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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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(409 days)
Beta TCP Granules Bone Void Filler (BVF) is indicated to be gently packed into bony voids or gaps of the skeletal system (i.e., extremities and pelvis). These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone. Beta TCP Granules is indicated only for bony voids or gaps that are not intrinsic to the stability of the bony structure. Beta TCP Granules BVF will resorb and be replaced with bone during the healing process.
Beta TCP Granules Bone Void Filler is composed of porous, osteoconductive, resorbable beta- tricalcium phosphate (B-TCP) granules for repair of bony defects. The single use Beta TCP Granules sterile kit contains: Calcium Phosphate granules contained in a plastic vial packaged within two industry standard peel pouches that provide a double sterile barrier.
Here's a breakdown of the acceptance criteria and the study information for the Beta TCP Granules device, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Chemistry | Phase pure beta-tricalcium phosphate | Composed of phase pure beta-tricalcium phosphate (via FTIR and XRD) |
| Crystallinity | Crystalline, phase-pure beta-tricalcium phosphate with no other crystalline or amorphous phases | Crystalline, phase-pure beta-tricalcium phosphate with no other crystalline or amorphous phases detected (via X-ray Diffraction) |
| Physical Form | Porous granules | Porous granules (via Scanning Electron Microscopy). Subject device is spherical; predicate device is irregular. |
| Porosity | Interconnected porosity within the range of currently approved beta tricalcium phosphate bone void fillers | Interconnected porosity falls within the range (via Mercury Intrusion Porosimetry) |
| Solubility | Similar solubility profiles to predicate device | Demonstrated similar solubility profiles (via in vitro dissolution measuring Ca2+ ion concentration) |
| Biocompatibility | Compliant with ISO 10993-1 | Biocompatible and meets requirements of ISO standards |
| Sterility | Sterility Assurance Level (SAL) 10^-6 | Validated to SAL 10^-6 with radiation dose of 25kGy - 40 kGy (in accordance with ISO 11137-2006) |
| Risk Management | Identified hazards acceptable and/or mitigated to an acceptable level | Identified hazards acceptable and/or mitigated, residual risk deemed acceptable |
| Resorption & Bone Ingrowth | Resorbed over time and allows bone ingrowth | Resorbed over time and allows bone ingrowth (demonstrated in animal model) |
| Safety Profile | Maintain previously demonstrated safety profile of beta-TCP materials | Maintains previously demonstrated safety profile of beta-TCP materials |
2. Sample Size Used for the Test Set and Data Provenance
- The primary "test set" for demonstrating substantial equivalence was a comparison of critical specifications between the Beta TCP Granules and the predicate device, Cerasorb M Ortho (K040216). This involves direct laboratory analysis of material properties rather than human patient data.
- Data Provenance: The document does not explicitly state the country of origin for the lab-based material characterization studies. It is implicitly "prospective" in the sense that these tests were conducted on the Beta TCP Granules product for the submission.
- Animal Study: A "large animal, cancellous bone defect model" was used for non-clinical animal data. The document does not specify the exact sample size (number of animals) for this study, nor its country of origin. This would be considered prospective animal data specifically generated for this submission.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
- This device submission relies on non-clinical testing (material characterization and animal studies), not on human clinical data or expert interpretation of images/diagnoses.
- Therefore, the concept of "experts establishing ground truth for the test set" in the context of human clinical data or diagnostic accuracy studies is not applicable here. The "ground truth" for the material properties was established by validated analytical methods and scientific standards.
4. Adjudication Method for the Test Set
- Not applicable. As noted above, this submission relies on non-clinical laboratory and animal studies, not human clinical data that would require adjudication of findings.
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
- Not applicable. This device is a resorbable bone void filler and does not involve AI or human image interpretation for diagnosis or treatment planning in a clinical setting.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
- Not applicable. This device is a material product, not an algorithm.
7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)
- The "ground truth" for this submission is based on:
- Scientific and Analytical Measurements: For chemistry, crystallinity, physical form, porosity, and solubility, the ground truth was established by validated laboratory techniques (FTIR, XRD, SEM, Mercury Intrusion Porosimetry, ICP-AES) according to scientific standards.
