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The KODAK DirectView DR 3000 System is a permanently installed diagnostic x-ray system for generation of x-rays for examination of various anatomical regions.

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The provided text describes a 510(k) premarket notification for the Kodak DirectView DR 3000 System, a stationary x-ray system. However, it does not contain any information about acceptance criteria, device performance metrics, study designs, sample sizes (for training or testing), ground truth establishment, or expert qualifications necessary to answer the request.

The document is a clearance letter from the FDA stating that the device is substantially equivalent to legally marketed predicate devices, thereby permitting it to be marketed. It focuses on regulatory aspects like compliance with federal regulations, registration, labeling, and good manufacturing practices.

Therefore, I cannot provide the requested table or details about the study because the information is not present in the given text.

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The CR Systems are compact laser scanners capable of reading the latent image formed on a storage phosphor imaging plate and producing a digital image for projection radiography applications. This excludes mammography applications for the Kodak Ektascan Storage Phosphor Reader and the Kodak Eclipse Image Processing Software in the United States.

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I am sorry, but the provided text does not contain information about acceptance criteria, device performance, or any study details. It is a letter from the FDA to Eastman Kodak Company regarding the 510(k) premarket notification for "Kodak Eclipse Image processing software," confirming its substantial equivalence to a predicate device.

Therefore, I cannot fulfill your request for information about acceptance criteria and study details based on the given input.

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The KODAK CR-7400 Digital Radiography System is intended for digital dental radiography using a phosphor storage screen for radiographic diagnostic intraoral and extraoral images.

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The provided text is a 510(k) premarket notification letter from the FDA to Kodak Health Group regarding the KODAK CR 7400 Digital Radiography System. This document approves the device based on substantial equivalence to a predicate device but does not contain information about the acceptance criteria, specific study designs, or detailed performance data typically found in a clinical study report or a more comprehensive technical document.

Therefore, I cannot extract the information required to answer your request. The document explicitly states:

"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)."

This indicates that the approval is based on equivalence to existing devices, not necessarily on a detailed study proving it meets specific acceptance criteria in the manner you've outlined for AI or diagnostic performance studies. The 510(k) process often relies on demonstration of similar technical characteristics and performance to legally marketed predicate devices.

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The KODAK PACS is an image management system whose intended use is to provide completely scaleable local and wide area PACS solutions for hospital and related institutions/sites, which will archive/distribute/retrieve and display images and data from all hospital modalities and information systems. This includes the display of structured reports from CAD systems with DICOM "for presentation" mammography images.

The KODAK PACS is an image management system.

The provided documents are a 510(k) clearance letter for the KODAK PACS and its Statement of Intended Use. They do not contain sufficient information to answer the detailed questions about acceptance criteria, study design, and performance metrics for a medical device's AI component. The KODAK PACS described here is an "image management system," which based on the 2006 date, likely refers to a Picture Archiving and Communication System (PACS) for storing, retrieving, distributing, and displaying medical images. It notes the display of "structured reports from CAD systems with DICOM 'for presentation' mammography images," implying it can integrate with CAD (Computer-Aided Detection) systems, but it is not itself a CAD system or an AI-based diagnostic tool.

Therefore, most of the specific questions cannot be answered from the provided text.

Here's a breakdown of what can and cannot be answered:

1. A table of acceptance criteria and the reported device performance:

   • Cannot be answered. The document describes a PACS system for image management and display, not an AI diagnostic device with specific performance metrics. There are no acceptance criteria or performance data provided.

2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective):

   • Cannot be answered. No study details are provided as this is a PACS system clearance, not a performance study for a diagnostic algorithm.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience):

   • Cannot be answered. Ground truth establishment is not relevant for a PACS system's clearance as described here.

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

   • Cannot be answered. Not applicable for a PACS system clearance.

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:

   • Cannot be answered. No MRMC study is mentioned. The device is a PACS, not an AI assistance tool.

