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Actifuse is a synthetic bone grafting material intended to fill, augment, and/or reconstruct maxillofacial osseous bone defects including periodontal, oral and craniomaxillofacial applications. These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone. The product provides a synthetic bone grafting material that resorbs and is replaced by bone during the healing process.

Products in the Actifuse™ family are bioactive phase-pure silicon-substituted calcium phosphate osteoconductive bone graft substitutes, comprising a single-phase calcium phosphate scaffold, either granules or granules delivered in a matrix of resorbable polymer. The interconnected and open porous structure of the calcium phosphate phase of Actifuse is similar to human cancellous bone.

The provided document is a 510(k) Premarket Notification for a bone graft substitute (Actifuse™ Bone Graft Substitute). This type of regulatory submission is for medical devices and focuses on demonstrating substantial equivalence to a legally marketed predicate device, not on proving a device's performance against specific acceptance criteria through a clinical study as would be typical for AI/software-as-a-medical-device (SaMD) products.

Therefore, the information requested in your prompt (e.g., acceptance criteria, test set sample size, ground truth establishment, MRMC studies, standalone performance, training set details) is not applicable to this document, as it describes a material-based medical device, not a diagnostic AI or imaging device.

Here's why the prompt questions are not directly answerable by this document:

• Acceptance Criteria & Reported Performance: The document doesn't define specific quantitative performance metrics or acceptance criteria for the Actifuse device in the way an AI diagnostic device would (e.g., sensitivity, specificity). Instead, it relies on demonstrating bioactivity and osteostimulation through in-vitro studies and claiming substantial equivalence to existing predicate devices.
• Sample Size (Test Set), Data Provenance, Experts, Adjudication, MRMC, Standalone Performance: These concepts are relevant to studies evaluating AI algorithms, typically involving human interpretation of medical images or data. They do not apply to the in-vitro and in-vivo (not stated in this excerpt, but common for such devices) testing used to characterize a bone graft material.
• Ground Truth: For a bone graft, "ground truth" would likely refer to histological analysis of new bone formation in vivo or clinical outcomes. While the document mentions in-vitro studies, it does not detail a clinical study with established ground truth for performance.
• Training Set: AI models require training data. This device is a physical material, not an AI algorithm.

What the document does describe in terms of "testing" is:

1. Bench testing: "shown Actifuse™ family of devices to meet the requirements of all relevant standards for bone graft substitutes." (This implies compliance with material properties, sterility, biocompatibility, etc., but specific criteria and results are not detailed).
2. Bioactivity (in-vitro): Growth of an apatite layer in simulated body fluid, with a 29% faster formation compared to a non-silicate control.
3. Osteostimulatory (cell culture): Accelerated cellular responses (metabolic activity, proliferation) compared to a non-silicate control.

The key takeaway is that the regulatory pathway for Actifuse is based on substantial equivalence to existing devices and in-vitro characterization, not on a clinical study demonstrating AI-like diagnostic performance against a defined ground truth.

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Actifuse™ is a bone void filler intended only for orthopaedic applications as a filler for gaps and voids that are not intrinsic to the stability of the bony structure. Actifuse is indicated to be packed gently into bony voids or gaps of the skeletal system, i.e. extremities, pelvis, and spine, including use in posterolateral fusion procedures with appropriate stabilizing hardware. 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 by bone during the healing process.

Actifuse is a phase-pure calcium phosphate osteoconductive bone void filler, comprising a single-phase calcium phosphate scaffold, either granules or granules delivered in a matrix of resorbable polymer. 0.8wt% silicon (Si) is incorporated into the crystalline structure. The interconnected and open porous structure of Actifuse™ is similar to human cancellous bone.

The provided text is for a 510(k) Premarket Notification for a bone graft substitute called Actifuse. This type of submission focuses on demonstrating substantial equivalence to a predicate device, rather than conducting a de novo study to establish performance against acceptance criteria in the same way one would for a novel diagnostic AI device. Therefore, much of the requested information (like sample sizes for test sets, expert-established ground truth, MRMC studies, or training set details) is not present because it is not typically part of a 510(k) for a bone void filler based on material composition.

