DI-2000 enables the user to autoarchive lossless or lossy compressed images locally or at a remote archive site. Supports DICOM 3.0 Query and Retrieve Service Class.

Supports scanning of films or phosphor plates in batch mode prior to entering patient information. Once scanned, images can be sent to multiple destinations.

Device Description

A detailed description of each of all functions is contained in the Functional Requirements Specification, included as Appendix B. The following feature comparison provides an easy way to identify the changes between the initial 510(k) for DICOM Client submitted December 1995, and this addendum for DI-2000.

AI/ML Overview

The provided document is a 510(k) Summary for a medical device (DI-2000 DICOM Client) submitted in 1998. It details the device's features, comparisons to equivalent devices, and information regarding safety and effectiveness. However, it does not explicitly contain a study designed to prove specific acceptance criteria with reported device performance metrics in the way a modern clinical or performance study report might.

Instead, the document primarily focuses on establishing substantial equivalence to legally marketed predicate devices and outlining the software's functionality and hazard analysis. The "Test Data and Conclusions" section refers to "Appendix B," which is not provided in the input, but based on the context of a 510(k) submission from 1998 for PACS components (which are considered accessories to medical imaging devices), it is highly unlikely to contain a multi-reader, multi-case study with human readers or detailed standalone algorithm performance.

Here's an analysis based on the available information:

Acceptance Criteria and Device Performance

Based on the provided text, specific, quantitative acceptance criteria with corresponding performance metrics are not explicitly stated or presented in a table format. The document describes the device's features and its compliance with standards, implying that meeting these features and standards constitutes "acceptance."

The key "performance" aspect discussed is related to image compression, specifically Wavelet compression. The document describes the technical methodology of Wavelet compression, its mathematical underpinnings, and asserts that it can achieve "no appreciable effect on image quality" when performing lossless compression. It also states that "After an image has undergone a wavelet transform, an effort is made to detect those regions of the transform which have little or no contrast. Once such a region has been identified, it is quantized (stored with fewer bits of precision than those parts of the transform which appear important). It is in the quantization steps that all loss occurs. Once quantization is performed, it is not possible to retrieve the original, higher presentation." This describes the mechanism of lossy compression and implies a trade-off between compression ratio and original image fidelity.

Given the absence of a direct table, I can infer some "acceptance criteria" from the product's features and standards, and the "reported device performance" as implied functionalities:

Acceptance Criteria (Implied)	Reported Device Performance (Implied)
DICOM 3.0 Compliance	Supports DICOM 3.0 Query and Retrieve Service Class; Conforms to DICOM standard image formats
Support for various compression methodologies	Supports Lossless (JPEG, Wavelet in hardware/network) and Lossy (JPEG, Wavelet) compression
Ability to autoarchive images (lossless or lossy)	Enables user to autoarchive lossless or lossy compressed images locally or remotely
Support for scanning films or phosphor plates in batch mode	Supports scanning of films or phosphor plates in batch mode
Ability to send images to multiple destinations	Once scanned, images can be sent to multiple destinations
Quality assurance functions	Includes Quality Assurance Function
Image processing algorithms	Includes Image Processing Algorithm
System checks and balances for user errors/data integrity	System provides checks and balances for potential user errors (e.g., failing to save images, assigning duplicate IDs). Transaction cannot be completed if data transfer compromises image quality.
Compliance with ACR/NEMA DICOM 3.0	Listed as a voluntary standard.
Compliance with 21 CFR 1020.10 (for stationary x-ray systems)	Listed as a requirement.
Compliance with CCITT and ISO/IEC 10918-1 for compression	Listed as a voluntary standard.

Study Information (Based on Available Text):

The document does not describe a detailed scientific study with specific performance metrics such as accuracy, sensitivity, or specificity. Instead, it seems to rely on:

Hazard Analysis: To identify, evaluate, and mitigate risks.
Feature Comparison: Demonstrating equivalence to predicate devices based on shared and improved features.
Compliance with Standards: Adherence to established industry and regulatory standards.
Assertions of Functionality: Stating what the software "can do" or "supports."

