The Extremity Medical Suture Anchor is intended for the fixation of soft tissue to bone in shoulder. foot/ ankle, knee, hand/wrist, and elbow in the following procedures:

Shoulder: Rotator Cuff Repair, Bankart Repair, Biceps Tenodesis, Acromio-Clavicular Separation Repair, Deltoid Repair. Capsular Shift of Capsulolabral Reconstruction.

Foot/Ankle: Lateral Stabilization, Medial Stabilization, Achilles Tendon Repair, Hallux Valgus Reconstruction, Mid-foot reconstruction, Metatarsal Ligament Repair/Tendon Repair, Bunionectomy.

Knee: Medial Collateral Ligament Repair. Lateral Ligament Repair. Patellar Tendon Repair. Posterior Oblique Ligament Repair, Iliotibial Band Tenodesis.

Hand/Wrist: Scapholunate Ligament Reconstruction, Ulnar or Radial Collateral Ligament Reconstruction.

Elbow: Biceps Tendon Reattachment, Tennis Elbow Repair, Ulnar or Radial Collateral Ligament Reconstruction.

Device Description

The Extremity Medical Suture Anchor is an implantable device manufactured from Titanium Alloy (6AL-4V ELI, per ASTM F136). The suture anchor is preloaded with two or three sutures depending on the size of the anchor. The suture material is Size #2 Teleflex Force Fiber. The device is recommended to be used for the repair of soft tissue to bone. The suture anchor and sutures are assembled to an inserter which is used to screw the anchor into bone. The product is provided pre-packaged and sterile via EtO sterilization.

AI/ML Overview

The provided document is a 510(k) premarket notification for the Extremity Medical Suture Anchor, a medical device used for the fixation of soft tissue to bone. The document does not describe the acceptance criteria or the study that proves the device meets the acceptance criteria in the manner requested. Instead, it focuses on demonstrating substantial equivalence to a predicate device.

Here's an analysis based on the information provided in the document, highlighting why the requested information about AI/algorithm performance and ground truth is not applicable or present:

The device in question, the "Extremity Medical Suture Anchor," is a physical implantable device, not an AI or algorithmic medical device. Therefore, many of the requested categories related to AI performance, ground truth, training sets, and expert adjudication are not relevant to this type of medical device submission.

However, I can extract information related to the physical device's testing:

Device Acceptance Criteria and Performance (as applicable for a physical medical device):

Acceptance Criteria (Implied)	Reported Device Performance (Implied from substantial equivalence)
Equivalent Indications for Use	The modified Suture Anchor and predicate devices are equivalent in terms of indications for use.
Equivalent Design	The modified Suture Anchor and predicate devices are equivalent in terms of design.
Equivalent Material Mechanical Properties	The modified Suture Anchor and predicate devices are equivalent in terms of material mechanical properties.
Satisfactory Pull-out Strength	Bench testing, including pull-out strength, was performed and compared to the predicate device. (The report implies satisfactory performance by concluding substantial equivalence, but specific numerical criteria or results are not provided.)

Explanation Regarding AI/Algorithm-Specific Questions:

Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective):
- Not Applicable. This is a physical medical device. The "test set" in this context refers to bench testing of the physical implant, not a data set for an algorithm.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience):
- Not Applicable. There is no "ground truth" to establish for an AI algorithm. Bench testing for pull-out strength would involve engineering and materials science experts and validated testing methodologies, but not clinical "ground truth" in the AI sense.
Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not Applicable. Again, this is for a physical device, not an AI algorithm.
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:
- Not Applicable. This device is not an AI diagnostic tool that human readers would interact with.
If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- Not Applicable. This is a physical implantable device.
The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- Not Applicable. The "ground truth" for a physical device's performance relies on validated engineering tests (e.g., ASTM standards for mechanical properties) and comparison to predicate devices, not clinical or pathological ground truth in the context of diagnostic algorithms.
The sample size for the training set:
- Not Applicable. This is a physical device, no training data for an algorithm.
How the ground truth for the training set was established:
- Not Applicable. This is a physical device, no training data or ground truth for an algorithm.

Summary of what the document does state regarding testing:

Study Type: Non-clinical bench testing was performed.
Specific Tests: Pull-out strength testing was explicitly mentioned.
Comparison: The results of the bench testing were compared to the predicate device (K083151 - Suture Anchor from Extremity Medical).
Clinical Testing: "No clinical testing was performed."
Conclusion: The submission concludes that the modified Suture Anchor is "substantially equivalent" to its predicate device based on indications for use, materials, design, and test data (including the unspecified pull-out strength results) and principles of operation. This "substantial equivalence" is the regulatory criterion met, rather than specific performance metrics against pre-defined acceptance criteria, which are not detailed in this summary.

