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The SurFuse ™ II Putty and ExFuse ™ II Putty are bone filling materials indicated for dental intraosseous, oral and maxillofacial defects, including periodontal/infrabony defects; alveolar ridge augmentation; dental extraction sites; sinus lifts; cystic defects.

The SurFuse ™ II Putty and ExFuse ™ II Putty are derived from human allograft bone tissue that is processed into a powder and demineralized using a hydrochloric acid process. The demineralized bone matrix (DBM) is combined with a resorbable carrier, carboxymethylcellulose (CMC) and formulated into a putty-like consistency. The ExFuse ™ II Putty also contains cancellous bone powder. They are provided sterile for single patient use. The products are provided sterile for single patient use.

The provided text describes the 510(k) summary for the SurFuse™ II Putty and ExFuse™ II Putty, which are bone grafting materials. This document focuses on demonstrating substantial equivalence to predicate devices rather than providing a detailed clinical study with specific acceptance criteria and performance metrics in the way a diagnostic device submission might. Therefore, many of the requested elements for acceptance criteria and study design are not explicitly present in the provided text.

Based on the information given, here's what can be extracted and what cannot:

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

The document does not specify quantitative acceptance criteria with numerical targets. Instead, it focuses on demonstrating equivalence through:

• Donor Suitability: Compliance with FDA regulations (21 CFR Part 1270 and Part 1271) and AATB-certified tissue banks for donor bone.
• Viral Inactivation: Validation assessment for potency against HIV-1, BHV, BVDV, HAV, and PPV.
• Biocompatibility: Demonstrated as non-toxic and biocompatible according to ISO 10993.
• Osteoconductivity: Ability to grow bone in vivo in the dog alveolar bone model.
• Osteoinductivity: Osteoinductive potential shown in vivo in the athymic (nude) rat muscle pouch model and correlated with an in vitro BMP-2 ELISA assay.

Since specific quantitative "performance" metrics for these criteria are not given (e.g., "X% reduction in viral load," "Y units of new bone growth"), a direct table with numerical acceptance criteria and reported values cannot be constructed from the provided text. The reported "performance" is qualitative, stating that the devices met these assessments.

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

• Osteoconductivity Study: "dog alveolar bone model." The sample size (number of dogs) is not specified.
• Osteoinductivity Study: "athymic (nude) rat muscle pouch model." The sample size (number of rats) is not specified.
• Data Provenance: The studies are described as in vivo animal models. The country of origin for the studies is not specified, though the submitter is HansBiomed Corp. from Korea, and donor bone is sourced from AATB-certified tissue banks in the United States.

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 type of information is not applicable and not provided. The studies involve animal models and in vitro assays, not human clinical evaluations requiring expert interpretation of primary data (like images). The "ground truth" for osteoconductivity and osteoinductivity would be determined by histological analysis and quantitative measures in the animal models and biophysical/biochemical assays, typically assessed by pathologists or laboratory scientists, but the number and qualifications of such individuals are not detailed.

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

This is not applicable and not provided. Adjudication methods like 2+1 or 3+1 are typically used for human reader studies where there's a need to resolve discrepancies in expert interpretations (e.g., radiology case readings). These methods are not relevant to the in vivo animal model or in vitro assay studies 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

This is not applicable and not provided. MRMC studies are for evaluating the impact of AI assistance on human diagnostic performance, typically in imaging. This device is a bone grafting material, and its evaluation does not involve AI or human readers for diagnostic purposes.

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

This is not applicable and not provided. This device is a physical material, not an algorithm.

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

• Osteoconductivity and Osteoinductivity: The ground truth appears to be based on pathology/histology and biochemical assays (BMP-2 ELISA) from in vivo animal models. The formation of new bone in the different animal models is the objective ground truth.
• Biocompatibility: The ground truth is established by adherence to ISO 10993 standards for non-toxicity and biocompatibility, likely through in vitro and in vivo tests described in those standards.
• Viral Inactivation: The ground truth is based on the effectiveness of the manufacturing and sterilization processes in inactivating specified viruses, assessed by validation studies.

8. The sample size for the training set

This is not applicable and not provided. The assessment described here involves characterization of the material's biological properties, not machine learning or AI, so there is no concept of a "training set."

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

This is not applicable for the same reason as point 8.