Here's an breakdown based on your requested points, highlighting what is not present in the provided text:

A table of acceptance criteria and the reported device performance: As detailed above, explicit quantitative criteria and performance results in a table are not provided. The "acceptance criteria" are inferred from the stated functionalities and compliance needs.
Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective): Not specified. The document mentions "Test Data and Conclusions" are in Appendix B (which is missing). However, the general tone of the document, focusing on software features and DICOM compliance for a PACS component, suggests that "test data" would likely pertain to functional testing and adherence to DICOM standards rather than clinical image-based performance testing.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not specified. This information is typically found in studies evaluating image interpretation or diagnostic accuracy, which is not the primary focus of this submission for a DICOM client software.
Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not specified.
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 study was not done or described. This type of study is associated with AI-powered diagnostic aids, which is not what the DI-2000 DICOM Client (a PACS component for digitization and transfer) is.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: No, a standalone algorithm performance study (in a diagnostic sense) was not done or described. The "Image Processing Algorithm" feature mentioned would likely refer to general image display adjustments rather than a diagnostic algorithm. The primary "algorithm" discussed is image compression (JPEG and Wavelet), where the performance is described in terms of its technical mechanism and effect on image size and, anecdotally, "no appreciable effect on image quality" for lossless compression.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not specified. As there's no mention of a diagnostic performance study, there's no ground truth explicitly defined for such a purpose. For functional testing, the "ground truth" would be the expected behavior of the software according to its design specifications and DICOM standards.
The sample size for the training set: Not applicable/Not specified. This device is a DICOM client software, not an AI/Machine Learning model that would require a "training set" in the conventional sense of pattern recognition or diagnostic algorithms. Its development would involve software engineering and testing.
How the ground truth for the training set was established: Not applicable/Not specified. See point 8.

Conclusion:

The provided 510(k) summary for the DI-2000 DICOM Client focuses on demonstrating substantial equivalence through feature comparison, adherence to standards, and a hazard analysis for a software accessory to medical imaging systems. It does not present a detailed clinical or performance study with quantified acceptance criteria and measured device performance metrics in the way modern AI/CADx devices often do. The "Test Data and Conclusions" are referred to an Appendix (B) which is not available, but given the nature of the device and the submission date (1998), it's highly improbable that it would contain the type of study details requested.

Summary

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K98 0213

Addendum to 510(k) for DICOM Client K955708

510(k) Summary

1. Identification

MAR 1 7 1998

January 7, 1998 Date:

Lumisys, Inc. Submitter: 1350 North Kolb Tucson, AZ 85715

Contact:

Trindy LeForge (520) 751-6842 (520) 298-1400 (FAX)

Device Name 2.

Trade Name: DI-2000 DICOM Client Common Name:

Registration Number 3.

2029024

4. Classification

No formal classifications have been issued for PACS components. For purposes of determining substantial equivalence they have been considered to be accessories to medical imaging devices. A stationary x-ray system is a permanently installed diagnostic system intended to generate and control x-rays for examination of various anatomical regions. Accessories to a stationary x-ray system, such as digitizing application software, have been classified as Class II Radiology Devices under 21 CFR 892.1680.

5. Standards

Performance: Voluntary:

None established. ACR/NEMA DICOM 3.0

Requirements of 21 CFR 1020.10.

CCITT (Consultative Committee on International Telephone and Telegraph) and ISO/IEC 10918-1 for compression.

6. Labeling

See Appendix A.

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Safety and Effectiveness Information 7.

Hazard Analysis

Formal analysis of the design for potential and existing hazards takes place during the requirements phase, the design phase, and during the testing phase. All potential existing hazards are analyzed using the following steps:

Determine if hazard exists in the product. Hazard Identification .
- Level of Concern Determine whether the hazard is of minor, moderate, or major concern.
Determine all possible causes through analysis or testing. Possible Causes .
- Identify possible methods of controlling or eliminating the Methods of Control hazard.
Decide upon corrective action to mitigate the hazard. Corrective Action .

