The Medstone, Radiographic Linear Tomography Option is designed as an optional additional device to the Medstone UroPro 2000 table, intended for use in general radiology. It is designed to enable the production of diagnostic radiologic images of a specific linear cross-sectional plane of the body, eliminating unwanted anatomy and detail by motion blurring of other planes.

This device is designed to provide and control the sweep speed and angle of a tomography function to enable the production of a properly imaged X-ray film to accomplish diagnostic imaging of a patient.

The table and tomography option are intended to be used by trained professionals, schooled in proper radiology procedures, techniques, positioning and safety.

Device Description

The Medstone, Radiographic Linear Tomography Option is designed as an 'add-on' optional device to enable the production of radiologic images of a specific linear cross-sectional plane of the body by blurring or eliminating detail from other planes. A high degree of emphasis for the design of this device was placed on error detection and reliability as well as usability and safety.

AI/ML Overview

The provided 510(k) summary for the Medstone Linear Tomography Option does not include the typical acceptance criteria and a detailed study proving the device meets those criteria, as one might expect for a modern AI/software as a medical device (SaMD).

Instead, this submission primarily relies on substantial equivalence to a predicate device (Pausch Corporation Microtom, Tomographic Option) based on non-clinical performance data and an absence of clinical performance data being deemed necessary.

Here's an analysis based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

Given that this is a linear tomography option rather than an AI/SaMD, the "acceptance criteria" are more about functional equivalence and safety rather than performance metrics like sensitivity, specificity, or AUC.

Acceptance Criteria (Inferred from Substantial Equivalence)	Reported Device Performance (Medstone Linear Tomography Option)
Functional Equivalence:
- Tomographic Movement Type	LINEAR
- Input/Line Voltage	110 VAC 1-phase
- Input/Line Frequency	50/60 Hz
- Patient positioning and image production capabilities	Enables production of diagnostic radiologic images of a specific linear cross-sectional plane.
Performance Parameters (within acceptable deviation):
- Fulcrum Range	0 mm to 250 mm
- Tomographic Angles	20°, 10°, 5°
- Exposure Times (controlled by X-Ray Generator)	0.2 to 1.6 secs.
- Operational performance ('sweep time' per 'sweep angle')	Within 20% differential of predicate, equivalent with respect to imaging output.
Safety and Effectiveness:
- Error detection and reliability	High degree of emphasis placed on these.
- Usability and safety	High degree of emphasis placed on these.
- Absence of new questions of efficacy or substantial risk	No new questions of efficacy or substantial risk raised.

Note: The reported performance is primarily a comparative statement against the predicate device, asserting "complete equivalence" in safety and effectiveness.

2. Sample Size for Test Set and Data Provenance

Not Applicable. The submission states: "It has been concluded that clinical performance data for the Medstone Linear Tomographic, device was not needed for this 510(k) process. The determination of substantial equivalence is, therefore, not based on an assessment of clinical performance for the purpose of this 510(k) process."
There is no mention of a "test set" in the context of clinical data or image analysis. Performance was assessed via non-clinical comparisons and engineering specifications.

3. Number of Experts and Qualifications for Ground Truth

Not Applicable. As no clinical performance study was conducted, there was no need for expert review to establish ground truth from clinical data. The assessment was based on engineering and functional comparisons.

4. Adjudication Method for Test Set

Not Applicable. No clinical test set or adjudication process was required or mentioned.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No. No MRMC study was conducted or mentioned. The device is a hardware option for an X-ray table, not an AI-assisted diagnostic tool.

6. Standalone (Algorithm Only) Performance Study

Not Applicable. This device is a mechanical/electronic add-on option for an X-ray table, not a standalone algorithm or software. It facilitates image acquisition, not interpretation.

7. Type of Ground Truth Used

Technical Specifications and Functional Equivalence. The "ground truth" for this submission was implicitly defined by the technical specifications and operational performance of the predicate device. The Medstone device had to demonstrate comparable technical parameters and functional output (e.g., sweep speed, angles, fulcrum range, image output).

8. Sample Size for Training Set

Not Applicable. As there is no AI/machine learning component, there is no "training set."

9. How Ground Truth for Training Set Was Established

Not Applicable. No training set was used.

