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The KODAK Ektascan Imagelink System (KEIS) is a DICOM conferment product designed for use within a Picture Archiving and Communication System (PACS).

The KODAK Ektascan Imagelink System is composed of two major components, the KODAK Digital Science Medical Modality Acquisition Unit and the KODAK Digital Science Medical Printer Interface Unit. These systems can exit together or independently on a network.

The KODAK Ektascan Imagelink System [KEIS] is composed of components common to all image management systems for image acquisition, printing, review, archive/retrieval, and communications. These components can be combined into customized solutions for the management of diagnostic image information.. Evaluation of soft and or hard copy output provides adequate opportunity for competent human intervention.

This 510(k) summary describes a device, the KODAK Digital Science Medical Modality Acquisition Unit, which is a component of a Picture Archiving and Communications System (PACS). The submission focuses on comparing the new device's features to a substantially equivalent predicate device (KODAK Ektascan Imagelink System) rather than presenting a study where acceptance criteria are explicitly defined and performance is measured against them.

Therefore, many of the requested details about acceptance criteria, study design, and ground truth establishment are not present in this document. The document primarily relies on the equivalence of the new device to the predicate device to establish safety and effectiveness.

Here's a breakdown of what can be extracted based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Note: The document defines 'acceptance criteria' implicitly through the comparison to the predicate device, KODAK Ektascan Imagelink System. The "reported device performance" is the claim of equivalence in functionality and technical specifications. No explicit numerical performance metrics or acceptance thresholds are provided.

2. Sample size used for the test set and the data provenance

• Sample Size: Not applicable. This document does not describe a clinical study with a test set of patient data. It is a technical comparison for substantial equivalence.
• Data Provenance: Not applicable.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

• Not applicable as no clinical test set requiring expert ground truth was described.

4. Adjudication method for the test set

• Not applicable as no clinical test set requiring adjudication was described.

5. 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. This device is a PACS component (acquisition unit and printer interface unit) with the indication for "image management systems for image acquisition, printing, review, archive/retrieval, and communications." It is not an AI algorithm intended to assist human readers in diagnostic tasks, nor is there any mention of an MRMC study.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

• No. This device is a hardware/software system for imaging management, not an algorithm being evaluated for standalone diagnostic performance. The document explicitly states: "Evaluation of soft and or hard copy output provides adequate opportunity for competent human intervention."

7. The type of ground truth used

• Not applicable as no clinical study or diagnostic performance evaluation was described. The "ground truth" for the submission is the technical specifications and claimed functionality of the predicate device.

8. The sample size for the training set

• Not applicable as this is not an AI/machine learning device undergoing a training process with data.

9. How the ground truth for the training set was established

• Not applicable.

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The KODAK Ektascan Imagelink System (KEIS) is a DICOM conferment product designed for use within a Picture Archiving and Communication System (PACS).

The KODAK Ektascan Imagelink System is composed of two major components, the KODAK Digital Science Medical Modality Acquisition Unit and the KODAK Digital Science Medical Printer Interface Unit. These systems can exit together or independently on a network.

The KODAK Ektascan Imagelink System [KEIS] is composed of components common to all image management systems for image acquisition, printing, review, archive/retrieval, and communications. These components can be combined into customized solutions for the management of diagnostic image information.. Evaluation of soft and or hard copy output provides adequate opportunity for competent human intervention.

This 510(k) summary describes a Picture Archiving and Communications Systems (PACS) Component, specifically the KODAK Digital Science Medical Printer Interface Unit (K961740) and its associated Medical Modality Acquisition Unit. The document explicitly states it is a comparison to a predicate device and does not contain information about acceptance criteria or a study proving the device meets said criteria.

The document is a "510(k) SUMMARY OF SAFETY AND EFFECTIVENESS" for a medical device that has been classified as Class II, a classification for devices that are considered to pose a moderate risk to patients and thus require general and special controls to assure their safety and effectiveness.

The purpose of a 510(k) submission is to demonstrate that the new device is substantially equivalent to a legally marketed predicate device. This is primarily achieved through a "comparison of features" table, as provided in the document.

Therefore, I cannot provide the requested information because it is not present in the provided text. The document focuses on establishing substantial equivalence to a predicate device based on features and intended use, rather than presenting acceptance criteria and performance study results.

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The KDS FD is designed to allow operators and physicians greater access to images by transmitting them electronically over networks instead of physically sending films. The system allows for much quicker consultations with experts in distant facilities. Also, archiving electronically for faster image recall and assembly of historical studies can be accomplished with ease. The KDS FD is a DICOM conformant digitization product designed for use within a Picture Archiving and Communication System (PACS).

Kodak's Film Digitizer (KODAK DIGITAL SCIENCE Film Digitizer or KDS FD) is a system designed to convert X-ray films into digital images for display, transmission, and/or archiving. The KDS FD is designed to accomplish its interface over the American College of Radiology-National Electrical Manufacturers Association (ACR-NEMA) standard known as DICOM (Digital Imaging and Communications in Medicine) which gives direct access to imaging devices, Local Area Networks (LANs), and Wide Area Networks (WANs).

