Search Results

The InfiMed i*™ Digital X-ray Imaging System is a high resolution digital imaging system intended to replace conventional film techniques, or existing digital systems, in multipurpose or dedicated applications specified below. The iSm Digital X-78V Imaging System enables an operator to acquire, display, process, export images to portable media, send images over a network for long term storage and distribute hardcopy images with a laser printer. Image processing algorithms enable the operator to bring out diagnostic details difficult to see using conventional imaging techniques. Images can be stored locally for temporary storage. The ism Digital X-ray Imaging System has the ability to interface with a variety of image receptors from CCD cameras to commercially available flat panel detectors. The major system components include an image receptor, computer, monitor and imaging software.

For the DR application, the InfiMed i *** Digital X-ray Imaging System is intended for use in general radiographic examinations and applications (excluding fluorosopy, angiography, and mammography).

For the RF/DSA application, the InfiMed if TM Digital X-ray Imaging System is intended for use where general fluoroscopy, interventional fluoroscopy or anglography imaging procedures are performed.

The InfiMed i*™ Digital X-ray Imaging System is a high resolution digital imaging system designed for digital X-ray imaging through the use of an X-ray detector. The InfiMed i-TM Digital X-ray Imaging System is designed to support general radiography (excluding mammography), fluoroscopy, interventional fluoroscopy or angiography imaging procedures through a single common imaging platform.

The modified InfiMed i'm Digital X-ray Imaging System consists of an X-ray imaging receptor (any of the following: CCD Camera, Trixell Pixium 3543, Trixell Pixium 4600, Varian PaxScan 4336R, Varian PaxScan 4343R, Carestream Health Detector, Samsung LTX240AA01-A, Toshiba FDX 4343R, DRTECH FLAATZ 560, Samsung SDX-4336CP), computer, monitor, and the digital imaging system.

I am sorry, but the provided text does not contain the detailed information necessary to complete the acceptance criteria table or answer most of the questions about the study.

The document discusses validation tests and states that "all release criteria have been met," but it does not provide the specific acceptance criteria or the reported device performance metrics. It also mentions "Clinical Data submitted is consistent with FDA guidance document...," but it does not describe the actual clinical study design, sample sizes, ground truth establishment, or expert involvement.

Therefore, I cannot fulfill your request for this specific document.

Ask a specific question about this device

The InfiMed i5TM Digital X-ray Imaging System is a high resolution digital imaging system intended to replace conventional film techniques, or existing digital systems, in multipurpose or dedicated applications specified below. The i5TM Digital X-ray Imaging System enables an operator to acquire, display, process, export images to portable media, send images over a network for long term storage and distribute hardcopy images with a laser printer. Image processing algorithms enable the operator to bring out diagnostic details difficult to see using conventional imaging techniques. Images can be stored locally for temporary storage. The i5TM Digital X-ray Imaging System has the ability to interface with a variety of image receptors from CCD cameras to commercially available flat panel detectors. The major system components include an image receptor, computer, monitor and imaging software.

For the DR application, the InfiMed i5TM Digital X-ray Imaging System is intended for use in general radiographic examinations and applications (excluding fluoroscopy, angiography, and mammography).

For the RF/DSA application, the InfiMed i5TM Digital X-ray Imaging System is intended for use where general fluoroscopy, interventional fluoroscopy or angiography imaging procedures are performed.

The InfiMed i5TM Digital X-ray Imaging System is a high resolution digital imaging system designed for digital X-ray imaging through the use of an X-ray detector. The InfiMed i5TM Digital X-ray Imaging System is designed to support general radiography (excluding mammography), fluoroscopy, interventional fluoroscopy or angiography imaging procedures through a single common imaging platform.

The modified InfiMed i5TM Digital X-ray Imaging System consists of an X-ray imaging receptor (any of the following: CCD Camera, Trixell Pixium 3543, Trixell Pixium 4600, Varian PaxScan 4336R, Varian PaxScan 4343R, Carestream Health Detector, Samsung LTX240AA01-A, Toshiba FDX 4343R, DRTECH FLAATZ 560), computer, monitor, and the digital imaging system.

This document is a 510(k) premarket notification for the InfiMed i5TM Digital X-ray Imaging System (with FLAATZ 560). It asserts substantial equivalence to a predicate device (InfiStitch for i5TM, K101833) and does not contain detailed acceptance criteria and performance data for a standalone or comparative effectiveness study.

