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CaP Spheres Pellet Pack™ is intended for use as a bone void filler for bony voids or gaps that are not intrinsic to the stability of the bony structure. These defects may be surgically created osseous defects resulting from traumatic injury to the bone. CaP Spheres Pellet Pack™ is intended to be used in conjunction with autograft bone as a bone graft extender and gently packed into bony voids or gaps in the posterolateral spine. CaP Spheres Pellet Pack™ provides a bone void filler that resorbs and is replaced by the growth of new bone during the healing process.

CaP Spheres Pellet Pack™ is a synthetic, osteoconductive, and resorbable bone void filler device consisting of hollow and microporous biphasic calcium phosphate spheres contained within a resorbable mesh pouch to aid in intraoperative handling. The device may be implanted directly, or hydrated with saline or autologous blood, and is intended to be combined with autograft.

The provided text describes a medical device, CaP Spheres Pellet Pack™, and its FDA 510(k) submission. However, it does not contain information about acceptance criteria, a study proving the device meets those criteria, or details regarding AI/ML device performance.

The document is a 510(k) clearance letter and summary for a physical medical device (bone void filler), not an AI/ML powered device. Therefore, the requested information regarding acceptance criteria, test set details, expert involvement, MRMC studies, or standalone algorithm performance, as commonly applied to AI/ML devices, is not present in this text.

The text focuses on:

• Device Description: What the CaP Spheres Pellet Pack™ is.
• Indications for Use: When and how the device should be used.
• Substantial Equivalence: Comparison to existing, legally marketed predicate devices to show it's as safe and effective.
• Performance Testing: Bench testing (physical, chemical, degradation), biological safety, sterilization, shelf-life, and an in vivo animal study.

The closest information related to "acceptance criteria" is the overall demonstration of "substantial equivalence" to predicate devices, and that all performance tests "yielded acceptable results." However, specific numerical acceptance criteria for performance metrics (like sensitivity, specificity, AUC) are not defined, as they are not typically applicable to this type of device in the same way they are for diagnostic AI/ML products.

Therefore, I cannot provide a table of acceptance criteria and reported device performance, or answer the subsequent questions, as the input document does not contain this information for an AI/ML device.

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Sorrento Bone Graft Substitutes are intended for use as a bone void filler to fill voids or gaps of the skeletal system in the extremities and pelvis not intrinsic to the bony structure. Sorrento Bone Graft Substitutes are also indicated for use in the treatment of surgically created osseous defects created from traumatic injury to the bone. Sorrento Bone Graft Substitutes must be wetted with bone marrow aspirate. Following placement in the bony void or gap (defect), Sorrento Bone Graft Substitutes are resorbed and replaced with bone during the healing process

Sorrento BioGlass Bone Graft Substitute is a resorbable bone void filler made from a matrix of highly purified collagen (ASTM F2212) that has high porosity beta tricalcium phosphate (TCP) granules (ASTM F1088) and Bioglass 45S5 (ASTM F1538) dispersed throughout. The implant is provided as sterile, for single-use in double peel packages.

The document is a 510(k) summary for the Sorrento™ Bioglass Bone Graft Substitute. It does NOT describe an AI/ML powered device, nor does it detail an AI/ML study.

Therefore, I cannot provide the requested information about acceptance criteria or a study proving an AI device meets acceptance criteria. The document focuses on demonstrating substantial equivalence of a bone graft substitute to predicate devices through biocompatibility, bench testing, and animal studies.

Here's an analysis of what the document does provide, structured to address your points, though many will be flagged as "Not Applicable (N/A)" for an AI device:

1. Table of Acceptance Criteria and Reported Device Performance

As this is not an AI/ML device, the acceptance criteria and performance are related to the material properties and biological response of the bone graft substitute, not AI model metrics.

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

• Test Set Sample Size: For the animal study, the document mentions "rabbits" but does not specify the exact number of animals used.
• Data Provenance: The animal study was conducted to compare the device with predicate and reference devices. No country of origin is specified. It is a prospective animal study.

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)

• N/A. This device does not involve expert-established ground truth in the context of AI/ML. The evaluation involved radiographic and histomorphometric analysis in an animal model, which would typically be performed by trained veterinary pathologists or researchers, but no specific number or qualifications are provided in this regulatory summary.

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

• N/A. This is not relevant for the type of study described (biocompatibility, bench testing, animal study for a bone graft).

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

• N/A. This document describes a bone graft substitute, not an AI device. No MRMC study was conducted.

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

• N/A. This document describes a bone graft substitute, not an AI algorithm.

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

• For the animal study, "performance was evaluated radiographically and histomorphometrically." Histopathological and radiographic findings in animal models serve as the "ground truth" to assess bone regeneration and material integration.

8. The sample size for the training set

• N/A. This document describes a bone graft substitute. There is no AI model, and therefore no training set.