- Biological Standards: For biocompatibility, the ground truth was adherence to ISO 10993-1.
- Validated Sterilization Protocols: For sterility, adherence to ISO 11137-2006 for SAL 10^-6.
- Animal Model Outcomes: For resorption and bone ingrowth, the ground truth was the observation of these phenomena in a "large animal, cancellous bone defect model."
8. The Sample Size for the Training Set
- Not applicable. This device is a physical product and does not involve a "training set" in the context of machine learning or AI. The product itself is the subject of characterization.
9. How the Ground Truth for the Training Set Was Established
- Not applicable. As there is no training set, there is no ground truth to establish for it.
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(147 days)
Cerasorb® MIX 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® MIX granules are intended to be gently packed into the bony voids or gaps of the skeletal system (i.e., extremities, posterolateral spine, and pelvis). Cerasorb® MIX is not indicated for use in load-bearing applications. It does not possess sufficient mechanical strength, therefore, standard internal or external stabilization techniques must be followed to obtain rigid stabilization. Following placement in the bony voids or gaps, the Beta-tricalcium phosphate granules are gradually resorbed and replaced with new bone.
The Cerasorb® MIX Device is a mixture of two legally marketed bone void filler devices, the Cerasorb Ortho granules subject of K014156 and Cerasorb M Ortho granules subject of K040216. The bone replacement and bone regeneration material Cerasorb MIX consists of ≥99% pure phase beta-tricalcium phosphate (beta-TCP). The Cerasorb® and Cerasorb® M mixture includes granule sizes of 500-1000 um and 1000-2000 um. The mixing ratio is 1cc to 1cc of Cerasorb® and Cerasorb® M granules.
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.
This 510(k) summary for the Cerasorb® MIX device is for a medical device (bone void filler), not an AI/ML powered device. As such, the typical acceptance criteria and study designs associated with AI/ML device performance (e.g., sensitivity, specificity, AUC, MRMC studies, standalone performance, ground truth establishment with experts) are not applicable.
The document demonstrates substantial equivalence to predicate devices based on:
- Identical Technological Characteristics: The Cerasorb® MIX is a mixture of two previously cleared bone void fillers (Cerasorb® Ortho and Cerasorb® M Ortho) with identical base material (beta-tricalcium phosphate) and similar granule sizes.
- Identical Intended Use, Contraindications, Warnings, Precautions, and Adverse Events: The labeling of Cerasorb® MIX is the same as the predicate devices.
- Established Safety and Biocompatibility: The safety and biocompatibility of calcium phosphates, the core material, have been established through prior clearances and a long history of clinical use.
Therefore, the "acceptance criteria" for this device are met by demonstrating substantial equivalence to its predicate devices, rather than through a performance study with quantitative metrics for AI/ML outputs.
Here's a breakdown of the requested information, adapted for this device type:
1. Table of Acceptance Criteria and Reported Device Performance
| Criterion/Characteristic | Acceptance Criteria (Demonstrated by Substantial Equivalence via Predicates) | Reported Device Performance (as demonstrated by equivalence to predicates) |
|---|---|---|
| Material Composition | Consists of ≥99% pure phase beta-tricalcium phosphate (beta-TCP), identical to predicate devices. | Cerasorb® MIX consists of ≥99% pure phase beta-tricalcium phosphate (beta-TCP), confirming material identity with predicate Cerasorb® Ortho granules (K014156) and Cerasorb® M Ortho granules (K040216). |
| Granule Sizes (Mixture) | Mixture of granule sizes used in predicate devices (500-1000 µm from Cerasorb® and 1000-2000 µm from Cerasorb® M). | The Cerasorb® and Cerasorb® M mixture includes granule sizes of 500-1000 µm and 1000-2000 µm. The mixing ratio is 1cc to 1cc. This falls within the previously cleared ranges of 50-2000 µm for Cerasorb® Ortho and 50 µm-8000 µm for Cerasorb® M Ortho, demonstrating that the chosen sizes are well-established. |
| Intended Use | Same as predicate devices: bone void filler for voids or gaps not intrinsic to stability, filling defects caused by surgery, trauma, or degenerative process in skeletal system (extremities, posterolateral spine, pelvis); not for load-bearing applications; gradually resorbed and replaced by new bone. | The stated intended use for Cerasorb® MIX is identical to the predicates, covering use as a bone void filler for non-load-bearing applications in various anatomical sites, with the mechanism of gradual resorption and replacement by new bone. |