Here's what can be extracted and what is explicitly not available based on the provided text:

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

This information is not provided in the document. The text states: "Validation was completed in accordance with the Validation Protocols included with this submission. Protocols were designed, executed and documented according to the Design Validation process with predetermined test methods and corresponding acceptance criteria. In conclusion, all release criteria have been met and the modified i5TM Digital X-ray Imaging System is as safe and effective as the predicate device." However, the specific acceptance criteria and the quantitative or qualitative results of the device performance against those criteria are not detailed.

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

This information is not provided. The document makes a general statement about "Clinical Data submitted" being consistent with FDA guidance, but does not specify the sample size, provenance, or whether the data was retrospective or prospective.

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):

This information is not provided. The document does not describe the establishment of a ground truth with experts. Since this is a 510(k) submission primarily focused on substantial equivalence to a predicate device rather than a de novo clinical trial, such detailed expert review might not have been a primary component of the submission described here.

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

This information is not provided. As no details about expert review or ground truth establishment are given, adjudication methods are also absent.

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:

This information is not provided. The document describes the device as a "high resolution digital imaging system" and mentions "Image processing algorithms enable the operator to bring out diagnostic details difficult to see using conventional imaging techniques," but it does not present itself as an AI-assisted diagnostic tool for which an MRMC study demonstrating improvement with AI would be conducted. The focus is on replacing conventional film techniques or existing digital systems and achieving equivalent or better image quality than the predicate device.

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

This information is not explicitly stated or detailed. The document refers to "Validation Protocols" and "release criteria" being met, suggesting some form of internal testing. However, it does not delineate specific standalone performance metrics for an algorithm without human intervention, especially not in the context of diagnostic accuracy. The device is described as an "imaging system" where an "operator" acquires, displays, and processes images.

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

This information is not provided. The document refers to "Clinical Data" but does not specify how the ground truth for that data (if any was used for specific performance evaluation) was established.

8. The sample size for the training set:

This information is not provided. The document does not describe the use of a "training set" in the context of machine learning model development. The "Image processing algorithms" mentioned are likely traditional image processing techniques rather than contemporary machine learning algorithms that require large training sets.

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

This information is not provided, as there is no mention of a training set or its ground truth.

Ask a specific question about this device

The InfiMed i one Digital X-ray Imaging System is a high resolution digital imaging system intended to replace conventional film techniques, or existing digital systems, in multipurpose or dedicated applications specified below. The i2M Digital X-ray Imaging System enables an operator to acquire, display, process, export images to portable media, send images over a network for long term storage and distribute hardcopy images with a laser printer. Image processing algorithms enable the operator to bring out diagnostic details difficult to see using conventional imaging techniques. Images can be stored locally for temporary storage. The i2m Digital X-ray Imaging System has the ability to interface with a variety of image receptors from CCD cameras to commercially available flat panel detectors. The major system components include an image receptor, computer, monitor and imaging software.

For the DR application, the InfiMed i-714 Digital X-ray Imaging System is intended for use in general radiographic examinations and applications (excluding fluoroscopy, angiography, and mammography),

For the RF/DSA application, the InfiMed i TM Digital X-ray Imaging System is intended for use where general fluoroscopy, interventional fluoroscopy or angiography imaging procedures are performed.

The InfiMed i-TM Digital X-ray Imaging System is a high resolution digital imaging system designed for digital X-ray imaging through the use of an X-ray detector. The InfiMed i?™ Digital X-ray Imaging System is designed to support general radiography (excluding mammography), fluoroscopy, interventional fluoroscopy or angiography imaging procedures through a single common imaging platform.

The modified InfiMed ism Digital X-ray Imaging System consists of an X-ray imaging receptor (any of the following: CCD Camera, Trixell Pixium 3543, Trixell Pixium 4600, Varian PaxScan 4336R, Varian PaxScan 4343R, Carestream Health Detector, Samsung LTX240AA01-A, Toshiba FDX 4343R, Trixell Pixium RF4343), computer, monitor, and the digital imaging system.

The provided text describes the Infimed Nexus DRF Digital X-ray Imaging System and its substantial equivalence to a predicate device. However, it does not contain specific details about acceptance criteria, a dedicated study proving device performance against those criteria, or the methodology typically associated with such studies (sample sizes, expert qualifications, adjudication, MRMC studies, ground truth details, training set information).

