(196 days)
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.
§ 888.3045 Resorbable calcium salt bone void filler device.
(a)
Identification. A resorbable calcium salt bone void filler device is a resorbable implant intended to fill bony voids or gaps of the extremities, spine, and pelvis that are caused by trauma or surgery and are not intrinsic to the stability of the bony structure.(b)
Classification. Class II (special controls). The special control for this device is the FDA guidance document entitled “Class II Special Controls Guidance: Resorbable Calcium Salt Bone Void Filler Device; Guidance for Industry and FDA.” See § 888.1(e) of this chapter for the availability of this guidance.