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510(k) Data Aggregation
(277 days)
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.
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(89 days)
Cerasorb ORTHO in granular form is intended for use as a bone void filler for voids or gaps that are not intrinsic to the stability of the bony structures. It is indicated for filling of bone defects, caused by surgery, trauma or degenerative process. Cerasorb ORTHO granules are intended to be gently packed into the bony voids or gaps of the skeletal system. The material should not be packed in dry form, it should be mixed with autologous blood (blood from the void or venous blood). The implanted material must be in direct contact with the bleeding vital bone.
Cerasorb ORTHO granules have no weight-bearing capacity. Therefore, osteosynthetic measures may be required.
Following placement in the bony voids or gaps, the Beta-Tricalciumphosphate granules are gradually resorbed and substituted by vital, natural bone.
Cerasorb ORTHO is a porous resorbable bone void filler for the repair of bony defects. Chemically the material consists of pure phase Beta-Tricalciumphosphate, as described in the ASTM F 1088 - 87 (reapproved 1992). It is an osteoconductive implant with interconnected porosity. The implant is provided sterile in granular form, granular sizes being 500 - 1000um or 1000 - 2000 um.
When Cerasorb ORTHO is placed in the defect site with direct contact with the viable host bone, it guides the three-dimensional regeneration of bone. As the Cerasorb ORTHO granules resorbs, newly formed bone grows into the space previously occupied by the granular Beta-Tricalciumphosphate material. Cerasorb ORTHO was shown to have 90% or greater resorption in animal studies and was also shown to resorb well clinically.
Here's an analysis of the provided text regarding the Cerasorb ORTHO Synthetic Bone Void Filler, focusing on acceptance criteria and supporting studies.
Important Note: The provided document is a 510(k) summary, which focuses on demonstrating substantial equivalence to a predicate device rather than presenting a detailed clinical study for the subject device. As such, information typically found in a standalone clinical trial report (like detailed sample sizes for test sets, ground truth methodology for training, MRMC studies, or detailed performance metrics against specific acceptance criteria) is generally not present here. The performance is largely inferred from its similarity to the predicate device and general material properties.
Acceptance Criteria and Reported Device Performance
The acceptance criteria for Cerasorb ORTHO are implicitly derived from its substantial equivalence to the predicate device, Vitoss™ Scaffold Synthetic. The following table summarizes the key performance attributes that indicate equivalence rather than explicit numerical acceptance criteria.
| Acceptance Criteria (Inferred from Predicate Equivalence) | Reported Device Performance (Cerasorb ORTHO) |
|---|---|
| Material Composition: Must be β-Tricalciumphosphate. | β-Tricalciumphosphate, Ca₃(PO₄)₂. Its chemical composition is consistent with ASTM F 1088 - 87 (reapproved 1992). |
| Structure: Porous, with interconnected porosity. | Interconnective porosity. Micropores >0<80µm. Consistent with previous predicate. |
| Osteoconductivity: Must support bone growth. | Osteoconductive (+) - Guides three-dimensional regeneration of bone. |
| Resorption: Must resorb over time to be replaced by bone. | Resorption (+) - Gradually resorbed and substituted by vital, natural bone. 90% or greater resorption shown in animal studies and also shown to resorb well clinically. |
| Bone Remodeling: Must allow for bone remodeling. | Bone remodeling (+) - As granules resorb, newly formed bone grows into the space. |
| Mechanical Properties: Non-weight-bearing. | Granules have no weight-bearing capacity. Execution of osteosynthetic measures eventually necessary. |
| Sterility: Sterile, single-use. | Sterile (gamma radiation), single use only. |
| Biocompatibility: Must be biocompatible. | Established. (Implicitly demonstrated by material composition and predicate equivalence, animal studies). |
| Intended Use/Indication: Bone void filler. | Bone void filler for voids or gaps not intrinsic to stability, indicated for filling bone defects caused by surgery, trauma, or degenerative processes. Same as predicate. |
| Patient Population: Patients with bone voids/gaps. | Patients with bone voids or gaps, caused by surgery, trauma or degeneration. Similar to predicate, with degeneration added as a cause. |
| Anatomical Location: Skeletal system. | Skeletal system (extremities, spine, pelvis). Same as predicate. |
| Labeling Consistency: Warnings, precautions, etc. | Same intended use, contraindications, warnings, precautions and adverse events as predicate. |
Study Details Proving Device Meets Acceptance Criteria
2. Sample Sizes and Data Provenance:
* Test Set Sample Size: Not explicitly stated for human clinical data in this 510(k) summary. The document mentions "animal studies" for resorption and "resorb well clinically," but does not provide details about the number of animals or human patients evaluated in these clinical observations/studies.
* Data Provenance: The document states "animal studies" and "resorb well clinically". No specific country of origin is mentioned for these informal clinical observations. The 510(k) process relies heavily on pre-market data, often including literature review, in-vitro testing, and animal studies, rather than large-scale prospective human trials for demonstrating substantial equivalence. The predicate device (Vitoss™ Scaffold Synthetic) would have its own data provenance, which is not detailed here.
3. Number of Experts and Qualifications for Ground Truth:
* This is not applicable as the document does not describe a study involving expert assessment or interpretation of results in the way it would for an AI/diagnostic device. The "ground truth" for material properties like osteoconductivity and resorption is established through scientific testing and observation, not expert consensus on images or clinical classifications.
4. Adjudication Method for the Test Set:
* Not applicable as this is not a study requiring expert adjudication of results.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
* No, a MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic imaging interpretation or other tasks where human readers' performance is being measured and compared, often with and without AI assistance. This document describes a bone void filler material, not a diagnostic device.
6. Standalone (Algorithm Only) Performance Study:
* No, a standalone algorithm performance study was not done. This is not an algorithm-based device.
7. Type of Ground Truth Used:
* The "ground truth" for this device's performance characteristics (e.g., osteoconductivity, resorption, biocompatibility) is based on:
* Material Science Principles: Properties of β-Tricalciumphosphate.
* Animal Studies: For resorption rates and bone formation ("90% or greater resorption in animal studies").
* Clinical Observations/Experience: "resorb well clinically." (Informal, not detailed).
* ASTM Standards: Compliance with ASTM F 1088 - 87 for material composition.
* Performance characteristics of the legally marketed predicate device.
8. Sample Size for the Training Set:
* Not applicable. There is no AI model or algorithm being "trained" for this medical device. The "training" in a broad sense would be the cumulative scientific knowledge and experimental data on β-Tricalciumphosphate and bone regeneration.
9. How the Ground Truth for the Training Set Was Established:
* Not applicable, as there is no training set in the context of an AI device. The foundational knowledge used to develop and validate the device's properties comes from established scientific literature, previous animal studies, and known characteristics of similar materials (like the predicate device).
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