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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.

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.

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.

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.

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