(88 days)
BoneSource® Hydroxyapatite Cement (HAC) is cement indicated for the augmentation or restoration of bony contour in the craniofacial skeleton.
BoneSource® Hydroxyapatite Cement (HAC) is a self-setting, calcium phosphate cement that hardens in an aqueous environment at body temperature and consists solely of calcium phosphate compounds. The cement is mixed freshly at the of implantation and can be applied directly onto the area requiring augmentation. BoneSource® remains malleable for up to 20 minutes during which time it can be contoured as desired.
BoneSource® is composed of two phosphates of calcium (i.e., dicalcium phosphate and tetracalcium phosphate). At the time of use, BoneSource® is combined with sterile water, sterile saline or sodium phosphate solution (.25M), and under in-vitro conditions (37°C), hardens in approximately 20 minutes. An isothermic setting reaction occurs which yields pure hydroxyapatite after four hours with no significant dimensional changes and no by-products. The compressive strength of BoneSource® is >= 50 MPa. The pH of the BoneSource® paste during the setting reaction has been determined to be in the range of 6.5 to 8.5. As a consequence of its apatitic nature, the product is highly compatible with both soft and hard tissue. Approximately 45% of the implant volume consists of micropores (the remainder is solid) with an average pore size of
Acceptance Criteria and Device Performance for BoneSource® Hydroxyapatite Cement (HAC)
The BoneSource® Hydroxyapatite Cement (HAC) is intended for the augmentation or restoration of bony contour in the craniofacial skeleton. The provided document is a Summary of Safety and Effectiveness for its premarket notification (K970400).
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria for BoneSource® HAC are derived from various in-vitro, animal, and clinical studies, focusing on safety, effectiveness, and material properties. Since the document is a premarket notification for substantial equivalence, the "acceptance criteria" are implicitly demonstrated through performance comparisons to a predicate device and established safety/effectiveness benchmarks.
| Feature / Acceptance Criteria | Reported Device Performance for BoneSource® HAC |
|---|---|
| Material Properties: | |
| Setting Time (to harden) | ≤ 20 minutes at 37°C (Reported: Hardens in approximately 20 minutes at 37°C) |
| Full Apatitic Conversion | Complete after 4 hours (Reported: X-ray diffraction patterns demonstrate setting reaction is complete after four hours, becoming totally apatitic with no by-products.) |
| pH range during setting | 6.5 to 8.5 (Reported: pH of the BoneSource® paste during the setting reaction has been determined to be in the range of 6.5 to 8.5, verified by lab testing.) |
| Dimensional Stability | No significant dimensional changes/shrinkage (Reported: No significant dimensional changes and no shrinkage observed after setting at 37°C by comparing dimensions of molds with set samples.) |
| Compressive Strength | ≥ 50 MPa (Reported: Compressive strength is ≥ 50 MPa, comparable to predicate device's 50-70 MPa.) |
| Porosity/Pore Size | **Approx. 45% micropores, 10% due to technical error and all explants as failures, investigators deemed explants not device-related. Deemed effective regardless of demographics or clinical characteristics.) |
| Safety (Cranial Defects): | |
| No adverse effects on blood chemistry (Ca, Cl, Na, K, HCO3, PO4) | No adverse effect on lab values expected (Reported: Evaluation of blood chemistry levels showed the presence of BoneSource® HAC is not expected to adversely affect laboratory values.) |
| Incidence of complications (defect- & patient-specific) | Majority presented no complications; no untoward rate (Reported: Majority of 175 implants presented no defect-specific complications. Majority of 103 patients presented no patient-related complications. Incidence of complications and adverse events not occurring at a rate considered untoward for the patient population. Adverse events not considered device-related when administered as intended.) |
| Non-device related adverse events/death | Adverse events not device-related (Reported: 5 adverse events: 2 deaths from cancer (not device-related), 1 stroke post-tumor removal, 1 hematoma, 1 CSF leak with protocol violation. None reported considered related to BoneSource® HAC when administered as intended.) |
Study Information
The acceptance criteria are supported by a combination of in-vitro testing, animal studies, biocompatibility testing, and a non-randomized clinical study.
2. Sample Size and Data Provenance:
- Test Set (Clinical Study):
- Sample Size: 103 patients, presenting 175 cranial defects.
- Data Provenance: Not explicitly stated, but the study was conducted under an approved IDE (Investigational Device Exemption) across three sites. Typically, IDE studies for FDA submissions are conducted in the United States and are prospective. The clinical study data was presented to FDA in support of a prior 510(k) (K953339).
- Type: Prospective, non-randomized clinical study.
3. Number of Experts and Qualifications for Ground Truth (Clinical Study):
- Expert involvement: The document mentions "Investigator and Medical Monitor" who did not consider explants to be device-related. It does not explicitly state the number or specific qualifications (e.g., years of experience) of these individuals or other experts involved in establishing ground truth for the clinical study. However, for an IDE study, these roles would typically be filled by qualified medical professionals, such as neurosurgeons or radiologists, depending on the specific evaluation criteria.
4. Adjudication Method (Clinical Study):
- Adjudication Method: Not explicitly detailed. The statement "none were considered by the Investigator and Medical Monitor to be device-related" implies an expert review and consensus or judgment (possibly 2+0 if only these two roles were involved) for assessing device-related adverse events and explants. No formal multi-expert adjudication method like "2+1" or "3+1" is described.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
- No, an MRMC comparative effectiveness study was not performed. This document describes a medical device (a bone cement), not an AI algorithm. Therefore, the concept of improving human readers with AI assistance is not applicable.
6. Standalone (Algorithm Only) Performance:
- No, a standalone (algorithm only) performance study was not performed. This document is about a physical medical device, not an algorithm or AI system.
7. Type of Ground Truth Used:
- In-vitro Studies: Physics/chemistry measurements, quantitative comparisons (e.g., X-ray diffraction patterns, pH measurements, dimensional measurements, compressive strength tests).
- Animal Studies: Histology, radiographic evaluation (Computed Tomography, X-rays), gross observations by researchers/veterinarians, clinical observations (e.g., absence of infection, extrusion).
- Clinical Study:
- Effectiveness: Radiographic evaluation of implant stability (volume loss) and assessment of device explants by investigators.
- Safety: Laboratory data (blood chemistry), observation of postoperative complications (defect-specific, patient-specific), and assessment of adverse events by investigators and medical monitors.
8. Sample Size for the Training Set:
- Not applicable. This document describes a physical medical device and its preclinical and clinical evaluation, not an AI algorithm that requires a "training set."
9. How the Ground Truth for the Training Set was Established:
- Not applicable. As stated above, there is no AI algorithm training set involved in this submission.
§ 878.3550 Chin prosthesis.
(a)
Identification. A chin prosthesis is a silicone rubber solid device intended to be implanted to augment or reconstruct the chin.(b)
Classification. Class II.