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

   • Cannot be answered. Not applicable; this is an image management system, not a standalone algorithm.

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

   • Cannot be answered. Not applicable to the clearance of a PACS system.

8. The sample size for the training set:

   • Cannot be answered. No training set for an AI algorithm is mentioned.

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

   • Cannot be answered. Not applicable.

Summary of available information:

• Trade/Device Name: KODAK PACS
• Regulation Number: 21 CFR 892.2050
• Regulation Name: Picture archiving and communications system
• Regulatory Class: II
• Product Code: LLZ
• Intended Use: To provide completely scalable local and wide area PACS solutions for hospital and related institutions/sites, which will archive/distribute/retrieve and display images and data from all hospital modalities and information systems. This includes the display of structured reports from CAD systems with DICOM "for presentation" mammography images. (This last part indicates its ability to integrate with CAD, not that it is a CAD system itself).

In conclusion, the provided documents pertain to the regulatory clearance of a PACS system, which is infrastructure for medical image management, and not a device that would require the kind of performance study details requested for an AI diagnostic or assistance tool.

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The KODAK CARESTREAM PACS is an image management system whose intended use is to provide completely scaleable local and wide area PACS solutions for hospital and related institutions/sites, which will archive/distribute/retrieve and display images and data from all hospital modalities and information systems.

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The provided document is a 510(k) clearance letter for the "Kodak Carestream PACS" device. This letter indicates that the device has been found substantially equivalent to a legally marketed predicate device.

However, this document does not contain information about acceptance criteria, device performance studies, sample sizes, expert qualifications, or ground truth establishment.

The 510(k) clearance process primarily focuses on demonstrating substantial equivalence to a predicate device, which often relies on comparison of technical characteristics and intended use, rather than extensive new clinical performance studies. While some performance testing is implied for regulatory submission, the details of such testing are not included in this particular FDA letter.

Therefore, I cannot provide the requested information from the given text. A complete description of acceptance criteria, study details, and performance metrics would typically be found in the manufacturer's 510(k) submission itself, not in the FDA's clearance letter.

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The KODAK DirectView DR System Detector is intended to capture for display radiographic images of human anatomy. It is intended for use in general projection radiographic applications wherever conventional screen-film systems may be used.

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This document is a 510(k) clearance letter from the FDA for the Kodak DirectView DR System Detector. It does not contain information about acceptance criteria or specific study details to prove the device meets those criteria.

Therefore, I cannot fulfill your request for the detailed information as it is not present in the provided text. The document focuses on regulatory approval based on substantial equivalence to a predicate device, rather than providing performance data from a specific study.

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The KODAK DirectView DR 7500 System is a permanently installed diagnostic x-ray system for generation of x-rays for examination of various anatomical regions.

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The provided FDA 510(k) clearance letter (K051258) for the "Kodak DirectView DR 7500 System" does not contain the detailed information required to answer your specific questions about acceptance criteria and study design.

This document is a regulatory clearance letter acknowledging that the device is substantially equivalent to a predicate device. It confirms that the FDA has reviewed the manufacturer's premarket notification and determined that the device can be marketed.

Why the information is not present:

• 510(k)s focus on substantial equivalence: The primary purpose of a 510(k) submission is to demonstrate that a new device is as safe and effective as a legally marketed predicate device, not necessarily to prove its absolute performance against specific metrics in a detailed clinical study for novel devices.
• Detailed study data is often proprietary: Even if a study was conducted, the detailed methodology, acceptance criteria, specific performance metrics, and a full breakdown of the study population are typically found in the full 510(k) submission document itself, which is not usually made public in its entirety as part of the clearance letter. The clearance letter summarizes the FDA's decision.
• The device is an X-ray system: This device is a "Stationary x-ray system" used for generating x-rays. While image quality is crucial, the "performance" here likely refers to technical specifications, dose output, and image acquisition capabilities, rather than a diagnostic AI algorithm's performance metrics like sensitivity/specificity for disease detection.

