(533 days)
Bicera™ Resorbable Bone Substitute is intended for use as a bone void filler for voids or gaps that are not intrinsic to the stability of the bony structure. Bicera™ Resorbable Bone Substitute is indicated for use in the treatment of surgically created osseous defects or osseous defects resulting from traumatic injury to the bone. Bicera™ Resorbable Bone Substitute is intended to be packed into bony voids or gaps of the skeletal system as a bone void filler (i.e., extremities and pelvis). This product provides a bone void filler that resorbs and is replaced by bone during the healing process.
Bicera™ Resorbable Bone Substitute is a bioceramic medical device that its composition of crystalline phase contains 60% hydroxyapatite (HAP) and 40% beta-tricalcium (B-TCP). Bicera™ is a bone void filler for orthopedic surgery. It is indicated for use in the treatment of surgically created osseous defects or osseous defects resulting from traumatic injury to the bone. This composite material is acretts resumity in vivo and is replaced by new bone. Bicera™ Resorbable Bone Substitute is supplied sterile in various shapes and sizes.
Here's a breakdown of the acceptance criteria and the study that proves the device meets them, based on the provided text:
Acceptance Criteria and Device Performance
The core of the "acceptance criteria" for Bifcera™ Resorbable Bone Substitute is demonstrating substantial equivalence to an existing predicate device, MBCPTM Bone Graft Substitute (K032268). This is achieved by comparing several technological characteristics and demonstrating similar performance in biological and in-vivo settings.
Table of Acceptance Criteria and Reported Device Performance:
| Characteristic | Acceptance Criteria (Predicate Device: MBCPTM) | Reported Device Performance (Bicera™) | Notes |
|---|---|---|---|
| Composition (wt%) | 60% HAP and 40% β-TCP | 60% HAP and 40% β-TCP | Identical composition |
| Porosity (%) | 70 | 79.22 ± 1.04 | Bicera™ has slightly higher porosity. The submission implies this is acceptable for substantial equivalence, likely due to similar intended function and in-vivo performance. |
| Pore size (µm) | 450 ± 49 | 442.65 ± 80.31 | Very similar pore size, within the reported range of the predicate. |
| Ca/P | 1.60 ± 0.02 | 1.61 | Very similar Ca/P ratio, indicating similar mineralization properties. |
| Density (g/cm³) | 0.87 ± 0.04 | 0.64 ± 0.03 | Bicera™ has a lower density. This correlates with its higher porosity. Accepted due to other factors demonstrating substantial equivalence. |
| Pore structure | Interconnected pores | Interconnected pores | Identical pore structure, crucial for bone ingrowth. |
| Specific surface area (m²/g) | 1.8 ± 0.1 | 1.57 | Similar specific surface area. |
| Compressive strength (MPa) | 3.04 ± 0.79 | 1.80 ± 0.24 | Bicera™ has lower compressive strength. This difference is accepted likely because the device is "not intrinsic to the stability of the bony structure" and is a bone void filler. |
| Biocompatibility | Acceptable as per ISO 10993, ASTM F-1408-97, USP, FDA guidelines (implied from predicate) | Acceptable results for cytotoxicity, sensitization, irritation, acute systemic toxicity, pyrogen, and subcutaneous implantation study. | Demonstrated good affinity with surrounding tissue with no inflammatory or adverse reaction. |
| Resorption Profile & New Bone Formation | Substantially equivalent to predicate (implied from predicate's established performance) | Substantially equivalent to predicate in a long bone animal critical-sized defect model. | Demonstrated over time at multiple post-op evaluations. |
Study Details
The provided document describes studies conducted to demonstrate substantial equivalence, primarily focusing on non-clinical tests.
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Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- Test Set (Animal Study): The document mentions a "long bone animal critical sized defect model." It does not specify the exact sample size (number of animals or defects) used in this model.
- Data Provenance: The study was conducted by the submitter, Wiltrom Corporation (Taiwan). The provenance for the animal study is therefore prospective as it was specifically conducted for this submission.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- The document does not specify the number of experts or their qualifications for establishing ground truth in the animal study. The evaluation likely involved veterinary pathologists or histologists specializing in bone healing, but this is not explicitly stated.
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Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- The document does not describe any adjudication method used for the animal study results. The evaluation of resorption and new bone formation would typically involve histological assessment, often by one or more trained pathologists, but formal adjudication is not mentioned.
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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, an MRMC comparative effectiveness study was not done. This device is a bone substitute material, not an AI-powered diagnostic tool. Therefore, the concept of "human readers improve with AI" is not applicable here.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- No, this is not applicable. The device is a physical medical implant, not an algorithm.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- For the animal study comparing resorption and new bone formation, the ground truth was based on histopathological evaluation (pathology) of the bone defect sites at multiple post-operative evaluations. This is a standard method for assessing bone graft performance in animal models.
- For the biocompatibility tests (cytotoxicity, sensitization, etc.), the ground truth was established by standardized laboratory test methods (e.g., cell viability assays, skin irritation tests) which have defined endpoints for acceptability.
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The sample size for the training set:
- Not applicable. This device is a physical product, not a machine learning algorithm, so there is no "training set."
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How the ground truth for the training set was established:
- Not applicable, as there is no training set for this device.
§ 888.3045 Resorbable calcium salt bone void filler device.
(a)
Identification. A resorbable calcium salt bone void filler device is a resorbable implant intended to fill bony voids or gaps of the extremities, spine, and pelvis that are caused by trauma or surgery and are not intrinsic to the stability of the bony structure.(b)
Classification. Class II (special controls). The special control for this device is the FDA guidance document entitled “Class II Special Controls Guidance: Resorbable Calcium Salt Bone Void Filler Device; Guidance for Industry and FDA.” See § 888.1(e) of this chapter for the availability of this guidance.