(193 days)
Vocalis Gel is indicated for vocal fold medialization and vocal fold insufficiency that may be improved by injection of a soft tissue bulking agent. Vocalis 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 phonation. Vocal fold insufficiency associated with serious aspiration difficulties may be an urgent indication. The product is intended to be durable for a minimum of one month.
Sterile, latex free, non-pyrogenic, high yield strength, isotonic, clear gel injectable implant. The gel consists primarily of sterile water for injection (USP), glycerin (USP) and mannitol (USP). The high yield strength is created by small amounts of carbomer (USP). The gel carrier allows tissue infiltration over time. All components are listed as GRAS (Generally Recognized as Safe 21 CFR 182). The character of the gel allows it to be very thick and cohesive but sheer to be easily injected through very fine needles with minimal force.
Here's an analysis of the provided text regarding the acceptance criteria and supporting studies for the Vocalis Gel device.
Acceptance Criteria and Device Performance for Vocalis Gel
Unfortunately, the provided document does not explicitly state specific acceptance criteria (e.g., numerical targets for performance metrics) for Vocalis Gel.
Instead, the document focuses on demonstrating substantial equivalence to predicate devices and fulfilling general regulatory requirements for medical devices. The primary "performance" is implicitly demonstrated through biocompatibility, sterilization, and pre-clinical safety assessments.
The device's intended effect, "vocal fold medialization and vocal fold insufficiency that may be improved by injection of a soft tissue bulking agent...to meet the opposing fold at the midline for improved phonation" and being "durable for a minimum of one month," are clinical outcomes rather than quantifiable device performance metrics presented in this 510(k) summary.
Based on the available information, the closest approximation to "acceptance criteria" and "reported device performance" are as follows:
| Acceptance Criteria (Inferred from 510(k) process) | Reported Device Performance (Summary of results) |
|---|---|
| Biocompatibility: Device must be biocompatible when injected into soft tissues. | "The battery of preclinical safety studies and animal implant studies show that Vocalis Gel is biocompatible when injected into soft tissues." |
| Safety - Non-irritant: Device must not cause irritation. | "Results identified Vocalis Gel as a non-irritant..." |
| Safety - Non-toxic: Device must not be toxic. | "...and nontoxic with no concerns for long-term safety." |
| Sterility Assurance Level (SAL): Sterilization process must achieve a 10⁻⁶ SAL. | "Cycle parameters were validated using an overkill methodology to 10⁻⁶ SAL." |
| Mechanical Properties: Gel must be capable of being easily injected through fine needles with minimal force. (Implied by description: "the character of the gel allows it to be very thick and cohesive but sheer to be easily injected through very fine needles with minimal force.") | "The character of the gel allows it to be very thick and cohesive but sheer to be easily injected through very fine needles with minimal force." |
| Primary Risks: Identified risks must be associated with nasopharyngoscopy and injection laryngoplasty (as typical for the procedure). | "The risks identified are primarily associated with nasopharyngoscopy and injection laryngoplasty." |
Study Details Proving Device Meets Acceptance Criteria:
The provided document describes pre-clinical tests rather than a study with a defined "test set" or "ground truth" as might be seen for diagnostic AI devices.
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Sample size used for the test set and the data provenance:
- Test Set Sample Size: Not specified in terms of number of subjects or samples. The document refers to "in vivo and in vitro tests" and "animal implant studies" but does not give specific numbers for these.
- Data Provenance: Not explicitly stated (e.g., country of origin). The studies appear to be laboratory-based pre-clinical (in vitro and in vivo animal) rather than human clinical data. They are retrospective in the sense that they were conducted before the 510(k) submission.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This concept is not applicable to the type of pre-clinical studies described. Ground truth, in this context, would be established by scientific methods and validated assays (e.g., cytotoxicity assays, irritation tests, histological analysis for biocompatibility in animal models) performed by trained laboratory personnel or specialists in relevant fields (e.g., toxicology, pathology). There is no mention of "experts" in the sense of clinical reviewers adjudicating results for the pre-clinical tests.
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Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable. This concept pertains to human review of data, typically in diagnostic or qualitative assessment studies. The pre-clinical tests described would be evaluated based on objective scientific measurements and established criteria for toxicity, irritation, etc.
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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. Vocalis Gel is an injectable medical device, not a diagnostic imaging or AI-assisted system for human readers. Therefore, an MRMC study is not relevant to its evaluation.
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If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- Not applicable. This refers to AI algorithm performance. Vocalis Gel is a physical medical device.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- For biocompatibility: Histological analysis from animal implants, and various laboratory assays (e.g., cytotoxicity, hemocompatibility).
- For irritation, sensitization, acute and sub-chronic toxicity, genotoxicity, and hemolysis: Standardized in vivo (animal) and in vitro (cell culture, biochemical) assays with pre-defined endpoints and controls.
- For sterility: Biological indicators and physical parameters measured during the sterilization cycle to confirm a 10⁻⁶ SAL.
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The sample size for the training set:
- Not applicable. This device does not involve a "training set" in the context of machine learning or AI.
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How the ground truth for the training set was established:
- Not applicable. See point 7.
In summary, the provided document for Vocalis Gel focuses on demonstrating the device's safety, biocompatibility, and manufacturing quality through pre-clinical laboratory and animal studies, rather than clinical performance metrics with specific numerical acceptance criteria typically seen for diagnostic devices or those with direct, quantifiable output. The acceptance is based on demonstrating substantial equivalence to predicate devices and fulfilling these fundamental safety and sterilization requirements.
§ 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.