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DBX® Strip is indicated as a bone void filler for treatment of surgically created osseous voids or gaps that are not intrinsic to the stability of the bony structure. It can be used in the pelvis, extremities, and the posterolateral spine for posterolateral fusion. DBX® Strip, when used for posterolateral spine fusion, may be used with autograft.

DBX® Strip is for single patient use only.

DBX® Strip is a flat, malleable device composed of human demineralized bone matrix (DBM), sodium hyaluronate (NaHy), sodium phosphate dibasic buffer and gelatin (procine origin). DBX® Strip is for single patient use only and is available in five sizes.

The provided text describes a 510(k) submission for the DBX® Strip, a bone void filler. The submission focuses on demonstrating substantial equivalence to a previously cleared device (K042829) rather than presenting a de novo study with explicit acceptance criteria and performance data. Therefore, many of the requested criteria cannot be directly extracted from this document.

Here's an analysis based on the information available:

1. Table of Acceptance Criteria and Reported Device Performance & 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 & 6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

This information is not applicable as the device is a bone void filler, not an AI/imaging device. The submission is not for a software-as-a-medical-device (SaMD) or an AI-powered diagnostic tool. The "acceptance criteria" discussed are related to demonstrating substantial equivalence for a medical device, primarily through biocompatibility and osteoinductivity potential, rather than performance metrics like sensitivity, specificity, accuracy, or reader improvement, which are typical for AI studies.

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

This information is not applicable in the context of an AI/imaging study's "test set" because the submission is for a medical device (bone void filler). The "studies" mentioned are laboratory tests (biocompatibility, sterility, osteoinductivity, viral clearance) and a reference to prior clinical use of the materials. No specific "test set" of patient data in the AI sense is described.

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):

This information is not applicable for the same reason as above. There is no "ground truth" to be established by clinical experts in the context of an AI study.

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

This information is not applicable as there is no "test set" requiring adjudication by multiple experts.

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

The "ground truth" for this device's safety and effectiveness is established through:

• Biocompatibility testing: Compliance with ISO 10993 standards.
• Sterility testing: Compliance with USP .
• Osteoinductivity potential: Demonstrated in an athymic mouse model.
• Viral clearance: Laboratory testing with model viruses.
• Previous clinical use: The materials used in the device have a "long history of safe and effective clinical use."

These are primarily laboratory and regulatory compliance-based "ground truths" for the device's properties, not clinical "ground truths" for diagnostic accuracy.

8. The sample size for the training set:

This information is not applicable. There is no "training set" as this is not an AI/machine learning device.

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

This information is not applicable. Since there is no training set, there is no ground truth established for it.

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DBX® Strip is indicated as a bone void filler in the spine for the treatment of surgically created osseous voids or gaps that are not intrinsic to the stability of the bony structure. DBX Strip is indicated for use in the posterior elements of the spine for posterolateral fusion only.

DBX Strip is for single patient use only.

DBX Strip® is a flat, malleable device composed of demineralized bone matrix ("NaHy"), sodium phosphate dibasic buffer and gelatin (DDNF); Soundin 17/8/2017 is for single patient use only and is available in five sizes.

The provided document is a 510(k) summary for a medical device (K042829 for DBX® Strip), which focuses on demonstrating substantial equivalence to a predicate device rather than providing detailed acceptance criteria and study results for device performance. Medical devices in this class often rely on

• comparison to a previously cleared device (predicate device) and
• performance testing (e.g., biocompatibility, sterility, mechanical properties, etc.) to demonstrate safety and effectiveness.

The document does not contain the specific information requested regarding acceptance criteria and detailed study results as would be found in a clinical trial report or a more extensive engineering report.

However, based on the information provided, here's what can be inferred and what is explicitly stated:

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

The document states: "The safety and effectiveness is adequately supported by the substantial equivalence information and performance testing results provided within this Premarket Notification."
It specifically mentions:

• Osteoinductivity Potential: "DBX Strip® is osteoconductive and has been shown to have osteoinductive potential in an athymic mouse model."
• Viral Inactivation: "A panel of model potential human viruses... demonstrated suitable viral inactivation potential of the process further reduces the risk of viral contamination beyond donor testing and screening procedures."

Implied Acceptance Criteria (not explicitly stated with numerical targets):

2. Sample size used for the test set and the data provenance

• Osteoinductive Potential Study: The document mentions "an athymic mouse model." It does not specify the sample size (number of mice) used in this study.
• Viral Inactivation Study: The document states "A panel of model potential human viruses." It does not specify the number of viruses or the sample size for inactivation testing.
• Provenance: This testing would be considered prospective as it's performed specifically for regulatory submission. The country of origin for the data is not explicitly stated, but the submission is to the US FDA by a US-based sponsor ("Musculoskeletal Transplant Foundation" in Edison, NJ).

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

This information is not provided in the document. The studies mentioned (athymic mouse model, viral inactivation) are laboratory/animal model studies, not human clinical studies requiring expert ground truth establishment for diagnostic performance.

4. Adjudication method for the test set

This information is not applicable/not provided as the document describes laboratory/animal model performance testing, not a diagnostic study requiring adjudication.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done

No, a multi-reader multi-case comparative effectiveness study was not mentioned or implied. This type of study is typically for evaluating the diagnostic performance of an AI algorithm in comparison to human readers. The DBX® Strip is a bone void filler, not a diagnostic device.

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

No, this product is a physical bone void filler, not an algorithm. Therefore, "standalone" algorithm performance is not applicable.

7. The type of ground truth used

• Osteoinductive Potential: The "ground truth" would be established by observing bone formation (or lack thereof) in the athymic mouse model, likely through histological analysis.
• Viral Inactivation: The "ground truth" would be established by laboratory assays measuring the reduction in viral load after the inactivation process.

8. The sample size for the training set

This is not applicable as DBX® Strip is a physical medical device, not an AI/algorithm-based device that requires a training set.

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

This is not applicable for the same reason as above.

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