The TDM Plate and Screw Systems are indicated for fixation of fractures, fusions, osteotomies, non-unions, and malunions of bones appropriate for the size of the device.

Mini and Mid Locking Plate and Screw System:
The Mini and Mid Locking Plate and Screw System is intended to be used in the hands, wrist, and small bones in the foot.

Small Locking Plate and Screw System:
The Small Locking Plate and Screw System is indicated for the clavicle, scapula, olecranon, humerus, radius, ulna, tibia, and fibula.

The TDM Screws (1.5mm and larger, Solid and Cannulated) are intended to be used with the plate for internal bone fixation for bone fractures, fusions, osteotomies and non-unions in the foot, hand, wrist, clavicle, scapula, olecranon, humerus, radius, ulna, tibia, and fibula.

Device Description

The TDM Plate and Screw system consists of a family of flat and contoured plates and screws that make up the Mini and Mid Locking Plate and Screw System and the Small Locking Plate and Screw System. The Plates are constructed from Titanium alloy (Ti-6AL-4V) or pure Titanium (Ti) and come in a variety of configurations. The Plates are intended to be used with locking and non-locking screws and non-locking low profile Screws. The Screw are constructed from Titanium alloy (Ti-6AL-4V) and are available as threaded locking screws, cortical or cancellous, cannulated screws from 1.5mm to 4.0 in diameter and range from 6mm to 100 in length.

AI/ML Overview

The provided text is a 510(k) premarket notification for a medical device (TDM Plate and Screw System). It describes the device, its indications for use, and a summary of performance testing to demonstrate substantial equivalence to predicate devices. However, it does NOT include acceptance criteria for a quantitative performance metric, nor does it describe a study that uses a test set against ground truth with experts and specific adjudication methods.

Instead, the performance data section mentions nonclinical tests and engineering analysis conducted in accordance with ASTM standards (F543-17 and F1264-16) to establish substantial equivalence. These standards are typically for mechanical properties and material compatibility, not for diagnostic or clinical performance against ground truth as would be evaluated for AI/ML-driven devices.

Therefore, I cannot fulfill your request for a table of acceptance criteria and reported device performance with the specific details requested (sample size for test set, data provenance, number of experts, adjudication method, MRMC study, standalone performance, type of ground truth, training set size, and ground truth establishment for training set). This type of information is generally found in submissions for devices that rely on algorithmic performance, often involving image analysis or diagnostic support, which is not the case for this bone fixation system.

Here's a breakdown of what can be extracted and what cannot:

1. Table of Acceptance Criteria and Reported Device Performance:

Cannot provide. The document does not describe specific acceptance criteria (e.g., sensitivity, specificity, accuracy thresholds) or reported device performance in a clinical or diagnostic context. The "Performance Data" section refers to mechanical tests.

2. Sample size used for the test set and the data provenance:

Cannot provide. The document describes mechanical tests, not a study involving a test set of data (e.g., images, patient records).

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

Not applicable. There is no "ground truth" in the clinical or diagnostic sense for this type of mechanical device evaluation. The "ground truth" for mechanical testing would be the physical properties measured in a lab.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:

Not applicable. No such adjudication method is described as there isn't a test set with expert interpretation.

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, an MRMC study was NOT done. This type of study is relevant for AI/ML diagnostic tools, not for a bone plate and screw system.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

Not applicable. This device is a physical implant, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):

Not applicable. The "ground truth" for mechanical testing would be direct measurements of physical properties (e.g., ultimate tensile strength, fatigue life), not expert consensus or pathology in a clinical context.

8. The sample size for the training set:

Not applicable. There is no mention of a "training set" for this device, as it is not an AI/ML-driven product.

9. How the ground truth for the training set was established:

Not applicable. As there is no training set, this question is not relevant.

Summary of available "Performance Data" from the document:

The "Performance Data" section states:
"The following testing was performed in accordance with the ASTM F543-17 and ASTM F1264-16:

Static 4-Point Bending
Axial Pullout
Torsional
The nonclinical tests and engineering analysis demonstrate that the TDM Plate and Screw Systems is as safe, as effective, and is substantially equivalent to the legally marketed predicate device."

This indicates that mechanical and material performance was evaluated, likely against the thresholds or expectations set by the referenced ASTM standards, which are considered the "acceptance criteria" for this type of device in terms of its physical integrity and performance. The study demonstrating this is the suite of nonclinical tests and engineering analysis performed according to those standards.

Summary

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December 5, 2024

Image /page/0/Picture/1 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health and Human Services logo on the left, and the FDA logo on the right. The FDA logo is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.

