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KINEX™ Bioactive is intended for use as a bone void filler and autograft extender for voids or gaps that are not intrinsic to the stability of the bony structure. These osseous defects may be surgically created or created from traumatic injury to the bone. KINEX™ Plus Putty and KINEX™ Plus Gel are intended to be gently packed into bony voids or gaps of the skeletal system (i.e., the extremities, pelvis, and spine) and should be combined with bone marrow aspirate. KINEX™ Strip, KINEX™ Plus Strip, KINEX™ Putty and KINEX™ Gel are intended to be gently packed into bony voids or gaps of the skeletal system (i.e., the extremities, pelvis) and should be combined with bone marrow aspirate. KINEX™ resorbs and is replaced with bone during the healing process.

KINEX™ Bigactive is a resorbable bone void filler for the repair of bony defects. It is an osteoconductive and osteostimulative material that guides bone regeneration. When KINEX™ is placed in direct contact with host bone, new bone grows in apposition to the surfaces of the implant. As the implant resorbs, bone and other connective tissues grow into the space previously occupied by KINEX™.

KINEX™ implants consist of bioglass (per ASTM F1538), collagen (per ASTM F2212), and hyaluronic acid, and are available in putty, gel, and strip forms to accommodate surgical and anatomical needs.

The provided text is a 510(k) summary for a medical device (KINEX™ Bioactive), which primarily focuses on establishing substantial equivalence to predicate devices for regulatory clearance. It describes the device, its intended use, and states that performance data supported its equivalence. However, it does not contain the detailed information required to answer many of your specific questions about acceptance criteria, a specific study's methodology, or a statistical comparison of performance.

Here's a breakdown of what can and cannot be answered based on the provided text:

What can be extracted/inferred:

• Device Performance (General): The document states "Performance data demonstrates substantial equivalence to the predicate device." and "KINEX™ implants are as safe, as effective, and perform as well as or better than the predicate devices."
• Type of Testing: "In vivo performance testing (tibia defect model and posterolateral spine fusion model) and biocompatibility testing were conducted..."
• Guidance Followed: "...in accordance with the 'Guidance for Industry and FDA Staff; Class II Special Controls Guidance Document: Resorbable Calcium Salt Bone Void Filler Device,' June 2, 2003." This guidance would contain acceptance criteria, but they are not explicitly listed in this document.
• Ground Truth Type (Inferred for in vivo studies): For in vivo animal models, ground truth is typically assessed through histological analysis, micro-CT, or other imaging techniques to evaluate bone formation, resorption, and integration.

What cannot be extracted from the provided text:

• A table of acceptance criteria and reported device performance: This document only provides a high-level statement about meeting acceptance criteria (via substantial equivalence). It does not list specific numerical performance metrics or acceptance thresholds.
• Sample size used for the test set and data provenance: The document mentions "tibia defect model and posterolateral spine fusion model" but does not give sample sizes, animal species, or country of origin.
• Number of experts used to establish the ground truth for the test set and their qualifications: This information is not present.
• Adjudication method for the test set: Not mentioned.
• If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and its effect size: This is highly unlikely for a bone void filler device and is not mentioned. MRMC studies are typical for diagnostic imaging AI.
• If a standalone performance study was done: The provided text indicates in vivo testing but doesn't differentiate between standalone performance vs. comparison to a predicate in a statistically rigorous way described for AI. The "substantial equivalence" framework means the device is compared to existing devices, not necessarily tested in isolation against absolute performance metrics in the same way an AI model might be.
• The sample size for the training set: Not applicable for this type of device and study. There's no AI model being "trained."
• How the ground truth for the training set was established: Not applicable for this type of device either.

Based on the available information, here is a summary without the specific details that are not present:

The KINEX™ Bioactive device underwent in vivo performance testing in both a tibia defect model and a posterolateral spine fusion model, in addition to biocompatibility testing. These studies were conducted in accordance with the "Guidance for Industry and FDA Staff; Class II Special Controls Guidance Document: Resorbable Calcium Salt Bone Void Filler Device," issued June 2, 2003.

