The Tandry CMF System is a Maxillofacial plate and screw system intended for osteotomy, stabilization and rigid fixation of maxillofacial/midface fractures and reconstruction including infraorbital area and maxillofacial, and mandibular and maxillary correction surgery.

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

· 1.2mm upper-face plates Orbital floor region, zygomatic region, and dento-alveolar region
· 1.5mm mid-face plates Zygomatic region, orbital floor region, and maxilla
· 2.0 mm mini plates Orthognathics midface/mandible
· 2.0/2.3mm mandible plates Mandibular

Device Description

The Tandry CMF Plate System consists of various sized plates and screws. The plates and screws are fabricated from pure titanium and Ti-6Al-4V. The plates are designed to distribute for respective anatomical and indicated areas, besides, they can be used with self-tapping, self-drilling, emergency self-tapping and locking screws.

AI/ML Overview

This document is a 510(k) Premarket Notification from Microware Precision Co., Ltd. for their Tandry CMF Plate System. It describes the device, its intended use, and compares it to predicate devices to demonstrate substantial equivalence.

Based on the provided text, here's an analysis of the acceptance criteria and study information:

Key Takeaway: The submission explicitly states that clinical studies were NOT required to support substantial equivalence for this device. Therefore, information related to clinical performance, human reader studies, and specific AI acceptance criteria (which would typically be evaluated in such studies) is not present in this document. The "study" here refers to non-clinical tests.

1. A table of acceptance criteria and the reported device performance

The document does not present a formal table of acceptance criteria in the sense of a numerical performance target (e.g., sensitivity, specificity, accuracy) combined with reported device performance from a clinical study. This is because, as stated, clinical studies were not required.

Instead, the acceptance criteria are implicitly met by demonstrating substantial equivalence to predicate devices through non-clinical testing (biomechanical tests, biocompatibility, reprocessing, and sterilization).

Here's a breakdown of the non-clinical test results:

Acceptance Criteria (Implied by Predicate Equivalence)	Reported Device Performance (Non-Clinical)
Biomechanical Performance	- ASTM F543 and F382 (bone plate and screw performance) were performed.- The results support substantial equivalence to predicate devices.
Biocompatibility	- Sample preparation per ISO 10993-12.- Biological Safety Assessment guided by ISO 10993-1.- Cytotoxicity testing per ISO 10993-5.- The previous testing results for the predicate device (Tandry Locking Plate System K171904) are utilized, asserting the proposed device meets validation requirements.
Reprocessing and Sterilization	- Previous testing results for the predicate device (Tandry Locking Plate System K171904) are utilized, as the material, manufacturing process, geometry, physico-chemical, body/fluid contact, and sterilization process are the same.- Validated steam sterilization instructions to a sterility assurance level (SAL) of 10-6 using the biological indicator overkill method (in accordance with ANSI/AAMI/ISO 17665-1 and ANSI/AAMI/ISO 14937).
Design Characteristics	- Dimensions, shape, and sizes are similar to predicate devices (as detailed in the comparative table on page 6).
Material Composition	- Fabricated from pure titanium (ASTM F67) and Ti-6Al-4V (ASTM F136), which are standard materials used in predicate devices.

2. Sample size 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 no clinical test set or human data was used for a performance study. The "test set" for this submission consists of device samples evaluated in non-clinical lab settings (biomechanical and biocompatibility tests). No specific sample sizes for these lab tests are provided in the summary, other than "representative samples."

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 as no clinical study with expert interpretation was conducted.

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

This information is not applicable as no clinical study with human readers requiring adjudication was conducted.

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 MRMC comparative effectiveness study was done or required. The device is a traditional medical implant (plate and screw system), not an AI-powered diagnostic or assistive technology.

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

This information is not applicable as the device is not an algorithm or AI system.

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

For the non-clinical tests, the "ground truth" is defined by established engineering standards and biological safety guidelines (e.g., ASTM standards for biomechanics, ISO series for biocompatibility and sterilization). There is no clinical "ground truth" (like pathology or outcomes data) established or reported because no clinical study was performed.

8. The sample size for the training set

This information is not applicable as the 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 as the device is not an AI/ML algorithm that requires a training set.

In summary, the document details a 510(k) submission for a traditional mechanical medical device, where substantial equivalence is demonstrated through non-clinical bench testing and comparison to predicate devices, rather than through clinical trials or AI performance evaluations.

