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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.

EquivaBone is a biocompatible bone graft substitute material consisting of Calcium Phosphate (CaP3), Carboxymethylcellulose (CMC) and Demineralized Bone Matrix (DBM). EquivaBone is supplied in a single use kit as sterile powders and hydration 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 remodels during the healing process.

The provided text describes a 510(k) premarket notification for a medical device called EquivaBone Osteoinductive Bone Graft Substitute (EquivaBone). The primary purpose of this notification is to demonstrate substantial equivalence to a legally marketed predicate device.

Regarding acceptance criteria and a study to prove the device meets these criteria, the document focuses on changes to the device's De-mineralized Bone Matrix (DBM) source and a new method for assessing osteoinductivity.

Here's a breakdown of the requested information based on the provided text:

1. A table of acceptance criteria and the reported device performance

2. Sample size used for the test set and the data provenance

The document does not explicitly state the sample size for the test set used in the correlation study for osteoinductive potential or for the comparison of DBM sources.

The data provenance is also not explicitly stated in terms of country of origin or whether it was retrospective or prospective. It is a correlation study comparing an in vitro assay (C2C12) to an in vivo assay (athymic rat implantation) to establish a new test method.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

The document does not provide information on the number of experts or their qualifications for establishing ground truth. The "ground truth" for the osteoinductive potential correlation study appears to be the in vivo osteoinduction (OI) score of 1 from the athymic rat implantation model for the predicate device.

4. Adjudication method for the test set

The document does not describe any adjudication method.

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

No MRMC comparative effectiveness study was conducted or mentioned in the document. This device is a bone graft substitute, not an AI-assisted diagnostic tool.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

This question is not applicable as the device is a bone graft substitute, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

For the osteoinductive potential, the ground truth was based on the in vivo osteoinduction (OI) score of 1 from the athymic rat implantation model for the predicate device. For DBM source equivalence, the ground truth appears to be the established chemical composition, physical properties, and performance characteristics of the DBM from the original source (AlloSource).

8. The sample size for the training set

The document does not explicitly mention a "training set" in the context of device performance or an algorithm. For the osteoinductive potential correlation study, the document describes a validation effort for a new assay method, but not a separate training set.

9. How the ground truth for the training set was established

As there's no mention of a traditional "training set" in the context of a machine learning algorithm, this question is not directly applicable. The correlation study established a relationship between an in vitro assay and a previously accepted in vivo method, where the in vivo results define the benchmark for osteoinductivity.

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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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Alpha-bsm 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. Alpha-bsm 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.

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 alveolar defects: (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.

Alpha-bsm 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 silicone bulb 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. Alpha-bsm Bone Substitute Material is an osteoconductive material that is resorbed and replaced by natural bone over time.

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 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.

The provided text describes several bone substitute materials (Alpha-bsm, Beta-bsm, Gamma-bsm, EquivaBone) and their intended uses. However, it does not contain information about specific acceptance criteria or a study designed to prove the device meets those criteria in terms of a quantifiable performance metric (e.g., accuracy, sensitivity, specificity).

Therefore, I cannot populate most of the requested fields. The document primarily focuses on:

• Device Description: What the device is composed of and how it works.
• Intended Use: The medical conditions and anatomical locations for which the device is indicated.
• Predicate Devices: Other legally marketed devices to which the current devices claim substantial equivalence.
• Regulatory Classification: Device class, product code, and classification panel.

The only mention of "Performance Data" is general: "Testing consistent with Class II Special Controls Guidance Document: Dental Bone Grafting Material Devices (dated April 28, 2005) has been submitted." This statement indicates that some performance testing was carried out, but it doesn't describe the specific criteria, the study design, or the results of that testing.

Here's a breakdown of the requested information based on the provided text, with many fields necessarily marked as "Not provided" or "Not applicable":

Acceptance Criteria and Study Details for ETEX Bone Substitute Materials (K091729)

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample size used for the test set and the data provenance

• Sample Size (Test Set): Not provided.
• Data Provenance (Country of origin, retrospective/prospective): Not provided.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

• Not applicable, as a test set with expert-established ground truth for a performance study is not described in this document. The approval is based on substantial equivalence to predicate devices, supported by general performance testing per guidance documents.

4. Adjudication method for the test set

• Not applicable, as a test set requiring adjudication is not described.

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. This device is a bone substitute material, not an AI or imaging diagnostic device that would involve human readers or AI assistance.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

• Not applicable. This device is a bone substitute material.

7. The type of ground truth used

• Not applicable in the context of a diagnostic or AI performance study. For bone substitute materials, "ground truth" typically refers to histological analysis of bone formation, biomechanical testing, or clinical outcomes, but no details of such specific "ground truth" establishment are provided for a defined test set in this document.

8. The sample size for the training set

• Not applicable. This device is a bone substitute material. No mention of a "training set" for an algorithm.

