Search Results

The ILUMIEN with C7 Dragonfly, Dragonfly DUO, or Dragonfly OPTIS Imaging Catheter is intended for the imaging of coronary arteries and is indicated in patients who are candidates for transluminal interventional procedures. The C7 Dragonfly, Dragonfly DUO, or Dragonfly OPTIS Imaging Catheter is intended for use in vessels 2.0 to 3.5 mm in diameter. The C7 Dragonfly, Dragonfly DUO, or Dragonfly OPTIS Imaging Catheter is not intended for use in the left main coronary artery or in a target vessel which has undergone a previous bypass procedure.

The ILUMIEN will further acquire radio frequency signal outputs from both a distal intracoronary pressure transducer and a proximal aortic pressure transducer to determine the physiological parameter, Fractional Flow Reserve (FFR). The physician may use the FFR parameter, along with knowledge of patient history, medical expertise and clinical judgment to determine if therapeutic intervention is indicated.

The Dragonfly OPTIS Imaging Catheter with the OCT Imaging System is intended for the imaging of coronary arteries and is indicated in patients who are candidates for transluminal interventional procedures. The Dragonfly OPTIS Imaging Catheter is intended for use in vessels 2.0 to 3.5 mm in diameter. The Dragonfly OPTIS Imaging Catheter is not intended for use in the left main coronary.

The ILUMIEN is a cart-mounted computer and Imaging Engine (or optical engine) placed inside an ergonomically designed mobile cart with a mains power cable. It also includes the Drive-motor and Optical Controller (DOC), which provides the interconnection between the ILUMIEN System and the Dragonfly Catheter. The cart is equipped with two display monitors (one for the console operator, and the other for the physician), as well as a keyboard and mouse.

The cart also contains an isolation transformer for electrical safety and includes two AO and PW USB Receivers which accept the distal intracoronary and proximal aortic pressure signals and status information from the AO Interface Unit and PressureWire® Aeris (K080813) respectively, and communicate the FFR data for display on the ILUMIEN system.

The Dragonfly OPTIS Imaging Catheter is a sterile, single-use intravascular catheter consisting of a catheter body external sheath and an internal rotating fiber optic imaging core. The external sheath serves two primary functions: 1) to facilitate placement of the device into the coronary artery and 2) to cover and protect the inner rotating fiber optic imaging core.

The inner rotating fiber optic imaging core emits near infrared light to the tissue and receives reflected light. It is driven by a stainless steel torque wire visible under fluoroscopy and pulled back through the window tube of the external sheath by the DOC. The emitted and returned reflected light are combined and processed by the ILUMIEN Optis System software to construct an OCT image. The patient is never exposed to moving parts as the external sheath completely covers the rotating imaging core.

The provided text is a 510(k) summary for the Lightlab Imaging, Inc. ILUMIEN with Dragonfly OPTIS Imaging Catheter. It indicates that the device has been found substantially equivalent to a predicate device (Lightlab Imaging, Inc. ILUMIEN, K111200). However, the document does not contain specific acceptance criteria, reported performance metrics as a table, or details about patient studies for the new device's performance.

The document discusses performance testing in a general sense, noting that hardware/firmware are unchanged and that software verification/validation, as well as design verification/validation (bench testing), were conducted in compliance with FDA regulations. Crucially, it states: "The results of this testing conclude the software has met these requirements. Design verification and validation was also performed on the ILUMIEN and Dragonfly OPTIS Imaging Catheter in compliance with internal design control procedures which included bench testing. The results of this testing concludes the ILUMIEN and Dragonfly OPTIS Imaging Catheter is determined to be safe and effective and is substantially equivalent to the predicate ILUMIEN device."

This implies that the device meets safety and effectiveness requirements, demonstrating substantial equivalence to its predicate, but it does not provide a specific study with acceptance criteria and results. The 510(k) process is about demonstrating substantial equivalence to an already marketed device, not necessarily proving efficacy through new clinical trials with defined acceptance criteria for a novel device.

Therefore, many of the requested details are not available in the provided text.

Here is a summary of what can be extracted or inferred, and what is not available:

1. Table of acceptance criteria and the reported device performance

• Not available in the provided text. The document states that testing was conducted and concluded the device is safe, effective, and substantially equivalent, but it does not specify quantitative acceptance criteria or detailed performance metrics. It refers to compliance with various electrical safety, EMI, laser safety, and DICOM standards, but these are compliance standards, not performance thresholds for clinical accuracy or diagnostic capabilities.

