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Accell Connexus™ DBM Putty is a bone filling material indicated for augmentation or reconstructive treatment of alveolar ridge. This includes:

• Filling of defects after root resection, apicoectomy and cystectomy -
• Filling of extraction sockets to enhance preservation of the alveolar ridge -
• Elevation of maxillary sinus floor -
• Treatment of periodontal defects -

Accell Connexus™ DBM Putty 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 a reverse phase carrier and formulated to a paste or putty-like consistency.

Accell Connexus DBM Putty is osteoconductive and osteoinductive bone filling material. The osteoinductive potential is demonstrated in athymic mouse model.

The provided text is a 510(k) Premarket Notification for a medical device, Accell Connexus DBM Putty. It does not contain any information about acceptance criteria or a study that proves the device meets specific performance criteria in the way a diagnostic AI/ML device would.

This document describes a medical device (bone graft material) and seeks clearance based on "substantial equivalence" to a predicate device. For such devices, performance is typically demonstrated through material data, animal studies, and comparison to existing products, rather than the kind of AI/ML performance metrics (like sensitivity, specificity, F1-score, or ROC AUC) that would have acceptance criteria and be proven through a clinical study with detailed ground truth, expert adjudication, and statistical analysis as implied by your questions.

Therefore, I cannot provide the requested information in the format of your questions, as the input document does not contain it.

Here's a breakdown of why each of your requested points cannot be answered from the provided text:

1. A table of acceptance criteria and the reported device performance: No such criteria or performance metrics (like sensitivity, specificity, accuracy) are mentioned. The document relies on substantial equivalence.
2. Sample size used for the test set and the data provenance: No test set in the diagnostic sense is mentioned. Clinical studies with sample sizes are not discussed for performance evaluation in this context.
3. Number of experts used to establish the ground truth... and their qualifications: Ground truth in the context of diagnostic performance (e.g., image interpretation) is not applicable here.
4. Adjudication method... for the test set: Not applicable as there is no test set for diagnostic performance evaluation.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done...: No MRMC study or comparison of human readers with/without AI assistance is mentioned. The device is a bone putty, not an AI or diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable; the device is a physical bone graft material, not an algorithm.
7. The type of ground truth used: For a device based on substantial equivalence, the "ground truth" revolves around its material properties, biocompatibility, and intended use matching those of the predicate device, often supported by animal studies for osteoinductivity. The text states "The osteoinductive potential is demonstrated in athymic mouse model," which is a form of pre-clinical "ground truth" for one property.
8. The sample size for the training set: Not applicable. This is not an AI/ML device that requires training data.
9. How the ground truth for the training set was established: Not applicable.

What the document does state about performance:

• "Accell Connexus DBM Putty is osteoconductive and osteoinductive bone filling material."
• "The osteoinductive potential is demonstrated in athymic mouse model." (This is the closest to a performance study mentioned).
• "Product safety and effectiveness is adequately supported by the substantial equivalence information, materials data, and animal test results provided in this Premarket Notification."

In summary, this document is for a traditional medical device submitting a 510(k) for substantial equivalence, not for an AI/ML diagnostic device with performance characterized by detailed statistical metrics against a ground truth established by experts.

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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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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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