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The VF Gel is indicated for vocal fold medialization in the treatment of vocal fold insufficiency, where insufficiency may be improved by injection of a soft tissue bulking agent. VF Gel injection augments the size of the displaced or deformed vocal fold so that it may meet the opposing fold at the midline for improved glottal closure. Improved glottal closure may allow improved phonation, improvement of cough, and an improved ability to protect the airway during swallowing. VF Gel is a temporary implant that degrades over time. The product is intended to be durable for a minimum of one month.

Sterile, latex free, non-pyrogenic, highly thixotropic, high yield strength clear gel with a neutral pH. The durability of the gel is due to slow degradation of the synthetic gel carrier. The thixotropic character of the gel allows it to be a very thick and cohesive gel but able to be injected through very fine needles with minimal force.

This document describes a 510(k) summary for a medical device called "VF Gel." The summary focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study to prove acceptance criteria with specific performance metrics. Therefore, many of the requested data points (e.g., sample sizes for training/test sets, ground truth establishment, expert qualifications, MRMC studies, standalone performance) are not applicable or available in this type of submission.

Here's a breakdown of the information that can be extracted from the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

The submission does not present a table of quantitative acceptance criteria or specific device performance metrics in the way one might expect for an AI/algorithm-based device. Instead, the "acceptance criteria" are implied by the demonstration of "substantial equivalence" to a predicate device, meaning the new device (VF Gel) is as safe and effective as the legally marketed predicate. The "reported device performance" is essentially that it meets the requirements of a substantially equivalent device.

The table below summarizes the comparison of "VF Gel Plus" (the subject device) to "VF Gel" (the predicate device) from Table 7: Substantial Equivalence Summary, which outlines the characteristics compared to establish equivalence. The "Impact on Safety and Effectiveness" column effectively serves as the "reported device performance" in this context, indicating that the new device does not raise new safety or effectiveness concerns.

2. Sample size used for the test set and the data provenance:

• Sample Size for Test Set: This information is not provided in the 510(k) summary. The submission focuses on a comparison of characteristics to a predicate device, not a performance study with a test set of patient data.
• Data Provenance: This information is not provided. As it's a device for vocal fold medialization, any "performance evaluations and comparison testing" mentioned are likely preclinical (e.g., benchtop, material characterization), or may refer to clinical experience with the predicate device, but specific data provenance for a test set is absent.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

• This information is not applicable/not provided. The submission does not detail a study involving expert-established ground truth for a test set in the context of an AI/algorithm. The "ground truth" for this medical device's approval is based on its physical and functional equivalence to a legally marketed predicate device.

4. Adjudication method for the test set:

• This information is not applicable/not provided. There is no described test set or expert adjudication process for such a test set.

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:

• This information is not applicable/not provided. This is a submission for a physical medical implant (gel), not an AI/algorithm. Therefore, an MRMC study related to AI assistance is irrelevant.

6. If a standalone (i.e. algorithm only, without human-in-the-loop performance) was done:

• This information is not applicable/not provided. This is a physical medical device, not an algorithm.

7. The type of ground truth used:

• The "ground truth" in this context is the established safety and effectiveness of the predicate device. The VF Gel's "ground truth" is that its design, materials, function, and intended use are similar enough to the predicate device that it can be considered substantially equivalent. This is based on material properties, biocompatibility, and functional evaluations rather than expert consensus on patient outcomes or pathology from a dataset.

8. The sample size for the training set:

• This information is not applicable/not provided. This is a physical medical device, not an AI/algorithm that requires a training set.

9. How the ground truth for the training set was established:

• This information is not applicable/not provided. As above, there is no training set for a physical device.

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The VF Gel Plus is indicated for vocal fold medialization in the treatment of vocal fold insufficiency, where insufficiency may be improved by injection of a soft tissue bulking agent. VF Gel Plus injection augments the size of the displaced or deformed vocal fold so that it may meet the opposing fold at the midline for improved glottal closure. Improved glottal closure may allow improved phonation, improvement of cough, and an improved ability to protect the airway during swallowing. VF Gel Plus is a temporary implant that degrades over time. The product is intended to be durable for a minimum of one month.

Sterile, latex free, non-pyrogenic, semi-solid, cohesive subdermal implant. The principal durable component is synthetic calcium hydroxylapatite. The semi-solid nature is created by suspending the calcium hydroxylapatite particles in a high yield strength thixotropic gel. The isotonic gel carrier consists primarily of sterile water for injection (USP), glycerin (USP) and mannitol (USP). The thixotropic high yield strength gel is created by the carbomer (NF). The calcium hydroxylapatite particles are 25 to 45 microns in size while being smooth but irregular in shape and are present in the product at 30% by volume.

The provided text describes a 510(k) summary for a medical device called "VF Gel Plus." It focuses on establishing substantial equivalence to a predicate device rather than presenting a study with acceptance criteria and device performance metrics in the way one might find for an AI/ML device or a diagnostic accuracy study.

Therefore, many of the requested elements (e.g., sample size for test set, number of experts, adjudication method, MRMC study, standalone performance, training set details) are not applicable or not present in the provided document, as it outlines a regulatory submission for a physical implant, not a data-driven model.

However, I can extract information related to the device's intended use and the general claim of performance based on comparison to a predicate device.

Here's a breakdown of the information that is available or derivable from the text:

1. A table of acceptance criteria and the reported device performance

The document does not specify quantitative acceptance criteria with corresponding device performance metrics in the traditional sense of a clinical trial for a diagnostic device. Instead, it claims substantial equivalence to a predicate device based on design, materials, function, intended use, and performance evaluations.

2. Sample size used for the test set and the data provenance

• Sample Size: Not specified. The document refers to "performance evaluations and comparison testing" but does not detail a specific test set size or methodology for a clinical study with a control group. This is common for 510(k) submissions for physical implants where equivalence is demonstrated through non-clinical testing (e.g., material compatibility, degradation) and comparison to the predicate's known clinical performance, rather than a new large-scale clinical trial.
• Data Provenance: Not specified.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

• Not Applicable. This type of information is relevant for studies involving human interpretation or data labeling, such as for AI/ML or diagnostic accuracy studies. The provided document is for a physical implant where ground truth would typically relate to material properties, biocompatibility, and functional outcomes in in vitro or in vivo (animal) models, or clinical observation, rather than expert consensus on a test set.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set

• Not Applicable. See point 3.

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 is a physical medical implant, not an AI-assisted diagnostic or decision support tool where "human readers" or AI assistance would be relevant.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done

• Not Applicable. This is a physical medical implant, not a standalone algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

• Implied Ground Truth: For this type of device, the "ground truth" would pertain to the physical and biological performance of the implant, such as:
  • Biocompatibility (e.g., no adverse tissue reactions)
  • Material properties (e.g., degradation rate, injectability, stability)
  • Functional outcome (e.g., ability to augment vocal fold, leading to improved phonation, cough, airway protection) – these are assessed clinically but the study demonstrating equivalence likely relies on laboratory/pre-clinical data and existing knowledge of the predicate.
• The document states "VF Gel Plus performance data meet the applicable standards and fulfill the device requirements as defined in the user specifications," implying that performance was measured against established benchmarks for similar devices.

8. The sample size for the training set

• Not Applicable. This is not an AI/ML device that requires a training set.

9. How the ground truth for the training set was established

• Not Applicable. This is not an AI/ML device that requires a training set.

In summary, the provided document is a 510(k) summary for a physical medical implant asserting substantial equivalence to an existing device. It does not contain the detailed study design, acceptance criteria, and performance metrics typically found in clinical trials for diagnostic devices or AI/ML products.

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