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NB3D is indicated for bony voids or gaps that are not intrinsic to the stability of the bony structures. These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone. NB3D is indicated to be gently packed into bony voids or gaps of the skeletal system (extremities and pelvis) un-hydrated or in conjunction with bone marrow aspirate or autogenous blood, or in the posterolateral spine in conjunction with bone marrow aspirate and autograft bone as a bone graft extender. The product provides a bone void filler that resorbs and is replaced with bone during the healing process.

NB3D is a resorbable porous, calcium phosphate bone void filler that provides a scaffold for the in-growth of new bone. NB3D is an osteoconductive implant with an interconnected porosity similar to human cancellous bonc.

NB3D is a semi-rigid three dimensional construct that consists of porous hydroxyapatite granules suspended within porous porcine gelatin-based foam matrix. It is provided in the form of strips and shapes that can be further cut as required at the time of surgery.

When hydrated at the point of use, NB3D becomes a compressible and elastic sponge that allows the shape of the implant to conform to the defect maximizing direct contact with viable host bone. nanOss Bioactive 3D is provided sterile by prior exposure. NB3D is provided with a sterile, single use syringe.

This 510(k) expended clearance of NB3D for use in bony voids or gaps of the skeletal system (extremities and pelvis) and added various shapes.

The input describes a 510(k) submission for a medical device called NB3D Bone Void Filler. This submission focuses on demonstrating substantial equivalence to previously cleared predicate devices rather than providing a performance study with detailed acceptance criteria and expert-driven ground truth.

Therefore, many of the requested categories for the acceptance criteria and study proving device performance cannot be filled based on the provided text. The submission relies on demonstrating similarity in materials, technology, labeling, and animal performance to existing devices.

Here's an attempt to extract relevant information and note where the requested information is not available:

1. Table of Acceptance Criteria and Reported Device Performance

• Indications for Use: Same as K083033, extension to K111944.
• Operating Principle, Basic Design, Form, Manufacturing Principles, Sterilization, Shelf-Life, Packaging, Material Composition, Use of Rigid Fixation, S&E Profile, Volume: Same as K111944 for most, similar to K083033 for some.
• Performance: Performed substantially equivalent to K083033. |
  | Device is as safe, as effective and performs as well as or better than the predicate device and comparable to autograft. | Animal testing demonstrated that the device is as safe, as effective and performs as well as or better than the predicate device (K083033 Vitoss Foam Strip) and comparable to autograft. This was evaluated via macroscopic radiographic appearance, histomorphometric properties, and histological response. |
  | No new questions of Safety and Effectiveness are raised. | The technological characteristics of NB3D are identical to K111944 and similar to K083033 "to such an extent that no new questions of Safety and Effectiveness are raised." |
  | Fundamental scientific technology, device characteristics, components, material composition, and design are the same as predicate devices. | The document states: "The fundamental scientific technology of the subject system, device characteristics, components, material composition and design are the same as the predicate devices." |
  | No significant differences between NB3D Bone Void Filler and the predicate devices which would adversely affect the use of the product. | The document states: "There are no significant differences between NB3D Bone Void Filler and the predicate devices which would adversely affect the use of the product." |

2. Sample size used for the test set and the data provenance

• Sample Size: Not explicitly stated as a number of cases or subjects in a traditional test set. The performance evaluation was based on an "animal testing" study.
• Data Provenance: "Rabbit critically sized defect model." The specific country of origin is not mentioned, but it's typically conducted in a laboratory setting. This would be a prospective animal study, as defects were surgically created and the device implanted.

3. 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 study involved "radiographic appearance, histomorphometric properties, and histological response." These would typically be evaluated by veterinary radiologists, pathologists, and histologists, but the number and qualifications of individuals are not detailed.

4. Adjudication method for the test set

• Not specified. Given the nature of animal studies evaluating histomorphometry and histology, it's common for multiple evaluators to be involved, but an explicit adjudication method (e.g., 2+1, 3+1) is not mentioned.

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. This is a 510(k) submission for a bone void filler device, not an AI-powered diagnostic or assistive tool. Therefore, an MRMC study comparing human readers with and without AI assistance is not applicable and was not performed.

6. 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.

7. The type of ground truth used

• The ground truth in the animal study was established through histomorphometric properties, histological response, and radiographic appearance. This represents direct biological and imaging evidence from the animal model.

8. The sample size for the training set

• Not applicable. This is a traditional medical device, not an AI model that requires a training set.

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

• Not applicable, as there is no training set for an AI model.

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