The Stryker SonicPin System is intended to maintain alignment and fixation of bone fractures, osteotomies or bone grafts in hallux valgus applications in the presence of appropriate immobilization (e.g. rigid fixation implants, cast and brace). The Stryker SonicPin is designed only to be inserted with the SonicFusion equipment.

Device Description

The Stryker SonicPin System consists of a sterile bioresorbable pin (implant), the SonicFusion equipment as well as associated accessories and is intended to maintain alignment and fixation of bone fractures, osteotomies or bone grafts in hallux valgus applications in the presence of appropriate immobilization. The bioresorbable pin is implanted by the controlled application of ultrasound (SonicFusion technology). The ultrasonic energy is employed to liguefy the polymeric interface between the implant and the host bone to ensure a strong fixation with the bone after solidification.

AI/ML Overview

The provided text is a 510(k) Premarket Notification from the FDA for the Stryker SonicPin System. It describes the device, its intended use, indications for use, and summaries of non-clinical tests performed to demonstrate substantial equivalence to a predicate device.

Crucially, the document explicitly states: "Clinical testing was not required for this submission."

This means that the device's acceptance criteria and performance were not evaluated through a study involving human subjects or AI-assisted diagnostic performance. Instead, the clearance was based on demonstrating substantial equivalence to a previously cleared predicate device fundamentally through non-clinical testing.

Therefore, most of the requested information regarding acceptance criteria and a study proving the device meets those criteria (especially points 1 through 7, and 9 for a clinical context) cannot be extracted from this document, as a clinical study was not performed.

Here's what can be addressed based on the provided text:

Acceptance Criteria and Device Performance

Since no clinical study was conducted for this 510(k) submission, there are no acceptance criteria related to a diagnostic device's performance (e.g., sensitivity, specificity, or human improvement with AI). The acceptance here is based on the device demonstrating equivalence to its predicate through non-clinical means.

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

Acceptance Criteria (Non-Clinical)	Reported Device Performance (Non-Clinical)
Mechanical Performance:
- Static shear strength testing	Testing demonstrated that Stryker SonicPin System is equivalent in mechanical performance to the predicate device (K143063).
Polymer Characterization:
- Raw material characterization	Performed.
- Final, finished device characterization	Performed.
- In vitro degradation curve	Performed.
Magnetic Resonance (MR) Safety & Compatibility:
- Conformance to FDA Guidance (2014)	Scientifically based rationale demonstrated that the modified bioresorbable pin can be used in MR environment and is labeled as 'MR safe'.
Biocompatibility:
- Chemical characterization (ISO 10993-18)	Performed.
- Cytotoxicity testing (ISO 10993-5)	Performed.
- Biological and chemical risk assessment	Performed.
Bacterial Endotoxin Testing (BET):
- Meet specified endotoxin limit	Demonstrated that the modified bioresorbable pin meets the specified endotoxin limit.

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

This information is not applicable as no clinical test set was used for patient outcomes or diagnostic performance evaluation. The "test set" would refer to the physical devices subjected to non-clinical mechanical, material, and biocompatibility tests. The provenance of the data is from the manufacturer's (Stryker Trauma GmbH) non-clinical laboratory testing.

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

Not applicable as no clinical test set requiring expert ground truth for diagnostic or outcome assessment was used.

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

Not applicable as no clinical test set requiring adjudication was used.

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 device is a bioresorbable pin for bone fixation, not an AI diagnostic tool. No MRMC study was performed.

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

Not applicable. This is a physical medical device, not a standalone algorithm.

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

Not applicable for a clinical context. The "ground truth" for this submission was the established performance and safety profiles of the predicate device, against which the modified device's non-clinical performance was compared to demonstrate equivalence.

8. The sample size for the training set:

Not applicable. This is not an AI/ML device that requires a training set.

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

Not applicable.

