(122 days)
The OrthoHelixTM Syndesmosis Fixation Devices are indicated as adjunct fixation in repair involving metaphyseal and periarticular small bone fragments and surrounding soft-tissues where screws are not indicated and as an adjunct in external and intramedullary fixation systems involving plates and rods with fracture braces and casting. Specifically, the Syndesmosis Fixation Devices are intended to provide fixation during the healing process following a syndesmotic trauma such as fixation of ankle syndesmosis disruptions in connection with Weber B and C ankle fractures, as well as fixation of acromioclavicular separations due to coracoclavicular ligament disruptions.
The OrthoHelixTM Syndesmosis Fixation Devices are implant assembly constructs of metallic buttons and non-absorbable suture intended to aid in the reconstruction of bones in the hand, wrist, elbow, shoulder, foot, and ankle, particularly in the reconstruction of the syndesmosis joint in the ankle and the AC joint in the shoulder. The syndesmosis devices are offered in different configurations, one to be used with and one to be used without a plate. All metallic implant components are manufactured from titanium alloy. All suture implant components are UHMWPE non-absorbable suture.
The provided text is a 510(k) summary for a medical device (OrthoHelix™ Syndesmosis Fixation Devices) and primarily focuses on demonstrating substantial equivalence to predicate devices, rather than an AI/ML device that would typically have acceptance criteria, study data, and ground truth establishment in the way described in your request.
The document discusses mechanical testing to verify the strength of the implant construct. This is a very different type of "study" than what would be performed for an AI/ML device.
Therefore, many of the requested fields are not applicable or cannot be extracted from this document because it describes a physical medical device, not an AI/ML system.
Here's an attempt to answer based on the provided text, highlighting where information is not present or relevant:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (What was measured) | Reported Device Performance (Result) |
|---|---|
| Strength of the implant construct (suture + button design + interaction between components) | "The design differences were verified via mechanical testing to confirm that no new issues of safety and effectiveness have been raised with respect to the strength of the device." (Specific quantitative results or specific acceptance thresholds are not provided in this summary. The summary states that the testing confirmed no new safety/effectiveness issues compared to predicates, implying the performance was deemed acceptable relative to established predicate device performance.) |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: Not applicable in the context of an AI/ML device. For mechanical testing of a physical device, the "sample size" would refer to the number of devices tested. This specific number is not provided in the summary.
- Data Provenance: Not applicable in the context of an AI/ML device. The testing was mechanical testing of the physical OrthoHelix™ Syndesmosis Fixation Devices, not clinical data from patients.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
- Not Applicable. This device is a physical implant, not an AI/ML device that requires expert-established ground truth from medical images or patient records. The "ground truth" for mechanical testing would be the physical properties and performance metrics measured in a lab.
4. Adjudication Method for the Test Set
- Not Applicable. This is relevant for AI/ML studies involving human interpretation or clinical outcomes, not for mechanical testing of a physical device.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance
- No. This is not an AI/ML device. Therefore, no MRMC study, human reader improvement, or AI assistance enhancement analysis was performed or is relevant.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
- No. This is not an AI/ML device, so no standalone algorithm performance study was performed.
7. The Type of Ground Truth Used
- Mechanical Testing Results / Physical Properties: For this physical device, the "ground truth" for demonstrating substantial equivalence was derived from the results of mechanical tensile testing, which verified the strength and integrity of the implant construct. This is in comparison to the known performance of predicate devices.
- Not expert consensus, pathology, or outcomes data, as these relate to clinical data for diagnostics or prognostics, which is not the function of this device.
8. The Sample Size for the Training Set
- Not Applicable. This is not an AI/ML device that requires a training set.
9. How the Ground Truth for the Training Set Was Established
- Not Applicable. This is not an AI/ML device that requires a training set or ground truth establishment for it.
