The Riverpoint Medical OrthoButton AL is intended for use in the fixation of bone and soft tissue in orthopedic procedures requiring ligament or tendon reconstruction.

Device Description

The Riverpoint Medical OrthoButton ALTM is comprised of a braided ultra-high molecular weight polyethylene ("UHMWPE") adjustable loop combine with a titanium (Ti-6Al-4V ELI per ASTM F136) plate. The device is provided sterile for single use.

AI/ML Overview

This document describes the premarket notification for the Riverpoint Medical OrthoButton AL™ device. As an AI, I am designed to extract and synthesize information related to acceptance criteria and performance studies. However, the provided document does not contain the level of detail typically found in reports of studies proving a device meets acceptance criteria, particularly for AI/machine learning medical devices. This document is a 510(k) summary for a physical medical device (bone fixation fastener), not an AI/ML diagnostic tool.

Therefore, I cannot fulfill all parts of your request as they pertain to AI/ML device studies (e.g., sample size for training/test sets, number of experts, MRMC studies, ground truth establishment for AI).

However, I can extract information regarding the performance testing performed for this physical device and its acceptance criteria, to the extent described in the document.

Here's what can be extracted and what cannot:

1. Table of acceptance criteria and reported device performance:

Acceptance Criteria Category	Specific Test/Performance Parameter (as mentioned)	Reported Device Performance
Sterilization Validation	ISO11135-1:2007 requirements	Met
Biocompatibility Testing	ISO10993-1:2009 requirements	Met
Stability Testing	ISO 11607-1:2006 (product and packaging)	Met
Usability Validation	EN62366: 2008 requirements (simulated use)	Met
Mechanical Strength	Cyclic loading	Performed as intended, acceptance criteria met
Mechanical Strength	Ultimate load to failure conditions	Performed as intended, acceptance criteria met
Pyrogenicity	LAL and rabbit pyrogenicity testing	Does not raise additional concerns regarding pyrogenicity

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

Not specified for any of the performance tests. The document broadly states "testing" was performed.
Data Provenance: Not applicable in the context of this physical device's performance testing.

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

Not applicable. This document describes performance testing for a physical bone fixation device, not a diagnostic device requiring expert interpretation of results to establish ground truth.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

Not applicable. Adjudication methods are relevant for subjective interpretations, primarily in diagnostic studies, not for the objective physical/chemical tests described here.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done:

No, not performed/applicable. MRMC studies are for evaluating diagnostic imaging devices where human readers interpret results, often with and without AI assistance. This is a physical implantable device.

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

Not applicable. This is a physical device, not an algorithm.

7. The type of ground truth used:

For the physical tests, the "ground truth" is defined by the standards themselves (e.g., ISO, EN standards for sterilization, biocompatibility, packaging, and specific mechanical testing protocols for strength and elongation). The device performance is compared against the requirements of these standards.

8. The sample size for the training set:

Not applicable. There is no "training set" as this is not an AI/ML model.

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

Not applicable. There is no training set or AI model.

In summary: The provided 510(k) summary focuses on demonstrating substantial equivalence of a physical medical device (OrthoButton AL™) to a predicate device (OrthoButton CL®) through adherence to relevant engineering and biological performance standards. It does not contain information related to AI/ML device studies, which involve different types of acceptance criteria and validation methodologies.

Summary

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Public Health Service

Image /page/0/Picture/2 description: The image is a seal for the Department of Health & Human Services - USA. The seal is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an abstract image of three human profiles facing to the right, stacked on top of each other.

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

June 2, 2017

Riverpoint Medical Mr. Nathan Cook Director of Quality Assurance 825 NE 25th Avenue Portland, Oregon 97232

Re: K171060

Trade/Device Name: OrthoButton AL TM Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: Class II Product Code: MBI Dated: May 15, 2017 Received: May 15, 2017

Dear Mr. Cook:

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

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

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related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) 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 contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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/ReportaProblem/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 Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely,

Vincent J. Devlin -S for Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use Statement

510(k) Number (if known): K171060

Device Name: OrthoButton ALTM

Indications for Use:

The Riverpoint Medical OrthoButton AL is intended for use in the fixation of bone and soft tissue in orthopedic procedures requiring ligament or tendon reconstruction.