Here's an analysis of the available information in the context of the provided document, addressing what can be inferred or explicitly stated:

Acceptance Criteria and Device Performance

The document doesn't define explicit numerical acceptance criteria for device performance as you would expect for an AI diagnostic device (e.g., target sensitivity/specificity). Instead, the "acceptance criteria" are implicitly met by demonstrating substantial equivalence to a predicate device and adherence to relevant standards for Calcium Salt Bone Void Fillers.

• Same indications for use
• Same technological characteristics
• Same contraindications, risks, and potential adverse events | Actifuse™ is composed of a porous calcium salt equivalent to that contained in the predicate device and to that in routine clinical use.
  Actifuse™ has the same indications, contraindications, risks and potential adverse events as the predicate device. |
  | Safety and Effectiveness:
• Meeting requirements of all relevant standards for Calcium Salt Bone Void Fillers
• Providing a scaffold for rapid bone repair via bony infiltration of the porous scaffold | Testing has shown Actifuse™ to meet the requirements of all relevant standards for Calcium Salt Bone Void Fillers.
  Testing has confirmed Actifuse™ to be safe and effective in providing a scaffold for rapid bone repair via bony infiltration of the porous scaffold. |
  | Material Composition:
• Phase-pure calcium phosphate
• 0.8wt% silicon (Si) incorporated into crystalline structure
• Interconnected and open porous structure similar to human cancellous bone | Actifuse is a phase-pure calcium phosphate osteoconductive bone void filler, comprising a single-phase calcium phosphate scaffold... 0.8wt% silicon (Si) is incorporated into the crystalline structure. The interconnected and open porous structure of Actifuse™ is similar to human cancellous bone. |

Study Information (Based on Available Document)

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

   • Not specified. The document states "Testing has shown Actifuse™ to meet the requirements of all relevant standards" and "Testing has confirmed Actifuse™ to be safe and effective." However, it does not provide details about the specific studies, sample sizes, or data provenance. For a bone graft substitute, this "testing" would typically refer to biocompatibility, mechanical properties, and possibly animal studies, not human clinical test sets in the context of AI.

2. 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/Not specified. This pertains to establishing ground truth for diagnostic devices, particularly AI. For a bone graft substitute, "ground truth" would be established through laboratory analyses, histological examination (in animal studies), and potentially clinical follow-up for bone formation, but not typically through an expert panel reviewing diagnostic images.

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

   • Not applicable/Not specified. This is relevant for diagnostic image review.

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:

   • No, an MRMC study was not done. This type of study is specific to evaluating AI-assisted diagnostic tools.

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

   • No. This device is a physical bone graft substitute, not an algorithm.

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

   • Not explicitly stated in detail, but inferred "ground truth" for a bone graft substitute's performance would typically involve:
     • Biocompatibility testing (e.g., cell culture, implantation models).
     • Histological analysis (in animal studies) to confirm bone ingrowth and resorption.
     • Mechanical testing of the material.
     • Chemical analysis to confirm composition.
   • The document states "the product provides a bone void filler that resorbs and is replaced by bone during the healing process," implying that evidence of resorption and bone replacement would be the ultimate "outcome data" or "pathology" in relevant studies.

7. The sample size for the training set:

   • Not applicable/Not specified. This product is not an AI algorithm that requires a training set.

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

   • Not applicable/Not specified. This product is not an AI algorithm that requires a training set.

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Actifuse™ Actifuse™ ABX E-Z-fil Putty, Actifuse™ Shape Actifuse™ is a bone void filler intended only for orthopaedic applications as a filler for gaps and voids that are not intrinsic to the stability of the bony structure. Actifuse is indicated to be packed gently into bony voids or gaps of the skeletal system, i.e., extremities, pelvis, and spine, including use in posterolateral fusion procedures with appropriate stabilizing hardware. 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 by bone during the healing process. Actifuse™ Flow Actifuse™ Flow Bone Graft Substitute is a bone void filler intended only for orthopaedic applications as a filler for gaps and voids that are not intrinsic to the stability of the bony structure. Actifuse™ Flow Bone Graft Substitute can be injected into bony voids or gaps of the skeletal system. i.e., extremities, pelvis, and spine, including use in posterolateral spinal fusion procedures with appropriate stabilizing hardware. 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 by bone during the healing process.