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510(k) SUMMARY
| 510(k) SUMMARY | |
|---|---|
| Submitter Information | |
| Submitter's Name:Address: | OrthoHelix Surgical Designs, Inc.1065 Medina Rd, Suite 500Medina, Ohio 44256 |
| Telephone Number: | 330-869-9562 |
| Fax Number: | 330-247-1598 |
| Prepared By: | Liz Altenau |
| Contact Person:Date Prepared: | Brian Hockett or Derek Lewis12/16/2013 |
| Device Information | |
| Trade Name: | OrthoHelixTM Syndesmosis Fixation Devices |
| Common Name: | Suture Button |
| Classification Name: | Washer, Bolt Nut |
| Device Classification: | Single/multiple component metallic bone fixation appliances and accessoriesClass II per 21 CFR 888.3030Panel: Orthopedic, Product Code: HTN |
| Material Composition: | Titanium Alloy and UHMWPE Suture |
| Device Description: | The OrthoHelixTM Syndesmosis Fixation Devices are implant assembly constructs of metallicbuttons and non-absorbable suture intended to aid in the reconstruction of bones in the hand, wrist,elbow, shoulder, foot, and ankle, particularly in the reconstruction of the syndesmosis joint in theankle and the AC joint in the shoulder. The syndesmosis devices are offered in differentconfigurations, one to be used with and one to be used without a plate. All metallic implantcomponents are manufactured from titanium alloy. All suture implant components are UHMWPEnon-absorbable suture. |
| Intended Use: | The OrthoHelixTM Syndesmosis Fixation Devices are indicated as adjunct fixation in repairinvolving metaphyseal and periarticular small bone fragments and surrounding soft-tissues wherescrews are not indicated and as an adjunct in external and intramedullary fixation systems involvingplates and rods with fracture braces and casting. Specifically, the Syndesmosis Fixation Devicesare intended to provide fixation during the healing process following a syndesmotic trauma such asfixation of ankle syndesmosis disruptions in connection with Weber B and C ankle fractures, aswell as fixation of acromioclavicular separations due to coracoclavicular ligament disruptions. |
| Substantial Equivalence: | The new OrthoHelixTM Syndesmosis Fixation Devices are substantially equivalent to theOrthoHelix MaxLock ExtremeTM System (K123203). the Teleflex Force Fiber® Polyethylene Non-Absorbable Surgical Suture (K063778), the Arthrex TightRopeTM Syndesmosis Device (K043248),the Arthrex TightRopeTM Acromioclavicular (AC) Device (K052776), and the BiometToggleLocTM System (K083070). The indications of the OrthoHelix Syndesmosis Fixation Devicesdiffer from some of the predicate devices. The indications of the new OrthoHelix SyndesmosisFixation Devices do not introduce any new applications or intended uses than the predicates, butrather fit within the scope of use of the predicate devices. Therefore, no new issues of safety andeffectiveness are raised with respect to intended indications.The metallic components of the OrthoHelixTM Syndesmosis Fixation Devices conform to ASTMF136 Standard Specification for Wrought Titanium-6Aluminum-4Vanadium ELI Alloy for andSurgical Implant Applications. The implant suture conforms to USP 30- Absorbable SurgicalSutures for Knot Pull Tensile Strength, Needle Attachment and Diameter.In order to demonstrate substantial equivalence to the predicate devices that have the sameintended uses, mechanical tensile testing was performed. This testing was used to verify thestrength of the implant construct, including the suture and button design and the interactionbetween the assembly components. The new OrthoHelix devices use a similar mechanism as theArthrex and Biomet predicate devices: two metallic buttons connected via implantable suture. Thesurface area, shape, and hole diameters of the buttons differ. The implantable suture for theOrthoHelix differs from the predicates in either size or material. The design differences wereverified via mechanical testing to confirm that no new issues of safety and effectiveness have beenraised with respect to the strength of the device. |
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/1/Picture/12 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized symbol that resembles an abstract human form or a caduceus, with three curved lines representing the body and a stylized head.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G60 Silver Spring, MD 20993-0002
January 3, 2014
OrthoHelix Surgical Designs, Incorporated Mr. Brian Hockett Director of Engineering 1065 Medina Road, Suite 500 Medina, Ohio 44256
Re: K132733
Trade/Device Name: OrthoHelix™ Syndesmosis Fixation Devices Regulation Number: 21 CFR 888.3030 Regulation Name: Single/multiple component metallic bone fixation appliances and accessories Regulatory Class: Class II Product Code: HTN Dated: December 16, 2013 Received: December 17, 2013
Dear Mr. Hockett:
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 devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in
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Page 2 - Mr. Brian Hockett
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/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,
Ronald#99ean -S for
P
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): K132733
Device Name: OrthoHelixTM Syndesmosis Fixation Devices
Indications for Use:
The OrthoHelix™ Syndesmosis Fixation Devices are indicated as adjunct fixation in repair involving metaphyseal and periarticular small bone fragments and surrounding soft-tissues where screws are not indicated and as an adjunct in external and intramedullary fixation systems involving plates and rods with fracture braces and casting. Specifically, the Syndesmosis Fixation Devices are intended to provide fixation during the healing process following a syndesmotic trauma such as fixation of ankle syndesmosis disruptions in connection with Weber B and Cankle fractures, as well as fixation of acromioclavicular separations due to coracoclavicular ligament disruptions.
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 OF NEEDED)
AND/OR
Concurrence of CDRH, Office of Device Evaluation (ODE)
Page _ 1_ of
Casey L. Hanley, Ph.D.
Division of Orthopedic Devices
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§ 888.3030 Single/multiple component metallic bone fixation appliances and accessories.
(a)
Identification. Single/multiple component metallic bone fixation appliances and accessories are devices intended to be implanted consisting of one or more metallic components and their metallic fasteners. The devices contain a plate, a nail/plate combination, or a blade/plate combination that are made of alloys, such as cobalt-chromium-molybdenum, stainless steel, and titanium, that are intended to be held in position with fasteners, such as screws and nails, or bolts, nuts, and washers. These devices are used for fixation of fractures of the proximal or distal end of long bones, such as intracapsular, intertrochanteric, intercervical, supracondylar, or condylar fractures of the femur; for fusion of a joint; or for surgical procedures that involve cutting a bone. The devices may be implanted or attached through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.