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The Omega Medical Imaging, Inc. CS-series-FP (SSXI) systems are intended for use in radiographic/fluoroscopic application including cardiac, vascular, general radiographic/fluoroscopic diagnostic, and interventional x-ray imaging.

The Omega Medical Imaging, Inc. CS-series-FP (SSXI) systems incorporates a solid-state flat-panel detector (FPD) as an option to the cleared Omega Medical Imaging, Inc. CS-series fluoroscopy systems (K070834) in lieu of an image intensifier/CCD based imaging detector. The CS-series fluoroscopy single and dual plane x-ray imaging systems are configured with a floor mounted C-am and a patient table. The dual plane systems incorporate a ceiling suspended C-arm. The image detector utilizes a cesium iodide scintillator coupled to an amorphous silicon TFT panel. The caplured digital image is processed by the acquisition system which includes image processing, viewing functions, local storage, and DICOM compatibility.

The Omega Medical Imaging, Inc. CS-series-FP (SSXI) fluoroscopy system aims to provide imaging performance comparable to existing fluoroscopy systems by incorporating a solid-state flat-panel detector (FPD).

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

The document provides detailed technical specifications for the CS-series-FP (SSXI) system, which serve as its performance criteria. The device is reported to meet these specifications directly by listing them as characteristics of the system.

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The Omega R650 QDASM automatic beam limiting device is intended for use in X-ray diagnostic radiographic/fluoroscopic applications.

The Omega R 650 QDASM is an automatic beam limiting device designed for use in diagnostic radiographic/fluoroscopic applications. It includes square field shutters, spectral filters, and an additional lung filter for cardiac application. This device is substantially equivalent to the predicate devices with respect to technological characteristics.

The provided documentation does not contain a study demonstrating the device meets specific acceptance criteria based on performance metrics such as accuracy, sensitivity, or specificity. The submission is a 510(k) for an X-ray beam-limiting device, focusing on substantial equivalence to predicate devices rather than clinical performance studies.

Therefore, many of the requested details such as acceptance criteria, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, and ground truth establishment for a clinical or performance study are not applicable or not provided in this specific document.

The document primarily states that the device:

• "will comply with the applicable requirements of 21 CFR 1020.30, 21 CFR 1020.31, and 21 CFR 1020.32" (regulations for diagnostic X-ray systems and their components).
• "will comply with the international safety standards IEC 60601-1, IEC 60101-1-2, and IEC 60601-1-3."
• "will comply with CE Marking requirements."
• "will comply with UL 60601-1 and CAN/USA C22.2 No.601.1-M90."

These are compliance statements for safety and electrical standards, not performance metrics related to diagnostic accuracy or clinical utility that would require a study with the detailed elements requested.

Summary of available information (and lack thereof based on the request):

• Compliance with 21 CFR 1020.30, 1020.31, 1020.32 (Diagnostic X-ray system regulations)
• Compliance with IEC 60601-1, IEC 60101-1-2, IEC 60601-1-3 (International safety standards)
• Compliance with CE Marking requirements
• Compliance with UL 60601-1 and CAN/USA C22.2 No.601.1-M90 (Safety standards)

Reported Device Performance: The document states: "This device is substantially equivalent to the predicate devices with respect to technological characteristics." No specific performance metrics (e.g., accuracy, sensitivity, specificity, or quantitative benefit) are provided as would be expected for an AI/algorithm-based device's clinical performance. The "performance" here refers to its ability to function as a beam-limiting device in accordance with regulatory and safety standards, similar to the predicate devices.
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| 2. Sample size and data provenance for test set | Not applicable. The submission for this device (an X-ray beam-limiting collimator, not an AI diagnostic algorithm) does not include a clinical performance study using a test set of images or patient data. The basis for clearance is substantial equivalence to predicate devices based on technological characteristics and compliance with recognized standards. |
| 3. Number/qualifications of experts for ground truth | Not applicable. No clinical performance study was conducted to establish ground truth for a diagnostic task. |
| 4. Adjudication method for test set | Not applicable. |
| 5. MRMC comparative effectiveness study? Effect size? | No. This device is an automatic beam-limiting device (collimator) for X-ray systems, not an AI or imaging analysis software intended to assist human readers in interpretation or diagnosis. Therefore, no MRMC study comparing human readers with and without AI assistance was performed or would be relevant for this device type. |
| 6. Standalone performance study? | No standalone performance study (in the context of an algorithm's diagnostic accuracy) was reported. The device's "performance" is implicitly its ability to meet the stated technical specifications and safety standards as a physical component of an X-ray system. |
| 7. Type of ground truth used | Not applicable. There is no diagnostic ground truth established for this device's function. The "ground truth" relevant to this submission would be the compliance with engineering and safety standards. |
| 8. Sample size for training set | Not applicable. This is not an AI/ML device that requires a training set of data. |
| 9. How training set ground truth was established | Not applicable. |

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The Omega Medical Imaging, Inc. CS-Series systems are intended for use in radiographic/fluoroscopic applications including cardiac, vascular, general radiographic/fluoroscopic diagnostic, and interventional x-ray imaging.