Summary

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

February 23, 2015

Extremity Medical, LLC Mr. Brian Smekal Director, Regulatory Affairs 300 Interpace Parkway, Suite 410 Parsippany, New Jersey 07054

Re: K150166

Trade/Device Name: Extremity Medical 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: January 22, 2015 Received: January 26, 2015

Dear Mr. Smekal:

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

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Page 2 - Mr. Brian Smekal

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/Resourcesfor You/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 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 vours.

Mark N. Melkerson -S

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

Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.

510(k) Number (if known)

K150166

Device Name Extremity Medical Suture Anchor

Indications for Use (Describe)

The Extremity Medical Suture Anchor is intended for the fixation of soft tissue to bone in shoulder. foot/ ankle, knee, hand/wrist, and elbow in the following procedures:

Shoulder: Rotator Cuff Repair, Bankart Repair, Biceps Tenodesis, Acromio-Clavicular Separation Repair, Deltoid Repair. Capsular Shift of Capsulolabral Reconstruction.

Foot/Ankle: Lateral Stabilization, Medial Stabilization, Achilles Tendon Repair, Hallux Valgus Reconstruction, Mid-foot reconstruction, Metatarsal Ligament Repair/Tendon Repair, Bunionectomy.

Knee: Medial Collateral Ligament Repair. Lateral Ligament Repair. Patellar Tendon Repair. Posterior Oblique Ligament Repair, Iliotibial Band Tenodesis.

Hand/Wrist: Scapholunate Ligament Reconstruction, Ulnar or Radial Collateral Ligament Reconstruction.

Elbow: Biceps Tendon Reattachment, Tennis Elbow Repair, Ulnar or Radial Collateral Ligament Reconstruction.

Type of Use (Select one or both, as applicable)

Prescription Use (Part 21 CFR 801 Subpart D)

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

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

FOR FDA USE ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

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*DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW."

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Special 510(k) Summary of Safety and Effectiveness:

Suture Anchor

Submitter:	Extremity Medical, LLC.300 Interpace ParkwaySuite 410Parsippany, NJ 07054
Contact Person	Brian Smekal, MS, RACDirector, Regulatory AffairsPhone: (973) 588-8988Email: bsmekal@extremitymedical.com
Date Prepared	January 22, 2015
Trade Name	Extremity Medical Suture Anchor
Classification Nameand Number	Smooth or threaded metallic bone fixation fastener21 CFR 888.3040
Product Code	MBI (fastener, fixation, nondegradable, soft tissue)
Predicate Devices	K083151 - Suture Anchor (Extremity Medical)
Device Description	The Extremity Medical Suture Anchor is an implantable device manufacturedfrom Titanium Alloy (6AL-4V ELI, per ASTM F136). The suture anchor ispreloaded with two or three sutures depending on the size of the anchor. Thesuture material is Size #2 Teleflex Force Fiber. The device is recommended to beused for the repair of soft tissue to bone. The suture anchor and sutures areassembled to an inserter which is used to screw the anchor into bone. Theproduct is provided pre-packaged and sterile via EtO sterilization.
Indications for use	The Extremity Medical Suture Anchor is intended for the fixation of sutureand/or soft tissue to bone in the shoulder, foot/ankle, knee, hand/wrist, andelbow in the following procedures:Shoulder: Rotator Cuff Repairs, Bankart Repair, SLAP Lesion Repair, BicepsTenodesis, Acromio-Clavicular Separation Repair, Deltoid Repair, CapsularShift of Capsulolabral Reconstruction.Foot/Ankle: Lateral Stabilization, Medial Stabilization, Achilles Tendon Repair,Hallux Valgus Reconstruction, Mid-foot reconstruction, Metatarsal LigamentRepair/Tendon Repair, Bunionectomy.Knee: Medial Collateral Ligament Repair, Lateral Collateral Ligament Repair,Patellar Tendon Repair, Posterior Oblique Ligament Repair, Iliotibial BandTenodesis.Hand/Wrist: Scapholunate Ligament Reconstruction, Ulnar or Radial CollateralLigamentReconstruction
	Elbow: Biceps Tendon Reattachment, Tennis Elbow Repair, Ulnar or RadialCollateral Ligament Reconstruction.
Statement ofTechnologicalComparison	The modified Suture Anchor and predicate devices are equivalent in terms ofindications for use, design, and material mechanical properties.
Non-clinical Testing	Bench testing, including pull-out strength was performed and compared to thepredicate device.
Clinical Testing	No clinical testing was performed.
Conclusion	The modified Suture Anchor is substantially equivalent to its predicate device.This conclusion is based upon indications for use, materials, design, test data andprinciples of operation.

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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.