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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.

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).

The provided text describes the 510(k) summary for the Connexus Putty, a bone void filler. It details the device, its intended use, and substantial equivalence to predicate devices, but it does not contain specific acceptance criteria or a dedicated study demonstrating how the device meets such criteria through quantitative performance metrics.

Instead, the document focuses on demonstrating substantial equivalence primarily through:

• Technological Characteristics: Stating similarities in design, materials, and function with predicate devices, and that both are osteoconductive and osteoinductive.
• Viral Inactivation Validation: Describing a study that evaluated the viral inactivation potential of the DBM processing methods.
• Osteoinductivity Potential: Explaining an in vitro assay for osteoinductive potential of the DBM, validated against an in vivo athymic rat model.
• Product Performance Testing: Mentioning evaluations in rabbit and sheep models for safety and effectiveness, but without presenting specific performance data or acceptance criteria.

Therefore, many of the requested details cannot be extracted directly from this document because it is a 510(k) summary focused on substantial equivalence rather than a full study report with detailed acceptance criteria and performance data.

Here's an attempt to answer based on the available information:

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

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

• Viral Inactivation Validation: No specific sample size mentioned for viruses, just "a select panel of viruses." No data provenance specified.
• Osteoinductivity Potential (Test Set):
  • In vivo athymic rat model: 67 test lots were evaluated.
  • Data Provenance: Not specified, but likely laboratory-based. The study appears to be prospective in nature for validation, and then individual lots are tested prospectively.
• Product Performance Testing (Animal Models): Samples for "rabbit and sheep models" were used, but specific numbers are not provided. The data is likely prospective experimental data from these animal studies.

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)

Not applicable. The ground truth for viral inactivation is laboratory-based (viral assays). For osteoinductivity, it's based on biochemical markers (alkaline phosphatase) and histological confirmation of bone formation in rats, not expert review of images or clinical outcomes. For the animal performance studies, evaluation by "radiographic and histological methods" likely implies expert interpretation (e.g., veterinary pathologists, radiologists) but the number or qualifications are not stated.

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

Not applicable. This type of adjudication is typically for image-based diagnostic studies or clinical outcomes, which are not the primary focus of the performance data presented here.

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

Not applicable. This device is a bone void filler, not an AI-powered diagnostic tool.

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

Not applicable. This device is a physical medical device.

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

• Viral Inactivation: Direct viral load measurements and inactivation assays.
• Osteoinductivity:
  • In vitro: Alkaline phosphatase activity (biochemical marker).
  • In vivo (rat model): Histological confirmation of intramuscular bone formation (pathology/histology).
• Product Performance: Radiographic and histological findings in animal models (pathology/histology, imaging interpretation).

8. The sample size for the training set

Not applicable. This is a physical medical device, not an AI or machine learning algorithm requiring a "training set" in the conventional sense. The "validation" of the in vitro osteoinductivity assay against the in vivo model could be considered a form of training/validation, where the 67 test lots served to establish the correlation.

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

Not applicable in the typical AI sense. For the osteoinductivity assay validation, the ground truth for the in-vitro assay was established by correlating its results with the in-vivo osteoinductivity confirmed via histological analysis of intramuscular bone formation in athymic rats.

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