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Sygnal DBM is a bone void filler for voids or gaps that are not intrinsic to the stability of the bony structure. Sygnal DBM can be used alone or as an extender in the posterolateral spine with bone marrow. It is indicated for use in the treatment of surgically-created osseous defects or osseous defects created from traumatic injury.

Sygnal DBM is for single patient use only.

Sygnal DBM is completely resorbable and is composed of donated cortical bone. The bone granules are mixed with sodium hyaluronate (Hy) and carboxymethylcellulose (CMC). Sygnal DBM is available in sizes of 0.5 cc, 1.0 cc, 2.5 cc, 5.0 cc, and 10.0 cc.

The provided text describes a medical device called "Sygnal™ DBM," a bone void filler. However, it does not include information about acceptance criteria or a study proving the device meets those criteria, as typically found in submissions for Artificial Intelligence/Machine Learning (AI/ML) devices.

Instead, the document is a 510(k) summary for a Class II medical device, which focuses on demonstrating substantial equivalence to a predicate device. This type of submission generally relies on established safety and performance characteristics of the predicate and the materials used in the new device, rather than detailed performance studies with acceptance criteria for an AI algorithm.

Therefore, I cannot provide the requested information because it is not present in the provided input. The document describes:

• Device Description: Sygnal DBM is a resorbable bone void filler composed of donated cortical bone mixed with sodium hyaluronate and carboxymethylcellulose.
• Indications for Use: Treatment of surgically-created osseous defects or osseous defects from traumatic injury, alone or as an extender in the posterolateral spine with bone marrow.
• Safety and Effectiveness Information:
  • Biocompatibility: Established through long clinical use of components and laboratory testing per ISO 10993.
  • Sterility: Tested per current USP .
  • Osteoinductive Potential: Demonstrated in an athymic mouse model, with every lot assayed in vivo for positive osteoinductive potential for lot release. Crucially, it states: "Osteoinduction assay results in the athymic mouse model should not be interpreted to predict clinical performance in human subjects."
  • Viral Clearance and Inactivation: Evaluated for its potential to inactivate a panel of model human viruses.

The document is an FDA letter acknowledging substantial equivalence (K080405) to a legally marketed predicate device, allowing the sponsor to market Sygnal™ DBM.

In summary, none of the requested information regarding acceptance criteria or a study proving the device meets those specific acceptance criteria (as would be relevant for an AI/ML device) is available in the provided text.

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Sygnal DBM is a bone void filler for voids or gaps that are not intrinsic to the stability of the bony structure. Sygnal DBM can be used to fill bone voids in the extremities and pelvis. It is indicated for use in the treatment of surgically-created osseous defects or osseous defects created from traumatic injury.

Sygnal DBM is for single patient use only.

Sygnal DBM is completely resorbable and is composed of donated cortical bone. The bone granules are mixed with sodium hyaluronate (Hy) and carboxymethylcellulose (CMC). Sygnal DBM is available in sizes of 0.5 cc, 1.0 cc, 2.5 cc, 5.0 cc, and 10.0 cc.

The provided text describes the Sygnal™ DBM (Demineralized Bone Matrix) device, its indications for use, and a general statement about its safety and effectiveness. However, it does not contain details about specific acceptance criteria or a study proving the device meets those criteria in the context of device performance metrics typically reported for AI/algorithm-based devices (e.g., sensitivity, specificity, accuracy).

The document seems to be a 510(k) summary for a bone void filler, which is a biological product, not an AI or imaging device that would typically have performance metrics like those requested.

Therefore, I cannot fulfill most of the requested points because the information is not present in the provided text. I can only extract general information about the product itself.

Here's what can be inferred or stated based on the text:

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

   • Acceptance Criteria (Implied): The primary implied acceptance criterion for a DBM product for lot release is "Osteoinduction assay results in the athymic mouse model must prove positive for lot release."
   • Reported Device Performance: "Every lot of final product is assayed in vivo for its osteoinductive potential." The text states that "Standard testing performed in an athymic mouse model must prove positive for lot release."
   • Limitation: The document explicitly states: "Osteoinduction assay results in the athymic mouse model should not be interpreted to predict clinical performance in human subjects." This highlights that while this is a critical quality control step, it's not a direct measure of clinical performance in humans in the way an AI diagnostic might be measured.

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

   • Not applicable/Not provided in the context of typical device performance studies (e.g., for AI/imaging). The "test set" here refers to "every lot" of the DBM in an athymic mouse model. No human test set size or data provenance is mentioned for device performance evaluation.

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

   • Not applicable. The "ground truth" for the lot release assay is determined by the "positive" result in the athymic mouse model, not by human experts interpreting clinical data.

4. Adjudication method for the test set

   • Not applicable. The athymic mouse model is the assay, and the outcome is binary ("positive" or not).

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 is not an AI-assisted device.

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

   • Not applicable. This is not an algorithm-only device.

7. The type of ground truth used

   • Ground Truth: For lot release, the ground truth is "positive osteoinductive potential" as demonstrated in an athymic mouse model.

8. The sample size for the training set

   • Not applicable. This is not an AI/machine learning device that uses a "training set."

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

   • Not applicable.

In summary, the provided text pertains to the regulatory submission for a bone void filler, focusing on its composition, indications, biocompatibility, sterility, and osteoinductive potential as assessed in an in vivo animal model for lot release. It does not describe a clinical study or performance evaluation that would generate the typical acceptance criteria and performance metrics (e.g., sensitivity, specificity, accuracy) associated with medical devices for diagnosis or AI applications.

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