Acceptance Criteria and Device Performance:

Study Details (Limited Information):

1. Sample size for the test set and data provenance: Not specified in the provided text. The studies were in vivo animal models (tibia defect and posterolateral spine fusion models).
2. Number of experts and qualifications for ground truth: Not specified. For in vivo animal studies, experts would typically be veterinary pathologists, histologists, or orthopedic surgeons.
3. Adjudication method: Not specified.
4. Multi-reader multi-case (MRMC) comparative effectiveness study: Not applicable for this type of device submission and no such study was performed or mentioned.
5. Standalone performance study: The in vivo performance testing evaluates the device's biological response in an animal model. The core claim is substantial equivalence to predicates, implying a comparative context, but the animal studies themselves would characterize the device's fundamental performance.
6. Type of ground truth used: Inferred to be animal in vivo outcomes, likely assessed through histological analysis, imaging (e.g., micro-CT, radiography), and macroscopic evaluation of bone repair/fusion.
7. Sample size for the training set: Not applicable; this device is not an AI algorithm requiring a training set.
8. How the ground truth for the training set was established: Not applicable.

In essence, this 510(k) summary provides a regulatory overview of a traditional medical device, not a detailed technical report of an AI-powered diagnostic system, which is what most of your questions are geared towards. The "performance data" mentioned refers to standard biological, and possibly biomechanical, testing for bone void fillers, demonstrating its functional equivalence to existing products on the market.

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OsteoMimetic™ Synthetic Bone Matrix is intended for use as a bone void filler for voids or gaps that are not intrinsic to the stability of the bony structure. The OsteoMimetic matrix is indicated for use in the treatment of surgically created osseous defects or osseous defects resulting from traumatic injury to the bone in conjunction with standard measures.

OsteoMimetic Synthetic Bone Matrix is a synthetic, multicrystalline, porous form of ß-tricalcium phosphate [Cas(PO4)2]. The matrix physically fills bone defects to prevent the collapse of soft tissue and stabilize the blood clot. It provides a biocompatible, osteoconductive, and three-dimensional scaffold to facilitate new bone formation. As the matrix is resorbed, bone and other connective tissues grow into the space previously occupied by the matrix. OsteoMimetic Synthetic Bone Matrix is provided sterile as 1-2mm particles.

Here's an analysis of the provided text regarding the OsteoMimetic™ Synthetic Bone Matrix, focusing on acceptance criteria and study details.

Based on the provided K051775 document, there is no specific performance acceptance criteria or a dedicated study described to "prove the device meets acceptance criteria" in terms of clinical efficacy or diagnostic accuracy. This document is a 510(k) Premarket Notification, which typically focuses on demonstrating substantial equivalence to a previously legally marketed device (predicate device), rather than presenting new clinical efficacy data against defined performance thresholds.

The safety and effectiveness information in this document primarily relies on:

• Compliance with an ASTM standard for composition: ASTM F1088 "Standard Specification for Composition of Beta-Tricalcium Phosphate for Surgical Implantation."
• Biocompatibility testing: According to ISO 10993.
• Prior safe use of predicate devices.

Therefore, most of the requested fields related to a clinical study establishing performance criteria cannot be answered from this document.

Here's a breakdown of what can be extracted:

Acceptance Criteria and Reported Device Performance

Study Information (Based on Available Data)

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

   • Not applicable / Not provided. The document does not describe a clinical trial or performance study with a "test set" in the context of diagnostic accuracy or clinical efficacy. The substantial equivalence relies on existing data/knowledge of predicate devices and material standards.

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 applicable. No such ground truth establishment is described for a test set.

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

   • Not applicable. No test set or adjudication process is described.

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. This device (a bone void filler) is not an AI-powered diagnostic or assistive tool, so an MRMC study is irrelevant to its predicate device submission.

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

   • Not applicable. This is not an algorithm-based device.

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

   • Indirectly, safety and performance are inferred from conformance to material standards (ASTM F1088, ISO 10993) and the established history of predicate devices. There is no direct "ground truth" for clinical outcomes presented for this specific device in this document, as the submission focuses on substantial equivalence for a material.

