(18 days)
Beta-bsm Injectable Bone Substitute Material is an implantable bone graft that is a synthetic calcium phosphate, poorly crystalline hydroxyapatite material intended for use in filling bone voids or defects of the skeletal system (such as the extremities, spine and pelvis) that are not intrinsic to the stability of the bony structure. These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone. Beta-bsm Injectable Bone Substitute Material is a bone graft substitute that resorbs and is replaced with new bone during the healing process.
Gamma-bsm Moldable Bone Substitute Material is an implantable bone graft that is a synthetic calcium phosphate, poorly crystalline hydroxyapatite material intended for use in filling bone voids or defects of the skeletal system (such as the extremities, spine and pelvis) that are not intrinsic to the stability of the bony structure. These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone. Gamma-bsm Moldable Bone Substitute Material is a bone graft substitute that resorbs and is replaced with new bone during the healing process.
Beta-bsm Injectable Bone Substitute Material is synthetic, biocompatible bone graft substitute material. At the time of use, the powder component is combined with a specified volume of mixing solution and mixed to form a paste. Mixing is facilitated by a syringe-to-syringe mixing system. The resulting paste can be administered to the treatment site by injection or manual application. The material can be shaped into a desired form in-situ prior to implantation. After the paste is applied to the treatment site, it hardens at body temperature and converts to an apatitic calcium phosphate material. The end product, poorly crystalline hydroxyapatite (PCHA), is of low crystalline order with a similar chemical and crystalline structure to that of natural bone minerals. Beta-bsm Injectable Bone Substitute Material is an osteoconductive material that is resorbed and replaced by natural bone over time.
Gamma-bsm Moldable Bone Substitute Material is a synthetic, biocompatible bone graft substitute material. At the time of use, the powder component is combined with a specified volume of mixing solution and mixed to form a putty. The resulting putty is administered to the treatment site by manual application. The material can be shaped into a desired form in-situ prior to implantation. After the putty is applied to the treatment site, it hardens at body temperature and converts to an apatitic calcium phosphate material. The end product, poorly crystalline hydroxyapatite (PCHA), is of low crystalline order with a similar chemical and crystalline structure to that of natural bone minerals. Gamma-bsm Moldable Bone Substitute Material is an osteoconductive material that is resorbed and replaced by natural bone over time.
The provided document is a 510(k) premarket notification for two bone substitute materials, Beta-bsm Injectable Bone Substitute Material and Gamma-bsm Moldable Bone Substitute Material.
The document states under "Performance Data" for both devices:
"Regression testing consistent with Class II Special Controls Guidance Document: Resorbable Calcium Salt Bone Void Filler Device; Guidance for Industry and FDA Staff (dated June 2, 2003) has been submitted to show that the proposed changes to the predicate devices do not affect the risk profile of the devices."
This indicates that the submission relies on regression testing to demonstrate that the proposed changes to the predicate devices do not negatively impact their safety and effectiveness. This is a common approach for modifications to already cleared devices. It does not describe a de novo study evaluating the performance of the device against newly established acceptance criteria in the same way a novel device might be assessed. Instead, it suggests that the acceptance criteria are implicitly linked to maintaining the established risk profile of the predicate devices.
Therefore, the requested information about a new study with explicit acceptance criteria, sample sizes, expert involvement, and specific performance metrics for the current submission's devices is not detailed in this 510(k) summary. The document points to adherence to a guidance document for resorbable calcium salt bone void fillers as the basis for performance data.
Based on the provided text, a table of acceptance criteria and reported device performance, sample sizes, expert details, adjudication methods, MRMC studies, standalone studies, and how ground truth for training data were established cannot be fully extracted or described because the submission relies on regression testing against predicate device performance.
General Interpretation of the Document Regarding Performance:
- Acceptance Criteria: While not explicitly listed with numeric targets, the acceptance criteria are implied to be that the proposed changes to Beta-bsm and Gamma-bsm do not affect the risk profile of their respective predicate devices. This means the performance should be comparable to or not worse than the predicate devices' established performance. The "Class II Special Controls Guidance Document: Resorbable Calcium Salt Bone Void Filler Device" would outline the general expectations and testing methodologies for this type of device.
- Reported Device Performance: The document states that "Regression testing... has been submitted to show that the proposed changes... do not affect the risk profile." This is the reported performance – a demonstration of equivalence in risk profile, rather than a quantifiable performance metric for the current devices themselves.
In summary, this 510(k) is for a modification/predicate comparison, not a de novo study of a new device's absolute performance against novel acceptance criteria. Therefore, most of your specific questions are not directly answerable from this text.
§ 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.