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

• Not available in the provided text. The document mentions "bench testing" for design verification and validation but does not specify sample sizes or data provenance (e.g., country of origin, retrospective/prospective) for any test set that would evaluate clinical performance.

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

• Not available in the provided text. There is no mention of experts establishing ground truth for evaluating clinical performance. The testing described focuses on engineering compliance and bench tests.

4. Adjudication method for the test set

• Not available in the provided text. As clinical performance testing with a ground truth established by experts is not described, an adjudication method is also not mentioned.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and the effect size

• No, this was not done or at least not described in the document. The document does not mention any MRMC studies or human reader performance with or without AI assistance. The device is an imaging system and catheter, not an AI-based diagnostic tool that assists human readers in the way typically evaluated by MRMC studies.

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

• Not explicitly described as such. The device is an imaging system that produces OCT images and FFR parameters for a physician's use. It's not an algorithm producing a diagnostic output without human interpretation. Its performance is evaluated mechanically and through software validation, as outlined in the general "performance testing" section, but not in terms of standalone diagnostic accuracy in a clinical sense.

7. The type of ground truth used

• Not explicitly stated in a clinical context. For the engineering and software validation, the "ground truth" would be established by the specifications and expected behavior based on internal design control procedures and established standards (e.g., UL, IEC, DICOM, FDA regulations). For the "imaging" aspect, the ground truth would be the physical properties of the tested objects in bench experiments. No pathology or outcomes data is mentioned as ground truth.

8. The sample size for the training set

• Not applicable/Not available. The document describes modifications and upgrades to an existing imaging system and catheter. It does not refer to a machine learning or AI model that would require a "training set" in the conventional sense. The "software has been upgraded to revision D.2," indicating software development and testing, but not machine learning training.

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

• Not applicable/Not available. As there's no mention of a machine learning training set, there's no information on how its ground truth would be established.

In summary: The provided 510(k) summary focuses on demonstrating substantial equivalence through compliance with standards, verification, and validation of hardware and software modifications. It does not include specific clinical studies with defined acceptance criteria or expert-adjudicated performance data for the new device. The conclusion of substantial equivalence is based on the updated device having the same fundamental technological characteristics and indications for use as the predicate, with performance verified through bench testing and software validation against engineering standards and internal design controls.

Ask a specific question about this device

The Quix Digital Radiography Upgrade is based on a solid state imaging device and is intended for use in general radiographic examinations and applications wherever conventional film-screen systems may be used, excluding mammography, fluoroscopy, and angiography.

The Quix Digital Radiography Upgrade enables a conventional film-screen X-ray system to perform digital radiography exams by replacing the film-screen and the film-screen bucky with a digital bucky and operator console. The digital bucky incorporates a selenium-based flat panel detector with 16" x 17" imaging area. Images are displayed in approximately 10 seconds after exposure over a wide range of dose settings. The operator console provides local image storage and communicates with other network devices using DICOM 3.0 protocols.

The provided text is a 510(k) summary for the "Quix Digital Radiography Upgrade" device. This document is a premarket notification to the FDA to demonstrate that the device is substantially equivalent to legally marketed predicate devices. It focuses on comparing the new device's technical specifications and intended use against existing products.

Crucially, this document does not contain a study that proves the device meets acceptance criteria in the format typically used for performance claims of AI/ML-based devices (e.g., sensitivity, specificity, AUC, human reader studies).

Instead, the acceptance criteria for this type of device (a digital X-ray system) and the "study" demonstrating its equivalence are based on a comparison of its physical and performance specifications to those of existing, legally marketed predicate devices. The "acceptance criteria" are implied by the performance metrics of the predicate devices.

Here's an attempt to extract and interpret the information based on the provided text, acknowledging the limitations inherent in a 510(k) for a non-AI/ML device:

1. Table of acceptance criteria and the reported device performance

For a device like the Quix Digital Radiography Upgrade, the "acceptance criteria" are implicitly defined by the performance characteristics of its predicate devices. The "reported device performance" is the specifications of the Quix DR Upgrade.

Ask a specific question about this device

CANON X-RAY DIGITAL CAMERA CXDI-11 is indicated for use in generating radiographic Images of human anatomy. It is intended to replace radiographic film/screen systems in all general purpose diagnostic procedures.

CANON X-RAY DIGITAL CAMERA CXDI-11 provides digital image capture for conventional film/screen radiographic examinations. The device is intended to replace radiographic film/screen systems in all general purpose diagnostic procedures.