The document mentions "Validation Protocols" and "predetermined test methods and corresponding acceptance criteria" in its Non-clinical Tests Discussion, and states that "all release criteria have been met." It also refers to a "Clinical Data submitted is consistent with FDA guidance document... for Solid State X-ray Imaging Devices." However, it does not provide the actual acceptance criteria, the specific results against them, or the details of the clinical study itself.

Therefore, I cannot fully answer your request for specific details regarding acceptance criteria and the study proving the device meets them, as that information is not present in the provided text.

Based on the available information, here's what can be extracted and what information is missing:

Information Not Found in the Provided Document:

• A table of acceptance criteria and reported device performance.
• Sample size used for the test set.
• Data provenance (country of origin, retrospective/prospective) for any test data.
• Number of experts used to establish ground truth for the test set.
• Qualifications of those experts.
• Adjudication method for the test set.
• Results of a Multi-Reader Multi-Case (MRMC) comparative effectiveness study, including effect size.
• Results of a standalone (algorithm-only) performance study.
• Type of ground truth used (expert consensus, pathology, outcomes data, etc.) for either training or testing.
• Sample size for the training set.
• How ground truth for the training set was established.

Information Extracted (Limited):

The document broadly states that:

• "Validation Protocols were designed, executed and documented according to the Design Validation process with predetermined test methods and corresponding acceptance criteria."
• "In conclusion, all release criteria have been met and the modified i-TM Digital Xray Imaging System is as safe and effective as the predicate device."
• "Clinical Data submitted is consistent with FDA guidance document 'Guidance for Industry and/or for FDA Reviewers/Staff and/or Compliance: Guidance for the Submission of 510(k)'s for Solid State X-ray Imaging Devices'."

Essentially, the document confirms that non-clinical and clinical tests were performed, and acceptance criteria were met, but it does not specify what those criteria were or the detailed methodology and results of the studies. These details would typically be found in the actual validation protocols and study reports referenced, but they are not included in this 510(k) summary.

Ask a specific question about this device

The InfiMed i5m Digital X-ray Imaging System is a high resolution digital imaging system intended to replace conventional film techniques, or existing digital systems, in multipurpose or dedicated applications specified below. The i5m Digital X-ray Imaging System enables an operator to acquire, display, process, export images to portable media, send images over a network for long term storage and distribute hardcopy images with a laser printer. Image processing algorithms enable the operator to bring out diagnostic details difficult to see using conventional imaging techniques. Images can be stored locally for temporary storage. The i2m Digital X-ray Imaging System has the ability to interface with a variety of image receptors from CCD cameras to commercially available flat panel detectors. The major system components include an image receptor, computer, monitor and imaging software.

For the DR application, the InfiMed i-714 Digital X-ray Imaging System is intended for use in general radiographic examinations and applications (excluding fluoroscopy, angiography, and mammography).

For the RF/DSA application, the InfiMed if TM Digital X-ray Imaging System is intended for use where general fluoroscopy, interventional fluoroscopy or angiography imaging procedures are performed.

The InfiMed i m Digital X-ray Imaging System is a high resolution digital imaging system designed for digital X-ray imaging through the use of an X-ray detector. The InfiMed i-1 Digital X-ray Imaging System is designed to support general radiography (excluding mammography), fluoroscopy, interventional fluoroscopy or angiography imaging procedures through a single common imaging platforms.

The modified InfiMed if me Digital X-ray Imaging System consists of an X-ray imaging receptor (any of the following: CCD Camera, Trixell Pixium 3543, Trixell Pixium 4600, Varian PaxScan 4336R, Varian PaxScan 4343R, Carestream Health Detector, Samsung LTX240AA01-A, Toshiba FDX 4343R), computer, monitor, and the digital i maging system. The InfiStitch for i-m Digital X-ray Imaging System is an option which allows the operator to generate sequential radiographic images and electronically jointhum to create a single electronic image. This feature will be available for any InfiMed customer utilizing the i-The Digital X-ray Imaging System DR application on any flat parel detector.

The provided document is a 510(k) summary for the InfiMed InfiStitch for i5 Digital X-ray Imaging System. It describes the device, its intended use, and states that validation was completed with predetermined test methods and acceptance criteria. However, it does not provide a detailed breakdown of specific acceptance criteria or the study results that demonstrate the device meets those criteria.

