(50 days)
BioForm's Radiesse Laryngeal Implant is indicated for vocal fold medialization and vocal fold insufficiency that may be improved by injection of a soft tissue bulking agent. Radiesse Laryngeal 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.
Radiesse Laryngeal Implant is a sterile, non-pyrogenic injectable material consisting of calcium hydroxylapatite (CaHA) suspended in an aqueous formulation of USP grade pharmaceutical excipients consisting of sterile water, glycerin, and sodium carboxymethylcellulose, stabilized with a phosphate buffer. These excipients have prior and extensive use in intramuscular injectable pharmaceutical products including Cortone®, Decadron®, and Dalalone® drugs. Glycerin, sodium carboxymethylcellulose and phosphate buffer are listed in 21 CFR 182 as Generally Recognized as Safe (GRAS), Sections 182.1320, 182.1745, and 182.6285, respectively.
Calcium hydroxylapatite particles (30%-40% by volume) are combined with this aqueous formulation to create the implant media. The calcium hydroxylapatite meets ASTM F1185.
The provided text is a 510(k) summary for the Radiesse Laryngeal Implant. This documentation focuses on demonstrating substantial equivalence to predicate devices and detailing the device's biocompatibility, sterilization, and general safety. It does not contain information about specific clinical studies with acceptance criteria or performance metrics directly related to efficacy in human subjects.
Therefore, I cannot fulfill your request for:
- A table of acceptance criteria and reported device performance.
- Sample sizes for test set, data provenance, number of experts, adjudication methods, or ground truth for the test set.
- Information on multi-reader multi-case (MRMC) comparative effectiveness studies or standalone algorithm performance.
- Sample size for the training set or how ground truth was established for the training set.
The document primarily states:
Acceptance Criteria/Performance (Implied Safety/Equivalence):
- Biocompatibility: "The battery of prectinical safety studies and animal implant studies show that the Radiesse Laryngeal Implant is biocompatible when injected into soft tissues." (Section 4.6)
- Sterilization: Processed in-house using a computer-controlled autoclave system, validated to an "overkill methodology to 10-6 SAL." (Section 4.7)
- Pre-Clinical Safety: "In vivo and In vitro tests were performed to address cytotoxicity, sensitization, mutagenticity, and hemolysis. Results identified the Radiesse Laryngeal Implant as nontoxic with no concerns for long-term safety." (Section 4.8)
- Substantial Equivalence: The device is deemed substantially equivalent to predicate devices (K060812 Juliesse™ Injectable Laryngeal Augmentation Implant and K013243 Coaptite Laryngeal Augmentation System) for its stated intended use. This is the primary "acceptance criterion" for a 510(k) clearance.
Study that Proves Device Meets Acceptance Criteria:
The studies mentioned are:
- Preclinical Safety Studies: These included "animal implant studies," "in vivo and in vitro tests" for cytotoxicity, sensitization, mutagenicity, and hemolysis. (Sections 4.6, 4.8)
- Sterilization Validation: An "overkill methodology to 10-6 SAL" was used for steam sterilization. (Section 4.7)
Summary of available information based on your request:
| Field | Information from Document |
|---|---|
| Acceptance Criteria & Reported Device Performance | - Biocompatibility: Demonstrated as biocompatible in soft tissues via preclinical safety studies and animal implant studies. |
- Sterilization: Achieved 10-6 SAL (Sterility Assurance Level) through validated steam sterilization.
- Toxicity: Identified as nontoxic with no long-term safety concerns based on in vivo and in vitro tests (cytotoxicity, sensitization, mutagenicity, hemolysis).
- Substantial Equivalence: Deemed substantially equivalent to predicate devices K060812 (Juliesse™) and K013243 (Coaptite). |
| Test Set Sample Size & Data Provenance | Not applicable / Not provided. The review is based on preclinical data and equivalence to existing devices, not a clinical test set with human performance data. |
| Number & Qualifications of Experts for Ground Truth | Not applicable / Not provided. |
| Adjudication Method for Test Set | Not applicable / Not provided. |
| MRMC Comparative Effectiveness Study Done? Effect Size? | No MRMC study was done or reported in this document. |
| Standalone (Algorithm Only) Performance Done? | Not applicable. This is a physical implant, not an algorithm. |
| Type of Ground Truth Used | For preclinical studies: biological endpoints (cytotoxicity, sensitization, etc.) and observations from animal implants. For substantial equivalence: comparison to predicate device characteristics and performance (as previously established). |
| Training Set Sample Size | Not applicable / Not provided. This term typically applies to machine learning algorithms, which is not the case here. |
| How Ground Truth for Training Set Established | Not applicable / Not provided. |
§ 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.