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

AlloFuse 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 an inert reverse phase carrier and formulated into a gel or putty-like consistency.

The carrier is a solution of polyethylene oxide polypropylene oxide block copolymer dissolved in water exhibiting reverse phase characteristics (i.e. an increase in viscosity as temperature increases).

Here's an analysis of the provided text, outlining the acceptance criteria and the studies mentioned for the AlloFuse Gel and Putty device:

Executive Summary:

The provided document describes the 510(k) submission for AlloFuse Gel and Putty, which claims substantial equivalence to the predicate device, DynaGraft® II. The primary "acceptance criteria" is demonstrating substantial equivalence due to the proposed device being the same in design, materials, and function as the predicate device. This is supported by:

1. Viral Inactivation Validation: Testing of the DBM processing method to ensure viral inactivation.
2. Osteoinductive Potential: An in vivo assay in athymic rats confirms osteoinductive potential for every lot.
3. Product Performance Testing: Reference to studies on the predicate device (DynaGraft® II) in rabbit and sheep models (radiographic and histological) and human clinical studies for spinal fusions.

1. Table of Acceptance Criteria and Reported Device Performance

It's important to note that the document does not explicitly present a table of numerical "acceptance criteria" and direct performance metrics for the AlloFuse device itself in the way one might see for a diagnostic AI model. Instead, the acceptance is based on demonstrating substantial equivalence to a predicate device. The performance data presented primarily pertains to the predicate device or the processing methods.

• Product Performance Testing (Predicate): DBM in RPM carrier (DynaGraft® II formulation) evaluated in rabbit and sheep models by radiographic and histological methods.
• Clinical Studies (Predicate): Clinical studies using DynaGraft® II DBM Putty and Gel for spinal fusions "demonstrating acceptable outcomes." |
  | Sterility & Donor Tissue Quality | AlloFuse is provided sterile and for single patient use. Donor bone meets AATB requirements. |

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

Due to the nature of this 510(k) submission, direct "test sets" for clinical performance of the new device (AlloFuse) are not reported. The submission relies on data from the predicate device and specific lab tests for the new device:

• Viral Inactivation Validation:
  • Sample Size: Not specified for the "select panel of viruses," but assumed to be multiple viruses representing various types.
  • Provenance: Lab-based (in-vitro) testing of the DBM processing method.
• Osteoinductive Potential:
  • Sample Size: Assumed to be adequate for "an in vivo assay to ensure osteoinductive potential of the final product," performed for every lot of final product.
  • Provenance: Athymic rat model (animal study), conducted by the manufacturer.
• Product Performance Testing (Predicate Device - DynaGraft® II):
  • Sample Size: Not specified for the rabbit and sheep models.
  • Provenance: Animal models (rabbit, sheep), nature (retrospective/prospective) not specified but typically prospective for such studies.
• Clinical Studies (Predicate Device - DynaGraft® II):
  • Sample Size: Not specified.
  • Provenance: Human clinical studies, typically prospective. Country of origin not specified, but likely US-based given the FDA submission.

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

Given this is a 510(k) for a device claiming substantial equivalence rather than a new drug or complex diagnostic, explicit "ground truth" established by a panel of human experts for a specific test set (like an AI study) is not detailed.

• Viral Inactivation: Ground truth would be based on established virology protocols and detection methods, likely performed by qualified microbiologists/virologists in a laboratory setting.
• Osteoinductive Potential: Ground truth is established by histological and potentially radiographic evaluation of new bone formation in the athymic rat model, assessed by experts in pathology and histology.
• Product Performance Testing (Predicate - Animal Models): Ground truth was established by radiographic and histological methods, interpreted by relevant veterinary or medical experts (e.g., veterinary radiologists, pathologists).
• Clinical Studies (Predicate - Human): Ground truth (acceptable outcomes in spinal fusions) would have been established by clinicians (e.g., orthopedic surgeons, radiologists) based on follow-up examinations, imaging, and patient outcomes.

4. Adjudication Method for the Test Set

No explicit adjudication method (e.g., 2+1, 3+1) is mentioned, as this is not an AI diagnostic study relying on human reader consensus. Outcomes from animal and human studies would be assessed via standard clinical or laboratory practices, which often involve multiple reviewers but not necessarily a formal adjudication process as seen in AI studies.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

No MRMC comparative effectiveness study was done. This 510(k) is for a bone void filler device, not an AI diagnostic tool. Therefore, there's no discussion of human readers improving with or without AI assistance.

