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NanOss BVF-E is intended for bony voids or gaps that are not intrinsic to the stability of bony structure. The product is indicated to be gently packed into bony voids or gaps in the skeletal system (extremities, pelvis). These defects may be surgically created osseous defects or defects created from traumatic injury to the bone. The product provides a bone void filler that resorbs and is replaced by the growth of new bone during the healing process.

Pioneer Surgical Technology NanOss BVF-E is a porous calcium phosphate material mixed with a gelatin based carrier. The product is an osteoconductive scaffold mixed with a gelatin carrier for use in repairing bony defects in spinal and general orthopedic indications.

The product is supplied sterile for single use in various configurations, as pre-mixed granules, or in separate containers to be combined by the user or as pre-molded strips and forms. A commercially available dispensing syringe and a mixing spatula are included in the package.

NanOss BVF is a macroporous ceramic granule composed of greater than 95% nanocrystalline hydroxyapatite. The calcium phosphate granules are presented as ground particles. The macroporous structure of the NanOss provides a resorbable osteoconductive scaffold.

The gelatin based carrier is presented as ground freeze-dried particles. The combined product forms a cohesive and adhesive material upon rehydration with surgical fluids, e.g. saline or blood.

The provided document describes a 510(k) premarket notification for a medical device called "Pioneer Surgical NanOss BVF-E," a resorbable calcium salt bone void filler. This type of submission focuses on demonstrating "substantial equivalence" to existing legally marketed devices, rather than conducting a de novo study with acceptance criteria and performance metrics in the way a new drug or high-risk medical device might.

Therefore, the concepts of "acceptance criteria" and "study that proves the device meets the acceptance criteria" as typically described for a new diagnostic or AI-driven device (e.g., sensitivity, specificity, AUC) are not directly applicable in this context.

Instead, the "acceptance criteria" for a 510(k) submission like this are met by demonstrating:

1. Substantial Equivalence: The new device is as safe and effective as a legally marketed predicate device. This is primarily done through comparison of technological characteristics, intended use, and performance testing.
2. Compliance with Special Controls (if applicable): For Class II devices, compliance with any relevant special controls guidance documents published by the FDA.

Here's how the provided information relates to your request, adapting the terminology to fit the 510(k) framework:

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

Since this is a 510(k) for a bone void filler, the "acceptance criteria" are not quantitative performance metrics like sensitivity or specificity. Instead, they are met by demonstrating the device is substantially equivalent to existing devices and complies with regulatory requirements. The "reported device performance" is the evidence gathered to support this substantial equivalence.

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

This information is not provided in the document. 510(k) submissions for devices like bone void fillers typically rely on non-clinical (benchtop, material characterization, biocompatibility) testing, and sometimes animal studies, rather than human clinical trials that would involve "test sets" or "data provenance" in the way an AI/diagnostic device would. The document mentions "Performance Testing" which is described as "chemical, physical, component biocompatibility, and handling characteristics," all of which are laboratory-based and not clinical trials with human data.

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)

This is not applicable and not provided. "Ground truth" established by experts is relevant for diagnostic or AI imaging devices, where human expert interpretation is the standard against which device performance is measured. For a bone void filler, the "ground truth" relates to its material properties, biocompatibility, and intended biological function, which are evaluated through lab tests and comparisons to known predicate devices, not expert consensus on interpretations.

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

This is not applicable and not provided. Adjudication methods are used in clinical studies involving human interpretation or complex outcomes, which are not detailed in this 510(k) submission for this type of device.

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

This is not applicable and not provided. An MRMC study is specific to imaging diagnostics, particularly those involving AI assistance, and is not relevant to a bone void filler material.

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

This is not applicable and not provided. This concept is related to AI algorithms; the NanOss BVF-E is a material implant, not an algorithm.

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

As explained in point 3, the "ground truth" for this device relates to its material properties, biocompatibility, and functional characteristics (e.g., resorbability, osteoconductivity, handling properties). This "ground truth" is established through:

• Chemical characterization: Confirming the composition (e.g., >95% nanocrystalline hydroxyapatite).
• Physical testing: Evaluating porosity, particle size, strength, etc.
• Biocompatibility testing: In vitro and in vivo (animal) studies to ensure the material is not toxic or does not cause adverse biological reactions.
• Comparison to predicate devices: Leveraging the established safety and effectiveness of similar, already marketed devices.

8. The sample size for the training set

This is not applicable and not provided. "Training set" refers to data used to train an AI algorithm. This device is a bone void filler, not an AI system.

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

This is not applicable and not provided for the same reasons as point 8.

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