The MedShape Solutions, Inc., ShapeLoc™ Soft Tissue Fastener is intended for fixation of soft tissue to bone in the shoulder, foot/ankle, knee, hand/wrist and elbow in the following 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 Anchiles 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
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
Elbow: Biceps Tendon Reattachment and Ulnar or Radial collateral Ligament Reconstruction

Device Description

The proposed ShapeLoc™ 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 ShapeLoc™ Soft Tissue Fastener is designed to use the principles of interference fit to reattached soft tissue intended for attachment into a hole created in bone. The ShapeLoc™ Soft Tissue Fastener body is comprised of an implant grade PEEK sleeve and implant grade PEEK insert. The outer sleeve is expanded into the bone hole, compressing the soft tissue against the bone wall; fastening it into place.

AI/ML Overview

Here's an analysis of the provided text regarding the acceptance criteria and study for the ShapeLoc™ Soft Tissue Fastener:

The document provided is a 510(k) summary for a medical device called the "ShapeLoc™ Soft Tissue Fastener." This type of submission is for demonstrating substantial equivalence to a predicate device, not necessarily for proving the absolute safety and effectiveness of a novel device through extensive clinical trials. Therefore, the "acceptance criteria" and "study" described are primarily focused on demonstrating equivalence in performance characteristics to a previously cleared device.

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are not explicitly stated with specific numerical thresholds for success, as might be seen in a clinical trial protocol. Instead, the document frames the assessment around "substantial equivalence" to the predicate device, the Arthrex Interference Screw (K062466), across various functional performance tests. The performance goal is to be comparable to or better than the predicate device in relevant mechanical properties.

Acceptance Criteria (Implied)	Reported Device Performance
Functional equivalence to predicate device in tissue fixation strength	"functional performance testing has been conducted in both Sawbone® and porcine bone analogues. This testing included monotonic soft tissue fixation strength (pull-to-failure), dynamic loosening testing for the deployed assembly."
Equivalence in dynamic loosening characteristics	"dynamic loosening testing for the deployed assembly"
Dimensional verification	"dimensional verification"
Material safety (biocompatibility)	"material safety testing (both bio... compatibility)"
Material safety (MRI compatibility)	"...and MRI compatibility)"
Substantial equivalence conclusion	"Analysis of the results supports the conclusion that the proposed device is substantially equivalent to the predicate device."

2. Sample Size Used for the Test Set and Data Provenance

The document does not explicitly state the specific sample sizes used for the functional performance testing. It mentions "Sawbone® and porcine bone analogues" as the materials for testing, implying an in-vitro or ex-vivo experimental setup. The data provenance is from this laboratory testing; there is no mention of human subject data, retrospective, or prospective studies in this summary.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications

This type of information is not applicable to the data presented in this 510(k) summary. The "ground truth" for the performance testing is based on objective measurements of mechanical properties (e.g., force required for pull-to-failure, displacement during dynamic loosening) from laboratory tests on bone analogues, not on expert interpretations of clinical data. Therefore, there were no experts establishing "ground truth" in the diagnostic sense.

4. Adjudication Method for the Test Set

This is not applicable to the data presented. Adjudication methods (like 2+1, 3+1) are typically used in clinical studies where multiple human readers interpret medical images or clinical data to reach a consensus ground truth. The presented study involves objective mechanical testing, where the "truth" is derived from direct measurements and engineering analysis.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study involves human readers evaluating cases, often with and without AI assistance, to measure diagnostic performance. The 510(k) summary describes laboratory-based mechanical performance testing for substantial equivalence, not a clinical diagnostic performance study. There is no AI component mentioned in the context of human reader improvement.

6. If a Standalone (i.e. algorithm only, without human-in-the-loop performance) Study was Done

No, a standalone algorithm performance study was not done. This device is a mechanical implant, not an AI algorithm. The performance evaluation is of the fastener's mechanical properties, not an algorithm's diagnostic or predictive capabilities.

7. The Type of Ground Truth Used

The "ground truth" for the performance evaluation in this context is based on objective mechanical measurements obtained from testing the device in "Sawbone® and porcine bone analogues." This includes measurements like force (for pull-to-failure) and displacement (for dynamic loosening). This is an engineering ground truth, not a clinical ground truth like pathology, expert consensus, or outcomes data.