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

Not applicable. This submission is for a medical device (bone void filler), not an algorithm or AI system.

7. The Type of Ground Truth Used

• Viral Inactivation Validation: Established lab-based measurements of viral reduction.
• Osteoinductive Potential: Histological evidence of new bone formation in an in vivo athymic rat model.
• Product Performance Testing (Predicate): Radiographic and histological findings in animal models.
• Clinical Studies (Predicate): Clinical outcomes (e.g., successful spinal fusion) and patient follow-up data.

8. The Sample Size for the Training Set

Not applicable. There is no "training set" in the context of an AI algorithm for this device. The development of the manufacturing processes and material formulation would be based on general scientific knowledge and prior product development, not a labeled dataset for training an algorithm.

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

Not applicable. As there is no AI training set, there is no ground truth established for it.

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For orthopedic applications as filler for gaps or voids that are not intrinsic to the stability of the bony structure. Connexus is indicated to be packed gently into bony gaps in the skeletal system as a bone graft extender and as a bone void filler of the extremities and pelvis. These defects may be surgically created or the result of traumatic injury to the bone.

Connexus 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 an inert reverse phase carrier and formulated to a putty-like consistency. The carrier is a solution of polyethylene oxide polypropylene oxide block copolymer dissolved in water exhibiting reverse phase characteristics (i.e., an increase in viscosity as temperature increases).

The provided text describes the 510(k) summary for the Connexus Putty, a bone void filler. It details the device, its intended use, and substantial equivalence to predicate devices, but it does not contain specific acceptance criteria or a dedicated study demonstrating how the device meets such criteria through quantitative performance metrics.

Instead, the document focuses on demonstrating substantial equivalence primarily through:

• Technological Characteristics: Stating similarities in design, materials, and function with predicate devices, and that both are osteoconductive and osteoinductive.
• Viral Inactivation Validation: Describing a study that evaluated the viral inactivation potential of the DBM processing methods.
• Osteoinductivity Potential: Explaining an in vitro assay for osteoinductive potential of the DBM, validated against an in vivo athymic rat model.
• Product Performance Testing: Mentioning evaluations in rabbit and sheep models for safety and effectiveness, but without presenting specific performance data or acceptance criteria.

Therefore, many of the requested details cannot be extracted directly from this document because it is a 510(k) summary focused on substantial equivalence rather than a full study report with detailed acceptance criteria and performance data.

Here's an attempt to answer based on the available information:

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

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

• Viral Inactivation Validation: No specific sample size mentioned for viruses, just "a select panel of viruses." No data provenance specified.
• Osteoinductivity Potential (Test Set):
  • In vivo athymic rat model: 67 test lots were evaluated.
  • Data Provenance: Not specified, but likely laboratory-based. The study appears to be prospective in nature for validation, and then individual lots are tested prospectively.
• Product Performance Testing (Animal Models): Samples for "rabbit and sheep models" were used, but specific numbers are not provided. The data is likely prospective experimental data from these animal 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)

Not applicable. The ground truth for viral inactivation is laboratory-based (viral assays). For osteoinductivity, it's based on biochemical markers (alkaline phosphatase) and histological confirmation of bone formation in rats, not expert review of images or clinical outcomes. For the animal performance studies, evaluation by "radiographic and histological methods" likely implies expert interpretation (e.g., veterinary pathologists, radiologists) but the number or qualifications are not stated.

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

Not applicable. This type of adjudication is typically for image-based diagnostic studies or clinical outcomes, which are not the primary focus of the performance data presented here.

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 void filler, not an AI-powered diagnostic tool.

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

Not applicable. This device is a physical medical device.

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

• Viral Inactivation: Direct viral load measurements and inactivation assays.
• Osteoinductivity:
  • In vitro: Alkaline phosphatase activity (biochemical marker).
  • In vivo (rat model): Histological confirmation of intramuscular bone formation (pathology/histology).
• Product Performance: Radiographic and histological findings in animal models (pathology/histology, imaging interpretation).

8. The sample size for the training set

Not applicable. This is a physical medical device, not an AI or machine learning algorithm requiring a "training set" in the conventional sense. The "validation" of the in vitro osteoinductivity assay against the in vivo model could be considered a form of training/validation, where the 67 test lots served to establish the correlation.

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

Not applicable in the typical AI sense. For the osteoinductivity assay validation, the ground truth for the in-vitro assay was established by correlating its results with the in-vivo osteoinductivity confirmed via histological analysis of intramuscular bone formation in athymic rats.

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