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GPS Advanced and GPS Advanced Cannula are intended for use to deliver FIBERGRAFT™ BG Putty GPS to a bone grafting site.

GPS Advanced is a sterile, single use dispenser for the delivery of FIBERGRAFT™ BG Putty GPS bone graft substitute. The dispenser has a ratcheted plunger that advances with each squeeze of its handle. The 5 cc GPS Advanced Cannula ("GPS Advanced Cannula") is available individually packaged and can be attached to the dispenser.

GPS Advanced is provided sterile via irradiation and GPS Advanced Cannula is provided sterile via ethylene oxide.

The GPS Advanced Cannula is provided empty and needs to be filled with FIBERGRAFT™ BG Putty GPS prior to use. FIBERGRAFT™ BG Putty GPS is a bioactive synthetic bone graft substitute in putty format made from 45S5 bioactive glass and has been previously cleared under K170306 (FIBERGRAFT™ BG Putty – Bone Graft Substitute) and K222276 (CONDUIT™ Cages and FIBERGRAFT™ BG Putty). FIBERGRAFT™ BG Putty GPS is not included in the GPS Advanced dispensing system.

Based on the provided FDA 510(k) clearance letter for "GPS Advanced and GPS Advanced Cannula," it's important to understand that this device is a piston syringe used for delivering a bone graft substitute. As such, the "acceptance criteria" and "study that proves the device meets acceptance criteria" are focused on the mechanical and functional performance of the syringe as a medical device, rather than the performance of an AI/ML algorithm or diagnostic tool.

Therefore, many of the typical questions asked about AI/ML device studies (like MRMC studies, standalone algorithm performance, AI training/test sets, ground truth establishment for AI) are not applicable to this type of device.

Here's a breakdown of the acceptance criteria and performance data as inferred from the document:

1. Table of Acceptance Criteria and Reported Device Performance

Explanation of Inferences:

• The document explicitly states that "The performance data for the subject devices consists of the following evaluations: Biological Risk Assessment, Sterilization Validation, Packaging and Shelf-Life Testing, including functional evaluation." These evaluations implicitly define the acceptance criteria for those aspects.
• The statement about "consistent with those of the primary predicate and reference device" implies that the new device must perform comparably to previously cleared devices in terms of its core technological characteristics and function.

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

This information is not explicitly detailed in the provided 510(k) summary. For a mechanical device like a syringe, "sample size" typically refers to the number of units tested for various validations (e.g., how many syringes were subjected to sterilization, packaging, or functional tests). The document does not specify these numbers.

• Data Provenance: Not applicable in the context of clinical data for AI/ML. The "data" here refers to test results from various engineering and biological validations of the device itself.

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

This concept is not applicable to this device. "Ground truth" in this context is established through engineering specifications, validated test methods (e.g., sterility testing, material biocompatibility standards), and direct functional testing, not by expert consensus on clinical images or interpretations.

4. Adjudication Method for the Test Set

This concept is not applicable to this device, as there's no "interpretation" or "diagnosis" being made that requires human adjudication. Device performance is determined by objective measurements and validation against established standards.

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 relevant for AI-assisted diagnostic devices where human readers (e.g., radiologists) interpret images with and without AI assistance. The GPS Advanced and GPS Advanced Cannula is a delivery device, not an AI diagnostic tool.

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

No, a standalone algorithm performance study was not done. This concept applies to AI/ML algorithms that perform a task independently (e.g., detecting a lesion on an image). The GPS Advanced and GPS Advanced Cannula is a physical medical device, not an algorithm.

7. The Type of Ground Truth Used

The "ground truth" for this device's performance is based on objective scientific and engineering standards and tests:

• Sterility Validation: Demonstration that the device meets established sterility assurance levels (e.g., SAL of 10^-6).
• Biocompatibility Standards: Compliance with ISO 10993 series for medical device biocompatibility.
• Functional Specifications: Ability to successfully deliver the specified volume of material, maintain pressure, resist leakage, and operate smoothly.
• Packaging Integrity Standards: Ability of the packaging to maintain sterility and physical integrity under specified conditions.
• Shelf-Life Parameters: Demonstration that the device retains its functional and sterile properties over its specified shelf-life.

