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The CrossFT™ Knotless Suture Anchor with Disposable Driver is intended to reattach soft tissue to bone in orthopedic surgical procedures. The device may be used in either arthroscopic or open surgical procedures. After the suture is anchored to the bone, it may be used to reattach soft tissue, such as ligaments, tendons, or joint capsules to the bone. The suture anchor system thereby stabilizes the damaged soft tissue, in conjunction with appropriate postoperative immobilization, throughout the healing period.

The CrossFT™ Knotless Suture Anchors with Disposable Driver are sterile, single use devices. The CrossFT™ Knotless Suture Anchors are manufactured from PolyEtherEtherKetone (PEEK™). The anchors are provided sterile, single use and preloaded on a disposable driver. The anchors are available in three sizes and nine configurations.

The provided document describes the "CrossFT™ Knotless Suture Anchor with Disposable Driver" and its substantial equivalence to a predicate device (K091549). This is a medical device, not an AI/ML device, and therefore the concepts of acceptance criteria related to algorithmic performance (like sensitivity, specificity, MRMC studies, standalone performance, ground truth establishment by experts, training/test set sizes, and data provenance) are not applicable in this context.

The document focuses on demonstrating substantial equivalence for a medical device through engineering and biological performance testing.

Here's an interpretation of the relevant information provided, focusing on what is available:

1. Table of Acceptance Criteria and Reported Device Performance

The document doesn't explicitly state quantitative acceptance criteria in a table format with corresponding reported performance values for each criterion. It broadly mentions completed performance testing to demonstrate the device performs as intended and is substantially equivalent.

However, based on the types of testing listed, we can infer general areas of acceptance. The "Reported Device Performance" is stated generally as having "met the endotoxin limits" and that the testing "demonstrates that the CrossFT™ Knotless Suture Anchor with Disposable Driver performs as intended and is substantially equivalent to the predicate device."

2. Sample Size for Test Set and Data Provenance

This information is not provided in the document. For a physical medical device, "test set" typically refers to the number of units or samples subjected to each performance test. The document also does not specify the country of origin of data or whether tests were retrospective/prospective.

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

This information is not applicable for this type of medical device submission. "Ground truth" established by experts is a concept central to evaluating diagnostic or AI/ML device performance. For this physical device, "ground truth" relates to engineering specifications, material properties, and biological safety standards.

4. Adjudication Method for the Test Set

This information is not applicable for this type of medical device submission. Adjudication methods (like 2+1, 3+1) are used to resolve disagreements among human readers/experts when establishing ground truth for diagnostic or AI/ML performance.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done

This is not applicable. MRMC studies are used to evaluate the comparative effectiveness of diagnostic methods (e.g., human readers with and without AI assistance) on a set of cases. This document describes a physical surgical implant.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) was Done

This is not applicable. This refers to algorithmic performance without human intervention, which is relevant for AI/ML devices.

7. The Type of Ground Truth Used

The "ground truth" for this device's performance would be defined by engineering specifications, material science standards, and established biological safety standards. For example, the "ultimate fixation strength" would have a specific quantifiable standard that the device must meet, derived from biomechanical requirements. The "met the endotoxin limits" is an example of meeting a specific biological safety standard, which acts as a "ground truth" for endotoxin levels.

8. The Sample Size for the Training Set

This is not applicable. "Training set" refers to data used to train an AI/ML algorithm. This document describes a physical medical device.

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

This is not applicable for the reasons stated above.

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