Actifuse™ is a bioactive phase-pure silicon-substituted calcium phosphate osteoconductive and osteostimulative bone void filler, comprising a single-phase calcium phosphate scaffold, either granules or granules delivered in a matrix of resorbable polymer. The interconnected and open porous structure of the calcium phosphate phase of Actifuse is similar to human cancellous bone.

This 510(k) summary describes a resorbable calcium salt bone void filler, Actifuse™. It isn't a typical AI/software device that would have specific performance metrics like sensitivity/specificity for diagnosis. Instead, the acceptance criteria and supporting studies focus on the biological and material properties of the bone graft substitute.

Here's an analysis of the provided information:

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 with specific numbers of samples for each test (e.g., number of in-vitro samples, number of cell cultures). The documentation generally refers to "in-vitro studies" and "cell culture studies."
• Data Provenance: The studies are described as "in-vitro studies" and "cell culture studies," implying laboratory-based testing. There is no mention of human or animal in-vivo test sets beyond the general assertion that "testing has confirmed Actifuse™ to be safe and effective." The document explicitly states: "The bioactive and osteostimulatory nature of Actifuse has not been correlated with human clinical experience." This indicates the data is from ex vivo (in vitro) experiments rather than in vivo clinical data.

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

• This information is not applicable in the context of this submission. The device is a material, not an imaging or diagnostic AI device that requires expert-established ground truth for performance evaluation. The "ground truth" for the material's properties generally comes from validated chemical, biological, and mechanical testing methods.

4. Adjudication Method for the Test Set

• Not applicable. As a material, there's no "adjudication method" in the sense of reconciling human expert opinions on a diagnostic outcome. Performance is based on objective scientific 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. This device is a bone graft substitute, not an AI or software device. Therefore, no MRMC study involving human readers and AI assistance would be relevant or conducted for its approval.

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 algorithm.

7. The Type of Ground Truth Used

• The "ground truth" for the material's performance relies on scientific measurements and established biological assays. This includes:
  • Chemical and structural analysis of the material for composition and porous structure.
  • In-vitro studies using simulated body fluid to observe apatite layer formation.
  • Cell culture studies to measure cellular responses (metabolic activity, proliferation).
  • Compliance with "relevant standards for Calcium Salt Bone Void Fillers," which would imply adherence to material and biocompatibility ground truths defined by those standards.

8. The Sample Size for the Training Set

• Not applicable. This device is a physical product (a bone graft substitute), not a machine learning model. Therefore, there is no "training set."

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

• Not applicable. As there is no training set for an AI model, this question is not relevant. The material's development and characterization would have involved standard scientific research and development procedures to understand its properties.

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Actifuse™ Flow Bone Graft Substitute is a bone void filler intended only for orthopaedic applications as a filler for gaps and voids that are not intrinsic to the stability of the bony structure. Actifuse™ Flow Bone Graft Substitute can be injected into bony voids or gaps of the skeletal system, i.e., extremities, pelvis, and spine, including use in posterolateral spinal fusion procedures with appropriate stabilizing hardware. 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 by bone during the healing process.

Actifuse™ Flow is phase-pure silicon-substituted calcium phosphate osteoconductive bone void filler, comprising a single-phase calcium phosphate scaffold delivered in a matrix of resorbable polymer. The interconnected and open porous structure inherent of the source material for the mineral phase of Actifuse is similar to human cancellous bone. Actifuse Flow is available as a hydrated putty.

This is a submission for a medical device (Actifuse™ Flow Bone Graft Substitute) and not an AI/ML device, so many of the requested fields (e.g., sample sizes for test/training sets, expert qualifications, MRMC studies) are not applicable. The provided document is a 510(k) Premarket Notification summary and an FDA clearance letter, which focuses on demonstrating substantial equivalence to a predicate device rather than performance metrics of an AI.

