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Ask a specific question about this device

Grafton™ DBM and Grafton Plus ™ DBM Paste are intended for use as a bone graft extender, bone graft substitute, and bone void filler in bony voids or gaps of the skeletal system (i.e., posterolateral spine, intervertebral disc space (excluding Flex or Crunch), pelvis and extremities) not intrinsic to the stability of the bony structure. The voids or gaps may be surgically created defects or defects created by traumatic injury to the bone. When used in intervertebral body fusion procedures, Graft™ DBM (excluding Flex or Crunch) and Grafton Plus ™ DBM Paste must be used with an intervertebral body fusion device cleared by FDA for use with a bone void filler.
Grafton™ DBM and Grafton Plus™ DBM Paste are absorbed/remodeled and replaced by host bone during the healing process.

Magnifuse™ Bone Graft is intended for use as a bone graft substitute in bony voids or gaps of the skeletal system (i.e., posterolateral spine, intervertebral disc space, pelvis and extremities) not intrinsic to the stability of the bony structure. Voids or gaps may be surgically created defects or defects created by traumatic injury to the bone.
Magnifuse™ Bone Graft may be used in a manner comparable to autogenous bone or allograft bone. Magnifuse™ Bone Graft may be mixed with fluid such as bone marrow aspirate, blood, sterile water, or sterile water in order to adjust consistency and handling of bone graft material.
When used in intervertebral body fusion procedures, Magnifuse™ Bone Graft must be used with an intervertebral body fusion device cleared by FDA for use with a bone void filler.
Magnifuse™ Bone Graft is resorbed/remodeled and is replaced by host bone during the healing process.

The Grafton™ DBM, Grafton Plus™ DBM Paste, and Magnifuse™ Bone Graft devices in this submission are human bone products containing human demineralized bone matrix (DBM).

Grafton™ DBM is a human bone product that contains human DBM with an inert additive. Grafton™ DBM is produced in particular physical forms (Grafton™ DBM Gel, Grafton™ DBM Putty, Grafton™ DBM Matrix, Grafton™ DBM Orthoblend) and/or handling property. Grafton™ DBM is provided in ready-to-use form and is intended in single patient, single use containers. Grafton™ DBM is identical to the device cleared in K051195.

Grafton Plus™ DBM Paste is human demineralized bone matrix combined with an inert additive to yield a product having a particular physical form and/or handling property. Grafton Plus™ DBM Paste is identical to the device cleared in K043048.

Magnifuse™ Bone Graft is a human bone allograft product containing human DBM and surface demineralized cortical bone chips sealed in an absorbable mesh pouch for intraoperative handling. It is intended for use in filling bony voids or gaps or the skeletal system not intrinsic to the stability of the bony structure. Magnifuse™ Bone Graft is provided ready-to-use in various package sizes by volume or dimension and is intended for single patient use. Magnifuse™ Bone Graft is identical to the device cleared in K082615.

This FDA 510(k) clearance letter (K251193) is for bone graft materials (Grafton™ DBM, Grafton Plus™ DBM Paste, Magnifuse™ Bone Graft) and does not describe an AI/software device or a study with "acceptance criteria" based on AI performance metrics like sensitivity, specificity, or reader studies.

The document details the substantial equivalence of new product formulations/expanded indications for use to previously cleared predicate and reference devices. The "performance" section refers to pre-clinical testing and leveraging prior clearances for bone graft characteristics (e.g., DBM properties, viral inactivation, shelf-life, biocompatibility in animal models, etc.), not a clinical study involving human readers or AI algorithm performance.

Therefore, I cannot provide the information requested in your prompt as it pertains to AI device acceptance criteria and performance studies. The document does not contain:

• A table of acceptance criteria and reported device performance for an AI system.
• Sample sizes for a test set, data provenance, or expert ground truth establishment for an AI study.
• Details on MRMC studies or human reader improvement with AI assistance.
• Standalone algorithm performance.
• Description of ground truth type for an AI system.
• Training set sample size or how ground truth for training was established for an AI system.

The "Performance" section explicitly states: "The devices' performance in the intervertebral body space was supported by a robust analysis of bone grafting materials in the prior posterolateral spine fusion studies." This refers to biological and mechanical performance of the bone graft materials themselves, not an AI software.