9. How the ground truth for the training set was established

• Not applicable.

Summary of Performance Data Mentioned:

The document repeatedly states: "Performance Data: Testing consistent with Class II Special Controls Guidance Document: Dental Bone Grafting Material Devices (dated April 28, 2005) has been submitted."

This indicates that the safety and effectiveness of the devices were supported by non-clinical (e.g., biocompatibility, physical properties, resorption characteristics) and potentially pre-clinical animal studies, as outlined in the referenced guidance document for bone grafting materials. However, the specific details of these tests, their acceptance criteria, and quantitative results are not included in this 510(k) summary. The basis for clearance is substantial equivalence to legally marketed predicate devices, implying that the new devices perform as safely and effectively as their predicates when used for their stated indications.

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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.

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 hydroxylapatite (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 text is a 510(k) summary for the Gamma-bsm Moldable Bone Substitute Material. This document focuses on the regulatory submission for a medical device and does not contain information typically found in a study proving a device meets acceptance criteria for an AI/software-as-a-medical-device (SaMD) product.

The request asks for information related to "acceptance criteria and the study that proves the device meets the acceptance criteria" in the context of an AI/SaMD, including details like sample sizes for test and training sets, expert qualifications, and adjudication methods. These types of details are not relevant to the physical bone void filler device described in the provided 510(k) summary.

Therefore, I cannot fulfill the request for information on acceptance criteria and a study proving the device meets those criteria, as the provided text relates to a physical medical device (bone void filler) and not a software/AI product. The submission is a "Traditional 510(k) Submission - Bone Void Fillers" and its performance data section refers to "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)". This indicates the type of testing performed would be for a physical material's properties (e.g., biocompatibility, mechanical strength, resorption rate) rather than performance characteristics of an AI algorithm.

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EquivaBone is an osteoinductive bone graft substitute that 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 voids or gaps may result from natural occurring bone disease, traumatic injury or surgical intervention.

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 resorb and remodels during the healing process. Each lot of DBM contained within EquivaBone is assayed for ostcoinductive 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 the EquivaBone Osteoinductive Bone Graft Substitute. It does not contain any information about acceptance criteria or a study proving device performance against such criteria for AI/ML-driven medical devices.

Instead, it describes a traditional medical device (a bone graft substitute) and its regulatory submission. The performance data section 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 indicates that the submission focuses on demonstrating substantial equivalence to predicate devices, rather than establishing specific performance metrics against pre-defined acceptance criteria through a clinical study as would be expected for AI/ML devices.

Therefore, I cannot populate the requested tables and information. The document details:

• Device Name: EquivaBone Osteoinductive Bone Graft Substitute
• Intended Use: To fill bony voids or gaps of the skeletal system of the extremities, spine, and pelvis that are not intrinsic to the stability of the bony structure.
• Materials: Synthetic calcium phosphate, carboxymethyl cellulose (CMC), and human demineralized bone matrix (DBM).
• Predicate Devices: CaP Plus (ETEX Corporation, K063050, K080329), EquivaBone Osteoinductive Bone Graft Substitute (ETEX Corporation, K090310), Actifuse™ (ApaTech Limited, K082575), Vitoss Bioactive Foam Bone Graft Substitute (Orthovita, K083033).
• Performance Data Mentioned: Regression testing to show changes to predicate devices do not affect risk profile, and assay for osteoinductive potential in an athymic nude mouse model for DBM.

This type of information is typical for a traditional 510(k) submission for a physical medical device, not an AI/ML clinical decision support system.

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EquivaBone is intended for use in filling bone voids or defects of the skeletal system (such as the extremities, 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. It is a bone graft substitute that resorbs and is replaced with new bone during the healing process.

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.

This document describes a 510(k) submission for a bone graft substitute, which is a material device, not an AI or imaging device. Therefore, many of the requested fields regarding acceptance criteria related to AI/imaging device performance metrics, such as sensitivity, specificity, MRMC studies, expert ground truth adjudication methods, and training/test set details, are not applicable.

Here's an interpretation of the provided text in the context of material device acceptance:

1. Table of Acceptance Criteria and Reported Device Performance

Specific Performance Claim: "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." This particular claim is a test for a specific material property, not a blanket statement of clinical performance in humans, and includes a disclaimer. The primary acceptance is based on demonstrating the changes do not affect the risk profile compared to the predicate. |
| Material Composition | Consistency with predicate device's material properties or demonstration that new materials are safe and effective for the stated intended use. | "EquivaBone is a biocompatible bone graft substitute material consisting of synthetic calcium phosphate, carboxymethyl cellulose (CMC) and human demineralized bone matrix (DBM)."