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RegenerOss Allograft Putty Plus Mineralized is a bone filling material indicated for dental intraosseous and oral/maxillofacial defects including: localized ridge augmentations, extraction sockets, cystic defects, sinus lifts, peri-implant defects, defects associated with root resection or apicoectomy, and periodontal defects.

Bone Filling Material used for augmenting deficient bone or filling bone defects in oral/dental applications. Allograft (Bone) Putty containing human allograft bone tissue (DBM) and mineralized cancellous chips, from the same donor, combined with a lipid carrier.

This is a 510(k) premarket notification for "RegenerOss Allograft Putty Plus Mineralized." The submission focuses on demonstrating substantial equivalence to a predicate device, rather than providing a standalone clinical study report with detailed acceptance criteria and performance metrics typically seen for de novo devices or PMA applications. Therefore, many of the requested points related to device performance in a clinical setting and expert involvement in ground truth establishment are not present in this document.

Here's an analysis based on the provided text:

Acceptance Criteria and Reported Device Performance

The document states that a "rigorous design control process is the basis for a substantial equivalence determination" and that "verification and validation activities have been performed successfully, as identified by the risk analysis, ensuring the modified device is as safe and effective as the predicate device. The predetermined acceptance criteria have been met."

However, specific numerical acceptance criteria and reported device performance (e.g., success rates, effect sizes) for clinical use are not explicitly provided in the given text. The study primarily focuses on demonstrating comparable characteristics to a predicate device through non-clinical testing.

Table of Acceptance Criteria and Reported Device Performance:

Study Details:

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

   • The primary "test set" for the osteoinductive potential evaluation was conducted in an athymic rat ectopic bone growth model. The specific sample size (number of rats or implants) is not provided in the document.
   • The functional testing (solubility, handling) would have involved samples of the device material itself, but the number of samples is not specified.
   • The data provenance is from non-clinical laboratory studies (animal model and in-vitro material testing) conducted by Biomet/Biomet Interpore Cross. It is retrospective in the sense that it's part of a design control process validation for a modification.

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

   • This information is not provided. The assessment of osteoinductive potential involved "histological scoring of new bone formation." This typically involves trained pathologists or histologists, but their number and qualifications are not disclosed in this 510(k) summary.

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

   • This information is not provided. Given the nature of a 510(k) submission focused on substantial equivalence through non-clinical testing, formal clinical adjudication methods are not typically detailed.

4. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

   • No, an MRMC comparative effectiveness study was not done. This device is a bone grafting material, not an imaging analysis AI or a diagnostic tool that involves human readers. Therefore, this question is not applicable to the submitted device.

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

   • Not applicable. This is a medical device (bone graft material), not an algorithm or AI system.

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

   • For the osteoinductive potential, the ground truth was based on histological scoring of new bone formation in the animal model. This implies a pathological assessment.
   • For functional testing, the "ground truth" refers to the measured physical and chemical properties of the material, which are scientifically quantifiable.

7. The sample size for the training set:

   • Not applicable. This is a medical device, not a machine learning model, so there is no "training set." The development process involved design inputs and verification/validation, but not machine learning training.

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

   • Not applicable. As there is no training set for a machine learning model.

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DBX® Inject is intended for use as a Demineralized Bone Matrix for voids or gaps that are not intrinsic to the stability of the bony structure. It can be used as follows:
Ridge augmentation
Filling of extraction sites
Craniofacial augmentation
Mandibular reconstruction
Repair of traumatic defects of the alveolar ridge, excluding maxillary and mandibular fracture
Filling resection defects in benign tumors, benign cysts, or other osseous defects in the alveolar ridge wall
Filling of cystic defect
Filling of lesions of periodontal origin
Filling of defects of endodontic origin
DBX® Inject is indicated for treatment of surgically created osseous defects or osseous defects created from traumatic injury. DBX® Inject can be used with bone marrow. DBX® Inject is for single patient use only.

DBX® Inject is osteoconductive, and has been shown to have osteoinductive potential in an athymic mouse model. Every lot of final DBX® Inject Paste will be assayed in vivo for osteoinductive potential. - Every lot of final DBX® Inject Putty product will be tested in an athymic mouse model or in an alkaline phosphatase assay, which has been shown to have a positive correlation with the athymic mouse model, to ensure the osteoinductive potential of the final product. Standard testing performed in an athymic mouse or alkaline phosphatase assay must prove positive for lot release. It is unknown how the osteoinductive potential, measured in the athymic mouse model or the alkaline phosphatase assay, will correlate with clinical performance in human subjects.
DBX® Inject is single-donor processed. The donor suitability criteria used to screen this donor are in compliance with the FDA regulations published in 21 CFR Part 1270 and Part 1271 Human Tissue Intended for Transplantation.

