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For orthopedic use, AlloFuse Plus Paste and Putty are intended for use as an autograft extender (i.e. extremities, posterolateral spine and pelvis) and as a bone void filler (i.e. extremities and pelvis) for bony voids or gaps that are not intrinsic to the stability of the bony structure. The AlloFuse Plus products are indicated to be packed gently into bony defects of the skeletal system. These defects may be surgically created or from the result of traumatic injury to the bone.

AlloFuse Plus 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 formulated into a paste or putty-like consistency.

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

This is a 510(k) premarket notification for the AlloFuse Plus Paste and Putty, which are resorbable calcium salt bone void filler devices. The submission focuses on demonstrating substantial equivalence to previously cleared predicate devices, rather than establishing de novo safety and effectiveness through extensive clinical trials.

The provided document does not contain a traditional table of acceptance criteria and reported device performance in the manner one would expect for a diagnostic or AI-driven medical device. Instead, the acceptance criteria are implicitly tied to demonstrating substantial equivalence and meeting established manufacturing and biological safety standards for tissue-based products.

Here's a breakdown of the requested information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Viral Inactivation Validation: "A select panel of viruses representing various virus types, sizes, shapes, and genomes was evaluated." The exact number of viruses and the specific experimental setup (e.g., how many replicates, sample sizes per condition) are not specified in this document. This is a laboratory-based study, not a human clinical test.
• Osteoinductive Potential: The test set involves "athymic rats." The exact number of rats used in the initial validation is not specified. For ongoing lot testing, it states "Every lot of final product is tested via an in vivo assay."
• Data Provenance: The studies are laboratory and animal studies conducted for regulatory submission purposes. The geographic origin of the lab or specific animal facility is not mentioned. These are prospective, controlled laboratory/animal studies designed to evaluate specific biological characteristics.

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

There is no mention of experts being used to establish "ground truth" in the context of human clinical data or image interpretation for this device. The evaluations described (viral inactivation, osteoinductivity, endotoxin/LAL) are laboratory or animal-based analyses typically performed by trained scientists and technicians specializing in those respective fields (e.g., virologists, histologists, toxicologists). These are not studies that require expert adjudication of clinical outcomes or images.

4. Adjudication Method for the Test Set

Not applicable. The studies described are laboratory and animal experiments with objective readouts (e.g., viral titer reduction, bone formation presence, endotoxin levels), not studies requiring human rater adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, If So, What Was the Effect Size of How Much Human Readers Improve with AI vs Without AI Assistance

Not applicable. This is not an AI-driven or diagnostic device. No MRMC study was conducted or mentioned.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

Not applicable. This is not an algorithm or AI device.

7. The Type of Ground Truth Used

• Viral Inactivation: The "ground truth" would be established by standard virological assays (e.g., cell culture infectivity assays) to quantify viral reduction logs.
• Osteoinductive Potential: The "ground truth" is typically established by histological examination of tissue sections from the athymic rat implants to confirm the presence of new bone formation (ectopic bone).
• Endotoxin/LAL: The "ground truth" is measured quantitatively using Limulus Amebocyte Lysate (LAL) assay, against established limits.

8. The Sample Size for the Training Set

Not applicable. This is not an AI/ML device that requires a training set. The "training" in this context refers to the development and optimization of the manufacturing process (demineralization, cleaning, formulation) that enables the described performance.

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

Not applicable, as there is no "training set" in the AI/ML sense. The process parameters (e.g., demineralization time, temperatures, concentrations) for manufacturing DBM and the final product are established through extensive research and development work, guided by scientific principles and iterative testing to achieve desired product characteristics (e.g., demineralization, retention of growth factors, sterility, rheology). This involves rigorous process validation, where various parameters are tested and optimized to consistently produce a product meeting specifications.

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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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