1. Table of Acceptance Criteria and Reported Device Performance

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

Not applicable. This is a medical device (bone graft substitute), not an AI/ML device. The testing referenced is bench testing on the physical properties of the material, not a clinical study on human data in the context of AI.

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

Not applicable (see point 2).

4. Adjudication method for the test set

Not applicable (see point 2).

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 not an AI.

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

Not applicable. This device is not an AI.

7. The type of ground truth used

For bench testing, the "ground truth" would be established by the physical and chemical properties of the material itself and its performance against established engineering or biological standards for bone graft substitutes. The document states "Bench testing has shown Actifuse™ Flow to meet the requirements of all relevant standards for Calcium Salt Bone Void Fillers" and that it was "confirmed...safe and effective in providing a scaffold for rapid bone repair via bony infiltration of the porous scaffold." This suggests compliance with pre-defined criteria rather than an expert consensus or pathology review of a specific clinical outcome dataset.

8. The sample size for the training set

Not applicable. This device is not an AI.

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

Not applicable. This device is not an AI.

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Actifuse ™ Shape is a bone void filler intended only for orthopaedic applications as a filler for gaps and voids that are not intrinsic to the stability of the bony structure. Actifuse Shape is indicated to be packed gently into bony voids or gaps of the skeletal system, i.e., extremities, pelvis, and spine, including use in posterolateral fusion procedures with appropriate stabilizing hardware. 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 by bone during the healing process.

Actifuse™ Shape is phase-pure silicon-substituted calcium phosphate osteoconductive bone void filler, comprising a single-phase calcium phosphate scaffold delivered in a matrix of resorbable polymer. The interconnected and open porous structure of the calcium phosphate phase of Actifuse Shape is similar to human cancellous bone.

The provided text is a 510(k) Premarket Notification summary for Actifuse™ Shape, a bone void filler. This type of submission focuses on demonstrating "substantial equivalence" to a legally marketed predicate device, rather than providing detailed clinical study data with specific acceptance criteria and performance metrics in the way a PMA (Premarket Approval) application would.

Therefore, the document does not contain information on many of the requested items, particularly those related to human-in-the-loop studies, ground truth establishment with experts, or detailed statistical performance metrics of the device as if it were an AI diagnostic tool.

However, I can extract the information that is present and indicate where the requested information is not available:

Acceptance Criteria and Device Performance

Additional Information Not Present in the Provided Document:

1. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): Not described. The "testing" mentioned is likely bench testing or pre-clinical animal studies to confirm material properties and biocompatibility, rather than human clinical trials with defined test sets for performance metrics in a diagnostic or AI context.
2. 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 in this context. The evaluation is not based on expert-adjudicated diagnostic performance of an AI.
3. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
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 is a bone void filler, not an AI diagnostic tool for image interpretation.
5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
6. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): The "ground truth" for a bone void filler involves demonstrating its material properties, biocompatibility, and ability to be resorbed and replaced by bone, likely through in vitro and in vivo (animal) studies mimicking the human healing process. No specific "ground truth" establishment with human experts for diagnostic purposes is described.
7. The sample size for the training set: Not applicable. This is not an AI/machine learning device.
8. How the ground truth for the training set was established: Not applicable.

Summary of what the document implies for this specific device:

The Actifuse™ Shape is a Class II medical device, cleared through the 510(k) pathway, meaning it demonstrates "substantial equivalence" to a legally marketed predicate device. The "testing" referred to is primarily to confirm its material characteristics, biocompatibility, and functionality (resorption and scaffolding for bone repair) meets relevant standards and is comparable to the predicate. This is a very different type of submission and testing methodology compared to what would be expected for an AI-powered diagnostic tool, which typically involves extensive clinical data, human reader input, and statistical performance metrics against a defined ground truth.

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Actifuse is a bone void filler intended only for orthopaedic applications as a filler for gaps and voids that are not intrinsic to the stability of the bony structure. Actifuse is indicated to be packed gently into bony voids or gaps of the skeletal system, i.e., extremities, pelvis, and spine, including use in posterolateral fusion procedures with appropriate stabilizing hardware. 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 by bone during the healing process.

