(66 days)
Beta-bsm Injectable Bone Substitute Material is an implantable synthetic calcium phosphate bone graft material that forms a nano-crystalline matrix that resorbs and is replaced with new bone during the healing process. It is indicated for use in filling and/or augmentation of bone voids, gaps or defects 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 intended to be used in bony voids or gaps to fill and/or augment dental intraosseous, intraoral and maxillofacial defects. These defects include, but are not limited to, periodontal/infrabony defects; alveolar ridge augmentation (osteotomy, apicoectomy, cystectomy); dental extraction sites (ridge maintenance, implant preparation/placement); sinus lifts; cystic defects; craniofacial augmentation.
Gamma-bsm Moldable Bone Substitute Material is an implantable synthetic calcium phosphate bone graft material that forms a nano-crystalline matrix that resorbs and is replaced with new bone during the healing process. It is indicated for use in filling and/or augmentation of bone voids, gaps or defects 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 intended to be used in bony voids or gaps to fill and/or augment dental intraosseous, intraoral and maxillofacial defects. These defects include, but are not limited to, periodontal/infrabony defects; alveolar ridge augmentation (osteotomy, apicoectomy, cystectomy); dental extraction sites (ridge maintenance, implant preparation/placement); sinus lifts; cystic defects; craniofacial augmentation.
EquivaBone Osteoinductive Bone Graft Substitute is an implantable synthetic calcium phosphate bone graft material that forms a nano-crystalline matrix combined with demineralized bone matrix that resorbs and is replaced with new bone during the healing process. It is indicated for use in filling and/or augmentation of bone voids, gaps or defects 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. EquivaBone Osteoinductive Bone Graft Substitute is intended to be used in bony voids or gaps to fill and/or augment dental intraosseous, intraoral and maxillofacial defects. These defects include, but are not limited to, periodontal/infrabony defects; alveolar ridge augmentation (osteotomy, apicoectomy, cystectomy); dental extraction sites (ridge maintenance, implant preparation/placement); sinus lifts; cystic defects; craniofacial augmentation.
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 under direct visualization using the syringe 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.
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.
Here's an analysis of the provided text to extract the acceptance criteria and study information for the Beta-bsm, Gamma-bsm, and EquivaBone devices:
1. Acceptance Criteria and Reported Device Performance
The acceptance criteria for these devices are primarily based on demonstrating substantial equivalence to predicate devices, especially regarding their intended use and technological characteristics. The performance data is assessed against the requirements outlined in the "Class II Special Controls Guidance Document: Dental Bone Grafting Material Devices (dated April 28, 2005)."
The reported device performance, for all three devices (Beta-bsm, Gamma-bsm, and Equivabone), is that they are "safe and effective for its intended use and performs as well as the predicate device."
| Criterion | Beta-bsm Injectable Bone Substitute Material Performance | Gamma-bsm Moldable Bone Substitute Material Performance | EquivaBone Osteoinductive Bone Graft Substitute Performance |
|---|---|---|---|
| Intended Use | Filling and/or augmentation of bone voids, gaps or defects not intrinsic to bony structure stability, including dental intraosseous, intraoral, and maxillofacial defects (periodontal/infrabony defects; alveolar ridge augmentation; dental extraction sites; sinus lifts; cystic defects; craniofacial augmentation). Device forms a nano-crystalline matrix that resorbs and is replaced with new bone during healing. | Filling and/or augmentation of bone voids, gaps or defects not intrinsic to bony structure stability, including dental intraosseous, intraoral, and maxillofacial defects (periodontal/infrabony defects; alveolar ridge augmentation; dental extraction sites; sinus lifts; cystic defects; craniofacial augmentation). Device forms a nano-crystalline matrix that resorbs and is replaced with new bone during healing. | Filling and/or augmentation of bone voids, gaps or defects not intrinsic to bony structure stability, including dental intraosseous, intraoral, and maxillofacial defects (periodontal/infrabony defects; alveolar ridge augmentation; dental extraction sites; sinus lifts; cystic defects; craniofacial augmentation). Device forms a nano-crystalline matrix combined with demineralized bone matrix that resorbs and is replaced with new bone during healing. 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. |
| Biomaterial | Proprietary calcium phosphate formula | Proprietary calcium phosphate formula | Proprietary calcium phosphate formula, carboxymethyl cellulose (CMC), demineralized bone matrix (DBM) |
| Primary Hydration Media | 0.9% sodium chloride solution conforming with the monograph for 0.9% Sodium Chloride Injection USP | 0.9% sodium chloride solution conforming with the monograph for 0.9% Sodium Chloride Injection USP | 0.9% sodium chloride solution conforming with the monograph for 0.9% Sodium Chloride Injection USP |
| Alternate Hydration Media | None (for Beta-bsm Injectable) - Note: The predicate for Orthopedic indications (K101557) had an "alternate Hydration Solution," suggesting the current submission for dental indications either doesn't provide one or the change is specifically about the provided one. | Autologous whole blood, autologous bone marrow aspirate | Autologous whole blood, autologous bone marrow aspirate |
| Sterilization | Gamma irradiation | Gamma irradiation | Gamma irradiation |
| Safety and Effectiveness | Assessed as safe and effective for intended use, performing as well as the predicate device, based on performance data submitted consistent with "Class II Special Controls Guidance Document: Dental Bone Grafting Material Devices (dated April 28, 2005)." | Assessed as safe and effective for intended use, performing as well as the predicate device, based on performance data submitted consistent with "Class II Special Controls Guidance Document: Dental Bone Grafting Material Devices (dated April 28, 2005)." | Assessed as safe and effective for intended use, performing as well as the predicate device, based on performance data submitted consistent with "Class II Special Controls Guidance Document: Dental Bone Grafting Material Devices (dated April 28, 2005)." For EquivaBone, the osteoinductive potential of each DBM lot is assayed in an athymic nude mouse model. |
| Substantial Equivalence (SE) | The FDA determined the device is substantially equivalent to legally marketed predicate devices. | The FDA determined the device is substantially equivalent to legally marketed predicate devices. | The FDA determined the device is substantially equivalent to legally marketed predicate devices. |
2. Sample Size Used for the Test Set and Data Provenance
The documents state that non-clinical testing was performed "consistent with Class II Special Controls Guidance Document: Dental Bone Grafting Material Devices (dated April 28, 2005)."
