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FIBERGRAFT™ BG Putty GPS - Bone Graft Substitute is indicated only for bony voids or gaps that are not intrinsic to the stability of the bony structure. FIBERGRAFT™ BG Putty GPS is indicated to be gently packed into bony voids or gaps of the skeletal system (i.e., posterolateral spine, intervertebral disc space, extremities and pelvis). These osseous defects may be the result of benign bone cysts and tumors (in adults and pediatric patients ≥ 6 years old), are surgically created or the result of traumatic injury to the bone. The product provides a bone void filler that resorbs and is replaced with bone during the healing process. FIBERGRAFT™ BG Putty GPS must be used with autograft in the posterolateral spine. When used in intervertebral body fusion procedures, FIBERGRAFT™ BG Putty GPS must be used on its own with an intervertebral body fusion device cleared by FDA for use with a bone void filler. FIBERGRAFT™ BG Putty GPS is not indicated for use in load-bearing applications; therefore, standard internal or external stabilization techniques must be followed to obtain rigid stabilization.

FIBERGRAFT™ BG Putty - Bone Graft Substitute is indicated only for bony voids or gaps that are not intrinsic to the stability of the bony structure. FIBERGRAFT™ BG Putty is indicated to be gently packed into bony voids or gaps of the skeletal system (i.e., posterolateral spine, intervertebral disc space, extremities and pelvis). These osseous defects may be the result of benign bone cysts and tumors (in adults and pediatric patients ≥ 6 years old), are surgically created or the result of traumatic injury to the bone. The product provides a bone void filler that resorbs and is replaced with bone during the healing process. FIBERGRAFT™ BG Putty must be used with autograft in the posterolateral spine. When used in intervertebral body fusion procedures, FIBERGRAFT™ BG Putty must be used on its own with an intervertebral body fusion device cleared by FDA for use with a bone void filler. FIBERGRAFT™ BG Putty is not indicated for use in load-bearing applications; therefore, standard internal or external stabilization techniques must be followed to obtain rigid stabilization.

FIBERGRAFT™ AERIDYAN™ Matrix - Bone Graft Substitute is indicated only for bony voids or gaps that are not intrinsic to the stability of the bony structure. FIBERGRAFT™ AERIDYAN™ Matrix is indicated to be gently packed into bony voids or gaps of the skeletal system (i.e., the posterolateral spine, extremities and pelvis). These osseous defects may be the result of benign bone cysts and tumors (in adults and pediatric patients ≥ 6 years old), are surgically created or the result of traumatic injury to the bone. The product provides a bone void filler that resorbs and is replaced with bone during the healing process. FIBERGRAFT™ AERIDYAN™ Matrix must be used with autogenous bone marrow aspirate and autograft in posterolateral spine. FIBERGRAFT™ AERIDYAN™ Matrix must be hydrated with saline or blood for pelvis and extremity applications.

FIBERGRAFT™ BG Matrix - Bone Graft Substitute is indicated only for bony voids or gaps that are not intrinsic to the stability of the bony structure. FIBERGRAFT™ BG Matrix is indicated to be gently packed into bony voids or gaps of the skeletal system (i.e., posterolateral spine, extremities and pelvis). These osseous defects may be the result of benign bone cysts and tumors (in adults and pediatric patients ≥ 6 years old), are surgically created or the result of traumatic injury to the bone. The product provides a bone void filler that resorbs and is replaced with bone during the healing process. FIBERGRAFT™ BG Matrix must be used with autogenous bone marrow aspirate and autograft in posterolateral spine.

FIBERGRAFT™ BG Putty GPS is an osteoconductive, resorbable, biocompatible bone graft substitute to be gently packed into defect sites and to be used as non-structural scaffolds. The FIBERGRAFT™ BG putty GPS is made from 45S5 bioactive glass, where the bioactive glass components are mixed with an absorbable/polymeric carrier to form a cohesive material. FIBERGRAFT™ BG Putty GPS is to be provided in a spindle drive syringe and is compatible with the GPS Cannula product.

FIBERGRAFT™ BG Putty is an osteoconductive, resorbable, biocompatible bone graft substitute to be gently packed into defect sites and to be used as non-structural scaffolds. The FIBERGRAFT™ BG putty is made from 45S5 bioactive glass, where the bioactive glass components are mixed with an absorbable/polymeric carrier to form a cohesive material.

FIBERGRAFT™ AERIDYAN™ Matrix product is composed of 45S5 bioactive glass (M-45 granules), boron bioactive glass (MS-B microspheres/Borospheres™) and bovine type I collagen. After hydration with saline, blood or bone marrow aspirate (BMA), the AERIDYAN™ Matrix can be applied directly to the defect site or molded into the desired shape and gently packed into the defect site as a non-setting putty. In posterolateral spine fusion applications, the product is intended to be hydrated with bone marrow aspirate (BMA) and mixed with autograft in a recommended 1:1 ratio. In pelvis and extremity applications, the product must be hydrated with saline or blood.

FIBERGRAFT BG Matrix product is composed of 45S5 bioactive glass components (M-45 granules, MS-45 microspheres) and bovine type I collagen. The BG Matrix after hydration with saline, blood, or bone marrow aspirate (BMA) can be applied to the defect site or can be molded into the desired shape and gently packed into the defect site as a non-setting putty. In the posterolateral spine fusion applications, the product is intended to be hydrated with BMA and mixed with autograft in a 1:1 ratio.

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Mg OSTEOINJECT™

Mg OSTEOINJECT™ is intended for bony voids or defects of the extremities and pelvis that are not intrinsic to the stability of the bony structure. These osseous defects may be the result of benign bone cysts and tumors (in adults and pediatric patients > 6 years old), may be surgically created osseous defects or osseous defects created by traumatic injury to the bone.

