Ankle: Mid-foot Reconstruction
Foot: Hallux valgus reconstruction
Hand: Ulnar or lateral collateral ligament reconstruction
Wrist: Scapholunate ligament reconstruction

Device Description

The implant system includes a 1.7mm diameter PEEK (polyether-etherketone) anchor. pre-mounted on a disposable inserter. The anchor is preloaded with USP size 0 Ultra High Molecular Weight Polyethylene suture. The device is designed to be inserted into a pre-formed hole using a single use disposable awl

AI/ML Overview

The provided text includes a 510(k) summary for the A.I.M.™ Suture Anchor, but it does not contain information about acceptance criteria or a study proving the device meets acceptance criteria. Instead, it focuses on demonstrating substantial equivalence to predicate devices. The study mentioned specifically details "anchor pull-out forces are equivalent or superior to a referenced predicate device", but it does not specify acceptance criteria or the full details of this study to meet your requested information.

Therefore, I cannot provide the requested table and study details. The document is primarily a regulatory submission for substantial equivalence.

Here's a breakdown of why I cannot fulfill your request based on the provided text:

Acceptance Criteria and Reported Performance: The document states, "Data have been provided in the submission that demonstrates that the anchor pull-out forces are equivalent or superior to a referenced predicate device." This indicates a performance metric (pull-out force) was evaluated and compared to a predicate, but neither specific numerical acceptance criteria nor the precise "reported device performance" values are provided.
Study Details (Sample size, data provenance, experts, adjudication, MRMC, standalone, ground truth, training set): The document mentions "anchor pull-out forces" were tested, but it does not offer any details about the study design, such as:
- Sample size for test set
- Data provenance (country, retrospective/prospective)
- Number or qualifications of experts
- Adjudication method
- MRMC comparative effectiveness study or effect size
- Standalone algorithm performance
- Type of ground truth used
- Sample size for the training set
- How ground truth for the training set was established

The submission's focus is on declaring substantial equivalence based on material history and general performance comparison to predicates, rather than presenting a detailed performance study with explicit acceptance criteria for a new type of device or an AI/software component, which is what your questions suggest.

Summary

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OCT 1 6 2013

510(k) SUMMARY OF SAFETY AND EFFECTIVENESS (Per 21 CFR 807.92)

General Company Information

Name: Anchor Innovation Medical, Inc.

Howard Schrayer Contact: Regulatory Consultant

Address: Anchor Innovation Medical, Inc. 5410 Edson Lane, Suite 308 Rockville, MD 20852

Telephone:	978-969-0070
Fax:	978-969-0169
Date Prepared	October 7, 2013

General Device Information

Product Name: A.I.M.™ Suture Anchor

Classification: "Non-degradable soft tissue fixation fastener" Product code: MBI - Class II

Predicate Device

Smith & Nephew, Inc.	Bioraptor™ 2.3 PK Suture Anchor.[510(k) Number K071586]
Mitek, Inc.	MiniLok Quick Anchor Plus™Suture Anchor[510(k) K030995]

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Description

Intended Use (Indications)

The A.I.M. ™ Suture Anchor is intended for use in arthroscopic, mini-open or open surgical procedures for fixation of soft tissue to bone.

The A.I.M. ™ Suture Anchor is intended for use in the following applications:

Ankle: Mid-foot Reconstruction .
Foot: Hallux valgus reconstruction o
Hand: Ulnar or lateral collateral ligament reconstruction ●
Wrist: Scapholunate ligament reconstruction .

Substantial Equivalence

This submission supports the position that the A.I.M.™ Suture Anchor is substantially equivalent to previously cleared devices, including those listed above. Data have been provided in the submission that demonstrates that the anchor pull-out forces are equivalent or superior to a referenced predicate device. Biocompatibility of the anchor was established through reference to data on file from the provider of the PEEK material. The referenced predicate devices include the same range of clinical uses in their labeling.

Conclusions

Anchor Innovation Medical, Inc. believes that the information provided establishes that similar legally marketed devices have been used for the same clinical applications as the A.J.M.™ Suture Anchor. The materials from which the Anchor Innovation Medical device is fabricated have an established history of use, and the devices have been tested in accordance with applicable FDA guidelines. The A.I.M. ™ Suture Anchor is substantially equivalent to previously marketed devices.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three stripes forming its wing, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged in a circular fashion around the eagle. The logo is black and white and appears to be a scanned image.

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

October 16, 2013

Anchor Innovation Medical, Incorporation Mr. Howard Schrayer Regulatory Consultant 5410 Edson Lane, Suite 308 Rockville, Maryland 20852

Re: K132461

Trade/Device Name: A.I.M. "" 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: August 28, 2013 . Received: August 29, 2013

Dear Mr. Schrayer:

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-related adverse events) (21 CFR 803); good manufacturing practice requirements as set

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Page 2 - Mr. Howard Schrayer

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 contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree 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" (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/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 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/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Erini DKeith

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

510(k) Number (if known): K132461

Device Name: A.I.M.™ Suture Anchor

Indications For Use:

The A.I.M.™ Suture Anchor is intended for use in arthroscopic, mini-open or open surgical procedures for fixation of soft tissue to bone.

The A.I.M. ™ Suture Anchor is intended for use in the following applications:

AND/OR

Ankle: Mid-foot Reconstruction Foot: Hallux valgus reconstruction Hand: Ulnar or lateral collateral ligament reconstruction Wrist: Scapholunate ligament reconstruction

Prescription Use X (Part 21 CFR 801 Subpart D) Over-The-Counter Use (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)

Casey L. Hanley, Ph.D.
Division of Orthopedic Devices

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.