The LUMISCAN 135 system is a laser phosphor plate digitizer designed for darkroom operation to read recorded patient radiation patterns in the plate and a plate eraser system to prepare the plate for re-use. The system is based on a fixed size scanning spot and is characterized by high spatial resolution and a wide gray scale dynamic range. This is achieved with a high intensity spot of light derived from a solid-state laser that is scanned across the plate as the plate is moved perpendicular to the beam scan. As the laser scans the plate, the phosphor's stored x-ray attenuated equivalent energy is released as a different light wavelength. The emitted light is collected and digitized to provide an image that can be stored on disk, transmitted to other systems for processing and manipulation, archived or printed onto film. After the plate has been read, it is placed on a high intensity sealed lightbox for erasure. Erasing the plate brings all the phosphors down to a ground state from which the plate is now ready to be reused to record a patient's anatomy from x-rav.

The LUMISCAN 135 houses a plate transport system, optics module and reading electronics. Separate from the LUMISCAN 135 is the eraser unit, Lumisys 135E, which incorporates high intensity lamps with a light-tight lid for returning the phosphors to zero.

The LUMISCAN 135 uses a solid state laser diode as the beam source. The laser is conditioned by a lens for beam forming and coupled to a fiber. From the fiber, the energy is directed to a scanning galvanometer. The galvanometer has a mirror that is oscillating precisely across the width of the plate and irradiating the plate with laser light. As the light impinges the plate, stored energy from the plate is emitted and collected in an integrating cylinder. The collected light is detected by a photomultiplier, converted to an analog signal which is logarithmically amplified, corrected for spatial variations in the integrating cylinder, and then digitized by an A/D converter.

AI/ML Overview

The provided document does not contain explicit acceptance criteria and a detailed study proving the device meets these criteria in the typical sense of a clinical trial or performance evaluation with specific metrics. Instead, it is a 510(k) summary for a medical device (Lumiscan 135 Phosphor Plate Digitizer), which aims to demonstrate substantial equivalence to previously marketed devices.

The document primarily focuses on:

Device Description and Intended Use: Explaining what the device does and how it functions.
Hazard Analysis and Safety Concerns: Addressing potential malfunctions and compliance with safety standards.
Substantial Equivalence Comparison: Benchmarking key technical specifications of the Lumiscan 135 against predicate devices (Fuji FCR AC-3, Kodak System 400 Reader, Agfa ADC Digitizer).

Therefore, I cannot populate all the requested fields with specific values directly from the provided text, as this type of information is generally not included in a 510(k) summary focused on substantial equivalence. However, I can extract the comparative technical specifications which serve as a form of "performance comparison" for substantial equivalence.

Here's an attempt to answer based on the available information, noting where data is absent or implied by the nature of a 510(k) submission:

1. Table of Acceptance Criteria and Reported Device Performance

The "acceptance criteria" for a 510(k) submission are typically derived from demonstrating that the device is as safe and effective as a predicate device. This is often shown through comparable technical specifications. The table below uses the comparative technical specifications presented in the document as a proxy for "reported device performance" and implied "acceptance criteria" (i.e., being comparable to or better than predicate devices in these aspects).

Performance Metric (Implied Acceptance Criteria)	Lumisys Lumiscan 135 Reported Performance	Predicate Devices (Fuji, Kodak, Agfa)
Scanning Area (max)	35 x 43 cm	35 x 43 cm (All listed)
Spot Size	100 microns	100 microns (Kodak), Not Known (Fuji), 120 microns (Agfa)
Dynamic Range	5 Decades	Not Known (All listed)
Gray Scale	12 Bit	10 Bit (Fuji), 12 Bit (Kodak, Agfa)
Digitizing Rate	60 per hour	70 per hour (Fuji, Agfa), 50 per hour (Kodak)
Laser Type/Power	30 mW Solid State	Not Known (Fuji), 30 mW HeNe (Kodak), 35 mW HeNe (Agfa)
Beam Scan Mechanism	Galvanometer	Polygonal Mirror (Fuji), Galvanometer (Kodak, Agfa)
Resolution X/Y	2.85 - 5 LP/mm	Not Known (Fuji, Kodak), 3-4.5 LP/mm (Agfa)
Pixels per mm (35 x 43)	5-10	Not Known (Kodak), 5-10 (Fuji)

Note on "Acceptance Criteria": In a 510(k) context, "acceptance criteria" are typically demonstrating substantial equivalence to a legally marketed predicate device. This means the new device must perform comparably in its intended use, typically through technical specifications and safety profile, rather than meeting a specific clinical accuracy threshold like an AUC or sensitivity/specificity.

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

The document does not describe a specific "test set" or a formal study with patient data for performance evaluation in the way a clinical trial would. The 510(k) process for this type of device relies heavily on demonstrating substantial equivalence through technical specifications, engineering testing, and adherence to safety standards. Therefore, "sample size" and "data provenance" for a clinical test set are not applicable or mentioned.

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

This information is not provided in the document as no specific test set or ground truth establishment process is described for clinical validation. The submission is focused on technical equivalence.

4. Adjudication Method for the Test Set

Since no clinical test set is described, an adjudication method is not applicable and not mentioned.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

No MRMC comparative effectiveness study is mentioned in the provided 510(k) summary. The document focuses on the technical specifications of the digitizer itself, not its impact on human reader performance.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) was done

This concept is not directly applicable to a phosphor plate digitizer. The device's primary function is to digitize analog X-ray information from a phosphor plate into a digital image for display and interpretation by a human. Its "performance" is inherent in the quality of the digitized image, measured by metrics like resolution, gray scale, dynamic range, and digitizing speed, as outlined in the comparison table above. There isn't an "algorithm-only" interpretation performance.

