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CarriGen Porous Bone Substitute is an injectable, self setting, macro-porous, osteoconductive, calcium phosphate bone graft substitute material that is intended to be used in bony voids or gaps to fill and/or augment dental intraosseous, intraoral and maxillofacial defects. These defects include periodontal/infrabony defects; alveolar ridge augmentation (sinusotomy, osteotomy, apicoectomy, cystectomy); dental extraction sites (ridge maintenance, implant preparation / placement); sinus lifts; cystic defects; and oral and maxillofacial augmentation. 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.

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, nano-crystalline hydroxyapatite (NCHA); 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.

Here's an analysis of the provided text regarding the CarriGen Bone Grafting Material and its acceptance criteria, structured as requested.

Important Note: The provided document is a 510(k) Summary and an FDA 510(k) clearance letter. It describes the device, its intended use, and substantial equivalence to predicate devices. It explicitly mentions "Testing data meeting the requirements of Class II Special Controls Guidance Document: Dental Bone Grafting Material Devices (dated April 28, 2005) has been submitted." However, the document itself does NOT contain the detailed acceptance criteria, the specific study design, or the performance results of such studies. It confirms that such data was submitted and found acceptable for 510(k) clearance, but the data itself is not presented here.

Therefore, for many of the requested points, the answer will be that the information is "Not Available in the provided document."

Acceptance Criteria and Device Performance

Study Details

1. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
   Not Available in the provided document.

2. 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 Available in the provided document. The type of testing submitted would likely be animal studies or mechanical/chemical bench testing, rather than expert evaluation of images, given it's a bone grafting material.

3. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
   Not Available in the provided document. This type of adjudication is typically for image-based diagnostic AI, which is not applicable to this physical bone grafting material.

4. 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. The CarriGen Porous Bone Substitute Material is a physical bone grafting material, not an AI or imaging diagnostic device. Therefore, MRMC studies involving human readers and AI assistance are not relevant.

5. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
   Not applicable. As a physical bone grafting material, this device does not have an "algorithm-only" or "human-in-the-loop" performance. Its performance is related to its osteoconductive properties, resorption rate, and replacement by natural bone.

6. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
   Not Available in the provided document. For a bone grafting material, ground truth would typically be established through histological analysis (pathology) of tissue samples from animal or human studies to assess new bone formation, material resorption, and integration.

7. The sample size for the training set:
   Not Applicable / Not Available. For a physical medical device like a bone graft, there isn't a "training set" in the context of machine learning or AI. Performance data would come from pre-clinical (e.g., animal) and potentially clinical studies.

8. How the ground truth for the training set was established:
   Not Applicable / Not Available. As above, the concept of a training set ground truth is not relevant for this type of device.

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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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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.

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.

Here's an analysis of the provided text regarding the CarriGen Porous Bone Substitute Material, focusing on the acceptance criteria and the study that proves the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance

Based on the provided document, the "acceptance criteria" for CarriGen are implicitly tied to demonstrating substantial equivalence to its predicate devices (OssiPro, EquivaBone Osteoinductive Bone Graft Substitute, and Gamma-bsm Moldable Bone Substitute Material). The document does not explicitly state quantitative acceptance criteria in terms of performance metrics with specific thresholds. Instead, it refers to "regression testing" as the method to demonstrate that changes do not affect the risk profile.

2. Sample Size Used for the Test Set and Data Provenance

• Sample Size for Test Set: Not explicitly stated. The document mentions "regression testing" but does not provide details on the number of samples or cases used for this testing.
• Data Provenance: Not specified. The document does not mention the country of origin of the data or whether it was retrospective or prospective.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

This information is not provided in the document. The submission focuses on demonstrating substantial equivalence through "regression testing" against existing predicate devices and a guidance document, rather than clinical studies requiring expert-adjudicated ground truth.

4. Adjudication Method for the Test Set

This information is not provided. As no details about expert ground truth or a clinical test set are included beyond "regression testing," no adjudication method is described.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size of AI Improvement

This information is not applicable and not provided. The device is a bone graft substitute material, not an AI or imaging diagnostic tool. Therefore, an MRMC study comparing human readers with and without AI assistance is irrelevant and was not conducted.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

This information is not applicable and not provided. The device is a physical bone graft substitute material, not a software algorithm.

7. The Type of Ground Truth Used

The concept of "ground truth" as typically understood in AI/diagnostic device evaluation (e.g., pathology, outcomes data, expert consensus) is not directly applicable here. The "proof" is based on demonstrating that modifications to an already cleared device (OssiPro) do not alter its safety or effectiveness, as assessed through "regression testing" against a guidance document and comparison to predicates. The implicit "ground truth" is that the predicate devices are safe and effective for their intended use.