Therefore, I cannot provide the requested information from the given text.

To find the details you're looking for, you would typically need to:

1. Access the full 510(k) submission: Sometimes these are available through Freedom of Information Act (FOIA) requests, or summaries might be present in publicly accessible FDA databases if the manufacturer chose to make more information public.
2. Review supporting documentation from the manufacturer: The manufacturer (Eastman Kodak Company, in this case) would have these details in their internal documentation or perhaps in published technical specifications for the device.

Based only on the provided document, here's what I can infer but not directly answer:

• Device Name: Kodak DirectView DR 7500 System
• Intended Use/Indications: "The KODAK DirectView DR 7500 System is a permanently installed diagnostic x-ray system for generation of x-rays for examination of various anatomical regions." This means it's for general diagnostic radiography.
• Regulatory Class: Class II
• Product Codes: KPR (System, X-Ray, Stationary) and MQB (Radiographic System, Digital)

Without the actual study report or further sections from the 510(k) submission that discuss performance data, I cannot populate the table or answer the specific questions about acceptance criteria, sample sizes, ground truth establishment, or clinical study design.

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The Kodak Color Medical Imager 1000 series medical printers are thermal print engines intended to produce continuous tone photographic quality hard copy output with integrated color management that adjusts printed colors to accurately match medical image monitors or user specified color profiles. The hardcopy output includes, however is not limited to, nuclear medicine, ultrasound, CT (especially 3-D reconstruction), MRI and Radiation Therapy planning. Images are suitable for medical image diagnosis use and referral. Digital images can be acquired from, but not limited to local area networks (LAN), Internet, medical image storage devices, or directly from digital medical image capture modalities. The system of printer and physical image is not a high-resolution device and is not intended for use with FFDM systems.

The KODAK Color Medical Imager 1000 is intended for use as a hard copy device for output from imaging source modalities used in medical imaging diagnosis and referral. Electronic image information signals are managed in the KODAK Color Medical Imager 1000 and transformed to heat a color donor ribbon and drive color dyes to a receptor sheet using thermal dye sublimation technology.

The provided text does not contain detailed information about specific acceptance criteria related to device performance in terms of diagnostic accuracy, nor does it describe a study that quantitatively proves the device meets such criteria through a clinical trial or performance evaluation with human readers.

Instead, the document focuses on regulatory compliance, safety, and substantial equivalence to a predicate device based on technical characteristics and adherence to voluntary standards.

Here's a breakdown of the information that can be extracted, and what is missing based on your request:

1. Table of acceptance criteria and reported device performance:

Missing Information (based on the provided text):

The document does not provide information on:

• Sample size used for the test set and the data provenance: There is no mention of a test set for performance evaluation in terms of diagnostic accuracy.
• Number of experts used to establish the ground truth for the test set and the qualifications of those experts: As there's no diagnostic performance study, there's no ground truth establishment for a test set.
• Adjudication method for the test set: Not applicable as no diagnostic performance study is described.
• 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: This is a non-AI device (a medical imager/printer), so an MRMC study with AI assistance is not relevant or described. The document mentions "Medical personnel review images displayed by the subject device and its predicates. This offers ample opportunity for competent human intervention in case of a malfunction or other failure," which refers to the human role in the diagnostic process after the image is printed, not as part of an AI-assisted interpretation study of the device itself.
• If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable for this type of device.
• The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable as no diagnostic performance study is described.
• The sample size for the training set: Not applicable, as this is not an AI/algorithm-based diagnostic device requiring a training set in that context.
• How the ground truth for the training set was established: Not applicable.

