The Lodox whole-body x-ray scanner is mainly intended for use in trauma wards where multiple injuries can be medically diagnosed in a very short time. It can also be used for normal x-ray examinations as is currently practised with general-purpose single-shot x-ray machines. A full image area is 1800 mm by 680 mm, and can be reduced to any size down to 100 mm by 100 mm anywhere within the image area.

Device Description

Lodox is a whole-body x-ray scanner that produces x-ray images that can be used for diagnostic purposes. It is an optical-based digital x-ray imager. It works by converting incident x-ray energy to visible light by use of a fluorescent screen optically coupled to a number of CCD cameras, which produce a digital image. The captured diagnostic image is stored in a database and is displayed on a highresolution, medical-quality monitor, where the diagnosis can be performed. The diagnostic image can be transmitted through a DICOM 3.0 compatible digital network for printing. The imaging area can be set from 100 mm x 100 mm x 680 mm on a special purpose patient trolley.

AI/ML Overview

Here's a breakdown of the acceptance criteria and study information for the Lodox Digital Radiography System, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are generally framed around achieving "substantial equivalence" to predicate devices (film radiography and an existing CT system) in terms of image quality and intended use. The performance metrics reported are primarily physical characteristics and a subjective clinical assessment.

Acceptance Criteria (Implied)	Reported Device Performance
Intended Use: General Human Radiography (excluding fluoroscopy, angiography, and mammography), specifically aimed at emergency room use, covering whole body including skull, spinal column, chest, abdomen, and extremities.	Lodox is intended for the same uses.
Image Quality (Spatial Resolution): Substantially equivalent to film.	Spatial resolution found to be "substantially equivalent to the predicate" (film) based on line-pair resolution and high/low contrast targets.
Clinical Diagnostic Quality: Digital images comparable/substantially equivalent to film.	Clinical study results showed diagnostic images were "comparable to film" and "substantially equivalent to film" according to radiologists.
Technological Characteristics: Similar key features to predicate devices.	Many features (e.g., fluorescent screen, CCD for image capture) align with predicate systems. Specific performance metrics are provided (see below).

Reported Device Performance (Specific Technological Characteristics):

Feature	Lodox (Device Performance)	Predicate (Film/Screen)
Whole body exposure	25 μGy	N/A
Chest exposure	0.21 mGy	2.57 mGy
CCD Pixel Size	26 x 26 μm	N/A
Half-Value Layer	4.35 mm	4.73 mm
Signal-to-Noise Ratio	2.57	2.16
Modulation Transfer Function	1.67 lp/mm (normal resolution)	2.34 lp/mm
Detective Quantum Efficiency	TBD (Waiting for new IEC standard)	TBD (Waiting for new IEC standard)
External Connectivity	DICOM 3.0	None
Image Storage	Hard Drive	X-ray film

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

Sample Size: 39 human subjects
Data Provenance: Not explicitly stated, but the company is based in South Africa. The phrasing "a range of anatomy was covered representative of general radiography" suggests these were clinical cases, likely prospective, where subjects were x-rayed by both methods.

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

Number of Experts: Two radiologists.
Qualifications: "a panel of two radiologists" - no further specific qualifications (e.g., years of experience) are provided in this document.

4. Adjudication Method for the Test Set

The document states, "The results were examined by a panel of two radiologists and found substantially equivalent to film." This implies a consensus-based adjudication or individual review leading to a uniform conclusion, but a specific method like 2+1 or 3+1 is not detailed. It's possible they independently reviewed and then discussed to reach consensus, or reviewed together.

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, an MRMC comparative effectiveness study was not done in the context of AI assistance. This device is a diagnostic imaging system, not an AI-assisted diagnostic tool. The study compared the image quality of the Lodox system against conventional film radiography.

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

This question is not applicable. The Lodox system is an X-ray imager, not an algorithm, and its performance is inherently linked to human interpretation of the images it produces. The study described is a comparison of the device's output (images) to conventional methods, which are then evaluated by human experts.

7. The Type of Ground Truth Used

The ground truth used was expert consensus (the findings of the two radiologists) which compared the diagnostic quality of images from the Lodox system to images from conventional film radiography. Since the predicate is film radiography, the "ground truth" to which Lodox images were compared was essentially "diagnostically acceptable images from conventional film radiography" as assessed by experts.

