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510(k) Data Aggregation
(25 days)
VITOSS SCAFFOLD SYNTHETIC CANCELLOUS BONE VOID FILLER
Vitoss Scaffold Synthetic Cancellous Bone Void Filler is intended for use as a bone void filler for voids or gaps that are not intrinsic to the stability of the bony structure. Vitoss Scaffold is indicated for use in the treatment of surgically created osseous defects or osseous defects created from traumatic injury to the bone. Vitoss Scaffold should not be used to treat large defects that in the surgeon's opinion would fail to heal spontaneously.
Vitoss Scaffold is intended to be packed into bony voids or gaps of the skeletal system (i.e., the extremities, spine and pelvis) and may be combined with autogenous blood and/or bone marrow. Following placement in the bony void or gap, the calcium phosphate scaffold resorbs and is replaced with bone during the healing process.
Vitoss Scaffold is a porous calcium phosphate resorbable bone void filler for the repair of bony defects. It is an osteoconductive porous implant with a trabecular structure that resembles the multidirectional interconnected porosity of human cancellous bone. Pore diameters in the scaffold range from 1 um to 1000 um (1 mm). The implant is provided sterile in block and morsel forms.
Vitoss Scaffold guides the three-dimensional regeneration of bone in the defect site into which it is implanted. When Vitoss Scaffold is placed in direct contact with viable host bone, new bone grows in apposition to the calcium phosphate surfaces of the implant. As the implant resorbs, bone and other connective tissues grow into the space previously occupied by the scaffold. Results from animal studies demonstrate that eighty percent of Vitoss Scaffold is resorbed within twelve weeks.
The Vitoss® Scaffold Synthetic Cancellous Bone Void Filler is a resorbable bone void filler for repairing bony defects. The device underwent a 510(k) review (K032409), indicating that its substantial equivalence to predicate devices (WMT-TCP and chronOS) was demonstrated based on various performance characteristics rather than a clinical study with specific acceptance criteria and a detailed study design.
1. Table of Acceptance Criteria and Reported Device Performance
Since this is a 510(k) submission for a medical device and not a diagnostic AI, the acceptance criteria are based on demonstrating substantial equivalence to predicate devices across several key performance and material characteristics, rather than specific accuracy metrics. The "reported device performance" reflects how Vitoss Scaffold compares to its predicates.
| Characteristic | Acceptance Criteria (Substantial Equivalence to Predicates) | Reported Vitoss Scaffold Performance |
|---|---|---|
| Intended Use | Same as predicate devices | Resorbable Synthetic Bone Void Filler (matches WMT-TCP, ChronOS) |
| Target Population | Individuals with bony defects from surgery/trauma | Individuals with bony defects resulting from surgery or trauma (matches WMT-TCP, ChronOS) |
| Anatomical Locations | Skeletal system (extremities, spine, pelvis) | Bony voids or gaps of the skeletal system, i.e., extremities, spine and pelvis (matches WMT-TCP, ChronOS) |
| Labeling | Same intended use as predicates | Labeling contains same intended use as predicate devices |
| Materials | β-Tricalcium Phosphate (satisfies ASTM F 1088) | β-Tricalcium Phosphate $Ca_3(PO_4)_2$ satisfies ASTM F 1088 (matches WMT-TCP, ChronOS) |
| Design: Physical Structure | Trabecular structure similar to cancellous bone | Trabecular structure similar to cancellous bone (matches WMT-TCP, ChronOS) |
| Design: Porosity | "Highly porous" (WMT-TCP) or 60-70% (ChronOS) | Approximately 90% |
| Design: Pore Size (range) | 100-500μm (ChronOS) | 1-1000μm |
| Performance: Osteoconductivity | Osteoconductive | Osteoconductive (matches WMT-TCP, ChronOS) |
| Performance: Resorption | "Resorbable" (WMT-TCP) or 6-12 months (ChronOS) | Demonstrated as 80% resorbed at twelve weeks |
| Performance: Mechanical Strength | Does not impart mechanical strength | Does not impart mechanical strength to surgical site (matches WMT-TCP, ChronOS) |
| Sterility | Gamma radiation, single use | Sterilized by gamma radiation, single use only (matches WMT-TCP, ChronOS) |
| Biocompatibility | Established | Established (matches WMT-TCP, ChronOS) |
| Dosage Form(s) | Granules/Blocks (WMT-TCP, ChronOS) | Morsels and Blocks |
The primary study mentioned proving the device's performance is an animal study demonstrating resorption.