This 510(k) summary describes a traditional medical device (Bone Void Filler) and not an AI/ML powered device. As such, the requested information (sample sizes, ground truth establishment, expert qualifications, HRMC studies, etc.) is not applicable and is not present in the provided document.

However, I can extract the acceptance criteria and refer to the studies mentioned in the document that were performed to demonstrate the device meets these criteria.

Acceptance Criteria and Reported Device Performance

Every lot of final DBX® Inject Putty product must be tested in an athymic mouse model or in an alkaline phosphatase assay (which has a positive correlation with the athymic mouse model) to ensure osteoinductive potential, and prove positive for lot release.

Note: It is unknown how the osteoinductive potential, measured in these models, will correlate with clinical performance in human subjects. | DBX® Inject is osteoconductive and has been shown to have osteoinductive potential in an athymic mouse model. Standard testing will be performed in an athymic mouse or alkaline phosphatase assay for lot release. |
| Viral Clearance and Inactivation | The processing method for the demineralized bone matrix must provide significant viral inactivation potential for a wide range of potential viruses. | The DBM processing methods were determined to provide significant viral inactivation potential for a wide range of potential viruses, as evaluated with a panel of model potential human viruses representing various types, sizes, shapes, and genomes. |
| Donor Suitability | Donor suitability criteria used to screen donors must be in compliance with FDA regulations published in 21 CFR Part 1270 and Part 1271 Human Tissue Intended for Transplantation. | DBX® Inject is single-donor processed, and the donor suitability criteria used are in compliance with FDA regulations 21 CFR Part 1270 and Part 1271. |

Statements regarding AI/ML specific information (as it pertains to a traditional medical device):

1. Sample size used for the test set and the data provenance: Not applicable. The studies mentioned are laboratory tests, not clinical trials with human patient data.
2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for osteoinductivity and viral inactivation is established through standardized laboratory assays.
3. Adjudication method for the test set: Not applicable. Laboratory assays follow predefined protocols.
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 not an AI-powered device.
5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an AI-powered device.
6. The type of ground truth used:
   • Osteoinductive potential: Athymic mouse model results or alkaline phosphatase assay results.
   • Viral clearance and inactivation: Results from standard viral inactivation assays using model viruses.
   • Donor suitability: Compliance with FDA regulations (21 CFR Part 1270 and Part 1271).
7. The sample size for the training set: Not applicable. This is not an AI-powered device.
8. How the ground truth for the training set was established: Not applicable. This is not an AI-powered device.

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PROGENIX® DBM Putty and PROGENIX® Plus may be used alone or in combination with autograft bone and/or autogenous bone marrow for use as a bone graft extender. substitute, and bone void filler in bony voids or gaps, not intrinsic to the stability of the bony structure, of the cranial, oral and maxillofacial region. The voids or gaps may be surgically created osseous defects or osseous defects created from traumatic injury to the bone. PROGENIX® DBM Putty and PROGENIX® Plus provide a bone void filler that is resorbed/remodeled and is replaced by host bone during the healing process.

PROGENIX® DBM Putty and PROGENIX® Plus are intended to be used alone or in combination with autogenous bone and/ or bone marrow aspirate for the augmentation of deficient maxillary and mandibular alveolar ridges and the treatment of cranial oral maxillofacial and dental intraosseous defects including but not limited to:

Ridge augmentation Filling of cystic defect Filling of extraction sites Filling of lesions of periodontal origin Craniofacial augmentation Filling of defects of endodontic origin Mandibular reconstruction Repair of traumatic defects of the alveolar ridge, excluding maxillary and mandibular fracture

Filling of resection defects in benign bone tumors, benign cysts or other osseous defects in the alveolar ridge wall.

The PROGENIX® products contain human demineralized bone matrix (DBM) in a biocompatible carrier. The carrier is a mixture of bovine collagen with a natural polysaccharide (sodium alginate). The components are mixed in phosphate buffered saline to achieve a flowable or moldable consistency. PROGENIX® is available in two versions: Putty and Plus. The PROGENIX® Plus version contains two different sized demineralized bone particles.

