(22 days)
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.
| Parameter | VF Gel (Predicate) Performance (Implied Acceptance Criteria for Subject Device) | VF Gel Plus (Subject) Performance (as reported) | Comparison |
|---|---|---|---|
| Indication for Use | Vocal fold medialization in the treatment of vocal fold insufficiency, to augment vocal fold size for improved glottal closure, allowing improved phonation, cough, and airway protection during swallowing. Temporary implant, durable for a minimum of one month. | Same | Equivalent |
| Target Population | Patients requiring temporary vocal fold medialization | Same | Equivalent |
| Surgical Approach | Percutaneous | Same | Equivalent |
| Design | Cohesive gel supplied in a syringe ready to use | Same | Equivalent |
| Materials | A gel of injection grade water, glycerin, mannitol and Carbopol 974P NF | Same as VF Gel with the addition of calcium hydroxylapatite particles | Equivalent |
| Biocompatibility | Meets ISO 10993 | Same | Equivalent |
| Materials Standards | NF/USP requirements | Same | Equivalent |
| Mechanism of Action | Gel providing temporary space filling | Same | Equivalent |
| Human Factors/How Supplied | Supplied Sterile in a syringe premixed and ready for injection | Same | Equivalent |
| Human Factors/Quantity Supplied | Supplied pre-filled in a syringe filled to 0.5 and 1.3 cc for use in individual patients | Same | Equivalent |
| Sterility | Supplied sterile ready to use, Not to be resterilized | Same | Equivalent |
| Compatibility with other Devices | Syringe has Luer lock syringe that is compatible with needles with Luer fitting | Same | Equivalent |
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.
§ 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.