8. The Sample Size for the Training Set

This information is not provided. The document describes a medical device, not an AI algorithm that typically requires a training set.

9. How the Ground Truth for the Training Set Was Established

This information is not applicable and not provided. As explained above, this is a physical medical device, not an AI algorithm with a training set and associated ground truth establishment.

Summary of the Study:

The "study" described in this 510(k) submission is referred to as "Regression testing consistent with Class II Special Controls Guidance Document: Resorbable Calcium Salt Bone Void Filler Device."

• Purpose: To demonstrate that the proposed changes to the predicate devices (OssiPro, EquivaBone, Gamma-bsm) do not affect the risk profile of the devices, thereby maintaining substantial equivalence for the modified CarriGen Porous Bone Substitute Material.
• Methodology (as implied): The specific tests performed under "regression testing" are not detailed, but they would typically involve physico-chemical characterization, mechanical testing, biocompatibility evaluations, and potentially in-vitro or in-vivo studies to confirm that the modified material's properties (such as setting time, conversion to apatitic calcium phosphate, porosity, osteoconductivity, and resorption rate) remain within acceptable limits and are comparable to the predicate devices and the requirements of the Special Controls Guidance Document.
• Conclusion: The submission of this testing was deemed sufficient by the FDA to issue a substantial equivalence determination, implying that the CarriGen device met the unstated acceptance criteria embedded within the guidance document and the substantial equivalence pathway.

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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

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

CaP Plus is a biocompatible bone graft substitute material consisting of synthetic calcium phosphate, an inert carrier, carboxymethyl cellulose (CMC) and human demineralized bone matrix (DBM). After implantation the product hardens at body temperature and resorbs and remodels during the healing process. Each lot of DBM contained within the 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.

The provided text is a 510(k) summary for the CaP Plus bone void filler and primarily focuses on establishing substantial equivalence to predicate devices, rather than presenting a detailed clinical study with acceptance criteria, performance metrics, and ground truth information as typically found in studies for diagnostic devices or AI algorithms.

Therefore, many of the requested fields cannot be directly extracted from the provided document. The device is a "bone void filler," which is a material implanted to aid bone healing, not a diagnostic or imaging device that would typically have acceptance criteria based on sensitivity, specificity, or AUC, nor "test sets" or "training sets" as these terms are used in the context of AI/ML performance evaluation.

Here's an attempt to answer the questions based solely on the provided text, acknowledging the limitations:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state quantitative acceptance criteria or detailed performance metrics in the format of a table as would be expected for a diagnostic or AI-powered device. The basis of acceptance is "substantial equivalence" to predicate devices, meaning it shares the same function and intended use, and its safety and effectiveness are "adequately supported by the substantial equivalence data and testing results provided within this premarket submission." These "testing results" are not detailed in the provided summary.

2. Sample Size Used for the Test Set and Data Provenance

Not applicable. The document describes a medical device (bone void filler) submission for regulatory clearance based on substantial equivalence, not a study evaluating an AI algorithm or diagnostic test on a "test set." The term "test set" is not used in the document. The document refers to "testing results" in the broader context of premarket submission data, but no specifics are provided regarding sample sizes for human or animal studies that might have been conducted to support biocompatibility or performance.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications

Not applicable. There is no mention of a "test set" and thus no "ground truth" established by experts in the context of an AI or diagnostic study.

4. Adjudication Method for the Test Set

Not applicable. There is no "test set" or adjudication process described.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance

Not applicable. This device is a bone void filler, not an AI or diagnostic tool. The document does not describe any MRMC studies or human reader performance with/without AI assistance.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

Not applicable. This is not an algorithm or AI device.

7. The Type of Ground Truth Used

Not applicable in the context of AI/ML. For a bone void filler, the "ground truth" for performance would generally refer to histological evidence of bone ingrowth, successful fusion (if applicable), and resorption of the material, typically demonstrated in animal models or clinical studies. However, the document does not detail the specific studies or their "ground truth" outcomes. It only states that the safety and effectiveness are supported by "testing results." For the DBM component, "osteoinductive potential" as assayed in an athymic nude mouse model can be considered a form of "ground truth" for that specific characteristic.

8. The Sample Size for the Training Set

Not applicable. This document is not about an AI device or a "training set."

9. How the Ground Truth for the Training Set Was Established

Not applicable. There is no "training set."

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