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The RoG™ 5.5 mm Suture Anchor is indicated for soft tissue reattachment procedures in the shoulder, elbow, wrist/hand, foot/ankle and knee. Specific indications are as follows:

. Shoulder indications: - Bankart repair, rotator cuff repair, SLAP lesion repair, capsule repair or capsulolabral reconstruction, acromio-clavicular separation, deltoid repair, biceps tenodesis.
Wrist/hand indications: Ulnar/Radial collateral ligament reconstruction, . scapholunate ligament reconstruction.
Eoot/Ankle indications: Achilles tendon repair/reconstruction, hallax valgus . reconstruction, lateral stabilization, medial stabilization, mid- and forefoot reconstructions.
. Elbow indications: - Biceps tendon reconstruction, ulnar or radial collateral ligament reconstruction, lateral epicondylitis repair.
Knee indications: Lateral collateral ligament repair, medial collateral ligament . repair, posterior oblique ligament repair, patellar ligament/tendon repair, iliotibial band tenodesis, joint capsule closure.

The RoG 2.9mm Suture Anchor is indicated for use in soft tissue reattachment procedures. Specific indications are as follows:

Shoulder indications: Bankart repair, rotator cuff repair, SLAP lesion repair, . capsule repair or capsulolabral reconstruction, acromio-clavicular separation, deltoid repair, biceps tenodesis.
Wrist/hand indications: Scapholunate ligament reconstruction. .
Elbow indications: Biceps tendon reconstruction, ulnar or radial collateral . ligament reconstruction.
Knee indications: Lateral collateral ligament repair, medial collateral ligament . repair, posterior oblique ligament repair, patellar ligament/tendon repair, iliotibial band tenodesis, joint capsule closure, extracapsular repair, vastus medialis obliquus (VMO) muscle advancement.

The RoG 5.5 mm Knotless Suture Anchor is indicated for soft tissue reattachment procedures in the shoulder, elbow, wrist/hand, foot/ankle and knee. Specific indications are as follows:

Shoulder indications: Bankart repair, rotator cuff repair, SLAP lesion repair, . capsule repair or capsulolabral reconstruction, acromio-clavicular separation, deltoid repair, biceps tenodesis.
Wrist/Hand indications: Ulnar/Radial collateral ligament reconstruction, . scapholunate ligament reconstruction.
Foot/Ankle indications: Achilles tendon repair/reconstruction, hallax valgus . reconstruction, lateral stabilization, medial stabilization, mid- and forefoot reconstructions.
Elbow indications: Biceps tendon reconstruction, ulnar or radial collateral . ligament reconstruction, lateral epicondylitis repair.
Knee indications: Lateral collateral ligament repair, medial collateral ligament . repair, posterior oblique ligament repair, patellar ligament/tendon repair, iliotibial band tenodesis, joint capsule closure.

Device Description

The subject device is screw-like in shape and composed exclusively of PEEK plastic. It is available in both standard ("knotted") and "knotless" configurations. It is also available in diameters of 5.5mm and 2.9mm and lengths of 10mm and 17mm. It is provided sterile and supplied with non-absorbable polyethylene suture. The anchor is supplied with reusable taps and guides of corresponding size.

AI/ML Overview

Here's an analysis of the provided text regarding the RoGTM Sports Medicine Suture Anchor, focusing on acceptance criteria and supporting studies:

It's important to note that the provided text is a 510(k) Summary for a medical device seeking substantial equivalence to a predicate device. This type of submission relies heavily on demonstrating that the new device is as safe and effective as a previously cleared device, rather than requiring extensive de novo clinical trials with rigorous acceptance criteria for novel performance.

Therefore, the information regarding "acceptance criteria" and "study that proves the device meets the acceptance criteria" will be focused on comparative performance to the predicate device and compliance with relevant standards, rather than clinical efficacy metrics typical of AI/software devices.

