Tandry Compression Screw System consists of 2.8mm, 4.1mm, 4.7mm, 5.5, and 7.5mm cannulated compression screw, 2.0mm compressions screw and 2.0mm compression pin. The 2.0mm compression pin features a beak-off groove between a shaft and compression screw body, the shaft can be separated from the compression screw body by bending it back and forth. The screw system has multiple lengths depending on the diameter of the screws and pins are fabricated from Ti-6Al-4V and anodized.

AI/ML Overview

The provided FDA 510(k) K220359 summary for the Tandry Compression Screw System does not describe an AI/ML medical device. It pertains to a physical medical device (bone fixation screws). Therefore, many of the requested elements for describing the acceptance criteria and study of an AI/ML device are not applicable or cannot be extracted from this document.

However, I can extract information related to the non-clinical performance testing of the physical device, including the acceptance criteria and the study that demonstrated compliance.

Here's the breakdown of the information that can be extracted, and where the requested AI/ML specific information is not available:

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

Acceptance Criteria	Reported Device Performance
Defined in FDA guidance document "Orthopedic Non-Spinal Metallic Bone Screws and Washers - Performance Criteria for Safety and Performance Based Pathway". This guidance document specifies performance criteria for various biomechanical tests (e.g., torsional strength, bending strength, fatigue life, screw pull-out).	The testing results and assessment indicated that the Tandry Compression Screw System meets the acceptance criteria defined in the FDA guidance document. (Specific numerical results are not provided in this summary but are indicated to have met the criteria.)
Biocompatibility requirements per ISO 10993-1.	The proposed device meets biocompatibility requirements.
Reprocessing and sterilization effectiveness, using predicate device data (K171904).	Performance and testing results of the predicate device (Tandry Locking Plate System K171904) regarding reprocessing and sterilization were utilized and deemed applicable, indicating the proposed device is expected to meet these criteria.

2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)

Test Set Sample Size: Not explicitly stated in this summary. Biomechanical testing would typically involve a specific number of screws for each test (e.g., 5-10 samples per test arm).
Data Provenance: Not explicitly stated. Non-clinical (bench) testing is typically conducted in controlled laboratory environments, possibly by the manufacturer or a contract testing organization.

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. This is a physical device, and its performance is evaluated through objective biomechanical and material testing, not through expert reading of images or data. Ground truth here refers to actual physical properties and performance metrics.

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

Not Applicable. Adjudication methods are relevant for subjective evaluations, typically in clinical studies or expert review of images/data. Biomechanical testing relies on measurable physical parameters.

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

Not Applicable. This is a physical device, not an AI/ML system that would assist human readers.

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

Not Applicable. This is a physical device, not a software algorithm.

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

For biomechanical performance: Direct measurement of physical properties and mechanical performance (e.g., torsion, bending, fatigue) against established engineering standards (ASTM F-543-17) and FDA guidance documents.
For biocompatibility: Laboratory testing results according to ISO 10993-1.
For reprocessing/sterilization: Laboratory testing results, leveraging prior data from a substantially equivalent predicate device (K171904).

8. The sample size for the training set

Not Applicable. There is no "training set" as this is not an AI/ML device.

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

Not Applicable. There is no "training set" as this is not an AI/ML device.

Additional Study Information Extracted:

Study Type: Non-clinical (bench) testing, including biomechanical tests, biocompatibility assessments, and reprocessing/sterilization validation.
Standards Utilized:
- ASTM F-543-17: Standard Specification and Test Methods for Metallic Medical Bone Screws
- Orthopedic Non-Spinal Metallic Bone Screws and Washers – Performance Criteria for Safety and Performance Based Pathway (FDA guidance)
- ANSI/AAMI/ISO 10993-1: 2018: Biological evaluation of medical devices – Part 1: Evaluation and testing within a risk management process.
- AAMI TIR30: 2011(R2016): A compendium of processes, materials, test methods, and acceptance criteria for cleaning reusable medical devices.
- ANSI/AAMI/ISO 17665-1: 2006/(R)2013: Sterilization of health care products – Moist heat – Part1: Requirements for the development, validation, and routine control of a sterilization process for medical devices.
- ANSI/AAMI/ISO 14937: 2009(R)2013: Sterilization of healthcare products – General requirements for characterization of a sterilizing agent and the development, validation and routine control of a sterilization process for medical devices.

Summary

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September 20, 2022

Image /page/0/Picture/1 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left, there is a seal for the Department of Health & Human Services. To the right of the seal, there is a blue square with the letters "FDA" in white. Next to the blue square, the words "U.S. FOOD & DRUG" are written in blue, with the word "ADMINISTRATION" written in a smaller font size below.

