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Origen DBM® with Bioactive Glass (NanoFUSE® DBM) is indicated to be gently placed into bony voids or gaps of the skeletal system that are not intrinsic to the stability of the bony structure. It is indicated to be placed into bony voids or gaps of the skeletal structure (e.g., the extremities and pelvis). These defects may be surgically created osseous defects or osseous defects created by traumatic injury to the bone. The product provides a bone graft substitute that remodels into the recipient's skeletal system.

Origen DBM® with Bioactive Glass (also registered with the FDA as NanoFUSE® DBM) is a malleable, putty-like, bone-void filler for use in general orthopedic applications. The product is comprised of human demineralized bone matrix (DBM) and synthetic calcium phosphor-silicate particulate material particles (45s5 bioactive glass), both coated with gelatin derived from porcine skin. These coated particles are packaged dry in a single use, polypropylene syringe (20 cc or 3 cc), double-wrapped in peel-back pouches, and final packaged in a dust cover paperboard carton. The 20 cc syringe will be filled with either of two different fill quantities of dry powder. identified as 10 cc or 5 cc final product volume. The 3 cc syringe will be filled with dry powder, identified as 2 cc final product volume. Origen DBM® with Bioactive Glass (NanoFUSE® DBM) is intended for single patient use only. At point of use, the surgeon will reconstitute the product with an appropriate sterile solution of his/her choice (sterile saline, water for injection). The coated particles rehydrate in less than 30 seconds and do not require mixing to form a uniform paste or putty. The material is then gently extruded by the surgeon into the appropriate bone voids. Origen DBM® with Bioactive Glass (NanoFUSE® DBM) is progressively resorbed and replaced by host bone during the osteo-remodeling process.

The provided text is a 510(k) summary for a medical device (Origen DBM® with Bioactive Glass / NanoFUSE® DBM). It describes the device, its intended use, and its substantial equivalence to a predicate device. However, it does not include detailed information about specific acceptance criteria and a study demonstrating the device meets those criteria, as typically found in clinical study reports or more detailed verification and validation documents.

The document primarily focuses on demonstrating that the modified manufacturing process for the applicant device does not affect its safety or effectiveness compared to the predicate device. It states, "The minor change in manufacturing process does not alter the fundamental scientific technology of the device and has been shown to have no effect on the safety or effectiveness of the device."

Therefore, based solely on the provided text, I cannot complete many of the requested sections as the specific "study that proves the device meets the acceptance criteria" in the way one might expect for a diagnostic or AI-driven device is not present. The document focuses on showing equivalence rather than a new standalone performance study with detailed metrics.

Here's what can be extracted and what cannot:

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

• Acceptance Criteria: Not explicitly stated in terms of quantitative metrics for performance. The overall acceptance criterion is "substantial equivalence" to the predicate device, implying that its safety and effectiveness are comparable.
• Reported Device Performance: The document only states that the modification "has been shown to have no effect on the safety or effectiveness of the device." No specific performance metrics (e.g., strength, resorption rate, osteoinductivity quantification) or their values are reported in this summary.

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

• Not applicable/Not mentioned. The document describes a manufacturing process change and asserts equivalence. It does not refer to a test set of data in the context of a performance study with a specific sample size.

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/Not mentioned. Ground truth establishment is not relevant to this type of 510(k) submission focused on a manufacturing change for a bone void filler.

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

• Not applicable/Not mentioned.

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 a diagnostic imaging device involving human readers or AI.

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

• Not applicable. This is not an AI algorithm.

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

• Not applicable/Not mentioned.

8. The sample size for the training set

• Not applicable/Not mentioned. This is not a machine learning model.

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

• Not applicable/Not mentioned.

Summary regarding the "Study that proves the device meets the acceptance criteria":

The core of this 510(k) submission is to demonstrate Substantial Equivalence to a legally marketed predicate device, specifically after a minor manufacturing process modification. The "study" (or rather, the justification) provided is that this manufacturing change results in a thicker paste-like form at initial extrusion but does not fundamentally alter the scientific technology or affect the safety or effectiveness of the device.

The document states:

• "The subject of this Special 510(k), the applicant version of Origen DBM® with Bioactive Glass (NanoFUSE® DBM), is produced under a modified manufacturing process to the legally marketed Origen DBM® with Bioactive Glass."
• "Origen DBM® with Bioactive Glass (NanoFUSE® DBM) has the same intended uses and indications and similar technological characteristics as the currently cleared version of Origen DBM® with Bioactive Glass."
• "The minor change in manufacturing process does not alter the fundamental scientific technology of the device and has been shown to have no effect on the safety or effectiveness of the device."
• It also notes that "Each lot of DBM used in manufacturing the applicant version of Origen DBM® with Bioactive Glass (NanoFUSE® DBM) will be screened for osteoinductivity in an in vitro assay," which implies an ongoing quality control measure, not a specific performance study for the 510(k) itself to demonstrate new acceptance criteria.

