(65 days)
These products are indicated for bony voids or gaps that are not intrinsic to the stability of the bony structure. They are indicated to be placed into bony voids or gaps of the skeletal system (e.g., extremities, spine, ilium and/or pelvis). These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone. The product provides a void filler that remodels into the recipient's skeletal system.
The CANCELLO-PURE™ Wedge is machined into a wedge shape from bovine bone processed with the BioCleanse® Tissue Sterilization Process. These products are preshaped for surgeon convenience.
Acceptance Criteria and Device Performance Study for CANCELLO-PURE™ Wedge
This document describes the acceptance criteria and the study that demonstrates the CANCELLO-PURE™ Wedge device meets these criteria, as presented in the provided 510(k) summary.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Criteria | Reported Device Performance | Study Supporting Performance |
|---|---|---|---|
| Material Equivalence | Materials are substantially equivalent to predicate devices. | The CANCELLO-PURE™ Wedge is machined from bovine bone. | Stated as "materials... [are] equivalent to predicate devices" in the 510(k) summary. |
| Design Equivalence | Design is substantially equivalent to predicate devices. | The device is machined into a wedge shape from bovine bone. | Stated as "design... [is] equivalent to predicate devices" in the 510(k) summary. |
| Function Equivalence | Function is substantially equivalent to predicate devices. | Provides a void filler that remodels into the recipient's skeletal system. | Stated as "function... [is] equivalent to predicate devices" in the 510(k) summary. |
| Remodeling Capability | Capable of remodeling comparably to allograft. | Processed bovine bone (used in CANCELLO-PURE™ Wedge) shows comparable remodeling to allograft. | Animal model study. |
| Viral Inactivation | BioCleanse® process capable of reducing a panel of viruses to below detectable limits. | The BioCleanse® process achieved reduction of a panel of viruses to below detectable limits. | Viral inactivation study using a worst-case representation of the BioCleanse® process. |
2. Sample Sizes and Data Provenance
-
Test Set Sample Size:
- Animal Model (Remodeling): Not explicitly stated. The document refers to "an animal model" without specifying the number of animals or cases.
- Viral Inactivation Study: Not explicitly stated regarding sample size beyond "a panel of viruses."
-
Data Provenance:
- Animal Model (Remodeling): The document does not specify the country of origin. It is a prospective study as it involves an "animal model."
- Viral Inactivation Study: The document does not specify the country of origin. It is a prospective study as it involved a "worst-case representation of the BioCleanse® process."
3. Number and Qualifications of Experts for Ground Truth
- Not Applicable. The provided document does not describe studies involving human medical image or diagnosis interpretation that would require expert adjudication for ground truth. The studies cited are an animal model and a viral inactivation study.
4. Adjudication Method for Test Set
- Not Applicable. As noted above, the studies do not involve human interpretation requiring adjudication.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- No. An MRMC comparative effectiveness study was not done. The document does not describe studies evaluating human reader performance, either with or without AI assistance, or any comparison to human readers.
6. Standalone (Algorithm Only) Performance Study
- No. A standalone algorithm performance study was not mentioned. The device is a physical bone void filler, not an AI algorithm. The performance studies relate to the biological and safety characteristics of the physical product.
7. Type of Ground Truth Used
- Animal Model (Remodeling): The ground truth for remodeling capability would be established through histological analysis, radiographic imaging, and potentially biomechanical testing of the bone regeneration in the animal model, comparing the CANCELLO-PURE™ Wedge to an allograft.
- Viral Inactivation Study: The ground truth for viral inactivation would be established by laboratory assays capable of detecting and quantifying viruses. "Below detectable limits" serves as the ground truth.
8. Sample Size for Training Set
- Not Applicable. There is no mention of a "training set" as this is not an AI/machine learning device. The studies described are for non-AI medical device validation.
9. How Ground Truth for Training Set was Established
- Not Applicable. As there is no training set mentioned, this question is not relevant.
§ 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.