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GlassBone Granules is an implant intended to fill bony voids or gaps of the skeletal system (i.e., extremities and pelvis). These osseous defects may be the result of benign bone cysts and tumors (in adults and pediatric patients ≥ 6 years old), are surgically created or the result of traumatic injury to the bone and are not intrinsic to the stability of the bony structure. GlassBone Granules resorbs and is replaced with bone during the healing process.

GlassBone Granules is a synthetic and biocompatible bone substitute device (bioactive glass 4555). GlassBone Granules is composed by weight of 4555 bioactive glass granules (45% SiO2, 6% P2O5, 24.5% CaO and 24.5% Na2O). It is sterilized with gamma irradiation and is single use and is available in different unit sizes.

The provided text describes the 510(k) premarket notification for "GlassBone Granules," a resorbable calcium salt bone void filler device. It focuses on demonstrating substantial equivalence to a predicate device, rather than proving the device meets specific performance criteria through a study with the detailed elements requested.

Therefore, I cannot provide a table of acceptance criteria and reported device performance, nor details about sample sizes, ground truth establishment, expert involvement, or comparative effectiveness studies (MRMC) as these are not present in the provided document.

The document states:

• "There was no clinical testing required to support the medical device as the indications for use is equivalent to the predicate device."

This means that the FDA's clearance for GlassBone Granules was based on its substantial equivalence to an already legally marketed predicate device (BonAlive Granules - K231528) and a reference device (NovaBone Resorbable Bone Graft Substitute - K052494), rather than a clinical study with new performance data.

Instead of a clinical study proving performance against acceptance criteria, the submission relied on non-clinical performance data (bench testing, animal testing, biocompatibility, sterility, and shelf life) to demonstrate that the device is as safe and effective as the predicate.

Here's a breakdown of what is in the document regarding the "study" that proves the device meets requirements, interpreted in the context of a 510(k) submission focused on substantial equivalence:

1. Table of "Acceptance Criteria" and "Reported Device Performance":
Not applicable in the traditional sense of a clinical trial for a standalone AI/software product, or a device requiring specific performance metrics against a disease state. The "acceptance criteria" here are implied by the standards and guidance documents followed to demonstrate equivalence.

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

• Sample size for test set: Not applicable as no clinical test set was used for a performance study. Non-clinical bench and animal testing typically use specific quantities of samples as per ASTM and ISO standards, but these details are not provided here.
• Data provenance: Not applicable for a clinical test set. The non-clinical data would have been generated in labs as part of the device development and validation.

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

• Not applicable as no clinical test set with human ground truth (e.g., image annotation) was established. The ground truth for non-clinical tests is based on objective measurements and established scientific methods (e.g., chemical analysis, microbiological assays).

4. Adjudication method for the test set:

• Not applicable as no clinical test set requiring human adjudication was used.

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 physical bone void filler, not an AI software. No MRMC study was conducted.

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

• Not applicable. This is not an algorithm/software device.

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

• For the non-clinical tests, the "ground truth" is based on the objective measurements and scientific standards applied in the bench (e.g., chemical composition analysis, particle size distribution) and animal (e.g., histological analysis of tissue response, biocompatibility markers) studies. There is no "ground truth" in the sense of clinical annotations or outcomes data from a patient cohort.

8. The sample size for the training set:

• Not applicable. This is not an AI/machine learning device that requires a training set.

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

• Not applicable.

In summary, the FDA document indicates that the "GlassBone Granules" device's safety and effectiveness were demonstrated through a comparison to a legally marketed predicate device and through robust non-clinical (bench and animal) testing that confirmed its material properties, biocompatibility, sterility, and shelf life, showing it performs comparably to established devices. No clinical studies or AI-specific performance evaluations were deemed necessary or conducted for this 510(k) submission.

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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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Vitoss® Bioactive Foam 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. Vitoss Bioactive Foam is indicated for use in the treatment of surgically created osseous defects or osseous defects created from traumatic injury to the bone. Vitoss Bioactive Foam should not be used to treat large defects that in the surgeon's opinion would fail to heal spontaneously.

Vitoss Bioactive Foam Bone Graft Substitute is intended to be used for filling bony voids or gaps of the skeletal system (i.e., the extremities, spine and pelvis). Following placement in the bony void or gap, the scaffold resorbs and is replaced with bone during the healing process.

Vitoss Bioactive Foam is a resorbable, osteoconductive implant with a trabecular structure that resembles the multidirectional interconnected porosity of human cancellous bone.

This submission describes a bone graft substitute (Vitoss Bioactive Foam), not an AI/ML powered medical device. Therefore, many of the requested categories for AI/ML device evaluation (like sample size for test sets, expert qualifications, MRMC studies, standalone performance, training sets, etc.) are not applicable to this document.

The document focuses on demonstrating substantial equivalence to existing predicate devices based on intended use, technological characteristics, and performance data from in vitro studies.

Here's an attempt to address the relevant points based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Not Applicable (N/A) for an AI/ML device.
• The "performance testing" mentioned refers to in vitro studies. No specific sample sizes for these in vitro tests (e.g., number of strips, number of simulated body fluid trials) are provided in this summary.
• The data provenance is from in vitro studies, not human clinical data.

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

• N/A for an AI/ML device.
• Ground truth for material properties (e.g., calcium phosphate formation) would be established by standard laboratory analytical methods, not human expert consensus in the context of clinical images.

4. Adjudication method for the test set

• N/A for an AI/ML device.

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 is not an AI-assisted diagnostic device.

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

• N/A. This is not an AI algorithm.

7. The type of ground truth used

• The ground truth for the in vitro performance data (osteostimulatory properties) was based on laboratory measurements/observations of calcium phosphate formation in a simulated body fluid, as observed by standard analytical techniques.

8. The sample size for the training set

• N/A for an AI/ML device.

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

• N/A for an AI/ML device.

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