(14 days)
The MedShape Solutions, Inc., ExoShape™-XL Interference Fixation Device is intended for fixation of soft tissue to bone 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 Liqament Reconstructions and Repairs and Tendon Transfers
Elbow: Biceps Tendon Reattachment and Ulnar or Radial collateral Ligament Reconstruction
The ExoShape™-XL Interference Fixation Device is a line extension offering additional sizes within the current cleared product line and is substantially equivalent to the ShapeLoc (original product name) Soft Tissue Fastener, cleared under K101808. The technological characteristics of the ExoShape™-XL and the ShapeLoc Interference Fixation Devices are equivalent.
The provided text describes a Special 510(k) submission for the MedShape Solutions ExoShape™-XL Interference Fixation Device, which is a line extension of an already cleared device. The submission focuses on demonstrating substantial equivalence to predicate devices rather than proving performance against specific acceptance criteria for a novel device.
Therefore, the requested information about acceptance criteria, a study proving device meeting these criteria, sample sizes, data provenance, expert involvement, adjudication methods, MRMC studies, standalone performance, and ground truth establishment cannot be fully provided from the given document. This document is a regulatory submission for a device modification (line extension) based on substantial equivalence, not a detailed clinical or performance study report with explicit acceptance criteria and corresponding results as typically seen for entirely new devices or software.
However, based on the provided text, here's what can be extracted and inferred:
1. Table of Acceptance Criteria and Reported Device Performance:
The document does not explicitly list numerical acceptance criteria. Instead, it states that "Functional performance testing was conducted in both Sawbone® and porcine bone analogues. This testing included monotonic soft tissue fixation strength and other dimensional verification. Analysis of the results supports the conclusion that the proposed device is substantially equivalent to the listed devices."
This implies that the acceptance criterion was likely substantial equivalence in performance (particularly fixation strength and dimensional characteristics) compared to the predicate devices. The "reported device performance" is that it met this substantial equivalence.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Substantial equivalence in: | Met. Analysis of results supports the conclusion that the proposed device is substantially equivalent to the listed devices. |
| - Monotonic soft tissue fixation strength | Demonstrated to be substantially equivalent to predicate devices. |
| - Dimensional characteristics | Demonstrated to be substantially equivalent to predicate devices. |
2. Sample size used for the test set and the data provenance:
- Sample Size: Not explicitly stated. The document mentions "functional performance testing" was conducted but does not provide details on the number of samples (devices, Sawbones, or porcine bones) used.
- Data Provenance: The testing was conducted in "Sawbone® and porcine bone analogues." This indicates that the data is from pre-clinical, in-vitro (Sawbone) and ex-vivo (porcine bone) testing. The document does not mention human data (prospective or retrospective).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable to this type of submission. This device is a physical medical implant, and the testing described is mechanical performance (fixation strength, dimensions), not diagnostic or interpretative. Thus, there is no "ground truth" established by human experts in the context of interpretation, nor are there experts involved in establishing a "ground truth" for mechanical testing in the way that there would be for, say, an AI-powered image analysis system.
4. Adjudication method for the test set:
- Not applicable. As described above, this is mechanical performance testing, not expert interpretation.
5. 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:
- No. This is a physical medical device (implant) and not an AI-powered system designed to assist human readers or perform diagnostic tasks. Therefore, no MRMC study would be relevant or conducted.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- Not applicable. This is a physical medical device (implant), not an algorithm or AI system. Its performance is inherent in its mechanical properties.
7. The type of ground truth used:
- For the mechanical functional performance testing (e.g., monotonic soft tissue fixation strength, dimensional verification), the "ground truth" would be established by engineering measurements and biomechanical test standards/protocols. The performance of the predicate devices would serve as a benchmark against which the new device's performance is compared to establish substantial equivalence.
8. The sample size for the training set:
- Not applicable. This is a physical medical device, not a machine learning model. There is no "training set."
9. How the ground truth for the training set was established:
- Not applicable. (See #8).
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MEDSHAP SOLUTIONS
JUN 1 0 2011
11/2
Special 510(k) Page 9 of 144
Special 510(k) Summary
Special 510(k) Number:
Date Prepared:
May 26, 2011
KIII471
This Special 510(k) summary is being submitted in accordance with the requirements of 21 CFR 807.92.
