The Stryker SERFAS 90-S Max electrosurgical probe is indicated for resection, ablation, and coagulation of soft tissue and hemostasis of blood vessels in orthopedic and arthroscopic procedures of joints such as the knee, shoulder, elbow, hip, ankle, and wrist.

Device Description

The Stryker SERFAS 90-S Max electrosurgical probe (hereafter referred to as "Proposed device") is an accessory to the SERFAS Energy System, marketed through K041810 and K160050, and the Crossfire Arthroscopy System, marketed through K071859, which is intended for resection, ablation, and coagulation of soft tissue via radiofrequency (RF) ablation. RF ablation probes are the main tool used in most arthroscopic procedures for the removal of tissue and the coagulation of bleeding vessels. The Proposed device is a disposable single-use electrosurgical device provided sterile via Ethylene Oxide sterilization.

AI/ML Overview

The provided text describes a 510(k) premarket notification for a medical device, the Stryker® SERFAS 90-S Max Electrosurgical Probe. The document focuses on demonstrating substantial equivalence to a predicate device through performance testing.

Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:

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

The document lists several performance tests and states that the device "Pass"ed each one. While specific numerical acceptance criteria are not explicitly detailed in the table, the "Description" column implies the criteria (e.g., "Determines if a probe can last its full lifetime without failure," "Determines if the probe tip can withstand normal and side force"). The reported device performance is "Pass" for all tests.

Test Name	Description	Acceptance Criteria (Implied)	Reported Device Performance
Aggressive Use	Determines if a probe can last its full lifetime withoutfailure	Probe lasts its full lifetime without failure	Pass
Tip Cantilever	Determines if the probe tip can withstand the normal andside force	Probe tip withstands normal and side force	Pass
Torsion in a Slot	Determines if the probe tip can withstand torsional forces	Probe tip withstands torsional forces	Pass
Bending Moment	Verifies failure mode while probe is used in pryingmanner	Probe performs as expected during prying (no premature failure)	Pass
Impact	Determines a probe can survive an impact of a hard object	Probe survives impact of a hard object	Pass
Electrode Pull	Determines the force at which the electrode is pulled out ofthe probe tip assembly	Electrode remains assembled above a specified pull force	Pass
Heat	Determines if the probe tip can withstand extremetemperatures	Probe tip withstands extreme temperatures	Pass
Captured Tip	Determines strength of probe tip assembly	Probe tip assembly meets specified strength requirements	Pass
Leak	Determines if probe will allow leakage.	Probe does not allow leakage	Pass
Heat Shrink	Determines mechanical strength of heat shrink	Heat shrink meets specified mechanical strength	Pass
Mechanical Force	Determines if the probe can withstand representativecompressive force on shaft	Probe withstands representative compressive force on shaft	Pass
Shaft Compression	Determines if the probe can withstand representativecompressive force on shaft	Probe withstands representative compressive force on shaft	Pass
Thermal Damage	Determines the thermal effect on tissue of the proposeddevice compared to the reference device.	Thermal effect on tissue comparable to reference device	Pass

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

The document mentions "Bench performance testing" but does not specify the sample size used for each test. It also does not mention the data provenance (e.g., country of origin, retrospective or prospective).

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

This information is not provided in the document. The tests described are primarily physical/mechanical performance tests, not clinical evaluations that would typically involve expert ground truth establishment.

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

This information is not provided as the tests are objective physical/mechanical measurements, not subjective evaluations requiring adjudication.

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 is not applicable to this device. The Stryker® SERFAS 90-S Max Electrosurgical Probe is a physical electro-surgical instrument, not an AI-powered diagnostic or assistive tool for human "readers" (e.g., radiologists). Therefore, an MRMC study related to AI assistance would not be relevant.

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

This is not applicable to this device, as it is a physical surgical probe, not an algorithm.

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

For the performance tests listed, the "ground truth" would be established by engineering specifications, physical measurements against those specifications, and comparison to the predicate/reference device's performance (e.g., for thermal damage). It's not a ground truth derived from expert consensus, pathology, or outcomes data in the typical sense applied to diagnostic devices.

8. The sample size for the training set:

This is not applicable. This document describes a physical medical device and its performance testing, not an AI/algorithm-based device that would require training data.