8. The Sample Size for the Training Set

The document does not provide information regarding a training set. This is consistent with the nature of the device; it's an imaging capture system, not an AI model that requires a discrete training phase. The "clinical testing" described serves as the validation of its performance, not a training set for an algorithm.

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

This question is not applicable as no training set or AI model is described as part of the Lodox Digital Radiography System's development or evaluation in this document.

Summary

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AUG 0 6 2002

Image /page/0/Picture/1 description: The image shows the logo for Lodox, a company specializing in diamond sharp imaging. The logo features the word "LODOX" in large, bold letters, with the tagline "DIAMOND SHARP IMAGING" underneath. The company's website address, "WWW.LODOX.COM," is displayed below the tagline. The logo is simple and professional, conveying the company's focus on high-quality imaging.

KOI.3999

LODOX SYSTEMS (PTY) LTD P O Box 784055 Sandton South Africa 2146

Registration Number 2000/024615/07

+27 11 2693791 Tel: +27 11 2693792 Fax: E-mail: herman@lodox.com

510(K) SUMMARY

[As required by 21CFR807.92]

Date Prepared [21CFR807.92(a)(1)] 5.1

November, 2001

5.2 Submitter's Information [21CFR807.92(a)(1)]

Company Name:	Centric Capital Ventures LLC (aDelaware Limited LiabilityCompany)
Establishment
Registration
Number:	13-4104540
Street Address:	177 East 79th Street, Suite 4
City:	New York
State/Province:	New York, 10021
Country:	USA
Telephone:	212-439-0746
Facsimile:	212-452-0756
Contact Person:	Bradley Sacks
Contact Title:	Managing Partner
Contact email:	bradsacks@earthlink.net

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5.3 Trade Name, Common Name, Classification [21CFR807.92(a)(2)]

Trade Name: Common Name: Classification Name: Device Class: Product Code:
Lodox Digital Radiography System Solid State X-ray Imager (SSXI) Class II 90MQB

Identification of Predicate Device(s) [21CFR807.92(a)(3)] 5.4 -

Equivalency is based on the Elscint EXCEL 2000 ELITE CT system (K884671) and the Siemens Polydoros 80 system (K950883) and bucky (x-ray film holder) using conventional radiographic film (21CFR892.1840).

Description of the Device [21CFR807.92(a)(4)] 5.5

The captured diagnostic image is stored in a database and is displayed on a highresolution, medical-quality monitor, where the diagnosis can be performed.

The diagnostic image can be transmitted through a DICOM 3.0 compatible digital network for printing.

The imaging area can be set from 100 mm x 100 mm x 680 mm on a special purpose patient trolley.

5.6 Intended Use [21CFR807.92(a)(5)]

Lodox is a digital x-ray imager intended as a replacement for x-ray film for general human radiography (excluding fluoroscopy, angiography, and mammography). It is specifically aimed at emergency room use.

Lodox allows radiographic exposures of the whole body including skull, spinal column, chest, abdomen, and extremities. Radiographic exposures may be taken of a patient lying on the patient trolley in any angle from the Anterior-Posterior view to the lateral view, or with the patient in the standing or prone positions.

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Technological Characteristics [21CFR807.92(a)(6)] 5.7

Feature	Lodox	ElscintEXCEL2000ELITE CTK884671	SiemensPolydoros80K950883	Bucky withFilm /Screen892.1840
510(k)Regulation	Pending
Intended Use	General Human Radiography
Fluorescentscreen toconvert x-raysto light	Yes	Yes	No	Yes
Whole bodyradiograph	Yes	Yes 1		No
Whole bodyexposure 2	25 μGy	80,5 μGy 1		-
Chestexposure 3	0,21 mGy	-		2,57 mGy
CCD tocapture image	Yes	Yes		No
CCD PixelSize	26 x 26 μm	Not Available		-
Half-ValueLayer	4,35 mm	-		4,73 mm
Signal-to-Noise Ratio	2,57	-		2,16
ModulationTransferFunction 4	1,67 lp/mm 5	-		2,34 lp/mm 4
DetectiveQuantumEfficiency	TBD 6	-		TBD 6
ExternalConnectivity	DICOM 3.0	None	None	None
Image Storage	Hard Drive	Hard Drive		X-ray film

