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DynaGraft II Dental 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 -

DynaGraft® II Dental is derived from selected donated human borne 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 gel or putty-like consistency.

The provided text is a 510(k) summary for the DynaGraft® II Dental device. It describes the device, its intended use, and its substantial equivalence to predicate devices, but it does not contain acceptance criteria or study data demonstrating performance against specific metrics.

Therefore, I cannot fulfill your request for:

1. A table of acceptance criteria and the reported device performance: This information is not present in the document. The document notes "Pre-clinical animal data and clinical data demonstrate that DynaGraft® II support bone ingrowth and stimulates active bone formation in a variety of bony defects," but it does not provide specific performance metrics or acceptance criteria for these outcomes.
2. Sample size used for the test set and the data provenance: This information is not explicitly stated. The document mentions "clinical case studies" but does not specify their size or origin.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: This information is not present.
4. Adjudication method for the test set: This information is not present.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and the effect size: This information is not present.
6. If a standalone (i.e. algorithm only, without human-in-the-loop performance) was done: The device is a "human bone graft material," not an AI algorithm, so this question is not applicable.
7. The type of ground truth used: The document refers to "bone ingrowth and stimulates active bone formation" and "bone repair," which would likely be assessed through histological examination or imaging in pre-clinical and clinical studies. However, the specific methodology for establishing
   "ground truth" (e.g., pathology, expert consensus) is not detailed.
8. The sample size for the training set: This information is not applicable as the device is not an AI algorithm requiring a training set.
9. How the ground truth for the training set was established: This information is not applicable.

Summary of what is available from the document:

• Device Name: DynaGraft® II Dental
• Intended Use: Bone filling material for augmentation or reconstructive treatment of the alveolar ridge, including filling defects after root resection, apicoectomy, and cystectomy; filling extraction sockets; elevation of the maxillary sinus floor; and treatment of periodontal defects.
• Predicating Device: Tissue Bone Matrix Sponge (K960267) and autograft.
• Basis for Substantial Equivalence: Similar design, construction, and function to predicate devices, with the main human component (donor DBM) being the same. Both are osteoconductive and have osteoinductive potential, providing a scaffold for bone ingrowth and stimulating bone growth. Differences in carriers (collagen for TBM vs. reverse phase carrier for DynaGraft II) were deemed not to affect safety or effectiveness as they are all resorbable and perform the same function.
• Testing Mentioned: Pre-clinical animal data and clinical data, biocompatibility, extensive bench and animal testing, and clinical case studies to confirm device resorption and bone healing. It also states that "Demineralized bone has been used in clinical practice for more than 25 years with no remarkable safety issues."

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

DynaGraft II is derived from selected donated human bone tissue that has been processed into particles. The demineralized bone matrix (DBM) is combined with a hydrogel carrier and formulated to a gel or putty-like consistency. The carrier is a solution of polyethylene oxide polypropylene oxide block copolymer exhibiting reverse phase characteristics (i.e., an increase in viscosity as temperature increases).

Here's an analysis of the provided text regarding the acceptance criteria and supporting studies for the DynaGraft II device:

Important Note: The provided document is a 510(k) Summary, which is a premarket notification to the FDA demonstrating substantial equivalence to a legally marketed predicate device. This type of document focuses on demonstrating equivalence rather than providing exhaustive details of standalone clinical trials for novel devices. As such, some of the information requested in your prompt (e.g., specific acceptance criteria for performance metrics, detailed statistical findings from a comparative effectiveness study, or precise sample sizes for human readers in an MRMC study) is not explicitly present in this summary.

1. Table of Acceptance Criteria and the Reported Device Performance

2. Sample Sizes Used for the Test Set and Data Provenance

• Viral Inactivation (Test Set): A "select panel of viruses" was used, representing "various virus types, sizes, shapes, and genomes." The exact number of viruses is not specified.
  • Data Provenance: Not explicitly stated, but implies laboratory testing performed by the manufacturer.
• Osteoinductivity (In Vivo Correlation Test Set): 67 test lots of DBM were assessed.
  • Data Provenance: Not explicitly stated, but implies laboratory and animal (athymic rat) testing.
• Product Performance (Animal Models): Conducted in "rabbit and sheep models." The specific number of animals or cases is not provided.
  • Data Provenance: Animal studies.
• Product Performance (Clinical Studies): "Clinical studies using DynaGraft II DBM Putty and Gel have been performed." The number of patients/cases is not specified.
  • Data Provenance: "Clinical studies" implies human data, but details like country of origin or prospective/retrospective nature are not given.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications

This information is not provided in the 510(k) summary. Given the nature of the studies (viral inactivation, in vitro osteoinductivity, animal models, and general "clinical studies" for "acceptable outcomes"), it's unlikely that "experts to establish ground truth" (in the sense of independent clinical review of images/data) would be explicitly detailed in this type of submission. The ground truth for the non-clinical studies would typically be based on established biological assays, histological analysis, and radiographic interpretation by trained personnel. For "clinical studies," the "acceptable outcomes" would likely have been determined by primary investigators.

4. Adjudication Method for the Test Set

This information is not provided. Given the nature of the studies, formal adjudication methods (like 2+1 or 3+1 for imaging studies) are not described. For the osteoinductivity assay, the "correlation" against a positive and negative DBM control suggests a comparative methodology rather than expert adjudication of individual samples.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done

No, an MRMC comparative effectiveness study is not explicitly mentioned or described. The document refers to "clinical studies" demonstrating "acceptable outcomes," but these are not detailed as MRMC studies comparing human readers with and without AI assistance. The device is a bone void filler, not an AI-powered diagnostic tool, so such a study would not typically be applicable.

• Effect Size: Not applicable, as no such study was described.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Study was Done

Not applicable. DynaGraft II is a medical device (bone void filler), not an algorithm or AI system. Its performance is inherent to the material properties and biological activity, not an algorithmic output.

7. The Type of Ground Truth Used

• Viral Inactivation: Based on standard virological assays to detect viral clearance/inactivation levels.
• Osteoinductivity (In Vitro): Alkaline phosphatase activity in myoblast cells, with positive and negative DBM controls. This assay was then validated against an in vivo athymic rat muscle pouch model (a biological standard for osteoinductivity, where bone formation in the muscle pouch is the ground truth).
• Product Performance (Animal Models): Radiographic and histological methods for assessing new bone formation, integration, and other healing parameters.
• Product Performance (Clinical Studies): "Acceptable outcomes," which can refer to a variety of clinical endpoints such as fusion rates, pain reduction, functional improvement, lack of complications, etc. The specific outcome data is not provided in detail.
• Substantial Equivalence: Comparison to legally marketed predicate devices based on design, materials, function, and regulatory compliance.

8. The Sample Size for the Training Set

Not applicable. DynaGraft II is a manufactured device, not an AI model that requires a training set. The "training" for the device's development involves material science, biological research, process optimization, and manufacturing controls.

9. How the Ground Truth for the Training Set Was Established

Not applicable, as there is no "training set" in the context of an AI algorithm.
For the development and optimization of the device itself, the "ground truth" during R&D would be established through a variety of methods:

• Material characterization: Chemical and physical tests to confirm composition and properties.
• Biocompatibility testing: In vitro and in vivo tests to ensure the material is not toxic or harmful.
• Process validation: Ensuring manufacturing processes consistently produce DBM with desired properties, including osteoinductivity. This relies on established biological assays (like the in vitro osteoinductivity assay validated against the athymic rat model) as a "ground truth" for material efficacy.

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