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Specific Criteria	Reported Device Performance	Comments
Design & Materials	Screw-like shape, PEEK plastic composition (5.5mm, 2.9mm diameters; 10mm, 17mm lengths), standard ("knotted") and "knotless" configurations, supplied with non-absorbable polyethylene suture, reusable taps and guides.	The device is screw-like in shape, composed exclusively of PEEK plastic. It is available in the described diameters and lengths in both standard and knotless configurations. It is supplied with non-absorbable polyethylene suture and reusable taps/guides.	Device design and material specifications match the description, implying compliance with the intended design.
Intended Use & Indications	Same indications for soft tissue reattachment procedures in shoulder, elbow, wrist/hand, foot/ankle, and knee as the predicate device (K111590).	The subject device lists identical specific indications for use across all three configurations (5.5mm, 2.9mm, 5.5mm Knotless) as those listed in the predicate device’s 510(k).	The intended use and indications are declared to be the same as the predicate device, establishing equivalence in clinical applicability.
Performance Characteristics	Performance characteristics should be equivalent to those described in K111590. Sutures supplied must meet U.S. Pharmacopeia requirements for non-absorbable suture and Class II Special Controls Guidance Document (Surgical Sutures; June 3, 2003).	"Performance characteristics of the anchors have not changed from those described in K111590." "Sutures supplied with the device meet the requirements of the U.S. Pharmacopeia for non-absorbable suture as well as all requirements of Class II Special Controls Guidance Document: Surgical Sutures; Guidance for Industry and FDA; June 3, 2003."	The device performance is deemed equivalent to the predicate, and the sutures meet the specified standards. This is a crucial statement for establishing substantial equivalence.
Safety Characteristics (Biocompatibility)	Device components (PEEK) must be safe per ISO 10993.	A Master File from the PEEK supplier demonstrates safety and compliance with ISO 10993.	The material's safety has been confirmed through regulatory standards.
Safety Characteristics (Sterilization)	Sterilization methods must comply with ISO 11135. Sterilant residues must be within limits of ISO 10993-7.	Sterilization is in compliance with ISO 11135. Sterilant residues are within the limits of ISO 10993-7.	Sterilization processes and residue levels comply with established international standards.
Expiration Date Extension	Anchor, suture, and packaging must be stable for the proposed extended period.	"Testing has shown the anchor, suture and packaging to be stable for the proposed period."	This is the specific "study" mentioned, confirming the stability for the extended shelf life.

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

The provided text does not specify a sample size for a "test set" or provide details on data provenance (e.g., country of origin, retrospective/prospective clinical data).

This is because the submission is for a material/design modification and an expiration date extension of an already cleared device (K111590). The focus is on demonstrating equivalence and stability, not on collecting new clinical performance data from a "test set" in the context of an AI/software device. The "testing" mentioned is likely focused on bench testing (e.g., tensile strength, degradation studies) for the expiration date extension.

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 and not provided in the document. This type of detail (expert consensus, qualifications) is common for AI/software devices where human experts establish ground truth for image interpretation or diagnosis. For a physical device like a suture anchor, "ground truth" is established by engineering specifications, material properties, and standardized testing.

4. Adjudication Method (e.g., 2+1, 3+1, none) for the Test Set

This information is not applicable and not provided. Adjudication methods are typically used in clinical studies or performance evaluation of diagnostic/AI devices where inter-observer variability needs to be resolved to establish a robust ground truth.

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

There was no MRMC comparative effectiveness study done. This is a physical, implantable medical device, not an AI/software device intended to assist human readers or clinicians in diagnosis or interpretation. The concept of "human readers improving with AI assistance" is not relevant here.

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

There was no standalone performance study in the context of an algorithm or AI. This is a physical medical device.

7. The Type of Ground Truth Used

For this physical device, the "ground truth" is established by:

Engineering Specifications: The design, dimensions, and materials of the suture anchor.
Material Standards: Compliance with ISO 10993 for biocompatibility of PEEK.
Sterilization Standards: Compliance with ISO 11135 and ISO 10993-7.
Suture Standards: Compliance with U.S. Pharmacopeia and FDA Class II Special Controls Guidance for Surgical Sutures.
Predicate Device Performance: The established safety and effectiveness of the legally marketed predicate device (K111590) serves as the "ground truth" for the overall device functionality and intended use.
Stability Testing: (Likely bench testing) to confirm the stability of the anchor, suture, and packaging over the extended shelf life.

8. The Sample Size for the Training Set

This information is not applicable and not provided. "Training set" refers to data used to train machine learning models, which is not relevant for this physical medical device submission.

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

This information is not applicable and not provided. As there is no training set for an AI model, there is no ground truth established for one.

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