(226 days)
CopiOs™ BVF, in combination with autologous bone marrow, is intended for use only for filling bone voids or gaps of the skeletal system (ie, extremities, pelvis, spine) that are not intrinsic to the stability of the bone structure. These voids may be a result of trauma or creation by surgeon. CopiOs™ BVF is intended to be gently packed into the void or gap and will resorb during the course of the healing process.
CopiOs™ BVF is a synthetic bone graft material consisting of mineralized, lyophilized collagen that has been formed into three-dimensional pads of various sizes for surgical implantation. The CopiOs™ BVF product sponge consists of dehydrothermally (DHT) cross-linked bovine dermal collagen mixed with calcium phosphate salt. The pads are approximately 67% mineral by weight. The fibrous collagen mixed with the calcium phosphate salt is cast into sponges as described in this application. The average porosity of the product was determined to be 93.39%, which allows for favorable conditions for cell migration and adherence to the collagenous matrix. Further, the calcium phosphate provides the mineral required for osteogenesis and the specific CopiOs™ BVF formulation provides a pH environment conducive for osteoinduction.
The provided text describes a 510(k) premarket notification for the CopiOs™ Bone Void Filler (BVF). The study supporting its substantial equivalence is a comparative animal study.
Here's an analysis of the acceptance criteria and study information, based on the provided document:
1. Table of acceptance criteria and the reported device performance
The document does not explicitly state quantitative "acceptance criteria" in the form of specific thresholds for success. Instead, it frames the performance in terms of "substantial equivalence" to a predicate device (HEALOS). The performance claims are qualitative comparisons.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Composition: Similar collagen and calcium phosphate components. | CopiOs™ BVF: 33% type 1 bovine collagen, 67% calcium phosphate salt. |
| HEALOS (predicate): 70% collagen, 30% non-ceramic hydroxyapatite. (Note: While different percentages, the document asserts substantial equivalence.) | |
| Physical Structure: Similar physical form and porosity. | CopiOs™ BVF: Mineralized, lyophilized collagen into 3D pads. Average porosity 93.39%. |
| HEALOS (predicate): Supplied as lyophilized product. (Implied similar physical structure). | |
| Resorption Rate: Resorbed by the body at a comparable rate. | CopiOs™ BVF & HEALOS: Resorption rates are "similar as evidenced in the comparative rabbit radial defect study." |
| Bone Regeneration/Remodeling: Promotes new bone formation and is remodeled equivalently. | CopiOs™ BVF & HEALOS: Both promote bone regeneration and are remodeled into new bone at equivalent rates "as demonstrated in the comparative rabbit radial defect study." |
| Intended Use & Target Population: Same use case and patient group. | CopiOs™ BVF & HEALOS: Intended for the same use (filling bone voids/gaps in skeletal system, combination with autologous bone marrow) and target populations. |
| Sterility: Device must be sterile. | CopiOs™ BVF & HEALOS: Both are sterile. |
| Favorable Environment for Cell Migration/Adherence: Provides suitable environment for cellular activity. | CopiOs™ BVF & HEALOS: Both provide a favorable environment for cell migration and adherence to the collagenous matrix. |
| pH Environment for Osteoinduction: Conducive to bone formation. | CopiOs™ BVF: Specific formulation provides a pH environment conducive for osteoinduction. (Not explicitly stated for HEALOS but implied through general equivalence). |
2. Sample size used for the test set and the data provenance
- Test Set Sample Size: The document mentions a "comparative rabbit radial defect study." The exact number of rabbits or defect sites used in this study (the "test set" for performance evaluation) is not specified in the provided text.
- Data Provenance: The study was a "comparative rabbit radial defect study," indicating animal data. The country of origin is not explicitly stated, but the sponsor is based in Minneapolis, Minnesota. The study would be considered prospective in nature, as it's an experimental design to evaluate the device.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
The document does not provide information on the number or qualifications of experts involved in establishing the ground truth for the rabbit study. Histological analysis or imaging interpretation, which would likely involve experts, is implied for assessing bone regeneration and resorption, but details are absent.
4. Adjudication method for the test set
The document does not specify an adjudication method for the test set.
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, a multi-reader multi-case (MRMC) comparative effectiveness study was not conducted, nor is this device an AI-based system. This question is not applicable to the provided information.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This question is not applicable as the device is a medical implant (bone void filler), not an algorithm or AI system.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
For the "comparative rabbit radial defect study," the ground truth for evaluating bone regeneration and resorption would likely be based on histopathology (microscopic examination of tissue samples) and potentially imaging analysis (e.g., radiography, micro-CT) of the radial defects. This would constitute a form of objective, scientific assessment.
8. The sample size for the training set
This device is not an AI/ML algorithm that requires a "training set" in the computational sense. Therefore, the concept of a training set sample size is not applicable. The "training" for this device's development would involve biological research and materials science, not data training.
9. How the ground truth for the training set was established
As in point 8, the concept of a "training set" and its ground truth in the context of AI/ML is not applicable to this bone void filler 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.