Therefore, I cannot provide a table of acceptance criteria and reported device performance from this document. Many of the requested details about the study are also not explicitly stated.

Based on the provided text, here's what can be extracted and what remains unknown regarding the acceptance criteria and the study:

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

• Acceptance Criteria: Not explicitly stated in the document. The document mentions "predetermined test methods and corresponding acceptance criteria" were used for validation, and "all release criteria have been met." However, it does not specify what those criteria are (e.g., specific quantitative metrics for image quality, resolution, stitching accuracy).
• Reported Device Performance: The document generally states that the modified device "delivers equivalent or better image quality as the predicate device" and is "as safe and effective as the predicate device." It does not provide specific performance metrics or data.

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

• Sample Size (Test Set): Not specified.
• Data Provenance (e.g., country of origin of the data, retrospective or prospective): Not specified. The document only mentions "Non-clinical Tests Discussion" and "Clinical Tests Discussion."

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

• Not specified.

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

• Not specified.

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 mention of a multi-reader multi-case (MRMC) comparative effectiveness study. This device is a digital X-ray imaging system with a stitching function, not an AI-assisted diagnostic tool in the sense of providing automated readings or decision support that would typically involve a detailed MRMC study to show reader improvement.

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

• The document implies that the device (including the InfiStitch algorithm) was tested, but it does not specify whether a standalone algorithm-only performance assessment was conducted separately from the overall system performance. The "InfiStitch" feature is an "option which allows the operator to generate sequential radiographic images and electronically join them to create a single electronic image," suggesting it's part of the operator's workflow rather than a fully autonomous diagnostic algorithm.

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

• Not specified. Given it's an imaging system, ground truth would likely relate to image quality assessment criteria (e.g., spatial resolution, contrast-to-noise ratio, geometric accuracy for stitching), but the specific methods are not detailed.

8. The sample size for the training set:

• The document does not mention a "training set." This type of device (digital X-ray imaging system with stitching function) typically undergoes verification and validation through engineering tests, phantom studies, and possibly human factors evaluations rather than machine learning training/testing paradigms with distinct training and test sets.

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

• Not applicable, as no training set is mentioned in the context of this device's validation.

In summary, the document states that validation was performed and that the device meets its release criteria, implying acceptance criteria were met. However, it does not provide the specific details of these criteria or the results of the studies in a manner that allows for the completion of the requested table and answers to most of the specific questions. The document focuses on demonstrating substantial equivalence to a predicate device rather than detailing specific performance metrics against pre-defined acceptance criteria for a novel algorithm.

Ask a specific question about this device

The InfiMed i5 TM Digital X-ray Imaging System is a high resolution digital imaging system intended to replace conventional film techniques, or existing digital systems, in multipurpose or dedicated applications specified below. The i TM Digital X-ray Imaging System enables an operator to acquire, display, process, export images to portable media, send images over a network for long term storage and distribute hardcopy images with a laser printer. Image processing algorithms enable the operator to bring out diagnostic details difficult to see using conventional imaging techniques. Images can be stored locally for temporary storage. The i5 TM Digital X-ray Imaging System has the ability to interface with a variety of image receptors from CCD cameras to commercially available flat panel detectors. The major system components include an image receptor, computer, monitor and imaging software.

For the DR application, the InfiMed i5 TM Digital X-ray Imaging System is intended for use in general radiographic examinations and applications (excluding fluoroscopy, angiography, and mammography).

For the RF/DSA application, the InfiMed i5 TM Digital X-ray Imaging System is intended for use where general fluoroscopy, interventional fluoroscopy or angiography imaging procedures are performed.

The InfiMed i5 TM Digital X-ray Imaging System is a high resolution digital imaging system designed for digital X-ray imaging through the use of an X-ray detector. The InfiMed i5 TM Digital X-ray Imaging System is designed to support general radiography (excluding mammography), fluoroscopy, interventional fluoroscopy or angiography imaging procedures through a single common imaging platform.

The InfiMed i5 TM Digital X-ray Imaging System consists of an X-ray imaging receptor (any of the following: CCD Camera, Trixell Pixium 3543, Trixell Pixium 4600, Varian PaxScan 4336R, Varian PaxScan 4343R, Carestream Health Detector, Samsung LTX240AA01-A), computer, monitor, and the digital imaging system.

