The LITHOSPEC™ Intracorporeal Lithotripter is intended to be used during urological procedures to crush and remove bladder, ureteral and renal stones.

Device Description

The LITHOSPECTM is a direct contact intracorporeal lithotripter which fragments bladder, ureteral and renal calculi by utilizing direct endoscopic techniques. The electromechanical technique ensures the delivery of high impact mechanical fragmentation power to the stone while eliminating the possibility of thermal injury. Four reusable Probes, having diameters: 0.8 mm, 1.6 mm, and 2.0 mm, are provided with the system. The LITHOSPEC™ is operated using standard endoscopic equipment.

AI/ML Overview

The provided text does not contain information about acceptance criteria and a study proving device performance in the context of typical AI/ML medical device evaluations (e.g., sensitivity, specificity, AUC, human reader studies).

Instead, this document is a 510(k) summary for a mechanical intracorporeal lithotripter (LITHOSPEC™), a physical medical device for crushing kidney stones. The "performance" described here refers to its mechanical capabilities and safety compliance, not AI algorithm performance.

Therefore, I cannot fulfill the request as the type of information requested (acceptance criteria and study design for AI/ML performance) is not present in the provided context for this particular device.

Here's why and what can be inferred:

Type of Device: The LITHOSPEC™ is a physical surgical tool, an "Intracorporeal Lithotripter," not an AI/ML diagnostic or predictive algorithm.
Performance Standards: The document states "No performance standards have been established for such devices under Sections 514 of the Federal Food, Drug, and Cosmetic Act." Instead, it complies with general electrical safety and EMC (Electromagnetic Compatibility) standards like IEC 601.1.2, IEC 801.1-801.5, EN 55011, and EN 50081-1. This is typical for electromechanical devices.
Substantial Equivalence: The primary "proof" of its safety and effectiveness for a 510(k) clearance is its "substantial equivalence" to predicate devices (EMS SWISS LITHOCLAST LITHOTRIPTER cleared under K951531 and K963285) in terms of intended use, technological characteristics, performance, and labeling. This means it is presumed to be as safe and effective as devices already on the market without needing extensive new clinical trials for performance metrics like sensitivity/specificity.

To directly answer your specific points based on the absence of this information in the provided text:

A table of acceptance criteria and the reported device performance: Not applicable/Not provided in the context of AI/ML performance. Performance mentioned relates to compliance with electrical safety and EMC standards.
Sample sized used for the test set and the data provenance: Not applicable. No "test set" in the AI/ML sense is mentioned.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable.
Adjudication method: Not applicable.
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 not an AI device.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an AI device.
The type of ground truth used: Not applicable in the AI/ML diagnostic sense. The "ground truth" for this device would be its mechanical ability to fragment stones safely, likely evaluated through bench testing, animal studies, and/or clinical experience demonstrating equivalent function to predicate devices, rather than a diagnostic 'truth'.
The sample size for the training set: Not applicable.
How the ground truth for the training set was established: Not applicable.

Summary

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510(k) Summary Medispec, Ltd.'s LITHOSPECTM 510(k) Number K_

MAR 1 2 1998

Applicant's Name:

Medispec, Ltd. 15200 Shady Grove Rd., Suite 350 Rockville, MD 20850

Contact Person:

Avner Spector 19110 Montgomery Village Ave., Suite 100 Gaithersburg, MD 20879 Telephone: 301-975-0092 Fax: 301-975-1057

Date Prepared:

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December xx, 1997

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Trade Name:

LITHOSPECTM Intracorporeal Lithotripter

Classification Name:

Bladder Stone Triptor

Classification:

The FDA has classified mechanical lithotriptor as a class II device (product code 78 FGK) and it is reviewed by the Urology and Lithotripsy Devices Branch.

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Predicate Devices:

K97479L
2 of 2

The LITHOSPECTM system is substantially equivalent to the EMS SWISS LITHOCLAST LITHOTRIPTER cleared under K951531 and K963285.

Performance Standards:

No performance standards have been established for such devices under Sections 514 of the Federal Food, Drug, and Cosmetic Act. However, the LITHOSPECTM complies with IEC 601.1.2, IEC 801.1-801.5, EN 55011, and EN 50081-1.

Indication for Use:

The LITHOSPEC™ Intracorporeal Lithotripter is intended to be used during urological procedures to crush and remove bladder, ureteral and renal stones.

Device Description:

Four reusable Probes, having diameters: 0.8 mm, 1.6 mm, and 2.0 mm, are provided with the system.

The LITHOSPEC™ is operated using standard endoscopic equipment.

Substantial Equivalence:

The LITHOSPEC™ Intracorporeal Lithotripter is substantially equivalent to the EMS SWISS LITHOCLAST LITHOTRIPTER cleared under K951531 and K963285 in respect to intended use, technological characteristics, performance, and labeling.

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Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which features three human profiles facing right. To the left of the symbol, the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular fashion.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. Avner Spector President MEDISPEC LTD. 19110 Montgomery Village Avenue Suite 100 Gaithersburg, MD 20879

Re: K974796

MAR 1 2 1998

LITHOSPECTM Intracorporeal Lithotripter Dated: December 17, 1997 Received: December 22, 1997 Regulatory Class: III 21 CFR 876.4480/Procode: 78 FFK

Dear Mr. Spector:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). 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 probibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please aote: this response to your premarket notification submission does not affect any obligation you might have under sections 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (2) CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4613. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address "http://www.fda.gov/cdrh/dsmaldsmamain.html".

Sincerely yours

Sincerely yours,

Lillian Yin, Ph.D.

Director, Division of Reproductive, Abdominal, Ear, Nose and Throat and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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INDICATIONS FOR USE

14974796 510(k) Number (if known):

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Device Name:

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LITHOSPECTM Intracorporeal Lithotripter

Indications for Use:

The LITHOSPEC™ Intracorporeal Lithotripter is intended to be used during urological procedures to crush and remove bladder, ureteral and renal stones.

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

Concurrence of CDRH, Office of Device Evaluation (ODE) (Division Sign-off) Division of Reproductive, Abdominal, Ear, Nose and Throat, and Radiological Devices

510(k) Number K97 4796

Prescription Use (Per 21 CFR 801.109)

Over the Counter Use

Robert R. Satting

(Division Sign-Off) Division of Reproductive, Abdominal, ENT, and Radiological Devices

510(k) Number K974796

8-6

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.”