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OsteoFlo HydroFiber is a bone void filler intended for use in osseous defects of the skeletal system that are not intrinsic to the stability of the bony structure i.e., the extremities, pelvis, intervertebral disc space, and posterolateral spine. These defects may be surgically created or the result of traumatic injury to the bone. OsteoFlo HydroFiber is indicated to be packed gently into bony voids or gaps of the extremities, pelvis, posterolateral spine, or intervertebral disc space, and may be used either standalone or in combination with autograft as a bone graft extender. The device is resorbed and replaced with host bone during the healing process. When used in intervertebral body fusion procedures, OsteoFlo HydroFiber must be used with an intervertebral body fusion device cleared by FDA for use with a bone void filler.

The OsteoFlo® HydroFiber™ is a resorbable bone void filler designed to be placed in bony defects, either surgically created (i.e., tumor removal), or the result of traumatic injury. The single-use device is supplied sterile and dry. The device requires mixing with aqueous solution (autograft, saline, blood, or bone marrow aspirate) prior to use. OsteoFlo HydroFiber may be used as standalone, equivalent to autograft, in conjunction with autograft, or as a bone graft extender.

It appears there's a misunderstanding. The provided FDA 510(k) clearance letter for the OsteoFlo HydroFiber device is for a Resorbable Calcium Salt Bone Void Filler Device, which is a physical implantable device.

The request asks for information typically associated with AI/ML-based medical devices, particularly regarding:

• A table of acceptance criteria and reported device performance (often including metrics like sensitivity, specificity, AUC for AI models)
• Sample sizes for test sets, data provenance
• Expert involvement for ground truth establishment (e.g., radiologists for image interpretation)
• Adjudication methods
• Multi-reader multi-case (MRMC) studies
• Standalone performance (algorithm only) vs. human-in-the-loop performance
• Types of ground truth (e.g., pathology, outcomes data)
• Training set sample size and ground truth establishment

The provided FDA letter does not contain any information related to AI/ML software performance or studies. Instead, it lists non-clinical performance data for a physical medical device, such as:

• Biocompatibility
• Sterilization validation
• Packaging validation
• Shelf-life testing
• Endotoxin validation
• Material characterization
• Dimensional stability assessment
• In vivo evaluation (Rabbit Metaphyseal Defect Model)
• Pyrogenicity Testing

Therefore, I cannot fulfill your request based on the provided text, as the document describes the clearance of a physical bone void filler, not an AI/ML software device. The acceptance criteria and performance studies mentioned in the document are for the physical properties and biological interactions of an implantable material, not for the diagnostic or analytical performance of an AI algorithm.

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MagnetOs MIS is intended to fill bony voids or gaps of the skeletal system, i.e., the extremities, pelvis, intervertebral disc space, and posterolateral spine. The osseous defects may be surgically created or the result of traumatic injury to the bone and are not intrinsic to the stability of the bony structure. In the extremities, pelvis, intervertebral disc space and posterolateral spine, MagnetOs MIS may be used standalone or with autograft as a bone extender. When used in intervertebral body fusion procedures, MagnetOs MIS must also be used with an intervertebral body fusion device cleared by FDA for use with a bone void filler.

MagnetOs MIS resorbs and is replaced with bone during the healing process.

MagnetOs MIS includes a synthetic, resorbable, osteoconductive bone void filler for the repair of bony defects. MagnetOs MIS graft material is a mixture of ceramic granules premixed with a synthetic polymeric binder that provides cohesion between the granules. The ceramic portion of MagnetOs MIS consists of 65–75% tri-calcium phosphate (TCP – Ca3(PO4)2) and 25–35% hydroxyapatite (HA – Ca10(PO4)6(OH)2) granules.

While the polymeric binder is rapidly resorbed after implantation, the granules of MagnetOs MIS guide the three-dimensional regeneration of bone in the defect site into which it is implanted. New bone will be deposited on the surface of the graft when placed next to viable host bone. The graft resorbs and is replaced by bone during the natural process of bone remodeling.

MagnetOs MIS graft material is provided in a 5cc pre-filled cartridge, packed together with a delivery system kit in a ready-to-use format. The MagnetOs MIS delivery system allows users to apply the bone graft into the defect. MagnetOs MIS is gamma-sterilized and sterile packaged for single use only.

