The ShockPulse-SE Lithotripsy System is an electromechanical device capable of fragmenting calculi and aspirating stone debris. The ShockPulse-SE Lithotripsy System consists of generator, probes, transducer, cleaning stylet, wrench, power cord and nosecone. Footswitch is optional.

AI/ML Overview

The provided document is a 510(k) premarket notification for a medical device called the ShockPulse-SE Lithotripsy System. It outlines the regulatory review process and confirms the device's substantial equivalence to a predicate device.

However, this document does not contain the detailed information necessary to answer your specific questions related to acceptance criteria, study design for device performance (especially for AI/ML models), sample sizes, ground truth establishment, expert qualifications, or MRMC studies.

This K171024 submission focuses on demonstrating substantial equivalence based on the device's technological characteristics, intended use, and general performance testing (electrical safety, EMC/EMI, biocompatibility, etc.). It describes a physical medical device (a lithotripsy system for kidney stones), not an AI/ML-driven diagnostic or therapeutic system.

Therefore, I cannot provide the requested information for the following reasons:

No AI/ML Component: The ShockPulse-SE Lithotripsy System is an electrohydraulic lithotriptor. There is no mention of any AI or machine learning component in its design or function. Your questions are specifically tailored to the evaluation of AI/ML devices.
Performance Data Limitations: The document lists general performance tests (e.g., "Mass removal rate," "Drill rate," "Displacement," "Frequency") and states "Pass" for all of them. However, it does not provide:
- Specific acceptance criteria values (e.g., "Mass removal rate must be > X mg/s").
- The detailed methodology of these performance tests.
- Any information on "test sets," "training sets," "ground truth," "expert consensus," "adjudication," or "human reader studies" as these are not relevant to the type of device being described.

In summary, the provided text does not contain the information requested in your prompt because it describes a traditional medical device, not an AI/ML system. If you have a document describing an AI/ML medical device, I would be happy to analyze it for the requested details.

Summary

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

August 21, 2017

Cybersonics, Inc. Samradni Patil Regulatory Affairs Manager Knowledge Park, 5340 Fryling Road, Suite 101 Erie. PA 16510

Re: K171024

Trade/Device Name: ShockPulse-SE Lithotripsy System Regulation Number: 21 CFR§ 876.4480 Regulation Name: Electrohydraulic Lithotriptor Regulatory Class: II Product Code: FEO Dated: July 24, 2017 Received: July 25, 2017

Dear Samradni Patil:

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.

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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 (reporting of medical device-related 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 (DICE) 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 (DICE) 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.

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Benjamin R. Fisher, Ph.D. Director Division of Reproductive, Gastro-Renal, and Urological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K171024

Device Name ShockPulse-SE Lithotripsy System

Indications for Use (Describe)

ShockPulse-SE Lithotripsy System is intended to be used for the fragmentation of urinary tract calculi in the kidney, ureter and bladder.

Type of Use (Select one or both, as applicable)
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X Prescription Use (Part 21 CFR 801 Subpart D)

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

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Cybersonics Inc.

510(k) Summary of Safety and Effectiveness Cybersonics Inc. ShockPulse-SE Lithotripsy System

General Information

Manufacturer:	Cybersonics, Inc.Knowledge Park5340 Fryling Road, Suite 101Erie, Pennsylvania 16510 USAPhone: 814 898 4734Fax: 814 898 4737
Establishment Registration Number:	3004216443
Contact Person:	Samradni PatilManager, Regulatory Affairs
Date Prepared:	April 3, 2017

Device Information

Classification Name:	Device Classification Name:Electrohydraulic lithotriptor,Regulation / CFR Citation Number: 21CFR 876.4480Product Code: FEOClass: II
Trade Name:	ShockPulse-SE Lithotripsy System
Generic/Common Name:	Lithotripter, Ultrasonic Intracorporeal

Predicate Devices

Predicate Device	ShockPulse-SE LithotripsySystem (K142428)
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Special 510(k) Notification

Device Description

Intended Use/Indication for Use

ShockPulse-SE Lithotripsy System is intended to be used for the fragmentation of urinary tract calculi in the kidney, ureter and bladder.

Comparison of Technological Characteristics with the Predicate Devices

	Predicate Device	Proposed Device
Device Name	ShockPulse-SE Lithotripsy System	ShockPulse-SE Lithotripsy System
510(k) Number(s)	K142428	To be Assigned
Product Code	FEO	FEO
IntendedUse/Indication forUse	ShockPulse-SE Lithotripsy System isintended to be used for the fragmentationof urinary tract calculi in the kidney,ureter and bladder.	ShockPulse-SE Lithotripsy System isintended to be used for the fragmentationof urinary tract calculi in the kidney,ureter and bladder.
Principle ofoperation	Ultrasonic technology that uses atransducer to convert electrical energy toultrasonic frequency vibrations that traveldown the probe and break up stones.	Ultrasonic technology that uses atransducer to convert electrical energy toultrasonic frequency vibrations that traveldown the probe and break up stones.
Applied Part Type	Type BF	Type BF
UltrasonicMaximum Outputto Transducer	100 Watts	100 Watts
UltrasonicFrequency	19,500 Hz – 21,500 Hz	19,500 Hz – 21,500 Hz
SterilizationMethod fordisposable probes	Ethylene Oxide	Ethylene Oxide
SterilizationMethod ofreusable probes	Prevac Cycle (USA), Prevac Flash Cycle	Prevac Cycle (USA), Prevac Flash Cycle
Materialfor 3.76mm and3.40mm probetube	304 Stainless Steel	304 Stainless Steel coated with diamondlike carbon
Material for1.83mm, 1.50mmand 0.97mmprobe tube	304 Stainless Steel	304 Stainless Steel

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Device modifications described in the submission do not affect the intended use or the technological characteristics of the ShockPulse-SE Lithotripsy System.

Performance Data

Testing has confirmed that the proposed ShockPulse-SE Lithotripsy System functions as intended and is substantially equivalent to the predicate device.

Performance Testing Performed
Electrical Safety	Pass
EMC/EMI	Pass
Biocompatibility	Pass
Bioburden	Pass
EO Residuals	Pass
Mass removal rate	Pass
Drill rate	Pass
Displacement	Pass
Frequency	Pass

Conclusions

The proposed ShockPulse-SE Lithotripsy System is substantially equivalent to the predicate device. The modifications in the device do not affect the intended use or the technological characteristics for the system and do not raise different questions of safety or effectiveness.

Regulation Number and Section

§ 876.4480 Electrohydraulic lithotriptor.

(a)
Identification. An electrohydraulic lithotriptor is an AC-powered device used to fragment urinary bladder stones. It consists of a high voltage source connected by a cable to a bipolar electrode that is introduced into the urinary bladder through a cystoscope. The electrode is held against the stone in a water-filled bladder and repeated electrical discharges between the two poles of the electrode cause electrohydraulic shock waves which disintegrate the stone.(b)
Classification. Class II. The special control for this device is FDA's “Guidance for the Content of Premarket Notifications for Intracorporeal Lithotripters.”