CANON X-RAY DIGITAL CAMERA CXDI-11 is used to directly capture and convert conventional projection X-ray images to digital images. A sub-sampled image can be displayed on a preview monitor for viewing. The diagnostic image can be transmitted through a digital network for printing. The device provides digital image capture for conventional film/screen radiographic examinations. CANON X-RAY DIGITAL CAMERA CXDI-11 differs from traditional X-ray systems in that instead of exposing a film for subsequent wet chemical processing to create a hardcopy image, a device is used to capture the image in electronic form. The digital data are then used to produce diagnostic hardcopy and reference-softcopy images.

Here's a breakdown of the acceptance criteria and the study details for the Canon X-Ray Digital Camera CXDI-11, based on the provided text:

Acceptance Criteria and Device Performance

The provided document doesn't explicitly state "acceptance criteria" in a numerical or percentage format typically seen. Instead, the study's goal was to demonstrate that the image quality of the Canon Digital Radiography System (CXDI-11) was substantially equivalent to conventional x-ray film. This qualitative assessment of "substantial equivalence" is the de-facto acceptance criteria.

Additional Performance Metrics (not explicitly linked to "acceptance criteria" but included in comparison):

Study Details

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

   • Sample Size: Not explicitly stated as a number of cases or images. The document mentions "various inpatient cases."
   • Data Provenance: Not specified, but given the context of a 510(k) summary for a US market application, it's reasonable to infer that the data was likely from a US (or generally Western) clinical setting. It is a retrospective study as it involved evaluating "analog films... read twice."

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

   • Number of Experts: Not specified. The document states "Qualified readers evaluated both digital and analog films."
   • Qualifications of Experts: Not explicitly stated, beyond being "Qualified readers." Typically, for imaging studies, these would be radiologists, but their specific experience level is not provided.

3. Adjudication Method for the Test Set:

   • Not explicitly stated. The study involved "Qualified readers evaluated both digital and analog films." There's no mention of multiple readers reaching a consensus or any formal adjudication process beyond individual readers' assessments. The mention of readers reading analog films twice to assess consistency suggests individual reader scoring rather than a consensus approach for the primary equivalency comparison.

4. 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, an MRMC comparative effectiveness study was not done in the context of human readers improving with AI assistance.
   • This study was a comparison between a new digital radiography system (CXDI-11) and a conventional film/screen system, not an AI-assisted interpretation study. The CXDI-11 device is a capture device, not an AI interpretation tool.

5. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done:

   • Yes, in essence, a comparison of the "standalone" performance of the imaging systems was done. The study's primary objective was to evaluate the image quality of films generated by the CXDI-11 compared to conventional film, as assessed by human readers. While human readers were involved in the assessment, the focus was on the inherent quality of the image produced by the device, not the reader's diagnostic performance with or without the device (beyond assessing image quality).

6. The Type of Ground Truth Used (Expert Consensus, Pathology, Outcomes Data, etc.):

   • The "ground truth" for the comparison of image quality was based on expert subjective assessment by "qualified readers." They evaluated the images for "overall image quality, as well as for image quality with respect to specific anatomical areas." There's no mention of objective pathology or outcomes data being used to establish a 'true' diagnosis or lesion presence for the purpose of image quality assessment. The "ground truth" here is the perceived quality by experts.

7. The Sample Size for the Training Set:

   • Not applicable / Not mentioned. The CXDI-11 is an X-ray digital camera, a hardware device for capturing images. It's not an AI algorithm that learns from a training set of data. The document describes a clinical evaluation study for image quality, not the development or training of an AI model.

8. How the Ground Truth for the Training Set was Established:

   • Not applicable / Not mentioned. As explained above, there is no AI algorithm training set for this device.

Ask a specific question about this device

These radiographic intensifying screens have application whenever a high image quality radiographic examination such as mammography is required.

Ultra-Vision® Mammography Detail and Ultra-Vision® Mammography Fast Detail are ultraviolet activated rare earth intensifying screens. The phosphor is niobium activated lutetium tantalate.

The provided 510(k) summary for K974423 (Ultra-Vision® Mammography Detail and Ultra-Vision® Mammography Fast Detail) describes a comparison to a predicate device but does not contain a study or detailed acceptance criteria as one would expect for a modern AI/CAD device.

This submission is for radiographic intensifying screens, which are hardware components, not a software algorithm or AI device. Therefore, the questions related to AI/CAD performance (like MRMC studies, standalone performance, training sets, expert ground truth adjudication) are not applicable to this type of device.

