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MEDINAUT Plus Kyphoplasty System is intended to be used as a conventional bone tamp for the reduction of fractures and/or creation of a void in cancellous bone in the spine (including use during balloon kyphoplasty with a PMMA-based bone cement that is cleared for use in kyphoplasty procedures), hand, tibia, radius, and calcaneus.

The MEDINAUT Plus Kyphoplasty System is designed to reduce compression fracture and create a void in cancellous bone in the spine. By creating a space in the operating point, the major benefits of MEDINAUT Plus Kyphoplasty System are the reduction in pain and the increase of patient s functional abilities, which allow for the patient's return to the previous level of activity. The MEDINAUT Plus Kyphoplasty System consists of the Balloon Expander, Balloon Catheter, Cement Dispenser System, Cement Mixer System and Syringe. The Balloon Catheter consists of an inner-outer tube, Y-port and an inflatable balloon located at the distal tip. The radiopaque markers located at the distal and proximal end allow fluoroscopic visualization of the deflated balloon catheter during positioning. The Balloon Expander consists of a gauge, housing, a half nut, a plunger, a piston, a hose, a luer connector and a 3 way valve. The Balloon Expander is used for inflating the balloon by rotating the plunger clockwise. The lock mechanism maintains pressure. The Cement Dispenser System consists of Cannula, Needle (3 types: Bevel, Diamond, Trocar), Spacer, Biopsy, Biopsy Cap. Cement Filler, Cement Pusher and Cement Side Filler. The Cement Mixer System consists of Cement Mixer, Tube, Cap, Funnel and Pusher. The user can mix cement inside the cylinder by moving the mixer up and down repeatedly and apply the cement into a patient by rotating the pusher handle. The Syringe is an optional device. If there is air found in the Catheter Balloon before surgery, the user can remove the air with this syringe. All the components including Balloon Expander, Balloon Catheter, Cement Dispenser System. Cement Mixer System and Syringe are supplied sterile and are disposable.

The provided text, K182287, outlines the 510(k) summary for the MEDINAUT Plus Kyphoplasty System. However, it does not describe acceptance criteria and a study proving the device meets those criteria in the context of an AI/algorithm-driven device performance evaluation (such as sensitivity, specificity, accuracy, or human reader improvement).

Instead, this document is a regulatory submission for a physical medical device (an inflatable bone tamp for kyphoplasty) and focuses on demonstrating substantial equivalence to a predicate device through non-clinical testing (bench tests, biocompatibility, sterilization, shelf life).

Therefore, I cannot extract the requested information (points 1-9) as it pertains to AI/algorithm performance studies typically found in submissions for AI-enabled software as a medical device (SaMD). The concepts of "acceptance criteria for algorithm performance," "sample size for test set," "number of experts," "adjudication method," "MRMC study," "standalone performance," "ground truth," and "training set" are not applicable to the non-clinical bench testing and physical device comparisons described in this 510(k) summary.

The document's "Non-Clinical Testing" section describes physical and material property tests:

• Sterilization validation: Ensuring the device can be sterilized.
• Shelf life validation: Ensuring the device maintains its properties over time.
• Biocompatibility testing: Ensuring the materials are safe for use in the body.
• Bench tests:
  • Visual Inspection
  • Size Measurement
  • Liquid leakage under pressure
  • Tensile force
  • Burst strength
  • Balloon fatigue
  • Inflated balloon size
  • Balloon deflation
  • EO Gas residue
  • Sterility Test
  • Balloon rated burst pressure (RBP) in constrained condition
  • Balloon rated burst pressure (RBP) in unconstrained condition
  • Freedom from leakage and damage on inflation
  • Balloon diameter to inflation pressure
  • Insertion force and withdrawal force

These tests are to confirm the physical and mechanical integrity and safety of the device, not the performance of an AI algorithm. The conclusion states that the test results supported "substantial equivalence to the predicate devices" based on these physical characteristics and performance.

In summary, none of the requested information regarding AI/algorithm performance studies can be provided from this document because it describes a physical medical device, not an AI/algorithm-driven one.

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