8. The Sample Size for the Training Set

This concept is not applicable for this device. "Training set" refers to data used to train AI/ML algorithms. The GPS Advanced and GPS Advanced Cannula is a mechanical device, not an AI/ML system.

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

This concept is not applicable for this device, as there is no "training set" in the AI/ML sense.

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GPS Advanced and GPS Advanced Cannula are intended for use to deliver FIBERGRAFT™ BG Putty GPS to a bone grafting site.

GPS Advanced is a sterile, single use dispensing system for the delivery of FIBERGRAFT™ BG Putty GPS bone graft substitute. The instrument system includes 1) a dispenser with a ratcheted plunger that advances with each squeeze of its handle and 2) two 5 cc GPS Advanced Cannulas which can be attached to the dispenser to deliver FIBERGRAFT™ BG Putty GPS. The 5 cc GPS Advanced Cannula (hereafter referred to as "GPS Advanced Cannula") is also available individually packaged. GPS Advanced and GPS Advanced Cannula are provided sterile via irradiation. GPS Advanced Cannulas are provided empty and need to be filled with FIBERGRAFT™ BG Putty GPS prior to use. FIBERGRAFT™ BG Putty GPS is a bioactive synthetic bone graft substitute in putty format made from 45S5 bioactive glass and has been previously cleared under K170306 (FIBERGRAFT™ BG Putty – Bone Graft Substitute) and K222276 (CONDUIT™ Cages and FIBERGRAFT™ BG Putty). FIBERGRAFT™ BG Putty GPS is not included in the GPS Advanced dispensing system.

The provided document does not contain information about acceptance criteria or a study proving that the device meets those criteria, as it relates to performance with AI.

The document is a 510(k) premarket notification for a medical device called "GPS Advanced; 5 cc GPS Advanced Cannula," which is a dispensing system for a bone graft substitute. The review focuses on the substantial equivalence of this device to legally marketed predicate devices, primarily regarding its mechanical and material characteristics, sterility, usability, and packaging.

The relevant section, "H. Performance Data," lists the following evaluations:

• Biological Risk Assessment
• Sterilization Validation
• Usability Engineering Evaluation
• Packaging and Shelf Life Testing, including functional evaluation

These are standard engineering and safety tests for a medical device that does not involve AI.

Therefore, I cannot provide the requested information regarding acceptance criteria for AI performance or a study demonstrating such performance.

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FIBERGRAFT® Aeridyan™ Matrix - Bone Graft Substitute is indicated only for bony voids or gaps that are not intrinsic to the stability of the bony structure. FIBERGRAFT® Aeridyan™ Matrix is indicated to be gently packed into bony voids or gaps of the skeletal system (i.e., the posterolateral spine, extremities 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 resorbs and is replaced with bone during the healing process. FIBERGRAFT® Aeridyan™ Matrix must be used with autogenous bone marrow aspirate and autograft in posterolateral spine. FIBERGRAFT® Aeridyan™ Matrix must be hydrated with saline or blood for pelvis and extremity applications.

FIBERGRAFT® Aeridyan™ Matrix product is composed of 4585 bioactive glass (M-45 granules), boron bioactive glass (MS-B microspheres/Borospheres™) and bovine type I collagen. After hydration with saline, blood or bone marrow aspirate (BMA), the Aeridyan™ Matrix can be applied directly to the defect site or molded into the desired shape and gently packed into the defect site as a non-setting putty. In posterolateral spine fusion applications, the product is intended to be hydrated with bone marrow aspirate (BMA) and mixed with autograft in a recommended 1:1 ratio. In pelvis and extremity applications, the product must be hydrated with saline or blood.

This document describes the Prosidyan, Inc.'s FIBERGRAFT® Aeridyan™ Matrix Bone Graft Substitute. The acceptance criteria described in the document are based on demonstrating substantial equivalence to predicate devices, focusing on physical and chemical properties, functional performance in animal studies, and biocompatibility.

Here's an analysis based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Test Set 1 (Posterolateral Spine Study):
  • Sample Size: 71 skeletally mature rabbits.
  • Data Provenance: Prospective animal study (rabbit model), likely conducted in a research facility (country not specified).
• Test Set 2 (Femoral Condyle Defect Study):
  • Sample Size: 44 skeletally mature rabbits.
  • Data Provenance: Prospective animal study (rabbit model), likely conducted in a research facility (country not specified).
• Other tests (Biocompatibility, physical/chemical, etc.): Sample sizes for these in vitro tests are not specified but would typically follow ISO standards. Data provenance is implied to be laboratory testing.

