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The Accell Family of products are intended for filling voids and gaps in the skeletal system that are not intrinsic to the stability of the bony structure. The products are indicated for use as bone graft extenders in the spine, extremities and pelvis, or as bone void fillers in the extremities and pelvis. The voids or gaps may be surgically created defects or the result of traumatic injury to the bone.

Accell DBM family of products are used for orthopaedic bone grafting procedures. They are osteoconductive human allogenic demineralized bone filling materials for use as fillers for gaps or voids that are not intrinsic to the stability of the bony structure.

Accell DBM family of products are products that are manufactured using human donor demineralized bone and may contain up to 70% poloxamer reverse phase medium carrier (RPM). The demineralized bone is derived from human ground, cortical allograft bone. Poloxamer RPM is an inactive product ingredient that is utilized as a containing agent for the demineralized bone and provides appropriate product handling characteristics for the products.

The products of the Accell DBM family are comprised of the same DBM and RPM components as found in DynaGraft II Gel, FDA cleared under 510(k) number K040419 and Connexus cleared under 510(k)'s K050690 and K052098. In addition, the Accell DBM family of products may contain up to a maximum of 70% of RPM carrier. This is the concentration of RPM already cleared in DynaGraft II gel.

Acceptance Criteria and Device Performance Study for IsoTis Accell DBM Family of Products (K061880)

This submission for the IsoTis Accell DBM Family of Products focuses on demonstrating substantial equivalence to predicate devices, primarily through material characterization and animal studies, rather than clinical efficacy against a specific set of performance criteria for human use.

1. Acceptance Criteria and Reported Device Performance

The provided 510(k) summary does not outline specific numerical acceptance criteria for device performance. Instead, the "acceptance criteria" are implied by demonstrating substantial equivalence to predicate devices primarily through:

• Material Characterization: Ensuring the chemical composition, pH, and physical characteristics of the carrier (poloxamer RPM granules) are consistent with previously cleared products.
• Resorption Studies: Demonstrating suitable resorption rates of both the carrier and the DBM in animal models, comparable to the predicate.
• Osteoinductivity Potential: Verifying that each lot of DBM exhibits osteoinductive potential using an in vitro assay correlated to an athymic rat assay.
• Viral Inactivation: Confirming the processing methods effectively inactivate a panel of viruses.
• Safety and Performance in Animal Models: Demonstrating no safety or performance issues in animal studies (critical size defects, spinal fusion) compared to the predicate.

Given this, a table of acceptance criteria and reported device performance would look like this:

2. Sample Size for Test Set and Data Provenance

The provided document does not specify exact sample sizes for each animal study conducted for the Accell DBM family of products. It mentions:

• Carrier Resorption: "A resorption study has been performed to examine the rate and extent of carrier elimination in male adult rats." (No sample size provided)
• DBM Resorption: "Resorption of the DBM was demonstrated during rabbit animal studies." (No sample size provided)
• Specific Performance Studies: "These studies included rabbit tibial critical size defects and rabbit spinal fusion studies." (No sample size provided)

The data provenance is prospective animal studies conducted in rabbits and rats. There is no indication of country of origin for the data; typically, such studies would be conducted in the country of device manufacture or where the research facilities are located.

The document also references "Several animal studies were performed on both Connexus and DynaGraft II Gel and were submitted as part of their original 510(k) submissions (K050690 and K040419)." This suggests reliance on previously submitted data for predicate devices.

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

This submission relies on animal models and laboratory testing (in vitro), not human clinical data with expert-established ground truth. Therefore, there were no human experts used to establish ground truth for a test set in the traditional sense involving clinical outcomes. The "ground truth" for the animal studies would be the physiological and histological observations made by veterinarians, pharmacologists, and histopathologists during the animal experiments, but their specific number and qualifications are not detailed.

For the in vitro osteoinductive potential assay, the validation to the athymic rat model serves as the ground truth correlation, established through laboratory methods rather than expert clinical consensus.

4. Adjudication Method for the Test Set

The concept of an adjudication method (e.g., 2+1, 3+1) is not applicable here as the studies are animal and in vitro based, not human clinical trials requiring consensus on clinical endpoints. The interpretation of animal study results would typically be done by the research team involved (e.g., veterinary pathologists, histologists) following standard scientific protocols.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study is relevant for diagnostic devices where human readers interpret medical images or data, and AI assistance is being evaluated for its impact on reader performance. This device is a bone void filler/graft extender, not a diagnostic tool.

6. Standalone (Algorithm Only) Performance Study

No, a standalone (algorithm only) performance study was not done. This is not a software algorithm or AI device that operates independently. The "device" is a physical material (Demineralized Bone Matrix with a carrier).

7. Type of Ground Truth Used

The ground truth used was:

• Animal Outcomes/Histopathology: For resorption studies (in rats and rabbits) and safety/performance in animal models (tibial critical size defects, spinal fusion in rabbits). This involves observation of tissue remodeling, graft integration, and absence of adverse reactions.
• In Vitro Assay Correlation: For osteoinductive potential, where an in vitro cell culture assay was validated to correlate with an athymic rat osteoinductive potential assay.
• Laboratory Characterization: For chemical composition, pH, and physical characteristics of the carrier, confirmed through analytical testing.
• Viral Inactivation Assays: For demonstrating the efficacy of processing methods against a panel of viruses.

8. Sample Size for the Training Set

The concept of a "training set" in the context of machine learning or AI is not applicable to this submission. The device is a medical material, and its development and testing involve traditional biological and material science studies, not AI model training. Therefore, there is no training set as typically defined for AI/ML products.

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

As there is no training set in the AI/ML sense, this question is not applicable. The "ground truth" for the various performance aspects of the material (as described in point 7) was established through established scientific methodologies in animal research, in vitro assays, and chemical characterization.

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