PROGENIX® DBM Putty and PROGENIX® Plus are single use products intended for use in the oralmaxillofacial region. Additionally, these products are not designed to impart any mechanical strength to the surgical site. Both versions are provided in readyto-use malleable forms that may be molded or manipulated by the surgeon into various shapes. These products have been shown to be osteoinductive in an athymic rat assay. as well as osteoconductive, allowing for bony ingrowth across the graft site while resorbing at a rate consistent with bony healing.

The provided text is a 510(k) summary for the Medtronic Sofamor Danek PROGENIX® device. It describes the product, its intended use, and its substantial equivalence to previously cleared devices. However, this document does not contain the kind of information requested regarding acceptance criteria and studies that prove the device meets those criteria, especially in the context of device performance metrics like sensitivity, specificity, etc.

The 510(k) process for devices like PROGENIX® (a bone void filler) typically relies on demonstrating substantial equivalence to a predicate device based on similar materials, intended use, technological characteristics, and performance data (which often includes biocompatibility, mechanical properties, and osteoinductivity/osteoconductivity in animal models). It usually does not involve "acceptance criteria" in the sense of predictive algorithm performance (e.g., sensitivity, specificity) against a ground truth, as might be found for AI/ML-driven diagnostic or image analysis devices.

Therefore, I cannot populate the requested table and answer the questions based on the provided text. The document focuses on regulatory approval based on demonstrating equivalence, not on a detailed clinical performance study with acceptance criteria for statistical metrics.

Here's why the information isn't available in the provided text:

• Type of Device: PROGENIX® is a medical device (bone void filler) composed of human demineralized bone matrix (DBM) and a biocompatible carrier. It's a biological/material product, not a software algorithm or diagnostic tool that would typically have performance metrics like sensitivity, specificity, or rely on human expert consensus for "ground truth" in the way an AI diagnostic device would.
• 510(k) Process for this device: The 510(k) summary confirms "substantial equivalence" to previously cleared predicate devices (other DBM products). This means the FDA determined the new device is as safe and effective as a legally marketed device and does not raise different questions of safety and effectiveness. This determination relies on demonstrating similar intended use, technological characteristics, and performance data (e.g., osteoinductivity in rats, osteoconductivity, resorption rate). It does not typically involve human reader studies or comparison to an AI algorithm.
• Missing Information: The document does not discuss:
  • Specific quantitative acceptance criteria (e.g., statistical thresholds for performance).
  • Clinical studies designed to measure such criteria in humans (beyond showing it is resorbed and replaced by host bone).
  • Test sets, training sets, data provenance, expert ground truth establishment, or multi-reader multi-case studies. These are concepts relevant to AI/ML or diagnostic device evaluations, not directly to a bone graft material's regulatory submission as presented here.

In summary, the provided document is a regulatory clearance for a medical device (bone void filler) based on substantial equivalence, not a clinical study report for an AI/ML or diagnostic device with performance metrics and acceptance criteria as outlined in your request.

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PROGENIX® DBM Putty and PROGENIX® Plus are intended for the augmentation of deficient maxillary and mandibular alveolar ridges and the treatment of oralmaxillofacial and dental intraosseous defects including but not limited to:

Ridge augmentation

Filling of cystic defect

Filling of extraction sites

Filling of lesions of periodontal origin

Craniofacial augmentation

Filling of defects of endodontic origin

Mandibular reconstruction

Repair of traumatic defects of the alveolar ridge, excluding maxillary and mandibular fracture

Filling of resection defects in benign bone tumors, benign cysts or other osseous defects in the alveolar ridge wall.

PROGENIX® contains human demineralized bone matrix (DBM) in a biocompatible carrier. The carrier is a mixture of bovine collagen with a natural polysaccharide (sodium alginate). The components are mixed in phosphate buffered saline to achieve a flowable or moldable consistency. PROGENIX® is available in two forms: Putty and Plus. The PROGENIX® Plus version contains two different sized demineralized bone particles.

PROGENIX® DBM Putty and PROGENIX® Plus are single use products intended for use in the oralmaxillofacial region. Additionally, these products are not designed to impart any mechanical strength to the surgical site. Both versions are provided in ready-to-use malleable forms that may be molded or manipulated by the surgeon into various shapes. These products have been shown to be osteoinductive in an athymic rat assay, as well as osteoconductive, allowing for bony ingrowth across the graft site while resorbing at a rate consistent with bony healing.