Actifuse™ ABX E-Z-fil Putty is phase-pure silicon-substituted hydroxylapatite osteoconductive bone void filler, comprising a single-phase calcium hydroxylapatite scaffold delivered in a matrix of resorbable polymer. The interconnected and open porous structure of the hydroxylapatite phase of Actifuse ABX E-Z-fil Putty is similar to human cancellous bone. Actifuse™ ABX E-Z-fill Putty is available as a hydrated putty.

Here's an analysis of the provided text regarding the acceptance criteria and study for the Actifuse™ ABX E-Z-fil Putty Bone Graft Substitute:

Based on the provided document (K071206), the review process for Actifuse™ ABX E-Z-fil Putty was a 510(k) Premarket Notification. This regulatory pathway relies on demonstrating "substantial equivalence" to a legally marketed predicate device, rather than requiring extensive clinical trials to prove newfound safety and effectiveness.

Therefore, the document does not contain the typical "acceptance criteria" for performance metrics like sensitivity, specificity, or accuracy that would be seen in a study evaluating a diagnostic or AI-driven device. Instead, the "acceptance criteria" are related to demonstrating that the new device is as safe and effective as its predicate.

1. Table of Acceptance Criteria and Reported Device Performance:

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

This information is not provided in the document. As a 510(k) submission primarily relies on demonstrating substantial equivalence through existing data on predicate devices and bench testing, detailed clinical "test sets" with patient data (e.g., country of origin, retrospective/prospective) are typically not included in this summary unless new clinical data was specifically required, which is not indicated here. The document mentions "bench testing," implying laboratory-based studies.

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

This information is not applicable/provided. Since the evaluation was based on demonstrating substantial equivalence primarily through technical characteristics and bench testing against standards, there's no mention of experts establishing a "ground truth" for a clinical test set in the context of diagnostic device validation.

4. Adjudication Method for the Test Set:

This information is not applicable/provided. No clinical test set requiring adjudication in the context of expert consensus (like for imaging studies) is described.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done, and Effect Size of Human Readers Improve with AI vs without AI Assistance:

This information is not applicable. The device is a bone void filler, a physical medical device, not an AI-driven image analysis or diagnostic tool. Therefore, an MRMC study comparing human readers with and without AI assistance is irrelevant to this device.

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

This information is not applicable. As stated above, this is a physical medical device, not an algorithm.

7. The Type of Ground Truth Used:

For the "safety and effectiveness" claim, the ground truth was based on:

• "Relevant standards for Calcium Salt Bone Void Fillers": This implies adherence to established industry or regulatory standards for material properties, biocompatibility, mechanical performance, etc.
• "Bony infiltration of the porous scaffold": This likely refers to in vitro or in vivo (animal) studies demonstrating the biological activity of the material in promoting bone ingrowth, assessed perhaps through histological analysis or imaging.

8. The Sample Size for the Training Set:

This information is not applicable/provided. The concept of a "training set" is typically associated with machine learning or AI algorithms. For a physical medical device like a bone void filler, product development involves material science, engineering, and biological testing, rather than an AI training/testing paradigm.

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

This information is not applicable/provided for the reasons stated in point 8.

In summary, the provided document for K071206 describes a 510(k) premarket notification for a physical medical device. The "acceptance criteria" and "proof" primarily revolve around demonstrating substantial equivalence to a predicate device through shared technological characteristics, intended use, and bench testing against established standards, rather than clinical trial results with specific performance metrics (like sensitivity, specificity) for a diagnostic tool or AI algorithm.

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Pore-Si is a bone void filler intended only for orthopaedic applications as a filler for gaps and voids that are not intrinsic to the stability of the bony structure. Pore-Si is indicated to be packed gently into bony voids or gaps of the skeletal system, i.e. extremities, spine and pelvis. These defects may be surgically created osseous defect or osseous defects created from traumatic injury to the bone. The product provides a bone void filler that resorbs and is replaced by bone during the healing process.

Pore-Si is phase-pure hydroxylapatite osteoconductive bone void filler, comprising a single-phase calcium hydroxylapatite scaffold. The interconnected and open porous structure of Pore-Si is similar to human cancellous bone. Pore-Si is available as irregularly shaped chips of 2 different sizes, to suit surgeon preference.

