(266 days)
The VF LiquiGel 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 LiquiGel 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 LiquiGel 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.
The provided document is a 510(k) Premarket Notification for the VF LiquiGel device by Coapt Systems, Inc. This type of submission focuses on demonstrating substantial equivalence to a predicate device rather than providing extensive clinical study data (such as those for novel devices or PMAs) that would typically include detailed information on acceptance criteria and specific study outcomes in the way requested.
The document states that "The VF LiquiGel performance data meet the applicable standards and fulfill the device requirements as defined in the user specifications," but does not provide the specific acceptance criteria or detailed results of a study designed to prove the device meets those criteria. Instead, it relies on demonstrating substantial equivalence in design, materials, function, and intended use to a legally marketed predicate device (VF Gel, K080956).
Therefore, I cannot provide all the requested information because it is not contained within the provided text. The document is primarily a comparison to a predicate device to establish substantial equivalence.
Here's the information that can be extracted or inferred:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly present acceptance criteria for performance in a quantitative way. Instead, it compares characteristics of the VF LiquiGel to its predicate, VF Gel, and states equivalency. The "reported device performance" is essentially that it is "Equivalent" to the predicate in all assessed parameters, implying it meets the same functional and safety profiles.
| Parameter | VF Gel (Predicate) Performance / Acceptance | VF LiquiGel (Subject) Reported Performance | Comparison | Impact on Safety and Effectiveness |
|---|---|---|---|---|
| Indication for Use | Indicated for vocal fold medialization in treatment of vocal fold insufficiency; augments vocal fold size for improved glottal closure, phonation, cough, and airway protection. Temporary implant, durable for minimum one month. | Same | Equivalent | None |
| Target Population | Patients requiring temporary vocal fold medialization | Same | Equivalent | None |
| Surgical Approach | Percutaneous or transoral | Same | Equivalent | None |
| Design | Cohesive gel supplied in a syringe ready to use | Same | Equivalent | None |
| Materials | A gel of injection grade water, glycerin, mannitol, NaOH and Carbopol 974P NF | Same, with a slightly lower pH | Equivalent | None |
| Biocompatibility | Meets ISO 10993 | Same (Implied: Meets ISO 10993) | Equivalent | None |
| Materials Standards | NF/USP requirements | Same (Implied: Meets NF/USP requirements) | Equivalent | None |
| Mechanism of Action | Gel providing temporary space filling | Same | Equivalent | None |
| Human Factors/How Supplied | Supplied Sterile in a syringe premixed and ready for injection | Same | Equivalent | None |
| 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 | None |
| Sterility | Supplied sterile ready to use, Not to be resterilized | Same | Equivalent | None |
| Compatibility with other Devices | Syringe has Luer lock syringe that is compatible with needles with Luer fitting | Same | Equivalent | None |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document does not describe a clinical "test set" in the context of a prospective or retrospective study on patients using the VF LiquiGel. The evaluation is based on performance evaluations and comparison testing to the predicate device (Section 10.1, Substantial Equivalence Comparison, 1. Indications Summary; 3. Performance Summary), likely bench testing and material characterization, rather than a clinical study with a patient sample size. Therefore, there's no information on data provenance from human subjects or study design (retrospective/prospective).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
Not applicable. As there is no described clinical test set for this 510(k) submission, there are no experts establishing ground truth for such a set. The "ground truth" for substantial equivalence is based on regulatory and scientific comparison to the predicate device's established safety and effectiveness.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. There is no described clinical test set requiring adjudication.
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 a medical implant (a gel), not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
Not applicable. This device is a medical implant (a gel), not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" in this 510(k) context is the established safety and effectiveness profile of the predicate device (VF Gel, K080956) and the scientific understanding of the materials and mechanism of action, validated through material characterization and biocompatibility testing (meeting ISO 10993 and NF/USP requirements). No clinical outcomes data for the subject device are presented to establish ground truth.
8. The sample size for the training set
Not applicable. This is not an AI/machine learning device. The "training set" doesn't apply here.
9. How the ground truth for the training set was established
Not applicable. This is not an AI/machine learning 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.