The provided text is a 510(k) summary for a medical device called PROGENIX® Plus, a resorbable calcium salt bone void filler device. It is a Special 510(k) for a device modification, seeking to include a new formulation to an already cleared product line. The primary goal is to demonstrate substantial equivalence to predicate devices, not necessarily to prove a specific level of performance against quantitative acceptance criteria through a clinical study.

Therefore, the information typically requested in your template (e.g., sample sizes for test/training sets, expert qualifications, MRMC studies, standalone performance, specific ground truth types) is largely not applicable in this context, as a clinical study with such detailed parameters was not conducted or required for this type of submission.

Instead, the "acceptance criteria" and "study" are focused on demonstrating the osteoinductive potential and viral inactivation effectiveness of the product, primarily through non-clinical testing, and showing substantial equivalence to existing devices.

Here's a breakdown based on the available information:

Acceptance Criteria and Reported Device Performance

Study Details

Given the nature of a 510(k) for a bone void filler, the "studies" refer to non-clinical tests rather than human clinical trials involving extensive statistical analysis of human performance.

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

   • Osteoinductivity Assay: The sample size would refer to the number of athymic nude rats used in the in vivo assay. This information is not provided in the summary.
   • Viral Inactivation: Not applicable in terms of a "test set" like a clinical study. It refers to in vitro validation studies on the manufacturing process.
   • Data Provenance: Not explicitly stated, but typically these non-clinical studies are conducted in a controlled laboratory environment (e.g., manufacturer's labs or contract research organizations), likely in the country of manufacture (USA for Medtronic Sofamor Danek). All data would be prospective for the purpose of validating the new formulation.

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

   • Osteoinductivity Assay: The "ground truth" for osteoinductivity would be established by histopathological evaluation of the rat tissue. The number and qualifications of the pathologists or histologists performing this evaluation are not provided.
   • Viral Inactivation: The ground truth is based on established virology assays to quantify viral reduction. The experts would be virologists and microbiologists within the testing facility. This information is not provided.

3. Adjudication method for the test set:

   • Osteoinductivity Assay: Adjudication methods for histological evaluation (e.g., multiple pathologists reviewing slides) are not specified. Standard practice may involve independent review, but it's not detailed here.
   • Viral Inactivation: 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 device is a bone void filler, not an AI-powered diagnostic imaging device.

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

   • Not applicable. This is a physical medical device.

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

   • Osteoinductivity: Histopathology (microscopic examination of tissue samples for the presence of osteoblasts, chondroblasts, and woven bone).
   • Viral Inactivation: Quantitative virology assays (measuring reduction in viral titers).

7. The sample size for the training set:

   • Not applicable. This is not an AI/machine learning device requiring a training set in that sense. The "training" for the product refers to the development and manufacturing processes.

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

   • Not applicable. As above, it is not an AI/ML device.

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PROGENIX™ DBM Putty is intended for the augmentation of deficient maxillary and mandibular alveolar ridges and the treatment of oralmaxillofacial and dental intraosseous defects including but not limited to:

Ridge augmentation
Filling of cystic defect
Filling of extraction sites
Filling of lesions of periodontal origin
Craniofacial augmentation
Filling of defects of endodontic origin
Mandibular reconstruction
Repair of traumatic defects of the alveolar ridge, excluding maxillary and mandibular fracture
Filling of resection defects in benign bone tumors, benign cysts or other osseous defects in the alveolar ridge wall.

PROGENIX™ DBM Putty contains human demineralized bone matrix (DBM) in a biocompatible carrier. The carrier is a mixture of bovine collagen with a natural polysaccharide (sodium alginate). The components are mixed in phosphate buffered saline to achieve a flowable or moldable consistency. All DBM used in the preparation of PROGENIX™ DBM Putty must induce bone formation when evaluated in a validated athymic nude rat assay. Although, findings from an animal model are not necessarily predictive of human clinical results.