Based on the provided FDA 510(k) clearance letter for MagnetOs MIS, the device is a bone void filler, which is a Class II medical device. The information details the device's characteristics and its substantial equivalence to predicate devices, primarily based on design, materials, and existing data from previously cleared products.

However, the provided document does not contain any information about acceptance criteria and a study that proves the device meets those criteria, specifically regarding AI/ML performance, diagnostic accuracy, or human reader improvement. The document focuses on the physical and material properties of the bone void filler and its delivery system, along with regulatory compliance related to device classification and manufacturing.

Therefore, I cannot fulfill your request to describe the acceptance criteria and the study proving the device meets them in the context of AI/ML performance, ground truth, expert adjudication, or MRMC studies. The document explicitly states: "No additional animal performance or clinical data was provided to support substantial equivalence for the proposed indications. Instead, animal and clinical data from previous clearances of the additional predicate devices were leveraged to support the current submission, as recommended in the FDA's Class II Special Controls Guidance document for Resorbable Calcium Salt Bone Void Filler Devices."

This indicates that the clearance was based on demonstrating the new device's material and design equivalence to already cleared devices, rather than new clinical or AI performance studies for this specific submission.

If you have a different document or would like to provide more context about an AI/ML component related to a similar device, please do so, and I would be happy to analyze it.

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Synthecure Synthetic Calcium Sulfate is an implant intended to fill bony voids or gaps of the skeletal system (i.e. extremities and pelvis). These osseous defects are surgically created or the result of traumatic injury to the bone and are not intrinsic to the stability of the bony structure. Synthecure Synthetic Calcium Sulfate resorbs and is replaced with bone during the healing process.

Synthecure is provided sterile for single use only. Synthecure is biodegradable and biocompatible and may be used at an infected site.

Synthecure Synthetic Calcium Sulfate is indicated to be implanted into defects not intrinsic to the structural stability of the skeletal system. Synthecure is biocompatible and may be implanted at an infected site. Synthecure Synthetic Calcium Sulfate is presented as a powder and mixing solution which when mixed together forms a paste which may be injected, digitally implanted or applied to a mold provided to produce pellets.

The provided FDA 510(k) clearance letter pertains to a medical device called "Synthecure Synthetic Calcium Sulfate," a resorbable calcium salt bone void filler. The document focuses on demonstrating substantial equivalence to predicate devices through non-clinical testing.

Based on the provided text, the device is a bone void filler and not a device that would typically have the acceptance criteria in the format requested. The document does not describe a study involving a "test set" with ground truth, expert adjudication, or human reader performance with or without AI assistance, as these are concepts more relevant to diagnostic or AI-powered devices.

Therefore, many of the requested sections (2, 3, 4, 5, 6, 7, 8, 9) are not applicable to the information contained in this FDA clearance letter. The letter focuses on demonstrating the physical, chemical, and biological safety and performance of the bone void filler device through a series of non-clinical tests.

However, I can extract the acceptance criteria as described for the non-clinical tests and the reported performance based on the information provided.

Acceptance Criteria and Study for Synthecure Synthetic Calcium Sulfate

The Synthecure Synthetic Calcium Sulfate is a resorbable calcium salt bone void filler. The provided 510(k) summary outlines non-clinical testing performed to demonstrate its safety and substantial equivalence to predicate devices, rather than a clinical study with a detailed test set and ground truth as might be expected for diagnostic or AI devices.

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

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: Not specified in terms typically used for diagnostic or AI studies. For the animal study, the sample size is not explicitly stated number of New Zealand White Rabbits, but it's an animal model.
• Data Provenance: The document implies that all testing (bench, animal, etc.) was conducted by or for Austin Medical Ventures, Inc. in support of their 510(k) submission. It's not applicable in terms of "country of origin for human data" as these are non-clinical studies.

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

Not applicable. This device is a bone void filler, and its evaluation relies on physical, chemical, and biological testing, not on expert interpretation of diagnostic images or clinical assessments to establish ground truth in the way a diagnostic device would.

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

Not applicable. This device does not involve adjudication of expert opinions or 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. This is not an AI-assisted diagnostic device.

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

Not applicable. This is not a software algorithm or AI device.