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

The document does not mention the use of human experts to establish ground truth for the animal studies. The evaluation relied on objective measures:

• Radiographic data
• Histomorphometric data
• Biomechanical data (for posterolateral spine study)
• Histological data (for femoral condyle study)

4. Adjudication Method for the Test Set

Not applicable, as ground truth was established by objective measurements in animal models (radiographic, histomorphometric, biomechanical, histological data), not through expert review or consensus.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not conducted. The studies described are animal studies comparing the device's performance to predicate devices and positive controls through objective biological and physical measurements, not human reader performance with or without AI assistance.

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

This question is not applicable to the device described. The FIBERGRAFT® Aeridyan™ Matrix is a physical bone graft substitute, not an algorithmic or AI-based device. Therefore, the concept of "standalone algorithm performance" doesn't apply.

7. The Type of Ground Truth Used

The ground truth used in the animal studies was objective biological and physical measurements:

• Radiographic data: Imaging evidence of bone healing and fusion.
• Histomorphometric data: Quantitative analysis of tissue morphology, including bone formation, graft resorption, and new bone growth.
• Biomechanical data: Measurement of the mechanical strength of the fused/healed bone (for the spine study).
• Histological data: Microscopic examination of tissue structures (for the femoral condyle study).

8. The Sample Size for the Training Set

This question is not applicable. The device is a physical bone graft substitute, not a machine learning model that requires a training set.

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

This question is not applicable, as there is no training set for this type of device.

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FIBERGRAFT® AERIDYAN Matrix - Bone Graft Substitute is indicated only for bony voids or gaps that are not intrinsic to the stability of the bony structure. FIBERGRAFT® AERIDYAN Matrix is indicated to be gently packed into bony voids or gaps of the skeletal system (i.e., posterolateral spine). 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. FIBERGRAFT® AERIDYAN Matrix must be used with autogenous bone marrow aspirate and autograft in posterolateral spine.

FIBERGRAFT® AERIDYAN Matrix product is composed of 45S5 bioactive glass (M-45 granules), boron bioactive glass (MS-B microspheres) and bovine type I collagen. After hydration with bone marrow aspirate (BMA), the AERIDYAN Matrix can be applied directly to the defect site or molded into the desired shape and gently packed into the defect site as a nonsetting putty. In the posterolateral spine fusion applications, the product is intended to be hydrated with BMA and mixed with autograft in a 1:1 ratio.

This document describes a 510(k) premarket notification for a medical device called FIBERGRAFT® AERIDYAN Matrix Bone Graft Substitute. The provided text outlines the device's characteristics and its comparison to predicate devices, but does not describe acceptance criteria or a study that proves a device meets acceptance criteria in the context of an Artificial Intelligence (AI) or machine learning device.

The document discusses performance data for a bone graft substitute, which involves physical and chemical property evaluation studies, functional performance animal studies, and biocompatibility tests. These are traditional medical device testing methods, not AI/ML model validation.

Therefore, I cannot provide the requested information regarding acceptance criteria, study details, sample sizes, expert involvement, adjudication methods, MRMC studies, standalone AI performance, or ground truth establishment for an AI/ML device based on the given text.

The information provided pertains to a physical medical device, not a digital health product with AI/ML components.

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FIBERGRAFT® BG Matrix - Bone Graft Substitute is indicated only for bony voids or gaps that are not intrinsic to the stability of the bony structure. FIBERGRAFT® BG Matrix is indicated to be gently packed into bony voids or gaps of the skeletal system (i.e., posterolateral spine, extremities 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 resorbs and is replaced with bone during the healing process. FIBERGRAFT® BG Matrix must be used with autogenous bone marrow aspirate and autograft in posterolateral spine.

FIBERGRAFT® BG Matrix product is composed of 45S5 bioactive glass components (M-45 granules, MS-45 microspheres) and bovine type I collagen. The BG Matrix after hydration with saline or blood can be applied to the defect site or can be molded into the desired shape and gently packed into the defect site as a non-setting putty. In the posterolateral spine fusion applications, the product is intended to be hydrated with bone marrow aspirate (BMA) and mixed with autograft in a 1:1 ratio.

