The Cybersonics, Cyberwand Dual Probe Ultrasonic Lithotripsy system is an electromechanical device capable of fragmenting and aspirating calculi. The hand piece consists of an ultrasonic transducer containing the piezo-electronic elements, which are driven by a generator operating at 21 ± 1 kHz. The resulting longitudinal waves are propagated along the ultrasonic dual probe to the target stone. The ultrasonic transducer probes are hollow, permitting simultaneous suction.

AI/ML Overview

The provided K052135 document describes the Cybersonics Cyberwand Dual Probe Lithotripter, which is intended for the percutaneous fragmentation and removal of kidney stones. The basis for substantial equivalence is primarily against other legally marketed ultrasonic lithotripters, specifically the EMS Swiss Lithoclast Ultra (K012445) and the Karl Storz Calcuson (K973251).

Acceptance Criteria and Study Details

The document does not explicitly state "acceptance criteria" as a set of quantified thresholds. Instead, it presents a comparison of technological characteristics and performance metrics, particularly drill rate, against predicate devices to demonstrate substantial equivalence. The implication is that if the Cyberwand performs "as well or better" than the predicates, it meets the unstated acceptance criteria for safety and effectiveness.

Here’s a breakdown of the information requested based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criterion (Implied)	Reported Device Performance (Cybersonics Cyberwand)	Predicate Performance (e.g., LithoClast Ultra)
Technological Characteristics:
Operating Frequency	20–22 kHz	24–26 kHz (LithoClast Ultra); 25–26kHz (Storz Calcuson)
Utilities	120–240 Vac	120–240 Vac
Autoclavable probes and hand piece	Yes	Yes
Probes threaded for assembly	Yes	Yes
Probe length (standard)	400 mm	400 mm
Probe OD ≤ 3.75mm	Yes	Yes
Ultrasonic Probe tip excursion ≤100 µm	Yes	Yes
Detachable hand piece	Yes	Yes
Handpiece with rear suction connection	Yes	Yes
Piezo stack with Titanium horn	Yes	Yes
Detachable footswitch	Yes	Yes
Table Top Generator	Yes	Yes
Applied Part BF	Yes	Yes
Performance (Drill Rate):
Mean Drill Rate (seconds)	8.7 +/- 0.9	10.9 +/- 1.0 (LithoClast Ultra)

Notes on Acceptance Criteria: The document primarily focuses on demonstrating that the Cyberwand's technological characteristics are comparable to predicate devices. For performance, the "acceptance criterion" appears to be that its drill rate is comparable to or better than predicate devices. The study results show the Cyberwand had a faster mean drill rate than all listed predicate devices.

2. Sample Size Used for the Test Set and Data Provenance

Sample Size (Drill Rate Study):
- Cybersonics Cyberwand: 10 stones
- LithoClast Ultra: 10 stones
- Olympus LUS-2: 25 stones
- Circon-ACMI USL-2000: 25 stones
- Karl Storz Calcuson: 15 stones
- Olympus LUS-1: 12 stones
- Richard Wolf Model 2271-004: 10 stones
Data Provenance: The drill rate data was supplied by Indiana University School of Medicine. This suggests a prospective study specifically designed for this comparison.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts

This information is not provided in the document. The "ground truth" for the drill rate study appears to be the objective measurement of time taken to drill artificial stones. There is no mention of experts establishing a subjective ground truth.

4. Adjudication Method for the Test Set

This information is not applicable/provided. The drill rate study involves objective measurements of time, not subjective assessments 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

No MRMC comparative effectiveness study was done. This device is a medical instrument (lithotripter), not an AI-powered diagnostic or assistive tool for human readers. Therefore, the concept of human readers improving with AI assistance is not relevant to this submission.

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

Yes, a standalone performance study was done in the form of the drill rate comparison. The "algorithm" here is the device itself, and its performance (drill rate) was measured independently without human intervention influencing the fragmentation process, beyond operating the device.