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

For this type of device, "ground truth" is established through:

• Established standards and regulations: e.g., ISO 10993-1 for biocompatibility, ISO 11607 for packaging.
• Bench testing methodologies: Measuring physical and chemical properties.
• In-vivo animal models: Observing biological response, resorption rates, and bone ingrowth over time (e.g., 3, 6, and 12 weeks endpoints). The "truth" here is the biological reaction within the animal model.

8. The sample size for the training set

Not applicable. This is not a machine learning or AI device that requires a training set.

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

Not applicable. This is not a machine learning or AI device.

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NanoBone® SBX Putty is an implant intended to fill bony voids or gaps of the skeletal system (i.e., extremities, posterolateral spine, intervertebral disc space, and pelvis). These osseous defects are surgically created or the result of traumatic injury to the bone and are not intrinsic to the stability of the bony structure. NanoBone® SBX Putty resorbs and is replaced with bone during the healing process. When used in intervertebral body fusion procedures, NanoBone® SBX Putty must be used with an intervertebral body fusion device cleared by FDA for use with a bone void filler.

NanoBone® QD is an implant intended to fill bony voids or gaps of the skeletal system (i.e., extremities, posterolateral spine, intervertebral disc space, and pelvis). These osseous defects are surgically created or the result of traumatic injury to the bone and are not intrinsic to the stability of the bony structure. NanoBone® QD resorbs and is replaced with bone during the healing process. When used in intervertebral body fusion procedures, NanoBone® QD must be used with an intervertebral body fusion device cleared by FDA for use with a bone void filler.

NanoBone® SBX Putty and NanoBone® QD consist of NanoBone® granulate embedded in an aqueous gel. NanoBone granulate consists of phase-pure non-sintered nanocrystalline osteoconductive hydroxyapatite (HA) embedded in a highly porous silica gel matrix. The high porosity of the product includes nano pores, micro pores, and macro pores. The interconnected and open porous structure of the macro pores of the NanoBone® is similar to human cancellous bone. NanoBone® SBX Putty does not set in-situ following implantation.

NanoBone® SBX material is supplied in two different style applicators. The NanoBone® SBX Putty is supplied in a sterile applicator with an attached plunger. NanoBone® QD is an alternate packaging of the NanoBone® SBX Putty. NanoBone® QD is supplied in a sterile cartridge with a separate sterile plunger.

This document describes the FDA 510(k) clearance for NanoBone® SBX Putty and NanoBone® QD, which are resorbable calcium salt bone void filler devices. The clearance expands their indications for use to include intervertebral disc space.

Based on the provided text, there is no information about acceptance criteria, the study that specifically proves the device meets acceptance criteria, sample sizes for test or training sets, data provenance, expert involvement for ground truth, adjudication methods, MRMC studies, standalone algorithm performance, or the type of ground truth used. The document primarily focuses on establishing substantial equivalence to predicate devices for the expanded indication.

The clearance letter and 510(k) summary highlight the device's characteristics and its equivalence to previously cleared devices. It states that the "device's performance in intervertebral spine was supported by a robust analysis of bone grafting materials in the prior posterolateral spine fusion studies" and mentions that the submission is leveraged for sterility, shelf-life, endotoxin, pyrogenicity, biocompatibility, and characterizations/bench performance. However, it does not provide details of these studies in the format requested.

Therefore, for the specific questions asked, the answer is:

No information is provided in the document to address the following:

1. A table of acceptance criteria and the reported device performance: Not present. The submission relies on substantial equivalence and previous clearances, not on new performance data against specific acceptance criteria for this expanded indication.
2. Sample sizes used for the test set and the data provenance: Not present. The document references "prior posterolateral spine fusion studies" but does not detail their methodology, sample sizes, or data provenance.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not present.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not 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 relevant or present. This device is a bone void filler, not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not relevant or present, as this is not an AI algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not present for any specific study proving current performance. The "robust analysis of bone grafting materials in prior studies" is mentioned, implying some form of clinical or pre-clinical data, but the nature of the ground truth is not specified.
8. The sample size for the training set: Not relevant or present, as this is not an AI algorithm.
9. How the ground truth for the training set was established: Not relevant or present, as this is not an AI algorithm.

