DIGMI-2000 (GSI INTERNAL REFERENCE)/LD2800 (MARKETING NAME) by GENERAL SCANNING, INC.

The General Scanning model LD2800 laser film digitizer is intended to create copies of medical images stored on film when connected to a laser imager. It is intended for use in making copies of conventional x-ray films as well as films produced by imagers that fall in the ranges specified for size and optical density range detailed in the specifications.

Device Description

The digitizer utilizes laser light to scan the film, extracts the image data by measuring the transmitted light, converts it into digital form, and transmits the data over a digital link. A laser imager may then be used to print a copy of the original image.

The LD2800 contains the scanning laser and detection module, a film transport, and electronics to convert and transmit the image data and provide control and calibration.

AI/ML Overview

The provided document is a 510(k) summary for the LD2800 Film Digitizer. It describes the device, its intended use, and its substantial equivalence to predicate devices. However, this document does not contain any information regarding acceptance criteria or a study that proves the device meets specific acceptance criteria.

The 510(k) summary focuses on establishing substantial equivalence, which primarily involves demonstrating that the new device is as safe and effective as a legally marketed predicate device. This process typically relies on comparing technical specifications, intended use, and performance claims to those of existing devices rather than presenting a novel study against predefined acceptance criteria for the new device as would be seen for a new technology or clinical claim.

Therefore, I cannot provide the requested information from the given text.

To elaborate on why the requested information is not present:

Acceptance Criteria Table: There is no mention of specific performance metrics (e.g., accuracy, sensitivity, specificity, resolution, optical density range, signal-to-noise ratio) defined as acceptance criteria.
Study Proof: No experimental or clinical study is described that tests the LD2800 against pre-defined performance thresholds.
Sample Size and Data Provenance: Since no study is described, there's no information on sample size, test sets, or data provenance.
Number of Experts/Qualifications: There's no mention of experts establishing ground truth, as no study is detailed.
Adjudication Method: Not applicable as no study is described.
MRMC Study: This type of study would compare human performance with and without AI. The LD2800 is a film digitizer, not an AI-powered diagnostic tool, so such a study would not be relevant.
Standalone Performance: While the device has inherent performance characteristics (like resolution, optical density range), a formal "standalone study" with defined acceptance criteria for these is not provided in this document.
Type of Ground Truth: Not applicable, as no study is described.
Training Set Sample Size/Ground Truth: Not applicable, as this is a hardware device (film digitizer), not an algorithm that requires a training set.

Summary

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K973411

510(k) SUMMARY 2.

2.1	Company Name	General Scanning Inc. (GSI)500 Arsenal StreetWatertown, MA 02172 USA
2.2	Contact Person	Walter J. LesliePhone # (617) 924-1010 x197Fax # (617) 926-0708
2.3	Date	September 8, 1997	DEC - 4 1997
2.4	Device Name
	Classification Name	Image Digitizer
	Classification Number	90LMA - Radiology Device
	Common Name	Film Digitizer
	Trade/Proprietary Name	DigMi-2000 (Internal to GSI)LD2800 (Marketing Name)
2.5	Substantial Equivalence - Predicate Devices
	Lumiscan 85LF
	Lumiscan 100	K901423
	Konica	K9337830
	Nishimoto Sangyo ED-2000
	Nishimoto Sangyo ED-3500
2.6	Device Description and "Statement of Indications For Use"The General Scanning model LD2800 laser film digitizer is intended tocreate copies of medical images stored on film when connected to a laserimager. It is intended for use in making copies of conventional x-ray filmsas well as films produced by imagers that fall in the ranges specified forsize and optical density range detailed in the specifications.The digitizer utilizes laser light to scan the film, extracts the image data bymeasuring the transmitted light, converts it into digital form, and transmitsthe data over a digital link. A laser imager may then be used to print acopy of the original image.The LD2800 contains the scanning laser and detection module, a filmtransport, and electronics to convert and transmit the image data andprovide control and calibration.

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Image /page/1/Picture/0 description: The image shows the logo for the Department of Health & Human Services. The logo consists of a stylized eagle with three lines representing its wings and body. The words "DEPARTMENT OF HEALTH & HUMAN" are arranged in a semi-circle around the left side of the eagle.

DEC - 4 1997

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Walter M. Leslie Engineering Manager Optical Scanning Products Division General Scanning, Inc. 500 Arsenal Street Watertown, MA 02172

Re: K973411

LD 2800 Film Digitizer Dated: September 8, 1997 Received: September 9, 1997 Unclassified/Procode: 90 LMA

Dear Mr. Leslie:

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 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 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 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 requirement, as set forth in the Ouality System Regulation (OS) 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 note: this response to your premarket notification does not affect any obligation you might have under sections 531 through 542 of the Act for devices under 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 (21 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/dsmamain.html".

Sincerely yours,

hJliau Yu
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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Page

K973411 510(k) Number (if known):__

Device Name: LD2800 (MARKET NAME)

DTG-MI Zoos (GSI INFERNAL

Indications For Use:

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

	Concurrence of CDRH, Office of Device Evaluation (ODE)
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(Division Sign-Off)
Division of Reproductive, Abdominal, ENT, and Radiological Devices

510(k) Number	K973411
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Prescription Use(Per 21 CFR 801.109)	OR	Over-The-Counter Use
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(Optional Format 1-2-96)

Regulation Number and Section

§ 892.2030 Medical image digitizer.

(a)
Identification. A medical image digitizer is a device intended to convert an analog medical image into a digital format. Examples include Iystems employing video frame grabbers, and scanners which use lasers or charge-coupled devices.(b)
Classification. Class II (special controls; voluntary standards—Digital Imaging and Communications in Medicine (DICOM) Std., Joint Photographic Experts Group (JPEG) Std.). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.