(409 days)
Beta TCP Granules Bone Void Filler (BVF) is indicated to be gently packed into bony voids or gaps of the skeletal system (i.e., extremities and pelvis). These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone. Beta TCP Granules is indicated only for bony voids or gaps that are not intrinsic to the stability of the bony structure. Beta TCP Granules BVF will resorb and be replaced with bone during the healing process.
Beta TCP Granules Bone Void Filler is composed of porous, osteoconductive, resorbable beta- tricalcium phosphate (B-TCP) granules for repair of bony defects. The single use Beta TCP Granules sterile kit contains: Calcium Phosphate granules contained in a plastic vial packaged within two industry standard peel pouches that provide a double sterile barrier.
Here's a breakdown of the acceptance criteria and the study information for the Beta TCP Granules device, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Chemistry | Phase pure beta-tricalcium phosphate | Composed of phase pure beta-tricalcium phosphate (via FTIR and XRD) |
| Crystallinity | Crystalline, phase-pure beta-tricalcium phosphate with no other crystalline or amorphous phases | Crystalline, phase-pure beta-tricalcium phosphate with no other crystalline or amorphous phases detected (via X-ray Diffraction) |
| Physical Form | Porous granules | Porous granules (via Scanning Electron Microscopy). Subject device is spherical; predicate device is irregular. |
| Porosity | Interconnected porosity within the range of currently approved beta tricalcium phosphate bone void fillers | Interconnected porosity falls within the range (via Mercury Intrusion Porosimetry) |
| Solubility | Similar solubility profiles to predicate device | Demonstrated similar solubility profiles (via in vitro dissolution measuring Ca2+ ion concentration) |
| Biocompatibility | Compliant with ISO 10993-1 | Biocompatible and meets requirements of ISO standards |
| Sterility | Sterility Assurance Level (SAL) 10^-6 | Validated to SAL 10^-6 with radiation dose of 25kGy - 40 kGy (in accordance with ISO 11137-2006) |
| Risk Management | Identified hazards acceptable and/or mitigated to an acceptable level | Identified hazards acceptable and/or mitigated, residual risk deemed acceptable |
| Resorption & Bone Ingrowth | Resorbed over time and allows bone ingrowth | Resorbed over time and allows bone ingrowth (demonstrated in animal model) |
| Safety Profile | Maintain previously demonstrated safety profile of beta-TCP materials | Maintains previously demonstrated safety profile of beta-TCP materials |
2. Sample Size Used for the Test Set and Data Provenance
- The primary "test set" for demonstrating substantial equivalence was a comparison of critical specifications between the Beta TCP Granules and the predicate device, Cerasorb M Ortho (K040216). This involves direct laboratory analysis of material properties rather than human patient data.
- Data Provenance: The document does not explicitly state the country of origin for the lab-based material characterization studies. It is implicitly "prospective" in the sense that these tests were conducted on the Beta TCP Granules product for the submission.
- Animal Study: A "large animal, cancellous bone defect model" was used for non-clinical animal data. The document does not specify the exact sample size (number of animals) for this study, nor its country of origin. This would be considered prospective animal data specifically generated for this submission.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
- This device submission relies on non-clinical testing (material characterization and animal studies), not on human clinical data or expert interpretation of images/diagnoses.
- Therefore, the concept of "experts establishing ground truth for the test set" in the context of human clinical data or diagnostic accuracy studies is not applicable here. The "ground truth" for the material properties was established by validated analytical methods and scientific standards.
4. Adjudication Method for the Test Set
- Not applicable. As noted above, this submission relies on non-clinical laboratory and animal studies, not human clinical data that would require adjudication of findings.
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
- Not applicable. This device is a resorbable bone void filler and does not involve AI or human image interpretation for diagnosis or treatment planning in a clinical setting.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
- Not applicable. This device is a material product, not an algorithm.
7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)
- The "ground truth" for this submission is based on:
- Scientific and Analytical Measurements: For chemistry, crystallinity, physical form, porosity, and solubility, the ground truth was established by validated laboratory techniques (FTIR, XRD, SEM, Mercury Intrusion Porosimetry, ICP-AES) according to scientific standards.
- Biological Standards: For biocompatibility, the ground truth was adherence to ISO 10993-1.
- Validated Sterilization Protocols: For sterility, adherence to ISO 11137-2006 for SAL 10^-6.
- Animal Model Outcomes: For resorption and bone ingrowth, the ground truth was the observation of these phenomena in a "large animal, cancellous bone defect model."
8. The Sample Size for the Training Set
- Not applicable. This device is a physical product and does not involve a "training set" in the context of machine learning or AI. The product itself is the subject of characterization.
9. How the Ground Truth for the Training Set Was Established
- Not applicable. As there is no training set, there is no ground truth to establish for it.
§ 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.