Search Results

The 3D GraftRasp System is intended to be used in orthopedic procedures to rasp or decorticate bone from the transverse processes and/or facets, and for the delivery of hydrated allograft, or synthetic bone graft material to an orthopedic surgical site.

The 3D GraftRasp system contains various decortication rasps, graft pushers, a bone funnel, tools, and dilators. The 3D GraftRasp system is compatible with the Graftgun Universal Graft Delivery System for graft delivery to the surgical site. The decortication rasps can be used to rasp or decorticate bone from transverse processes and/or facets. After rasping, a 5cc or 7.5cc graft tube can be inserted into the rasp lumen to extrude graft from the tip of the rasp. A set of optional sequential dilators and rasp pushers may also be provided to aid in the use of the decortication rasp. A bone funnel may optionally be used to extrude graft through the rasps instead of the graftgun.

The provided text describes the 3D GraftRasp System, a medical device for orthopedic procedures, seeking 510(k) clearance from the FDA. It details device characteristics, indications for use, and a comparison to a predicate device (also the 3D GraftRasp System, K200431, from the same manufacturer).

However, the document does not contain specific acceptance criteria for a device performance study in the context of an AI/ML medical device, nor does it describe a study that proves the device meets such criteria for an AI/ML product. The performance data section focuses on non-clinical performance data for a mechanical medical device.

Therefore, I cannot extract the information requested in your prompt regarding acceptance criteria, study details, sample sizes, expert involvement, adjudication methods, MRMC studies, standalone performance, or ground truth establishment for an AI/ML device.

The performance data provided is for a mechanical physical device and includes:

• Biocompatibility testing: Per ISO 10993-1:2018.
• Sterilization validation: Per ISO 17665-1:2006/(R) 2013.
• Bench Testing:
  • Functionality Common Material Test: Tested extrusion of various graft materials through rasps using an acceptable hand force.
  • Rasp Functionality Test: Tested the rasping surface on a bone block for decortication capability without failure of teeth or main body.
  • Volume Dispensing Verification Test: Tested the Graftgun for accurate bone graft dispensing with each trigger squeeze.
• Simulated Use Validation Testing: Seven studies conducted with physicians (intended users) on cadavers and/or sawbones models to simulate typical use. This aimed to gather feedback and validate the device, labeling, usability, human factors, and technique.

This information does not align with the typical requirements for describing the acceptance criteria and study proving an AI/ML device's performance.

Ask a specific question about this device

The 3D GraftRasp System is intended to be used in orthopedic procedures to rasp or decorticate bone and for the delivery of hydrated allograft, autograft, or synthetic bone graft material to an orthopedic surgical site.

The 3D GraftRasp system contains various decortication rasps, graft pushers, a bone funnel, and dilators. The 3D GraftRasp system is compatible with the Graftgun Universal Graft Delivery System for graft delivery to the surgical site. The decortication rasps can be used to rasp or decorticate bone. After rasping, a 5cc or 7.5cc graft tube can be inserted into the rasp lumen to extrude graft from the tip of the rasp. A set of optional sequential dilators and rasp pushers may also be provided to aid in the use of the decortication rasp. A bone funnel may optionally be used to extrude graft through the rasps instead of the graftgun.

The provided document is a 510(k) Summary for a medical device called the "3D GraftRasp System." It does not contain information about the acceptance criteria or a study proving the device meets acceptance criteria in the context of an AI/ML powered device.

The document discusses the substantial equivalence of the 3D GraftRasp System to predicate devices based on technological characteristics and non-clinical performance data (biocompatibility, sterilization validation, and bench testing). The bench testing includes:

• Functionality Common Material Test: Verifies the Graftgun can successfully extrude various graft materials through the different rasps of the 3D GraftRasp System.
• Rasp Functionality Test: Confirms the rasping surface can decorticate a bone block without failure.
• Volume Dispensing Verification Test: Ensures the Graftgun dispenses an accurate amount of bone graft.

However, the nature of the device (a piston syringe and bone rasp) and the tests described align with a traditional medical device submission, not an AI/ML-powered device. Therefore, the specific information requested, such as sample sizes for test/training sets, data provenance, number of experts for ground truth, adjudication methods, MRMC studies, or standalone algorithm performance, is not applicable or present in this document.

Ask a specific question about this device