning with established standards and predicate device characteristics, rather than a single, defined "ground truth" dataset.
8. The Sample Size for the Training Set
The document does not mention a training set as this device is not an AI or algorithmic device that requires training. The design process included "extensive cadaver modeling and evaluations," which could be considered a form of developmental "training" for the device's design, but not in the machine learning sense of a "training set."
9. How the Ground Truth for the Training Set Was Established
As there is no mention of a training set for an algorithm, the concept of establishing ground truth for it is not applicable. The design verification process involved cadaver studies and comparison to predicate devices, where the "truth" would be successful performance against engineering and biological requirements.
§ 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.