| Biocompatibility | Established biocompatibility for calcium phosphates, as demonstrated by predicate devices. | Biocompatibility is "Established," as it was for both predicate devices. The materials are known and have a long history of safe clinical use, and prior testing for K014156 and K040216 confirmed safety and biocompatibility. |
| Sterility & Non-pyrogenicity | Sterile and non-pyrogenic, single patient use, as demonstrated by predicate devices. | Device is "Sterile, Non-pyrogenic, Single patient use," which is identical to both predicate devices. |
| Osteoconductivity | Osteoconductive properties, as demonstrated by predicate devices. | Cerasorb® MIX is "Osteoconductive," aligning with the performance characteristic of both predicate devices. |
| Mechanical Safety | Does not impart mechanical strength to the surgical site and requires standard stabilization techniques, as demonstrated by predicate devices. This demonstrates that the device itself does not have mechanical load-bearing properties. | Confirmed that the device "Does not impart mechanical strength to surgical site," and explicitly states it is "not indicated for use in load-bearing applications" due to insufficient mechanical strength, requiring standard stabilization techniques. This matches the mechanical safety profile of the predicate devices. |
| Adverse Events, Warnings, etc. | Labeling contains same intended use, contraindications, warnings, precautions, and adverse events as predicate devices, indicating no new or different safety concerns. | "Labeling contains same intended use, contraindications, warnings, precautions, and adverse events as predicate." This indicates that the safety profile and associated instructions for safe use are consistent with previously cleared devices. |
| Compliance with FDA Guidance | Meets applicable requirements of FDA guidance documents on bone void fillers as evidenced by the clearances of the predicate devices based on their underlying calcium phosphate salts and their long clinical history. | "Testing performed on the proposed device contained in K014156 and K040216 confirmed that the Cerasorb® MIX device meets the applicable requirements of the FDA guidance documents on bone void fillers." This statement refers to the foundational testing of the components, not new testing for the mixture. Because the mixture leverages components already established to meet these requirements, the mixture also meets them by extension. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not applicable. This submission relies on demonstrating substantial equivalence to predicate devices that have already undergone testing and have a history of safe clinical use. There is no new "test set" in the context of an AI/ML performance evaluation for this device. The documentation provided does not detail new clinical studies or a specific test set. The efficacy and safety are inferred from the established performance of the constituent materials.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Not applicable. Ground truth establishment by experts is not relevant for this type of medical device submission. The device's characteristics are determined through material science and preclinical testing referenced from previous clearances, not through expert interpretation of data.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable. Adjudication methods are used in studies involving human interpretation or uncertain outcomes (e.g., diagnostic imaging). This is not relevant for a bone void filler's substantial equivalence pathway.
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
- Not applicable. MRMC studies are specific to evaluating diagnostic accuracy or reader performance, typically with AI-assisted tools. This device is a material implant, not a diagnostic or AI system.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This submission is for a physical medical implant, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not applicable in the typical AI/ML sense. The "ground truth" for this device's safety and effectiveness is primarily established through:
- Material Science and Characterization: Chemical composition (beta-TCP purity), physical properties (granule size, porosity), and in vitro/in vivo biocompatibility testing of the constituent materials (calcium phosphates) from previous clearances.
- Clinical History/Outcomes Data: The "long history of safe clinical use" mentioned for calcium phosphates represents a form of outcomes data globally, but no specific new outcomes study is presented for the Cerasorb® MIX itself.
- Compliance with Standards: Meeting "applicable requirements of the FDA guidance documents on bone void fillers" based on prior testing of the predicate components.
8. The sample size for the training set
- Not applicable. "Training set" refers to data used to train AI/ML models. This is a physical device, so no training set is involved.
9. How the ground truth for the training set was established
- Not applicable. As there is no training set for an AI/ML model, there is no ground truth to be established for it.
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