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510(k) Data Aggregation
(313 days)
NuROs Bone Graft Substitute 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. NuROs Bone Graft Substitute resorbs and is replaced with bone during the healing process.
NuROs Bone Graft Substitute is an osteoconductive bone void filler with interconnective pore system. It is made of synthetic beta-tricalcium phosphate (B-TCP) indicated for bone void filling. It is suitable for individuals with bone voids of gaps, caused by surgery or trauma.
NuROs Bone Graft Substitute is available in granule type and block type with different volumes which are 1c.c, 2.5c.c, 5c.c, 10c.c, 20c.c, 25c.c and 30c.c. Granule types are provided in 0.2 ~ 0.5mm, 0.5 ~ 1mm, 1 ~ 2mm and 3mm of particle size. Block type is provided in 5mm x 5mm x 10mm, 5mm x 20mm, 10mm x 10mm x 10mm and 10mm x 25mm x 25mm size.
NuROs Bone Graft Substitute is pure ß-TCP with all crystalline phase. The Ca/P ratio is 1.5. The structure of the material is multidirectional interconnective porosity with >70% porosity. The propose device does not impart mechanical strength to surgical site.
The NuROs Bone Graft Substitute is gamma irradiated and provided for single use only.
The provided text describes the 510(k) summary for the NuROs Bone Graft Substitute, focusing on its substantial equivalence to a predicate device. Here's a breakdown of the acceptance criteria and the study information as requested:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Criteria/Tests | NuROs Bone Graft Substitute Reported Performance |
|---|---|---|
| Biocompatibility | ISO 10993-1 (Evaluation and testing) | "Testing performed on NuROs shows biocompatible with no significant adverse observations of any kind." "As a biomaterial, beta-TCP has consistently proven to be non-toxic, non-allergenic, and biocompatible and elicits no inflammation. No adverse system effects have been observed." |
| ISO 10993-3 (Genotoxicity, carcinogenicity, reproductive toxicity) | (Covered by general biocompatibility statement) | |
| ISO 10993-5 (In vitro cytotoxicity) | (Covered by general biocompatibility statement) | |
| ISO 10993-6 (Local effects after implantation) | (Covered by general biocompatibility statement and animal test, which includes histomorphometry) | |
| ISO 10993-10 (Irritation and skin sensitization) | (Covered by general biocompatibility statement) | |
| ISO 10993-11 (Systemic toxicity) | (Covered by general biocompatibility statement) | |
| ISO 10993-12 (Sample preparation and reference material) | (Standard applied for testing) | |
| Sterilization & Shelf Life | ISO 11737-1,-2; ISO 11137-2; ASTM F1980-07; ASTM F88-85; ASTM F1140:2000; ASTM D4332:2001; ASTM 1608; ASTM F1929-98 (microbiological methods, sterilization dose, accelerated aging, seal strength, pressurization failure, conditioning, microbial ranking, dye penetration) | (Implied to meet standards as part of overall safety and effectiveness assessment). The device is "gamma irradiated and provided for single use only." |
| Performance (Bench Tests) | Chemical Composition (pure beta-TCP, crystalline phase, no impurities) | "composed of pure beta-TCP and all crystalline phase, no other impurities were presented." |
| Elemental Analysis (Ca/P ratio) | "the ratio of Ca to P was approximately 1.5." (Matches predicate's stated 1.5) | |
| Structure Observation (porous structures) | "has similar porous structures." (Predicate: multidirectional interconnected porosity, NuROs: multidirectional interconnective pore system with >70% porosity) | |
| Specification of Device Porosity (>70% porosity, pore size) | ">70% porosity." "Pore size: 70 ~ 400 μm" (Predicate: 30 ~ 400 μm, slight difference acknowledged but deemed not problematic). | |
| TGA-residue Analysis (no unsintered material/trace elements) | "no unsintered material or any trace elements." | |
| Ultra Trace Elements (concentrations in accordance with standard) | "the ultra-trace elements concentrations were in accordance with the standard." | |
| pH Test | (Passed, results showed "same characteristics as the predicate device") | |
| Performance (Animal Test) | Degradation rate, bone-defect interface, and overall healing comparable to predicate device. Safety and effectiveness. | "the data showed that the proposed device, NuROs Bone Graft Substitute is as effective as the predicate device." "A series of safety tests were performed to assess the safety and effectiveness of the NuROs Bone Graft Substitute." |
| Conformity to Standard | ASTM F1088-04a Standard Specification for Beta-Tricalcium Phosphate for Surgical Implantation | "NuROs Bone Graft Substitute conforms to the recognized consensus standard specification for surgically implantable beta-tricalcium phosphate." |
| Overall Conclusion | Meet requirements of pre-defined acceptance criteria and intended uses regarding safety and effectiveness. | "All the test results demonstrate NuROs Bone Graft Substitute meets the requirements of its pre-defined acceptance criteria and intended uses." "The proposed device is substantially equivalent to the predicate device in design, operation, intended use and performance claims." "can be concluded that NuROs Bone Graft Substitute is as safe and effective as the predicate device." |
2. Sample size used for the test set and the data provenance
- Animal Test Specifics:
- Sample Size: Not explicitly stated as a number of animals in the provided text. It mentions "porcine models" and "Each tibia of the pig was drilled with two blind-ended tunnels" where "different bone grafts were implanted into each tunnel of each leg." This implies at least one pig, but likely more, given common practice in animal studies to achieve statistical power. However, no specific number is given.
- Data Provenance: Porcine models (Pigs). The study is prospective in terms of observing the effects after implantation.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- This information is not provided in the text. The animal study involved histomorphometry and imaging (CT Scans, X-rays), which would typically be evaluated by experts (e.g., veterinary pathologists, radiologists), but their number or qualifications are not mentioned.
4. Adjudication method for the test set
- The text does not describe any adjudication method. It states that CT Scans, X-rays, and Histomorphometry were taken to observe and assess the results. This implies expert interpretation, but no specific method for resolving discrepancies among multiple readers (if any) is detailed.
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 submission is for a bone graft substitute (a material implant), not an AI diagnostic/imaging device. Therefore, the concept of human readers improving with AI assistance is not applicable.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. As stated above, this is a material implant, not an algorithm or AI device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- For the animal study, the "ground truth" for assessing effectiveness (degradation rate, bone defects, healing) was established through a combination of:
- Direct observation: Measurements of defect diameters.
- Imaging: CT Scans and X-rays.
- Pathology/Histology: Histomorphometry.
- Comparative data: Effectiveness was assessed by comparing the NuROs device to the predicate device within the porcine models.
8. The sample size for the training set
- Not Applicable. This is a material implant, not a software/AI device that requires a training set.
9. How the ground truth for the training set was established
- Not Applicable. No training set was used for this type of device.
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