The provided text describes a medical device, Pore-Si Bone Graft Substitute, and its clearance through the 510(k) pathway. However, it does not contain information about specific acceptance criteria, a study proving the device meets these criteria, or any of the detailed aspects requested in the prompt (e.g., sample sizes, expert qualifications, MLMC studies, specific performance metrics like sensitivity/specificity, or training set details for an AI/algorithm).

The document is a 510(k) summary and FDA clearance letter, which focuses on demonstrating substantial equivalence to predicate devices rather than presenting detailed performance study results against predefined acceptance criteria in the way an AI/algorithm performance study would.

Here's how the provided information relates to the requested points, and where information is missing:

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

• Missing Information: The document states, "Extensive bench testing has shown Pore-Si to meet the requirements of all relevant standards for Calcium Salt Bone Void Fillers. Extensive preclinical testing has confirmed Pore-Si to be safe and effective in providing a scaffold for rapid bone repair via bony infiltration of the porous scaffolds." However, it does not specify what those requirements/standards are (i.e., the acceptance criteria) nor does it provide a table with reported quantitative performance metrics against those criteria.
• Implied Acceptance Criteria: The clearance is based on substantial equivalence to predicate devices, implying that the acceptance criteria are largely met by demonstrating similar technological characteristics, indications, contraindications, risks, and potential adverse events as the predicate devices. The "relevant standards" for "Calcium Salt Bone Void Fillers" would also constitute acceptance criteria, but they are not detailed here.

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

• Missing Information: No details about a specific "test set" are provided. The "preclinical testing" mentioned would have involved animal or in vitro models, but the sample sizes, study design, or data provenance (e.g., country of origin, retrospective/prospective) are not disclosed in this summary.

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

• Missing Information: Since details of a specific test set and ground truth establishment (as would be relevant for an AI/algorithm study) are not provided, this information is absent. The "ground truth" for a bone void filler would typically be histological analysis from preclinical studies or clinical outcomes in human trials, not expert consensus on images.

4. Adjudication method for the test set

• Missing Information: Not applicable as no specific test set requiring adjudication in the context of diagnostic performance is described.

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-powered diagnostic tool. Therefore, an MRMC study comparing human readers with and without AI assistance is not relevant to this product.

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

• Not Applicable: This device is a physical medical implant, not an algorithm or AI.

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

• Implied Ground Truth: For a bone graft substitute, the "ground truth" for effectiveness would typically involve histological evidence of bone formation and integration in preclinical animal models, and potentially clinical outcomes (e.g., fusion rates, successful healing) in human trials. For safety, it would involve biocompatibility studies and adverse event tracking. The document vaguely refers to "bony infiltration of the porous scaffolds" from preclinical testing, suggesting histological evaluation.

8. The sample size for the training set

• Not Applicable: This device is not an AI/algorithm, so there is no "training set."

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

• Not Applicable: As above.

Summary:

The provided document details the 510(k) clearance process for a bone graft substitute, emphasizing its substantial equivalence to previously cleared devices. It confirms that the device underwent "extensive bench testing" and "extensive preclinical testing" to confirm safety and effectiveness, meeting "relevant standards." However, it does not delve into the granular details of study designs, specific quantitative acceptance criteria, performance metrics, sample sizes, or ground truth methodologies that would be expected when evaluating an AI/algorithm's performance. The information requested in the prompt is specific to AI/algorithm performance studies, which is not what this document describes.

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ApaPore® is a bone void filler intended only for orthopedic applications as a filler for gaps and voids that are not intrinsic to the stability of the bony structure. ApaPore® is indicated to be packed gently into bony voids or gaps of the skeletal system, i.e. extremities, spine and pelvis. These defects may be surgically created osseous defect or osseous defects created from traumatic injury to the bone. The product provides a bone void filler that resorbs and is replaced by bone during the healing process.