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

• N/A. This document describes a bone graft substitute. There is no AI model, and therefore no training set or ground truth establishment method for it.

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NovaBone Bioactive Strip bone graft devices are indicated only for bony voids or gaps that are not intrinsic to the stability of the bony structure. NovaBone Bioactive Strip is indicated to be gently placed into bony voids or gaps of the skeletal system (i.e. the extremities and pelvis). These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone. NovaBone Bioactive Strip must be hydrated with autogenous bone marrow aspirate prior to implantation. The product provides a bone void filler that resorbs and is replaced with bone during the healing process.

NovaBone BIOACTIVE Strip is an osteoconductive bioactive device used for grafting osseous defects. The device is a mixture of bioactive calcium-phosphosilicate granules and a collagen binder. The bioactive glass particulate is composed solely of elements that exist in normal bone (Ca, P, Na, Si, O). The binder consists of bovine collagen. When hydrated with bone marrow aspirate, the device absorbs fluids to form a flexible graft matrix that is applied directly to the intended graft site. During healing, the graft particulate is absorbed and remodeled into new bone.

BIOACTIVE Strips are flexible after hydration and are not intended to be loadbearing. Therefore, bulk physical /mechanical properties such as compressive and tensile strengths are not applicable to device properties. The device is sterilized to a sterility assurance level of 100 using ethylene oxide.

I am sorry, but the provided text only refers to a medical device's 510(k) premarket notification and its substantial equivalence to predicate devices, focusing on regulatory aspects, material composition, and intended use. It does not contain information about acceptance criteria, device performance studies, sample sizes, expert qualifications, or ground truth establishment as would be relevant for an AI/ML powered device. Therefore, I cannot fulfill your request to describe those details based on the given document.

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NovaBone MacroFORM bone graft devices are indicated only for bony voids or gaps that are not intrinsic to the stability of the bony structure. NovaBone MacroFORM is indicated to be gently packed into bony voids or gaps of the skeletal system (i.e. the extremities and pelvis). These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone. NovaBone MacroFORM must be hydrated with autogenous bone marrow prior to implantation. The product provides a bone void filler that resorbs and is replaced with bone during the healing process.

NovaBone MacroFORM is an osteoconductive bioactive device used for grafting osseous defects. It is a composite of bioactive calcium-phospho-silicate granules and a collagen binder. The bioactive particulate is composed solely of elements that exist in normal bone (Ca, P, Na, Si, O). The collagen binder consists of bovine collagen. When mixed with bone marrow aspirate, the device forms a non-hardening graft that is applied directly to the intended graft site. The device is slowly absorbed during graft site healing.

During absorption of the collagen binder, the particulate material remaining undergoes a time-dependent kinetic modification of the surface to stimulate osteoblast activity and guide the formation of bone across the graft site. Specifically, a series of surface reactions on the particles results in the formation of a calcium phosphate layer that is substantially equivalent in composition and structure to the hydroxyapatite found in bone mineral. This apatite layer provides scaffolding onto which the patient's new bone will grow, allowing complete repair of the defect. During healing, the graft particulate is absorbed and remodeled into new bone.

MacroFORM is provided in three basic forms: loose granules, a composite plug and a composite block.

The provided document is a 510(k) summary for the NovaBone MacroFORM BIOACTIVE bone graft devices. It describes the device, its intended use, and argues for its substantial equivalence to predicate devices based on technological characteristics and performance.

However, the document does not contain the kind of information typically found in studies designed to establish specific acceptance criteria for performance metrics (like sensitivity, specificity, accuracy) or to quantify improvement with an AI system. This document is a regulatory submission focused on demonstrating substantial equivalence, not on detailed performance analysis against a set of quantitative acceptance criteria in the way you've framed the request.

Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them in the way you've outlined, according to the provided text. The information required for points 1-9 (e.g., sample size for test set, data provenance, number of experts for ground truth, adjudication method, MRMC study details, standalone performance, type of ground truth, training set sample size, how training ground truth was established) is absent from this regulatory document.

Summary of what can be gleaned from the document regarding performance:

• Device Performance Claim: The document states that "Functional in vivo testing in an animal model (rabbit tibia defect) was performed on MacroFORM using the primary predicate (K090731, NovaBone Porous) as a control. The results demonstrate that bone remodeling process for MacroFORM is equivalent to that of NovaBone Porous."
• Acceptance Criteria (Implicit): The implicit acceptance criterion appears to be "equivalence" in bone remodeling to the predicate device (NovaBone Porous) in the specified animal model. No specific quantitative metrics (e.g., percentage of bone fill, density, etc.) are provided as acceptance thresholds.
• Study Details:
  • Type of Study: Functional in vivo testing in an animal model.
  • Model: Rabbit tibia defect.
  • Comparison: MacroFORM was compared to the primary predicate, NovaBone Porous (K090731), as a control.
  • Ground Truth: The "bone remodeling process" was assessed, but the method of assessment (e.g., histology, imaging, quantitative measures) and how ground truth was established are not detailed.
  • Sample Size: Not specified for the animal study.
  • Training Set/AI Specifics: Not applicable as this is not an AI/software device.
  • Adjudication/Experts/MRMC: Not applicable.

