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These products are intended to be packed into bony voids or gaps to fill and/or augment dental intraosseous, oral and cranio-/maxillofacial defects. These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone, including

• . Periodontal defects;
• . Alveolar ridge augmentation;
• Extraction sockets (ridge preservation, implant preparation/ placement); .
• . Maxillary sinus floor elevation;
• Craniofacial augmentation; .
• Root resection, apicoectomy and cystectomy; .
• Tumor resection. .

One or more of the product formulations, depending upon specific anatomical location and physician and/or dentist preference, can be placed in the dental intraosseous defect site.

Regenafil®, Altiva DBM Paste, BioSet™, RTI Allograft Paste, and Osteofil® contain human demineralized freeze-dried bone allograft (DFDBA, also known as demineralized bone matrix, DBM) in an inert porcine gelatin carrier. Regenaform®, Altiva DBM with cortical cancellous chips, BioSet™ IC, RTI Allograft Paste IC, and Osteofil® ICM contain human DFDBA and human cortical-cancellous bone chips in an inert porcine gelatin carrier.

This document K080418 is a 510(k) premarket notification for bone grafting materials. The acceptance criteria and performance data are primarily focused on demonstrating substantial equivalence to predicate devices rather than directly presenting a study with specific quantitative acceptance criteria for device performance in a clinical trial.

Here's a breakdown based on the provided text:

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

The document does not present specific quantitative acceptance criteria in a typical "performance metrics" table format as one might expect for a diagnostic or AI device. Instead, the acceptance criteria are implicitly met by demonstrating "substantial equivalence" to predicate devices. The "performance" reported is the finding of this equivalence based on technological characteristics and results from animal and clinical studies.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document mentions "animal and clinical studies" but does not provide details on the sample size for these studies, nor does it specify the data provenance (e.g., country of origin, retrospective/prospective nature). The focus is on the conclusion of safety and effectiveness rather than the specifics of the underlying studies.

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)

This information is not provided in the document. The studies mentioned (animal and clinical studies) would typically involve experts to assess outcomes, but the submission does not detail their involvement or qualifications.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This information is not provided as the document doesn't detail the methodology of the "clinical studies" or how ground truth was established.

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

This is not applicable. The device is bone grafting material, not an AI or imaging device that would involve human "readers" or AI assistance. Therefore, an MRMC study and effect size in human improvement with AI are not relevant to this submission.

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

This is not applicable. The device is not an algorithm.

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

For osteoinductivity, the ground truth is established through a "modified athymic nude rat assay."
For the general claims of safety and effectiveness, the document refers to "animal and clinical studies." These would likely involve outcomes data such as bone formation, integration, healing, and potentially histological/pathological assessment, but the specifics are not detailed.

8. The sample size for the training set

This is not applicable. The device is bone grafting material. There is no "training set" in the context of an AI/machine learning model. The relevant "training" relates to the development of the bone graft material, which is a manufacturing and biological process, not an algorithmic one.

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

This is not applicable for the same reasons as #8.

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BioSet™ XCh is indicated only for bony voids or gaps that are not intrinsic to the stability of the bony structure. These products are indicated to be packed into bony voids or gaps of the skeletal system (e.g., the extremities, spine, ilium and/or pelvis). These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone. The product provides a bone void filler that resorbs and is replaced with bone during the healing process.

BioSet™ XCh is a combination of bovine bone chips processed with the BioCleanse Tissue Sterilization Process, human demineralized bone matrix, and a carrier derived from DBM from the same donor. BioSet™ XCh is available in volumes from 1 to 32cc.

The provided text does not contain any information about acceptance criteria or a study that proves the device meets specific performance criteria.

This document is a 510(k) summary for a medical device (BioSet™ XCh), which focuses on demonstrating substantial equivalence to a predicate device rather than presenting performance acceptance criteria or results from a dedicated study.

Here's why the requested information cannot be extracted from the provided text:

• Acceptance Criteria/Device Performance: These are typically quantitative metrics (e.g., sensitivity, specificity, accuracy, mechanical strength, biocompatibility test results) that the device must meet. The document only describes the device's components and intended use.
• Study Details: There's no mention of a clinical trial, in-vitro study, or any other type of study designed to evaluate the BioSet™ XCh's performance against specific endpoints.
• Sample Size, Data Provenance, Experts, Adjudication, MRMC, Standalone Performance, Ground Truth, Training Set: All of these relate to the methodology and results of a performance study, which is absent from this 510(k) summary.