ApaPore® is used in open bone voids that may be surgically created osseous defects or osseous defects created from traumatic injury to the bone. ApaPore® is intended for use on bone voids/gaps that are not intrinsic to the stability of the bony structure of the skeletal system, i.e., in the extremities, spine and pelvis.

ApaPore® is intended to be carefully packed into bony voids or gaps of the skeletal system (i.e. the extremities, spine or pelvis). Following placement in the bony void. the synthetic bone void filler ApaPore® provides a scaffold for new mature host bone growth.

ApaPore® is phase-pure hydroxylapatite osteoconductive bone void filler, comprising a single-phase calcium hydroxylapatite scaffold. The interconnected and open porous structure of ApaPore® is similar to human cancellous bone. ApaPore® is available as irregularly shaped chips of 2 different sizes, in a choice of 3 porosities to suit surgeon preference.

The provided text is related to a 510(k) summary for a medical device called ApaPore® Bone Graft Substitute. It mainly focuses on asserting substantial equivalence to predicate devices and does not describe a study involving detailed acceptance criteria and reported device performance in the way one would expect for a diagnostic or AI-driven device.

Based on the provided text, here's a breakdown of the requested information, noting where details are unavailable:

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

The document does not specify quantitative "acceptance criteria" or "reported device performance" in terms of specific metrics like sensitivity, specificity, accuracy, or other performance characteristics. Instead, it relies on demonstrating compliance with relevant standards and clinical use.

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

This information is not provided. The document states, "ApaPore® has been regularly used clinically for the past 16 months and no adverse events have been reported," but this is a general statement about clinical use, not a structured test set with a defined sample size or detailed data provenance.

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)

This information is not applicable and not provided. The device is a bone graft substitute, and its evaluation relies on bench testing and clinical safety observations, not on expert ground truth for interpretation like a diagnostic imaging device.

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

This information is not applicable and not provided. There is no mention of an adjudication method as there is no diagnostic test set being interpreted.

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

This is not applicable as the device is a bone graft substitute, not an AI-assisted diagnostic tool. No MRMC study was conducted or mentioned.

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

This is not applicable as the device is a physical bone graft substitute, not an algorithm.

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

For the safety and effectiveness claims, the "ground truth" seems to be established through:

• Bench Testing: "Extensive bench testing has shown ApaPore® to meet the requirements of all relevant standards for Calcium Salt Bone Void Fillers." This implies compliance with physical, chemical, and biological standards.
• Clinical Observation: "ApaPore® has been regularly used clinically for the past 16 months and no adverse events have been reported." This serves as real-world safety data.
• Biological/Physiological Outcome: The intended outcome is that the device "resorbs and is replaced by bone during the healing process" and "provides a scaffold for rapid bone repair via bony infiltration of the porous scaffolds." While detailed outcomes data from a specific study are not presented, these are the biological ground truths it aims to achieve.

8. The sample size for the training set

This is not applicable and not provided. The device is not an AI algorithm that requires a training set.

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

This is not applicable and not provided. The device is not an AI algorithm that requires a training set with established ground truth.

Summary of Device Evaluation in the Document:

The provided 510(k) summary for ApaPore® Bone Graft Substitute primarily relies on:

• Substantial Equivalence: It claims substantial equivalence to predicate devices (Isotis NV OsSatura™ BCP Bone Void Filler) based on shared materials (porous calcium salt, hydroxylapatite), similar physical presentation (irregular granules/chips), and identical indications, contraindications, risks, and potential adverse events.
• Bench Testing: The document states that "Extensive bench testing has shown ApaPore® to meet the requirements of all relevant standards for Calcium Salt Bone Void Fillers." While the specific standards and outcomes aren't detailed, this forms a basis for safety and performance claims.
• Clinical Experience (No Adverse Events): "ApaPore® has been regularly used clinically for the past 16 months and no adverse events have been reported." This provides real-world safety data, albeit not from a controlled clinical trial described here.

The document does not describe a clinical study with a defined test set, ground truth acquisition, expert involvement, or statistical analysis of performance metrics typically associated with diagnostic or AI-based devices. Its focus is on demonstrating safety and effectiveness for a Class II resorbable bone void filler through equivalence and compliance with established standards and observed clinical safety.

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