"Materials: Synthetic calcium phosphate and demineralized bone matrix (DBM)" (This is a description, not a performance metric, but relevant to the submission's scope). The submission is a "Special 510(k)" indicating changes to an already cleared device, implying the base materials were previously accepted. |
| Intended Use | The device's intended use must be substantially equivalent to a predicate device. | "EquivaBone is intended for use in filling bone voids or defects of the skeletal system (such as the extremities, 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. It is a bone graft substitute that resorbs and is replaced with new bone during the healing process." This aligns with the classification name "Filler, Bone Void, Osteoinductive." |
| Substantial Equivalence | The device must be demonstrably as safe and effective as a legally marketed predicate device. This is the overarching acceptance criterion for 510(k) submissions. | The FDA's letter states: "We have reviewed your Section 510(k) premarket notification... and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices..." This is the final determination that the device meets the acceptance criteria for substantial equivalence. |

2. Sample size used for the test set and the data provenance
The document mentions "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 test set for performance likely involved bench testing and potentially in-vitro or in-vivo animal studies typical for material devices, rather than human clinical data for this Special 510(k). The "athymic nude mouse model" is specifically mentioned for testing DBM osteoinductive potential.

• Sample Size for Test Set: Not explicitly stated in the provided text, but for bench testing, it refers to the number of samples tested according to the referenced guidance. For the "athymic nude mouse model," it refers to the number of animals used.
• Data Provenance: The athymic nude mouse model refers to animal (pre-clinical) data. The specific country of origin is not provided, but it's generated by the manufacturer (ETEX Corporation) or a contracted lab. The data would be prospective in the sense that the studies were designed and executed to test the device's properties.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. This is a material device. Ground truth for material properties is established through standardized laboratory assays and animal models, interpreted by scientists and technical experts in materials science, biology, and pathology, rather than human image readers or clinical experts in the context of this 510(k). The FDA reviewers are the "experts" who determine if the submitted data supports substantial equivalence.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. This pertains to human expert review/consensus for diagnostic data, which is not relevant for a material device's performance testing.

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. This is only relevant for diagnostic imaging AI devices.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
Not applicable. This applies to AI algorithms.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The type of "ground truth" for this device would be:

• Physical material properties: Measured through standardized laboratory tests (e.g., setting time, mechanical strength, biocompatibility tests).
• Biological properties: Demonstrated through in-vitro assays or in-vivo animal models (e.g., the athymic nude mouse model for osteoinductive potential).
• Biocompatibility data: Often derived from ISO standards testing.
• Resorption and remodeling characteristics: Typically assessed in animal models over time.

8. The sample size for the training set
Not applicable. This applies to AI/machine learning models.

9. How the ground truth for the training set was established
Not applicable. This applies to AI/machine learning models.

Summary for this Material Device:

The acceptance criteria for EquivaBone Osteoinductive Bone Graft Substitute were based on demonstrating substantial equivalence to its predicate devices (CaP Plus, K063050 and K080329). This was achieved through "regression testing consistent with Class II Special Controls Guidance Document: Resorbable Calcium Salt Bone Void Filler Device" to show that proposed changes did not affect the risk profile. Testing included assays for the osteoinductive potential of the DBM component using an athymic nude mouse model. The FDA's final letter confirmed the device met the criteria for substantial equivalence. The concepts of AI performance metrics (sensitivity, specificity, MRMC, training/test sets for algorithms, expert adjudication) are not relevant to this type of device submission.

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CaP Plus is intended for use in filling bone voids or defects of the skeletal system (such as the extremities, 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. It is a bone graft substitute that resorbs and is replaced with new bone during the healing process.

CaP Plus is a hiocompatible bone graft substitute material consisting of synthetic calcium phosphate, carboxymethyl cellulose (CMC) and human demineralized bone matrix (DBM). After implantation, the product hardens at body temperature; then resorbs and remodels during the healing process. Each lot of DBM supplied with CaP Plus is assayed for osteoinductive potential in an athymic nude mouse model. This may or may not be predictive of CaP Plus osteoinductivity in humans.

This document is a 510(k) summary for the ETEX Corporation Medical Device CaP Plus, a bone void filler. It details the device description, indications for use, and basis of substantial equivalence to predicate devices. Crucially, it does not contain information about acceptance criteria or a study proving the device meets said criteria. The document is a regulatory submission for premarket notification, affirming substantial equivalence based on existing data and prior predicate devices, rather than presenting new clinical study results with acceptance criteria.

Therefore, I cannot fulfill your request for:

1. A table of acceptance criteria and the reported device performance
2. Sample size used for the test set and data provenance
3. Number of experts used to establish ground truth and their qualifications
4. Adjudication method
5. MRMC comparative effectiveness study results or effect size
6. Standalone performance study
7. Type of ground truth used
8. Sample size for the training set
9. How ground truth for the training set was established

The document focuses on regulatory compliance through substantial equivalence, not on a detailed performance study with acceptance criteria as one would typically find for a diagnostic or AI-driven device.

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