Tandry Locking Plate System is intended to provide fixation during fractures, fusions, and osteotomies for bones including the clavicle, pelvis, scapula and calcaneal, small bones including the metatarsals, tarsals and phalanges; long bones including the radius, ulna, humerus, olecranon, fibula, femur, and tibia.

In addition, Tandry Locking Hip Plate System is in fixation of fractures to the proximal femur. The plates are indicated for use in trochanteric, pertrochanteric, and basilar neck fracture.

Each plate is indicated to be used in the following anatomic regions:

1.5mm and 2.0mm locking plates Metacarpals, metatarsals, tarsals, and phalanges
2.4mm locking plates Radius, wrist, and ulna
3.5 mm locking plates Clavicle, scapula, humerus, olecranon, pelvis, fibula, calcaneal, and tibia
5.0 mm locking plates Femur and tibia

Device Description

The Tandry Locking Plate System consists of various sized plates, screws and instruments. The plates are designed to distribute for local anatomies and can accept locking, cortex, shaft and cancellous screws. The screws are designed with self-tapping to promote the operation efficiency to insert the bones. The instruments are used for completing the surgery.

AI/ML Overview

Based on the provided text, the device in question, the "Tandry Locking Plate System," is a bone fixation device seeking 510(k) clearance, which means it is determined to be substantially equivalent to legally marketed predicate devices. This type of device, being a physical implant, does not involve AI or algorithms, and therefore, the acceptance criteria and study data provided in the document are not related to AI/algorithm performance.

The document describes non-clinical (biomechanical) testing to demonstrate substantial equivalence, rather than studies typically performed for AI-driven medical devices.

Therefore, I cannot provide information for the following points as they are not applicable to this type of device and the information provided:

A table of acceptance criteria and the reported device performance (in the context of AI/algorithms)
Sample sizes used for the test set and data provenance (for AI/algorithms)
Number of experts used to establish ground truth and qualifications (for AI/algorithms)
Adjudication method (for AI/algorithms)
MRMC comparative effectiveness study (for AI/algorithms)
Standalone performance (for AI/algorithms)
Type of ground truth used (for AI/algorithms)
Sample size for the training set (for AI/algorithms)
How ground truth for the training set was established (for AI/algorithms)

Instead, here is a summary of the acceptance criteria and study information provided in the document for the physical medical device:

The "Tandry Locking Plate System" is a bone fixation device, not an AI/algorithm-driven device. Its approval is based on demonstrating substantial equivalence to existing predicate devices through non-clinical testing, primarily biomechanical tests, rather than clinical studies or performance against AI-specific metrics.

Acceptance Criteria & Device Performance (Physical Device Context):

The acceptance criteria for this type of device are centered around demonstrating that its mechanical performance (strength, integrity) is comparable to that of legally marketed predicate devices.

Acceptance Criteria (Implied)	Reported Device Performance
Substantial Equivalence to predicate devices in terms of mechanical properties (plate and screw performance).	"Results indicate that the subject plate and screw are substantially equivalent to legally marketed devices offering a reasonable assurance of safety and effectiveness."
Compliance with relevant ASTM standards for biomechanical testing.	"The biomechanical tests ASTM F543 and F382 were performed to determine substantial equivalence for the Tandry Locking Plate System including the performance of plate and screw."
Material compliance with specified international standards.	"The Tandry Locking Plate System is fabricated from stainless steel 316L per ASTM F139, titanium alloy per ASTM F136 and unalloyed titanium per ASTM F67."

Study Details (for Physical Device):

Sample sizes used for the test set and the data provenance: Not specified in terms of number of test articles beyond "biomechanical tests ASTM F543 and F382 were performed." The "data provenance" would be from laboratory biomechanical testing.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. For biomechanical testing, the "ground truth" is the established mechanical properties and performance data from predicate devices and the physical test results.
Adjudication method: Not applicable. Biomechanical tests follow standardized protocols.
If a multi-reader multi-case (MRMC) comparative effectiveness study was done: No. This type of study is for diagnostic or AI-assisted devices where human readers interpret cases.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: No. This is a physical device, not an algorithm.
The type of ground truth used: For biomechanical testing, the ground truth is derived from the established mechanical properties and performance of predicate devices as measured through standardized laboratory tests.
The sample size for the training set: Not applicable. There is no "training set" for a physical medical device.
How the ground truth for the training set was established: Not applicable.

In summary, the provided document pertains to a traditional medical device (bone plate system) cleared via the 510(k) pathway, which primarily relies on demonstrating substantial equivalence through non-clinical (biomechanical) testing rather than AI-specific performance metrics or clinical studies involving human readers and AI assistance.

