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NanoFUSE® is indicated to be gently placed into bony voids or gaps of the skeletal system that are not intrinsic to the stability of the bony structure (i.e. the posterolateral spine and pelvis). These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone. NanoFUSE® must be used with autograft as a bone graft extender in the posterolateral spine and pelvis. The product provides a bone graft substitute that remodels into the recipient's skeletal system.

NanoFUSE® is a malleable, putty-like, bone-void filler. The product is comprised of a synthetic calcium phosphor-silicate particulate material particles (45S5 bioactive glass), both coated with gelatin derived from porcine skin. These coated particles are packaged dry in a single use, medical grade polymer syringe, double-wrapped in peel-back pouches, in a dust cover paperboard carton. An empty sterile syringe for addition of the hydration fluid of choice is also included in the sterile barrier packaging. NanoFUSE® is intended for single patient use only and is non-pyrogenic. Instructions for use are provided by way of a package insert in the paperboard carton.

At point of use, the surgeon reconstitutes the product with an appropriate sterile solution of choice (sterile saline, water for injection, or autologous whole blood). The coated particles rehydrate in less than 30 seconds and do not require mixing to form a uniform paste or putty. The material is then mixed with autograft and gently extruded by the surgeon into the bone void. NanoFUSE® is progressively resorbed and replaced by host bone during the osteo-remodeling process.

This document is a 510(k) premarket notification decision letter from the FDA for the NanoFUSE® line of resorbable calcium salt bone void filler devices. As such, it describes the device and its intended use, and compares it to predicate devices. It does not present a study with acceptance criteria and device performance results in the way a clinical study or a software algorithm study would.

Therefore, I cannot extract the information required in your prompt's format from the provided text. The document focuses on showing substantial equivalence to existing devices based on material composition, packaging, intended use, and in vivo animal studies, rather than clinical performance metrics and acceptance criteria for a diagnostic or AI device.

Specifically, the document contains:

• A product description: NanoFUSE® is a bone void filler made of synthetic calcium phosphor-silicate particulate material (45S5 bioactive glass) coated with gelatin derived from porcine skin. It's provided dry and reconstituted at the point of use.
• Indications for Use: To be gently placed into bony voids or gaps of the skeletal system that are not intrinsic to its stability (e.g., posterolateral spine and pelvis). It must be used with autograft as a bone graft extender.
• Predicate Devices: NanoFUSE® DBM (primary predicate, K142104) and NovaBone Putty – Bioactive Synthetic Bone Graft (reference predicate, K110368).
• Safety and Effectiveness Data: Mentions biocompatibility data adoption from the primary predicate (NanoFUSE® DBM) due to shared materials. It also states that in vivo rabbit model studies (24 weeks and 52 weeks) were conducted to evaluate posterolateral spine use and demonstrated substantial equivalence to the comparative control (NanoFUSE® DBM).

However, it lacks the following information for a study proving device meets acceptance criteria:

1. A table of acceptance criteria and reported device performance: This document does not provide quantitative performance metrics or a table comparing them to pre-defined acceptance criteria. The "substantial equivalence" claim is qualitative based on material and animal study findings.
2. Sample size used for the test set and data provenance: It mentions "two studies (24 weeks and 52 weeks)" in the rabbit model, but no specific sample sizes for the test set are given, nor details about data provenance (e.g., country of origin, retrospective/prospective).
3. Number of experts and their qualifications for ground truth: Not applicable, as this is an animal study for substantial equivalence, not a human reader or AI performance study.
4. Adjudication method: Not applicable.
5. MRMC comparative effectiveness study, effect size: Not applicable, as this is not an AI-assisted human reader study.
6. Standalone (algorithm only) performance: Not applicable, as this is a medical device (bone void filler), not a software algorithm.
7. Type of ground truth used: For the animal studies, the "ground truth" would be histological examination or other biological markers of bone remodeling/fusion, but this is not explicitly detailed.
8. Sample size for the training set: Not applicable, as this is not a machine learning/AI device.
9. How ground truth for the training set was established: Not applicable.

In conclusion, the provided text describes a traditional 510(k) submission for a physical medical device, focusing on substantial equivalence to predicates rather than a performance study with acceptance criteria as one would find for a diagnostic test or an AI/ML device.

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