Instead, the document focuses on:

• Substantial Equivalence: Stating that "Data demonstrating substantial equivalence of BioSet™ XCh to predicate devices has been submitted."
• Technological Characteristics Comparison: Highlighting that "The DBM and bovine bone chips are processed in the same manner as the predicate BioSet™ XC. BioSet™ XCh is simply a substitution of human DBM-derived carrier for the porcine gelatin carrier in the BioSet™ XC product."
• Safety Aspects: Mentioning "Viral inactivation studies of the manufacturing process demonstrate a significant reduction of a representative panel of viruses." (While this is a study, it's specific to viral inactivation, not overall device performance or acceptance criteria in the context of efficacy or clinical outcomes).

Therefore, I cannot populate the table or answer the specific questions about acceptance criteria and performance studies based on the provided text.

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These products are indicated for bony voids or gaps that are not intrinsic to the stability of the bony structure. They are indicated to be placed into bony voids or gaps of the skeletal system (e.g., extremities, spine, ilium and/or pelvis). These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone. The product provides a void filler that remodels into the recipient's skeletal system.

The CANCELLO-PURE™ Wedge is machined into a wedge shape from bovine bone processed with the BioCleanse® Tissue Sterilization Process. These products are preshaped for surgeon convenience.

Acceptance Criteria and Device Performance Study for CANCELLO-PURE™ Wedge

This document describes the acceptance criteria and the study that demonstrates the CANCELLO-PURE™ Wedge device meets these criteria, as presented in the provided 510(k) summary.

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Sizes and Data Provenance

• Test Set Sample Size:

  • Animal Model (Remodeling): Not explicitly stated. The document refers to "an animal model" without specifying the number of animals or cases.
  • Viral Inactivation Study: Not explicitly stated regarding sample size beyond "a panel of viruses."

• Data Provenance:

  • Animal Model (Remodeling): The document does not specify the country of origin. It is a prospective study as it involves an "animal model."
  • Viral Inactivation Study: The document does not specify the country of origin. It is a prospective study as it involved a "worst-case representation of the BioCleanse® process."

3. Number and Qualifications of Experts for Ground Truth

• Not Applicable. The provided document does not describe studies involving human medical image or diagnosis interpretation that would require expert adjudication for ground truth. The studies cited are an animal model and a viral inactivation study.

4. Adjudication Method for Test Set

• Not Applicable. As noted above, the studies do not involve human interpretation requiring adjudication.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

• No. An MRMC comparative effectiveness study was not done. The document does not describe studies evaluating human reader performance, either with or without AI assistance, or any comparison to human readers.

6. Standalone (Algorithm Only) Performance Study

• No. A standalone algorithm performance study was not mentioned. The device is a physical bone void filler, not an AI algorithm. The performance studies relate to the biological and safety characteristics of the physical product.

7. Type of Ground Truth Used

• Animal Model (Remodeling): The ground truth for remodeling capability would be established through histological analysis, radiographic imaging, and potentially biomechanical testing of the bone regeneration in the animal model, comparing the CANCELLO-PURE™ Wedge to an allograft.
• Viral Inactivation Study: The ground truth for viral inactivation would be established by laboratory assays capable of detecting and quantifying viruses. "Below detectable limits" serves as the ground truth.

8. Sample Size for Training Set

• Not Applicable. There is no mention of a "training set" as this is not an AI/machine learning device. The studies described are for non-AI medical device validation.

9. How Ground Truth for Training Set was Established

• Not Applicable. As there is no training set mentioned, this question is not relevant.

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This device is for use in graft fixation (for example, ligament and tendon), in cruciate ligament reconstruction surgeries. The Sterling IF Screw Eyelet devices are to be used with Sterling Interference Screw HT.

The Sterling IF Screw Eyelet is manufactured from bovine bone processed with the BioCleanse® Tissue Sterilization Process. The Sterling IF Screw Eyelet is 25mm long by 8mm wide with an oval eyelet. The subject Sterling IF Screw Eyelet devices are to be used with Sterling Interference Screw HT cleared via K060253.

This document describes the Sterling® IF Screw Eyelet, a soft tissue graft fixation device. However, the provided text does not contain any information about acceptance criteria or a study proving that the device meets such criteria.

The document is a 510(k) summary and FDA clearance letter, which focuses on demonstrating substantial equivalence to predicate devices, not on performance criteria or specific studies.

