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Synthetic Bone Graft Particulate is intended to be used to augment the alveolar bone in tooth extraction procedures. (i.e., use in extraction sockets only)

Synthetic Bone Graft Particulate is a synthetic absorbable osteoconductive bone graft substitute manufactured from 45S5 bioactive glass. The device is in particulate form with a size range of 0.5 mm to 1 mm.

The device is intended for augmenting alveolar bone in tooth extraction procedures. At time of use, the device is mixed with sterile saline to form a wet sandy paste that is applied to the defect. Synthetic Bone Graft Particulate is progressively resorbed and replaced by new bone tissue during the healing process.

It is supplied sterile, packaged in a rubber stopper-sealed glass bottle within a sterile barrier package (Tyvek-sealed PETG box). The device packages are protected by carboard box.

The provided document is a 510(k) summary for a medical device called "Synthetic Bone Graft Particulate." It focuses on demonstrating substantial equivalence to a predicate device ("PerioGlas - Bioglass Bone Graft Particulate") for regulatory clearance.

This document does not contain acceptance criteria or study details for an AI/ML-driven device's performance. The "performance data" section (Section 7) describes non-clinical tests (sterilization, shelf-life, biocompatibility, chemical/physical properties) and an animal study for the bone graft material itself, not for an AI/ML system.

Therefore, I cannot extract the requested information about acceptance criteria and the study proving the device meets those criteria in the context of an AI/ML device. The device described in the document is a physical medical implant (synthetic bone graft particulate), not an AI/ML software or system.

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The INION BIORESTORE™ implants are bone graft substitutes indicated only for bony voids or gaps that are not intrinsic to the stability of the bony structure. INION BIORESTORE™ is indicated 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 provides a bone void filler that resorbs and is replaced with bone during the healing process.

Inion BioRestore™ is an osteoconductive and osteostimulative bioactive bone graft device. In vivo tests have demonstrated more bone formation at each post-implantation timepoint and more total bone formation compared to other osteoconductive devices such as hydroxyapatite. In vitro cell culture tests with human adipose mesenchymal stem cells have demonstrated an osteostimulative effect, defined as the active stimulation of osteoblast proliferation and differentiation as evidenced by alkaline phosphatase activity. This stimulation has been attributed as being the result of the interaction between osteoblasts and the ionic dissolution products released from Inion BioRestore™ during its absorption. Clinical data on humans on rate and extent of bone formation observed in cell culture and animal models has not been established.

Bioactive materials are those materials that elicit a specific biological response at the interface of the material that results in the formation of a bond between the tissues and the material. Osteostimulation is a "... property of some bioactive materials to enhance, actively stimulate both the proliferation and differentiation of progenitor cells (e.g. mesenchymal stem cells) ... "1.2

Inion BioRestore™ system consists of different size cylinders, blocks and morsels made of degradable bioactive glass. When implanted, a kinetic modification of the surface occurs, resulting in the formation of a calcium phosphate layer that is essentially similar 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. Based on pre-clinical testing, most of the material degrades in vivo in six months. The material is radiopaque. Inion BioRestore™ implants are intended for single use and are provided sterile to the user. They are completely synthetic and noncollagenous.

This 510(k) summary for Inion BioRestore™ describes a medical device clearance based on substantial equivalence to predicate devices, rather than a study against a pre-defined set of acceptance criteria with detailed performance metrics. Therefore, several requested categories of information directly related to performance studies with acceptance criteria, ground truth, and expert evaluation are not applicable or not provided in this document.

Here's a breakdown of the requested information based on the provided text:

Table of Acceptance Criteria and Reported Device Performance

Study Information

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

   • Test set and data provenance specific to a performance study: Not explicitly stated. The document refers to "in vivo tests" and "in vitro cell culture tests," but does not provide details on sample sizes or data provenance (e.g., country of origin, retrospective/prospective nature) for these tests in the context of a "test set" for regulatory evaluation against acceptance criteria.
   • The "performance data and specifications" mentioned in the substantial equivalence statement are used to compare the device to predicates, not against a standalone test set for specific acceptance criteria.

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

   • Not applicable as no specific "test set" requiring expert ground truth establishment for regulatory acceptance is detailed in this 510(k) summary. The evaluation relies on comparison to predicate devices and general pre-clinical testing results.

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

   • Not applicable as no specific "test set" with a need for expert adjudication is detailed.

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 is a bone graft substitute, not an AI-assisted diagnostic tool. Therefore, an MRMC study related to human reader performance with or without AI assistance is irrelevant and not mentioned.

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

   • Not applicable. This device is a physical bone graft substitute, not an algorithm.

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

   • For the "in vivo tests" demonstrating bone formation: The "ground truth" would likely be based on histological analysis, imaging (e.g., radiography, micro-CT) for assessing bone growth, and potentially gross examination by animal pathologists or histology experts. However, specific details are not provided.
   • For the "in vitro cell culture tests": The "ground truth" for osteostimulation is evidenced by "alkaline phosphatase activity," which is a biochemical marker for osteoblast differentiation.

