The MedShape, Inc., ExoShape Duo Soft Tissue Fastener is intended for fixation of soft tissue to bone in the shoulder, foot/ankle, knee, hand/wrist and elbowing procedures:

Shoulder. Rotator Cuff Repairs, Bankart Repair, SLAP Lesion Repair, Biceps Tenodesis, Acromio-Clavicular Separation Repair, Deltoid Repair. Capsular Shift or Capsulolabral Reconstruction
Foot/Ankle: Lateral Stabilization, Medial Stabilization, Achilles Tendon Repair, Hallux Valgus Reconstruction, Mid-foot Reconstruction, Metatarsal Ligament Repair. Flexor Hallucis Longus for Achilles Tendon Reconstruction and Tendon Transfers
Knee: Cruciate Ligament Repair, Medial Collateral Ligament Repair, Lateral Collateral Ligament Repair. Patellar Tendon Repair. Posterior Oblique Ligament Repair, Iliotibial Band Tenodesis
Elbow. Biceps Tendon Reattachment and Ulnar or Radial collateral Ligament Reconstruction
Hand/Wrist Scapholunate Ligament Reconstruction, Ulnar Collateral Ligament Reconstruction. Radial Collateral Ligament Reconstruction. Carpometacarpal Joint Arthroplasty (basal thumb joint arthroplasty), Carpal Ligament Reconstructions and Repairs and Tendon Transfers

Device Description

The proposed ExoShape® Duo Soft Tissue Fastener is a sterile, single use, orthopedic implant intended to be used for fixation of tissue including ligament or tendon to bone and bone tendon bone. The ExoShape® Duo Soft Tissue Fastener is designed to use the principles of both interference fit and bearing area to reattach soft tissue intended for insertion into a hole created in bone,
The ExoShape® Duo Soft Tissue Fastener body is comprised of two interlocking PEEK. Both components are expanded into the bone hole. compressing the soft tissue against the bone wall and locking the implant to the bone; fastening the assembly into place.

AI/ML Overview

The provided FDA 510(k) summary for the MedShape ExoShape® Duo Soft Tissue Fastener describes the device and its indications for use, but it does not contain the detailed performance study information requested to fill out the table and answer all the questions.

The document states: "functional performance testing has been conducted in Sawbone® bone analoque. This testing included monotonic soft tissue fixation strength (pull-to-failure) and other dimensional verification and material safety testing (both bio and MRI compatibility). Analysis of the results supports the conclusion that the proposed device is substantially equivalent to the predicate devices."

However, it does not provide:

Specific acceptance criteria values (e.g., minimum pull-out strength in Newtons).
Reported device performance values against those criteria.
Details about the study design beyond "monotonic soft tissue fixation strength (pull-to-failure)".
Sample sizes used for testing.
Information about expert involvement for ground truth, adjudication methods, or comparative effectiveness studies with human readers, as this is a physical medical device, not an AI/software device.
Specific ground truth types (other than implied physical measurements).
Any information regarding training sets, as it's a physical device, not a machine learning model.

Therefore, I can only provide a partial answer based on the available text.

Acceptance Criteria and Device Performance

The document broadly mentions functional performance testing to establish substantial equivalence. However, it does not explicitly list quantitative acceptance criteria or the specific numerical performance results of the ExoShape® Duo Soft Tissue Fastener in a table format. It simply states that analysis of the results supports substantial equivalence.

Acceptance Criteria (Not explicitly stated in document)	Reported Device Performance (Not explicitly stated in document)
Expected: - Monotonic soft tissue fixation strength (pull-to-failure) meeting or exceeding predicate devices.	Implied: - Met or exceeded the performance of predicate devices in monotonic soft tissue fixation strength.
Expected: - Dimensional verification	Implied: - Dimensions were verified to be appropriate.
Expected: - Material safety (biocompatibility)	Implied: - Found to be biocompatible.
Expected: - MRI compatibility	Implied: - Found to be MRI compatible.