2. Sample Size Used for the Test Set and Data Provenance
The provided document refers to "animal studies" as the basis for resorption performance.
- Sample Size: Not explicitly stated as "sample size" in the context of a clinical study; it refers to the number of animals used in the study. This number is not specified in the document.
- Data Provenance: Animal studies (implies pre-clinical, laboratory setting, potentially domestic, but country of origin is not specified).
- Retrospective or Prospective: Animal studies are typically prospective in design, where interventions are applied, and outcomes are observed.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
N/A. This is a medical device for bone void filling, not a diagnostic AI device requiring expert-established ground truth for image interpretation or similar tasks. The "ground truth" for resorption would have been established through methods like histology, imaging, or biochemical assays in the animal model.
4. Adjudication Method for the Test Set
N/A. Not applicable to a non-diagnostic medical device study where ground truth is established through experimental measurements rather than human interpretation.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not conducted for this device. This type of study is relevant for diagnostic devices (especially imaging-based AI) to assess the impact of AI assistance on human reader performance.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance)
N/A. This is a physical bone void filler, not an algorithm or AI system. Its performance is intrinsic to its material properties and biological interaction.
7. Type of Ground Truth Used
The document mentions "Results from animal studies demonstrate that eighty percent of Vitoss Scaffold is resorbed within twelve weeks." This indicates that the ground truth for resorption was likely established through observational data collected from animal models, using methods such as:
- Histology: Microscopic examination of tissue samples to assess material presence and bone ingrowth.
- Imaging: X-rays or micro-CT to quantify scaffold volume change over time.
- Gravimetric analysis: Measuring the remaining mass of the implant.
- Biochemical markers: Assessing bone remodeling.
The specific method(s) are not detailed, but it falls under experimental/outcomes data from animal models.
8. Sample Size for the Training Set
N/A. As this is not an AI/ML device, there is no "training set" in the conventional sense. The "training" for the device's design and manufacturing process would come from material science research, preclinical testing, and potentially predicate device data.
9. How the Ground Truth for the Training Set Was Established
N/A. No training set for an algorithm is applicable here. The development and validation of the device would rely on established scientific principles for biomaterials, in vitro testing, and the aforementioned animal studies, not on "ground truth" for a training set.
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(357 days)
VITOSS SCAFFOLD SYNTHETIC CANCELLOUS BONE VOID FILLER
Vitoss Scaffold Synthetic Cancellous Bone Void Filler is intended only for use, as a bone void filler for voids or gaps that are not intrinsic to the stability of the bony structure. Vitoss Scaffold is indicated for use in the treatment of surgically created osseous defects or osseous defects created from traumatic injury to the bone. Vitoss Scaffold should not be used to treat large defects that in the surgeon's opinion would fail to heal spontaneously.
Vitoss Scaffold is intended to be gently packed into bony voids or gaps of the skeletal system (i.e., the extremities, spine and pelvis). Following placement in the bony void or gap, the calcium phosphate scaffold resorbs and is replaced with bone during the healing process.
Vitoss Scaffold is a porous calcium phosphate resorbable bone void filler for the repair of bony defects. It is an osteoconductive porous implant with a trabecular structure that resembles the multidirectional interconnected porosity of human cancellous bone. Pore diameters in the scaffold range from 1 um to 1000 µm (1 mm). The implant is provided sterile in block and morsel forms.
Vitoss Scaffold guides the three-dimensional regeneration of bone in the defect site into which it is implanted. When Vitoss Scaffold is placed in direct contact with viable host bone, new bone grows in apposition to the calcium phosphate surfaces of the implant. As the implant resorbs, bone and other connective tissues grow into the space previously occupied by the scaffold. Results from animal studies demonstrate that eighty percent of Vitoss Scaffold is resorbed within twelve weeks.
The provided text describes a 510(k) summary for the "Vitoss™ Scaffold Synthetic Cancellous Bone Void Filler" and its comparison to a predicate device, Pro Osteon 500R. The submission focuses on demonstrating substantial equivalence to the predicate device, not on meeting specific, quantitative acceptance criteria through a standalone study with a device performance table, as might be done for an AI/software device. Hence, most of the requested information regarding acceptance criteria, sample sizes, expert involvement, and ground truth for a study is not present in this document.
Here's an analysis of what information is available from the text in relation to your request:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly state quantitative "acceptance criteria" in the format of a performance table with specific thresholds that the new device must meet to be considered "accepted." Instead, it presents a comparison to a predicate device (Pro Osteon 500R) across various characteristics, implying that performance comparable to or better than the predicate is the criterion for substantial equivalence.