Summary of the Study (as described in the document):

The document describes a substantial equivalence determination study rather than a clinical performance study. The core "study" is a comparison of the KODAK Color Medical Imager 1000 to a predicate device, the Codonics EP-1000 Medical Color dry imager (K030690). The "proof" that the device meets acceptance criteria primarily relies on:

1. Similarity in Intended Use: The intended uses are stated to be similar.
2. Technological Characteristics: The subject device is stated to use the "same technical design base" as the predicate device.
3. Adherence to Voluntary Standards: The device meets recognized safety and performance standards (DICOM, SMPTE, UL 60950, IEC 60601-1-1, ISO 12207, and ISO 14971).
4. Safety Profile: Both devices have no patient contact and do not control other patient-affecting devices. The document highlights the role of human medical personnel in reviewing images as a safeguard.

In essence, the "study" is a regulatory submission process demonstrating that the new device is "as safe and effective" as a legally marketed predicate device based on direct comparison of its design, intended use, and compliance with general safety and performance standards, rather than a clinical trial measuring diagnostic accuracy using a test set and ground truth.

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The KODAK Medical Imager 300 Imager is intended use as a hard copy device for output from digital imaging source modalities for use in medical imaging diagnosis and referral. Electronic image information signals are managed in the Medical Imager 300 and transformed thermally to develop Eastman Kodak imaging media. The system of printer and physical image is intended for use with a variety of modalities, including, but not limited to CR, DR, CT, MRI, Ultrasound, Nuclear Medicine, etc. for diagnostic use by medical radiologists and communications to referring physicians and their patients. The system of printer and physical image is not a high resolution device and is not intended for use with FFDM systems.

The imagers receive image data from the modality. User control is performed directly by the modality or through the host control. KODAK imaging media is removed from a cartridge and transported to the imaging station. Image data addresses the individual pixel elements in the thermal print head. The heat of the thermal head reacts the thermally sensitive film to produce the image and the film exits the printer. Software is used to control the image management and machine functions. AIQC (Automated Image Quality Control) matches printing power with film characteristics to provide consistently high image quality.

The provided text focuses on the 510(k) summary for the KODAK Medical Imager 300 Thermal Printer, which is a hardcopy device for medical images. It primarily discusses the device's intended use, technological characteristics, and its substantial equivalence to a predicate device based on safety standards.

Crucially, the document does NOT contain information about acceptance criteria, device performance metrics (e.g., sensitivity, specificity, accuracy), sample sizes for test sets, data provenance, expert qualifications, ground truth establishment, MRMC studies, or standalone algorithm performance.

The "Performance Data" section merely states: "Safety and effectiveness are assured via meeting voluntary standards, including: DICOM, SMPTE, UL 2601-1, IEC 60601-1, ISO 12207 and ISO 14971." This refers to compliance with general industry and safety standards for medical devices, not specific diagnostic performance metrics or a study demonstrating clinical accuracy.

Therefore, I cannot fulfill your request for the detailed table and study information as the provided text lacks this content. The device described is a thermal printer, which outputs images, and its performance is assessed in terms of image quality consistency and safety compliance, rather than diagnostic accuracy metrics typically associated with AI/CAD devices.

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The KODAK DirectView CR cassette holds a storage phosphor screen which is exposed by radiographic equipment for the recording of a patient radiation pattern. The cassette is loaded into a compact laser scanner capable of reading the latent image. The Kodak DirectView CR 15 x 30 cm cassette and storage phosphor screen can be used for general radiology and dental panoramic radiography applications.

The Kodak DirectView CR 15 x 30 cm cassette size is designed to perform general radiography and panoramic dental exams when used with the Kodak DirectView CR 850 and CR 950 systems. The cassette system (cassette and storage phosphor screen adhered to the cassette plate) can be used in common dental panoramic x-ray dental units designed to accept cassettes that meet the ISO 4090 standard. The CR cassette is a standard x-ray diagnostic cassette used for computed radiography. The panel materials are consistent with the current design of the CR cassette and include Corus Hylite and Toray Panel. The Corus Hylite panel includes two lavers of aluminum, with polypropylene (plastic) in the middle, and is covered with Omnova (clear viny) with printing on the second surface). On the tube side of the cassette there is Toray Carbon Fiber Panel that consists of four layers of carbon fiber. The storage phosphor plate is attached to the honeycomb panel. The lead mylar that is in place under the phosphor layer of the screen was removed in the CR 15 x 30 cm cassette in order to accommodate Automatic Exposure Control (AEC) in dental x-ray units.