Study Details (Based on available information)

Sample size used for the test set and the data provenance:
- Sample Size: Not specified in the provided text.
- Data Provenance: The testing was conducted in "Sawbone® bone analogue," which implies a laboratory, in-vitro setting, rather than human or animal data. No country of origin for the data is mentioned. The study is experimental (performance testing), not retrospective or prospective in a clinical sense.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable as this is a physical device being tested for mechanical properties, not an AI/software requiring expert adjudication for ground truth.
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable as this is a physical device. Ground truth would be based on direct measurement of physical properties.
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 is a physical orthopedic implant, not an AI-assisted diagnostic tool.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is a physical device performing a mechanical function. Its performance is inherently standalone in that it's the device itself being tested, not an algorithm.
The type of ground truth used:
- The ground truth would be based on physical measurements of performance (e.g., force required for pull-out, dimensional accuracy) derived from the "monotonic soft tissue fixation strength (pull-to-failure)" and "dimensional verification" tests.
The sample size for the training set:
- Not applicable. This is a physical device, not an AI/machine learning model, so there is no training set.
How the ground truth for the training set was established:
- Not applicable. As above, there is no training set for a physical device.

Summary

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Image /page/0/Picture/1 description: The image shows the logo for MedShape. The logo consists of a stylized letter "M" with a square on top and a circle on the bottom. To the right of the logo is the word "MEDSHAPE" in block letters. The logo is black and white.

Traditional 510(k) Page 10 of 91

510(k) Summary

Date Submitted: September 5, 2013

This 510(k) summary is being submitted in accordance with the requirements of 21 CFR 807.92(e).

Submitter: A. MedShape. Inc. 1575 Northside Drive, Suite 440 Atlanta, Georgia 30318
B. Company Contact: Stephen Laffoon Sr. Research & Development Engineer (678) 235-3324 (direct) (404) 249-9158 (fax) stephen.laffoon@medshape.com
். Device Information: ExoShape® Duo Soft Tissue Fastener Trade Name(s):

Common Name(s): Fastener, Fixation, bone

D. Classification Name: Fastener, Fixation, Non-degradable, Soft Tissue HWC/MBI 21 CFR 888.3040
E. Predicate Device(s): MedShape, Inc., ExoShape® Soft Tissue Anchor, K101808 & K111471 MedShape, Inc., Eclipse™ Soft Tissue Fastener, K123350

L Physical Description:

The ExoShape® Duo Soft Tissue Fastener body is comprised of two interlocking PEEK. Both components are expanded into the bone hole. compressing the soft tissue against the bone wall and locking the implant to the bone; fastening the assembly into place.

G. Indications for Use:
The ExoShape® Duo Soft Tissue Fastener is indicated for fixation of soft tissue to bone in the shoulder, foot/ankle, knee, hand/wrist and elbow in the following procedures:

1575 Northside Drive, Suite 440, Atlanta, GA 30318 678-235-3311 phone 404-249-9158 fax

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K132783 (2/2)

Traditional 510(k) Page 11 of 91

Shoulder: Rotator Cuff Repairs, Bankart Repair, SLAP Lesion Repair, Tenodesis, Acromio-Clavicular Separation Repair. Biceps Deltoid Repair, Capsular Shift or Capsulolabral Reconstruction
Stabilization, Medial Stabilization, Achilles Tendon Lateral Foot/Ankle: Repair. Hallux Valgus Reconstruction. Mid-foot Reconstruction, Metatarsal Ligament Repair, Flexor Hallucis Longus for Achilles Tendon Reconstruction and Tendon Transfers
Cruciate Ligament Repair, Medial Collateral Ligament Repair, Knee: Lateral Collateral Ligament Repair, Patellar Tendon Repair, Posterior Oblique Ligament Repair, Illiotibial Band Tenodesis
Biceps Tendon Reattachment and Ulnar or Radial collateral Elbow: Ligament Reconstruction
Hand/Wrist: Scapholunate Ligament Reconstruction, Ulnar Collateral Reconstruction, Ligament Radial Collateral Ligament Reconstruction, Carpometacarpal Joint Arthroplasty (basal thumb joint arthroplasty), Carpal Ligament Reconstructions and Repairs and Tendon Transfers
H. Comparison of Technological Characteristics: The ExoShape® Duo Soft Tissue Fastener is substantially equivalent in function and intended use to the following predicate devices:

MedShape, Inc., ExoShape® Soft Tissue Anchor, K101808 & K111471 MedShape, Inc., Eclipse™ Soft Tissue Fastener, K123350

All fasteners are comprised of implant grade PEEK. All fasteners have the same indications for use. In addition, functional performance testing has been conducted in Sawbone® bone analoque. This testing included monotonic soft tissue fixation strength (pull-to-failure) and other dimensional verification and material safety testing (both bio and MRI compatibility). Analysis of the results supports the conclusion that the proposed device is substantially equivalent to the predicate devices.

9/9/13

Stephen Laffoon Sr. Research & Development Engineer

Image /page/1/Picture/12 description: The image shows the logo for Medshape. The logo consists of a stylized letter "a" with a square on top, followed by the word "MEDSHAPE" in block letters. The logo is in black and white.

1575 Northside Drive, Suite 440 Atlanta, GA 30318 877-343-7016 phone 404-249-9158 fax

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DEPARTMENT OF HEALTH & HUMAN SERVICES

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 or bird-like symbol with three curved lines representing its body and wings. The logo is surrounded by text that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" in a circular arrangement.

Public Health Service

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

December 9, 2013

MedShape, Incorporated Mr. Stephen Laffoon Senior Research & Development Engineer 1575 Northside Drive Northwest, Suite 440 Atlanta, Georgia 30318

Re: K132783

Trade/Device Name: ExoShape® Duo Soft Tissue Fastener Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: Class II Product Code: MBI, HWC Dated: September 5, 2013 Received: September 12, 2013

Dear Mr. Laffoon:

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. Stephen Laffoon

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 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" (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/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,

Ronald P. Jean -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 :

510(k) Number: _K132783

Device Name: ExoShape® Duo Soft Tissue Fastener

Indications for Use:

The MedShape, Inc., ExoShape Duo Soft Tissue Fastener is intended for fixation of soft tissue to bone in the shoulder, foot/ankle, knee, hand/wrist and elbowing procedures:

Shoulder. Rotator Cuff Repairs, Bankart Repair, SLAP Lesion Repair, Biceps Tenodesis, Acromio-Clavicular Separation Repair, Deltoid Repair. Capsular Shift or Capsulolabral Reconstruction
Foot/Ankle: Lateral Stabilization, Medial Stabilization, Achilles Tendon Repair, Hallux Valgus Reconstruction, Mid-foot Reconstruction, Metatarsal Ligament Repair. Flexor Hallucis Longus for Achilles Tendon Reconstruction and Tendon Transfers
Cruciate Ligament Repair, Medial Collateral Ligament Repair, Lateral Knee: Collateral Ligament Repair. Patellar Tendon Repair. Posterior Oblique Ligament Repair, Iliotibial Band Tenodesis
Biceps Tendon Reattachment and Ulnar or Radial collateral Ligament Elbow. Reconstruction
Hand/Wrist Scapholunate Ligament Reconstruction, Ulnar Collateral Ligament Reconstruction. Radial Collateral Ligament Reconstruction. Carpometacarpal Joint Arthroplasty (basal thumb joint arthroplasty), Carpal Ligament Reconstructions and Repairs and Tendon Transfers

Prescription Use × AND/OR (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 OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Casey L. Hanley, Ph.D.

Page 1 of 1

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.