(242 days)
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.
| Category | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|
| Indications for Use | Must be align with the predicate device and be substantiated by performance evaluations. | "The 'Indication Statement' for the VF Gel Plus is substantiated by the results of the performance evaluations and comparison testing to the predicate device." |
| Technological Characteristics | Must be substantially equivalent in design, materials, and fundamental scientific technology. | "The VF Gel Plus is substantially equivalent in design, materials and fundamental scientific technology to the predicate device." |
| Overall Safety & Effectiveness | Must not raise new issues regarding safety or effectiveness compared to the predicate device. | "No new issues of safety or effectiveness were raised for the VF Gel Plus Device. Therefore, safety and effectiveness are reasonably assured..." |
| Durability | Intended to be durable for a minimum of one month. | "The product is intended to be durable for a minimum of one month." |
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.
§ 874.3620 Ear, nose, and throat synthetic polymer material.
(a)
Identification. Ear, nose, and throat synthetic polymer material is a device material that is intended to be implanted for use as a space-occupying substance in the reconstructive surgery of the head and neck. The device is used, for example, in augmentation rhinoplasty and in tissue defect closures in the esophagus. The device is shaped and formed by the suregon to conform to the patient's needs. This generic type of device is made of material such as polyamide mesh or foil and porous polyethylene.(b)
Classification. Class II.