Summary

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11/10/22

Microware Precision Co., Ltd. Harrison Du General Manager No. 12, Keyuan 2nd Rd., Situn District Taichung, 40763 TAIWAN

Re: K220360

Trade/Device Name: Tandry CMF Plate System Regulation Number: 21 CFR 872.4760 Regulation Name: Bone Plate Regulatory Class: Class II Product Code: JEY, DZL Dated: October 11, 2022 Received: October 12, 2022

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 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 (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.

Sherrill Lathrop Blitzer

for Andrew Steen Assistant Director DHT1B: Division of Dental and ENT Devices OHT1: Office of Ophthalmic, Anesthesia. Respiratory, ENT and Dental 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) K220360

Device Name Tandry CMF Plate System

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

· 1.2mm upper-face plates Orbital floor region, zygomatic region, and dento-alveolar region
· 1.5mm mid-face plates Zygomatic region, orbital floor region, and maxilla
· 2.0 mm mini plates Orthognathics midface/mandible
· 2.0/2.3mm mandible plates Mandibular

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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Microware

K220360

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: Nov. 10. 2022

Registration Number: 3007738812

Device Name: Tandry CMF Plate System

Common Name: Bone Plate and Bone Screw

Classification Name: Class II, 21 CFR 872.4760

Product Code: JEY and DZL

Predicate Device Information:

Primary device: Stryker Leibinger Universal CMF System (K022185) Reference device: MCI - CMF System (K182758) Tandry Locking Plate System (K171904) Synthes Midfacial System (K953806)

Device Description:

Indication for use:

The Tandry CMF System is a Maxillofacial plate and screw system intended for osteotomy, stabilization and rigid fixation of maxillofacial/midface fractures and reconstruction including infraorbital area, zygomatic area and maxillofacial, and maxillary correction surgery.

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

1.2mm upper-face plates Orbital floor region, zygomatic region, and dento-alveolar region .

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Microware

· 1.5mm mid-face plates Zygomatic region, orbital floor region, and maxilla
· 2.0 mm mini plates Orthognathics midface/mandible
2.0/2.3mm mandible plates Mandibular

Technological Characteristics:

The Tandry CMF Plate System is fabricated from titanium alloy per ASTM F136 and unalloyed titanium per ASTM F67. The screws are made of titanium alloy conforming to ASTM F136 and its surfaces are colored-anodized. The plates are manufactured in commercially pure titanium conforming to ASTM F67 and its surfaces are colored-anodized and type 2-anodized. The design feature for the Tandry CMF Plate System is similar to the predicate devices including dimensions, shape and sizes as following Table 1.

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 CMF Plate System including the performance of plate and screw.
Biocompatibility
Representative samples of each of the subject devices was subjected to the following: "Biocompatibility sample preparation was made according to ISO 10993-12. Biological Safety Assessment guided by ISO 10993-1. Cytotoxicity testing was performed per ISO 10993-5.
Reprocessing and sterilization
Since the material, manufacturing process, geometry & physico-chemical, body/ fluid contact and sterilization process of the proposed device is the same as Tandry Locking Plate System K171904, the performance and testing result of the predicate can be utilized in the proposed device. The testing results support the proposed device to meet the validation requirement.

The steam sterilization instructions are validated to a sterility assurance level (SAL) of 10-6 using the biological indicator overkill method. The sterilization test is performed in accordance with ANSI/AAMI/ISO 17665-1 and ANSI/AAMI/ISO 14937. The subject device is a single-use device.

The Tandry CMF 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 CMF Plate System in the MR environment is unknown. Scanning a patient who has this device may result in patient injury.

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Summary of Substantial Equivalence:

The Tandry CMF Plate System is substantially equivalent to the predicated devices. Result of non-clinical tests and the similarities with the legally marketed predicate device have demonstrated substantial equivalence.