Therefore, I cannot provide the requested information in the format specified. The information about the Sterling® IF Screw Eyelet is limited to:

• Proprietary Name: Sterling® IF Screw Eyelet
• Common Name: soft tissue graft fixation device
• Product Code: HWC. Orthopedics Panel
• Regulation Number: 21 CFR 888.3040 for Smooth or threaded metallic bone fixation fastener.
• Description: Manufactured from bovine bone, processed with BioCleanse® Tissue Sterilization Process. 25mm long by 8mm wide with an oval eyelet. To be used with Sterling Interference Screw HT.
• Intended Use: Graft fixation (e.g., ligament and tendon) in cruciate ligament reconstruction surgeries.
• Substantial Equivalence: To LinX HT (design/function) and Sterling Interference Screw ST and Sterling Interference Screw HT (materials/function).
• Material Source: Closed herd in the U.S.A.
• Viral Inactivation Study: Worst-case representation of BioCleanse® process showed a reduction of a panel of viruses to below detectable limits.

To address each point of your request directly based on the provided text:

1. A table of acceptance criteria and the reported device performance: Not provided in the text.
2. Sample size used for the test set and the data provenance: Not provided in the text. (The mention of a viral inactivation study doesn't specify a "test set" in the context of device performance, nor does it provide sample size or provenance for general device acceptance.)
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not provided in the text.
4. Adjudication method: Not provided in the text.
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 and not provided in the text. (This is not an AI-assisted device for diagnostic imaging or similar applications.)
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable and not provided in the text.
7. The type of ground truth used: Not provided in the text. (The viral inactivation study implies laboratory assay results for "ground truth" on viral reduction, but this is not about overall device performance acceptance criteria.)
8. The sample size for the training set: Not provided in the text.
9. How the ground truth for the training set was established: Not provided in the text.

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BioSet™ XC is indicated only for bony voids or gaps that are not intrinsic to the stability of the bony structure. These products are indicated to be packed into bony voids or gaps of the skeletal system (e.g., the extremities, spine, ilium and/or pelvis). These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone. The product provides a bone void filler that resorbs and is replaced with bone during the healing process.

BioSet™ XC is a combination of bovine bone processed with the BioCleanse Tissue Sterilization Process, human demineralized bone matrix, and porcine gelatin. BioSet™ XC is available in volumes from 1 to 32cc.

The provided text is a 510(k) summary for the BioSet™ XC device and an FDA clearance letter. It does not contain information about acceptance criteria, device performance, a study to prove acceptance criteria, sample sizes, expert involvement, adjudication methods, multi-reader multi-case studies, or standalone algorithm performance.

The document describes the device, its intended use, and its technological characteristics, primarily focusing on its composition and how it relates to predicate devices for demonstrating substantial equivalence. The FDA letter confirms the device's clearance based on this substantial equivalence.

Therefore, I cannot fulfill the request for information regarding acceptance criteria and study details based on the provided text.

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The STERLING® Interference Screw ST is used to provide interference fixation of f moral and/or tibial tunnels in anterior cruciate ligament reconstruction using a soft tissue graft, and fixation during posterior cruciate ligament reconstruction utilizing a soft tissue graft.

The STERLING® Interference Screw HT is used to provide interference fixation in anterior cruciate ligament reconstruction using a bone-tendon-bone graft, and fixation during posterior cruciate ligament reconstruction utilizing a bone-tendonbone graft.

The STERLING® Interference Screw HT is machined from processed bovine cortical bone, with lengths ranging from 20 to 35mm and diameters ranging from 7 to 12 mm. The STERLING® Interference Screw HT is threaded and has an external squared-drive.

The STERLING® Interference Screw ST is machined from processed bovine cortical bone, with lengths ranging from 20 to 35mm and diameters ranging from 7 to 12 mm. The STERLING® Interference Screw ST is threaded and has an internal hexdrive.

The provided text is a 510(k) summary for the STERLING® Interference Screw HT and ST devices. This document focuses on demonstrating substantial equivalence to predicate devices and does not contain information on acceptance criteria or a study proving device performance against such criteria. The studies mentioned are related to material characteristics and remodeling in an animal model, not clinical performance metrics typically associated with acceptance criteria for AI/ML-based devices.

Therefore, I cannot provide the requested information about acceptance criteria and a study that proves the device meets them, as the provided input does not contain this kind of data. The document describes a traditional medical device (bone fixation screw) and its regulatory submission, not a software or AI/ML device that would typically have acceptance criteria presented in the manner requested.

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The STERLING® Interference Screw HT is intended for use in an arthroscopic or open ACL and/or PCL reconstruction by a trained medical professional.
The STERLING® Interference Screw HT is used to provide interference fixation in anterior cruciate ligament reconstruction using a bone-tendonbone graft; fixation during posterior cruciate ligament reconstruction utilizing a bone-tendon-bone graft.