In conclusion, while the document confirms a study was done for in vivo performance and biocompatibility to support substantial equivalence, it does not provide the granular details relevant to an AI/diagnostic device's acceptance criteria and validation study as requested.

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FM-02 Bone Graft Substitute is intended for use as a bone void filler for voids or gaps that are not intrinsic to the stability of the bony structure. FM-02 is indicated for use in the treatment of surgically created osseous defects or osseous defects created from traumatic injury to the bone.

FM-02 Bone Graft Substitute is intended to be used for filling bony voids or gaps of the skeletal system (i.e., the extremities, pelvis and posterolateral spine), and may be combined with saline, autogenous blood, and/or bone marrow. Following placement in the bony void or gap, the scaffold resorbs and is replaced with bone during the healing process.

FM-02 Bone Graft Substitute is a resorbable porous bone void filler for the repair of bony defects. It is an osteoconductive, porous implant with a trabecular structure that resembles the multidirectional interconnected porosity of human cancellous bone. The implant is >70% porous and the pore diameters range from 1 um to 1000 um.

FM-02 Bone Graft Substitute guides the three-dimensional regeneration of bone in the defect site into which it is implanted. When FM-02 Bone Graft Substitute 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 the scaffold.

The provided document is a 510(k) summary for a medical device (FM-02 Bone Graft Substitute). It focuses on demonstrating substantial equivalence to a predicate device rather than providing a detailed clinical study demonstrating performance against specific acceptance criteria for AI or diagnostic imaging.

Therefore, the requested information elements related to AI/algorithm performance (acceptance criteria table, sample sizes for test/training sets, ground truth establishment, expert adjudication, MRMC studies, standalone performance) are not applicable or cannot be extracted from this document.

However, I can describe the performance data provided in the document which supports the substantial equivalence claim.

1. Table of Acceptance Criteria and Reported Device Performance

The device is a bone graft substitute, and its "performance" is assessed against physical and biological standards required for such materials, rather than diagnostic accuracy metrics. The acceptance criteria are essentially meeting the requirements of specific ASTM standards and demonstrating characteristics comparable to the predicate device.

• Wettability
• Fluid retention
• Wash away resistance
• Homogeneity
• Radiopacity
• Bioactivity
• SEM comparisons
  These tests demonstrated that FM-02 is "substantially equivalent to the predicate device and does not raise new questions of safety and effectiveness." |
  | Physical/Chemical Characterization (vs. Predicate Device) | Evaluation of:
• XRD (X-ray diffraction)
• FTIR (Fourier-transform infrared spectroscopy)
• ICP (Inductively coupled plasma atomic emission spectroscopy)
• Porosity
  (These were evaluated for the predicate device, implying FM-02 shared similar characteristics or was evaluated against these established parameters for comparison.) |

Study Proving Device Meets Acceptance Criteria:

The document describes non-clinical performance testing to demonstrate substantial equivalence, rather than a clinical study evaluating diagnostic performance. The study described focuses on characterizing the material and comparing its properties to a legally marketed predicate device and to established material standards.

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 applicable in the context of a bone graft substitute material characterization study. The "test set" would refer to samples of the FM-02 material itself, tested in laboratory settings. The number of samples per test (e.g., how many specimens for wettability) is not specified.
• Data Provenance: Not specified in terms of country of origin. This would be laboratory testing conducted by Orthovita, Inc. or a contracted lab. The data is prospective in the sense that the testing was performed specifically to support this 510(k) submission.

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. "Ground truth" in this context would refer to the true physical/chemical properties of the material, which are determined by objective laboratory measurements and adherence to scientific standards (e.g., ASTM, ISO). Expert consensus is not relevant for establishing the "truth" of these material properties.

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

Not applicable. This is not a study requiring expert adjudication of results, but rather objective laboratory 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 device is a bone graft substitute, not an AI or diagnostic imaging device.

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

Not applicable. This device is a bone graft substitute, not an AI or diagnostic imaging device.

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

The "ground truth" for the performance data presented is based on objective laboratory measurements against established standards (ASTM F 1088-04a, ISO 10993-1) and comparison of physical/chemical properties to a predicate device. This involves analytical chemistry techniques (XRD, FTIR, ICP), microscopy (SEM), and various physical property tests (wettability, fluid retention, etc.).

8. The sample size for the training set

Not applicable. This is not an AI/machine learning study.

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

Not applicable. This is not an AI/machine learning study.

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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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