The DI-2000 software was analyzed for potential hazards. A summary of hazards that were considered and found not to be exposures in the design of DI-2000 are included in Appendix E.

Level of Concern

The level of concern for the DI-2000 software is considered low for the following reasons:

If the transfer of data cannot be completed without compromising the image quality, the 1. transaction cannot be completed, and therefore, the image quality cannot be lost.
The system provides checks and balances for potential user errors, such as failing to save 2. images, or assigning duplicate IDs. The system will not allow users to proceed until images are cleared or saved appropriately.
These checks and balances are re-validated with each release of the product. Separate test 3. plans exercise these specific points within the system. Products are not released until all checks and balances are fully validated.

8. Photographs

See Appendix B.

9. Device Description

Features	DICOM Client	DI-2000
Patient Information Modification	Y	Y
Delete Patient Information	Y	Y
Fax Report	Y	N
Print DICOM Image	Y	Y
Export DICOM images to TIFF	Y	N
Annotate DICOM Images	Y	N
Window/Level Preset Settings	Y	N
Image Flip	Y	Y
90 degree Image Rotation	Y	Y
Features	DICOM Client	DI-2000
180 degree Image Rotation	Y	Y
Black/White Inversion	Y	Y
Multiple Image Display	Y	N
Token/Iconic Display	Y	Y
DICOM Send	Y	Y
DICOM Receive	Y	Y
DICOM Query User	Y	N
DICOM Query Provider	Y	Y
DICOM Retrieve User	Y	N
DICOM Retrieve Provider	Y	Y
DICOM Echo	Y	Y
LAN/WAN Communication	Y	Y
Zoom/Unzoom	Y	N
Copy to Clipboard	Y	N
JPEG Compression lossy/lossless	Y	Y
iJPEG Compression	Y	Y
Analog modem support	Y	Y
Lumisys Film Digitizers connection capability	Y	Y
Industry Standard Digital Communication Support	Y	Y
Display Resolution	Up to 2K	Up to 2K
Communication Media Supported	ATM, ISDN,Analog modems,Ethernet, FDDI,Token Ring,Analog PhoneLines	ADSL, CableModem, Routers,Brouters, Internet,ATM, ISDN,Analog modems,Fast Ethernet,Gigabit Ethernet,Ethernet, FDDI,Token Ring, AnalogPhone Lines
DICOM Print	N	Y
Images Displayed	CT, MR, US, CR,NM, Plain Films	CT, MR, US, CR,NM, Plain Films
Color Images	Y	Y
Cine Loop Viewing	Y	Y
Measurement Tools	Y	Y
DICOM Removable Media Support	N	Y
Wavelet Compression	N	Y

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DI-2000 Components

The following is a list of the minimum recommended requirements for the DI-2000 software:

Pentium 200MHz CPU or equivalent. 1.
64MB of RAM 2.
2MB video board capable of 1024-by-760 screen resolution at 16K colors. 3.
14-inch monitor capable of displaying a 1024-by-760 screen. 4.
న. 2GB local hard drive
Iomega Corp JAZ drive for local archive and redundancy capabilities. 6.
Network connection of 10/100 Base-T Ethernet card. 7.

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Microsoft Windows NT Workstation 3.51 or 4.0 operating system with Service Pack 3 or 8. later.
Sybase SQL Anywhere installed as the local database. 9.
1. Symantec Corp. pcANYWHERE version 8.0.

Comparison with Equivalent Devices 10.