PROGENIX™ DBM Putty is a single use product intended for use in the oralmaxillofacial region. Additionally, this product is not designed to impart any mechanical strength to the surgical site. PROGENIX™ DBM Putty is provided in ready-to-use malleable forms that may be molded or manipulated by the surgeon into various shapes. This product has been shown to be osteoconductive as well as osteoinductive in an athymic rat assay, allowing for bony ingrowth across the graft site while resorbing at a rate consistent with bony healing

The provided text is a 510(k) premarket notification for a medical device called PROGENIX™ DBM Putty. This document focuses on demonstrating substantial equivalence to existing devices rather than presenting a study of the device's performance against specific acceptance criteria in a clinical setting.

Therefore, many of the requested sections about explicit acceptance criteria, detailed study design, and performance metrics are not directly found in the provided text. The submission is a regulatory filing for market clearance, not typically a detailed report on clinical trial outcomes with specific statistical thresholds.

Here's an analysis based on the available information:

Acceptance Criteria and Device Performance

Since this is a 510(k) submission for a bone void filler, the "acceptance criteria" are primarily related to substantial equivalence to predicate devices and demonstrating the device's ability to induce bone formation and be osteoconductive. No specific numerical performance metrics are provided in the context of clinical acceptance criteria.

The key "performance" mentioned is in an animal model:

Study Details (Based on available information)

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

   • The primary "test set" described for performance is an athymic nude rat assay. The exact number of animals (sample size) is not specified in this document.
   • Data Provenance: Animal model data (athymic nude rat assay). The location of the assay or the origin of the facility is not stated, but it's part of the product development for a US company. This would be considered prospective data generation for the purpose of demonstrating device characteristics.

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

   • Not applicable in the context of this animal model. The "ground truth" for the animal assay (e.g., presence/absence of bone formation, rate of resorption) would be determined by standard histological and imaging analyses conducted by trained veterinary pathologists or researchers, but specific details about their number or qualifications are not provided as it's a foundational biological assay.

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

   • Not applicable. Adjudication methods like 2+1 or 3+1 are typically used for human clinical assessments or image interpretation where expert agreement is needed to establish a "ground truth" diagnosis. This document references an animal assay where outcomes are generally assessed objectively through histological examination.

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 product, not an AI-powered diagnostic device, so MRMC studies involving human readers and AI assistance are not relevant.

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

   • Not applicable. This device is a bone void filler, not an algorithm. Performance is evaluated on its biological effects (osteoinduction, osteoconduction, resorption) within a biological system.

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

   • For the animal assay, the ground truth for osteoinduction, osteoconduction, and resorption rate would be established through histopathology (microscopic examination of tissue samples) and potentially imaging techniques appropriate for small animal models.

7. The sample size for the training set:

   • Not applicable. This product is a physical bone void filler, not a machine learning model, so there is no "training set" in the context of AI.

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

   • Not applicable for the reason stated in point 7.

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These products are intended to be packed into bony voids or gaps to fill and/or augment dental intraosseous, oral and cranio-/maxillofacial defects. These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone, including

• . Periodontal defects;
• . Alveolar ridge augmentation;
• Extraction sockets (ridge preservation, implant preparation/ placement); .
• . Maxillary sinus floor elevation;
• Craniofacial augmentation; .
• Root resection, apicoectomy and cystectomy; .
• Tumor resection. .

One or more of the product formulations, depending upon specific anatomical location and physician and/or dentist preference, can be placed in the dental intraosseous defect site.

Regenafil®, Altiva DBM Paste, BioSet™, RTI Allograft Paste, and Osteofil® contain human demineralized freeze-dried bone allograft (DFDBA, also known as demineralized bone matrix, DBM) in an inert porcine gelatin carrier. Regenaform®, Altiva DBM with cortical cancellous chips, BioSet™ IC, RTI Allograft Paste IC, and Osteofil® ICM contain human DFDBA and human cortical-cancellous bone chips in an inert porcine gelatin carrier.

This document K080418 is a 510(k) premarket notification for bone grafting materials. The acceptance criteria and performance data are primarily focused on demonstrating substantial equivalence to predicate devices rather than directly presenting a study with specific quantitative acceptance criteria for device performance in a clinical trial.

Here's a breakdown based on the provided text:

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

The document does not present specific quantitative acceptance criteria in a typical "performance metrics" table format as one might expect for a diagnostic or AI device. Instead, the acceptance criteria are implicitly met by demonstrating "substantial equivalence" to predicate devices. The "performance" reported is the finding of this equivalence based on technological characteristics and results from animal and clinical studies.

