(337 days)
The CODMAN® CRANIOSORB™ Absorbable Fixation System is intended for surgical procedures in which internal fixation is required to align and stabilize bony tissue for craniofacial skeletal reconstruction and the repair of traumatic fractures of the craniofacial skeleton.
The CODMAN® CRANIOSORB™ Absorbable Fixation System consists of The CODMAN® Clearn of craniofacial reconstruction. The Imm thick plates, mesit, and rivers to be esseesined in various shapes and sizes typical of other marketed fixation devices. The biocompatible implant material used to manufacture the plates and mesh is a blend of poly(D,L-Lactide), polycaprolactone, and polydioxanone. The rivets are constructed of poly L-lactic acid (PLLA).
The provided text describes a medical device called the CODMAN® CRANIOSORB™ Absorbable Fixation System. It details its purpose, materials, and a summary of performance testing.
Here's an analysis of the acceptance criteria and study information provided in the text:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Reported Device Performance | Comments |
|---|---|---|
| Mechanical Performance | ||
| Retained Strength Over Time | Performance assessed | No specific quantitative acceptance criteria or results are provided. The text only states that retained strength over time was evaluated. |
| Dimensional Stability | Performance assessed | No specific quantitative acceptance criteria or results are provided. The text only states that dimensional stability was evaluated. |
| Simulated Bend Testing | Performance assessed | No specific quantitative acceptance criteria or results are provided. The text only states that simulated bend testing was conducted. |
| Pullout/Pushout Testing | Performance assessed | No specific quantitative acceptance criteria or results are provided. The text only states that pullout/pushout testing was conducted. |
| Biocompatibility | ||
| Cytotoxicity | Performance assessed | No specific acceptance criteria or quantitative results are provided. The text only states that cytotoxicity was performed. |
| Sensitization | Performance assessed | No specific acceptance criteria or quantitative results are provided. The text only states that sensitization was performed. |
| Implantation Studies of Tissue Reaction | Performance assessed | No specific acceptance criteria or quantitative results are provided. The text only states that implantation studies of tissue reaction were performed. |
2. Sample Size Used for the Test Set and Data Provenance
The document does not provide details on the sample sizes used for the specific performance tests (retained strength, dimensional stability, bend, pullout/pushout). It also does not specify the data provenance (e.g., country of origin, retrospective/prospective). The testing appears to be laboratory-based physical and chemical testing rather than clinical study data.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
This information is not applicable to the provided document. The "tests" described are physical and biocompatibility tests of the device components themselves, not studies involving human interpretation or diagnosis where expert "ground truth" would be established.
4. Adjudication Method for the Test Set
This information is not applicable to the provided document for the same reasons as point 3.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. The document focuses on the physical and biocompatibility characteristics of the device, not on diagnostic performance or human reader interaction with an AI system.
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 fixation system, not an algorithm or AI system.
7. The Type of Ground Truth Used
The "ground truth" for the device's performance is established through standard engineering principles and biocompatibility testing methodologies. For example, for mechanical tests, the ground truth would be the physical properties measured against pre-defined engineering specifications. For biocompatibility, the ground truth would be the standard biological reactions defined by regulatory guidelines. The document does not explicitly state these specifications but implies they exist for "device suitability."
8. The Sample Size for the Training Set
This information is not applicable. The device is a physical product, not an AI model that requires a training set.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable for the same reason as point 8.
§ 872.4760 Bone plate.
(a)
Identification. A bone plate is a metal device intended to stabilize fractured bone structures in the oral cavity. The bone segments are attached to the plate with screws to prevent movement of the segments.(b)
Classification. Class II.