- A. Submitter: MedShape Solutions, Inc. (MSS) 1575 Northside Drive, Suite 440 Atlanta, Georgia 30318 Registration #10026693
- B. Company Contact: Jack Griffis Vice President, Research & Development (678) 235-3311 (direct) (404) 249-9158 (fax) Jack.Griffis@MedShape.com
- ். Device Information: Trade Name: Common Name:
ExoShape™-XL Interference Fixation Device Fastener, Fixation, bone, non-degradable
- D. Classification Name: Fastener, Fixation, Non-degradable, Soft Tissue HWC/MBI 21 CFR 888.3040
- E. Predicate Device(s): MSS, ShapeLoc Interference Fixation Device, K101808 Parcus Medical PEEK CF Interference Screw, K091093 Arthrex® Interference Screw, K062466
F. Labeling and Intended Use:
No substantive changes to the labeling or Instructions for Use have been made to the submitted information of the MedShape predicate per K101808.
The proposed ExoShape™-XL Interference Fixation Device has the same intended uses as the previously cleared predicate device per K101808. As such, both devices are 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
- Lateral Stabilization, Medial Stabilization, Achilles Tendon Foot/Ankle: Repair, Hallux Valgus Reconstruction, Mid-foot Reconstruction, Metatarsal Ligament Repair, Flexor Hallucis Longus for Anchiles Tendon Reconstruction and Tendon Transfers
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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 Reconstruction, Ligament 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 -
ு. Substantial Equivalence Summary:
The ExoShape™-XL Interference Fixation Device is a line extension offering additional sizes within the current cleared product line and is substantially equivalent to the ShapeLoc (original product name) Soft Tissue Fastener, cleared under K101808. The technological characteristics of the ExoShape™-XL and the ShapeLoc Interference Fixation Devices are equivalent. It is important to note that the ShapeLoc product name was changed to ExoShape™ after clearance, and the two names are considered interchangeable.
In addition, the ExoShape™-XL is substantially equivalent to the original predicate Arthrex® Interference Screw, cleared under K062466 and the additional predicate Parcus Medical PEEK CF Interference Screw, cleared under K091093. Any differences between the ExoShape™-XL Interference Fixation Device and the listed predicates ShapeLoc, Arthrex® or Parcus Medical Interference Screw Devices are considered minor and do not raise questions concerning safety and effectiveness.
Functional performance testing was conducted in both Sawbone® and porcine bone analogues. This testing included monotonic soft tissue fixation strength and other dimensional verification. Analysis of the results supports the conclusion that the proposed device is substantially equivalent to the listed devices. Based on the information submitted, MedShape Solutions, Inc. has determined that the proposed ExoShape™-XL Interference Fixation Device is substantially equivalent to the currently marketed device.
A
Jack Griffis Vice President, Research & Development
Image /page/1/Picture/11 description: The image shows the logo for Medshape Solutions. The word "MEDSHAPE" is in large, bold, sans-serif font on the top line. Underneath the first word is a horizontal line, and below that is the word "SOLUTIONS" in a smaller, sans-serif font. The text is black on a white background.
1575 Northside Drive, Suite 440 Atlanta, GA 30318 404-249-9155 phone 404-249-9158 fax
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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 depiction of an eagle or bird-like figure with three wing-like shapes extending upwards and to the right. The bird is positioned above a circular text that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA".
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
MedShape Solutions, Inc (MSS) % Mr. Jack Griffis Vice President, Research & Development 1575 Northside Drive, Suite 440 Atlanta, Georgia 30318
JUN 10 2011
Re: K111471
Trade/Device Name: ExoShape™-XL Interference Fixation Device Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: Class II Product Code: MBI, HWC Dated: May 26, 2011 Received: May 27, 2011
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.
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,
Erin L Keith
Jr 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:
Device Name: ExoShape™-XL Interference Fixation Device
Indications for Use:
The MedShape Solutions, Inc., ExoShape™-XL Interference Fixation Device is intended for fixation of soft tissue to bone in the following procedures:
- Rotator Cuff Repairs, Bankart Repair, SLAP Lesion Repair, Biceps Shoulder: 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
- Hand/Wrist: Scapholunate Ligament Reconstruction, Ulnar Collateral Ligament Reconstruction. Radial Collateral Ligament Reconstruction. Carpometacarpal Joint Arthroplasty (basal thumb joint arthroplasty), Carpal Liqament Reconstructions and Repairs and Tendon Transfers
- Elbow: Biceps Tendon Reattachment and Ulnar or Radial collateral Ligament Reconstruction
Prescription Use X AND/OR (Part 21 CFR 801 Subpart D)
D/OR
Over
(21 C
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)
(Division Sign-Off)
Division of Surgical, Orthopedic,
and Restorative Devices
| 510(k) Number | K111471 |
|---|---|
| (1/1) |
Page 1 of 1
§ 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.