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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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NB3D Bone Void Filler is intended for bony voids or gaps that are not intrinsic to the stability of bony structure. These defects may be surgically created osseous defects or defects created from traumatic injury to the bone. The product is intended to be used in conjunction with bone marrow aspirate and autograft bone as a bone graft extender and gently packed into bony voids or gaps in the posterolateral spine. NB3D provides an open void/gap filler that resorbs and is replaced by the growth of new 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 bone.

The provided document is a 510(k) summary for the Pioneer Surgical Technology NB3D Bone Void Filler. This type of regulatory submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than providing device performance data against specific acceptance criteria from a clinical study. Therefore, the document does not contain the detailed information requested regarding clinical study design, acceptance criteria, sample sizes, ground truth establishment, or expert adjudication.

Instead, it relies on comparative testing and established standards to show that the new device is as safe and effective as existing ones.

Here's a breakdown of what is available and what is not available based on your request:

1. Table of acceptance criteria and the reported device performance:

• Not Available directly. The document does not specify quantitative acceptance criteria (e.g., success rates, sensitivity, specificity) for a clinical performance study. It states that characterization testing and animal testing were performed to demonstrate substantial equivalence to predicate devices.
• Reported performance (Indirectly): The document affirms that NB3D has "the same intended use," "uses the same operating principle," "incorporates the same basic design," "incorporates the same or very similar materials," and "has similar packaging and is sterilized using the same materials and processes" as the predicate devices. The implication is that its performance is equivalent to these already-cleared devices.

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

• Not Available for human clinical data. The document mentions "Animal testing performed to demonstrate substantial equivalence ... in a rabbit posterolateral spine fusion model." The sample size for this animal study is not specified, nor is the country of origin, or whether it was retrospective or prospective.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

• Not Available. This information pertains to human clinical studies or expert review processes, neither of which are detailed in this 510(k) summary.

4. Adjudication method for the test set:

• Not Available. As above, this is relevant for human clinical studies and not present in this submission.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, 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/software-based diagnostic tool. Therefore, MRMC studies and AI assistance metrics are not relevant.

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

• Not Applicable. Again, this pertains to AI/software performance, not a bone void filler.

7. The type of ground truth used:

• Animal Model Observations/Assessments: For the animal study, the document states "determination of radiographic, biomechanical, histological and other characteristics of the subject device and the predicate Vitoss Bioactive device." These assessments served as the "ground truth" for evaluating the performance in that specific animal model.

8. The sample size for the training set:

• Not Applicable/Not Available. The concept of a "training set" is typically for machine learning algorithms. For a physical medical device like a bone void filler, there isn't a "training set" in this context.

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

• Not Applicable/Not Available. As with point 8, this question is not relevant for this type of device submission.

Summary of available information regarding the "study that proves the device meets the acceptance criteria":

The "study" cited is animal testing and characterization testing.

• Characterization testing: Included methods described in ISO 10993-3, ISO 10993-5, ISO 10993-10, ISO 10993-11, and ASTM F1185. These are standards related to biocompatibility and material properties. The specific acceptance criteria within these standards are not detailed in the summary, but the implication is that the device met them.
• Animal testing: Performed "to demonstrate substantial equivalence included determination of radiographic, biomechanical, histological and other characteristics of the subject device and the predicate Vitoss Bioactive device in a rabbit posterolateral spine fusion model."
  • Test set sample size: Not specified.
  • Data provenance: "rabbit posterolateral spine fusion model" (animal study).
  • Ground truth: Radiographic, biomechanical, and histological observations.
  • Goal: To show equivalence to a predicate device (Vitoss Bioactive) in an animal model.

In essence, the 510(k) process for this device relies on demonstrating that it is "substantially equivalent" to already-approved devices through comparison of design principles, materials, intended use, and pre-clinical testing, rather than presenting a full clinical trial with defined acceptance criteria and performance statistics for human subjects.

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