Lumisys, Inc., believes that DI-2000 is substantially equivalent to the following medical devices in commercial distribution:

Manufacturer	Product (Trade Name)	510(k)#	Decision Date
Howtek, Inc.	Digitizer Director™	K972191	9/8/97
DeJarnette ResearchSystems	ImageShare Film Digitizer 1000™	K963628	11/7/96
DeJarnette ResearchSystems	ImageShare Secondary CaptureAcquisition Station; ImageShareComputed Radiography AcquisitionStation	K963594	11/7/96
Mitra Imaging, Inc.	Film Express	K970652	5/2/97

Feature Comparison

Feature	DI-2000	DigitizerDirector™	ImageShare™	Film Express
Bulk Transfer	Y	N	N	N
DICOM 3.0 Compliance	Y	Y	Y	Y
Windows NT 4.0	Y	Y	N	Y
Internet Connectivity	Y	Y	Y	N
Variable Compression	Y	N	Y	N
Wavelet Compression	Y	N	N	N
JPEG Lossless, Lossy, EnhancedCompression	Y	N	N	Y
Remote Administration andManagement Support	Y	N	N	N
Image Processing Algorithm	Y	N	MANUAL	N
Automatic Disk Maintenance	Y	N	N	N
Auto-Transmit	Y	N	N	Y
Supports Lumisys, Inc., digitizersand Computed Radiography	Y	N	Y	Y
Quality Assurance Function	Y	Y	Y	Y
Patient Identification on the Plate	Y	N	N	N
Local Archive Functionality	Y	Y	N	N
Batch Mode Scanning	Y	Y	N	N
Network Printing Support	Y	N	Y	N
Confirmed Delivery	Y	N	N	Y

11. Image Compression Technology

DI-2000 supports the following compression methodologies:

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Compression Type	Algorithms
Lossless	In hardware, via network
	JPEG
	Wavelet
Lossy	JPEG
	Wavelet

In general, the software conforms to the image formats described in the DICOM standard.

Wavelet compression description.

DI-2000 supports the use of wavelet compression in addition to JPEG (described in the original submission of the 510(k), K955708, December 5, 1995.) Images that have been compressed using the wavelet technique are included in Appendix B.

Wavelet transform based compression involves the representation of an image at a variety of scales of resolution. The wavelet transform itself is performed by repeatedly filtering the image with a pair of high and low pass digital filters which obey strict mathematical constraints. Often referred to as a multi-resolution decomposition, the wavelet transform allows fine details in an image (otherwise known as "contrast" information) to be separated from larger scale trends. In this implementation, the requested compression ratio controls the degree of contrast identified. After an image has undergone a wavelet transform, an effort is made to detect those regions of the transform which have little or no contrast. Once such a region has been identified, it is quantized (stored with fewer bits of precision than those parts of the transform which appear important). It is in the quantization steps that all loss occurs. Once quantization is performed, it is not possible to retrieve the original, higher presentation. Following quantization, standard lossless compression techniques are used which includes run-length encoding. These techniques perform quite well as they are generally operating on data which contains large runs of zero with no appreciable effect on image quality.

As the rows of the image are sent to the compressor, the lengths are padded to a multiple of 16 and then the row transform is performed. After all of the lines have been sent, the last line is copied as many times as needed to pad the height to a multiple of 16. The image is then sent off to have its columns transformed; this completes the first-level decomposition

HH	HL
LH	HH

Figure 1 Subband structure of single-level wavelet transform

For each of the three high-frequency quadrants, an energy mapping is computed. Each quadrant is broken up into 8x8 sub-blocks and the energy of each sub-block is computed.

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These energy values are sent off to a clustering algorithm which partitions them into 4 levels. Each 8x8 sub-block in the quadrant is labeled with one of the four levels. The resulting three mappings are stored to be used later in partitioning of the subbands.

1	1	2	4
3	3	2	2
1	4	3	3
1	2	2	1

Figure 2 Example of energy partitioning map of a high-frequency quadrant.

The decomposition is finished by doing one more level in the high frequency quadrants and then performing the standard decomposition in the LL quadrant until the lowest resolution subband image dimensions are at some specified level.

Table 3 Subband structure of a full wavelet decomposition.