7. The sample size for the training set:

   • Not applicable. This device is a physical bone graft substitute, not an AI model that requires a "training set."

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

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

In summary, this 510(k) clearance is based on demonstrating "substantial equivalence" to existing predicate devices, leveraging pre-clinical (in vivo and in vitro) data for general characterization rather than a specific performance study against defined acceptance criteria with a detailed clinical test set and expert evaluation. The document confirms that there are "no applicable mandatory performance standards" for this device.

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The INION BIORESTORE™ implants are bone graft substitutes indicated for bony voids or gaps that are not intrinsic to the stability of the bony structure; packing into bony voids or gaps to fill and/or augment dental intraosseous, oral and craniomaxillofacial defects. These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone, including: e.g., periodontal/infrabony defects; alveolar ridge augmentation (sinusotomy, osteotomy); dental extraction sites (ridge maintenance, implant preparation/placement); sinus lifts; cystic defects; and craniofacial augmentation.

Inion BioRestore™ is an osteoconductive and osteostimulative bioactive bone graft substitute used either separately or in conjunction with autogenous or allograft bone. When implanted, a kinetic modification of the surface occurs, resulting in the formation of a calcium phosphate layer that is essentially similar 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. Inion BioRestore™ system consists of different size cylinders, blocks and morsels made of degradable bioactive glass. Inion BioRestore™ implants degrade in vivo in six months based on pre-clinical data. The material is radiopaque. Inion BioRestore™ implants are intended for single use and are provided sterile to the user. They are completely synthetic and non-collagenous.

This document is a 510(k) summary for Inion BioRestore™, a bone graft substitute, and does not contain information about acceptance criteria or a study that proves the device meets specific performance criteria.

The 510(k) process is primarily focused on demonstrating substantial equivalence to a legally marketed predicate device, rather than detailed performance studies with acceptance criteria or comparative effectiveness studies.

Therefore, I cannot provide the requested information based on the provided text. The document refers to "performance data and specifications presented" for demonstrating substantial equivalence, but it does not describe what those specific data points or acceptance criteria were. It also mentions "pre-clinical data" for degradation, but not details of the study.

Here's a breakdown of why each point cannot be answered:

1. A table of acceptance criteria and the reported device performance: Not present. The document focuses on showing equivalence to predicate devices, not on meeting predefined performance metrics.
2. Sample sized used for the test set and the data provenance: Not present. No specific test set or study data is detailed.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable/present. No test set requiring expert ground truth is described.
4. Adjudication method: Not applicable/present.
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 document describes a medical device (bone graft substitute), not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable.
7. The type of ground truth used: Not applicable/present.
8. The sample size for the training set: Not applicable/present.
9. How the ground truth for the training set was established: Not applicable/present.

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The intended use of PerioGlas Putty is to provide a safe, biocompatible synthetic bone graft material for use in oral, dental intraosseous, and craniofacial defects. It is used alone in a manner comparable to autogenous bone graft chips or allograft bone particulate (Demineralized Freeze Dried Bone) or may be mixed with either (typically 1:1 ratio v/v) as a bone graft extender. Typical uses include:

• Periodontal/Infrabony defects
• Ridge Augmentation (sinusotomy, osteotomy, cystectomy)
• Extraction sites maintenance/augmentation, implant (ridge preparation/ placement)
• Sinus lifts
• Cystic cavities
• Cranio-facial augmentation

For larger defects, a mixture of PerioGlas Putty with an equal volume of allograft or autograft bone and bone marrow may improve new bone formation.

PerioGlas Putty is an osteoconductive, bioactive, bone void filler device. The device is intended for dental intraosseous, oral, and cranio-/maxillofacial bony defects and is supplied sterile. PerioGlas Putty is a two-component device composed of a synthetic bioactive glass particulate mixed with a binder. The a melt-derived calcium-phosphorus-sodium-silicate major component is designed specifically for for its absorbability (Bioglass) particulate and osteoconductive nature. The second component is gelatin powder, selected for its biocompatibility and physical gelation properties to act as a temporary binding agent for the particulate. The gelatin is rapidly absorbed from the graft site to permit tissue infiltration between the Bioglass particles and replacement of the particles by host bone during the healing process.

I'm sorry, but the provided text does not contain the information needed to answer your request. The document describes a 510(k) premarket notification for a medical device (PerioGlas Putty - Bioactive Bone Graft Gel) and focuses on demonstrating substantial equivalence to predicate devices, rather than presenting a study with specific acceptance criteria and performance data.

Therefore, I cannot provide:

• A table of acceptance criteria and reported device performance.
• Sample sizes used for test sets or data provenance.
• Number and qualifications of experts for ground truth.
• Adjudication method.
• MRMC comparative effectiveness study details.
• Standalone algorithm performance.
• Type of ground truth used.
• Sample size for the training set.
• How ground truth for the training set was established.

This document is primarily about regulatory clearance based on substantial equivalence, not a detailed performance study with the metrics you've requested.

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