7. The Type of Ground Truth Used (Expert Consensus, Pathology, Outcomes Data, etc.)

The ground truth for the drill rate study was objective performance measurement based on artificial stone fragmentation time. This is a direct physical measurement, not dependent on expert consensus, pathology, or clinical outcomes data.

8. The Sample Size for the Training Set

Not applicable/provided. This submission does not describe a machine learning or AI algorithm that would require a training set. The device is a physical electromechanical lithotripter.

9. How the Ground Truth for the Training Set was Established

Not applicable/provided for the reasons stated above (no AI/ML training set).

Summary

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K052135

Image /page/0/Picture/1 description: The image shows the word "CYBERSONICS" in a simple, sans-serif font. To the left of the word is a stylized graphic, possibly a logo, that resembles a curved line or a letter. The text and graphic are in black and stand out against a white background.

DEC 2 0 2005

510(k) Summary per 807.92(c) for Cybersonics, Inc.

CYBERWAND DUAL PROBE LITHOTRIPTER

SPONSOR

CYBERSONICS, INC.

5368 Kuhl Road Erie, Pennsylvania 16510-4703 USA Phone: 814-899-4220 Fax: 814-899-1410 Contact Person: William A. Stoll Date Prepared: August 01, 2005

DEVICE NAME

Trade/Proprictary Name: Cybersonics, Cyberwand Dual Probe Lithotripter Common/Usual Name: Intracorporeal ultrasonic lithotripter Classification Name: Lithotripter, Ultrasonic Class: 11 (876.4480) 78 FFK

DEVICE EQUIVALENCE

Substantially equivalent to the legally marketed EMS Swiss Lithoclast Ultra.

DEVICE DESCRIPTION

INTENDED USE

The Cybersonics, Cyberwand Dual Probe Lithotripter is intended to be used for the percutaneous fragmentation and removal of kidney stones.

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BASIS FOR SUBSTANTIAL EQUIVALENCE

Cybersonics Cyberwand Dual Probe Lithotripter is substantially equivalent to the Electro Medical Systems SA Swiss LithoClast Ultra (K012445), and Karl Storz Electro Medical Systems oripter (K973251) which have been cleared for the Calcuson Oftrasonic Ention por (emoval of kidney stones. Information on these perculancous fragmentation and removal of this submission. The Cyberwand Dual Probe systems can be found in section 11 or this succifications as compared with the predicate devices. Substantial equivalence has also been demonstrated by stone predicate devices. Duostantal equivalention of that the Cybersonics, Cyberwand Dual Probe Lithotripter results in fragmentation of a variety of standard artificial stone I 1000 Enthoulpter results in 1988
materials (ranging from soft to hard) when tested against predicate ultrasound lithotripters.

	StorzCalcuson	OlympusLUS-2	EMSLithoClastUltra	CybersonicsCyberwand
Comparison of Technological Characteristics
OperatingFrequency	25--26kHz	23.5kHz	24--26kHz	20--22kHz
Utilities	120--240 Vac	120--240 Vac	120--240 Vac	120--240Vac
Autoclavableprobes and handpiece	Yes	Yes	Yes	Yes
Probes threadedfor assembly	Yes	Yes	Yes	Yes
Probe length( standard )	400 mm	400 mm	400 mm	400 mm
Probe OD ≤3.75mm	Yes	Yes	Yes	Yes
Ultrasonic Probetip excursion≤100 µm	Yes	Yes	Yes	Yes
Detachable handpiece	Yes	Yes	Yes	Yes
Handpiece withrear suctionconnection	Yes	Yes	Yes	Yes
Piezo stack withTitanium horn	Yes	Yes	Yes	Yes
Detachablefootswitch	Yes	Yes	Yes	Yes
Table TopGenerator	Yes	Yes	Yes	Yes
Applied Part BF	Yes	Yes	Yes	Yes

