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Q-FIX with Needles is intended for use for the reattachment of soft tissue to bone.

Q-FIX with Needles use is only intended for the reattachment of soft tissue to bone for the following indications:

Foot and Ankle

• Medial or lateral instability repairs/reconstructions
• Achilles tendon repairs/reconstructions

Q-FIX with Needles is an all-suture anchor that consists of a fixation device intended to provide the reattachment of tissue to bone. The 1.8 mm implant is manufactured from braided polyester with ultra high molecular weightpolyethylene (UHMWPE) sutures with needles and is pre-loaded into a disposable tool designed to facilitate direct insertion into a pre-drilled bone hole. The device includes a handle and a deployment knob used to deploy one soft anchor implant into the joint spaceand a suture with needles compartment with a release handle.

Q-FIX with Needles includes two versions,

• Q-FIX with Needles, #0 SUTURE includes an all-sutureanchor loaded with . a #1 hot stretched tension suture and 2 #0 repair sutures
• . Q-FIX with Needles, MINITAPE includes an all-suture anchor loaded with a #1 hot stretched tension suture and 1 MINITAPE repairsuture

In addition, the Drill for Q-FIX with Needles, 2.2mm and Extremities Guide, Universal, are used to prepare the bone to insert the anchor.

The provided text is a 510(k) summary for the O-FIX With Needles device, a medical device for reattaching soft tissue to bone. It does not contain information about acceptance criteria and study results for an AI/ML device. The document describes the device itself, its intended use, comparison with predicate devices, and non-clinical performance testing.

Therefore, I cannot fulfill your request for:

• A table of acceptance criteria and reported device performance for an AI/ML device.
• Sample size used for the test set and data provenance for an AI/ML study.
• Number of experts and their qualifications for establishing ground truth for an AI/ML study.
• Adjudication method for an AI/ML study.
• MRMC comparative effectiveness study results for an AI/ML device.
• Standalone performance for an AI/ML algorithm.
• Type of ground truth used for an AI/ML device.
• Sample size for the training set and how its ground truth was established for an AI/ML device.

The document states under "PERFORMANCE TESTING - NON-CLINICAL 8":
"For the non-clinical performance testing, both Q-FIX with Needles SKUs have been assessed for the following functional tests:

• Insertion and deployment
• With the use of the Extremities Guide, Universal and the Drill for Q-FIX with Needles
• Suture slide
• Fixation
• Cyclic UTS and displacement
• Needle attachment strength
• Knot tensile strength

For the non-clinical performance testing, the Drill for Q-FIX with Needles has been assessed for the following functional tests:

• Force and torque to drill
• Torque to fail

Q-FIX with Needles devices met performance specifications for insertion strength, fixation, cyclic loading, UTS. Therefore, Q-FIX with Needles is equivalent to its predicate devices."

This is the only information provided regarding "acceptance criteria" and "device performance" in the context of the physical device. The study is a non-clinical performance testing intended to demonstrate substantial equivalence to predicate devices, not an AI/ML model.

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