After the decomposition, the 2nd, 3rd, and 4th level subbands are each partitioned into 4 sequences by the mapping constructed in step 2. The 2nd level subbands are subdivided into 4x4 subblocks and one of the mappings is superposed on this subdivision. The 3d level subbands are subdivided into 2x2 subblocks and, again, one of the mappings are superposed on this subdivision. Finally, one of the mappings is superposed onto the 4" level subbands. Recall that in step 2, three mappings were constructed. The particular mappings applied to each of the 2nd-4th level subbands can be obtained by referring to figure 3. These mappings partition each of the 2nd-4th level subbands into 4 sequences which constitute one part of the bands making up the transformed data Each of the remaining higher level subbands form the other set of transform bands. For each transform band, we calculate the normalized kurtosis, the 40 moment divided by the squared variance, and then matched to a generalized Gaussian distribution. The normalized kurtosis of a generalized Gaussian distribution with exponent $\alpha$ and variance $\sigma$2 is given by

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$$\frac{E\left[\mathbf{x}^{*}\right]}{\sigma^{2}} = \frac{\Gamma(\frac{1}{\alpha})}{\Gamma(\frac{3}{\alpha})\Gamma(\frac{1}{\alpha})} \frac{1}{\alpha}.$$

where I is the ordinary Gamma function. The kurtosis is then matched to one of the predetermined generalized Gaussian exponents .5, .75, 1.0, 1.5, 2.0. This exponent, along with the variance, is used to supply the generalized Gaussian pdf model for the given transform band.

The transform bands, along with there model parameters a and o2 and the length of the band, are sent to a bit-allocator which then returns the step sizes to be used in the quantization of each transform band.

12. Test Data and Conclusions

See Appendix B.

13. Software Information

For a list and brief description of software functions, a description of the software development methods, and a description of software test procedures, see Appendix C.

Truthful and Accurate Statement 14.

As required by 21 CFR 807.87(j) a Truthful and Accurate Statement is contained in Appendix D.

15. Confidentiality

Portions of the attached enclosure are confidential.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Trindy LeForge Director, Ouality Assurance Lumisys, Inc. 1350 North Kalb Road Tucson, Arizona 85715

Re:

K980213 DI-2000 (Digital Interface) Dated: January 7, 1998 Received: January 9, 1998 Regulatory class: Unclassified Procode: 90 LMA

MAR 17 1998

Dear Mr. LeForge:

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 castment 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 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 Feberal 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 (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 submission does not affect any obligation you might have under sections 531 through 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 (21 CFR Part 801 and additionally 809.10 for yitro 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/cdrb/dsma/dsmamain.httml":

Sincerely yours,

Lillian Xia, Ph.D.

Lillian Yin, Ph.D. Director, Division of Reproductive Abdominal, Ear, Nose and Throa and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

Image /page/7/Picture/15 description: The image shows a partial view of a logo or emblem, featuring the text 'DEPARTMENT OF HEALTH & HU'. The text is arranged in a curved manner, suggesting it is part of a circular design. The visible portion of the emblem includes stylized graphic elements, possibly representing abstract shapes or symbols associated with health or the department it represents.

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4955708- 1498 0213 510(k) Number:

DICOM Client Device Name: DI-2000

Indications for Use:

DI-2000 is intended to utilize a scanner and software interface to digitize either radiology film or computed radiography exposed phosphor plates.

DI-2000 is a DICOM 3.0 compliant radiological digitization application.

DI-2000 enables the user to autoarchive lossless or lossy compressed images locally or at a remote archive site. Supports DICOM 3.0 Query and Retrieve Service Class.

Supports scanning of films or phosphor plates in batch mode prior to entering patient information. Once scanned, images can be sent to multiple destinations.

Users:

The DI-2000 will be located in a radiology department or clinic, or in a mobile radiology van. DI-2000 will support reading and digitizing exposed CR plates or radiology film. The expected users are as follows:

Radiologists Radiology Technologists System Administrator within the radiology department

Thiel le. S. ymm

(Division Sign-Off) Division of Reproductive, Abdominal, EN and Radiological Devic 510(k) Number

Prescription Use
(Per 21 CFR 801.109)

Lumisys, Inc.

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.