Summary

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Microware Precision Co., Ltd. Harrison Du General Manager No. 12. Keyuan 2nd Rd., Situn District Taichung City 407630 Taiwan

Re: K171904

Trade/Device Name: Tandry Locking Plate 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: June 19, 2017 Received: June 26, 2017

September 18, 2018

Dear Harrison Du:

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 mav, 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 avare 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

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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/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.

Mark N. Melkerson -S

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) K171904

Device Name Tandry Locking Plate System

Indications for Use (Describe)

In addition, Tandry Locking Hip Plate System is in fixation of fractures to the proximal femur. The plates are indicated for use in trochanteric, pertrochanteric, and basilar neck fracture.

Each plate is indicated to be used in the following anatomic regions:

· 1.5mm and 2.0mm locking plates Metacarpals, metatarsals, tarsals, and phalanges
· 2.4mm locking plates Radius, wrist, and ulna
· 3.5 mm locking plates Clavicle, scapula, humerus, olecranon, pelvis, fibula, calcaneal, and tibia
· 5.0 mm locking plates Femur and tibia

Type of Use (Select one or both, as applicable)
X Prescription Use (Part 21 C.FR 801 Subnart D)	Over-The-Counter Ise (21 CFR 801 Subpart C)

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Microware

510(K) Summary

Submitter's Name: Microware Precision Co., Ltd. Address: No. 12, Keyuan 2nd Rd., Situn District, Taichung City 40763, Taiwan Tel: +886-4-24636275 # 100 Fax: +886-4-24636276

Contact Name: Harrison Du

Preparation date: Sep, 18, 2018

Registration Number: 3007738812

Device Name: Tandry Locking Plate System

Common Name: Bone Plate and Bone Screw

Classification Name: Class II, 21 CFR 888.3030 and 21 CFR 888.3040

Product Code: HWC and HRS

Predicate Device Information:

Microware Bone Plates and Bone Screws & Microware DHS/DCS Plate System (K072562) Synthes LCP Distal Femur Plates (K062564) Synthes 4.5mm Titanium LCP Proximal Tibia Plating System (K023802) Synthes LCP Proximal Tibia Plate (K011978) Synthes LCP Distal Tibia Plates (K013248) Synthes (USA) Modular Mini Fragment LCP System (K063049) Synthes (USA) 1.5mm Mini Fragment LCP System (K090047)

Device Description:

Indication for use:

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Microware

Tandry Locking Plate System is intended to provide fixation during fractures, fusions, and osteotomies for bones including the clavicle, pelvis, scapula and calcaneal, small bones including the metacarpals, wrist, metatarsals, tarsals and phalanges; long bones including the radius, ulna, humerus, olecranon, fibula, femur, and tibia.

In addition, Tandry Locking Hip Plate System is intended for use in fixation of fractures to the proximal femur. The plates are indicated for use in trochanteric, intertrochanteric, and basilar neck fracture.

Each plate is indicated to be used in the following anatomic regions:

1.5mm and 2.0mm locking plates Metacarpals, metatarsals, tarsals, and phalanges
2.4mm locking plates Radius, wrist, and ulna
3.5 mm locking plates Clavicle, scapula, humerus, olecranon, pelvis, fibula, calcaneal, and tibia
· 5.0 mm locking plates Femur and tibia

Technological Characteristics:

The Tandry Locking Plate System is fabricated from stainless steel 316L per ASTM F139, titanium alloy per ASTM F136 and unalloyed titanium per ASTM F67. The design feature for the Tandry Locking Plate System are similar to the predicate devices including dimensions, shape and sizes.

Summary of Performance Data (Nonclinical and/or Clinical)

Clinical Test

Clinical studies are not required to support substantially equivalent.

Non-Clinical Test

Biomechanical Test
The biomechanical tests ASTM F543 and F382 were performed to determine substantial equivalence for the Tandry Locking Plate System including the performance of plate and screw. Results indicate that the subject plate and screw are substantially equivalent to legally marketed devices offering a reasonable assurance of safety and effectiveness.
The Tandry Locking Plate System has not been evaluated for safety and compatibility in the MR environment. It has not been tested for heating, migration, or image artifact in the MR environment. The safety of the Tandry Locking Plate System in the MR environment is unknown. Scanning a patient who has this device may result in patient injury.

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Microware

Summary of Substantial Equivalence:

The Tandry Locking Plate System is substantially equivalent to the predicated devices. Result of non-clinical tests and the similarities with the legally marketed predicate device indicate the device will perform within the intended use and no new issues of safety or efficacy have been raised.

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.