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 mentions "animal and clinical studies" but does not provide details on the sample size for these studies, nor does it specify the data provenance (e.g., country of origin, retrospective/prospective nature). The focus is on the conclusion of safety and effectiveness rather than the specifics of the underlying studies.

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 provided in the document. The studies mentioned (animal and clinical studies) would typically involve experts to assess outcomes, but the submission does not detail their involvement or qualifications.

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

This information is not provided as the document doesn't detail the methodology of the "clinical studies" or how ground truth was established.

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. The device is bone grafting material, not an AI or imaging device that would involve human "readers" or AI assistance. Therefore, an MRMC study and effect size in human improvement with AI are not relevant to this submission.

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

This is not applicable. The device is not an algorithm.

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

For osteoinductivity, the ground truth is established through a "modified athymic nude rat assay."
For the general claims of safety and effectiveness, the document refers to "animal and clinical studies." These would likely involve outcomes data such as bone formation, integration, healing, and potentially histological/pathological assessment, but the specifics are not detailed.

8. The sample size for the training set

This is not applicable. The device is bone grafting material. There is no "training set" in the context of an AI/machine learning model. The relevant "training" relates to the development of the bone graft material, which is a manufacturing and biological process, not an algorithmic one.

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

This is not applicable for the same reasons as #8.

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InterGro® Oral is a bone filling material indicated for dental intraosseous and oral/maxillofacial defects including: localized ridge augmentations, extraction sockets, cystic defects, sinus lifts, peri-implant defects, defects associated with root resection or apicoectomy, and periodontal defects.

InterGro® Oral is a resorbable, osteoconductive, and osteoinductive bone graft substitute that resorbs and is replaced with bone during the healing process. Its main component, demineralized cortical bone matrix (DBM), is derived from donor human tissue (allograft bone) and contains various growth factors including osteoinductive proteins. The DBM has been granulated, lyophilized and aseptically processed. In some versions of the product, calcium salt granules shall be incorporated to provide additional osteoconduction and enhanced structural strength. The carrier for InterGro® Oral is a resorbable, biocompatible, semi-viscous lipid. InterGro® Oral is provided ready-to-use in various physical consistencies. It is packaged in various sizes by volume for single patient use.

This document is a 510(k) Premarket Notification for the BIOMET 3i InterGro® Oral device, a bone grafting material. It is a submission to the FDA to demonstrate substantial equivalence to a predicate device. As such, it does not contain a study demonstrating the device meets acceptance criteria for reported performance. Instead, it focuses on demonstrating equivalence to an already legally marketed device based on intended use, materials, select performance properties, and handling.

Therefore, most of the requested information regarding acceptance criteria, study details, sample sizes, ground truth establishment, and human reader performance is not applicable to this type of regulatory submission.

Here's what can be extracted and what cannot:

1. Table of acceptance criteria and the reported device performance:

This information is not provided in the document. The document states: "Performance standards applicable to DBM base products have not been published by the FDA." Instead of specific performance metrics, the submission focuses on establishing substantial equivalence to a predicate device.

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

Not applicable. This document does not describe a performance study with a test set of data in the context of device performance metrics. It's a regulatory submission for substantial equivalence.

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):

Not applicable. This document does not describe a performance study involving expert assessment of a test set to establish ground truth.

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

Not applicable. No such test set or adjudication is described in the document.

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 grafting material, not an AI-assisted diagnostic tool. Therefore, an MRMC comparative effectiveness study with human readers and AI assistance is not relevant or included.

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

Not applicable. This device is a bone grafting material, not an algorithm.

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

Not applicable. As no performance study with a defined test set and ground truth is described, this information is not available. The "ground truth" for this submission is implicitly the established safety and effectiveness of the predicate device (GRAFTON® DBM).

8. The sample size for the training set:

Not applicable. This document describes a new medical device (a bone grafting material), not a machine learning model that would require a training set.

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

Not applicable. As there is no training set, this information is not relevant.

Summary of what the document does provide regarding "performance":

The document states that BIOMET 3i intends to have Interpore Cross International manufacture and package the device "according to the regulations and standards that are appropriate to the risk that Class II devices reasonably present."