This document, a 510(k) summary for the KODAK Digital Science Film Digitizer L7501/L7506, primarily focuses on demonstrating substantial equivalence to a predicate device for regulatory clearance. It does not contain information about acceptance criteria, a specific study proving device performance against those criteria, or details regarding ground truth, expert involvement, or sample sizes typically found in performance studies for diagnostic algorithms.

Therefore, I cannot populate the requested table and answer the specific questions about acceptance criteria, study details, expert involvement, ground truth, and sample sizes based solely on the provided text.

The document discusses:

• Device Name: KODAK Digital Science Film Digitizer L7501 / L7506
• Intended Use: Converting X-ray films into digital images for display, transmission, and/or archiving within a PACS, facilitating remote consultations and faster image recall.
• Predicate Device: KODAK Film Digitizer ("FD")
• Substantial Equivalence: Claimed based on similar purpose, functionality, and image clarity/definition compared to the predicate device (Vortech (Kodak) FD system K915362). The main difference mentioned is hardware choice and some updates in patient information entry and networking standards (DICOM for KDS FD vs. ACR-NEMA 2.0 for FD).

To fulfill the request, a different type of document (e.g., a detailed performance study report or clinical validation report) would be needed.

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The KODAK DIGITAL SCIENCE (KDS) Medical Image and Information Library is a DICOM conformant archival product designed for use within a Picture Archiving and Communication System (PACS). The system utilizes a prefetching algorithm to facilitate fast access to previous imagery.

The system consists of three main components: 1) the host CPU (a Sun SPARCstation 5 or 20) with pre-installed propriatary software, 2) the magnetic BI ARCORACIP S OF 201 orage Array RAID subsystem), and 3) a KODAK DIGITAL SCIENCE ADL 150 writeable CD jukebox. The RAID subsystem and the CD jukebox are managed by a hierarchical storage library that presents these two subsystems to the system software running on the host CPU as a single, very large filesystem. The power supply Provides power to operate the unit from a line voltage for 100, 120, 220, or 240 VAC, 50/60 Hz.

This 510(k) notification describes a medical image and information library system, not a device that would typically have performance-based acceptance criteria in the context of diagnostic accuracy or equivalent studies. The device is for image storage, distribution, and archival within a Picture Archiving and Communication System (PACS). As such, the "performance" here relates to its technical specifications and functionality as an archival system, rather than clinical efficacy as a diagnostic tool.

Therefore, the requested information elements (1-9) such as reported device performance, sample sizes for test sets, expert involvement, MRMC studies, standalone performance, and ground truth establishment are not applicable in the traditional sense for this type of device submission.

The "acceptance criteria" for a device like the KODAK DIGITAL SCIENCE Medical Image and Information Library would primarily revolve around its technical specifications, compliance with standards (like DICOM), and functional equivalence to its predicate device. The "study" proving it meets these criteria would be the technical documentation and comparison provided in the 510(k) submission itself.

However, I can extract information related to its technical specifications and comparison to the predicate device, which serves as its form of "performance" and "acceptance criteria" in this context.

Here's an interpretation based on the provided text, modified to fit the context of an archival imaging system:

1. Table of Acceptance Criteria (Technical Specifications) and Reported Device Performance

Note regarding "Acceptance Criteria": For this type of device, the "acceptance criteria" are largely based on demonstrating substantial equivalence to a predicate device and meeting technical specifications and industry standards (e.g., DICOM conformance). The provided "predicate device" column serves as the benchmark against which the new device is compared.

2. Sample size used for the test set and the data provenance:

• Not Applicable. This device is an image storage and retrieval system. It does not perform diagnostic functions that require a "test set" of patient data in the sense of clinical evaluation for accuracy. The "testing" would involve functional tests, performance benchmarks (e.g., retrieval speed, storage capacity verification), and DICOM conformance tests, not clinical data sets for diagnostic performance.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

• Not Applicable. See point 2. No ground truth establishment related to diagnostic accuracy is relevant for an image archival system.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:

• Not Applicable. See point 2.

5. 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:

• Not Applicable. This device is an archival system, not an AI-assisted diagnostic tool.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:

• Not Applicable. This device is an infrastructure component (archival system), not an algorithm that performs a standalone task requiring performance evaluation against human interpretation. Its standalone "performance" would relate to its technical specifications for storage, retrieval, and DICOM conformance.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):

• Not Applicable. See point 2. The "ground truth" for this device would be its adherence to technical specifications, proper functioning of its storage and retrieval mechanisms, and compliance with DICOM standards, all verified through engineering and functional testing.

8. The sample size for the training set:

• Not Applicable. This device is a hardware/software system for image archiving, not a machine learning model that requires a "training set."

9. How the ground truth for the training set was established:

• Not Applicable. See point 8.

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