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XeroSyn bone void filler is an implant intended to fill bony voids or gaps of the skeletal system (i.e., extremities and pelvis). XeroSyn is used with autograft as a bone graft extender in the extremities and pelvis. These osseous defects may be surgically created or the result of traumatic injury to the bone and are not intrinsic to the stability of the bony structure. XeroSyn resorbs and is replaced with bone during the healing process.

XeroSyn bone void filler is a synthetic bone graft substitute designed for use as an autograft extender in the extremities and the pelvis. XeroSyn bone void filler is a sol-gel synthesized bioactive, osteoconductive bone void filler. The chemical composition of XeroSyn is very similar to the predicate, Altapore, containing elements that exist naturally in bone (Ca, P, O, H, Si), albeit at different ratios. The sol-gel synthesis process produces porous microparticles which are silane treated to enhance the particle growth to form the desired granule size. The interconnected highly porous structure of XeroSyn readily absorbs body fluids and facilitates quick and easy mixing with autogenous bone.

XeroSyn bone void filler is supplied in a sterile glass vial within a sterile pouch and contains 1 gram of XeroSyn micro-granules sized 20-30 um, 80% total porosity, and appears as a fine white powder. XeroSyn does not set in situ following implantation.

XeroSyn is bioactive as supported by the Kokubo test. This in vitro test shows the formation of a surface apatite layer when the synthetic graft material is immersed in a standard simulated body fluid with the ion concentration of human blood plasma. This apatite layer provides scaffolding onto which the patient's new bone will grow.

Here's a breakdown of the acceptance criteria and study information for the XeroSyn Bone Void Filler, based on the provided document:

Acceptance Criteria and Device Performance

The document does not explicitly present a table of "acceptance criteria" in a typical quantitative sense with pass/fail thresholds. Instead, it describes various performance aspects and states that the "test results met the acceptance criteria" by demonstrating "substantial equivalence" to the predicate device. For this reason, the table below will compare the subject device (XeroSyn) to the predicate device (AltaPore) as presented in the "Substantial Equivalence of the Subject and Predicate Device" table in the original document, which implicitly serves as the acceptance criteria for many attributes.

Summary of How Device Meets Acceptance Criteria:
The document explicitly states: "Each of the following test results met the acceptance criteria and support the substantial equivalence of the proposed device as compared to the predicate for its intended use." It highlights similarities in intended use, indications for use, basic design, materials, and sterility. While there are some differences in chemical composition (silicon dioxide glass vs. calcium phosphate salt), design (microgranule size), porosity, sterility method, and duration of implant, the overall conclusion is that these differences do not raise new questions of safety or effectiveness. The key functional characteristics such as bioactivity, osteoconductivity, resorption, and biocompatibility are presented as being met and similar to the predicate.

Study Details:

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

   • Test Set (Animal Study): The document states that a "standard and reproducible critical size cancellous bone defect model in skeletally mature female New Zealand (NZ) White Rabbits" was used. The specific number of animals (sample size) is not explicitly provided in the document.
   • Data Provenance: The study was an animal study conducted in New Zealand White Rabbits. It is a prospective study assessing the in vivo response. Country of origin of the study conduct is not specified beyond the animal breed.

2. 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 information is not provided in the document. The document describes bench testing (in vitro) and an animal study (in vivo), but for these types of studies, "ground truth" is typically established through direct experimental observation, histological analysis, and analytical measurements rather than expert consensus on a test set.

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

   • This information is not applicable and not provided in the context of bench or animal testing as described. Adjudication methods are typically relevant for human clinical reads or interpretations.

4. 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, an MRMC comparative effectiveness study was not done. This document describes the premarket notification for a bone void filler product, which is a physical implant, not an AI software/device that assists human readers.

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

   • No, this is not applicable. The device is a bone void filler, not an algorithm.

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

   • For Bench Testing (Bioactivity, Chemical Composition, Physical Properties): Ground truth was established through analytical characterization techniques (e.g., Kokubo test for apatite formation, SEM, FTIR spectral analyses, chemical composition analysis, porosity measurements).
   • For Animal Testing (Safety and Effectiveness): Ground truth ("in vivo response") was established through direct observation and likely histological analysis of tissue samples at 2, 4, 6, and 12 weeks post-implantation in the rabbit bone defect model. The study was used to determine "safety and effectiveness."

7. The sample size for the training set:

   • This information is not applicable as this is not a machine learning/AI device that requires a training set. The "training set" for the development of XeroSyn would be the R&D process focusing on material science, which is not detailed in terms of "sample size" in this context.

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

   • This information is not applicable for the reasons stated above.

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