(84 days)
Accell Evo3 is intended for filling voids and gaps in the skeletal system that are not intrinsic to the stability of the bony structure. The product is indicated for use as a bone graft extender in the spine, extremities and pelvis. Accell Evo3 may also be used as a bone void filler in the posterolateral spine, extremities and pelvis. The voids or gaps may be surgically created defects or the result of traumatic injury to the bone.
Accell Evo3 is a moldable putty that contains ground, cortical de-mineralized bone marrix (DBM) in particulate and solubilized forms as well as a poloxamer reverse phase medium for proper handling. The device is packaged in a prefiled open-bore polycarbonate syringe and terminally sterilized by e-beam radiation. The DBM used to manufacture Accell Evo3 is only obtained from AATB-accredited facilities.
Here's a breakdown of the acceptance criteria and the study information based on the provided text, formatted as requested:
Acceptance Criteria and Device Performance
The acceptance criteria are implied by the claim of "effective bone formation through fusion" and "equivalence to autograft." The device performance is the demonstration that it met these criteria.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Effective bone formation through fusion | Demonstrated effective bone formation through fusion (in posterolateral rabbit spine model) |
| Equivalence to autograft | Radiographic, histological, and biomechanical evidence of equivalence to autograft (in posterolateral rabbit spine model) |
| Provides a favorable environment that stimulates bone growth and remodeling (Osteoconductivity) | Accell Evo3 is an osteoconductive bone void filler. It creates a favorable environment for bone growth and remodeling. |
| Osteoinductive potential | Assayed in vitro for bone morphogenetic protein-2, with in vitro assay validated to an in vivo (athymic mouse) osteoinductive assay. |
| Biocompatible and safe | DBM processing methods evaluated for viral inactivation potential, determined to provide significant viral inactivation. |
| Resorption over time | Device is resorbed over time. |
Study Information
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Sample sized used for the test set and the data provenance:
- Test Set Sample Size: Not explicitly stated as a number of rabbits, but the study was conducted in a "posterolateral rabbit spine model."
- Data Provenance: Animal study (rabbit model), likely prospective (an experimental study designed to test the device). Country of origin is not specified.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not specified. The assessment involved "Radiographic, histological and biomechanical evidence," suggesting evaluation by relevant experts in these fields (e.g., veterinary radiologists, histopathologists, biomechanical engineers), but their number or specific qualifications are not provided.
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Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not specified.
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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. This was not an MRMC study comparing human readers or AI assistance. It was an animal study evaluating direct device performance.
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If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- N/A. This device is a bone void filler, not an algorithm.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The ground truth was established through radiographic, histological, and biomechanical evidence from the animal model. This combines imaging findings, tissue analysis (pathology), and functional/mechanical testing to assess bone formation and fusion.
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The sample size for the training set:
- N/A. This is not an AI/machine learning device, so there is no "training set."
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How the ground truth for the training set was established:
- N/A.
§ 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.