(36 days)
The OsteoMed ExtremiLOCK Wrist Plating System is indicated for fracture fixation, fusion and osteotomies of wrist and other bones appropriate for the size of the device. It is intended for use in trauma, general surgery and reconstructive procedures.
OsteoMed ExtremiLOCK Wrist Plating System implants are intended for single use only.
The OsteoMed ExtremiLOCK Wrist Plating System is a rigid fixation and fusion system consisting of plates and screws in various configurations along with the appropriate instrumentation to facilitate modification and implantation. Plates are anatomically pre-contoured in various shapes and sizes. Screws are provided with variable angle locking and non-locking heads and are either fully threaded or partially threaded in various lengths. These screws are either solid core or cannulated and can be used with or without plates. The system also contains K-wire implants.
The implants of the OsteoMed ExtremiLOCK Wrist Plating System are made from Titanium per ASTM F-67 (Plates), Titanium Alloy per ASTM F-136 (plates, screws and washer), and Stainless Steel per ASTM F-138( K-wires). The dimensional modifications to the screws include the addition of flutes (for screw lengths ≤ 16mm), tapered tip, decrease in thread pitch, and of the system has already been cleared through OsteoMed wrist predicate 510(k) K152145.
This document is a 510(k) premarket notification for the OsteoMed ExtremiLOCK Wrist Plating System. It does not describe a study involving an AI/ML powered medical device. Instead, it details the substantial equivalence of a new version of a wrist plating system to a predicate device. Therefore, much of the requested information regarding AI/ML device studies, such as acceptance criteria tables, sample sizes for test/training sets, expert adjudication, MRMC studies, or standalone algorithm performance, is not applicable.
However, based on the provided text, I can infer the acceptance criteria and the nature of the "study" (verification testing) for this specific medical device.
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria Category | Specific Criteria / Standard Met | Reported Device Performance |
|---|---|---|
| Mechanical Strength | Meet minimum requirements as specified in ASTM F543. | "The verification testing confirmed the screws met minimum requirements as specified in ASTM F543 or performed equal or better compared to the predicate devices. The screws met the mechanical strength criteria for the intended use." |
| Performance Equivalence | Performed equal or better than the predicate devices. | "Performance equivalence was shown through the verification comparison to the predicate devices." |
| Indications for Use | Consistent with predicate device. | Stated as "similarities in indications for use" to the OsteoMed predicate device. |
| Material | Consistent with predicate device (Titanium per ASTM F-67, Titanium Alloy per ASTM F-136, Stainless Steel per ASTM F-138). | Stated as "similarities in... material" to the OsteoMed predicate device. |
| Function, Design, Technology | Consistent with predicate device. | Stated as "similarities in... function, design, technology" to the OsteoMed predicate device. |
| Shelf Life & Sterilization | Consistent with predicate device. | Stated as "similarities in... shelf life, sterilization" to the OsteoMed predicate device. |
| Operational Principles | Consistent with predicate device. | Stated as "similarities in... operational principles" to the OsteoMed predicate device. |
2. Sample size used for the test set and the data provenance:
- Sample Size: The document does not specify the exact number of screws or plates tested. It broadly refers to "the screws (subject device)" as being part of the verification testing.
- Data Provenance: The testing was conducted internally by OsteoMed as part of their premarket notification process to demonstrate substantial equivalence. The document does not provide details on the country of origin of the data beyond "OsteoMed" (based in Addison, Texas, USA). This is prospective testing, specifically designed to evaluate the new device.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This question is not applicable as the "ground truth" for this device is based on engineering standards (ASTM F543) and mechanical performance comparisons, not human expert interpretation of data. The ground truth is objective mechanical strength and performance.
4. Adjudication method for the test set:
- This is not applicable as the evaluation is based on objective mechanical testing against engineering standards rather than subjective assessments requiring adjudication.
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:
- This is not applicable. The device is a physical medical implant (wrist plating system), not an AI-powered diagnostic or assistive tool for human readers.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- This is not applicable. The device is a physical medical implant, not an algorithm.
7. The type of ground truth used:
- The ground truth used for this premarket notification's "performance characteristics & testing" is engineering standards (specifically ASTM F543) and direct mechanical performance comparison to a legally marketed predicate device.
8. The sample size for the training set:
- This is not applicable. There is no AI/ML training set mentioned or implied for a physical medical implant undergoing mechanical verification testing.
9. How the ground truth for the training set was established:
- This is not applicable, as there is no AI/ML training set.
