The MDS Injection Screw is intended for the fixation of bone fractures and bone reconstructions of the humerus. The MDS Injection Screws can be used to deliver injectable bone void fillers to a surgical site and are compatible with applicable MDS plating systems.

Device Description

Miami Device Solutions (MDS) Injection Screws enable fixation of simple and complex fractures of the humerus. The MDS Injection Screws are only to be used in combination with compatible MDS 3.5T plating systems in the humerus (Proximal Humerus Plating System, K141493/K161058; MDS Plating System, K172786). When inserted through a 3.5T plate screw hole, injection screw placement is possible at any angle within a 40° cone. MDS Injection Screws can be used with or without bone void fillers. Fenestrations along the screw length allow bone void filler delivery directly into the surgical site.

AI/ML Overview

This document (K173556) is a 510(k) premarket notification for a medical device called the "Injection Screw." It does not contain information about acceptance criteria or a study proving the device meets them in the context of an AI/ML software. Instead, it demonstrates substantial equivalence to predicate devices through non-clinical performance testing.

Therefore, I cannot answer the questions as they relate to AI/ML device acceptance criteria and studies. The device in this document is a physical medical implant (a bone screw), and the "performance data" refers to mechanical testing.

However, I can provide the information available in the document regarding the device's technical validation:

1. Table of Acceptance Criteria and Reported Device Performance
This document does not specify "acceptance criteria" in the typical sense of a target metric for an AI/ML system (e.g., accuracy, sensitivity, specificity).
Instead, it references industry standards and internal testing to demonstrate the physical device's mechanical properties and functionality.

Acceptance Criteria (Implicit from referenced standards)	Reported Device Performance
Mechanical Performance Testing
ASTM F543 Standard Specification and Test Method for Metallic Bone Screws	Testing performed to demonstrate compliance and comparable performance to predicates. (Specific numerical results not provided in this summary.)
Angular Stability	Testing performed to demonstrate comparable performance to predicates. (Specific numerical results not provided in this summary.)
Fatigue Strength	Testing performed to demonstrate comparable performance to predicates. (Specific numerical results not provided in this summary.)
BVF Delivery (Bone Void Filler)
Cadaver Lab (for Injectability/Extrudability/Extraction Torque)	Testing performed to demonstrate functionality and comparable performance to predicates. (Specific numerical results not provided in this summary.)
Injectability/Extrudability/Extraction Torque	Testing performed to demonstrate functionality and comparable performance to predicates. (Specific numerical results not provided in this summary.)
BVF Characterization	Testing performed to demonstrate comparable performance to predicates. (Specific numerical results not provided in this summary.)

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
Not applicable/provided for an AI/ML context. The document refers to "non-clinical (laboratory/performance) testing" and "Cadaver Lab" for functional testing of the physical screw. Specific sample sizes for mechanical tests would relate to the number of screws tested, and "cadaver lab" would refer to the number of cadaveric specimens used. These details are not elaborated in the 510(k) summary.

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 ground truth is established through engineering and materials science principles and testing, not expert consensus on interpretations.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. This concept is relevant for expert review in diagnostic studies, not for the mechanical testing of a bone screw.

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 diagnostic system.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is a physical device, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for this device's performance is based on established engineering principles, material science data, and mechanical testing results compliant with industry standards like ASTM F543. For the BVF delivery aspect, it refers to "cadaver lab" testing, which implies direct observation and measurement of the physical phenomenon.

8. The sample size for the training set
Not applicable. This is a physical device, and the concept of "training set" is for AI/ML models.

9. How the ground truth for the training set was established
Not applicable.

In summary: The provided document is for a traditional physical medical device (bone screw) and addresses its substantial equivalence through non-clinical performance and engineering analysis, not through the evaluation of an AI/ML algorithm. Therefore, many of the requested details pertaining to AI/ML device validation are not present or applicable.

Summary

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July 13, 2018

Biedermann Medtech, Inc. Michelle Montesino Regulatory Affairs Specialist 7620 NW 25th Street Unit 3 & 4 Miami, Florida 33122

Re: K173556

Trade/Device Name: Injection Screw Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth Or Threaded Metallic Bone Fixation Fastener Regulatory Class: Class II Product Code: HWC Dated: June 8, 2018 Received: June 11, 2018

Dear Michelle Montesino:

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. The general controls provisions of the Act include requirements for annual registration. Iisting 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); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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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 medical devices and radiation-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,

Vincent J. Devlin -S

for

Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation 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) K173556

Device Name Injection Screw

Indications for Use (Describe)

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
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Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

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510(k) SUMMARY

Submitter Name:	Biedermann Medtech, Inc.
Submitter Address:	7620 NW 25th Street, Unit 3 & 4;Miami, FL 33122
Contact Person:	Michelle MontesinoPhone: (786) 422-1400 Ext. 106Fax: (786) 422-1401Anderson GiraldoPhone: (786) 422-1400 Ext 115Fax: (786) 422-1401
Date of Submission:	07/12/2018
Manufacturer Name:	Biedermann Medtech, Inc.
Manufacturer Address:	7620 NW 25th Street, Unit 3 & 4;Miami, FL 33122
Registration Number:	3013248720
Contact Name:	Markku Biedermann
Title:	Chairman
Device Trade Name:	Injection Screw
Device Common Name:	Primary: Screw, Fixation, Bone
Classification Names:	Primary: Screw, Fixation, Bone
Classification Code:	Primary: HWC – Class II
Classification Panel:	Orthopedic
Regulation Number:	Primary: 21 CFR section 888.3040 – Smooth or threaded metallicbone fixation fastener
Predicate Device:	Primary K142776 Flow-Fx Flow-Screw Secondary K151146 N-Force Fixation System Secondary K161058 Miami Device Solutions CannulatedScrew Secondary K132502,K140769 Variax 2 System Bone Screws

Reference Devices:

Paragon 28, Inc.; The Monster Screw System: Instrument Reprocessing Instructions for Reusable Instruments – K151418

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Miami Device Solutions, LLC; Distal Radius Plating System -K161292/K162635

Etex Corp., Beta-bsm Injectable Bone Substitute Material -K101557

Miami Device Solutions Proximal Humerus Plating System Multiuse Screw - K141493

Device Description:

Materials: Titanium alloy.

Intended Use:

Substantial Equivalence Statement:

Documentation is provided which demonstrates that the MDS Injection Screw is equivalent to its predicate in terms of material, design, intended use, and performance characteristics.

Performance Data:

Non-Clinical Performance and Conclusions:

The results of non-clinical (laboratory/performance) testing as well as engineering analysis such as the following for subject devices demonstrate that the device is as safe and as effective as the predicates:

Mechanical Performance Testing -
- ASTM F543 Standard Specification and Test Method for Metallic Bone Screws O
- Angular Stability O
- Fatigue Strength o
BVF Delivery -
- Cadaver Lab O
- Injectability/Extrudability/Extraction Torque O
- BVF Characterization O

Substantial equivalence is demonstrated in the performance testion of the submission by comparing subject and predicate designs. Comparison of the design, intended use, and testing demonstrate that the MDS Injection Screw performs as well as the predicate devices and should thereby be considered substantially equivalent.

Clinical Performance and Conclusions:

Clinical data and conclusions were not needed for this device.

Conclusion

The MDS Injection Screw is substantially equivalent to the predicate 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.