(112 days)
The ORTHOLOC™ SPS is intended for fractures and fracture dislocations, osteotomies, and non-unions of the proximal humerus, particularly in osteopenic bone.
ORTHOLOC™ SPS is a plating system designed to provide anatomical reduction and stable primary fixation of the proximal humerus using implanted plates and screws. The plates are available in three designs: Standard, Posterior, and Greater Tuberosity (GT) and are manufactured from stainless steel per ASTM F138. The system also includes locking cortical and cancellous screws manufactured from stainless steel per ASTM F2229 and non-locking cortical screws manufactured from stainless steel per ASTM F138. The system is provided non-sterile and requires steam sterilization prior to use.
This document describes acceptance criteria and outlines performance testing for the ORTHOLOC™ SPS Shoulder Plating System. However, it does not describe a study involving an AI/algorithmic device or its performance against acceptance criteria. Instead, it describes non-clinical bench testing for a physical medical device (bone plating system).
Therefore, I cannot populate the requested table and answer the study-specific questions (2-9) about AI device performance, sample sizes, ground truth, experts, or MRMC studies.
Here's the information that can be extracted from the provided text regarding the physical device and its testing:
Acceptance Criteria and Device Performance (Based on Non-Clinical Bench Testing):
| Acceptance Criteria Category | Specific Test Performed | Reported Device Performance / Conclusion |
|---|---|---|
| Mechanical Performance | Plate Bending and Fatigue (to ASTM F382-17) | Supports substantial equivalence to predicate devices. |
| Screw Torsion, Driving Torque, and Axial Pullout (to ASTM F543-17) | Supports substantial equivalence to predicate devices. | |
| Engineering Analysis of the Greater Tuberosity Plate | Supports substantial equivalence to predicate devices. | |
| Cross Sectional Analysis comparing the subject and predicate plates | Supports substantial equivalence to predicate devices. | |
| Safety and Effectiveness | N/A (addressed by performance testing and comparison to predicates) | Does not raise new questions of safety or effectiveness. |
| Substantial Equivalence | Comparison of technological characteristics with predicate devices | Substantially equivalent in intended use, materials, design, and sterilization method to the predicate devices. Design differences do not raise new issues and are supported by performance testing. |
Regarding the study, based on the provided text:
- Sample size used for the test set and the data provenance: Not applicable. The testing described is non-clinical bench testing of a physical device, not an AI model.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable.
- Adjudication method for the test set: Not applicable.
- 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, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. The document explicitly states: "No clinical studies were performed."
- If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an algorithmic device.
- The type of ground truth used: Not applicable for an AI device. For the physical device testing, the "ground truth" would be established engineering standards (ASTM F382-17, ASTM F543-17) and comparative physical properties with predicate devices.
- The sample size for the training set: Not applicable. This is not an AI/algorithmic device.
- How the ground truth for the training set was established: Not applicable.
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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: on the left, there is the Department of Health & Human Services logo, which features a stylized human figure. To the right of this is the FDA logo, which includes the letters 'FDA' in a blue box, followed by the words 'U.S. FOOD & DRUG ADMINISTRATION' in blue text.
October 5, 2018
Tornier Inc. Renee Stoffel Senior Regulatory Affairs Specialist 10801 Nesbitt Avenue South Bloomington, Minnesota 55437
Re: K181587
Trade/Device Name: ORTHOLOCTM SPS Shoulder 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: August 30, 2018 Received: August 31, 2018
Dear Ms. Stoffel:
We have reviewed vour 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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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 of medical device-related adverse events) (21 CFR 803) for
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devices or postmarketing safety reporting (21 CFR 4. Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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 comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Laurence D. Coyne -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 (if known) K181587
Device Name ORTHOLOC™ SPS Shoulder Plating System
Indications for Use (Describe)
The ORTHOLOC™ SPS is intended for fractures and fracture dislocations, osteotomies, and non-unions of the proximal humerus, particularly in osteopenic bone.
| Type of Use (Select one or both, as applicable) | |
|---|---|
X | Prescription Use (Part 21 CFR 801 Subpart D)
| | Over-The-Counter Use (21 CFR 801 Subpart C)
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Image /page/3/Picture/1 description: The image shows the word "TORNIER" in large, blue, serif font. To the right of the word is a blue hexagon containing a stylized letter "T" that is also blue. The letter "T" is made up of two smaller hexagons.