It further mentions the use of voluntary performance standards such as:

• Materials certifications
• In-house Standard Operating Procedures (SOPs)
• FDA Guidance Documents
• AATB Standards (American Association of Tissue Banks)
• ASTM Standards (American Society for Testing and Materials)

The "study" in this context is the 510(k) Premarket Notification process itself, which aims to demonstrate substantial equivalence to a predicate device, GRAFTON® DBM (Gel, Flex, Putty, Matrix, Crunch). The conclusion drawn is: "The safety and effectiveness of InterGro® Oral is adequately supported by the substantial equivalence information, materials data, and testing results provided within this premarket notification. InterGro® Oral was found to be substantially equivalent to the predicate device based on the intended use, base materials, select performance properties, and use of a handling material."

This means that instead of proving the device meets specific numerical acceptance criteria (as one might find for a diagnostic tool's sensitivity/specificity), the "acceptance criterion" for this submission is that it is substantially equivalent to a legally marketed and safe/effective predicate device based on the factors listed above. Specific performance test results (e.g., biocompatibility testing, mechanical properties, osteoinductivity data for DBM) would have been part of the "materials data, and testing results" provided in the full 510(k) submission, even if not explicitly detailed in this summary.

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OrthoBlast® It DBM Paste and Putty are bone filling materials indicated for augmentation or reconstructive treatment of alveolar ridge. This includes:

• Filling of defects after root resection, apicoectomy and cystectomy ・
• Filling of extraction sockets to enhance preservation of the alveolar ridge -
• Elevation of maxillary sinus floor -

OrthoBlast® II DBM Paste and Putty is derived from selected donated human bone tissue that has been processed into particles. The bone particles are subsequently demineralized using a hydrochloric acid process. The demineralized bone matrix (DBM) is combined with a reverse phase carrier, cancellous chips from the same donor, and then formulated to a paste or puttylike consistency.
OrthoBlast® II DBM Paste and Putty are osteoconductive and osteoinductive bone filling material. The osteoinductive potential is demonstrated in athymic mouse model.

This document is a 510(k) summary for a medical device called OrthoBlast II DBM Paste and Putty, seeking clearance from the FDA. It is not a study report detailing acceptance criteria or device performance based on a study, but rather a regulatory submission for market clearance.

Therefore, the requested information regarding acceptance criteria, device performance, sample sizes, ground truth establishment, expert qualifications, adjudication methods, or MRMC studies is not available in the provided text.

Here's why and what information is available:

• Nature of the Document: This is a 510(k) "Premarket Notification." The purpose of a 510(k) is to demonstrate that the new device is "substantially equivalent" to a legally marketed predicate device. It's not a clinical trial report that establishes new performance metrics through a study against predefined acceptance criteria.
• "Performance Data" Section (Section 7): This section states: "Product safety and effectiveness is adequately supported by the substantial equivalence information, materials data, and animal test results provided in this Premarket Notification."
  • This indicates that "performance" in this context refers to demonstrating equivalence and safety through existing data, material characterization, and animal studies, not necessarily human clinical trials with statistical acceptance criteria.
  • It also states "The osteoinductive potential is demonstrated in athymic mouse model." This is an animal study, not a human clinical study.

What can be extracted from the provided text is:

1. Device Name and Intended Use:

• Proprietary Name: OrthoBlast® II Demineralized Bone Matrix Paste and Putty
• Intended Use: Bone filling materials indicated for augmentation or reconstructive treatment of alveolar ridge. This includes:
  • Filling of defects after root resection, apicoectomy and cystectomy
  • Filling of extraction sockets to enhance preservation of the alveolar ridge
  • Elevation of maxillary sinus floor

2. Predicate Device:

• DynaGraft II Dental (Demineralized Bone Matrix) [K043573]

3. Basis for Equivalence (Instead of Acceptance Criteria):

The device is considered "substantially equivalent" based on:

• Utilizing ground, human donor cortical demineralized bone.
• Utilizing an inactive poloxamer reverse phase carrier (RPM).
• Having the same indications for use.
• Being provided sterile.
• Intended for single patient use.

Differences noted for context (though not acceptance criteria):

• Predicate device (DynaGraft II) contains more demineralized bone by weight and volume and less synthetic carrier.
• OrthoBlast II incorporates the same donor's cancellous tissue in particulate form, while DynaGraft II does not.

In summary, the provided text does not contain the information required to fill out the table and answer the specific questions about acceptance criteria and a study proving device meets acceptance criteria, as it is a regulatory submission for substantial equivalence rather than a detailed study report.

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