The FIBERGRAFT® BG Matrix product was previously cleared in K171284. There has not been any change to the device since the last clearance.

The provided text describes the FIBERGRAFT® BG Matrix Bone Graft Substitute but does not contain a discrete table of acceptance criteria and reported device performance. It also lacks specific details on sample sizes, ground truth establishment, expert involvement, or comparative effectiveness studies in the format requested.

However, based on the information provided, here's an attempt to structure the answer, highlighting what is available and noting the missing information:

Description of Acceptance Criteria and Study to Prove Device Meets Acceptance Criteria for FIBERGRAFT® BG Matrix Bone Graft Substitute

The performance of the FIBERGRAFT® BG Matrix was established through physical and chemical property evaluation studies, functional performance animal studies, and biocompatibility tests. The device's substantial equivalence to predicate devices for its intended use as a synthetic bone void filler was the primary goal, demonstrating that it functions as intended without raising new safety or effectiveness concerns.

1. Table of Acceptance Criteria and the Reported Device Performance

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

• Rabbit Posterolateral Spine Fusion Study:
  • Sample Size: 53 skeletally mature rabbits.
  • Data Provenance: Animal study (specifically, rabbit model). The text implies prospective data collection within the study design. Country of origin not specified.
• Rabbit Critical Size Distal Femur Defects Study:
  • Sample Size: 42 skeletally mature rabbits.
  • Data Provenance: Animal study (specifically, rabbit model). The text implies prospective data collection within the study design. Country of origin not specified.

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

The provided text describes animal studies with data evaluated using radiographic, histological, histomorphometric, and biomechanical data. It does not mention human experts establishing ground truth for the test set in the context of clinical images or diagnostic performance. Instead, ground truth is inferred from the scientific measurements and observations made in the animal models.

4. Adjudication method for the test set

Not applicable, as the clinical adjudication of diagnostic assessments by human readers is not the focus of these animal performance studies. The evaluation methods (radiographic, histological, histomorphometric, biomechanical data) are objective measurements.

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. The studies described are animal studies evaluating the performance of a bone graft substitute, not a diagnostic AI device requiring human reader assessment.

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 algorithm.

7. The type of ground truth used

The ground truth in these animal studies was established through:

• Histology: Microscopic examination of tissue.
• Histomorphometry: Quantitative analysis of tissue structure.
• Radiography: X-ray imaging for bone formation/healing.
• Biomechanical data: Measurements of mechanical properties of the bone.
  These are direct scientific measurements of material integration and functional outcomes in a living organism.

8. The sample size for the training set

Not applicable. As this is a medical device (bone graft substitute) and not an AI/algorithm, there is no concept of a "training set" in the context of machine learning. The studies described are performance evaluations of the physical product.

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

Not applicable, as there is no "training set" for this type of medical device.

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FIBERGRAFT® BG Matrix - Bone Graft Substitute is indicated only for bony voids or gaps that are not intrinsic to the stability of the bony structure. FIBERGRAFT® BG Matrix is indicated to be gently packed into bony voids or gaps of the skeletal system (i.e., posterolateral spine). 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. FIBERGRAFT® BG Matrix must be used with autogenous bone marrow aspirate and autograft in posterolateral spine.

FIBERGRAFT® BG Matrix product is composed of 45S5 bioactive glass components (M-45 granules, MS-45 microspheres) and bovine type I collagen. The product is intended to be hydrated with BMA and mixed with autograft in a 1:1 ratio.

The provided text is a 510(k) summary for the FIBERGRAFT® BG Matrix Bone Graft Substitute. It describes the device, its intended use, and substantial equivalence to predicate devices. However, this document does not describe "acceptance criteria" or a "study that proves the device meets the acceptance criteria" in the context of an AI/ML medical device performance study.

Instead, the document details performance testing for a bone graft substitute, which involves:

• Physical and chemical property evaluation studies.
• Functional performance animal studies (specifically, a rabbit study comparing the device to a predicate and controls).
• Biocompatibility tests (ISO 10993).
• Packaging evaluations, shelf life, and real-time aging testing.
• Bacterial endotoxin testing.

The document states that the rabbit study evaluated device performance using "radiographic, histological, histomorphometric, and biomechanical data" and concluded that the device performs "substantially equivalently to the predicate device and positive control."