Date Prepared: October 4, 2018
Administrative Information
| Name:Address: | Tornier, Inc.10801 Nesbitt Avenue SouthBloomington, MN 55437United States of America |
|---|---|
| Contact Person: | Renee Stoffel |
| Title: | Sr. Regulatory Affairs Specialist |
| Phone: | 952-683-7471 |
| Fax: | 952-426-7601 |
Device Information
| Name of Device: | ORTHOLOC™ SPS Shoulder Plating System |
|---|---|
| Common Name (s): | Humeral Plating System |
| Classification Name: | Single/multiple component metallic bone fixation appliances and accessories |
| Regulatory Class: | II |
| Regulation Number: | 888.3030 |
| Product Code: | HRS, HWC |
Predicate Device Information
| Primary Predicate: | K011815, SYNTHES LCP PROXIMAL HUMERUS PLATES |
|---|---|
| Additional Predicates: | K000684, SMALL FRAGMENT DYNAMIC COMPRESSION LOCKING(DCL) SYSTEMK011335, SYNTHS ONE-THIRD TUBULAR DCL PLATEK041860, SYNTHES (USA) LCP PROXIMAL HUMERUS PLATES, LONGK082625, SYNTHES (USA) 3.5MM LCP PERIARTICULAR PROXIMALHUMERUS PLATESK100146 and K102352, EVOLVE EPS ORTHOLOCK111432, EVOLVE (R) TRIAD (TM) PLATING SYSTEM AND EVOLVE (RTRIAD (TM) BONE SCREWS |
Device Description
ORTHOLOC™ SPS is a plating system designed to provide anatomical reduction and stable primary fixation of the proximal humerus using implanted plates and screws. The plates are available in three designs: Standard, Posterior, and Greater Tuberosity (GT) and are manufactured from stainless steel per ASTM F138. The system also includes locking cortical and cancellous screws manufactured from stainless steel per ASTM F2229 and non-locking cortical screws manufactured from stainless steel per ASTM F138. The system is provided non-sterile and requires steam sterilization prior to use.
Tornier, Inc. ORTHOLOCTM SPS
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Image /page/4/Picture/1 description: The image shows the word "TORNIER" in large, blue, serif font. To the right of the word is a blue hexagon containing a stylized letter "T" inside. The letter "T" is also blue and has a smaller, stylized "T" shape inside of it. The logo appears to be for a company or organization called "Tornier".
Indications for Use
The ORTHOLOC™ SPS is intended for fractures and fracture dislocations, osteotomies, and non-unions of the proximal humerus, particularly in osteopenic bone.
Comparison of Technological Characteristics with the Predicate Devices
The ORTHOLOC™ SPS is substantially equivalent in intended use, materials, design, and sterilization method to the predicate devices. The design differences do not raise new issues of safety or effectiveness and are supported by performance testing.
Non-clinical Performance Testing
Non-clinical bench testing (mechanical testing) was performed to demonstrate substantial equivalence to the predicate devices.
- o Plate Bending and Fatigue to ASTM F382-17
- Screw Torsion, Driving Torque, and Axial Pullout to ASTM F543-17 ●
- Engineering Analysis of the Greater Tuberosity Plate ●
- Cross Sectional Analysis comparing the subject and predicate plates
Clinical Testing
No clinical studies were performed.
Conclusions
The ORTHOLOC™ SPS does not raise new questions of safety or effectiveness. Differences in technological characteristics have been addressed with performance testing. The results of performance testing for the ORTHOLOC™ SPS system support substantial equivalence to the predicate devices.
§ 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.