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The RIGIDLOOP Titanium Button is intended for fixation of soft-tissue to bone for the following indications when used with PERMATAPE™ 2.5mm Suture, #2 ORTHOCORD® Suture, #2 DYNACORD™ Suture, or equivalent nonabsorbable or partially-absorbable high strength operative suture:

Shoulder:
Acromioclavicular repair
Pectoralis major / minor repair1
Biceps tenodesis

Elbow:
Ulnar or radial collateral ligament reconstruction
Biceps tendon reattachment

Knee:
Cruciate ligament reconstruction1
Extracapsular repair: MCL, LCL, and Posterior oblique ligament
Patellar tendon repair
Meniscal root repair2

1 PERMATAPE 2.5mm suture must be used for pectoralis major/minor repair and cruciate ligament reconstruction
2 Size 0 or size 2/0 ORTHOCORD Suture may be used for meniscal root repair.

RIGIDLOOP Cortical Fixation System XL Implant
When used in conjunction with the RIGIDLOOP Cortical Fixation System, the RIGIDLOOP Cortical Fixation System XL Implant is intended for fixation of soft tissue to bone in orthopedic procedures such as ACL repairs.

When used in conjunction with the RIGIDLOOP Titanium Button, the RIGIDLOOP Cortical Fixation System XL Implant is intended for fixation of soft-tissue to bone for the following indications:

Shoulder:
Pectoralis major / minor repair
Biceps tenodesis

Elbow:
Ulnar or radial collateral ligament reconstruction
Biceps tendon reattachment

Knee:
Cruciate ligament reconstruction
Extracapsular repair: MCL, LCL, and Posterior oblique ligament
Patellar tendon repair
Meniscal root repair

RIGIDLOOP Titanium Button
The proposed RIGIDLOOP Titanium Button is a cortical fixation device that provides a means of fixation of soft tissue to bone in orthopedic reconstructive surgery. The device consists of a titanium button implant that is provided with pre-attached leading and trailing sutures that are non-implantable. The white leading utility suture is composed of UHMWPE (device high molecular weight polyethylene) and the green trailing suture is composed of #5 Ethibond®. This device is provided sterile and is for single use only.

RIGIDLOOP Cortical Fixation System XL Implant
The RIGIDLOOP XL Implant is an extra-large titanium button implant that is currently intended for use with the already cleared RIGIDLOOP Cortical Fixation System devices (K130814). The RIGIDLOOP XL Implant can now also be used with the proposed RIGIDLOOP Titanium Button for the proposed indications. The RIGIDLOOP XL Implant is used in cases of cortical breaching. This device is provided sterile and is for single use only.

The provided text describes the regulatory clearance for the RIGIDLOOP™ Titanium Button and RIGIDLOOP™ Cortical Fixation System XL Implant. It does not contain information about a medical device involving AI, image analysis, or any study that would typically involve acceptance criteria related to accuracy, sensitivity, or specificity.

Specifically, the document focuses on:

• The FDA's 510(k) clearance for a surgical implant (bone fixation fastener).
• The device's indications for use (fixation of soft-tissue to bone for various orthopedic repairs).
• A comparison to predicate devices, emphasizing substantial equivalence based on material, design, and non-clinical performance testing (e.g., fixation strength, biological safety, sterility, packaging, shelf-life).
• A clear statement: "No animal or clinical studies were required."

Therefore, I cannot fulfill your request to describe acceptance criteria and a study proving device performance (including accuracy metrics, sample sizes, expert ground truth, etc.) because such information is not present in the provided text. The device described is a physical implant, not a software or AI-based diagnostic/assessment tool.

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PERMATAPE™ Suture is indicated for use in general soft tissue approximation, and/or ligation, including use with allograft tissue for orthopedic procedures.

PERMATAPE™ Suture is a synthetic, sterile, flat braided suture composed of dyed and un-dyed, non-absorbable polyethylene.

This document is a 510(k) summary for a medical device called PERMATAPE™ SUTURE. The document details the device's characteristics, intended use, and a comparison to predicate devices to establish substantial equivalence.

Based on the provided text, here is the information requested:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present a table of acceptance criteria with corresponding performance metrics like a typical AI/ML study would. Instead, it refers to industry standards and predicate device comparisons.

2. Sample size used for the test set and the data provenance

This information is not provided in the document. The document describes a physical medical device (surgical suture), not a software or AI/ML device that would typically involve test sets of data. The testing mentioned (USP Tensile Strength, bacterial endotoxin) would involve physical samples of the suture, but the sample sizes for these tests are not specified, nor is the "data provenance" as it would apply to data in an AI context.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

This information is not applicable to this document. This is a physical medical device submission, not an AI/ML device where "experts" would establish ground truth for a test set. The "ground truth" for a suture would be its physical properties, which are measured using standardized methods.

4. Adjudication method for the test set

This information is not applicable to this document. Adjudication methods like "2+1, 3+1" are relevant for AI/ML device studies where discrepancies in expert labels or model predictions need resolution. For a physical device, performance is measured against established standards.

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

This information is not applicable to this document. An MRMC study is relevant for AI/ML devices that assist human readers (e.g., radiologists interpreting images). This device is a surgical suture, which does not involve human "readers" or AI assistance in that context.

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

This information is not applicable to this document. The device is a surgical suture; it is not an algorithm and does not have "standalone" performance in the context of AI.

7. The type of ground truth used

For the physical characteristics of the suture, the "ground truth" is established by adherence to established industry standards and test methods, specifically:

• USP Tensile Strength for Surgical Sutures
• FDA's Special Controls Guidance document for Surgical Sutures
• Requirements for bacterial endotoxin testing

8. The sample size for the training set

This information is not applicable and not provided. This is a physical medical device, not an AI/ML device requiring a "training set" of data in the common sense. The manufacturing process of the suture is the "training" in a very loose analogy, but it's not a data-driven training set.

9. How the ground truth for the training set was established

This information is not applicable and not provided. As explained above, this device does not utilize a "training set" in the context of AI/ML. The "ground truth" for the manufacturing process would be established by quality control procedures and specifications for materials and manufacturing methods, but these details are not provided in this regulatory summary.

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