(324 days)
The Dyna Locking Trochanteric Nail™ is intended to be implanted into the intramedullary canal and head of femur for alignment, stabilization, fixation of fractures caused by trauma or disease including followings:
- Pertrochanteric fractures
- Intertrochanteric fractures
- Comminuted fractures
- Segmental fractures
- Fracture with bone loss
- Proximal and distal fractures
- Non-unions and malunions
- Subtrochanteric fractures(only for long nail: more than 320mm)
Dyna Locking Trochanteric Nail™ is consists of Trochanteric Nail for Femur, Neck Screw, Locking Screw for Distal Fixation, and Caps. Distal end part has hole and slot on the transverse direction for screw fixation. Proximal part is designed for neck screw and quide pin which is for insertion of anti-rotation quide wire. Above Neck screws have two types: built-in wedge wing type and without wedge wing type. A built-in wedge wing Neck screw is used as an assembly, and a without wedge wing can be used alone. A user can select the type of Neck screw according to the condition of the patient. Distal part of trochanteric nail uses the cortical type screws. All implants are single use only.
This document is a 510(k) Pre-market Notification from the FDA, which primarily focuses on establishing substantial equivalence of a new medical device to a previously cleared one. It does not contain the detailed information about acceptance criteria and a study that proves the device meets those criteria in the way you've outlined.
Specifically:
- This document describes a medical device (Dyna Locking Trochanteric Nail™) and its intended use, and argues for its substantial equivalence to a predicate device.
- It states that "Mechanical strength evaluations per ASTM F543 and geometrical comparisons to the predicate device demonstrate that the subject device's mechanical performance is substantially equivalent to the predicate device." This is the extent of the performance testing information provided.
Therefore, most of the information requested in your prompt (detailed acceptance criteria tables, sample sizes, expert ground truth, adjudication methods, MRMC studies, standalone algorithm performance, training set details) is not present in this type of FDA clearance letter. These details would typically be found in the full 510(k) submission, which is a much more extensive document but not publicly available in this format from the FDA's website.
Based on the provided document, here's what can be answered:
1. A table of acceptance criteria and the reported device performance
- Acceptance Criteria: The document mentions "Mechanical strength evaluations per ASTM F543" as the basis for evaluation. ASTM F543 specifies mechanical test methods for metallic internal fixation devices. The acceptance criteria would be that the device meets the performance requirements (e.g., strength, stiffness, fatigue life) defined by this standard for intramedullary fixation rods, and that its performance is equivalent to or better than the predicate device.
- Reported Device Performance: The document states: "Mechanical strength evaluations per ASTM F543... demonstrate that the subject device's mechanical performance is substantially equivalent to the predicate device." No specific numerical performance values or detailed acceptance criteria are listed.
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not provided. The document only references "Mechanical strength evaluations per ASTM F543" which implies bench testing on device samples, not studies involving patient data.
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)
- Not applicable/Not provided. This type of information is relevant for AI/ML device studies involving human interpretation or clinical outcomes, not for mechanical device equivalence assessments.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable/Not provided.
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
- No. This is a mechanical device, not an AI diagnostic device that assists human readers.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- No. This is a mechanical device, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- For mechanical testing, the "ground truth" would be the engineering specifications and performance limits defined by the ASTM F543 standard.
8. The sample size for the training set
- Not applicable/Not provided. This is not an AI/ML device requiring a training set.
9. How the ground truth for the training set was established
- Not applicable/Not provided.
In summary, the provided document is an FDA 510(k) clearance letter for a mechanical orthopedic implant, asserting its substantial equivalence to a predicate device based on mechanical testing. It does not involve AI/ML technology or detailed clinical studies with human readers or patient data in the way your prompt describes.
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March 3, 2023
Innosys Co., Ltd. Yu-Jin Kang RA Specialist 20, Sandan-ro 76beon-gil(Rd) Uijeongbu-si, Gyeonggi-do 11781 Korea. South
Re: K221084
Trade/Device Name: Dyna Locking Trochanteric Nail™ Regulation Number: 21 CFR 888.3020 Regulation Name: Intramedullary fixation rod Regulatory Class: Class II Product Code: HSB. HTY Dated: February 28, 2023 Received: March 1, 2023
Dear Yu-Jin Kang :
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.
