Search Results
Found 2 results
510(k) Data Aggregation
(161 days)
Norian PDC is intended to fill and/or augment periodontal bone wall defects, extraction socket defects, and cysts or other defects in the alveolar ridge or wall.
Norian PDC Cement is intended to be used in the treatment of periodontal bone wall defects, extraction socket defects, and for repair of cysts or other defects in the alveolar ridge or wall.
Norian PDC is a paste-like bone cement which is intended to fill and/or augment periodontal bone wall defects, extraction socket defects, and cysts or other defects in the alveolar ridge or wall. Norian PDC is an injectable and moldable, biocompatible, bone cement. The Norian PDC Reactants Pack contains the two sterile components used in Norian PDC: Calcium Phosphate Powder and Sodium Phosphate Solution. The Reactants Pack is mixed in a pneumatic mixer to form a smooth, viscous paste which is applied to the operative site. Norian PDC cures into a carbonated apatite that is substantially similar to the mineral component of bone, and over time, the Norian PDC is gradually resorbed over time.
The provided text is a 510(k) summary for the Norian® PDC™ bone cement. It describes the device, its intended use, and device testing. However, it does not contain the detailed information needed to answer the specific questions about acceptance criteria for a device's performance, a specific study proving it, or AI/human reader performance.
The document states: "Biocompatibility testing showed that Norian PDC Cement is acceptable for its intended use as a bone implant material. Norian Cement passed all tests, and showed no toxic, mutagenic or irritating effect." This is a general statement about meeting biocompatibility requirements, not specific performance metrics (like accuracy, sensitivity, specificity) for a diagnostic or AI-based device, nor details of a study with human readers.
Therefore, I cannot provide the requested information based on the provided text. The questions are geared towards the evaluation of AI/diagnostic devices, which is not the subject of this 510(k) summary for a bone cement.
Ask a specific question about this device
(224 days)
Norian CRS is intended for filling craniofacial defects in the restoration or augmentation of bony contours of the craniofacial skeleton (including fronto-orbital, malar, and mental areas) such as burr hole voids and other craniofacial defects, with a surface area no larger than 25cm2.
Norian Craniofacial Repair System (Norian CRS) is a paste-like bone cement which is intended for the restoration or augmentation of bony contours in the craniofacial skeleton, such as burr hole voids and other cranial defects. Norian CRS is an injectable and moldable, biocompatible, bone coment. The Norian CRS Reactants Pack contains the two sterile components used in Norian CRS: Calcium Phosphate Powder and Sodium Phosphate Solution.
When the Reactants Pack is mixed, a smooth, viscous paste is applied directly to the opcrative site, where it hardens in about 10 minutes to provide initial structural support. Within 24 hours, Norian CRS cures into a carbonated apatie that is similar to the mincral component of bone. The compresssive strength of Norian CRS is approximately 50MPa. Over time, Norian CRS is gradually resorbed.
The Norian Mixer. Delivery Device, and Delivery Needles are used to mix and deliver the Norjan CRS to the operative site.
This document describes the Norian CRS (Craniofacial Repair System), a bone cement intended for filling craniofacial defects. The information provided outlines its technological characteristics, performance data, and regulatory approval.
Here's an analysis of the acceptance criteria and study information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Performance Metric) | Reported Device Performance |
|---|---|
| X-ray Diffraction - Setting Time | Set (initial hardening) occurs at about 10 minutes. |
| X-ray Diffraction - Reaction Completion | Reaction is greater than 90% complete by 24 hours. |
| X-ray Diffraction - Cured Material Composition | Cures to become an apatite of low crystalline order with no by-products present. |
| pH Value Determination - pH Range | pH range of Norian CRS is 6.0-8.0 (measured during and after setting). |
| Dimensional Verification - Dimensional Change | No significant dimensional changes (<1%) at body temperature (37°C), determined by comparing mold dimensions with Norian CRS samples. |
| Solubility Testing | Solubility and solubility products were found to be equivalent to the predicate device (Osteogenics BoneSource® Hydroxyapatite Cement). |
| Porosity Testing | Average percent porosity was found to be equivalent to the predicate device. Both materials resulted in microporous structures of polycrystalline apatite. |
| Biocompatibility Testing - (General) | Passed all tests, showed no toxic, mutagenic, or irritating effect. Deemed acceptable for its intended use as a bone implant material. |
| Sterilization - Method & Standard Compliance | Gamma radiation, following ANSI/AAMI ST32-1992, Method 3A/3B. The Reactants Pack is sterile and for single use. |
| Compressive Strength | Approximately 50MPa (mentioned in Device Description, not framed as a "test" but a characteristic). While not explicitly an "acceptance criterion" in the performance data section, it's a critical performance characteristic presented. For the purpose of this table, it's included as a desired performance trait the device exhibits. |
2. Sample Size Used for the Test Set and Data Provenance
The provided document does not specify the sample sizes used for any of the in vitro tests (X-ray diffraction, pH, dimensional verification, solubility, porosity, biocompatibility).
The data provenance is in vitro testing as explicitly stated in the "Performance Data" section. There is no mention of human subject data, animal studies (beyond general "biocompatibility testing" which is typically done in vitro first, then potentially in vivo, but the document only mentions "passed all tests" without detailing the nature of those tests), or retrospective/prospective studies in a clinical context.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not applicable to the provided document. The studies described are in vitro laboratory tests to determine physical and chemical properties of the bone cement. There is no mention of subjective assessments by experts requiring ground truth establishment in this context.
4. Adjudication Method for the Test Set
This information is not applicable. As the studies are in vitro laboratory tests measuring objective physical and chemical properties, there is no need for adjudication methods typically used in subjective expert assessments or clinical trials.
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
This information is not applicable. The device is a bone cement, not an AI-powered diagnostic or assistive technology for human readers. Therefore, an MRMC comparative effectiveness study involving human readers and AI is irrelevant to this device.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
This information is not applicable. The device is a physical bone cement, not a standalone algorithm.
7. The Type of Ground Truth Used
For the in vitro performance tests, the "ground truth" is largely based on standard scientific measurement techniques and established material science principles. For example:
- X-ray Diffraction: The patterns and intensity of diffracted X-rays directly reveal crystallographic structure and phase composition.
- pH Value Determination: Direct measurement using a pH meter.
- Dimensional Verification: Direct measurement of dimensions.
- Solubility and Porosity Testing: Standard laboratory techniques for these material properties.
- Biocompatibility Testing: Compliance with recognized international standards for biocompatibility (e.g., ISO 10993 series), which involves specific in vitro and/or in vivo tests to assess cytotoxicity, irritation, sensitization, etc. The document mentions "Good Laboratory Practice regulation" and that tests "passed all tests."
The primary "ground truth" for the device's overall substantial equivalence is its comparison to the predicate device, Osteogenics BoneSource® Hydroxyapatite Cement. The document asserts equivalence based on similar material properties and behavior.
8. The Sample Size for the Training Set
This information is not applicable. The Norian CRS is a physical medical device (bone cement), not a machine learning model or algorithm that requires a training set in the computational sense.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable. As explained above, there is no training set for this type of device.
Ask a specific question about this device
Page 1 of 1