Comparison to Predicate (Vitoss Scaffold vs. Pro Osteon 500R):
| Feature/Performance Metric | Vitoss™ Scaffold (Submitted Device) | Pro Osteon 500R (Predicate Device) |
|---|---|---|
| Intended Use | Synthetic Bone Void Filler for individuals with bony defects resulting from surgery or trauma | Synthetic Bone Void Filler for individuals with bony defects resulting from surgery or trauma |
| Target Population | Individuals with bony defects resulting from surgery or trauma | Individuals with bony defects resulting from surgery or trauma |
| Anatomical Locations | Bony voids or gaps of the skeletal system (extremities, spine, pelvis) | Bony voids or gaps of the skeletal system (extremities, spine, pelvis) |
| Labeling | Same intended use, contraindications, warnings, precautions, adverse events as predicate | Same intended use, contraindications, warnings, precautions, adverse events as Vitoss |
| Chemical Composition | Calcium salt | Calcium salts |
| Mineral Phase(s) | β-Tricalcium Phosphate Ca3(PO4)2 | Hydroxyapatite Cajo(PO4)g(OH)2, Calcium Carbonate CaCO3 |
| - Physical Structure | Trabecular structure similar to cancellous bone | Trabecular structure similar to cancellous bone |
| · Porosity | Approximately 90% | Approximately 55% |
| · Pore Size (range) | 1-1000 µm | 280-779 µm |
| Osteoconductivity | Osteoconductive | Osteoconductive |
| Resorption® | Demonstrated as 76% resorbed at six weeks and 86% resorbed at twelve weeks | Reported as 20% resorbed at six weeks and 45% resorbed at twelve weeks |
| Bone Remodeling | Demonstrated as 0.6 (ratio of bone in implant to adjacent bone) at six weeks and 1.2 at twelve weeks | Demonstrated as 0.4 (ratio of bone in implant to adjacent bone) at six weeks and 0.5 at twelve weeks |
| Mechanical Strength | Does not impart mechanical strength to surgical site | Does not impart mechanical strength to surgical site |
| Sterility | Sterilized by gamma radiation, single use only | Sterilized by gamma radiation, single use only |
| Biocompatibility | Established | Established |
| Dosage Form(s) | Morsels (1-4 mm sizes) and blocks (9x23mm cylinder) | Morsels (1-4 mm sizes) |
The "study" proving the device meets the "acceptance criteria" (which is substantial equivalence to the predicate) is the Non-clinical Performance Data.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document refers to "Pre-clinical animal data" and "Results from animal studies" to demonstrate performance characteristics like resorption and bone ingrowth.
- Sample size: Not specified.
- Data provenance: "Animal studies." No country of origin is mentioned. These would be prospective animal studies.
The document also refers to "clinical practice for more than 25 years" and "dentistry and oral reconstructive surgery" and "orthopedic problems" for calcium-based ceramic materials in general, and a "review of FDA's Manufacturer and User Facility Device Experience Database (MAUDE), conducted on 12/13/1999" regarding the predicate device (Pro Osteon 500R) and other devices with product code MQV.
- Sample size: Not specified for the historical clinical data. MAUDE review would cover any reported incidence but not a specific study size.
- Data provenance: Historical clinical data (likely worldwide, though not specified) and the MAUDE database (US data). This would be retrospective for the MAUDE review and general clinical use.
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)
This information is not provided in the document. The "ground truth" for the animal studies would likely involve histological analysis or other objective measurements in the animals, not human expert interpretation in the way one might evaluate an AI diagnostic device.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not provided as it's not applicable to the type of pre-clinical animal studies or MAUDE database review described.
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
- No MRMC comparative effectiveness study was done. This is a medical device (bone void filler), not an AI/software diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- No standalone algorithm performance study was done. This is a medical device, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For the animal studies:
- Ground Truth Type: Likely objective measurements of bone ingrowth, resorption rates, and tissue integration, probably based on histological analysis or imaging (e.g., X-rays, micro-CT) of the animal models. The document mentions "bone growth," "bone ingrowth," and "bone remodeling."
For the MAUDE database review:
- Ground Truth Type: Real-world adverse event reports.
8. The sample size for the training set
This information is not applicable as this is not an AI/machine learning device requiring a training set.
9. How the ground truth for the training set was established
This information is not applicable as this is not an AI/machine learning device.
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