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The SpeedFix Suture Implant with inserter is indicated for use in fixation of soft tissue to bone. Examples of such procedures include:

Shoulder: Bankart Repair, SLAP lesion repair, acromio-clavicular separation, rotator cuff repair, capsule shift/capsule-labral reconstruction, biceps tenodesis and deltoid repair Ankle: Lateral instability, medial instability, Achilles tendon repair/reconstruction and midfoot reconstruction

Foot: Hallux valgus reconstruction

Elbow: Tennis elbow repair, biceps tendon attachment

Knee: Extra-capsular repairs: reattachment of: medial collateral ligament, posterior oblique ligament or joint capsule closure to anterior proximal tibia; extra capsular reconstruction, ITB tenodesis; patellar ligament and tendon avulsions

The SpeedFix Suture Implant is a bone anchor that facilitates the attachment of tissue to bone. The SpeedFix Suture System consists of an implant and associated instruments for installation of the implant that is designed for specific indications in arthroscopic and orthopedic procedures.

The following device-specific instrumentation is part of this submission:

SpeedLock Drill, Bone Drill
Bone Hole Locator
SpeedLock Drill Guide, Drill Guide

Here's an analysis of the provided text regarding the SpeedFix Suture System (K101437), focusing on acceptance criteria and the supporting study:

1. Table of Acceptance Criteria and Reported Device Performance

The provided document describes a substantial equivalence determination, not a study setting specific numeric acceptance criteria for performance such as accuracy, sensitivity, or specificity. Instead, the "acceptance criteria" are based on demonstrating that the SpeedFix Suture System is as safe and effective as the predicate device (Opus® SpeedLock® Knotless Fixation Device K090615).

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

• Sample Size: The document does not specify a numerical sample size (e.g., number of anchors, number of tests). It only states "in vitro testing conducted involved insertion of the anchors in a simulated human bone substrate followed by both static and cyclic fatigue testing."
• Data Provenance: The testing was "in vitro," meaning it was conducted in a laboratory setting, not with human or animal subjects. The data is thus retrospective in the sense that it evaluates the device's characteristics, but it's not clinical data. The country of origin for the data is not specified, but the manufacturer is ArthroCare Corporation in Sunnyvale, CA, USA, so it's likely U.S.-based or from a facility associated with the U.S. company.

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

Not applicable. This was a bench test (in vitro mechanical testing) comparing a new device to a predicate device based on FDA guidance for bone anchors. It did not involve expert review or establishment of "ground truth" in the diagnostic context.

4. Adjudication Method for the Test Set

Not applicable. There was no expert review or adjudication process, as the "test set" was mechanical testing of the device itself.

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 device is a surgical implant (suture system/bone anchor), not a diagnostic or AI-assisted device. Therefore, MRMC studies involving human readers and AI assistance are not relevant to this submission.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

Not applicable. This is a medical device (implantable hardware), not an algorithm or AI system.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)

For the in vitro bench testing, the "ground truth" can be considered the objective mechanical properties and performance characteristics (e.g., pull-out strength, fatigue resistance) measured according to established engineering and material science standards outlined in the "US FDA Guidance Document for Testing Bone Anchors." The "truth" is whether the new device's performance falls within an acceptable range compared to that of the predicate device, demonstrating equivalent safety and effectiveness based on these measurable physical properties.

8. The Sample Size for the Training Set

Not applicable. This device is not an AI/ML algorithm that requires a "training set."

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

Not applicable. As above, this device does not involve a training set.

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