- Sample Size: The specific sample sizes for non-clinical tests (e.g., in-vitro, bench studies, animal studies) are not detailed in the provided summaries. The summaries only state that testing was performed according to the guidance.
- Data Provenance: The document does not specify the country of origin of the data or whether the studies were retrospective or prospective. Given that they are non-clinical studies for device clearance, they would typically involve studies conducted in a controlled lab environment.
For EquivaBone specifically: There's mention of DBM being "assayed for osteoinductive potential in an athymic nude mouse model." This indicates an animal model study was part of the non-clinical testing for this specific characteristic. The sample size for this mouse model is not provided.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts
No information is provided regarding traditional "ground truth" establishment by experts in the context of diagnostic performance or clinical outcomes for these devices.
Since the submission is for a "Special 510(k) Submission - Alternate Hydration Solution" and relies on non-clinical testing and substantial equivalence, the "ground truth" is established by demonstrating that the modified device (with the alternate hydration solution) maintains the same performance characteristics as the predicate device and meets established material and biological safety standards. This is typically assessed by regulatory bodies (like the FDA) and their expert reviewers, rather than external clinical experts establishing a ground truth for a test set in the way one might for an AI diagnostic device.
4. Adjudication Method for the Test Set
Not applicable. This is not a clinical trial involving human subject adjudication of diagnostic findings. The regulatory review process involves evaluation of non-clinical data by regulatory scientists and engineers.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No. An MRMC comparative effectiveness study is not mentioned as it is not typically required for this type of device modification (alternate hydration solution) and regulatory pathway (Special 510(k) based on substantial equivalence and non-clinical data). The focus is on demonstrating that the new hydration solution does not negatively impact the established performance and safety of the device.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance)
Not applicable. These are inert/resorbable bone graft substitute materials, not AI algorithms or diagnostic devices.
7. Type of Ground Truth Used
The "ground truth" in this context is implicitly "performance equivalence to the predicate device and adherence to recognized material and biological safety standards." This is established through non-clinical testing (e.g., material characterization, biocompatibility testing, mechanical properties, resorbability studies) as outlined by the "Class II Special Controls Guidance Document: Dental Bone Grafting Material Devices."
For EquivaBone, an additional "ground truth" element for osteoinductivity is established via the athymic nude mouse model for each lot of DBM.
8. Sample Size for the Training Set
Not applicable. These are physical medical devices, not AI models that require training sets. The "training" for the device's development would involve R&D and engineering, but not in the AI sense.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no "training set" in the context of AI. The development process for these medical devices involves established engineering and scientific principles, quality systems, and regulatory guidelines to ensure safety and effectiveness.
§ 872.3930 Bone grafting material.
(a)
Identification. Bone grafting material is a material such as hydroxyapatite, tricalcium phosphate, polylactic and polyglycolic acids, or collagen, that is intended to fill, augment, or reconstruct periodontal or bony defects of the oral and maxillofacial region.(b)
Classification. (1) Class II (special controls) for bone grafting materials that do not contain a drug that is a therapeutic biologic. The special control is FDA's “Class II Special Controls Guidance Document: Dental Bone Grafting Material Devices.” (See § 872.1(e) for the availability of this guidance document.)(2) Class III (premarket approval) for bone grafting materials that contain a drug that is a therapeutic biologic. Bone grafting materials that contain a drug that is a therapeutic biologic, such as biological response modifiers, require premarket approval.
(c)
Date premarket approval application (PMA) or notice of product development protocol (PDP) is required. Devices described in paragraph (b)(2) of this section shall have an approved PMA or a declared completed PDP in effect before being placed in commercial distribution.