The core of this 510(k) clearance is demonstrating substantial equivalence to predicate devices and leveraging data from previously cleared versions of the product for safety and performance aspects (sterility, shelf-life, biocompatibility, etc.) rather than presenting a new clinical study with defined acceptance criteria for the expanded indication. The "performance" section specifically references previous clearances and studies, implying that new primary clinical data specifically for this expanded indication's acceptance criteria wasn't generated but rather extrapolated from existing data and the predicate device's performance.

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Porous Biologic Scaffold is a bone void filler intended for use in osseous defects of the skeletal system that are not intrinsic to the stability of the bony structure. These defects may be surgically created or the result of traumatic injury to the bone. Porous Biologic Scaffold is indicated to be packed gently into bony voids or gaps of the pelvis, intervertebral disc space, and posterolateral spine and is used combined with autograft as a bone graft extender. The device is resorbed and replaced with host bone during the healing process. When used in intervertebral body fusion procedures, Porous Biologic Scaffold must be used with an intervertebral body fusion device cleared by FDA for use with a bone void filler.

Porous Biologic Scaffold is a resorbable bone void filler that is available in two versions:

Version 1 is comprised of a porous collagen mesh that is either prefilled or separately packaged with human demineralized allograft bone matrix. In the prefilled format, the demineralized bone matrix is completely enclosed inside the collagen mesh. In the separately packaged format, an open-ended collagen mesh bag is supplied with separately packaged demineralized bone matrix and is filled and sewn closed with absorbable suture by the clinician. Version 1 of the Porous Biologic Scaffold may be hydrated with blood, saline, or bone marrow aspirate, and is combined with autograft bone prior to implantation.

Version 2 is comprised of a porous resorbable collagen mesh bag either prefilled or separately packaged with activated biphasic ceramic granules. In the prefilled format, the biphasic granules are completely enclosed inside the collagen mesh. In the separately packaged format, an openended collagen mesh bag is supplied with separately packaged biphasic granules and is filled and sewn closed with absorbable suture by the clinician. Version 2 of the Porous Biologic Scaffold may be hydrated with blood, saline, or bone marrow aspirate, and is combined with autograft bone prior to implantation.

Both formats of the Porous Biologic Scaffold are supplied terminally sterile and are available in sizes of 18 x 50 mm, 18 x 100 mm, 24 x 50 mm, and 24 x 100 mm.

This document is an FDA 510(k) clearance letter for a medical device called "Porous Biologic Scaffold." It's important to note that this document primarily focuses on regulatory clearance based on substantial equivalence to predicate devices, rather than presenting a detailed clinical study demonstrating acceptance criteria for an AI/software-based medical device.

Therefore, I cannot extract the information required for an AI/software-based medical device's performance study acceptance criteria, as this document describes a physical medical device (bone void filler) and its regulatory clearance process, which relies on demonstrating equivalence to previously cleared devices rather than extensive new clinical performance studies with acceptance criteria like those for AI.

The document states:

• "The subject device has been previously cleared under K240775, which serves as a Reference Device. This submission is leveraged to support the device's sterility, shelf-life, endotoxin, pyrogenicity, biocompatibility, and characterizations/bench performance as recommended in FDA's Class II Special Controls Guidance Document for Resorbable Calcium Salt Bone Void Filler Devices."
• "The device's performance in the intervertebral body space was supported by a robust analysis of bone grafting materials in the prior posterolateral spine fusion studies."
• "Based on the clinical analysis, the device is substantially equivalent to the predicates."

These statements indicate that the "performance" demonstrated is primarily based on established characteristics (sterility, biocompatibility, material properties) and leveraging prior studies on similar devices or the same device from a previous submission, rather than a new, detailed clinical trial with specific acceptance criteria that would be typical for an AI software.

Therefore, I cannot fill out the requested table and answer the detailed questions about acceptance criteria specific to an AI/software study because the provided text describes a physical medical device and its substantial equivalence clearance, not an AI/software performance study.

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BonVie+ is an implant intended to fill bony voids or gaps of the skeletal system (i.e., the extremities and pelvis). These osseous defects are surgically created or the result of traumatic injury to the bone and are not intrinsic to the stability of the bony structure. BonVie+ resorbs and is replaced with bone during the healing process.