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Image /page/0/Picture/1 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" around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, stacked on top of each other.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
May 19, 2016
OsteoMed Ms. Kathryn Jayne Senior Specialist, Regulatory Affairs 3885 Arapaho Road Addison, Texas 75001
Re: K161041 Trade/Device Name: OsteoMed ExtremiLOCK Wrist Plating System Regulation Number: 21 CFR 888.3030 Regulation Name: Single/multiple component metallic bone fixation appliances and accessories Regulatory Class: Class II Product Code: HRS, HWC Dated: April 14, 2016 Received: April 15, 2016
Dear Ms. Jayne:
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 Parts 801); medical device reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set
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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/ResourcesforYou/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 yours,
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
510(k) Number (if known): _K161041
Device Name: OsteoMed ExtremiLOCK Wrist Plating System
Indications for Use:
The OsteoMed ExtremiLOCK Wrist Plating System is indicated for fracture fixation, fusion and osteotomies of wrist and other bones appropriate for the size of the device. It is intended for use in trauma, general surgery and reconstructive procedures.
OsteoMed ExtremiLOCK Wrist Plating System implants are intended for single use only.
Prescription Use X (Part 21 CFR 801 Subpart D)
AND/OR
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)
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Image /page/3/Picture/1 description: The image shows the word "OSTEOMED" in blue, with a gray swoosh underneath. The word is in a bold, sans-serif font. The blue color is a medium shade, and the gray is a light shade. The swoosh is curved and extends from the left to the right of the word.
510(k) Summary
| Submitter Information | OsteoMed3885 Arapaho RoadAddison, Texas 75001Phone: (972) 677-4600Fax: (972) 677-4601 |
|---|---|
| Contact Person | Ms. Kathryn Jayne |
| Date Prepared | May 13, 2016 |
| Proprietary Name: | OSTEOMED EXTREMILOCK WRIST PLATING SYSTEM |
| Common Name: | Wrist Fixation System |
| Classification Names: | 21 CFR 888.3030: Single/multiple component metallic bonefixation appliances and accessories21 CFR 888.3040: Smooth or threaded metallic bone fixationfastener |
| Product Codes: | HRS, HWC |
| Class: | II |
| Predicate: | OsteoMed ExtremiLOCK Wrist Plating System, K152145 |
| Classification Names: | 21 CFR 888.3030, Single/multiple component metallic bonefixation appliances and accessories;21 CFR 888.3040: Smooth or threaded metallic bone fixationfastener |
| Product Code: | HRS, HWC |
| Class: | II |
| Device Description | The OsteoMed ExtremiLOCK Wrist Plating System is a rigidfixation and fusion system consisting of plates and screws invarious configurations along with the appropriate instrumentationto facilitate modification and implantation. Plates are anatomicallypre-contoured in various shapes and sizes. Screws are providedwith variable angle locking and non-locking heads and are eitherfully threaded or partially threaded in various lengths.Thesescrews are either solid core or cannulated and can be used with orwithout plates. The system also contains K-wire implants. |
| The implants of the OsteoMed ExtremiLOCK Wrist PlatingSystem are made from Titanium per ASTM F-67 (Plates),Titanium Alloy per ASTM F-136 (plates, screws and washer), andStainless Steel per ASTM F-138( K-wires). The dimensionalmodifications to the screws include the addition of flutes (for screwlengths ≤ 16mm), tapered tip, decrease in thread pitch, and | |
| of the system has already been cleared through OsteoMed wristpredicate 510(k) K152145. | |
| Indications for use/Intended Use | The OsteoMed ExtremiLOCK Wrist Plating System is indicatedfor fracture fixation, fusion and osteotomies of wrist and otherbones appropriate for the size of the device. It is intended for usein trauma, general surgery and reconstructive procedures. |
| OsteoMed ExtremiLOCK Wrist Plating System implants areintended for single use only. | |
| PerformanceCharacteristics &Testing & Clinical | Performance: Verification testing was conducted to assess theperformance of the screws (subject device). The verificationtesting confirmed the screws met minimum requirements asspecified in ASTM F543 or performed equal or better compared tothe predicate devices. The screws met the mechanical strengthcriteria for the intended use.Performance equivalence was shown through the verificationcomparison to the predicate devices. |
| Clinical Testing is not required to support substantial equivalence. | |
| Substantial Equivalence | The basis of substantial equivalence for this device, OsteoMedExtremiLOCK Wrist Plating System, is based on similarities inindications for use, material, function, performance, design,technology, shelf life, sterilization, and operational principles to theOsteoMed predicate device. Performance comparisons wereperformed which verified that the modified screws met requiredmechanical strength criteria for their intended use compared to thepredicate devices listed in this summary. OsteoMed has shownthat the non-clinical tests demonstrate that the subject device is assafe and effective as the predicate device. |
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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.