(90 days)
The Skeletal Dynamics Forearm Plating System is indicated for the treatment of fractures, fusions, and osteotomies of the radius and ulna.
The Skeletal Dynamics Forearm Plating System include Midshaft Radius Plates and Midshaft Ulna Plates, manufactured from titanium alloy (ASTM F-136) and available in multiple lengths and hole configurations.
The provided text describes a 510(k) submission for the "Skeletal Dynamics Forearm Plating System." This type of submission is for medical devices, specifically bone fixation appliances, not AI or software medical devices. Therefore, the information requested regarding acceptance criteria and studies that prove device meets criteria for an AI/ML device (e.g., sample size for test set, number of experts for ground truth, MRMC studies, standalone performance) is not applicable to this document.
The document focuses on demonstrating substantial equivalence to a predicate device, which is a common pathway for medical devices in the US.
Here's the relevant information that can be extracted from the provided text, modified to address the non-AI nature of the device:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (Demonstrated Equivalency) | Reported Device Performance |
|---|---|
| Intended Use (similar to predicate) | Treatment of fractures, fusions, and osteotomies of the radius and ulna. |
| Indications for Use (similar to predicate) | Treatment of fractures, fusions, and osteotomies of the radius and ulna. |
| Materials (similar to predicate) | Titanium alloy (ASTM F-136). |
| Design (fundamental scientific technology) (similar to predicate) | Midshaft Radius Plates and Midshaft Ulna Plates, multiple lengths and hole configurations. |
| Performance (Mechanical Testing) (equivalent to predicate) | Met requirements of ASTM F382 (Standard Specification and Test Methods for Metallic Bone Plates). |
| Sterility (similar to predicate) | Not explicitly detailed but stated as similar to predicate. |
| Packaging (similar to predicate) | Not explicitly detailed but stated as similar to predicate. |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not applicable as this is a traditional medical device (bone plate system), not an AI/ML device that uses test sets or data provenance in the same way. The performance was demonstrated through mechanical testing.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This information is not applicable. Ground truth establishment by experts is relevant for diagnostic or AI-driven devices. For a bone plate system, performance is assessed through standardized mechanical tests.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not applicable. Adjudication methods are typically used for establishing ground truth in clinical trials or for evaluating human expert performance, not for the mechanical testing of a bone plate.
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 information is not applicable. An MRMC study is relevant for diagnostic AI tools that assist human readers. This device is a surgical implant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is not applicable. This is a physical medical device, not an algorithm.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
The "ground truth" for this device's performance is established through standardized mechanical testing, specifically ASTM F382, which evaluates the physical properties and strength of the metallic bone plates. The goal is to demonstrate that the device performs equivalently to the predicate devices under these test conditions.
8. The sample size for the training set
This information is not applicable. This device is not an AI/ML algorithm that requires a training set.
9. How the ground truth for the training set was established
This information is not applicable. This device is not an AI/ML algorithm.
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June 1, 2020
Skeletal Dynamics, Inc. Diana Taylor Sr. Regulatory Affairs Specialist 7300 N. Kendall Drive, Suite 400 Miami, Florida 33156
Re: K200538
Trade/Device Name: Skeletal Dynamics Forearm 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 Dated: March 2, 2020 Received: March 3, 2020
Dear Diana Taylor:
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. 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.
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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 devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
Shumaya Ali, MPH Assistant Director DHT6C: Division of Restorative, Repair and Trauma Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K200538
Device Name
Skeletal Dynamics Forearm Plating System
Indications for Use (Describe)
The Skeletal Dynamics Forearm Plating System is indicated for the treatment of fractures, fusions, and osteotomies of the radius and ulna.
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 logo for Skeletal Dynamics. On the left side of the logo is a green and blue abstract symbol that looks like four leaves arranged in a square. To the right of the symbol is the word "skeletal" in blue, with a registered trademark symbol next to it. Below the word "skeletal" is the word "dynamics" in blue.
7300 North Kendall Drive | Suite 400 | Miami, Florida 33156
phone: 305.596.7585
fax: 305.596.7591
510(k) SUMMARY Skeletal Dynamics Inc.'s Forearm Plating System
Submitter
Skeletal Dynamics, Inc. 7300 N. Kendall Drive, Suite 400 Miami, FL 33156 Phone: 305-596-7585 Facsimile: 305-596-7591 Contact Person: Diana Taylor Date: June 1, 2020
Name and Classification
Name: Forearm Plating System Plate, Fixation, Bone Common Name: 21 CFR §888.3030 Requlatory Classification: Class: Class II Product Code: HRS
Predicate Devices
Primary Predicate: Acumed, LLC, Congruent Bone Plate System, K102998, 01/04/2011 Additional Predicate: Skeletal Dynamics, GEMINUS Plate System K122737, 10/03/2012
Device Description
The Skeletal Dynamics Forearm Plating System include Midshaft Radius Plates and Midshaft Ulna Plates, manufactured from titanium alloy (ASTM F-136) and available in multiple lengths and hole configurations.
Indications for Use
The Skeletal Dynamics Forearm Plating System is indicated for the treatment of fractures, fusions, and osteotomies of the radius and ulna.
Summary of Technological Characteristics
The substantial equivalence of the Skeletal Dynamics Forearm Plating System to the predicate device is demonstrated by similarities in intended use, indications for use, materials, design (fundamental scientific technology), performance, sterility and packaging and does not present any new issues of safety or effectiveness.
Performance Testing
Engineering analysis and mechanical testing demonstrated that the Skeletal Dynamics Forearm Plating System is equivalent to the predicate device currently marketed. Mechanical testing, which established equivalency, includes ASTM F382, Standard Specification and Test Methods for Metallic Bone Plates, Therefore, the subject device is as safe and effective as the legally marketed predicate device.
Conclusions
The Skeletal Dynamics Forearm Plating System is substantially equivalent to the predicate devices identified in this premarket notification.
§ 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.