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These 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 a biodegradable bone graft substitute made of bioactive, biodegradable glass. 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 non-pyrogenic.

With this modification, additional packaging sizes and packaging configurations are introduced for the Inion BioRestore™ morsels.

This document is a 510(k) premarket notification for the Inion BioRestore device. The information provided primarily focuses on the regulatory aspects, device description, and verification testing related to packaging modifications for an existing bone graft substitute. As such, the document does not contain the typical acceptance criteria and a study design for a software or AI-based medical device.

Therefore, many of the requested details, such as those related to AI algorithm performance, human reader studies, or training/test set ground truth establishment for an AI device, are not applicable to this submission.

However, I can extract the information that is present concerning the physical device's verification testing and acceptance criteria related to its packaging and shelf-life.

Here's the information based on the provided text, aligning with the closest relevant aspects of your request:

Acceptance Criteria and Device Performance for Inion BioRestore (Packaging Modification)

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size: Not explicitly stated for each specific test (biological safety, sterilization, shelf life, transportation). The document mentions "evaluation was conducted," "validation was conducted," "studies were performed," and "a test was performed," implying a sample was used for each.
• Data Provenance: Not explicitly stated regarding country of origin or specific patient data as this relates to a physical device's integrity and sterility, not clinical data from patients. The testing appears to be laboratory-based and engineering-based (e.g., sterilization validation, physical handling tests). The submission itself originates from Tampere, Finland (Manufacturer: Inion Oy).

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

• Not Applicable in the context of an AI device's ground truth. For this physical device's packaging verification, the "ground truth" would be established by validated scientific and engineering methods, adhering to relevant standards (e.g., ISO, ASTM for sterilization, shelf-life, and transportation testing). These tests are typically performed by qualified laboratory personnel and engineers, but specific numbers and qualifications are not provided in this regulatory summary.

4. Adjudication Method for the Test Set

• Not Applicable in the context of an AI device's ground truth adjudication. For physical device testing, results are adjudicated against pre-defined engineering and performance specifications, not through consensus of expert readers.

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

• No, not done. This type of study is relevant for AI-assisted diagnostic devices, not for the physical device (bone graft substitute) described here, nor its packaging modifications.

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

• No, not applicable. This refers to AI algorithm performance, which is not the subject of this 510(k) submission.

7. Type of Ground Truth Used

• For the physical device's performance related to packaging and shelf-life, the "ground truth" is based on:
  • Validated laboratory measurements (e.g., sterility testing, material degradation analysis).
  • Engineering specifications and standards (e.g., for packaging integrity, transport resilience).
  • Biological safety assessments based on established toxicology and biocompatibility standards.

8. Sample Size for the Training Set

• Not Applicable. This refers to an AI training set, which is not relevant to this submission.

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

• Not Applicable. This refers to an AI training set's ground truth, which is not relevant to this submission.

Summary regarding the device (Inion BioRestore) as a whole (not just AI/Software):

The Inion BioRestore is described as a resorbable bone void filler device made of bioactive, biodegradable glass. The 510(k) submission (K191764) is specifically for a modification to the device, introducing "additional packaging sizes and packaging configurations" for existing morsels. The document emphasizes that "There are no changes to the implant, i.e. Inion BioRestore morsels are the same." Therefore, the submission primarily focuses on ensuring that the new packaging does not negatively impact the safety, sterility, or efficacy of the device, and that it maintains its shelf life and integrity during transport.

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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 The 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 laver 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.

The provided text does not contain information about acceptance criteria or a study proving that the Inion BioRestore™ device meets specific acceptance criteria.

The document is a 510(k) summary for the Inion BioRestore™ device, primarily focusing on establishing substantial equivalence to a predicate device (Inion BioRestore™ K070998). It describes the device, its principles of operation, indications for use, and confirms that it is substantially equivalent to the predicate. The FDA letter confirms the substantial equivalence determination.

Therefore, I cannot fulfill your request for the tables and details about acceptance criteria and the study that proves the device meets them, as this information is not present in the provided text.

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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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