NOTE

1. CT in scan mode.
2._ Measured on bed with no patient present.
1. An average taken of 10 chest x-ray cases.
4_ Measured on bed, along its width, at 3% contrast.
5_ In normal resolution mode (5 x 5 binning) and perpendicular to scan direction.
6_Work Group (WG33) in IEC/SC62B is currently developing a new IEC standard for measurement of the DQE of digital x-ray imaging detectors. This is due to be published within the first quarter of 2002. Lodox DQE performance will be determined according to this standard once it is published.

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Non-clinical Testing [21CFR807.92 (b)(1)] 5.8

Lodox uses a fluorescent screen of the type used in film/screen radiography to convert xrays to light. A high-resolution, CCD-based, sensor captures this light.

To verify the spatial resolution and determine its equivalence to film, tests were performed using line-pair resolution and high and low contrast targets. Resolution was found to substantially equivalent to the predicate.

Clinical Testing [21CFR807.92 (b)(2)] 5.9

In an image quality study, 39 human subjects were x-rayed both conventionally and with Lodox. A range of anatomy was covered representative of general radiography. The results were examined by a panel of two radiologists and found substantially equivalent to film.

5.10 Conclusions [21CFR807.92 (b)(3)]

Images taken using the digital technology of Lodox were substantially equivalent to images taken on the Elscint EXCEL 2000 ELITE CT system based on the following:

1. Whole-body radiographs could be taken on both systems.
  Images taken using the digital technology of Lodox were substantially equivalent to standard film images based on the following:
1. The results from studies showed that the digital images were comparable to film.
1. Laboratory test results also supported the equivalence to standard film images shown in clinical studies. This clinical outcome supported the diagnostic imaging quality of the digital system as being equal to film/screen.

It was concluded that Lodox is equivalent to the Elscint EXCEL 2000 ELITE CT system (K884671) and the Siemens Polydoros 80 system (K950883) and bucky (x-ray film holder) using conventional radiographic film (21CFR892.1840) based upon the following criteria:

Lodox has the same intended use as the predicate devices; and, ●
Lodox has radiographic performance equivalent to the predicate devices. .

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Image /page/4/Picture/1 description: The image is a black and white logo for the U.S. Department of Health and Human Services. The logo features a stylized image of three human profiles facing to the right. The profiles are stacked on top of each other, with the top profile being the largest and the bottom profile being the smallest. The profiles are all connected by a single line that runs from the top of the top profile to the bottom of the bottom profile. The logo is surrounded by the words "DEPARTMENT OF HUMAN SERVICES - USA" in a circular pattern.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Lodox Systems (Pty) LTD % Mr. Bradley Sacks Managing Partner Centric Capital Ventures, LLC 177 East 79th Street, Suite 4 NEW YORK NY 10021

Re: K013999

AUG 0 6 2002

Trade/Device Name: Lodox Whole Body X-ray Scanner Regulation Number: 21 CFR 892.1750 Regulation Name: Computed tomographic x-ray system Regulatory Class: II Product Code: 90 JAK Dated: May 10, 2002 Received: May 13, 2002

Dear Mr. Sacks:

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.

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); 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.

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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 (21 CFR Part 801), please contact the Office of Compliance at one of the following numbers, based on 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 Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). Other general information on vour responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.

Sincerely vours,

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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4. SECTION D - STATEMENT OF INDICATIONS FOR USE

Applicant	Lodox Systems (Pty) LTD
510(k) Number (if known)	N/A K013999
Device Name	Lodox X-ray Scanner

Indications for use:

Prescription Use

Yorind A. higrom
(Division Sign-Off)

Division of Reproductive, Abdon and Radiological Device 510(k) Number

Regulation Number and Section

§ 892.1750 Computed tomography x-ray system.

(a)
Identification. A computed tomography x-ray system is a diagnostic x-ray system intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data from the same axial plane taken at different angles. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II.