7. The sample size for the training set:

   • Not applicable. There is no "training set" in the context of this 510(k) submission.

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

   • Not applicable. There is no "training set" or associated ground truth establishment described.

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CELLPLEX™ TCP Synthetic Cancellous Bone can be combined with autogenous bone marrow aspirate and/ or blood and is indicated for bony voids or gaps that are not intrinsic to the stability of the bony structure. The CELLPLEX™ TCP Synthetic Cancellous Bone is intended to be gently packed into bony voids or gaps of the skeletal system (i.e., 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 resorbs and is replaced with bone during the healing process.

CELLPLEX™ TCP Synthetic Cancellous Bone is a porous calcium phosphate bone void filler made from tricalcium phosphate for the repair of bony defects. It is osteoconductive with a trabecular structure that resembles the multidirectional interconnected porosity of human cancellous bone. The implant is provided sterile for single patient use. CELLPLEX™ TCP Synthetic Cancellous Bone guides the three-dimensional regeneration of bone in the defect site into which it is implanted. Pores in the device range from 100 to 400 um nominally. When CELLPLEX™ TCP Synthetic Cancellous Bone is placed in direct contact with viable host bone, new bone grows in apposition to the calcium phosphate surfaces of the implant, filling the pores with new bone. As the implant is bioabsorbed, bone grows into the space previously occupied by the bone graft substitute.

This document is a 510(k) summary for a bone graft substitute, and as such, it focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study with specific acceptance criteria and performance metrics described in the prompt.

Therefore, many of the requested elements (acceptance criteria table, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, training set details) are not applicable or not provided in this type of regulatory submission.

Here's what can be extracted based on the provided text:

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

This document does not present a table of specific acceptance criteria (e.g., in terms of sensitivity, specificity, or quantitative measurements for a diagnostic device) and reported device performance against those criteria. Instead, it asserts "substantial equivalence" to predicate devices.

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

Not applicable. This document refers to substantiating equivalence through a comparison of "intended use, material composition, and design features" and "mechanical properties," along with general "testing results" rather than a clinical study with a defined test set.

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. This is not a study involving expert-established ground truth for a diagnostic device.

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

Not applicable. This is not a study involving adjudication of a test set.

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 not a study of a diagnostic AI device.

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

Not applicable. This is not a study of a diagnostic AI device.

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

Not applicable. The "proof" of meeting criteria in this context is through substantial equivalence to legally marketed predicate devices, not through a ground truth comparison in a clinical study. The document states:

• "The safety and effectiveness of the CELLPLEX™ TCP Synthetic Cancellous Bone is adequately supported by the substantial equivalence information, and testing results provided within this Premarket Notification."

8. The sample size for the training set

Not applicable. This is not a machine learning or AI device that requires a training set.

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

Not applicable. This is not a machine learning or AI device that requires a training set.

Summary of what is provided regarding "proving the device meets the acceptance criteria" (in the context of a 510(k) for a bone graft substitute):

The device, CELLPLEX™ TCP Synthetic Cancellous Bone, meets its "acceptance criteria" (which are implicitly defined by the requirements for substantial equivalence) by demonstrating the following:

• Substantial Equivalence:
  • To WMT-TCP Bone Graft Substitute (K022629): The intended use, material composition, and design features of CELLPLEX™ TCP are substantially equivalent to this predicate device.
  • To VITOSS™ Scaffold Synthetic Cancellous Bone Void Filler (K994337): The mechanical properties of CELLPLEX™ TCP are substantially equivalent to this predicate device.

The "study" or justification for equivalence is based on:

• A comparative analysis of the device's characteristics (intended use, material composition, design features, mechanical properties) against the identified predicate devices.
• "Testing results provided within this Premarket Notification" (the specifics of which are not detailed in this summary, but would be in the full submission).

The regulatory body (FDA) reviewed this information and concluded that the device is "substantially equivalent" to legally marketed predicate devices, thus allowing it to be marketed.

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