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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.

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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.

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.

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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.

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