The STERLING® Interference Screw HT is machined from processed bovine cortical bone, with lengths ranging from 20 to 35mm and diameters ranging from 7 to 12 mm. The STERLING® Interference Screw HT is threaded and has an external squared-drive.

The provided text describes a 510(k) premarket notification for the STERLING® Interference Screw HT, a bone fixation screw made from processed bovine cortical bone. This document focuses on demonstrating substantial equivalence to a predicate device and includes details about an animal study and a viral inactivation study.

However, the information required for a comprehensive acceptance criteria and study description, particularly in the context of device performance metrics and evaluation methodology (like sample sizes, ground truth establishment, expert qualifications, and MRMC studies often associated with AI/software devices), is not present in the provided text.

The primary acceptance criteria and performance data available are related to comparability of remodeling in an animal model and viral inactivation efficiency. There are no reported device performance values in terms of statistical metrics (sensitivity, specificity, accuracy, etc.) because this is a physical medical device (a screw), not a diagnostic algorithm or AI.

Here's a breakdown of what can be extracted and what is missing based on your request:

Acceptance Criteria and Study for STERLING® Interference Screw HT

Given that the device is a physical bone fixation screw, the "acceptance criteria" and "device performance" in this context refer to biological and safety aspects rather than diagnostic or AI performance metrics.

1. Table of Acceptance Criteria and Reported Device Performance

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

• Animal Model: The text states "in an animal model" but does not specify the sample size (number of animals or implants) or the species used for the remodeling study.
• Viral Inactivation Study: The text refers to "a viral inactivation study" but does not specify the sample size (number of tests or replicates) or the specific viruses in the "panel of viruses."
• Data Provenance: The animal study and viral inactivation study are likely prospective studies conducted specifically for this submission. The text doesn't specify the country of origin for the studies, but the device is manufactured from bovine bone from a "closed herd located in the U.S.A."

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 text. For a physical device like a screw, "ground truth" would typically refer to histopathological analysis for remodeling or detailed laboratory assays for viral inactivation. The expertise would lie with veterinary pathologists, microbiologists, and other laboratory scientists.

4. Adjudication Method for the Test Set

This information is not provided in the text. Methods like 2+1 or 3+1 adjudication are typically relevant for human-interpreted data (e.g., radiology reads), which is not the case here.

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, an MRMC comparative effectiveness study was not done. This type of study is specific to AI/software devices that assist human readers in diagnostic tasks. The STERLING® Interference Screw HT is a physical medical device.

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

No, a standalone performance study in the context of an algorithm's performance was not done. This is not applicable to a physical medical device.

7. The Type of Ground Truth Used

• Biological Performance (Remodeling): Implied ground truth would be histology and biological markers assessed in the animal model.
• Safety (Viral Inactivation): Ground truth would be established through laboratory viral assays determining the presence and quantity of infectious viral particles.

8. The Sample Size for the Training Set

This information is not applicable as there is no "training set" in the context of a physical device or an AI algorithm.

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

This information is not applicable for the reasons stated above.

In summary: The provided 510(k) summary focuses on demonstrating substantial equivalence of a physical medical device (a bone screw) by comparing its material, design, and function to a predicate device, and by presenting evidence of its biological remodeling capacity and viral inactivation safety through an animal study and a viral study, respectively. It does not contain information related to AI or diagnostic performance metrics, expert evaluation, or ground truth establishment in the way these terms are typically used for AI-based devices.

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STERLING® Cancellous Chips and STERLING® Cancellous Cubes are indicated for bony voids or gaps that are not intrinsic to the stability of the bony structure. They are indicated to be placed into bony voids or gaps of the skeletal system (e.g., extremities, spine, ilium and/or pelvis). These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone. The product provides a void filler that remodels into the recipient's skeletal system.

STERLING® Cancellous Chips and STERLING® Cancellous Cubes are manufactured from bovine bone processed with the BioCleanse" Tissue Sterilization Process. STERLING® Cancellous Chips and STERLING® Cancellous Cubes are provided in 1-10mm sizes, with 15-90cc per package.

This document, a 510(k) summary for the STERLING® Cancellous Chips and STERLING® Cancellous Cubes, does not contain the detailed information requested regarding acceptance criteria and a study proving the device meets those criteria.

This submission is a premarket notification to the FDA to demonstrate substantial equivalence to a legally marketed predicate device (PolyGrafi™ BGS). The information provided focuses on the device's description, intended use, and a summary of technological characteristics, rather than a detailed performance study with acceptance criteria.