Therefore, I cannot provide the requested information about acceptance criteria and a study proving device performance as it relates to an AI/ML device. The document is for a medical device (bone graft substitute), not an AI/ML algorithm.

If you can provide a document describing a clinical study or performance evaluation for an AI/ML medical device, I would be happy to help answer your questions according to the format you've provided.

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FIBERGRAFT® BG Putty - Bone Graft Substitute is indicated only for bony voids or gaps that are not intrinsic to the stability of the bony structure. FIBERGRAFT® BG Putty is indicated to be gently packed into bony voids or gaps of the skeletal system (i.e., posterolateral spine, extremities 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 resorbs and is replaced with bone during the healing process. FIBERGRAFT® BG Putty must be used with autograft in the posterolateral spine.

FIBERGRAFT® BG Putty is not indicated for use in load-bearing applications; therefore, standard internal or external stabilization techniques must be followed to obtain rigid stabilization.

The FIBERGRAFT®BG Putty is an osteoconductive, resorbable, biocompatible bone graft substitute to be gently packed into defect sites and to be used as non-structural scaffolds. The FIBERGRATT® BG putty is made from 45S5 bioactive glass, where the bioactive glass components are mixed with an absorbable binder to form a cohesive material.

The provided text does not contain information about acceptance criteria or a study that proves a device meets specific performance criteria in terms of accuracy, sensitivity, or specificity, as would be relevant for an AI/ML device.

Instead, the document is a 510(k) premarket notification for a medical device called "FIBERGRAFT® BG Putty Bone Graft Substitute". The 510(k) clearance process focuses on demonstrating "substantial equivalence" to a legally marketed predicate device, rather than proving performance against specific quantitative accuracy metrics for software.

The performance data discussed relates to:

• Physical and chemical property evaluation studies: These confirmed in vitro functionality and bioactivity, but it explicitly states, "The in vitro bioactivity test results have not been correlated to clinical performance."
• Biocompatibility tests (ISO 10993 testing): This demonstrates the material's safety for biological contact.
• Packaging evaluations, shelf life testing, and real-time aging testing.
• Bacterial endotoxin testing.
• Functional performance animal studies:
  • Ovine model: Evaluated in critical size defects in skeletally mature sheep (total of 58 tested samples). This study demonstrated evidence of new bone formation with "substantially equivalent performance compared to the predicate device."
  • Rabbit posterolateral spine fusion model: Compared to predicate devices and positive controls in 71 skeletally mature rabbits. This study also showed "substantially equivalently to the predicate devices."

The animal studies used radiographic, histomorphometric, and biomechanical data to evaluate performance, which are methods for assessing bone formation and structural integrity. However, the document does not present specific acceptance criteria in a table format with corresponding device performance metrics (e.g., bone volume percentages, fusion rates above a certain threshold) that could be definitively extracted and formatted as requested. The conclusion is based on "substantial equivalence" to predicate devices, meaning it performs as safely and effectively without raising new safety or effectiveness concerns, rather than meeting a predefined quantitative performance target.

Therefore, I cannot fulfill the request to provide a table of acceptance criteria and reported device performance, nor details about sample sizes for test sets, data provenance, expert ground truth, adjudication methods, MRMC studies, or standalone algorithm performance, as these concepts are not addressed in the provided 510(k) summary for this type of device.

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FIBERGRAFT™ BG Morsels - Bone Graft Substitute is indicated only for bony voids or gaps that are not intrinsic to the stability of the bony structure. FIBERGRAFT™ BG Morsels is indicated to be gently packed into bony voids or gaps of the skeletal system (i.e., posterolateral spine, extremities 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 resorbs and is replaced with bone during the healing process. FIBERGRAFT™ BG Morsels must be used with autogenous bone marrow aspirate and autograft in the posterolateral spine.

FIBERGRAFT™ BG Morsels is not indicated for use in load-bearing applications; therefore, standard internal or external stabilization techniques must be followed to obtain rigid stabilization.