Here's the information that can be extracted based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance:

The document doesn't explicitly state "acceptance criteria" but provides a comparison table against a predicate device, implying that performance similar to or better than the predicate is the basis for substantial equivalence. The "reported device performance" are the values for the new devices from this comparison.

Explanation: The "Acceptance Criteria (Implied by Predicate)" column represents the performance characteristics of the predicate device (Microvision™ Detail). The new devices are considered substantially equivalent because their performance in these metrics is comparable or improved. For example, the new devices show higher speed and potentially higher MTF and X-ray absorption, which are considered improvements for a mammography intensifying screen. The change in phosphor material is noted but acceptable if the performance metrics are met.

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

• Not applicable / Not provided. This submission is for hardware components (intensifying screens). Performance metrics like Speed, MTF, and X-ray Absorption are typically measured in a laboratory setting using standardized testing methods, not a "test set" of patient data in the context of AI. Data provenance (country of origin, retrospective/prospective) is not relevant for this type of device.

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

• Not applicable. Ground truth in the context of expert review is for diagnostic accuracy of an AI or human reader on patient images. This device is an intensifying screen, whose performance is measured through physical properties, not diagnostic interpretation.

4. Adjudication method for the test set:

• Not applicable. See point 3.

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 is not an AI device.

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

• Not applicable. This is not an AI device. The measurements of Speed, MTF, and X-ray Absorption are inherent standalone performance characteristics of the screen itself.

7. The type of ground truth used:

• Laboratory measurements/Physical properties. The "ground truth" for this device's performance relies on rigorous physical measurements of parameters like spectral sensitivity, light output, spatial resolution (MTF), and x-ray absorption, typically conducted under controlled laboratory conditions using established standards for radiographic screen testing.

8. The sample size for the training set:

• Not applicable. This is not an AI device, so there is no "training set."

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

• Not applicable. See point 8.

Ask a specific question about this device

The Direct Radiography™ device provides a digital image capture capability for conventional radiographic examinations (excluding fluoroscopic, angiographic, and mammographic applications). The device has application wherever conventional screen-film systems are currently used.

The Sterling Diagnostic Imaging Direct RadiographyTM device is used to directly capture and convert conventional projection X-ray images to digital images. A sub-sampled image can be displayed on a preview monitor for viewing. The diagnostic image can be transmitted through a digital network for diagnostic viewing and printing. The device provides digital image capture for conventional radiographic examinations (excluding fluoroscopic, angiographic, and mammographic applications). The Direct RadiographyTM device differs from traditional X-ray systems in that instead of exposing a film for subsequent wet chemical processing to create a hardcopy image, a device called a digital array is used to capture the image in electronic form. The digital data are then used to produce hardcopy and softcopy images.

The provided document is a 510(k) summary for the "Sterling Diagnostic Imaging Direct Radiography™" device. This device is described as a system to directly capture and convert conventional projection X-ray images to digital images.

However, the document does not contain information regarding detailed acceptance criteria, specific device performance metrics, or any studies demonstrating that the device meets such criteria.

The document primarily focuses on:

• Device Description: What the device is and how it works (digital image capture instead of film).
• Intended Use: For conventional radiographic examinations (excluding fluoroscopic, angiographic, and mammographic applications) wherever screen-film systems are currently used.
• Predicate Device Comparison: It compares the digital nature of the Sterling device to the analog nature and chemical processing of traditional screen-film systems, concluding substantial equivalence for conventional radiographic examinations.
• FDA Clearance Letter: A letter from the FDA stating that the device is substantially equivalent to the predicate and can be marketed.

Since the document is a 510(k) summary, it aims to establish substantial equivalence to a predicate device rather than providing extensive performance studies with detailed acceptance criteria typically found in clinical trial reports or technical specifications for newer, novel devices. The determination of "substantially equivalent" implies that the new device is as safe and effective as a legally marketed predicate device, and thus, extensive de novo performance studies with separate acceptance criteria might not have been required or documented in this specific submission summary.

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

Ask a specific question about this device

Accessory to a cassette to convert X-Ray energy into light energy.

Not Found

The provided text is a 510(k) clearance letter from the FDA for "Konica Intensifying Screens MD100 and MM150." This type of document declares substantial equivalence to a predicate device and does not contain information about acceptance criteria or specific study details as would be found in a clinical study report or a premarket approval (PMA) application.

Therefore, I cannot extract the requested information regarding acceptance criteria and study details from the provided text. The document is a regulatory approval, not a scientific study report.

Ask a specific question about this device