This 510(k) submission (K040373) for the KODAK DirectView CR Cassette / GP / 15 x 30 cm does not describe a study with acceptance criteria and device performance in the typical sense of a diagnostic algorithm or predictive model. Instead, it focuses on demonstrating substantial equivalence of a physical medical device (an X-ray cassette) to a previously cleared predicate device. Therefore, the information provided in the input does not directly align with the requested structure for acceptance criteria and study details for an AI/algorithm-based device.

However, I can extract and present the relevant information provided in the context of substantial equivalence for a physical medical device. The "acceptance criteria" here are implicitly tied to the performance requirements for an X-ray cassette, and the "study" is the comparison made to the predicate device.

Here's an interpretation based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

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

This is not applicable in the context of this 510(k) submission. The "test set" here would refer to the physical cassette itself being compared. The comparison is primarily based on design specifications, materials, and functional claims relative to a predicate device, rather than a clinical trial with a "test set" of patient data.

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

Not applicable. Ground truth for a physical X-ray cassette's performance is established by engineering specifications, material properties, and regulatory standards, not by expert interpretation of clinical images from a "test set." The FDA reviewers evaluate the technical documentation.

4. Adjudication Method for the Test Set

Not applicable. There isn't a "test set" of cases requiring adjudication in this type of submission.

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 a passive X-ray cassette, not an AI or imaging interpretation algorithm. Therefore, an MRMC study related to human reading performance with or without AI assistance is irrelevant.

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

Not applicable. The device is a physical X-ray cassette, not an algorithm.

7. The Type of Ground Truth Used

The "ground truth" implicitly used for demonstrating substantial equivalence are:

• Engineering Specifications: Design, materials, and manufacturing standards for X-ray cassettes.
• Regulatory Standards: Adherence to standards like ISO 4090 for dental panoramic cassettes.
• Predicate Device Performance: The established, cleared performance of the Kodak Ektascan SP Cassette (K925997) / Kodak DirectView CR Cassette serves as the benchmark for "truth."

8. The Sample Size for the Training Set

Not applicable. This is a physical device, not a machine learning algorithm, so there is no training set.

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

Not applicable. There is no training set for this device.

Summary of the Study that Proves the Device Meets Acceptance Criteria:

The "study" proving the device meets its (implicit) acceptance criteria is the Substantial Equivalence demonstration. The manufacturer asserts and provides documentation to support that the KODAK DirectView CR 15 x 30 cm cassette is substantially equivalent to the Kodak Ektascan SP Cassette (K925997) (currently marketed as the Kodak DirectView CR Cassette).

The key arguments for this demonstration are:

• Identical Function and Performance: The new cassette size is stated to be "identical in function and performance" to the predicate.
• Consistent Panel Materials: The panel materials are consistent with the current design, using Corus Hylite and Toray Panel.
• AEC Accommodation: A specific design modification (removal of lead mylar) was made to accommodate Automatic Exposure Control (AEC) in dental X-ray units, which is a functional enhancement for specific applications.
• Unchanged Image Processing Software: The device uses the same, previously cleared, image processing software algorithm, ensuring consistent image quality and processing characteristics.
• Broad Application: It maintains suitability for general radiology and dental panoramic radiography and is compatible with ISO 4090 standard dental X-ray units.

The FDA reviewed these claims and determined that the device is substantially equivalent, allowing it to be marketed. This regulatory approval serves as the "proof" that the device meets its acceptance criteria for safety and effectiveness, based on its equivalence to a device already on the market.

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