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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 (i.e., the extremities, pelvis and posterolateral spine). These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone. NanoFUSE® DBM must be used with autograft as a bone graft extender in the posterolateral spine. The product provides a bone graft substitute that remodels into the recipient's skeletal system.

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. 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, or autologous whole blood). 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. NanoFUSE® DBM is progressively resorbed and replaced by host bone during the osteo-remodeling process.

Here's an analysis of the provided text regarding the NanoFUSE® DBM device, focusing on acceptance criteria and supporting studies.

Important Note: The provided document is a 510(k) summary, which focuses on demonstrating substantial equivalence to a predicate device for marketing clearance. It does not typically include detailed clinical trial results or performance metrics in the same way a PMA (Pre-Market Approval) or a more extensive clinical study report would. Therefore, much of the requested information, particularly quantitative performance metrics and details about ground truth establishment, training sets, and MRMC studies, is not present in this document.

Description of Acceptance Criteria and Study to Prove Device Meets Criteria

The NanoFUSE® DBM device is a bone void filler intended for use in general orthopedic applications, specifically in bony voids or gaps of the skeletal system (extremities, pelvis, and posterolateral spine). The document describes a 510(k) submission, which aims to demonstrate that a new device is as safe and effective as a legally marketed predicate device. Therefore, the "acceptance criteria" are primarily related to showing substantial equivalence to the predicate, with specific focus on biological safety, performance characteristics, and the new indication for use in the posterolateral spine.

1. Table of Acceptance Criteria and Reported Device Performance

Given the nature of the 510(k) submission, the "acceptance criteria" are implied by the comparison to the predicate and the specific tests conducted. Quantitative performance metrics as commonly seen in diagnostic device evaluations are not explicitly stated for this type of device in this document.

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

• Sample Size for Test Set: Not specified in this 510(k) summary. The document mentions an "in vivo" evaluation for the posterolateral spine indication, and possibly an "in vivo athymic rat implant or cell bioassay" for osteoinductivity, but no details on the number of subjects/animals are provided.
• Data Provenance: Not specified. Given the nature of a 510(k), it likely includes a combination of internal bench testing, animal studies, and potentially a summary of existing clinical data for the predicate device. Country of origin for data is not mentioned, nor is a definitive statement on retrospective or prospective nature of all data, though "in vivo" studies would be prospective.

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

• Number of Experts & Qualifications: Not applicable/not specified. This document is not evaluating a diagnostic device that requires expert interpretation for a "ground truth" test set. The evaluation is primarily based on material properties, biocompatibility, and in vivo assessment of bone formation/integration.

4. Adjudication Method for the Test Set

• Adjudication Method: Not applicable. This document does not describe a process that would require expert adjudication of a test set, as might be found in a diagnostic imaging study.

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

• MRMC Study: No, this type of study is not mentioned as it is typically relevant for diagnostic devices where human readers interpret medical images or data. NanoFUSE® DBM is a therapeutic/device implant, not a diagnostic tool.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

• Standalone Performance: Not applicable. This concept applies to AI algorithms. NanoFUSE® DBM is a physical medical device (bone void filler). The "device performance" refers to its biological and mechanical properties, not an algorithmic output.

7. The Type of Ground Truth Used

• Type of Ground Truth: The "ground truth" for a bone void filler generally involves:
  • Histology/Pathology: For in vivo studies, this would confirm bone formation, material degradation, and biocompatibility in animal models. The document mentions "in vivo" evaluation for the spine and "in vivo athymic rat implant" for osteoinductivity, implying such histological assessment.
  • Biocompatibility Standards: Compliance with ISO 10993 standards serves as a "ground truth" for biocompatibility.
  • Bench Test Results: Measurable physical/chemical properties from in vitro bench testing.
  • Clinical Outcomes/Radiographic Evidence: While not detailed in this summary, a full clinical evaluation for a similar device would typically involve radiographic evidence of bone healing/integration and clinical follow-up for adverse events.

8. The Sample Size for the Training Set

• Sample Size for Training Set: Not applicable/not specified. This concept is for AI/machine learning models. NanoFUSE® DBM is a physical medical device.

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

• How Ground Truth for Training Set Was Established: Not applicable. (See #8).

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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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