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For orthopedic applications as filler for gaps or voids that are not intrinsic to the stability of the bony structure. Connexus is indicated to be packed gently into bony gaps in the skeletal system as a bone graft extender and as a bone void filler of the extremities and pelvis. These defects may be surgically created or the result of traumatic injury to the bone.

IsoTis OrthoBiologics is expanding the range of sizes previously cleared in 510(k) K050690 to include Connexus, 0.5cc. The intended use of this additional size does not change from that previously cleared.

Connexus is derived from selected donated human bone tissue that has been processed into particles. The bone particles are subsequently demineralized using a hydrochloric acid process. The demineralized bone matrix (DBM) is combined with an inert reverse phase carrier and formulated to a putty-like consistency.

The carrier is a solution of polyethylene oxide polypropylene oxide block copolymer dissolved in water exhibiting reverse phase characteristics (i.e., an increase in viscosity as temperature increases).

Here's a breakdown of the acceptance criteria and the study information for the Connexus, 0.5cc device, based on the provided text:

Acceptance Criteria and Device Performance

The provided document, a 510(k) Summary for Connexus, 0.5cc, does not explicitly state quantitative acceptance criteria for its performance. Instead, it focuses on demonstrating substantial equivalence to a predicate device (Connexus, K050690) and adherence to various standards and validated processes.

The "reported device performance" is described in terms of the results of these tests and validations, rather than specific numerical targets met.

Table of Acceptance Criteria and Reported Device Performance

Study Details

This document describes a pre-market notification (510(k)) for a medical device, which typically relies on demonstrating substantial equivalence to a legally marketed predicate device rather than conducting large-scale clinical trials. The "studies" mentioned are primarily pre-clinical or in-vitro validations.

Here's a breakdown of the specific points requested:

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

   • Viral Inactivation Validation: "A select panel of viruses representing various virus types, sizes, shapes, and genomes were evaluated." (Specific number not provided). Data provenance is from in vitro laboratory validation.
   • Osteoinductivity Potential (DBM component):
     • In vitro assay: Not specified, but each lot of DBM is tested.
     • In vivo athymic rat model validation: "67 out of 67 test lots" that passed the in vitro assay were confirmed in the in vivo model. This indicates a sample size of 67 athymic rat tests. Data provenance is from in vivo animal testing.
   • Overall Product Performance: Evaluated in "rabbit and sheep models." (Specific sample sizes not provided). Data provenance is from in vivo animal testing.

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

   • The document does not mention human experts establishing ground truth for the presented studies.
   • For the osteoinductivity study, the "ground truth" (or validation reference) for the in vitro assay was the in vivo athymic rat model (confirmation of intramuscular bone formation).
   • For animal performance studies, ground truth was established by "radiographic and histological methods" which would typically involve qualified veterinary pathologists or radiologists, but no specific number or qualifications are mentioned.

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

   • Not applicable/Not mentioned. The studies described are lab validations and animal studies, not human reader assessments requiring adjudication.

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 MRMC or AI-assisted studies are mentioned. This device is a bone void filler, not an AI-powered diagnostic tool.

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

   • Not applicable. This device is a physical bone void filler, not an algorithm.

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

   • Viral Inactivation: Laboratory validation of viral reduction efficacy (presumably based on standard laboratory assays and controls).
   • Osteoinductivity Potential:
     • In vitro: Alkaline phosphatase activity assay (biochemical marker).
     • In vivo (for validation of in vitro assay): Histological confirmation of intramuscular bone formation in athymic rats (pathology).
   • Overall Product Performance (animal models): Radiographic and histological methods (imaging and pathology).

7. The sample size for the training set:

   • Not applicable as this is not an AI/machine learning product requiring a training set in the conventional sense. The "training" for the DBM osteoinductivity assay involved validating it against 67 athymic rat cases.

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

   • If we consider the validation of the in vitro osteoinductivity assay as a "training" of the assay to predict in vivo performance, then the ground truth for its validation was established by histological confirmation of intramuscular bone formation in athymic rats.

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