BonVie+ is an osteo-conductive bone void filler. It is supplied sterile in a kit comprised of 1] a pack containing polymers and Ca-salt in powdered form, 2] ampoules containing a biocompatible solution (acetone) for mixing and granulation, and 3] a silicone mat containing cavities of various sizes to form granules of various sizes. The powder formulation comprises hydroxyapatite (HA), calcium carbonate (CaCO3), and calcium chloride (CaCl2) particles with degradable polymers poly(caprolactone) (PCL), poly(ethylene qlycol) (PEG), and poly(lactide-co-dlycolide) (PLGA). The biocompatible solution used for mixing is acetone. Once mixed and granulated, the HA and CaCO3 particles are dispersed throughout the entire structure of the device. Upon implantation, the HA and CaCO3 particles resorb over time. The polymer-based binding matrix also resorb with time. When BonVie+ is placed in direct contact with viable bone and the surrounding biologic fluid environment, porous regions form in the filler material and are infiltrated with bone tissue. Bone formation occurs in apposition to the HA and CaCO3 surface and within the pores of the device resorbs, bone grows into the space previously occupied by the filler material.

This document is a 510(k) summary for a medical device called BonVie+, a resorbable calcium salt bone void filler. The information provided outlines the device, its intended use, and a summary of non-clinical tests to demonstrate substantial equivalence to a predicate device, EP Granules™ BVF.

Based on the provided text, the device itself (BonVie+) is a bone void filler and not an AI/Software device. Therefore, the acceptance criteria and study information typically associated with AI/ML-based medical devices (like those involving test sets, training sets, expert ground truth, MRMC studies, etc.) are not present in this document.

The document describes the device's physical and chemical properties, manufacturing, and preclinical testing to show equivalence to a predicate. It does not mention any AI or software components that would require the kind of performance evaluation requested (e.g., diagnostic accuracy metrics like sensitivity, specificity, AUC).

Therefore, I cannot provide the requested information regarding acceptance criteria, study details, sample sizes, expert involvement, or MRMC studies, as the provided text does not describe a study involving an AI/Machine Learning component.

To directly answer your prompt based on the provided text:

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

• Acceptance Criteria: Not explicitly stated in terms of quantitative performance metrics for an AI/Software device. The FDA's acceptance is based on "substantial equivalence" to a predicate device, demonstrated through non-clinical tests.
• Reported Device Performance:
  • In-vitro Degradation and Surface Characterizations of BonVie+
  • X-ray Diffraction (XRD) of BonVie+
  • Residual Solution in BonVie+ granules
  • Usability Testing
  • Compression testing
  • Sterilization and packaging validation
  • Biocompatibility testing in accordance with ISO 10993
  • Pyrogenicity testing/endotoxin monitoring.
  • Note: Specific numerical results or statistical outcomes from these tests are not provided in this summary. The summary only lists the types of tests performed to support substantial equivalence.

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

• Not applicable as this is not a study of an AI/Software device performance on a test set of data. The tests listed are for material properties and device safety.

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

• Not applicable as no "test set" or "ground truth" (in the context of AI/Software performance) is mentioned for this medical device.

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

• Not applicable.

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 MRMC study was mentioned. This device does not appear to involve human readers or AI assistance in interpretation.

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 (expert consensus, pathology, outcomes data, etc.):

• Not applicable. The "ground truth" for this device's acceptance is its compliance with material properties, sterility, biocompatibility, and mechanical performance demonstrated through standard testing, not diagnostic accuracy against a clinical ground truth.

8. The sample size for the training set:

• Not applicable.

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

• Not applicable.

In summary, the provided FDA 510(k) letter and summary describe a traditional medical device (bone void filler) and its non-clinical testing for substantial equivalence, not an AI/ML-driven device. Therefore, the specific criteria and study methodologies you've asked about, which are pertinent to AI/ML device evaluations, are not present in this document.

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Moldable Bone Void Filler and Moldable Bone Void Filler + CCC is an implant intended to fill bony voids or gaps of the skeletal system (i.e., extremities and pelvis). These osseous defects are surgically created or the result of traumatic injury to the bone and are not intrinsic to the stability of the bony structure. Moldable Bone Void Filler and Moldable Bone Void Filler + CCC can be used with autogenous bone marrow. Moldable Bone Void Filler and Moldable Bone Void Filler + CCC resorbs and are replaced with bone during the healing process.

Moldable Bone Void Filler and Moldable Bone Void Filler + CCC are for single patient use only.