Mg OSTEOINJECT™ can be used as an adjunct to conventional rigid hardware fixation by supporting the bone fragments during the surgical procedure only in the extremities and pelvis.

Once the material has set, it acts as a temporary support medium and is not intended to provide structural support during the healing process.

Mg OSTEOINJECT™ is intended to be placed into bony voids either before or after final fixation.
Mg OSTEOINJECT™ is resorbed and replaced with bone during the healing process.
Mg OSTEOINJECT™ is not intended to treat large defects that in the surgeon's opinion would fail to heal spontaneously.

Mg OSTEOREVIVE™

Mg OSTEOREVIVE™ is intended for bony voids or defects of the extremities, posterolateral spine, intervertebral disc space, and pelvis that are not intrinsic to the stability of the bony structure. These osseous defects may be the result of benign bone cysts and tumors (in adults and pediatric patients > 6 years old), may be surgically created osseous defects or osseous defects created by traumatic injury to the bone.

Mg OSTEOREVIVE™ can be used as an adjunct to conventional rigid hardware fixation by supporting the bone fragments during the surgical procedure only in the extremities and pelvis.

Once the material has set, it acts as a temporary support medium and is not intended to provide structural support during the healing process.

Mg OSTEOREVIVE™ is intended to be placed into bony voids either before or after final fixation.
Mg OSTEOREVIVE™ is resorbed and replaced with bone during the healing process.
Mg OSTEOREVIVE™ must be used with morselized autograft and/or allograft bone in the posterolateral spine.

When used in intervertebral body fusion procedures Mg OSTEOREVIVE™ must be used with morselized autograft and/or allograft bone with an intervertebral body fusion device cleared by FDA for use with a bone void filler.

Mg OSTEOREVIVE™ is not intended to treat large defects that in the surgeon's opinion would fail to heal spontaneously.

Mg OSTEOCRETE™

Mg OSTEOCRETE™ is intended for bony voids or defects of the extremities, posterolateral spine, intervertebral disc space, and pelvis that are not intrinsic to the stability of the bony structure. These osseous defects may be the result of benign bone cysts and tumors (in adults and pediatric patients > 6 years old), may be surgically created osseous defects or osseous defects created by traumatic injury to the bone.

Mg OSTEOCRETE™ can be used as an adjunct to conventional rigid hardware fixation by supporting the bone fragments during the surgical procedure only in the extremities and pelvis.

Once the material has set, it acts as a temporary support medium and is not intended to provide structural support during the healing process.

Mg OSTEOCRETE™ is intended to be placed into bony voids either before or after final fixation.
Mg OSTEOCRETE™ is resorbed and replaced with bone during the healing process.
Mg OSTEOCRETE™ must be used with morselized autograft and/or allograft bone in the posterolateral spine.

When used in intervertebral body fusion procedures Mg OSTEOCRETE™ must be used with morselized autograft and/or allograft bone with an intervertebral body fusion device cleared by FDA for use with a bone void filler.

Mg OSTEOCRETE™ is not intended to treat large defects that in the surgeon's opinion would fail to heal spontaneously.

This submission includes three (3) devices with separate trade names bundled into the single 510(k) application. The purpose of this application is to expand the indications to include specific language for use in pediatric patients > 6 years old. The subject devices are a magnesium-based synthetic bone void filler that is moldable, drillable, resorbable, adhesive/cohesive, radiopaque, and osteoconductive. The subject devices consist of a powder component (magnesium-based compound) and a mixing solution (buffered saline). Once the components are mixed intra-operatively prior to implantation, an acid-base reaction occurs to form a cohesive paste. Once the product is placed into the bony void, the paste will adhere to the adjacent bone during the curing process. The devices are provided sterile to the end user for single-use only in various sizes from 3 cc to 15 cc.

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Allomatrix® Injectable Putty, Allomatrix C, and Allomatrix® DR products are indicated only for bony voids or gaps that are not intrinsic to the stability of the bony structure. Allomatrix® products are intended to be gently packed into bony voids or gaps of the skeletal system (i.e., the extremities and pelvis). These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone.

AlloMatrix® Custom Putty is indicated only for bony voids or gaps that are not intrinsic to the stability of bony structure. AlloMatrix® Custom Putty is intended to be gently packed into bony voids or gaps of the skeletal system as a bone graft extender (spine), and as a bone void filler in the extremities and pelvis. These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone.

The Allomatrix® family of bone void fillers are comprised of demineralized bone matrix (DBM), a range of cancellous bone matrix (CBM) granules, and a binder of surgical-grade calcium sulfate and carboxymethylcellulose (CMC). Allomatrix® is available in four formulations and various volumes to accommodate surgeon needs. After mixing, the resultant putty can then be handled and placed in the appropriate bone voids.

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Device 300423 Granules is indicated only for bony voids or gaps that are not intrinsic to the stability of the bony structure. Device 300423 Granules is indicated to be gently packed into bony voids or gaps of the skeletal system (i.e., posterolateral spine, ilium 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.

Device 300423 Granules must be used with blood or autogenous bone marrow aspirate and autograft in posterolateral spine.

Device 300423 Granules is an osteoconductive, dry, porous, resorbable bone graft substitute which consists of calcium phosphate granules of proprietary alpha-tricalcium phosphate (α-TCP) and hydroxyapatite (HAp). The single-patient, single-use product is supplied sterile (via X-ray irradiation) as 0.25-1 or 0.8-2 mm granules packaged in 6 mL glass vials. The glass vials containing Device 300423 Granules are individually packaged in A-PET blisters and sealed with polyethylene (HDPE) Tyvek film.

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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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