Search Results
Found 1 results
510(k) Data Aggregation
(277 days)
Cerasorb Ortho Foam
Cerasorb Ortho Foam is an implant intended to fill bony voids or gaps of the skeletal system (i.e., extremities and pelvis). These osseous defects are surgically created or the result of traumatic injury to the bone and are not intrinsic to the stability of the bony structure. Cerasorb Ortho Foam resorbs and is replaced with bone during the healing process.
Cerasorb Ortho Foam is a highly porous composite material for bone augmentation and regeneration applications, consisting of porcine collagen and a resorbable ceramic. Through the use of pure phase ß-tricalcium phosphate with a regular interconnected porous structure, a degradation of the biomaterial is achieved simultaneously to natural bone regeneration. The pure phase B-tricalcium phosphate is made according to ASTM F 1088-04a. The ß-tricalcium phosphate component of Cerasorb Ortho Foam is a mixture of Cerasorb M Ortho and Cerasorb Ortho, which received previous 510(k) clearances (K040216 and K014156, respectively). The device has been tested to meet pyrogen limit specifications. Cerasorb Ortho Foam is available in five different sizes and two versions (mouldable foam and flexible foam strip) and serves to fill bone defects in the entire skeletal system.
Here's an analysis based on the provided document regarding the acceptance criteria and study for the Cerasorb Ortho Foam device:
This document is a 510(k) premarket notification for a medical device called Cerasorb Ortho Foam. The purpose of a 510(k) submission is to demonstrate that the new device is "substantially equivalent" to a legally marketed predicate device, rather than proving its absolute safety and effectiveness through extensive clinical trials as would be required for a PMA (Premarket Approval). Therefore, the "acceptance criteria" and "study" described here are focused on demonstrating substantial equivalence to a predicate, not necessarily meeting a specific performance metric in a standalone sense.
1. Table of Acceptance Criteria and Reported Device Performance:
| Feature/Criteria | Predicate Device (Vitoss Scaffold Foam Bone Graft Material) Performance | Proposed Device (Cerasorb Ortho Foam) Performance (Claimed) | Rationale for Equivalence |
|---|---|---|---|
| Intended Use | Bone void filler for skeletal system (extremities, spine, pelvis) | Bone void filler for skeletal system (extremities, pelvis) | Substantially equivalent (minor difference in explicitly listed anatomical locations, but overall 'bone void filler' function is same). |
| Target Population | Individual with bony defect resulting from surgery or trauma | Individual with bony defect resulting from surgery or trauma | Identical |
| Anatomical Locations | Bony voids/gaps of extremities, spine, and pelvis | Bony voids/gaps of extremities and pelvis | Substantially equivalent (exclusion of 'spine' for proposed device not deemed significant, implies similar general application). |
| Labeling | Contains comparable intended use, warnings, and precautions | Contains comparable intended use, warnings, and precautions | Substantially equivalent |
| Chemical Composition | Calcium salt with Type I bovine collagen | Calcium salt with Type I and Type III porcine collagen | Equivalent, with rationale for porcine collagen for safety. |
| Mineral Phases | ß-Tricalcium phosphate Ca3(PO4)2 | ß-Tricalcium phosphate Ca3(PO4)2 | Identical |
| Physical Structure | Trabecular structure similar to cancellous bone | Trabecular structure similar to cancellous bone | Identical |
| Pore Size (range) | 1-1000 µm | 0.1-500 µm | Within same general range, with statement "No significant functional implications are expected." |
| Osteoconductivity | Osteoconductive | Osteoconductive | Identical |
| Mechanical Strength | Does not impart mechanical strength to surgical site | Does not impart mechanical strength to surgical site | Identical |
| Sterility | Sterilized by gamma irradiation, single use only | Sterilized by gamma irradiation, single use only | Identical |
| Biocompatibility | Established | Established | Established, implying performance is comparable. |
| Dosage Form(s) | Cylinders (Blocks), Strips, Packs, Flow, Shapes | Strips, Packs (Mouldable Foam and Flexible Foam Strip) | Different specific forms, but both offer forms for filling voids. |
| New Bone Formation (Animal Study) | Not explicitly quantified, but implied successful performance | Performed at least as well as the predicate device | Demonstrated non-inferiority to predicate in animal model. |
| Fibrosis and Inflammation (Animal Study) | Not explicitly quantified, but implied successful performance | Occurrence evaluated | Implied comparable or acceptable levels. |
2. Sample Size Used for the Test Set and Data Provenance:
- Test Set (Animal Study): The document states "A comparative study in sheep using the critical size defect model was performed." It does not specify the exact number of sheep used (sample size) or the number of defects created/treated.
- Data Provenance: The study was "in sheep," which indicates animal data. The location of the study (country of origin) is not explicitly stated in this document but implied to be part of the manufacturer's (curasan AG, Germany) activities. It is a prospective animal study designed for comparison.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:
- The document does not mention the number of experts used or their qualifications for establishing ground truth in the animal study. The evaluation focused on "amount and quality of newly formed bone" and "occurrence of fibrosis and inflammation," which would typically involve histological analysis and potentially expert pathology assessment, but specifics are omitted.
4. Adjudication Method for the Test Set:
- The document does not provide details on an adjudication method. It simply states that bone formation, fibrosis, and inflammation were "evaluated." This suggests standard scientific evaluation by the researchers involved in the study, but no formal adjudication process with independent experts is described.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:
- No, an MRMC comparative effectiveness study was not done. This type of study typically involves human readers (e.g., radiologists) evaluating medical images or cases with and without AI assistance to measure improvement in diagnostic performance. The Cerasorb Ortho Foam is a physical bone void filler, not an AI software device.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- This question is not applicable. Cerasorb Ortho Foam is a physical medical device (bone void filler), not an algorithm or AI system.
7. The Type of Ground Truth Used:
- For the animal study (test set): The ground truth was established through histological evaluation of the amount and quality of newly formed bone, and the occurrence of fibrosis and inflammation at the surgical site in the sheep. This is a form of direct biological/pathological assessment.
8. The Sample Size for the Training Set:
- This question is not applicable. Cerasorb Ortho Foam is a physical medical device. It does not involve a "training set" in the context of machine learning or AI. The product's development would have involved various material science and biological compatibility tests, but not a dataset for training an algorithm.
9. How the Ground Truth for the Training Set Was Established:
- This question is not applicable, as there is no "training set" for this type of device.
Ask a specific question about this device
Page 1 of 1