The Medi-6000 consists of a transparency film digitizer and paper CCD scanner that is used to digitize radiographs or X-ray film as well as paper reports or doctor's orders. When the Medi-6000 is used to digitize radiographic films, the digital image is intended for use in primary, secondary and over reading applications. This device is not to be used for primary image diagnosis in mammography. The target users of the device are medical professionals or trained staffs.

Device Description

The Medi-6000 is a digitizer that can easily transfer x-ray films into a digital format for patients, hospitals, and office records. It can capture details in bright and dark areas of x-ray films and provide the medical professionals a convenient method to digitize the roentgenogram for the electric data storage.

AI/ML Overview

The provided 510(k) summary for the Microtek International, Inc. Medi-6000 Medical Image Digitizer (K091288) contains limited information regarding detailed acceptance criteria and a specific study proving the device meets them. It primarily focuses on demonstrating substantial equivalence to predicate devices based on technological characteristics and intended use.

Here's an analysis based on the available text:

1. Table of Acceptance Criteria and Reported Device Performance:

The document mentions specific technological characteristics, which act as de facto performance criteria for comparison with predicate devices. However, explicit "acceptance criteria" for a study are not presented in a formal table or detailed manner. The performance criteria are implied by the device's specifications and the comparison to predicate devices.

Acceptance Criteria (Implied)	Reported Device Performance (Medi-6000)
High optical resolution	600 dpi
Dynamic range	4.0 Dmax
Grayscale depth	16-bit

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

The document does not explicitly state a sample size for a test set. There is no mention of a clinical or image-based study with a test set of images. The performance testing section states "The performance testing results for the Medi-6000 digitizer demonstrated that the device meets its intended use specifications," but it doesn't describe the methodology, sample selection, or data provenance (e.g., country of origin, retrospective/prospective nature of data).

3. Number of Experts Used to Establish Ground Truth and Qualifications:

The document does not mention using experts to establish ground truth for any test set, as no specific image-based study is described. The assessment appears to be based on physical device specifications and comparison to predicate devices.

4. Adjudication Method for the Test Set:

Since no test set or image-based study is described, there is no information provided on any adjudication method.

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

The document does not mention any MRMC study. The device is a digitizer, and the regulatory filing focuses on its ability to convert physical films to digital images, not on its impact on human reader performance in interpreting those images.

6. Standalone Performance Study:

The document discusses "Performance Testing" which indicates a standalone assessment of the digitizer's capabilities (e.g., resolution, Dmax, grayscale). This implies a standalone evaluation of the algorithm/device's ability to digitize images according to its specifications. However, the details of this testing (e.g., number of films digitized, specific tests performed) are very brief. It states: "The performance testing results for the Medi-6000 digitizer demonstrated that the device meets its intended use specifications and therefore meets the requirements necessary for its intended use as a component of a PAC or Teleradiology system." This suggests internal testing was conducted on the device's technical performance characteristics.

7. Type of Ground Truth Used:

For the performance specifications (resolution, Dmax, grayscale), the "ground truth" would likely be technical measurements against established industry standards or calibrated test patterns. For example, resolution would be measured using line pair patterns, and Dmax would be measured with calibrated densitometers. There is no mention of expert consensus, pathology, or outcomes data as ground truth for this device, which is primarily a hardware digitizer.

8. Sample Size for the Training Set:

The document does not mention a training set as this device is a film digitizer, not an AI/machine learning algorithm that requires training data.

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

This question is not applicable as there is no training set for a film digitizer.

Summary of Findings:

The 510(k) summary for the Microtek Medi-6000 Medical Image Digitizer is primarily a submission for a hardware device seeking substantial equivalence to existing predicate film digitizers. The "performance testing" described is focused on the device's technical specifications (resolution, dynamic range, grayscale) rather than a clinical study evaluating diagnostic accuracy or reader performance using digitized images. Therefore, many of the typical elements expected for an AI/CADe device study (like test set size, expert ground truth, MRMC studies, or training sets) are not present or not relevant in this document. The acceptance criteria are essentially the device's specifications aligning with or improving upon those of the predicate devices.

