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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 bony structure. These defects may be surgically created 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. CarriGen PF is a mixing syringe pre-filled with the previously cleared CarriGen Porous Bone Substitute Material. The CarriGen PF system eliminates the need to transfer the CarriGen powder to the mixing syringe. After mixing, CarriGen 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 Bone Substitute Material is an osteoconductive material that is resorbed and replaced by natural bone over time.

This document describes a 510(k) premarket notification for CarriGen® PF, a resorbable calcium salt bone void filler device. The information provided demonstrates the device's substantial equivalence to predicate devices, but it does not contain the detailed information necessary to fully address all parts of your request regarding acceptance criteria and performance studies for an AI/ML medical device.

Specifically, this document does not describe:

• A table of acceptance criteria and reported device performance in the context of an AI/ML algorithm. The acceptance criteria mentioned are for the physical properties of a bone void filler.
• Sample sizes, data provenance, ground truth establishment, expert qualifications, or adjudication methods for an AI/ML test set.
• MRMC or standalone studies for an AI/ML algorithm.

Therefore, I can only provide the information that is available in the document, which primarily pertains to the physical and chemical properties of the bone void filler, not an AI/ML device.

Here's an analysis of the provided text based on your request, highlighting what is present and what is missing:

Acceptance Criteria and Device Performance (Based on Device Type - Bone Void Filler)

The document primarily focuses on the physical and chemical performance characteristics of the CarriGen® PF bone void filler, not an AI/ML algorithm.

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

The document states that "The information summarized in the Design Control Activities Summary demonstrates that the CarriGen PF meets the pre-determined acceptance criteria for the verification activities." However, it does not provide a table with specific acceptance criteria values and corresponding reported performance values. It only lists the types of performance testing conducted:

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

• Sample Size for Test Set: Not specified in the provided text. The testing mentioned is for the physical and chemical properties of the material, not a data-driven AI test set.
• Data Provenance (e.g., country of origin of the data, retrospective or prospective): Not applicable or not specified, as this is for material testing, not patient data for an AI/ML algorithm.

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

• Not applicable. This information is relevant for AI/ML performance studies involving human expert interpretations of data (e.g., medical images). The document describes testing of a physical medical device.

4. Adjudication method for the test set

• Not applicable. This information is relevant for AI/ML performance studies involving multiple human readers.

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 document describes a traditional medical device (bone void filler), not an AI/ML software.

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

• Not applicable. This document describes a traditional medical device (bone void filler), not an AI/ML software.

7. The type of ground truth used

• For material properties: The ground truth for the performance testing (e.g., working time, setting time, compression strength, biocompatibility, endotoxin levels) would be established by standardized testing methods and specifications (e.g., ASTM standards, ISO standards, USP monographs for biocompatibility and endotoxin). The "truth" is determined by the physical and chemical measurements aligning with the pre-defined acceptable ranges for these properties.
• For AI/ML: Not applicable in this document.

8. The sample size for the training set

• Not applicable. This document describes a traditional medical device (bone void filler), which does not have a "training set" in the context of an AI/ML algorithm. Its properties are inherent to its formulation and manufacturing process.

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

• Not applicable. No training set for an AI/ML algorithm is mentioned.

In summary, the provided FDA 510(k) clearance letter and summary describe the regulatory review of a physical medical device (a bone void filler). It details the device's indications for use, description, predicate devices, and the types of performance testing conducted to demonstrate substantial equivalence of its physical and chemical properties. It does not contain any information relevant to the development, testing, or performance of an artificial intelligence or machine learning-based medical device.

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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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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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