The Bfix® Orthopedic External Fixator Systems is an external fixation system that consists of various components used for the external stabilization of bone fractures. The external fixators components includes ring, connecting rods, thread rods, posts, couplings, telescopic struts, static struts, washer, clamps and pins that combined to construct different frame configuration which is appropriate for each specification application. The metallic bone pin is implanted into bone and then connected with the external components to form a rigid construct which holds the bone fragments rigidly in place.

AI/ML Overview

The provided text is a 510(k) summary for the Bfix® Orthopedic External Fixator Systems, which is a medical device for bone stabilization. This document details the device's intended use, comparison to predicate devices, and the non-clinical testing performed to demonstrate substantial equivalence.

However, the questions you've asked are typically relevant to the performance of an AI/ML-based medical device, particularly in terms of its diagnostic or evaluative capabilities. The Bfix® Orthopedic External Fixator Systems is a physical device, and therefore the concepts of "acceptance criteria" and "study that proves the device meets the acceptance criteria" are addressed through mechanical performance testing rather than diagnostic accuracy or human reader studies.

Here's how the provided information relates to your questions, with clarifications on why some questions are not applicable to this type of device:

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

The document states that the mechanical performance of the proposed device has been conducted according to ASTM F1541-17 and ASTM F543-17. These ASTM standards themselves define the acceptance criteria (e.g., minimum load to failure, maximum deformation under load, fatigue life cycles) and the test methods to measure performance (e.g., static bending strength, torsional stiffness, axial pull-out strength). The reported device performance would be the specific values obtained from these tests for the Bfix® system, which are then compared against the criteria within these ASTM standards and often against the predicate device's performance.

Specific results are not explicitly provided in this 510(k) summary (which often summarizes but doesn't include raw data), but the statement "Performance testing data demonstrates that the proposed device is safety and effectiveness as the predicated device" implies that the Bfix® system met these acceptance criteria when compared to the predicate device and relevant standards.

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

For a physical device like an external fixator, "sample size" refers to the number of physical devices or components tested. The standards (ASTM F1541-17 and ASTM F543-17) would specify the required sample sizes for each type of mechanical test. The provenance is that the tests were performed on the Bfix® Orthopedic External Fixator Systems manufactured by Aike (Shanghai) Medical Instrument Co., Ltd. within China. These would be prospective tests performed specifically for this 510(k) submission.

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

This question is not applicable to this type of physical device. "Ground truth" established by experts (like radiologists for image analysis) is relevant for diagnostic or AI/ML-based devices. For mechanical devices, the "ground truth" is established by the physical testing methods described in the ASTM standards, and performance is measured by calibrated testing equipment, not human expert interpretation.

4. Adjudication method for the test set

This question is not applicable. Adjudication (e.g., 2+1, 3+1 consensus) is used to resolve disagreements among human experts in diagnostic studies. For mechanical testing, the results are quantitative measurements, not subjective interpretations.

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

This question is not applicable. An MRMC study is specific to evaluating the impact of an AI/ML device on human reader performance, typically in diagnostic imaging. This device is a surgical implant, not an AI diagnostic tool.

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

This question is not applicable. This device is a physical product, not an algorithm.

7. The type of ground truth used

This question is not applicable in the context of expert consensus or pathology for a physical device. The "ground truth" for a mechanical device's performance is derived from objective physical measurement against established engineering standards (ASTM F1541-17, ASTM F543-17) and comparison to the predicate device's known performance. For example, the "ground truth" for static bending strength is the force required to break the device as measured by a load cell, not a human interpretation.

8. The sample size for the training set

This question is not applicable. "Training set" refers to data used to train an AI/ML model. This device is a physical product and does not involve AI/ML.

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

This question is not applicable for the same reason as question 8.

Summary regarding the Bfix® Orthopedic External Fixator Systems:

The "acceptance criteria" for the Bfix® Orthopedic External Fixator Systems are the performance metrics defined by the relevant ASTM standards (ASTM F1541-17 and ASTM F543-17) for external fixators, as well as demonstrating substantial equivalence in performance to the predicate device (Orthofix Galaxy Fixation System).

