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MaxiGen™ is an implant intended to fill bony voids or gaps of the skeletal system i.e., posterolateral spine. 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. MaxiGen™ resorbs and is replaced with bone during the healing process

MaxiGen™ is a resorbable bone void filler, combining Human Demineralized Bone Matrix (DBM) with calcium sulfate and carboxymethylcellulose (CMC). MaxiGen™ comes in the form of a kit with a premeasured and premixed DBM, calcium sulfate, and CMC powder, premeasured mixing solution, the tools for mixing the components, and a 5cc syringe. After the powder is hydrated using all the mixing solution supplied in the kit, the resultant putty can then be handled and placed in the appropriate bone voids, or it can be injected using the syringe supplied in the kit. This product is supplied sterile for permanent resorbable device, implanted in bone tissue.

The provided text does not contain information about acceptance criteria or a study proving that an AI device meets acceptance criteria. The document is an FDA 510(k) clearance letter for a medical device called "MaxiGen™," which is a resorbable calcium salt bone void filler. It describes the device's indications for use, materials, testing for biocompatibility and performance (osteoconduction and osteoinduction), and comparison to predicate devices, but it does not involve any AI technology or related performance metrics.

Therefore, I cannot provide the requested information.

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The BellaFuse™ is an implant intended to fill bony voids or gaps of the skeletal system, i.e. posterolateral spine. 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. Bellafuse™ resorbs and is replaced with bone during the healing process.

Device Identification and Materials of Use:
BellaFuse™ is a resorbable bone void filler, combining Human Demineralized Bone Matrix (DBM) with gelatin. The primary component of this BVF product is demineralized particle bone, which is derived from human donor cortical bone. The additional porcine gelatin is a biocompatible component which maintains the shape and enhances flexibility.
Device Characteristics:
This product is provided in several flexible sheet sizes ranging from 10x10x2.5mm to 50x100x5.0mm. It is supplied sterile for single patient use.
Body Contact:
BellaFuse™ is a permanent resorbable device, implanted in bone tissue.

I am sorry, but the provided text does not contain the detailed information necessary to complete the table and answer the questions regarding acceptance criteria, device performance, and study specifics as outlined in your request.

The document is a 510(k) premarket notification summary for a medical device called BellaFuse™. It discusses the device's intended use, description, mechanism of action, and a summary of testing for serological, biocompatibility, osteoconduction, and osteoinductive potential. However, it does not provide:

• Specific numerical acceptance criteria for performance. It states the device "was tested successfully to fully assess the performance to grow bone" and "was shown to have osteoinductive potential," but doesn't quantify these successes with specific metrics or thresholds.
• Detailed reported device performance outcomes. While it mentions new bone growth, it doesn't provide statistical results like sensitivity, specificity, accuracy, or quantitative measures of bone growth in the context of specific acceptance criteria.
• Sample sizes for test sets, training sets, or data provenance. Only a sample size of "nude rat muscle pouch model" (n=?) is mentioned for osteoinductive potential, and no other sample sizes are given.
• Information about experts, ground truth establishment, adjudication methods, or MRMC studies.
• Specifics on how the ground truth for training or test sets was established.

Therefore, I cannot populate the table or answer most of the questions based on the provided text.

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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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The SurFuse™ Gel, SurFuse™ Putty, ExFuse™ Gel, and ExFuse™ Putty products are indicated for bony voids or gaps that are not intrinsic to the stability of the bony structure. They are intended to be gently packed into bony voids or gaps of the skeletal system (posterolateral spine). These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone.

The SurFuse™ and ExFuse™ family of products 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 or gel-like consistency. The ExFuse™ products also contain cancellous bone powder. The products are provided sterile for single patient use.

The provided text is a 510(k) summary for the HansBiomed Corp. SurFuse™ and ExFuse™ devices. This type of submission is for medical devices and focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than presenting a standalone study with detailed acceptance criteria and performance metrics typically seen for AI/ML-driven software as a medical device.

Therefore, the requested information specifically related to acceptance criteria, sample sizes for test and training sets, expert qualifications, adjudication methods, multi-reader multi-case studies, and ground truth types are not available in the provided document, as these are primarily associated with the validation of AI/ML diagnostic or prognostic algorithms.

The document discusses safety and performance in a more general sense for a bone void filler product, focusing on biocompatibility, osteoinductivity, and osteoconductivity, rather than an AI/ML algorithm's analytical or clinical performance.

Here's a breakdown of what can be extracted and what is missing:

The device is a physical medical device (resorbable bone void filler), not an AI/ML software. Therefore, the parameters typically used to describe AI/ML studies are not relevant or present.

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

• Acceptance Criteria: Not explicitly stated as pass/fail thresholds for quantitative metrics in an AI context. Instead, the acceptance is based on demonstrating safety (biocompatibility, viral inactivation) and performance (osteoinductivity, osteoconductivity) through established biological and in vivo models.
• Reported Device Performance:
  • Safety:
    • Donor bone obtained from AATB-certified tissue banks, screened for infectious viruses.
    • Manufacturing and sterilization processes validated to inactivate HIV-1, Bovine Herpes Virus (BHV), Bovine Viral Diarrhea Virus (BVDV), Hepatitis A Virus (HAV), and Porcine Parvovirus (PPV).
    • Biocompatibility testing (according to ISO 10993) performed, demonstrating devices are safe, nontoxic, and biocompatible.
  • Performance:
    • Osteoconductive ability: Successfully grown bone in the in vivo rabbit spinal model.
    • Osteoinductive potential:
      • Demonstrated new bone growth within muscle tissue in the athymic (nude) rat muscle pouch model.
      • Evaluated with a surrogate, in vitro BMP-2 ELISA assay, with results correlated with successful bone formation in the athymic rat for the same lots.
      • Each lot will be evaluated for osteoinductive potential using the in vitro assay.

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

• Sample Size (Test Set): Not specified for human data. For preclinical studies:
  • Rabbit spinal model: Sample size not specified.
  • Athymic (nude) rat muscle pouch model: Sample size not specified.
• Data Provenance: Preclinical animal models (rabbit and rat). Human data (if any for testing) is not described. 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)

• Not applicable. The ground truth for this type of device relies on biological outcomes in animal models (e.g., bone formation observed histologically) and in vitro assays, not on expert human interpretation of medical images or clinical cases.

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

• Not applicable. This is not an AI/ML diagnostic device requiring adjudication of human expert 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/ML device that assists human readers.

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

• Not applicable. This is a physical medical device, not an algorithm.

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

• Ground Truth (for performance):
  • Observation of bone formation in vivo (rabbit spinal model, athymic rat muscle pouch model).
  • Results of in vitro BMP-2 ELISA assay correlated with in vivo bone formation.
• Ground Truth (for safety/biocompatibility):
  • Viral inactivation validation studies.
  • ISO 10993 biocompatibility testing results.

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. There is no training set for this physical device.

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