(27 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 (i.e. the extremities, posterolateral 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 (i.e. the extremities, posterolateral 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.
CarriGen Porous Bone Substitute Material is an injectable, self setting, macro-porous, osteo-conductive, calcium phosphate bone graft substitute material that is intended for use to fill bony voids or gaps of the skeletal system of the extremities, spine (i.e. posterolateral spine), and the 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. CarriGen is a bone graft substitute that resorbs and is replaced with new bone during the healing process.
EquivaBone is a bone graft substitute that combines synthetic calcium phosphate and demineralized bone. It is resorbed and replaced with new bone during the healing process. It is intended for use to fill bony voids or gaps of the skeletal system of the extremities, spine (i.e. posterolateral 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 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 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.
CarriGen Porous 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. CarriGen Porous Carrier Bone Substitute Material is an osteoconductive material that is resorbed and replaced by natural bone over time.
EquivaBone is a biocompatible bone graft substitute material consisting of synthetic calcium phosphate, carboxymethyl cellulose (CMC) and human demineralized bone matrix (DBM). It is supplied in a single use kit as sterile powders and hydration solution that are mixed together at the time of use in the operating room to form flowable putty which is implanted manually or can be extruded through a syringe. After implantation the product hardens at body temperature and resorbs and remodels during the healing process. Each lot of DBM contained within EquivaBone is assayed for osteoinductive potential in an athymic nude mouse model. This may or may not be predictive of EquivaBone osteoinductivity in humans.
The provided text is a 510(k) summary for several bone substitute materials: Beta-bsm Injectable Bone Substitute Material, Gamma-bsm Moldable Bone Substitute Material, CarriGen Porous Bone Substitute Material, and EquivaBone Osteoinductive Bone Graft Substitute.
For all these devices, the section "Performance Data" states: "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 statement indicates that the performance data submitted for these devices is regression testing against a guidance document, rather than a detailed study with specific acceptance criteria and performance metrics for the devices themselves. Regression testing, in this context, implies that the manufacturer is demonstrating that changes to existing predicate devices do not introduce new risks or affect their established safety and effectiveness, rather than proving the de novo effectiveness of the device against specific, quantitative acceptance criteria.
Therefore, the document does not contain a table of acceptance criteria and reported device performance in the typical sense of a clinical or analytical study demonstrating performance against a predefined threshold. Instead, it refers to compliance with a guidance document for Class II Special Controls.
Given this, it's not possible to populate all the requested fields as they pertain to a traditional performance study. However, some fields can be addressed based on the information provided.
Acceptance Criteria and Study Information for Beta-bsm, Gamma-bsm, CarriGen, and EquivaBone
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria Category | Specific Criteria (from guidance for regression testing) | Reported Device Performance (from regression testing) |
|---|---|---|
| Safety and Effectiveness | Compliance with Class II Special Controls Guidance Document: Resorbable Calcium Salt Bone Void Filler Device; Guidance for Industry and FDA Staff (dated June 2, 2003) | Regression testing submitted to show that proposed changes to predicate devices do not affect the risk profile of the devices. |
| Material Properties | (Implied: Material properties of the modified device are substantially equivalent to predicate, as per guidance) | (Implied: Demonstrated continued substantial equivalence and no adverse impact from changes) |
| Biocompatibility | (Implied: Biocompatibility profiles of the modified devices are acceptable as per guidance) | (Implied: Demonstrated continued substantial equivalence and no adverse impact from changes) |
| Sterility | (Implied: Sterilization methods are validated and maintained as per guidance) | (Implied: Demonstrated continued substantial equivalence and no adverse impact from changes) |
| Packaging/Shelf Life | (Implied: Packaging and shelf life integrity maintained as per guidance) | (Implied: Demonstrated continued substantial equivalence and no adverse impact from changes) |
Note: The document explicitly states "Regression testing consistent with Class II Special Controls Guidance Document... has been submitted to show that the proposed changes to the predicate devices do not affect the risk profile of the devices." This means the acceptance criteria are largely based on maintaining the established safety and effectiveness profile of the predicate devices following certain changes, as outlined in the specified FDA guidance for Resorbable Calcium Salt Bone Void Filler Devices. The document does not provide specific quantitative performance metrics from a de novo study.
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
- Sample Size for Test Set: Not specified in the provided text. The term "regression testing" suggests re-testing of certain parameters or components affected by changes, rather than a full-scale clinical trial with a defined sample size for efficacy determination.
- Data Provenance: Not specified.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)
- Not applicable as this was regression testing against a guidance document, not a study requiring expert-established ground truth for a diagnostic or predictive algorithm.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
- Not applicable for the type of testing described (regression testing for device changes against guidance).
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. These are bone substitute materials, not imaging analysis or AI-assisted diagnostic devices.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
- Not applicable. These are physical implantable medical devices.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Not applicable in the context of device performance in a clinical or diagnostic assessment. The "ground truth" for the regression testing would be the established acceptable performance and safety profile of the predicate devices and the requirements of the Class II Special Controls Guidance Document.
8. The sample size for the training set
- Not applicable. There is no mention or indication of a training set as this is not a machine learning or AI-based device.
9. How the ground truth for the training set was established
- Not applicable. There is no mention or indication of a training set.
§ 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.