The provided text does not contain specific acceptance criteria or a detailed study description with performance metrics. Instead, it offers a 510(k) summary for the InfiMed i5™ Digital X-ray Imaging System, focusing on its substantial equivalence to predicate devices.

However, based on the non-clinical tests discussion, we can infer the general approach to validation.

Here's an analysis of the provided information relative to your request:

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

The document mentions: "Validation was completed in accordance with the Validation Protocol included with this submission. This protocol was designed, executed and documented according to the Design Validation process with predetermined test methods and corresponding acceptance criteria. In conclusion, all release criteria have been met and the i5™ Digital X-ray Imaging System is as safe and effective as the predicate devices."

However, no specific acceptance criteria or reported device performance metrics are provided in the text for inclusion in a table. The conclusion only states that all release criteria were met.

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

The document states "Non-clinical Tests Discussion: Validation was completed..." and "Clinical Data submitted is consistent with FDA guidance document...". However, it does not specify the sample size for any test set or provide details about data provenance (country of origin, retrospective/prospective).

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)

This information is not provided in the document.

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

This information is not provided in the document.

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

The document does not mention an MRMC comparative effectiveness study or any details about AI assistance. The system is described as a "digital imaging system intended to replace conventional film techniques, or existing digital systems." It focuses on image acquisition, display, processing, and distribution.

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

The document does not explicitly state that a standalone algorithm-only performance study was conducted. The system is presented as an integrated digital X-ray imaging system.

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

This information is not provided in the document. The general statement is that "Clinical Data submitted is consistent with FDA guidance document..." but it doesn't detail how ground truth was established for that data.

8. The sample size for the training set

The document does not mention a training set or its sample size, as it describes a digital imaging system rather than a machine learning model that would typically require a training set.

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

As no training set is mentioned, this information is not applicable/provided.

Ask a specific question about this device

The InfiMed Orion Fluoroscopic imaging system is a high resolution, digital imaging system designed for digital videography. It is intended to replace conventional film techniques in multipurpose or dedicated applications where general fluoroscopy, interventional fluoroscopy or angiography or cardiac imaging procedures are performed.

The Orion fluoroscopic imaging system allows the use of digital imaging to conventional X-ray system used in the general fluoroscopy, interventional fluoroscopy, angiography and cardiac imaging arcas. The system works by installing a CCD camera on the output of the image intensifier and digitizing the video output of the image intensifier. The digital image can then be displayed on the monitor, it can be stored to disk, or sent to an external device such as a laser imager or a DICOM network. The image can also be processed, including brightness and contrast, edge enhancement, zoom, and subtraction.

The provided document is a 510(k) summary for the InfiMed Orion Fluoroscopic Imaging System. It describes the device, its intended use, and claims substantial equivalence to predicate devices. However, this document does not contain information about acceptance criteria, device performance metrics, or a study detailing how the device meets such criteria.

Therefore, I cannot provide the requested table, sample sizes, expert details, adjudication methods, MRMC study information, standalone performance, or training set details as this information is not present in the provided text.

The document primarily focuses on:

• Device Description: A digital radiography system that replaces conventional film techniques in various fluoroscopic applications.
• Intended Use: High-resolution digital imaging for general fluoroscopy, interventional fluoroscopy, angiography, and cardiac imaging, allowing image viewing, enhancement, storage, and networking.
• Substantial Equivalence: Claims substantial equivalence to the InfiMed GoldOne and FC2000 Fluoroscopic Systems based on features and increased power.

To fulfill your request, a different type of document, such as a validation study report or a more detailed section of the 510(k) submission, would be required.

Ask a specific question about this device

The RTLX is a digital dental X-ray system with an intra-oral electronic sensor. Its intended use is to provide real-time x-ray images for dentists with a low X-ray dose By producing real-time imaging, the RTLX provides immediate information in the course of operative treatment, such as information on the position of instruments in internal structures.

RTLX, for "Real-Time, Low-Intensity X-ray" is the first X-ray imaging system that provides capabilities for instant, full motion, digital radiographs designed specifically for the dental imaging marketplace. RTLX provides capabilities for X-ray generation, radiograph capture, image storage, and image display at up to 24 fps. The full motion, digital radiographs enhance a clinicians ability for "point-and-view" radiographs reducing patient X-ray exposure and time in the chair and improving speed and accuracy for procedure performance. Product appearance and mechanical structure is designed to provide a user friendly system for sensor placement and video control. In addition, printouts can be made of individual video frames.