The Omega Medical Imaging, Inc. CS-Series systems are comprised of an x-ray source/image receptor positioning device in a permanently floor mounted C-Arm configuration with options of either an elevating only or elevating/tilt patient table. The system may also be configure with a ceiling suspended "C" for bi-plane operation. The positioning of the source/receptor is achieved by motorized motions controlled by the operator. The imaging is achieved by way of an image intensifier/CCD camera with digital image processing.

The provided text is a 510(k) summary for the Omega Medical Imaging, Inc. CS-Series radiographic/fluoroscopy system. It does not contain information about acceptance criteria or a study proving the device meets those criteria, as an acceptance criteria table and performance data are not typically included in a 510(k) summary for devices of this nature (angiographic X-ray systems).

A 510(k) submission primarily focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than providing detailed performance studies with acceptance criteria in the same way a new, high-risk device might. The document confirms that the device complies with relevant safety and performance standards (e.g., 21 CFR 1020.30, 21 CFR 1020.31, 21 CFR 1020.32, and various IEC and UL standards).

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

Here's why each specific point cannot be answered:

1. A table of acceptance criteria and the reported device performance: This information is not present in the 510(k) summary. The document states compliance with general safety and performance standards, but no specific acceptance criteria (e.g., for image quality, diagnostic accuracy) are listed, nor is performance data against such criteria.
2. Sample size used for the test set and the data provenance: Not applicable. No clinical or performance test set data (e.g., patient cases) is mentioned for proving diagnostic or clinical performance. The "testing" primarily refers to compliance with safety regulations and electrical standards.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. As there is no mention of a test set requiring ground truth, no experts for this purpose are stated.
4. Adjudication method for the test set: Not applicable. No test set requiring adjudication is mentioned.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done: No. MRMC studies are typically for evaluating diagnostic accuracy using human readers, often comparing AI-assisted vs. unassisted performance. This 510(k) summary is for an X-ray system, not an AI diagnostic algorithm, and therefore such a study is not part of this document.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: No. This device is an X-ray system, not a standalone algorithm. Its function is to acquire images, not to interpret them autonomously.
7. The type of ground truth used: Not applicable. Given the nature of the device and the content of the 510(k) summary, no ground truth (e.g., pathology, outcomes data) for diagnostic performance is discussed.
8. The sample size for the training set: Not applicable. This device is an X-ray system, not a machine learning algorithm that requires a training set. The software/firmware mentioned is for controlling mechanical subsystems and is obtained from certified suppliers, not developed by Omega Medical Imaging, Inc. for diagnostic purposes.
9. How the ground truth for the training set was established: Not applicable, as there is no training set mentioned for this device.

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The Omega Medical Imaging, Inc. e-VIEW systems are intended for use in radiographic/fluoroscopic applications including cardiac, vascular, general radiographic/fluoroscopic diagnostic, and interventional x-ray imaging.

The Omega Medical Imaging, Inc. e-VIEW systems are comprised of an x-ray source/image receptor positioning device in a permanently floor mounted C-Arm configuration. The positioning of the source/receptor is schieved by motorized motions controlled by the operator. The patient table can be configured with different motorized motions including elevating, Trendelenburg and vertical tilt, lateral and longitudinal table top travel, and lateral table top tilt. The imaging is achieved by way of an image intensifier/CCD camera with digitty in nage processing.

This 510(k) summary for the Omega Medical Imaging e-VIEW radiographic/fluoroscopy system does not contain the detailed study information typically found in a clinical trial report or a comprehensive performance study. Instead, it focuses on demonstrating substantial equivalence to predicate devices through technical specifications and compliance with safety standards.

Therefore, many of the requested categories regarding acceptance criteria and study particulars cannot be directly answered from the provided text.

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

1. Table of Acceptance Criteria and Reported Device Performance

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

• Not provided. This document is a 510(k) summary focusing on substantial equivalence through technical and regulatory compliance, not a clinical study report with patient data.

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

• Not applicable. No test set with ground truth established by experts is mentioned in this submission.

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

• Not applicable. No test set requiring expert adjudication is mentioned.

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 / Not done. This device is an X-ray system, not an AI-powered diagnostic tool, and there's no mention of a human-in-the-loop study or AI assistance.

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

• Not applicable / Not done. This refers to a medical imaging device itself, not a standalone algorithm.

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

• Not applicable. There is no mention of ground truth in the context of diagnostic performance studies. The "ground truth" implied for safety and performance is adherence to established engineering standards and equivalence to predicate devices.

8. The sample size for the training set

• Not applicable. No machine learning model or training set is discussed.