However, based on the provided text, I can extract what is mentioned:

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

This document does not present a formal table of acceptance criteria nor specific quantitative performance metrics. Instead, it makes two qualitative claims about performance:

2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective):

• Animal Model for Remodeling: The document mentions an "animal model" but provides no information on the sample size used, the specific type of animals, the country of origin, or whether the study was retrospective or prospective.
• Viral Inactivation Study: The document mentions a "viral inactivation study" but provides no information on the sample size (e.g., number of replicates, types of viruses), the country of origin for the data, or its retrospective/prospective nature.

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):

This information is not provided in the document for either the animal model or the viral inactivation study. The concept of "ground truth" as typically defined in AI/diagnostic studies (e.g., expert consensus on images or pathology confirmation) is not applicable here, as these are material science and biological efficacy studies.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:

This information is not applicable to the types of studies mentioned (animal model for remodeling, viral inactivation study), which typically involve laboratory measurements and histological/virological analyses rather than interpretation by 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:

This is not applicable. The device is a bone void filler, not an AI diagnostic tool. Therefore, an MRMC study is irrelevant.

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

This is not applicable. The device is a physical medical device, not an algorithm.

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

• Animal Model for Remodeling: The "ground truth" would likely be based on histological analysis and potentially imaging (e.g., X-ray, micro-CT) of bone formation and integration in the animal model, compared to allograft.
• Viral Inactivation Study: The "ground truth" would be based on quantitative virological assays to measure the reduction in viral titer after exposure to the BioCleanse® process.

8. The sample size for the training set:

This is not applicable. The document describes a physical medical device and its processing, not an algorithm that requires a training set.

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

This is not applicable for the reasons stated in point 8.

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The STERLING® Interference Screw ST is used to provide interference The STERENTO - and/or tibial tunnels in anterior cruciate ligament reconstruction using a soft tissue graft; fixation during posterior cruciate ligament reconstruction utilizing a soft tissue graft.

The STERLING® Interference Screw ST is machined from processed bovine cortical bone, with lengths ranging from 15 to 40mm and diameters ranging from 7 to 10 mm. The STERLING® Interference Screw ST is threaded, has an internal hex-drive, and has a rounded proximal head.

This document does not contain information about acceptance criteria or a study proving that a device meets such criteria. Instead, it is a 510(k) premarket notification for the "STERLING® Interference Screw ST" and the FDA's response letter.

The primary purpose of this document is to demonstrate "substantial equivalence" to predicate devices, not to present performance data against specific acceptance criteria.

Therefore, I cannot provide the requested table and study information based on the provided text.

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OPTEFORM® Allograft Full Disk; OPTEFORM® Allograft Partial Disk; OPTEFORM® Moldable Allograft Paste, Syringe; OPTEFORM® RT Allograft Paste; OSTEOFIL® IC Moldable Allograft Syringe; OSTEOFIL® ICM Moldable Strip; OSTEOFIL® RT ICM Moldable Allograft; RTI Allograft Paste IC; and RTI Allograft Strip IC are indicated for bony voids or gaps that are not intrinsic to the stability of the bony structure. They are indicated to be placed into bony voids or gaps of the skeletal system (e.g., the extremities, spine and pelvis). These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone. The product provides a bone void filler that remodels into the recipient's skeletal system.

These devices are bone paste products made by combining gelatin, dcmineralized bone matrix and cortical-cancellous bone chips.

The provided text is a 510(k) Summary for a medical device (bone void filler) and does not describe acceptance criteria or a study proving that the device meets such criteria. Instead, it focuses on demonstrating substantial equivalence to a predicate device.

Therefore, I cannot fulfill the request to describe acceptance criteria and the study that proves the device meets them based on the provided input.

However, I can extract information related to the performance data provided:

• Non-Clinical Performance Data Supporting Substantial Equivalence Determination: Results from studies in animal models indicate that these products can be used as a bone void filler with equivalent or better healing results when compared to the predicate device. Healing was evaluated radiographically, histologically, and mechanically.
• Osteoinductivity Screening: DBM (demineralized bone matrix) and finished product were screened for osteoinductivity in a rat assay. The document notes that "Findings from an animal model are not necessarily predictive of human clinical results."

This information suggests that animal studies were conducted to assess healing and osteoinductivity, using radiographic, histologic, and mechanical evaluations. However, specific acceptance criteria, sample sizes for test sets, ground truth establishment, or details about the experts involved are not available in this document.

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