The FIBERGRAFT™BG Morsels provide an osteoconductive, resorbable, biocompatible bone graft substitute that is to be gently packed into defect sites. The FIBERGRAFT™BG Morsels are made from crystalline 45S5 bioactive glass. Each granule of BG Morsels is created from a matrix of bioactive glass fibers and microspheres. Bioactive glass is defined as a group of glasses that has a compositional range that allows the formation of hydroxyapatite (HA) as a surface layer when exposed to an aqueous phosphate-containing solution such as simulated body fluid. The HA layer that forms in an aqueous phosphate-containing solution plays a significant role in forming a strong bond with natural bone. The granules provide an ultra-porous scaffold for desired biological response and improved handling characteristics, while optimizing radiopacity and resorption. BG Morsels are generally spherical in appearance and provided in granular form. The matrix is flash sintered to form a porous shell at its surface, which creates the generally spherical structure of the granules, while maintaining a level of porosity within each granule.

The provided document is a 510(k) summary for a medical device called FIBERGRAFT™ BG Morsels - Bone Graft Substitute. It does not describe an AI/ML medical device, nor does it detail a study involving human readers or AI assistance.

Therefore, I cannot provide the requested information regarding acceptance criteria and study details for an AI/ML medical device's performance because the provided text is about a bone graft substitute, not an AI/ML product.

The document focuses on demonstrating substantial equivalence to a predicate device for a physical bone graft substitute, involving:

• Physical Property Evaluations: Simulated distribution, whole package integrity, seal strength, accelerated and real-time aging tests.
• Biocompatibility Testing: ISO 10993 testing.
• Animal Studies:
  • Ovine Model: 58 skeletally mature sheep, evaluating device performance in critical sized cancellous bone defects (lateral distal femurs) over 24 weeks with interim evaluations (4, 8, 12, 24 weeks; min 3 animals/time point/group). Compared to positive control (predicate NovaBone Putty) and negative sham control (untreated defect). Data included radiographic, histological, histomorphometric, and biomechanical data.
  • Rabbit Model: 41 skeletally mature rabbits, evaluating device performance in a posterolateral spine fusion model over 26 weeks. Compared to predicate device and autograft (positive) control. Data included radiographic, histological, histomorphometric, and biomechanical data.
• In Vitro Studies: Demonstrating apatite layer formation on the surface in simulated body fluid (SBF).

This information does not align with the specific questions about AI/ML device performance, ground truth establishment by experts, or MRMC studies.

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FIBERGRAFT™ BG Putty - Bone Graft Substitute is indicated only for bony voids or gaps that are not intrinsic to the stability of the bony structure. FIBERGRAFT™ BG Putty 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. The product provides a bone void filler that resorbs and is replaced with bone during the healing process.

FIBERGRAFT™ BG Putty is not indicated for use in load-bearing applications; therefore, standard internal or external stabilization techniques must be followed to obtain rigid stabilization.

The FIBERGRAFT™ BG Putty is a osteoconductive, resorbable, biocompatible bone graff substitute to be gently packed into defect sites and to be used as non-structural scaffolds. The FIBERGRAFT™ BG putty is made from 45S5 bioactive glass, where the bioactive glass components are mixed with an absorbable binder to form a cohesive material.

The provided document is a 510(k) Summary for the FIBERGRAFT™ BG Putty Bone Graft Substitute. It describes the device, its intended use, and demonstrates substantial equivalence to predicate devices. However, this document does not contain a table of acceptance criteria or details of a study that directly proves the device meets specific performance acceptance criteria in the format requested.

Instead, it evaluates the device against predicate devices and relies on animal studies and biocompatibility testing. I will extract the available information as best as possible to answer your questions, but many points will be marked as "Not provided" or inferred from the context of a 510(k) submission.

Here's the breakdown of the information based on your request:

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

A specific table of acceptance criteria with numerical targets and corresponding device performance is not provided in the document. The document states that performance was evaluated and found "substantially equivalent" to predicate devices, and that the device "performs as safely and as effectively as the predicate device."

The closest statements to performance attributes are:

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: The document mentions a functional performance animal study: "A total of 58 tested samples were evaluated in the study from skeletally mature sheep." This refers to samples within the study, not necessarily individual animals.
• Data provenance:
  • Country of origin: Not provided.
  • Retrospective or prospective: The animal study described is a prospective study by its nature, designed to evaluate the device.

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

Not applicable/Not provided. This device is a bone graft substitute, and its performance is evaluated in an animal model using objective measures (radiographic, histological, histomorphometric, and biomechanical data), not by expert interpretation of images or clinical assessments in a human study that would typically require independent expert ground truth establishment.

