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Calcium Hydroxylapatite Vocal Fold Implant is indicated for vocal fold medialization and vocal fold insufficiency that may be improved by injection of a soft tissue-bulking agent. Calcium Hydroxylapatite Vocal Fold Implant 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.

Device Description

Calcium Hydroxylapatite Vocal Fold Implant is a ready to use product. Calcium Hydroxylapatite Vocal Fold Implant is comprised of calcium hydroxylapatite particles, blended into an aqueous gel formulated from sodium carboxymethyicellulose, glycerin, and a phosphate buffer. The gel acts as a carrier for the particles to facilitate placement. The main component of Calcium Hydroxylapatite Vocal Fold Implant is synthetic calcium hydroxylapatite, a material with over thirty years of use as an implant material used in orthopedics, neurosurgery, dentistry, otolaryngology, plastic surgery and ophthalmology. Calcium hydroxylapatite is also the main mineral component found in bones and teeth so it is a major component of the body. The calcium hydroxylapatite meets the requirements of ASTM F1185. The carrier consists of glycerin (USP) sodium carboxymethylcellulose (USP) and phosphate buffer (USP). The carrier resorbs in vivo, so that the calcium hydroxylapatite remains at the site of implantation, providing a scaffold for local tissue infiltration. This cellular infiltrated hydroxylapatite scaffold provides the longterm restoration and augmentation.

AI/ML Overview

Here's an analysis of the provided text regarding the acceptance criteria and study for the Calcium Hydroxylapatite Vocal Fold Implant:

1. Table of Acceptance Criteria and Reported Device Performance

Based on the provided text, no specific, quantifiable acceptance criteria (e.g., specific performance metrics, thresholds for success) for the device are detailed. The submission primarily focuses on establishing substantial equivalence to a predicate device rather than fulfilling pre-defined performance criteria through a separate clinical trial with specific endpoints.

The reported device performance is largely qualitative and comparative:

Acceptance Criterion (implicitly by substantial equivalence to predicate)	Reported Device Performance
Intended Use Equivalence: Vocal fold medialization and vocal fold insufficiency	Met: "Calcium Hydroxylapatite Vocal Fold Implant is indicated for vocal fold medialization and vocal fold insufficiency that may be improved by injection of a soft tissue-bulking agent." It also states, "The Calcium Hydroxylapatite Vocal Fold Implant is identically and physically to the predicate and has the identical intended use as the predicate device."
Technological Characteristics Equivalence: Composition, particle size, mechanism of action	Met: "Calcium Hydroxylapatite Vocal Fold Implant is a paste of calcium hydroxylapatite (calcium phosphate) particles in a gel carrier, identical to the predicate K070090 (Radiesse Laryngeal Implant))." "The principle component... 25 to 45 microns, to the calcium hydroxylapatite used in the predicate." "This is the same mechanism of action as the predicate device."
Biocompatibility: Non-irritant, non-toxic, no long-term safety concerns	Met: "The battery of preclinical safety studies and animal implant studies show that the Calcium Hydroxylapatite Vocal Fold Implant is biocompatible when injected into soft tissues." "Results identified the Calcium Hydroxylapatite Vocal Fold Implant as a nonirritant, nontoxic, with no concerns for long-term safety."
Sterilization: Sterile product	Met: "Calcium Hydroxylapatite Vocal Fold Implant will be sterilized using steam in accordance with ISO 17665."
Device Function: Augments vocal fold size, tissue infiltration	Met: "Calcium Hydroxylapatite Vocal Fold Implant injection augments the size of the displaced or deformed vocal fold..." "The calcium hydroxylapatite particles provide a non-resorbable scaffold for tissue infiltration." This is explicitly stated to be the "same mechanism of action as the predicate device."
Safety: Risk assessment according to ISO 14971	Met: "The primary risks with Calcium Hydroxylapatite Vocal Fold Implant have been identified through a risk assessment procedure in accordance with ISO 14971."

2. Sample Size Used for the Test Set and Data Provenance

The document does not describe a clinical "test set" in the context of a performance study with human subjects for the Calcium Hydroxylapatite Vocal Fold Implant. The primary evidence presented is comparison to a predicate device and pre-clinical (in vitro and animal) studies.

Pre-clinical tests: In vivo and in vitro tests were performed for biocompatibility. No specific sample sizes (e.g., N for animal studies or specific in-vitro replicates) are provided.
Data Provenance: The biocompatibility studies cited are "preclinical safety studies and animal implant studies" (source not specified further, but assumed to be internal or from contract labs) and "in vivo and in vitro tests" (source not specified). There's no mention of country of origin for this data or if it was retrospective or prospective in the context of a clinical trial.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

Not applicable. The submission does not describe a test set requiring expert-established ground truth for performance evaluation in the way a diagnostic AI would (e.g., reading images). The "ground truth" for the device's properties (biocompatibility, material composition, mechanism of action) comes from established scientific principles, ASTM standards (F1185 for the material), and laboratory testing.

4. Adjudication Method for the Test Set

Not applicable, as there is no described test set with human assessments 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 an implantable material, not an AI-assisted diagnostic or therapeutic tool for human readers. Therefore, an MRMC study is not relevant to its regulatory submission.

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

Not applicable. The device is a physical implant, not an algorithm.

7. The Type of Ground Truth Used

The "ground truth" used for this submission is based on:

Material Science and Chemistry: Adherence to ASTM F1185 for calcium hydroxylapatite.
Biocompatibility Testing: Results from in vivo and in vitro tests, as well as animal implant studies.
Sterilization Standards: Conformance to ISO 17665.
Risk Management Standards: Adherence to ISO 14971.
Predicate Device Equivalence: The primary ground truth for its intended use, mechanism of action, and safety profile is implicitly the established track record and regulatory approval of the legally marketed predicate device (K070090, Radiesse Laryngeal Implant).

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.

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