Moldable Bone Void Filler and Moldable Bone Void Filler + CCC are bone void fillers composed of processed demineralized bone matrix (DBM), a synthetic macromer hydrogel, and cortical cancellous bone chips (CCC) for Moldable Bone Void Filler + CCC only. Both are provided with an accessory kit containing pre-measured hydrating solution and a spatula to mix the components.

After the implant is hydrated, the resultant putty can then be handled and placed in the appropriate bone voids or gaps. Moldable Bone Void Filler and Moldable Bone Void Filler + CCC gradually resorb and are replaced with new bone during the healing process. At the 12 week timepoint, animal study data demonstrated new bone formation averages of 16.21% in the Optecure group, 13.8% in the Optecure + CCC group, 15.75% in the Exactech Optecure + CCC predicate group, and 12.08 % in the empty defect negative control group.

The provided text is a 510(k) summary for a medical device (Moldable Bone Void Filler and Moldable Bone Void Filler + CCC). This document focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study proving a device meets specific performance acceptance criteria for an AI/ML algorithm.

Therefore, most of the requested information regarding acceptance criteria, test sets, data provenance, expert ground truth, adjudication methods, MRMC studies, standalone performance, training sets, and ground truth establishment for AI/ML algorithms is not applicable to this document.

However, I can extract information related to the device's performance data as presented in the context of demonstrating substantial equivalence.

Here's a breakdown of what can and cannot be answered based on the provided text:

What can be extracted:

• Acceptance Criteria (Implicitly based on Predicate Equivalence): The primary "acceptance criterion" for this 510(k) clearance is substantial equivalence to a predicate device. This is repeatedly stated throughout the document. The performance data presented (animal study results) are used to support this claim of equivalence, not to meet a pre-defined numerical performance threshold for a specific task like classification or detection.
• Reported Device Performance (Animal Study): The document provides quantitative results from an animal study regarding new bone formation.

What cannot be extracted (as it pertains to AI/ML acceptance criteria and studies):

• A table of explicit acceptance criteria for an AI/ML device.
• Sample size used for a test set (in the context of AI/ML).
• Data provenance for a test set.
• Number of experts and their qualifications used to establish ground truth for a test set.
• Adjudication method for a test set.
• Multi-reader multi-case (MRMC) comparative effectiveness study, its effect size, or human reader improvement with AI assistance.
• Standalone (algorithm only) performance.
• The type of ground truth used (expert consensus, pathology, outcomes data, etc.) for an AI/ML model.
• Sample size for a training set for an AI/ML model.
• How ground truth for a training set was established for an AI/ML model.

Information Extracted from the Provided Text:

1. A Table of Acceptance Criteria and the Reported Device Performance:

As this document is for a non-AI/ML medical device seeking 510(k) clearance, the "acceptance criteria" are intrinsically tied to demonstrating substantial equivalence to an existing predicate device. The performance data presented are used to support this claim, rather than meeting a specific numerical target for an AI/ML algorithm.

• Optecure group (New Device): 16.21%
• Optecure + CCC group (New Device): 13.8%
• Exactech Optecure + CCC predicate group: 15.75%
• Empty defect negative control group: 12.08% |
  | Device does not raise any safety and effectiveness concerns as compared to the predicate device. | Non-clinical testing performed to support substantial equivalence and demonstrate safety and effectiveness included: Chemical and physical properties, Biocompatibility, Sterility, Shelf Life, and Animal Study. |

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

• The document refers to an "animal study" which contains performance data used to support substantial equivalence. It does not explicitly state the sample size (number of animals or defects) used in this animal study.
• The data provenance (country of origin, retrospective/prospective) for this animal study is not specified in the provided text.

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

• Not applicable. This is not an AI/ML device, and the ground truth for bone formation in an animal study would typically be established through histological analysis by trained pathologists or similar experts, but the number and qualifications are not provided.

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

• Not applicable. This is not an AI/ML device study involving human reader interpretation adjudication.

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. This is not an AI/ML device and no MRMC study was conducted or is relevant to this submission.

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

• Not applicable. This is a bone void filler, not an algorithm.

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

• For the animal study: The ground truth for "new bone formation" would typically be established through histological analysis (a type of pathology) of tissue samples from the animal defects. The document mentions "animal study data demonstrated new bone formation averages."

8. The sample size for the training set

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

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

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

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