Summary

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K013620

510(k) SUMMARY

[Submitted pursuant to 21 CFR 807.87 (h).]

1. Submitter Information:

Submitter:	Medstone International Incorporated100 Columbia, Suite 100Aliso Viejo, California, 92656
Telephone:	(949) 448-7700
Facsimile:	(949) 448-7880
Contact Person:	Ronald H. Bergeson, V.P., Regulatory Affairs
Date Prepared:	October 30, 2001
2. Device:
Trade/ Proprietary Name:	Medstone, Linear Tomography Option
Common/Usual Name:	Linear Tomography Option
Classification Name:	System, X-Ray, Tomographic

3. Predicate Device:

Pausch Corporation Microtom, Tomographic Option

4. Device Description:

5. Device Intended Use:

This device is designed to provide and control the sweep speed and angle of a

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tomography function to enable the production of a properly imaged X-ray film to accomplish diagnostic imaging of a patient.

The table and tomography option are intended to be used by trained professionals, schooled in proper radiology procedures, techniques, positioning and safety.

Device application:

Is the device a life-supporting or life sustaining device?	No
Is the device an implant device?	No
Is the device a sterile device?	No
Is the device for single use?	No
Is the device a diagnostic kit?	No
Is the device for prescription or 'over the counter' (OTC) use?	No
Is the device to be used in the hospital or physician's office?	Yes
Does the device contain a drug or biological product as a component?	No
Does the device design use software?	Yes
Level of concern for software (if applicable)?	Mino
Is the device a diagnostic kit?	No

6. Comparison of Device Technological Characteristics:

PARAMETER	MEDSTONE TOMO OPTION	PAUSCH TOMO OPTION
INPUT/LINE VOLTAGE	110 VAC 1-phase	110 VAC 1-phase
INPUT/LINE FREQUENCY	50/60 Hz	50/60 Hz
TOMOGRAPHIC MOVEMENT	LINEAR	LINEAR
FULCRUM RANGE	0 mm to 250 mm	0 mm to 240 mm
TOMOGRAPHIC ANGLES	20°, 10° and 5°	40°, 30°, 20° and 8°
EXPOSURE TIMES(Controlled by X-Rav Generator)	0.2, to 1.6 secs.	0.4, to 4.0 secs

7. Comparison of Non-Clinical Performance Data:

The assessment of non-clinical performance data as to visual indication of the technique factors, time, angle, layer height and all related safety and effectiveness issues indicates substantial equivalence. The operational performance as to 'sweep time' per degree of 'sweep angle' is within 20% differential and is equivalent with respect to imaging output. This comparison indicates no differences in performance between the Medstone International, Inc. device and the predicate Pausch device.

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8. Comparison of Clinical Performance Data:

It has been concluded that clinical performance data for the Medstone Linear Tomographic, device was not needed for this 510(k) process. The determination of substantial equivalence is, therefore, not based on an assessment of clinical performance for the purpose of this 510(k) process.

9. Conclusions from Non-Clinical and Clinical Tests:

The Medstone International Inc. Linear Tomographic Option perform the same function, in the same environment and have the same intended use as the Pausch Tomographic device.

A comparison of device specifications and principals of operation, indicates that no new questions of efficacy, or substantial risk are raised.

Performance tests of visual indication of the technique factors, time, angle, layer height and all related safety and effectiveness issues indicates complete equivalence between the Medstone International Inc. Linear Tomographic Option and the predicate Peusch Tomographic device.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of an eagle or bird, with three curved lines representing its wings or feathers. The bird is positioned within a circular border, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the upper portion of the circle.

Food and Drug Administratio 9200 Corporate Boulevard Rockville MD 20850

JAN 2 2 2002

Mr. Ronald H. Bergeson Vice President, Regulatory Affairs Medstone International, Inc. 100 Columbia, Suite 100 ALISO VIEJO CA 92656

Re: K013620 Trade/Device Name: Medstone, Linear Tomography Option Regulation Number: 21 CFR 892.1740 Regulation Name: Tomographic x-ray system Regulatory Class: II Product Code: 90 IZF Dated: October 18, 2001 Received: November 5, 2001

Dear Mr. Bergeson:

We have reviewed your Section 510(k) premarket notification of intent to market the device We have reviewed your Section 910(x) prometice is substantially equivalent (for the indications referenced above and nave decemblic are actrood predicate devices marketed in interstate for the stated in the cherosale) to regally management date of the Medical Device Amendments, or to commerce prior to May 28, 1776, the enaounce with the provisions of the Federal Food. Drug, devices that have been recassince in accessfire approval of a premarket approval application (PMA).
and Cosmetic Act (Act) that do not require approval of a premarket approva and Cosment ACT (Acc) that do not requent of the general controls provisions of the Act. The You may, dielefore, market the dovros, seejest to annual registration, listing of general controls provisions of the free labeling, and prohibitions against misbranding and adultcration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), IT your device is classifica (sec above) into extine major regulations affecting your device can be it may be subject to additional concess. Extrement with and 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 ITIcase oe advised that I DA 3 issuation or our device complies with other requirements of the Act that IDA has made a decommanding administered by other Federal agencies. You must of any roderal statures and roguirenents, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set (21 CFR Part 807), labornig (21 CFR Part 820); and if applicable, the electronic rolation and quality of stoms (QS) regisment

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This letter will allow you to begin marketing your device as described in your 510(k) prematket This letter will allow you to begin marketing your device to a legally marketed
notification. The FDA finding of substantial equivalence of your device to notification. The FDA finding of substantial equivalise 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
s the regulation and the filler of the fillers awmbers, based on the regula If you desire specific advice for your device of our laboring organization in the regulation number at the top of this letter:

8xx.1xxx	(301) 594-4591
876.2xxx, 3xxx, 4xxx, 5xxx	(301) 594-4616
884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx	(301) 594-4616
892.2xxx, 3xxx, 4xxx, 5xxx	(301) 594-4654
Other	(301) 594-4692

Additionally, for questions on the promotion and advertising of your device, please contact the Additionally, for questions on the pothouor and as encle or equation entitled, "Misbranding
Office of Compliance at (301) 594-4639. Also, please note the regulation on Office of Compliance at (301) 394-4057. This, Part 807.97). Other general information on by reference to premarket notification (21 Cr Cr r r the Division of Small Manufacturers,
your responsibilities under the Act may be obtained from the C001 or (301) A43-659 your responsibilities under the Acstiller in the 1000 638-2041 or (301) 433-2041 or (301) 443-6597
International and Consumer Assistance at its tollers (800) 638-2041 or (301 Internet address http://www.fda.gov/cdrl/dsma/dsmamain.html.

Sincerely yours,

Nancy C. Snogdon

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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Kobeck
Page 1 of

MEDSTONE INTERNATIONAL, INC.

INDICATIONS FOR USE

Unknown at this time. 510(k) Number:

Medstone, UroPro 2000, Tomographic Option Device Name:

Indications for Use:

The Medstone, Radiographic Linear Tomography Option is designed as an optional additional The Medstone, Radiographic Lincal I onography Option in use in general radiology. - It is
device to the Medstone UroPro 2000 table, intended for use in general radiology. - I designed to enable the production of diagnosic radiologic images of a specific linear crossdesigned to enable the finin since areasons and detail by motific linear crossdesigned to enable the production of diagnostic racionogle anaged and of a province of other planes.

This device is designed to provide and control the sweep speed and angle of a tomography
the same the the became of any first and consects imaged. Y-ray film to accomplish di This device is designed to provide and control the sweep spocallars and ang
function to enable the production of a properly imaged X-ray film to accomplish diagnstic imaging of a patient.

The table and tomography option are intended to be used by trained professionals, schooled
in the mography and submit was negitioning and safety I he table and toningtaphy option are are and safety.
in proper radiology procedures, techniques, positioning and safety.

(Please do not WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

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Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use

Over-The-Counter Use _

(Per 21 CFR 801.109)

Ylanci C. Brogdon

(Division Sign-Off) Division of Reproductive, Abdomin and Radiological Devices 510kki Nimma

(Optional Format 1-2-96)

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Regulation Number and Section

§ 892.1740 Tomographic x-ray system.

(a)
Identification. A tomographic x-ray system is an x-ray device intended to be used to produce radiologic images of a specific cross-sectional plane of the body by blurring or eliminating detail from other planes. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II.