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DeviceItem	Proposed device	Primary predicate device	Reference device 1	Reference device 2	Reference device 3	SE?
Device Name	Tandry CMF Plate System	Stryker LeibingerUniversal CMF System	MCI - CMF System	Synthes Midfacial System	Tandry Locking PlateSystem	NA
510K Number	K220360	K022185	K182758	K953806	K171904	NA
Trade Name	Tandry	Stryker	MCI	Synthes	Tandry	NA
Indication for Use	The Tandry CMF System isa Maxillofacial plate andscrew system intended forosteotomy, stabilization andrigid fixation ofmaxillofacial/midfacefractures and reconstructionincluding infraorbital area,zygomatic area andmaxillofacial,mandibular and maxillarycorrection surgery.Each plate is indicated tobe used in the followinganatomic regions:- 1.2mm upper-faceplates - Orbital floorregion, zygomaticregion, anddento-alveolar region- 1.5mm mid-face plates -Zygomatic region,	The Stryker LeibingerUniversal CMF System is aCranio-maxillofacial(CMF) plate and screwsystem intended forosteotomy, stabilization andrigid fixation of CMFfractures andreconstruction.	MCI - CMF System isintended for use inselective trauma of themidface, maxillofacialsurgery, reconstructiveprocedures, and selectiveorthognathic surgery ofthe maxilla, mandible andchin.	The Synthes MidfacialSystem is a plate andscrew system,manufactured fromcommercially pure (CP)titanium, and is intendedfor use in selective traumaof the midface andcraniofacial skeleton;craniofacial surgery;reconstructive procedures;and selective orthognathicsurgery of the maxilla andchin. The plates areavailable in a variety ofconfigurations toaccommodate variousfracture sites, and attach tobone via 1.3mm or 1.7mmself-tapping screws, with alow plate/screw profile.	Tandry Locking PlateSystem is intended toprovide fixation duringfractures, fusions, andosteotomies for bonesincluding the clavicle,pelvis, scapula andcalcaneal, small bonesincluding the metacarpals,wrist, metatarsals, tarsalsand phalanges; long bonesincluding the radius, ulna,humerus, olecranon, fibula,femur, and tibia.	No substantialdifferencesbetween subjectand referencedevice.Referencedevice 3 is onlyfor evaluation ofbiocompatibility, reprocessingand sterilization.

	orbital floor region, andmaxilla- 2.0 mm mini plates -Orthognathicsmidface/mandible- 2.0/2.3mm mandibleplates - Mandibular
Materials	Pure titanium: ASTM F67Titanium Alloy: ASTMF136	Pure titanium: ASTM F67Titanium Alloy: ASTMF136	Pure titanium: ASTM F67Titanium Alloy: ASTMF136	Pure titanium: ASTM F67	Pure Titanium: ASTM F67Titanium Alloy: ASTMF136Stainless steel: ASTMF138 and F139	No substantialdifferencesbetween subjectand referencedevice.
Dimensions	ScrewDiameter: 1.2 to 2.7mmLength: 3 to 20mmPlateThickness: 0.4 to 2.8mmHoles: 4 to 39 Holes	ScrewDiameter: 1.2 to 2.7mmLength: 3 to 42mmPlateThickness: 0.1 to 2.8mmHoles: 4 to 29 Holes	ScrewDiameter: 1.5 to 2.3mmLength: 4 to 20mmPlateThickness: 0.6 to 1.0mmHoles: 4 to 20 Holes	ScrewDiameter: 1.3 to 1.7mmLength: 3 to 18mmPlateThickness: 0.2 to 0.8mmHoles: 4 to 39 Holes	ScrewDiameter: 1.5 to 4.5mmLength: 6 to 160mmPlateThickness: 1.1 to 6.25mmHoles: 2 to 22 holes	No substantialdifferencesbetween subjectand referencedevice.
Surface	Colored-anodized andtype2-anodized	Colored-anodized	Colored-anodized	Colored-anodized	Colored-anodized fortitaniumElectrolytic polishing forStainless steel	No substantialdifferencesbetween subjectand referencedevice.
Sterilization	Non-sterilize. Steamsterilization before use.	Non-sterilize. Steamsterilization before use.	Non-sterilize. Steamsterilization before use.	Non-sterilize. Steamsterilization before use.	Non-sterilize. Steamsterilization before use.	No substantialdifferencesbetween subjectand referencedevice.

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Microware

Regulation Number and Section

§ 872.4760 Bone plate.

(a)
Identification. A bone plate is a metal device intended to stabilize fractured bone structures in the oral cavity. The bone segments are attached to the plate with screws to prevent movement of the segments.(b)
Classification. Class II.