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
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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 (QS) 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,
Image /page/1/Picture/5 description: The image shows a digital signature. The signature is for "Farzana Sharmin -S". The date of the signature is March 3rd, 2023. The time of the signature is 08:33:12 -05'00'.
For Jiping Chen, M.D., Ph.D., M.P.H. Division Director DHT6A: Division of Joint Arthroplasty 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) K221084
Device Name
Dyna Locking Trochanteric Nail™
The Dyna Locking Trochanteric Nail™ is intended to be implanted into the intramedullary canal and head of femur for alignment, stabilization, fixation of fractures caused by trauma or disease including followings:
- Pertrochanteric fractures
- Intertrochanteric fractures
- Comminuted fractures
- Segmental fractures
- Fracture with bone loss
- Proximal and distal fractures
- Non-unions and malunions
- Subtrochanteric fractures(only for long nail: more than 320mm)
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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510(k) Summary
| Manufacturer: | Innosys Co., Ltd.20, Sandan-ro 76beon-gil(Rd), Uijeongbu-si, Gyeonggi-do,11781, Korea, |
|---|---|
| Sponsor: | Innosys Co., Ltd.20, Sandan-ro 76beon-gil(Rd), Uijeongbu-si, Gyeonggi-do,11781, Korea, |
| Sponsor Contact: | Yu-Jin Kang, RA Specialist+82 31 860 6927ujkang@inno-sys.net |
| Date Prepared: | April 11, 2022 |
| Device Name: | Trade name: Dyna Locking Trochanteric Nail™ |
| Classification Name: | -Intramedullary Fixation Rod (HSB), per 21 CFR 888.3020-Smooth or threaded metallic bone fixation fastener (HTY), perCFR888.3040 |
| Common Name: | Intramedullary Fixation System |
| Product Code: | HSB, HTY |
Predicate Devices:
Purpose of submission:
The purpose of the current submission is
-
to add the new device, that does not have Wedge wings, which is different from the original device in the prior system(K093707).
-
to eliminate the separately registered Wedge wing and Neck screw that are already part of the Neck screw assembly.
Description of Device:
Dyna Locking Trochanteric Nail™ is consists of Trochanteric Nail for Femur, Neck Screw, Locking Screw for Distal Fixation, and Caps. Distal end part has hole and slot on the transverse direction for screw fixation. Proximal part is designed for neck screw and quide pin which is for insertion of anti-rotation quide wire. Above Neck screws have two types: built-in wedge wing type and without wedge wing type. A built-in wedge wing Neck screw is used as an assembly, and a without wedge wing can be used alone. A user can select the type of Neck screw according to the condition of the patient. Distal part of trochanteric nail uses the cortical type screws.
Image /page/3/Picture/12 description: The image contains the word "innosys" in a stylized font. The "inno" portion of the word is in a dark blue color, while the "sys" portion is in an orange color. The logo appears to be for a company or organization named Innosys.
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All implants are single use only.
Indications For Use:
The Dyna Locking Trochanteric Nail™ is intended to be implanted into the intramedullary canal and head of femur for alignment, stabilization, fixation of fractures caused by trauma or disease including followings:
- Pertrochanteric fractures
- Intertrochanteric fractures
- Comminuted fractures
- Segmental fractures
- Fracture with bone loss
- Proximal and distal fractures
- Non-unions and malunions
- Subtrochanteric fractures(only for long nail: more than 320mm)
Comparison Technological Characteristics
The predicate and proposed device have the similar intended use and basic fundamental scientific technology and share the following similarities;
- The similar indications for use
- Similar design features ●
- Incorporate the same materials
- The equivalent mechanical performance
Performance Testing
Mechanical strength evaluations per ASTM F543 and geometrical comparisons to the predicate device demonstrate that the subject device's mechanical performance is substantially equivalent to the predicate device.
Conclusion
The data and information provided in this submission support the conclusion that the Dyna Locking Trochanteric Nail™ is substantially equivalent to predicate device with respect to indications for use and technological characteristics.
Image /page/4/Picture/22 description: The image shows the logo for Innosys. The word "inno" is in blue, and the word "sys" is in orange. The logo is simple and modern.
§ 888.3020 Intramedullary fixation rod.
(a)
Identification. An intramedullary fixation rod is a device intended to be implanted that consists of a rod made of alloys such as cobalt-chromium-molybdenum and stainless steel. It is inserted into the medullary (bone marrow) canal of long bones for the fixation of fractures.(b)
Classification. Class II.