Search Results

The Lesion Probe and Generator system is intended to create radiofrequency (RF) heat lesions in nerve tissue. It is intended for use only by trained clinicians in a hospital or clinical setting.

The GFX Nerve Ablation System provides a minimally invasive technique for creating a neural lesion inhibiting the function of the target nerve. The Generator and probe are used as a system to both stimulate the nerve for the purpose of locating the probe correctly and to create a neural lesion to inhibit nerve function through the application of RF energy. The GFX Nerve Ablation probes are single use devices supplied sterile to the customer.

The provided text is a 510(k) summary for the GFX Nerve Ablation System. It describes the device, its indications for use, and its substantial equivalence to predicate devices. However, this document does not contain the detailed information required to answer your specific questions about acceptance criteria and the comprehensive study proving the device meets those criteria.

The "Summary of Testing" section (Section 6) simply states: "Device integrity and functionality were verified and/or validated using samples produced under routine manufacturing conditions." This is a very high-level statement and does not provide any of the specifics requested.

Therefore, I cannot populate the table or answer the specific questions because the necessary data is not present in the provided document.

To answer your request, I would need a different type of document, such as a detailed study report or a more comprehensive technical file submission, which would outline the specific tests performed, their acceptance criteria, results, sample sizes, ground truth establishment, and statistical analyses.

Ask a specific question about this device

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:

1. A table of acceptance criteria and reported device performance.
2. Sample sizes for test set, data provenance, number of experts, adjudication methods, or ground truth for the test set.
3. Information on multi-reader multi-case (MRMC) comparative effectiveness studies or standalone algorithm performance.
4. 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:

• 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. |

Ask a specific question about this device

BioForm's Juliesse is indicated as a resorbable implant material to aid in surgical reconstructions as a space occupying material in laryngeal surgical procedures for vocal fold medialization and augmentation. Juliesse is a temporary implant and resorbs within a period of 3-6 months.

Juliesse is a sterile, non-pyrogenic iniectable material consisting of an aqueous formulation of USP grade pharmaceutical excipients consisting of sterile water, glycerin, sodium carboxymethylcellulose and phosphate buffer.

I am sorry, but based on the provided text, there is no information about acceptance criteria, device performance tables, or a study that proves the device meets specific acceptance criteria using a test set.

The document is a 510(k) summary for Juliesse™ Injectable Laryngeal Augmentation Implant, primarily focusing on its substantial equivalence to a predicate device and its pre-clinical safety evaluations. It states that "the battery of preclinical safety studies and animal implant studies show that the Juliesse™ Injectable Laryngeal Augmentation Implant is biocompatible when injected into soft tissues" and that "In vivo and In vitro tests were performed to address irritation, sensitization, cytotoxicity, acute and sub-chronic toxicity, genotoxicity and hemolysis. Results identified the Juliesse™ Injectable Laryngeal Augmentation Implant as a nonirritant, and nontoxic with no concerns for long-term safety." However, these are general summaries of pre-clinical tests and do not provide the detailed information requested regarding specific acceptance criteria, performance metrics, sample sizes for test/training sets, expert qualifications, or adjudication methods for establishing ground truth.

Therefore, I cannot fulfill your request for the specific details outlined in your prompt.

Ask a specific question about this device