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

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

Summary

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January 26, 2018

Stryker Benjamin Krebs Quality Engineer 5900 Optical Court San Jose, California 95138

Re: K171391

Trade/Device Name: Stryker 90-S Max SERFAS Energy Probe Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical Cutting and Coagulation Device and Accessories Regulatory Class: Class II Product Code: GEI Dated: May 9, 2017 Received: May 11, 2017

Dear Benjamin Krebs:

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, 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 the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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,

Jennifer R. Stevenson -S For Binita S. Ashar, M.D., M.B.A., F.A.C.S. Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

X171391 510(k) Number (if known)

Stryker SERFAS 90-S Max Electrosurgical Probe Device Name

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1. General Information

510(k) Sponsor	Stryker Corporation
Address	5900 Optical CourtSan Jose, CA 95138
FDA Registration Number	2936485
Correspondence Person	Mr. Benjamin KrebsQuality EngineerStryker Corporation
Contact Information	Email: ben.krebs@stryker.comPhone: (408) 754-2897Fax: (408)-754-2969
Date Prepared	January 25, 2018

2. Device Identification

Proposed Device:
Proprietary Name	Stryker® SERFAS 90-S Max Electrosurgical Probe
Common Name	RF Probe
Classification Name	Electrosurgical Cutting and Coagulation Device and Accessories
Regulation Number	21 CFR 878.4400
Product Code	GEI
Regulatory Class	II

Primary Predicate Device:

Proprietary Name	Stryker® SERFAS 90-S Electrosurgical Probe
Common Name	RF Probe
Premarket Notification	K160050
Classification Name	Electrosurgical Cutting and Coagulation Device and Accessories
Regulation Number	21 CFR 878.4400
Product Code	GEI
Regulatory Class	II

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Reference Device:
Proprietary Name	SERFAS Energy System
Common Name	RF Probe
Premarket Notification	K041810
Classification Name	Electrosurgical Cutting and Coagulation Device and Accessories
Regulation Number	21 CFR 878.4400
Product Code	GEI
Regulatory Class	II

Device Description

3. Indications for Use

4. Comparison of Technological Characteristics with the Predicate Device

The Stryker SERFAS 90-S Max electrosurgical probe is similar to the predicate device with respect to technological characteristics and design. The modifications of the Proposed device, listed below, are minor and testing confirms that these modifications do not raise any new questions of safety or effectiveness, therefore supporting that the SERFAS 90-S Max electrosurgical probe is substantially equivalent to the predicate device currently on the market.

The following differences exist between the Proposed device and the predicate device:

Probe Tip (Electrode and Ceramic) Design ●
. Outer Lumen Heat Shrink Material

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5. Performance Testing

The Stryker SERFAS 90-S Max electrosurgical probe was tested for performance in accordance with internal design specifications and with the applicable performance standards, which established the substantial equivalence determination. The following non-clinical tests were conducted and are summarized in the table below:

Test Name	Description	Results
Aggressive Use	Determines if a probe can last its full lifetime withoutfailure	Pass
Tip Cantilever	Determines if the probe tip can withstand the normal andside force	Pass
Torsion in a Slot	Determines if the probe tip can withstand torsional forces	Pass
Bending Moment	Verifies failure mode while probe is used in pryingmanner	Pass
Impact	Determines a probe can survive an impact of a hard object	Pass
Electrode Pull	Determines the force at which the electrode is pulled out ofthe probe tip assembly	Pass
Heat	Determines if the probe tip can withstand extremetemperatures	Pass
Captured Tip	Determines strength of probe tip assembly	Pass
Leak	Determines if probe will allow leakage.	Pass
Heat Shrink	Determines mechanical strength of heat shrink	Pass
Mechanical Force	Determines if the probe can withstand representativecompressive force on shaft	Pass
Shaft Compression	Determines if the probe can withstand representativecompressive force on shaft	Pass
Thermal Damage	Determines the thermal effect on tissue of the proposeddevice compared to the reference device.	Pass

Bench performance testing was conducted to ensure that the device functioned as intended and met design specifications and acceptance criteria.

6. Conclusion

Based on the intended use, technological characteristics, performance testing, and non-clinical testing in comparison to the predicate device, the Stryker SERFAS 90-S Max electrosurgical probe does not raise any new questions of safety and effectiveness, therefore demonstrating substantial equivalence.

Regulation Number and Section

§ 878.4400 Electrosurgical cutting and coagulation device and accessories.

(a)
Identification. An electrosurgical cutting and coagulation device and accessories is a device intended to remove tissue and control bleeding by use of high-frequency electrical current.(b)
Classification. Class II.