In essence, the "study" for this Special 510(k) is the demonstration that the manufacturing change does not negatively impact the previously established safety and effectiveness of the predicate device, thereby maintaining substantial equivalence. Specific quantitative performance data comparing the new and predicate devices is not detailed in this summary.

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Origen™ DBM with Bioactive Glass is indicated for bony voids or gaps that are not intrinsic to the stability of the bony structure. It is indicated to be placed into bony voids or gaps of the skeletal system (e.g., the extremities and pelvis). These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone. The product provides a bone graft substitute that remodels into the recipient's skeletal system.

Origen™ DBM with Bioactive Glass is a malleable, putty-like bonevoid filler. The product is comprised of human demineralized bone matrix (DBM) and synthetic calcium phosphor-silicate particulate material particles, both coated with gelatin derived from porcine skin. These coated particles are packaged dry in a single use, polypropylene syringe (20 cc or 5 cc), double-wrapped in peel-back pouches, and final packaged in a dust cover paperboard carton. The 20 cc syringe will be filled with either of two different fill quantities of dry powder, identified as 10 cc or 5 cc final product volume. The 5 cc syringe will be filled with two additional fill quantities of dry powder, identified as 2.5 cc or 1 cc final product volume. Origen™ DBM with Bioactive Glass is intended for single patient use only. At point of use, the surgeon will reconstitute the product with an appropriate sterile solution of his/her choice (WFI, sterile normal saline). The coated particles rehydrate in less than 30 seconds and do not require mixing to form a uniform paste or putty. The material is then gently extruded by the surgeon into the appropriate bone voids. Origen™ DBM with Bioactive Glass is progressively resorbed and replaced by host bone during the osteo-remodeling process.

The provided text (K062459) is a 510(k) Summary for a medical device called "Origen™ DBM with Bioactive Glass." This document focuses on demonstrating substantial equivalence to existing predicate devices, rather than establishing specific acceptance criteria and proving performance through a standalone clinical study with defined endpoints and statistical significance.

Therefore, the requested information regarding acceptance criteria and a study proving the device meets them, particularly in the context of clinical performance metrics like sensitivity, specificity, accuracy, or human reader improvement, is not present in this document.

Here is what the document does describe in relation to non-clinical performance and substantial equivalence:

1. Table of Acceptance Criteria and Reported Device Performance:

This document does not present a table of acceptance criteria for a specific performance metric (e.g., accuracy, sensitivity) and then report the device's performance against it. Instead, it asserts substantial equivalence based on material composition, intended use, and comparative non-clinical studies.

2. Sample Size Used for the Test Set and Data Provenance:

• For the "bone formation and healing" study: The document does not specify the sample size used in this GLP compliant study.
• Data Provenance: The document does not explicitly state the country of origin or whether the study was retrospective or prospective for the "bone formation and healing" study, beyond it being a "GLP compliant study."
• For the "viral reduction study": The "test set" would be the viral models used. The document lists five specific viruses: bovine diarrhea virus (BVDV); hepatitis A virus (HAV); human immunodeficiency virus type 1 (HIV-1), porcine parvovirus (PPV); and pseudorabies virus (PrV).
• Data Provenance (Viral Reduction): Conducted by a CLIA certified testing laboratory (location not specified).

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

• This information is not provided in the document. The studies referenced are non-clinical (animal model, in vitro assay, viral reduction). Clinical ground truth established by experts is not described.

4. Adjudication Method for the Test Set:

• This information is not provided as the studies are not clinical trials requiring adjudication of endpoints by experts.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

• No, an MRMC comparative effectiveness study was not done as this is a bone void filler device, not an imaging or diagnostic AI device that would involve human readers interpreting cases.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study:

• This concept is not directly applicable. Origen™ DBM with Bioactive Glass is a physical medical device (bone void filler) used by a surgeon, not an algorithm. The "performance" is its biological effect (bone formation/healing), not an algorithmic output. The studies mentioned (osteoinuctivity assay, bone formation/healing study, viral reduction) are "standalone" in the sense they evaluate the biological/physical properties of the product itself.

7. Type of Ground Truth Used:

• For osteoinductivity: In vitro assay correlated to the athymic rat model.
• For bone formation and healing: Comparison to autogenous bone graft and predicate devices, implying assessment of osseous tissue formation or healing outcomes in a relevant animal model (though the specific outcome measures are not detailed).
• For viral reduction: Direct measurement of viral load reduction/elimination following the demineralization process.

8. Sample Size for the Training Set:

• This concept is not applicable as Origen™ DBM with Bioactive Glass is a physical medical device, not an AI/ML algorithm that requires a training set.

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

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

In summary: The provided 510(k) summary focuses on demonstrating "substantial equivalence" of the Origen™ DBM with Bioactive Glass to existing legally marketed predicate devices based on material composition, intended use, and non-clinical studies. It does not present detailed acceptance criteria for clinical performance or a standalone clinical study to prove those criteria are met in the way one would for a diagnostic AI device.

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