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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."

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.

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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

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.

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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.

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