The "study that proves the device meets the acceptance criteria" is the Non-Clinical Testing described in Section VII of the 510(k) summary, which included:

Static bending test
Static torsion test
Single bending test
Bending fatigue test
Axial pull-out test
Rotational torque test
Self-tapping performance

These tests are designed to mechanically characterize the device's strength, stiffness, durability, and securement capabilities against established benchmarks and the predicate device. The conclusion (Section IX) states that "Performance testing data demonstrates that the proposed device is safety and effectiveness as the predicated device," indicating that it successfully met the implied acceptance criteria based on these mechanical tests.

Summary

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Aike (Shanghai) Medical Instrument Co., Ltd. Hongying Gu OC Manager B320/B321/B322/B323, No. 1128, South Huicheng Road, Jiading Industrial District Shanghai, 200071 CHINA

Re: K200491

Trade/Device Name: Bfix® Orthopedic External Fixator Systems Regulation Number: 21 CFR 888.3030 Regulation Name: Single/Multiple Component Metallic Bone Fixation Appliances And Accessories Regulatory Class: Class II Product Code: KTT Dated: December 3, 2020 Received: December 9, 2020

Dear Hongying Gu:

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 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

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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 (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 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,

Ting Song, Ph.D., R.A.C. Assistant 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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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2020 See PRA Statement below.

510(k) Number (if known) K200491

Device Name

Bfix® Orthopedic External Fixator Systems

Indications for Use (Describe)

The Bfix® Orthopedic External Fixator Systems is intended to be used on adults patients for bone stabilization in the lower limbs.

The indication for use includes:

open or closed fractures in long bones;
bone defects or reconstructive procedure
limb lengthening

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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K200491-510(k) summary

I. Submitter

Aike (Shanghai) Medical Instrument Co., Ltd. B320, B321, B322, B323, No. 1128, South Huicheng Road, Jiading Industrial District, Shanghai, China

Contact person: Gu Hongying Position: QC Manager Phone: +086-13564123520 Fax: +086-021-69522433 E-mail: 314363362@qq.com Preparation date: 2020-9-08

II. Proposed Device

Trade Name of Device:	Bfix® Orthopedic External Fixator Systems
Common name:	External Fixator Systems
Regulation Number:	21 CFR 888.3030
Regulatory Class:	Class II
Product code:	KTT
Review Panel	Orthopedic

III. Predicate Devices

Predicate device 1

510(k) Number: K113770 Product Code: KTT Classification: 21 CFR 888.3030 Trade Name: Orthofix Galaxy Fixation System Common Name: External Fixation Device and Accessories Manufacturer: Orthofix Srl

IV. Device description

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application. The metallic bone pin is implanted into bone and then connected with the external components to form a rigid construct which holds the bone fragments rigidly in place.

V. Indication for use

The Bfix® Orthopedic External Fixator Systems is intended to be used on adults patients for bone stabilization in the lower limbs.

The indication for use includes:

open or closed fractures in long bones;
bone defects or reconstructive procedure
limb lengthening

VI. Comparison of technological characteristics with the predicate devices

The principle of operation for the proposed device and the predicated device is stabilization of bones through fixation with pin clamps to an external fixation frame built with rod. The Bfix® Orthopedic External Fixator System is similar to legally marketed predicated devices in that they are manufactured from similar materials, are of structurally similar size, strength and stiffness, and incorporated similar methods of assembly and adjustable.

VII. Non-Clinical Testing

The mechanical performance of the proposed device has been conduct tests according to ASTM F1541-17 and ASTM F543-17. The following tests were carried out:

Static bending test, ●
Static torsion test, ●
Single bending test ●
Bending fatique test ●
Axial pull-out test
Rotational torque test ●
Self-tapping performance .

VIII. Clinical Testing

It is not applicable.

IX. Conclusion

The proposed device has the same indication for use, has similar design features and technological characteristic as the predicate device. Performance testing data

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demonstrates that the proposed device is safety and effectiveness as the predicated device. Accordingly, the proposed device is substantially equivalent to the predicate device.

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.