5368 Kuhl Road • Erie, Pennsylvania 16510-4703 • TEL (814) 899-4220 • FAX (814) 899-1410

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Drill Rate ComparisonsDrill rate data supplied by Indiana University School of Medicine
Instrument	Stones Treated	Drill Rate in Seconds(Mean +/- SD)
Cyberwand	10	8.7 +/- 0.9
Litho Clast Ultra	10	10.9 +/- 1.0
Olympus LUS-2	25	28.8 +/- 2.7
Circon-ACMI USL-2000	25	31.7 +/- 8.1
Karl Storz Calcuson	15	40.3 +/- 8.1
Olympus LUS-1	12	60.5 +/- 13.5
Richard Wolf Model 2271-004	10	103.7 +/- 21.6

CONCLUSION

Cybersonics Cyberwand Dual Probe Lithotripter is substantially equivalent to the legally Cybersonics Cyberwand Daal Proov wand is as safe, as effective and performs as well or better than the predicate devices.

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Image /page/3/Picture/1 description: The image shows a circular seal with the words "Department of Health & Human Services" around the edge. Inside the circle is a stylized image of a bird or other winged creature. The image is in black and white and appears to be a scan or photocopy.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DEC 2 0 2005

Mr. William A. Stoll Manager of Quality Assurance & Regulatory Affairs Cybersonics, Inc. 5368 Kuhl Road ERIE PA 16510

Re: K052135

Trade/Device Name: Cyberwand Dual Probe Lithotripter Regulation Number: 21 CFR §876.4480 Regulation Name: Electrohydraulic lithotriptor Regulatory Class: II Product Code: FFK Dated: November 29, 2005 Received: November 30, 2005

Dear Mr. Stoll

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced we have levewed your socurer 5 retty prehentially equivalent (for the indications for use stated in above and nave decomments ad predicate devices marketed in interstate commerce prior to the enclosure) to tegany manectod production of the Medical Devices that have been May 20, 1770, the chanance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that reciassified in accordation while pro noval application (PMA). You may, therefore, market the do not require approval of a promation approvisions of the Act. The general controls provisions of the Act device, subject to the general volual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (Premarket If your device is classified (300 as 10) hitting major regulations affecting your Approval), it thay of subject to secured Regulations, Title 21, Parts 800 to 898. In addition, FDA uevice can be round in the concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that Please be advisou mai 1 DA s 135dailed of a see complies with other requirements of the Act of the Act of the FDA has made a decemination mad your as router Federal agencies. You must comply with all the Federal statues and regulations administration and listing (21 CFR Part 807); labeling Act s requirements, metading but hot minted to reguirements as set forth in the quality systems (QS) (21 CFR Part 801); good manufacturing product radiation control product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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This letter will allow you to begin marketing your device as described in your Section 5 I (k) This letter will allow you lo begin matketing your actives of your device of your device of your device to a legally
premarket notification. The FDA finding of substantial e premarket notification. The IDA finding of substantial equildine of your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please If you desire specific advice for your device on our laboring regulation () ( ) ( ) ( ) ( ) ( ) ( ) ( ) ( ) ( ) ( ) ( ) ( ) ( ) ( ) ( ) ( ) ( ) ( ) ( ) ( ) ( ) ( ) ( ) ( ) ( the top of this letter:

21 CFR 876.xxxx	(Gastroenterology/Renal/Urology)	240-276-0115
21 CFR 884.xxxx	(Obstetrics/Gynecology)	240-276-0115
21 CFR 892.xxxx	(Radiology)	240-276-0120
Other		240-276-0100

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Also, please note the regulation entitled, "Misoration on your responsibilities under the Act from the 807.97). You may obtain other general intonnation on your respections and its toll-free number (800) Division of Binan National of Street address 056-2041 of (2019/01/2019/2017/industry/support/index.html.

Sincerely yours,

Nancy C. Brogdon

Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known): K052135

Device Name: Cybersonics – Cyberwand Dual Probe Lithotripter

Indications for Use:

The Cyberwand Dual Probe Lithotripter is intended to be used for the fragmentation of urinary The Cyberwand Daily and bladder.

Prescription Use
(Part 21 CFR 801 Subpart D)

AND/OR

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

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Jennie A. Symm

(Division Sign-Off) Division of Reproductive, Abdominal, and Radiological Devices 510(k) Number

Page of of __

(Posted November 13, 2003)

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.”