8. The Sample Size for the Training Set

This is not applicable. The device is a physical medical implant, not an AI model that requires a training set. The term "training set" is relevant for machine learning algorithms.

9. How the Ground Truth for the Training Set Was Established

This is not applicable, as there is no training set for a physical implant device.

Summary

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510(k) Page _ of 2

510(k) Summary

NOV - 8 2010

510(k) Number: K101808

October 28th, 2010 Date Revised:

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

A. Submitter: MedShape Solutions, Inc. 1575 Northside Drive, Suite 440 Atlanta, Georgia 30318
B. Company Contact: Jack Griffis Vice President, Research & Development (404) 249-9155 x11 (direct) (404) 249-9158 (fax) Jack.Griffis@MedShape.com
C. Device Information: ShapeLoc™ Fastener Trade Name: Common Name: Fastener, Fixation, bone, non-degradable
D. Classification Name: Fastener, Fixation, Non-degradable, Soft Tissue HWC/MBI 21 CFR 888.3040
E. Predicate Device(s): Arthrex Interference Screw, K062466

F. Physical Description:

G. Indications for Use:
The ShapeLoc™ 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:

Shoulder: Rotator Cuff Repairs, Bankart Repair, SLAP Lesion Repair, Biceps Tenodesis, Acromio-Clavicular Separation Repair. Deltoid Repair, Capsular Shift or Capsulolabral Reconstruction

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Lateral Stabilization, Medial Stabilization, Achilles Tendon Foot/Ankle: Repair, Hallux Valqus Reconstruction, Mid-foot Reconstruction, Metatarsal Ligament Repair, Flexor Hallucis Longus for Anchiles Tendon Reconstruction and Tendon Transfers
Cruciate Ligament Repair, Medial Collateral Ligament Repair, Knee: Lateral Collateral Ligament Repair, Patellar Tendon Repair, Posterior Oblique Ligament Repair, Iliotibial Band Tenodesis
Reconstruction, Ulnar Collateral Hand/Wrist: Scapholunate Ligament Ligament Reconstruction, Radial Collateral Ligament Reconstruction, Carpometacarpal Joint Arthroplasty (basal thumb joint arthroplasty), Carpal Ligament Reconstructions and Repairs and Tendon Transfers
Elbow: Biceps Tendon Reattachment and Ulnar or Radial collateral Ligament Reconstruction
H. Comparison of Technological Characteristics:

The ShapeLoc™ Soft Tissue Fastener is substantially equivalent in function and intended use to the following predicate device:

Arthrex Interference Screw, K062466

Both fasteners are comprised of implant grade PEEK. Both fasteners have the same indications for use. In addition, functional performance testing has been conducted in both Sawbone® and porcine bone analogues. This testing included monotonic soft tissue fixation strength (pull-to-failure), dynamic loosening testing for the deployed assembly 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 device.

Jack Griffis

Jack Griffis Vice President, Research & Development

Image /page/1/Picture/11 description: The image shows the word "MEDSHAPE" in a bold, sans-serif font. The letters are all capitalized and evenly spaced. A horizontal line is placed directly underneath the word, spanning its entire length.

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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 tail feathers, representing the department's commitment to health, human services, and well-being. The eagle is encircled by the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" in a circular arrangement.

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

MedShape Solutions. Inc. % Mr. Jack Griffis 1575 Northside Drive, Suite 440 Atlanta, Georgia 30318

NOV - 8 2010

Re: K101808 Trade/Device Name: ShapeLoc Fastener Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: II Product Code: HWC, MBI Dated: October 28, 2010 Received: October 29, 2010

Dear Mr. Griffis:

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. Jack Griffis

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 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/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/Resourcesfor You/Industry/default.htm.

Sincerely yours,

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

Enclosure

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Indications for Use

510(k) Number: KID| 808

NOV - 8 2010

Device Name: ShapeLoc™ Soft Tissue Fastener

Indications for Use:

The MedShape Solutions, Inc., ShapeLoc™ Soft Tissue Fastener is intended for fixation of soft tissue to bone in the shoulder, foot/ankle, knee, hand/wrist and elbow in the following procedures:

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

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) mitte mxm (Division Sign Off) Division of Surgical, Orthopedic, and Restorative Devices

510(k) Number K101808

Page 1 of 1

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.