(81 days)
The Activmotion range is intended for knee osteotomy in adults.
The Activmotion range consists of pre-contoured tibial and femoral plates and screws in various sizes designed for knee osteotomy in adults. The plates and screws are manufactured from titanium alloy and color anodized. The implants of the Activmotion range will be provided non sterile for sterilization by health care professionals prior to use or provided sterile by gamma sterilization. The instruments of the Activmotion range will be provided non sterile for sterilization by health care professionals prior to use.
This document is a 510(k) summary for the ACTIVMOTION range, a medical device for knee osteotomy. It details the device's substantial equivalence to previously marketed devices rather than presenting a standalone study with acceptance criteria and performance data in the typical sense of algorithm-based AI devices.
Therefore, many of the requested elements for AI device studies, such as specific acceptance criteria for performance metrics (e.g., sensitivity, specificity), sample sizes for test sets in an AI context, expert qualifications for ground truth in AI, MRMC studies, and training set details, are not applicable here because this document describes a traditional, non-AI medical device (bone plates and screws).
However, I can extract the information relevant to the "study" that proves the device meets the acceptance criteria, which in this context means proving substantial equivalence through non-clinical testing.
Here's a breakdown of the available information:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (based on substantial equivalence) | Reported Device Performance |
|---|---|
| Intended Use (knee osteotomy in adults) | Matches predicate devices. The Activmotion range is intended for knee osteotomy in adults. (Page 4) |
| Design (pre-contoured tibial/femoral plates, screws) | Comparable to predicate devices. The Activmotion range consists of pre-contoured tibial and femoral plates and screws in various sizes designed for knee osteotomy in adults. (Page 4) |
| Materials Used (titanium alloy Ti-6Al-4V ELI) | Matches predicate devices. Manufactured from titanium alloy and color anodized. (Page 4) Conform to ASTM F136 and ISO 5832-3. (Page 4) |
| Mechanical Safety and Performance (bending strength, bending stiffness, torsional strength, axial pull-out strength) | "The analysis showed that the Activmotion range is as safe and as effective as the predicates." (Page 5) - Bending Strength & Stiffness: Engineering analysis conducted to compare to predicates. (Page 5) - Torsional Strength: ASTM F543 torsional testing performed on screws. (Page 5) - Axial Pull-out Strength: Engineering analysis conducted to compare. (Page 5) |
| Biocompatibility/Non-Pyrogenicity (endotoxin levels) | Endotoxin testing performed using LAL quantitative kinetic chromogenic method. (Page 5) The conclusion implies it met standards to be "as safe and as effective as the predicates." |
2. Sample size used for the test set and the data provenance
- Test Set Sample Size: Not applicable in the context of an AI device. For this hardware device, the "test set" refers to the physical samples of plates and screws subjected to engineering and mechanical testing. The specific number of samples for each test (e.g., how many screws for torsional testing) is not provided in this summary.
- Data Provenance: Not applicable in the context of an AI device. The tests were non-clinical, conducted as part of the device's development and regulatory submission.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- This information is not applicable as this is a traditional hardware medical device, not an AI/algorithm-based device requiring expert annotation for ground truth. Technical experts (engineers, material scientists) would have performed and interpreted the mechanical and material tests.
4. Adjudication method for the test set
- Not applicable for this type of device. Adjudication methods are typically used for expert review of images or data in AI studies where there might be disagreements among human experts.
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
- Not applicable. This device is a surgical implant (bone plates and screws), not an imaging or diagnostic AI tool. No human reader performance is involved.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- Not applicable. This is a hardware device, not an algorithm.
7. The type of ground truth used
- The "ground truth" for this device is based on established engineering standards and specifications (e.g., ASTM F543, ASTM F136, ISO 5832-3) and the mechanical performance of the predicate devices. The device's performance in terms of bending, torsion, pull-out strength, and material composition is compared against these benchmarks to establish substantial equivalence.
8. The sample size for the training set
- Not applicable, as this is not an AI device that requires a training set.