The RTLX includes an X-ray source and X-ray sensor assembly for generation and acquisition of X-ray signals. Additionally, power and X-ray control electronics are provided, and an image processor is utilized for radiograph acquisition, processing, and display. Mechanical design emphasizes appearance and functionality. Switches, LEDs, and a printer are provided for user input and feedback.

The provided 510(k) summary for the InfiMed RTLX Digital Imaging System does not contain information about specific acceptance criteria or a dedicated study proving the device meets them.

Instead, the submission focuses on demonstrating substantial equivalence to predicate devices. This is a common approach for 510(k) clearances, where a new device is shown to be as safe and effective as a legally marketed device. The information presented is primarily a comparison of features and technical specifications rather than performance metrics against predefined acceptance criteria.

Therefore, many of the requested details about acceptance criteria, study design, sample sizes, ground truth establishment, and expert involvement are not available in the provided text.

Here's an attempt to answer the questions based only on the provided text, highlighting where information is absent:

1. Table of Acceptance Criteria and Reported Device Performance

As noted, the submission does not define explicit acceptance criteria or report performance against them in the way one might expect for a study. Instead, it provides a comparative table of features and specifications against predicate devices to demonstrate substantial equivalence.

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

• Sample size for test set: Not provided. The submission does not describe a performance study with a test set of images or patients.
• Data provenance: Not applicable, as no specific test data is presented.

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

• Number of experts: Not applicable, as no ground truth establishment for a test set is described.
• Qualifications of experts: Not applicable.

4. Adjudication method for the test set

• Adjudication method: Not applicable, as no test set requiring adjudication is 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

• MRMC study: No. This submission pre-dates widespread AI integration and focuses on substantial equivalence of a new imaging modality itself, not an AI enhancement for readers.
• Effect size: Not applicable.

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

• Standalone study: Not applicable. The device is an integral system for image acquisition and display, designed for human-in-the-loop use by dentists. There is no "algorithm only" performance reported.

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

• Type of ground truth: Not applicable, as no formal ground truth was established for a performance study. The comparison is feature-based against existing predicate devices.

8. The sample size for the training set

• Sample size for training set: Not applicable. This device is not an AI/ML algorithm that requires a training set. It's a hardware and software system for image capture and display.

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

• Ground truth for training set: Not applicable, as there is no training set for an AI/ML model for this device.

In summary: The K992392 submission for the InfiMed RTLX is a 510(k) premarket notification that relies on demonstrating substantial equivalence to predicate devices. It does not include a performance study with explicit acceptance criteria, test sets, or ground truth establishment in the manner of an AI or diagnostic algorithm submission. The justification for clearance is based on the device having similar technological characteristics and intended use as existing legally marketed devices, implying that if the predicates are safe and effective, then the RTLX, being substantially equivalent, also is.

Ask a specific question about this device

The Stingray DR Solid State X-ray Imaging Device is intended for use in general radiographic examinations and applications wherever conventional screen-film systems may be used (excluding fluoroscopy, angiography, and mammography).

The Stingray DR system uses a flat panel x-ray detector that contains a CsI Scintillator and a Amorphous Si TFT array for conversion of X-rays into an electronic digital image. This system is to be used as a replacement for Screen film x-ray devices for X-ray images. The Stingray DR system has a Personal computer that is used for image storage and retrieval and image processing. The system allows for post processing of images. This allows for the potential to use images that might have been useless if taken on film due to, for example, incorrect technique since the Stingray DR system can post process the images, modify the output look up table and possibly bring out data that could not be seen under normal circumstances.

The provided document is a 510(k) premarket notification for a medical device (Stingray DR), which aims to demonstrate "substantial equivalence" to existing legally marketed predicate devices, rather than establishing de novo acceptance criteria and conducting a study to meet them in the same way a novel device might. The core of a 510(k) submission is to show that the new device performs "the same functions in the same environment" as its predicates and has "the same resolution".

Therefore, the analysis below is based on the information provided in the 510(k) summary, interpreting "acceptance criteria" as the performance metrics used for comparison to predicate devices, and "study" as the comparative analysis presented to justify substantial equivalence.

