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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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The Smith & Nephew Suture Anchors are intended for the reattachment of soft tissue to bone for the following indications: Hip: Hip capsule repair - Acetabular labrum reattachment/reconstruction Shoulder: Capsular stabilization - Bankart repair - Anterior shoulder instability - SLAP lesion repairs - Capsular shift or capsulolabral reconstructions Acromioclavicular separation repairs Deltoid repairs Rotator Cuff repairs Biceps Tenodesis Foot and Ankle: Hallux valgus repairs Medial or lateral instability repairs/reconstructions Achilles tendon repairs/reconstructions Midfoot reconstructions Metatarsal ligament/tendon repairs/reconstructions Bunionectomy Knee: Extra-capsular repairs - Medial collateral ligament - Lateral collateral ligament - Posterior oblique ligament Patellar realignment and tendon repairs - Vastus medialis obliquous advancement Iliotibial band tenodesis Elbow, Wrist, and Hand: Lateral epicondylitis repair Biceps tendon reattachment Ulnar or radial collateral ligament reconstructions

Subject of this Traditional 510(k) premarket notification is an addition to the indications for use for the Smith & Nephew, Inc. BIORAPTOR® 2.9, BIORAPTOR® 2.3 PK, OSTEORAPTOR®, and BIORAPTOR Knotless Suture Anchors. These suture anchors were cleared via premarket notifications K053344, K071586, K082215, and K093428, respectively, and have identical indications for use. Smith & Nephew, Inc. seeks to expand the existing indications for use for the subject devices to include acetabular labrum reconstruction.

The provided document is a 510(k) summary for Smith & Nephew suture anchors, seeking to expand their indications for use. It primarily focuses on demonstrating substantial equivalence to previously cleared predicate devices rather than proving a device meets specific acceptance criteria through a new study with performance metrics.

Therefore, many of the requested sections related to acceptance criteria, device performance from a test set, expert involvement, and ground truth are not explicitly available in the provided text. The submission relies on the prior clearances and the inherent characteristics of the device.

Here's an analysis based on the available information:

1. Table of Acceptance Criteria and Reported Device Performance

This document does not present specific quantitative acceptance criteria or reported device performance in the manner requested (e.g., sensitivity, specificity, accuracy for a diagnostic device). Instead, it states that "Smith & Nephew is relying on the mechanical testing (insertion strength, pull-out strength, and suture sliding) provided for the predicate devices as a measure of substantial equivalence." This implies that the acceptance criteria for these mechanical properties were met in the original clearances of the predicate devices, and because there have been no changes to the design or materials, they are still considered met.

2. Sample Size Used for the Test Set and Data Provenance

Not applicable. This submission doesn't describe a new study with a "test set" for performance evaluation in the context of diagnostic accuracy or a similar measurable outcome. The "test set" implicitly refers to the mechanical testing performed for the original clearances of the predicate devices. The document does not provide details on the sample sizes or data provenance (country of origin, retrospective/prospective nature) of these original mechanical tests.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Experts

Not applicable. There is no mention of experts establishing a "ground truth" for a test set in this 510(k) submission. The evaluation is based on mechanical properties and substantial equivalence to previously cleared devices.

4. Adjudication Method for the Test Set

Not applicable. No adjudication method is described for a test set in this submission.

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 a medical device for surgical procedures (suture anchors), not an AI-assisted diagnostic tool. An MRMC study is irrelevant to this submission.

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

Not applicable. This device is a physical surgical implant, not an algorithm.

7. The Type of Ground Truth Used

The "ground truth" for this type of device (suture anchors) is established through mechanical testing (e.g., measuring forces required for insertion, pull-out, and suture sliding) against engineering specifications and industry standards, and ultimately, through clinical outcomes data from the use of the device and its predicates. The submission references reliance on "mechanical testing" for the predicate devices and "published articles supporting the additional indication," suggesting that the clinical effectiveness and safety of such devices are established in the medical literature.

8. The Sample Size for the Training Set

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

9. How the Ground Truth for the Training Set was Established

Not applicable. This is not an AI/machine learning device.

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