Prescription Use _ X (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

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Image /page/3/Picture/0 description: The image contains the logo for Riverpoint Medical. The logo consists of a green square with rounded corners, inside of which are the letters "RP" in white. To the right of the square is the word "RIVERPOINT" in bold, black letters, with the word "MEDICAL" in smaller, black letters underneath.

K171060

510(k) SUMMARY

Riverpoint Medical OrthoButton® Line Extension

Submitter Information

Submitter's Name:	Riverpoint Medical
Address:	825 NE 25th Ave.Portland, OR 97232
Phone Number:	(503) 517-8001
Fax Number:	(503) 517-8002
Registration Number:	3006981798
Contact Person:	Nathan Cook(503) 517-8001
Date of Preparation:	March 31, 2017

Device Name

Trade Name:	OrthoButton ALTM
Common or Usual Names:	Suture Retention Device, Button Loop
Classification Name:	Fastener, Fixation, Non-Degradable, Soft Tissue

Device Classification

FDA Class:	II
Product Classification:	888.3040
Classification Code:	MBI
Review Panel	Orthopedic
Premarket Review	Office of Device EvaluationDivision of Orthopedic Devices (DOD)Joint and Fixation Devices Branch

Predicate Device

K160655 – Riverpoint Medical OrthoButton CL

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Image /page/4/Picture/0 description: The image contains the logo for Riverpoint Medical. The logo consists of a green square with rounded corners, inside of which are the letters "RP" in white. To the right of the square is the word "RIVERPOINT" in bold, black letters, with the word "MEDICAL" in smaller, black letters underneath.

Device Description

Intended Use / Indications for Use

The Riverpoint Medical OrthoButton AL™ is intended for use in the fixation of bone and soft tissue in orthopedic procedures requiring ligament or tendon reconstruction.

Performance Data

Non-clinical performance testing for the Riverpoint Medical OrthoButton AL 110 included sterilization validation per ISO11135-1:2007 - Sterilization of Health Care Products Ethylene Oxide Part 1: Requirements for the Development, Validation, and Routine Control of a Sterilization Process for medical devices, biocompatibility testing per ISO10993-1:2009 -Biological Evaluation of Medical Devices, stability testing on the product and packaging per ISO 11607-1:2006 - Packaging for terminally sterilized medical devices -- Part 1: Requirements for materials, sterile barrier systems and packaging systems, and simulated use Usability Validation performed per EN62366: 2008- Medical devices - Application of usability engineering to medical devices. The Riverpoint Medical OrthoButton AL™ was also evaluated for strength and elongation during cyclic loading and ultimate load to failure conditions. All acceptance criteria were met, and the Riverpoint Medical OrthoButton AL" 100 performed as intended.

Substantial Equivalence and Comparison of Technical Characteristics

The OrthoButton AL™ line extension is as safe and effective as the previously cleared OrthoButton CL®. The OrthoButton AL™ has the same intended use and indications for use, the same principles of operation, and similar technical characteristics as the predicate device. Both the OrthoButton AL 111 and the predicate device are sterilized using the same processes, are composed of the same material, and are tested per the same performance requirements. LAL and rabbit pyrogencity testing has demonstrated that the OrthoButton AL 100 does not raise any additional concerns regarding pyrogenicity. The minor difference in technical characteristics is limited to the ability for adjustment of the loop length. This difference does not raise new questions of safety or effectiveness; therefore, the OrthoButton ALTM line extension is substantially equivalent to the currently marketed predicate device.

Conclusion

The information provided in this Special 510(k) demonstrates that the Riverpoint Medical OrthoButton ALTM line extension is substantially equivalent to the predicate device.

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.