9. How the ground truth for the training set was established
- Not applicable, as this is not an AI device.
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February 27, 2018
Newclip Technics % J.D. Webb Official Correspondent The OrthoMedix Group, Inc. 1001 Oakwood Blvd Round Rock, Texas 78681
Re: K173746
Trade/Device Name: Activmotion Range 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: December 5, 2017 Received: December 8, 2017
Dear J.D. Webb:
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 of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820);
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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 the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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,
Katherine D. Kavlock -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) K173746
Device Name
Activmotion Range
Indications for Use (Describe)
The Activmotion range is intended for knee osteotomy in adults.
Type of Use (Select one or both, as applicable)
| ☑ Prescription Use (Part 21 CFR 801 Subpart D) |
|---|
| ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
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510(k) Summary for the ACTIVMOTION range 4.
In accordance with 21 CFR 807.92 of the Federal Code of Regulations, the following 510(k) summary is submitted for the Activmotion range.
Summary preparation date: December 01, 2017
| 1. Submitter: | Contact Person: |
|---|---|
| NEWCLIP TECHNICSP.A. de la Lande Saint Martin45 rue des GarottièresF-44115 Haute-Goulaine - FranceTelephone: (33) 2 28 21 37 12 | J.D. WebbThe OrthoMedix Group, Inc.1001 Oakwood BlvdRound Rock, TX 78681Telephone: 512-388-0199 |
| 2. Trade name: | Activmotion range |
| Common Name: | Plate, Fixation, Bone / Screw, Fixation,bone |
| Product code: | HRS - Plate, Fixation, BoneHWC - Screw, Fixation, Bone |
| Classification Name: | Single/multiple component metallic bonefixation appliances and accessories.(21 CFR part. 888.3030)Smooth or threaded metallic bone fixationfastener.(21 CFR part. 888.3040) |
3. Primary predicate or legally marketed devices which are substantially equivalent:
- Depuy Synthes Tomofix Osteotomy System of Synthes (K141796) .
Secondary predicate or legally marketed devices which are substantially equivalent:
- High Tibial Osteotomy System of Newclip Technics (K141548) •
- Anthem™ Fracture System of Globus Medical Inc (K163361) .
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Page 2/3 K173746
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Reference predicate :
- Alians Elbow Locking Plating System of Newclip Technics (K152289) .
| 4. Description of the device: | The Activmotion range consists of pre-contoured tibial and femoral plates andscrews in various sizes designed for kneeosteotomy in adults. |
|---|---|
| The plates and screws are manufacturedfrom titanium alloy and color anodized. | |
| The implants of the Activmotion range willbe provided non sterile for sterilization byhealth care professionals prior to use orprovided sterile by gamma sterilization.The instruments of the Activmotion rangewill be provided non sterile for sterilizationby health care professionals prior to use. | |
| Materials: | Titanium alloy Ti-6Al-4V ELI (conform toASTM F136 and ISO 5832-3). |
| Function: | The implants of Activmotion range areintended for knee osteotomy in adults. |
5. Substantial equivalence claimed to predicate devices:
The Activmotion range is substantially equivalent to the predicate devices in terms of intended use, design, materials used, mechanical safety and performance.
6. Indications for use:
The Activmotion range is intended for knee osteotomy in adults.
7. Non-clinical Test Summary:
The following tests were conducted:
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Engineering analysis was conducted to compare the bending strength and bending stiffness of the subject device plates to the predicates.
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ASTM F543 torsional testing was performed on the subject screws.
Engineering analysis was conducted to compare the axial pull-out strength.
- Endotoxin testing is performed using LAL quantitative kinetic chromogenic method.
The analysis showed that the Activmotion range is as safe and as effective as the predicates.
8. Clinical Test Summary:
No clinical studies were performed.
9. Conclusions Non-clinical and Clinical:
Newclip considers the Activmotion range to be equivalent to the predicate devices listed above. This conclusion is based upon the device's similarities in principles of operation, technology, materials, and indications for use.
§ 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.