7. The Type of Ground Truth Used

As there's no clinical performance study involving diagnosis or interpretation described, the concept of "ground truth" (e.g., expert consensus, pathology, outcomes data) in that sense is not applicable to this 510(k) summary. The ground truth for the technical specifications would be engineering measurements and calibrations.

8. The Sample Size for the Training Set

The document does not describe a "training set" for an algorithm, as this is a hardware device (digitizer) and not an AI/ML algorithm that requires training data in the modern sense.

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

Since no training set for an algorithm is described, this question is not applicable.

Summary

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MAY | | 1998

510(k) Summary

1. Company Identification

Lumisys Inc. 225 Humboldt Court Sunnyvale, CA 94089 Tel. (408) 733-6565 Fax (408) 733-6567

2. Official Correspondent

Garv J. Allsebrook Requlatory Affairs

3. Date of Submission

February 28, 1998

4. Device Name

Classification Name:	Image Digitizer
Common/Usual Name:	Phosphor Plate Digitizer
Proprietary Name:	Lumiscan 135 Phosphor Plate Digitizer (PPD)

5. Substantial Equivalence

Fuii, Computed Radiography FCR AC-3, K944046; Kodak, System 400 Reader, 510(k) # Not Known, Agfa ADC Digitizer, 510(k) # Not Known

6. Device Description and Intended Use

1980800

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digitized to provide an image that can be stored on disk, transmitted to other systems for processing and manipulation, archived or printed onto film. After the plate has been read, it is placed on a high intensity sealed lightbox for erasure. Erasing the plate brings all the phosphors down to a ground state from which the plate is now ready to be reused to record a patient's anatomy from x-rav.

7. Hazard Analysis

Potential hazards as a result of equipment malfunction are:

1. Phosphor plate may not digitize
1. Phosphor plate may digitize partially.
1. Image artifacts, and
1. Phosphor plate may not completely erase.

The software has been designed to provide a user with system messages in case of equipment malfunction. These messages are listed in the Operators' Reference Guide and include a probable cause with any recommended action(s). Any artifacts that may be introduced into a digitized image, such as vertical lines resulting from dirt on the optics, are obvious to a physician or technologist.

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8. Safety Concerns

The hardware complies with one or more of the following safety standards (or the most current revision at the time of testing):

UL 1950 CAN/CSA-C22.2 No. 950-93 TUV: EN 60950/08.92 EN 60950 A1/01.93 EN 60950 A2/08.93 EN 60825-1/03.94

Additionally, the hardware complies with CFR 47, Part 15 and DHHS Additionally, the marawards (21 CFR Subchapter J) as appropriate.

Substantial Equivalence 9.0

	Lumisys	Fuji	Kodak	Agfa
Product Name	Lumiscan 135	Fuji FCRAC-3	System 400Reader	ADCDigitizer
510(k) Number		K944046	Not Known	Not Known
Dimensions(WxHxD) (cm)	53x33x69	71x105x68	108x141x101	165x180x180
Weight (kg)	165	180	270	500
Power (VAC/A/Hz)	120/2/60 or220/1/50	120/2/60	120/2/60220/1/50	220/14/60
Scan Size (max)(WxL) (cm)	35 x 43	35 x 43	35 x 43	35 x 43
Spot Size (microns)	100	Not Known	100	120
Dynamic Range	5 Decades	Not Known	Not Known	Not Known
Gray Scale	12 Bit	10 Bit	12 Bit	12 Bit
Digitizing Rate	60 per hour	70 per hour	50	70 per hour
Laser	30 mWSolid State	Not Known	30 mWHeNe	35 mWHeNe
Beam Scan	Galvanometer	PolygonalMirror	Galvanometer	Galvanometer
Resolution X/Y	2.85 - 5LP/mm	Not Known	Not Known	3-4.5LP/mm
Pixels per mm (35 x 43)	5-10	5-10	Not Known	Not Known
Interface	PC, ISA orSCSI	Proprietary	Proprietary	Proprietary

The following products provide functions, which are substantially equivalent to this product:

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Image /page/3/Picture/0 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle with three lines forming its body and wings. The eagle is positioned within a circle, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged around the upper half of the circle. The text is written in all capital letters.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAY | |-1998

c/o Regulatory Management Services

Lumisys, Inc.

Gary J. Allsebrook

Official Correspondent

16303 Panoramic Way

San Leandro, CA 94578

Re:

K980809 Lumiscan 135 Phosphor Plate Digitizer Lumiscan 135E Eraser Dated: February 28, 1998 Received: March 3, 1998 Regulatory class: Unclassified Procode: 90 LMA

Dear Mr. Allsebrook:

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, narket 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 (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 note: 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 predication 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 vitto 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/odrb/dsmaldsmam.html".

Sincerely yours,
Kilian Yin

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 1 of 1

K980809

510(k) Number (if known):

Lumiscan 135 Phosphor Plate Digitizer (PPD) and Lumisys Device Name: 135E Eraser.

Indications For Use:

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per 21 CFR 901.109)

Over-the-Counter Use

John H. Seym
Division Sign Off

Division Sign-Off) Division of Reproductive, Abdominal, E and Radiological Devi

510(k) Number

(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.