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

Not applicable/Not provided. As noted above, this is an animal study with objective measurements, not a human clinical trial requiring adjudication of interpretations.

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/Not provided. This is not an AI/imaging device. It's a bone graft substitute.

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

Not applicable/Not provided. See above.

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

For the animal study, the "ground truth" equivalent would be the objective measurements obtained from the ovine model:

• Radiographic data
• Histological data
• Histomorphometric data
• Biomechanical data

These are direct measurements of biological and mechanical responses to the implant.

8. The sample size for the training set

Not applicable/Not provided. As this is a material science and biological response evaluation for a bone graft substitute, there is no "training set" in the context of machine learning algorithms. The development of the material itself would involve R&D and iterative testing, but not a "training set" in the requested sense.

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

Not applicable/Not provided. See above.

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FIBERGRAFT™ BG Morsels Bone Graft Substitute is indicated only for bony voids or gaps that are not intrinsic to the stability of the bony structure. FIBERGRAFT™ BG Morsels 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 . The product provides a bone void filler that resorbs and is replaced with the healing process.

FIBERGRAFT™ BG Morsels is not indicated for use in load-bearing applications; therefore, standard internal or external stabilization techniques must be followed to obtain rigid stabilization.

FIBERGRAFT™ BG Morsels provides an osteoconductive, resorbable, biocompatible bone graft substitute made from crystalline 45S5 bioactive glass. Each granule of FIBERGRAFT™ BG Morsels is created from a matrix of bioactive glass fibers and microspheres. Bioactive glass is defined as a group of glasses which has a compositional range that allows the formation of hydroxyapatite (HA) as a surface layer when exposed to an aqueous phosphate-containing solution such as simulated body fluid. The HA layer that forms in an aqueous phosphate-containing solution plays a significant role in forming a strong bond with natural bone. The granules provide an ultra-porous scaffold for desired biological response and improved handling characteristics, while optimizing radiopacity and resorption. FIBERGRAFT™ BG Morsels are generally spherical in appearance and provided in granular form. The matrix is flash sintered to form a porous shell at its surface, which creates the generally spherical structure of the granules, while maintaining a level of porosity within each granule. The primary purpose of this submission is to add the option to use blood to mix with the product prior to implantation. Changes were also made to the product trade name and the labeled volume sizes.

Here's an analysis of the provided text regarding the acceptance criteria and study for the FIBERGRAFT™ BG Morsels Bone Graft Substitute:

Based on the provided 510(k) summary, the device under review is primarily a modification to a previously cleared device. Therefore, the "acceptance criteria" and "study" are focused on demonstrating that the modified device remains substantially equivalent to its predicate, particularly concerning the new addition of using blood as a mixing agent.

1. Table of Acceptance Criteria and Reported Device Performance

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

The document does not specify the sample sizes used for the "fluid absorbability," "packability," or "handling characteristics" tests. It also does not mention the country of origin or whether the data was retrospective or prospective. It only states "testing was conducted."

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

The document does not mention the use of experts or their qualifications for establishing ground truth for the performance testing. The "testing" appears to be focused on physical and material properties rather than clinical outcomes requiring expert interpretation.

4. Adjudication Method for the Test Set

The document does not describe any adjudication method. This type of physical/material testing typically does not involve adjudication as it's not based on subjective interpretation.

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

The document does not describe an MRMC comparative effectiveness study. This type of study is typically done for diagnostic imaging devices where human readers interpret results with and without AI assistance. This device is a bone graft substitute, not an imaging AI.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

The document does not describe a standalone algorithm performance study. This is not an AI device. The performance testing conducted was on the physical properties of the bone graft substitute.

7. Type of Ground Truth Used

For the performance assessment, the "ground truth" seems to be established physical/material property standards and the performance of the predicate device. The tests (fluid absorbability, packability, handling at time zero and after aging) are compared implicitly or explicitly against the known acceptable characteristics of the predicate and expected performance for a bone graft substitute.

8. Sample Size for the Training Set

This device is not an AI/ML device, so there is no concept of a "training set" in the context of machine learning. The term "training set" is not applicable here.

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

Since there is no training set mentioned, this point is not applicable.

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