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

Re: K220359

Trade/Device Name: Tandry Compression Screw System Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth Or Threaded Metallic Bone Fixation Fastener Regulatory Class: Class II Product Code: HWC Dated: August 22, 2022 Received: August 22, 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 approv al 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 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/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 mediation-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, M.P.H. Assistant Director DHT6C: Division of Restorative, Repair and Trauma Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health

Enclosure

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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

510(k) Number (if known) K220359

Device Name Tandry Compression Screw System

Indications for Use (Describe)

Tandry Compression Screw System is intended for the treatment of fractures, and fusions of bone with the appropriate screw size.

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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510(K) Summary K220359

Submitter's Name: Microware Precision Co., Ltd.

Address: No. 12, Keyuan 2nd Rd., Situn District, Taichung City 40763, Taiwan Fax: +886-4-24636276 Tel: +886-4-24636275 # 100

Contact Name: Harrison Du

Preparation Date: September, 20, 2022

Registration Number: 3007738812

Trade Name: Tandry Compression Screw System

Common Name: Screw, Fixation, Bone

Classification Name: Smooth or threaded metallic bone fixation fastener

Classification: Class II

Classification Number: 21 CFR 888.3040

Product Code: HWC

Predicate Device Information:

Primary Predicate: APTUS® Cannulated Compression Screws (K133460) Additional Predicates: Tandry Locking Plate System (K171904)

Device Description:

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Indication for use:

Tandry Compression Screw System is intended for the treatment of fractures, osteotomies, and fusions of bone with the appropriate screw size.

Technological Characteristics:

The Tandry Compression Screw System is fabricated from titanium alloy per ASTM F136. The design feature for the Tandry Compression Screw System is 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
Based on the testing results and assessment, results indicate the Tandry Compression Screw System meets the acceptance criteria defined in the FDA guidance document, Orthopedic Non-Spinal Metallic Bone Screws and Washers - Performance Criteria for Safety and Performance Based Pathway, to support substantial equivalence.
Biocompatibility
According to the evaluation of the FDA guideline "Use of International Standard ISO 10993-1, Biological evaluation of Medical Devices - Part 1: Evaluation and Testing within a Risk Management process", and the proposed device meets biocompatibility requirement.
Reprocessing and sterilization Since the proposed device is substantial equivalence to Tandry Locking Plate System K171904, the performance and testing result of the predicate can be utilized in the proposed device as well.
The Tandry Compression Screw 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 Compression Screw System in the MR environment is unknown. Scanning a patient who has this device may result in patient injury.

Summary of Substantial Equivalence:

The Tandry Compression Screw System is substantially equivalent to the predicated devices. Result of non-clinical tests and the similarities with the legally marketed predicate the device will perform within the intended use and no new issues of safety or efficacy have been raised. Furthermore, the indications of the subject and primary predicate are equivalent.

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Microware

Standards utilized for non-clinical performance testing

ASTM F-543-17, Standard Specification and Test Methods for Metallic Medical Bone Screws
Orthopedic Non-Spinal Metallic Bone Screws and Washers – Performance Criteria for Safety and Performance Based Pathway
ANSVAAMI/ISO 10993-1: 2018, Biological evaluation of medical devices – Part1: Evaluation and testing within a risk management process.
AAMI TIR30: 2011(R2016), A compendium of processes, materials, test methods, and acceptance criteria for cleaning reusable medical devices.
ANSI/AAMI/ISO 17665-1: 2006/(R)2013, Sterilization of health care products – Moist heat – Part1: Requirements for the development, validation, and routine control of a sterilization process for medical devices.
ANSI/AAMI/ISO 14937: 2009(R)2013, Sterilization of healthcare products – General requirements for characterization of a sterilizing agent and the development, validation and routine control of a sterilization process for medical devices.

Regulation Number and Section

§ 888.3040 Smooth or threaded metallic bone fixation fastener.

(a)
Identification. A smooth or threaded metallic bone fixation fastener is a device intended to be implanted that consists of a stiff wire segment or rod made of alloys, such as cobalt-chromium-molybdenum and stainless steel, and that may be smooth on the outside, fully or partially threaded, straight or U-shaped; and may be either blunt pointed, sharp pointed, or have a formed, slotted head on the end. It may be used for fixation of bone fractures, for bone reconstructions, as a guide pin for insertion of other implants, or it may be implanted through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.