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.

Summary

{0}------------------------------------------------

510(k) SUMMARY

Premarket Notification: K112991

December 8, 2011

(1/3)

DEVICE: RoGTM Sports Medicine Suture Anchor

SPONSOR/MANUFACTURER:

RoG Sports Medicine, Inc. 16450 S. 104th Ave. Orland Park, IL 60467

SUMBITTER/REGULATORY CONTACT:

Curtis Raymond Orchid Design 80 Shelton Technology Center Shelton, CT 06484

FDA ESTABLISHMENT REGISTRATION NUMBER: (pending)

TRADE NAME, COMMON NAME, CLASSIFICATION:

TRADE NAME: Modified RoG™ Suture Anchor

COMMON NAME: Suture Anchor

CLASSIFICATION: Class II (ref.: 21 CFR 888.3040); Product Code MBI

PREDICATE DEVICE(S):

K111590 RoGTM Suture Anchor .

DESCRIPTION OF SUBJECT DEVICE:

INTENDED USE:

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.

{1}------------------------------------------------

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.

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 RoGTM 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.

PERFORMANCE CHARACTERISTICS:

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

{2}------------------------------------------------

Controls Guidance Document: Surgical Sutures; Guidance for Industry and FDA; June 3, 2003"

SAFETY CHARACTERISTICS:

The device is composed exclusively of polyetheretherketone (PEEK). A Master File demonstrating safety of the material has been supplied by the PEEK supplier and shows compliance to the requirements of ISO 10993. Sterilization of the device is in compliance with ISO 11135. Sterilant residues are within the limits of ISO 10993-7.

CONCLUSION(S):

The subject device has the same design considerations, assembly configurations, performance characteristics and indications for use as the predicate device. The proposed modification consists solely of extending the current expiration date. Testing has shown the anchor, suture and packaging to be stable for the proposed period.

{3}------------------------------------------------

DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle or bird-like symbol with three curved lines representing its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular fashion around the symbol.

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

RoG Sports Medicine, Inc. % Orchid Design Mr. Curtis Raymond 80 Shelton Technology Center Shelton, Connecticut 06484

DEC- = 8 2011

Re: K112991

Trade/Device Name: RoGTM Suture Anchor Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: Class II Product Code: MBI Dated: November 7, 2011 Received: November 8, 2011

Dear Mr. Raymond:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food. Drug. and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set

{4}------------------------------------------------

Page 2 - Mr. Curtis Raymond

forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportalProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, international and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours.

Sincerely yours,

Mark N. Melkerson

Director Division of Surgical, Orthopedic, and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{5}------------------------------------------------

Indications for Use

510(k) Number (if known): K

Device Name: RoGTM Suture Anchor

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.

{6}------------------------------------------------

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.

Prescription Use X AND/OR Over-The-Counter Use (Part 21 CFR 801 Subpart D) (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Michael Owens to MXM

(Division Sign-Oft) Division of Surgical, Orthopedic, and Restorative Devices

510(k) Number K112991

Regulation Number and Section

§ 888.3040 Smooth or threaded metallic bone fixation fastener.

(a)
Identification. A smooth or threaded metallic bone fixation fastener is a device intended to be implanted that consists of a stiff wire segment or rod made of alloys, such as cobalt-chromium-molybdenum and stainless steel, and that may be smooth on the outside, fully or partially threaded, straight or U-shaped; and may be either blunt pointed, sharp pointed, or have a formed, slotted head on the end. It may be used for fixation of bone fractures, for bone reconstructions, as a guide pin for insertion of other implants, or it may be implanted through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.