Search Results

-Augmentation or reconstructive treatment of the alveolar ridge.
-Filling of periodontal defects.
-Filling of defects after root resection, apicocetomy, and cystectomy.
-Filling of extraction sockets to enhance preservation of the alveolar ridge.
-Elevation of the maxillary sinus floor.
-Filling of periodontal defects in conjunction with products intended Tissue Regeneration (GTR) and Guided Bone Regeneration (GBR).
-Filling of peri-implant defects in conjunction with products intended for Guided Bone Regeneration (GBR).

Cytrans Granules is composed of carbonate apatite. The material of Cytrans Granules has been formulated in terms of carbonate apatite content to the mineral content of natural bone. As Cytrans Granules is completely synthetic, there are no animal derived ingredients in the formula. Cytrans Granules is gradually resorbed and eventually replaced with new bone. Resorption is by osteoclasts under acidic conditions. Cytrans Granules is manufactured by a validated manufacturing process which guarantees batch to batch conformity and reproducibility. It is sterilized via gamma irradiation and will be marketed/sold in sterile vials for single use.

The provided text describes the 510(k) submission for Cytrans Granules, a bone grafting material. While it discusses performance testing, it does not explicitly state acceptance criteria in a quantitative table or directly link numerical performance results to specific criteria. The document focuses on demonstrating substantial equivalence to a predicate device rather than meeting predefined acceptance criteria for a novel performance claim.

However, based on the information provided, we can infer the aspects of performance that were evaluated and deemed acceptable for the device to be considered substantially equivalent.

Here's an attempt to structure the information according to your request, acknowledging the limitations of the provided text:

Acceptance Criteria and Device Performance for Cytrans Granules

1. Table of Acceptance Criteria and Reported Device Performance

As specific quantitative "acceptance criteria" for the device's clinical performance are not explicitly stated in the document (which is common for 510(k) submissions focusing on substantial equivalence), the table below infers the performance aspects that were evaluated and found acceptable relative to the predicate devices and general expectations for bone grafting materials. The "Reported Device Performance" column reflects the findings from the non-clinical and clinical studies.

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

• Test Set (Clinical Study):

  • Sample Size: 22 cases (patients) for sinus floor augmentation (excluding 6 cases due to exclusion criteria).
  • Data Provenance: Japan (stated as "three institutions in Japan"). The study was prospective clinical testing.

• Test Set (Animal Studies):

  • Sample Size: Not explicitly stated beyond "a beagle dog model" where "three commercially available bone substitutes" were compared. It implies multiple animals were used, but the exact number is not provided.
  • Data Provenance: Not specified, but generally animal studies typically involve institutional animal care and use committee approval from the research facility.

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

• The document does not explicitly state the number of experts used or their detailed qualifications for establishing ground truth in the clinical study.
• For a clinical study involving sinus floor augmentation and dental implants, it is implicitly understood that the "ground truth" (e.g., successful implant placement, bone formation assessment, complication rates) would be established by qualified dental surgeons and potentially radiologists/pathologists involved in patient follow-up and evaluation (panoramic X-ray, CT imaging, tissue biopsy).
• The study was conducted across "three institutions in Japan," suggesting that multiple clinical professionals were involved in the evaluations.

4. Adjudication Method for the Test Set

• The document does not explicitly describe an adjudication method (e.g., 2+1, 3+1).
• Clinical trials typically involve standardized protocols for evaluation and data collection, and any discrepancies might be resolved by consensus or a senior investigator, but a formal adjudication process beyond standard clinical practice is not mentioned. Outcomes like "success rate...exceeded the level deemed to be effective" suggest a predefined standard, but not a specific adjudication protocol.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

• No, an MRMC comparative effectiveness study was not done in the context of comparing human readers' performance with and without AI assistance. This document describes a medical device (bone grafting material), not an AI-powered diagnostic or assistive tool.

6. Standalone Performance (Algorithm Only without Human-in-the-Loop Performance)

• Not applicable. This device is a bone grafting material, not an algorithm or AI system. Its performance is evaluated through its biological interaction within the patient's body, not as a standalone software algorithm.

7. Type of Ground Truth Used

• Clinical Study (Sinus Floor Augmentation):
  • Clinical Outcomes Data: Successful implant placement, lack of rotation/movement, implant placement torque, absence of complications.
  • Imaging Data: Opacity on panoramic X-ray and vertical residual bone on CT imaging confirming new bone formation.
  • Pathology/Histology: Tissue biopsy confirming new bone formation in all cases of the two-stage group.
• Animal Studies: New bone formation, bone-to-implant contact ratio (likely assessed histologically and/or with imaging).
• Biocompatibility Testing: Lab-based tests (Cytotoxicity, Sensitization, Genotoxicity, etc.) with established assay endpoints and interpretations.

8. Sample Size for the Training Set

• Not applicable. This is a medical device, not a machine learning model. Therefore, there is no "training set" in the context of AI/ML. The device's development involved material science, preclinical, and clinical testing, but not an ML training paradigm.

9. How the Ground Truth for the Training Set Was Established

• Not applicable. As there is no training set (for AI/ML), there is no ground truth established for it. The "ground truth" equivalent in medical device development would be the scientific and clinical validation of its material properties, biological interactions, and clinical efficacy through established testing methods and clinical trials.

Ask a specific question about this device