TDM Co., Ltd. % Jeena Mathai President Eerkie Corporation 4027 Runnymeade Dr Collegeville, Pennsylvania 19426

Re: K241128

Trade/Device Name: TDM Plate and Screw 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 23, 2024 Received: April 24, 2024

Dear Jeena Mathai:

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 (the 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 available 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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Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-device-advicecomprehensive-regulatory-assistance/unique-device-identification-system-udi-system.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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-regulatory

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assistance/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,

CHRISTOPHER FERREIRA -S

Christopher Ferreira, M.S. 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

Submission Number (if known)

K241128

Device Name

TDM Plate and Screw System

Indications for Use (Describe)

The TDM Plate and Screw Systems are indicated for fixation of fractures, fusions, osteotomies, nonunions, and malunions of bones appropriate for the size of the device.

Mini and Mid Locking Plate and Screw System:

The Mini and Mid Locking Plate and Screw System is intended to be used in the hands, wrist, and small bones in the foot.

Small Locking Plate and Screw System:

The Small Locking Plate and Screw System is indicated for the clavicle, scapula, olecranon, humerus, radius, ulna, tibia, and fibula.

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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K241128 510(k) SUMMARY

TDM Plate and Screw Systems

Sponsor:
Manufacturer	TDM Co. Ltd. 69, Cheomdan Venture So-ro, 37 beon-gil, Buk-gu Gwangju, 61003, Republic of Korea
Official Contact Phone:	Jungwook Choi +82-62-971-7460
Fax:	+82-62-971-7461
Contact Person	Jeena Mathai Eerkie Corporation mgsharemg@gmail.com
Date:	November 19, 2024
Device Name:	Bone Fixation, Plates and Screws
Common Name:	Plate, Fixation, Bone and Screw, Fixation, Bone (Primary) TDM Plate and Screw Systems
Classification Name:	Single/multiple component metallic bone fixation appliances and accessories Smooth or threaded metallic bone fixation fastener
Classification Number:	21 CFR 888.3030 (Primary): Single/multiple component metallic bone fixation appliances and accessories 21 CFR 888.3040 : Smooth or threaded metallic bone fixation fastener Class II
Product Code/Classification:	HRS (Primary), HWC class II
Description:	The TDM Plate and Screw system consists of a family of flat and contoured plates and screws that make up the Mini and Mid Locking Plate and Screw System and the Small Locking Plate and Screw System. The Plates are constructed from Titanium alloy (Ti-6AL-4V) or pure Titanium (Ti) and come in a variety of configurations. The Plates are intended to be used with locking and non-locking screws and non-locking low profile Screws. The Screw are constructed from Titanium alloy (Ti-6AL-4V) and are available as threaded locking screws, cortical or cancellous, cannulated screws from 1.5mm to 4.0 in diameter and range from 6mm to 100 in length.

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Indications For Use:	The TDM Plate and Screw Systems are indicated for fixation offractures, fusions, osteotomies, non-unions, and malunions of bonesappropriate for the size of the device.
	Mini and Mid Locking Plate and Screw System:The Mini and Mid Locking Plate and Screw System is intended to beused in the hands, wrist, and small bones in the foot.
	Small Locking Plate and Screw System:The Small Locking Plate and Screw System is indicated for theclavicle, scapula, olecranon, humerus, radius, ulna, tibia, and fibula.
	The TDM Screws (1.5mm and larger, Solid and Cannulated) areintended to be used with the plate for internal bone fixation for bonefractures, fusions, osteotomies and non-unions in the foot, hand,wrist, clavicle, scapula, olecranon, humerus, radius, ulna, tibia, andfibula.
Performance Data:	The following testing was performed in accordance with the ASTMF543-17 and ASTM F1264-16:- Static 4-Point Bending- Axial Pullout- TorsionalThe nonclinical tests and engineering analysis demonstrate thatthe TDM Plate and Screw Systems is as safe, as effective, and issubstantially equivalent to the legally marketed predicate device.
Predicate Device:	Primary predicate: TDM Co. Ltd. – TDM Plate and Screw Systems(K190391).Additional predicate: TDM Co. Ltd. – TDM Plate and Screw Systems(K171808).
Technological Characteristics	The TDM Plate and Screw Systems was shown to be substantiallyequivalent and has equivalent technological characteristics to itspredicate device through comparison in areas including design,labeling/intended use, material composition, function, range of sizes,and packaging.
Performance and SE Determination:	The TDM Plate and Screw Systems has been demonstrated to besubstantially equivalent to the predicate system(s) with respect totechnical characteristics, performance, and intended use. Theinformation provided within this premarket notification supportssubstantial equivalence of the subject device to the predicatedevice(s).

Regulation Number and Section

§ 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.