1. Table of "Acceptance Criteria" (Predicate Device Performance) and Reported Device Performance

For a 510(k) submission, the "acceptance criteria" are implicitly defined by the performance characteristics of the predicate devices. The InfiMed Stingray DR system aims to meet or exceed these characteristics to demonstrate substantial equivalence.

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

The document does not report specific sample sizes for a dedicated test set in the traditional sense of a clinical trial. The "study" here is a technical comparison against predicate devices. The performance data, specifically the spatial resolution, is demonstrated against the claimed specifications of existing, approved devices (Philips Digital Diagnost, Siemens THORAX FD and MULTIX FD, Canon Digital Radiography System).

• Test Set Description: Not applicable in the context of human-read or image-based test sets with patient data. The "test set" effectively consists of the published specifications and performance claims of the predicate devices.
• Data Provenance: The data provenance for the performance characteristics (e.g., spatial resolution) of the InfiMed Stingray DR would typically come from internal engineering and lab testing conducted by Trixell (the flat panel producer) and InfiMed. The document doesn't specify the country of origin of this test data, but given that InfiMed is located in Liverpool, NY, USA, it's likely testing was conducted there or by Trixell (a European company at the time) and validated by InfiMed. The data for predicate devices is based on their respective 510(k) submissions or publicly available specifications. Whether InfiMed performed prospective or retrospective comparisons against these specifications is not explicitly stated, but it would have involved prospective measurements on the Stingray DR system and retrospective comparison to predicate device specifications.

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

Not Applicable.
Since this is a technical comparison for substantial equivalence rather than a clinical performance study involving diagnostic accuracy, there were no human experts used to establish a "ground truth" for a patient-image test set. The ground truth for the device's technical specifications (like spatial resolution) is established through standardized physical measurements and engineering tests.

4. Adjudication Method for the Test Set

Not Applicable.
There was no adjudication method (e.g., 2+1, 3+1) because there was no human interpretation of images or establishment of ground truth by multiple experts in the reported comparison.

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

No.
A Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not conducted and is not mentioned in the provided text. This type of study would typically assess the impact of the device on human reader performance, which is not the focus of this 510(k) submission.

6. Standalone (Algorithm Only) Performance Study

The provided information focuses on the entire "Stingray DR system" which includes the detector, image processing, and a controlling PC. While the document mentions "defect compensation and image correction algorithms" as part of the system, it does not report a standalone performance study specifically for the algorithm without human-in-the-loop performance. The performance metric reported (spatial resolution) is a characteristic of the overall imaging chain.

7. Type of Ground Truth Used

The "ground truth" for the comparison is primarily based on technical specifications and physical performance measurements (e.g., spatial resolution measured in lp/mm). These are objective, quantifiable metrics derived from standard test patterns and methods, rather than clinical outcomes, pathology, or expert consensus on patient images.

8. Sample Size for the Training Set

Not Applicable.
The document does not refer to a "training set." As a 510(k) for a digital radiography system, it's not an AI/ML device in the modern sense that would require a distinct training set for algorithm development in this context. The "defect compensation and image correction algorithms" would have been developed and tuned using internal engineering data, but this is not disclosed as a "training set" with a specified sample size.

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

Not Applicable.
Since there is no mention of a "training set" in the context of an AI/ML algorithm requiring ground truth, this information is not provided. The performance (e.g., spatial resolution) of the system itself is validated through physical measurements and comparisons to predicate device specifications.

Ask a specific question about this device

The InfiMed Cardiovascular Workstation provides digital acquisition and review of cardiac images. The system can acquire images from a variety of sources ( including through DICOM transfer, real-time high resolution 1024 line analog secondary image capture and high speed direct digital connection). Patient images may be stored locally ( on hard drive, written to CD-R media and / or networks) or stored to permanent archive, using the DICOM standards. In addition, the Cardiovascular Workstation provides image review of patient studies in real-time or slow motion, as well as processing and analysis capability. Review functionality also includes multi-modality imaging to support diagnosis and therapy of cardiovascular patients. MR, CT, Nuclear, Ultrasound and CR imaging may be compared to cath lab cardiac and peripheral vascular angiography to enhance clinical analysis and save physician time. Images may be formatted for multi-modality display and printing on laser cameras.