Summary

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510(k) Summary

K091288

[As required by section 807.92(c)]

Submitter: Microtek International, Inc. 6, Industry East Road 3, Science-Based Industrial Park, Hsinchu, 30077, Taiwan, TEL: +886-3-5772155 FAX: +886-3-5772598

1. Official Correspondent: Mr. George Sun
1. Date of 510(k) Submittal: 29. April, 2009
1. Device Trade Name Medi-6000 Medical Image Digitizer
1. Common Name: Film digitizer
1. Classification Name: Image digitizer was classified in class II (21 CFR 892.2030)
1. Device Product Code: LMA
1. Predicate Device: Manufacturer: Howtek Incorporated Device name: Film digitizer Model name: Fulcrum 510(k) No.: K021949

Manufacturer: VIDAR Systems Corporation Device name: X-ray film digitizer Model name: P111, TeleRADPRO, VXR-12 plus 510(k) No.: K993597

1. Device Description:
  The Medi-6000 is a digitizer that can easily transfer x-ray films into a digital format for patients, hospitals, and office records. It can capture

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details in bright and dark areas of x-ray films and provide the medical professionals a convenient method to digitize the roentgenogram for the electric data storage.

10.Intended Use:
The Medi-6000 consists of a transparency film digitizer and paper CCD scanner that is used to digitize radiographs or X-ray film as well as paper reports or doctor's orders. When the Medi-6000 is used to digitize radiographic films, the digital image is intended for use in primary, secondary and over reading applications. The target users of the device are medical professionals or trained staffs.
11 Technological Characteristics:
The Medi-6000 with a high optical resolution of 600 dpi, a dynamic range of 4.0 Dmax, and the 16-bit grayscale, the Medi-6000 allows users to get better image details in just seconds.
12.Performance Testing:
The performance testing results for the Medi-6000 digitizer demonstrated that the device meets its intended use specifications and therefore meets the requirements necessary for its intended use as a component of a PAC or Teleradiology system.
1. Substantial Equivalence to Predicate Device:
  Medi-6000 is substantially equivalent to Fulcrum and P111. TeleRADPRO, and VXR-12 plus. Medi-6000 employs the resolution values same as that of Fulcrum, and better than P111, TeleRADPRO, and VXR-12 plus. Comparison table of the principal characteristics of these three devices is shown in the Section II and specification data for the Medi-6000 is included in Section I-3.

14.Conclusions:

In terms of intended use, construction, function, safety, operating environmental conditions and effectiveness of the Medi-6000 film digitizer is substantially equivalent to the predicate devices used for this application.

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Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three tail feathers, representing the department's mission to protect the health of all Americans and provide essential human services. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.

DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room - WO66-G609 Silver Spring, MD 20993-0002

Microtek International, Inc. % Mr. Hui-chen Kai, Supervisor Electronics Testing Center, Taiwan No. 8, Lane 29, Wenming Rd. Guisan, Taoyuan, 33383 TAIWAN

AUG 1 4 2009

Re: K091288

Trade/Device Name: Medi-6000 Medical Image Digitizer Regulation Number: 21 CFR 892.2030 Regulation Name: Medical image digitizer Regulatory Class: II Product Code: LMA Dated: July 17, 2009 Received: July 22, 2009

Dear Mr. Hui-chen Kai:

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); medical device reporting (reporting of medical

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device-related adverse events) (21 CFR 803); 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH0ffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803). please go to http://www.fda.gov/cdrh/mdr/ for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Lammy M. Moure

Janine M. Morris Acting Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known): Not known K091288

Device Name: Medi-6000 Medical Image Digitizer

Indications For Use:

Prescription Use V (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

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

Lopui Nh Nhay

vision of Reproductive, Abdominal and

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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.