Summary

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/0/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, stacked on top of each other.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

June 20, 2017

Stryker Trauma GmbH Dr. Heike Gustke Staff Regulatory Affairs Specialist. Trauma & Extremities Prof-Kuentscher-Str. 1-5 Schoenkirchen, DE 24232 Germany

Re: K170418

Trade/Device Name: Stryker SonicPin System Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth Or Threaded Metallic Bone Fixation Fastener Regulatory Class: Class II Product Code: HTY Dated: May 16, 2017 Received: May 24, 2017

Dear Dr. Gustke:

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, 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

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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 (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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 the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

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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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

510(k) Number (if known)

K170418

Device Name Stryker SonicPin System

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 C)

Form Approved: OMB No. 0910-0120

Expiration Date: January 31, 2017

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7 510(k) Summary
Proprietary Name:	Stryker SonicPin System
Common Name:	Pin, fixation, smooth
Regulation Description:	Smooth or threaded metallic bone fixation fastener
Regulation Number:	21 CFR 888.3040
Product Code:	HTY
Device Class:	Class II
Sponsor:	Stryker Trauma GmbH
	Prof.-Kuentscher-Str. 1-5
	24232 Schoenkirchen / Germany
Contact Person:	Dr. Heike Gustke
	Staff Regulatory Affairs Specialist
	Prof.-Kuentscher-Str. 1-5
	24232 Schoenkirchen / Germany
	heike.gustke@stryker.com
	Phone: +49 4348 702 637
	Fax: +49 4348 702 8637
Date Prepared:	June 6, 2017
Primary Predicate:	Stryker SonicPin System (K143063)

Description

This Traditional 510(k) submission is being supplied to the U.S. FDA to gain clearance to market the modified bioresorbable pin (implant) of Stryker SonicPin System. Modifications include changes of raw material specification for PLDLLA, concentration of color additive, packaging material, shelf life, storage conditions, and labeling documents. Multiple changes occurred by manufacturing.

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The bioresorbable pin is implanted by the controlled application of ultrasound (SonicFusion technology). The ultrasonic energy is employed to liguefy the polymeric interface between the implant and the host bone to ensure a strong fixation with the bone after solidification.

Intended Use

Indications for Use

Summary of Technologies

Device comparison demonstrated that the subject device is substantially equivalent to the previously cleared Stryker SonicPin System (K143063) in regards to intended use, indications for use, design, and operational principles as well as similar in regard to material.

Non-Clinical Test

Non-clinical laboratory testing was performed on Stryker SonicPin System under worst case scenario to determine substantial equivalence.

Mechanical testing was performed to evaluate the mechanical performance:

Static shear strength testing

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Testing demonstrated that Stryker SonicPin System is equivalent in mechanical performance to the predicate device (K143063). Further, the polymer characterization (for the raw material and final, finished device) and the in vitro degradation curve were performed.

Additionally, the magnetic resonance safety and compatibility were evaluated according to FDA Guidance 'Establishing safety and compatibility of passive implants in the magnetic resonance (MR) environment' (2014). The scientifically based rationale demonstrated that the modified bioresorbable pin (implant) of Stryker SonicPin System can be used in MR environment and is labeled as 'MR safe'.

Biocompatibility testing was performed to evaluate the biological safety of Stryker SonicPin System according to FDA Guidance 'Use of International Standard ISO 10993-1, Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process'. The following testing was performed:

Chemical characterization according to ISO 10993-18 .
Cytotoxicity testing according to ISO 10993-5
Biological and chemical risk assessment .

Testing demonstrated that Stryker SonicPin System is biocompatible.

The Bacterial Endotoxin Testing (BET) was performed and demonstrated that the modified bioresorbable pin (implant) of Stryker SonicPin System meets the specified endotoxin limit.

Clinical Testing

Clinical testing was not required for this submission.

Conclusion

Modifications made to the Stryker SonicPin System have been evaluated in comparison to the predicate device and non-clinical data have been used to support substantial equivalence.

The Stryker SonicPin System is substantially equivalent to the predicate device identified in this premarket notification.

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.