The InfiMed Cardiovascular Workstation CWS 5000 provides digital acquisition and review of DICOM images. The CWS 5000 will acquire ACC/NEMA DICOM images or real-time, high resolution 1024 line analog secondary image capture. The CWS 5000 output is ACC/NEMA DICOM. Patient images may be written to CD-R media according to the ACC/NEMA DICOM standards for permanent archive and/or patient interchange. In addition, the CWS 5000 provides DICOM image review including multi-modality imaging to support diagnosis and therapy of cardiovascular patients. MR, CT, Nuclear, Ultrasound and CR imaging may be compared to cath lab cardiac and peripheral vascular angiography to enhance clinical analysis and save physician time. Images may be formatted for multi-modality display and printing on laser cameras. The CWS 5000 is compatible with standard network technology and is conformant to DICOM standards.

The InfiMed Cardiovascular Workstation CWS 3000 provides DICOM image review including multi-modality imaging to support diagnosis and therapy of cardiovascular patients. Patient studies may be reviewed in real-time or slow motion using a knob on a dedicated cardiology remote control (optional). MR, CT, Nuclear, Ultrasound and CR imaging may be compared to cath lab cardiac and peripheral vascular angiography to enhance clinical analysis and save physician time. Images may be formatted for multi-modality display and printing on laser cameras. The CWS 3000 is compatible with standard network technology and is conformant to DICOM standards. In addition, the CWS 3000 is available with a high speed direct digital connection to the InfiMed Gold One for filmless operation including DICOM review, CD-R generation and networking.

The provided text does not contain any information about acceptance criteria or a study proving the device meets them. The document is a 510(k) summary for the InfiMed Cardiovascular Workstation CWS 3000/5000, focusing on demonstrating substantial equivalence to predicate devices.

Instead, the document provides:

• Device Description: Details the functionalities of the CWS 5000 and CWS 3000, including digital acquisition, review of DICOM images, multi-modality imaging support, storage options, and network compatibility.
• Intended Use: Describes the clinical purpose of the device, primarily for digital acquisition and review of cardiac images from various sources, facilitating multi-modality comparison and analysis.
• Predicate Device Comparison: A table comparing the CWS with two Kodak Digital Science Cardiac Viewers (K974086 and K960043) across various technical specifications like archiving format, viewing speed, display resolution, compression, review features, and input/output capabilities.
• Conclusion drawn from comparison: States that the CWS performs similar functions to predicate devices with some new features that do not raise new questions of efficacy or substantial risk.
• FDA Communication: A letter from the FDA indicating review of the 510(k) and a determination of substantial equivalence.
• Indications for Use: A formal statement of the device's intended use submitted to the FDA.

The document explicitly states: "Performance Data: Not required for the determination of substantial equivalence of this device." This indicates that a formal performance study with acceptance criteria was not part of this 510(k) submission process.

Therefore, I cannot provide the requested information regarding acceptance criteria and the study that proves the device meets them, as it is not present in the given text.

Ask a specific question about this device

The InfiMed Dental System is an image acquisition and management system that allows acquisition, processing, display, and print of filmless radiographs and/or color dental images. It consists of various components that acquire, store, display, and print radiographs and/or color dental images with patient information.

The InfiMed Dental System is an image acquisition and management system. Its capabilities include: Color image acquisition takes place from a standard S-video color camera. Radiograph acquisition takes place from a Charge Injection Device (CID) sensor custom designed for the application. Images can be directly printed and displayed on standard S-video equipment or transferred to a personal computer for acquisition and storage. If images are stored on the personal computer, dental image management software is utilized for patient data input, image processing, and image display on the computer monitor. In addition, printed reports are available from the personal computer.

The provided text from the FDA 510(k) premarket notification does not contain information regarding acceptance criteria, device performance studies, sample sizes, data provenance, ground truth establishment, or expert qualifications for the InfiMed Dental System.

The document is a letter from the FDA to InfiMed, Inc. confirming that their device, the "InfiMed Dental System" (K962422), has been found substantially equivalent to legally marketed predicate devices. It outlines the regulatory class, procode, and general controls applicable to the device.

The "Indications for Use" section describes the device's functionality: an image acquisition and management system for filmless radiographs and/or color dental images, consisting of components to acquire, store, display, and print these images with patient information. It details how color images are acquired (from a standard S-video color camera) and radiographs are acquired (from a Charge Injection Device (CID) sensor). It also mentions the capability for direct printing/display or transfer to a personal computer for acquisition, storage, patient data input, image processing, display, and printed reports.

Therefore, I cannot provide the requested information based on the given document.

Ask a specific question about this device