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

• Not applicable. No machine learning model or training set is discussed.

Summary of the Study (as described in the 510k summary):

The "study" presented here is not a clinical trial in the traditional sense, but rather a demonstration of substantial equivalence to previously cleared predicate devices. The methodology relies on:

• Comparative Analysis: The Omega e-VIEW system's design, intended use, and technical specifications are compared to those of the Siemens AXIOM ARTIS U Angiography System (K040675), Philips Integris H5000 Angiography System (K984545), and Omega Medical Imaging B200/C300 Fluoroscopy System (K902005). The conclusion is that the e-VIEW systems "do not introduce any new indications for use, nor does the use of the device result in any new potential hazard."
• Compliance with Recognized Standards: The primary "acceptance criteria" and "proof" presented are commitments to comply with a comprehensive list of FDA regulations (21 CFR 1020.30, 21 CFR 1020.31, 21 CFR 1020.32) and international safety standards (IEC 60601-1 series, UL 60601-1, CAN/USA C22.2 No.601.1-M90). This compliance serves as evidence that the device meets safety and basic performance expectations.

In essence, the submission asserts that because the e-VIEW system is designed to meet established safety standards and performs functions equivalent to existing, legally marketed devices, it can be considered safe and effective without requiring new clinical performance studies.

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The Omega R605 FACS automatic collimator is intended for use in diagnostic radiographic/fluoroscopic applications.

The Omega R 605FACS is an automatic collimator designed for use in diagnostic Trie Offically of tool AOO is an adtomatio continues round field shutters and an additional lung filter for cardiac application.

This submission is a 510(k) premarket notification for the Omega R605 FACS automatic collimator. The document describes the device and its intended use, and states that it is substantially equivalent to predicate devices. However, it does not contain the detailed study information typically required to prove a device meets specific acceptance criteria based on performance metrics.

Here's a breakdown of the requested information, highlighting what is missing from the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

• Explanation: The document states that the Omega R605 FACS collimator will comply with various safety standards (21 CFR 1020.30, 21 CFR 1020.31, 21 CFR 1020.32, IEC 60601-1, IEC 60101-1-2, IEC 60601-1-3, UL 60601-1, and CAN/USA C22.2 No.601.1-M90) and CE Marking requirements. However, it does not provide specific numerical acceptance criteria for performance parameters (e.g., accuracy of beam limiting, illumination levels, alignment tolerances) or data demonstrating the device actually met these criteria. This is a common characteristic of 510(k) summaries where compliance with recognized standards is stated, but the detailed test results are not included in the public-facing summary.

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

• Sample Size (Test Set): Not provided. The document does not describe a clinical or technical performance study with a specific test set.
• Data Provenance: Not applicable. No study data is presented.

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

• Not applicable. No study data is presented, and thus no ground truth establishment by experts is described.

4. Adjudication method for the test set:

• Not applicable. No study data is presented.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, if so, what was the effect size of how much human readers improve with AI vs without AI assistance:

• No. This device is an automatic collimator, not an AI-assisted diagnostic tool for human readers. Therefore, an MRMC study with human readers improving with AI assistance is not relevant to this device.

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

• Not explicitly described as a standalone algorithm study. The device itself is an automatic collimator, implying its function is standalone in terms of beam limiting. The document states it will comply with technical performance standards, which implies standalone technical testing was performed to demonstrate compliance. However, no specific details of such tests (e.g., methodology, results) are provided in this summary.

7. The type of ground truth used:

• Not applicable / Implied by standards compliance. For a physical device like a collimator, "ground truth" would relate to the objective, measurable accuracy of its physical functions (e.g., how precisely it limits the X-ray field compared to a known standard or reference measurement). The document implies that compliance with recognized safety and performance standards (like 21 CFR 1020.30, 1020.31, 1020.32, IEC 60601-1, etc.) serves as the basis for establishing that the device performs as intended. These standards specify physical requirements and testing methodologies.

8. The sample size for the training set:

• Not applicable. This is a physical medical device (automatic collimator), not a machine learning or AI algorithm that requires a training set of data.

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

• Not applicable. As above, this is not an AI/ML device requiring a training set.

Summary of the Study that Proves the Device Meets Acceptance Criteria (Based on the Provided Text):

The provided 510(k) summary does not detail a specific performance study with a test set, ground truth, or expert review in the way one would describe for a diagnostic imaging algorithm. Instead, the submission for the Omega R605 FACS automatic collimator relies on declaration of compliance with established regulatory and international standards to demonstrate its safety and effectiveness and its substantial equivalence to predicate devices.

The document states that the device "will comply" with:

• 21 CFR 1020.30, 21 CFR 1020.31, and 21 CFR 1020.32: These are U.S. FDA regulations pertaining to diagnostic X-ray systems and their components, specifically addressing performance standards for diagnostic X-ray sources, protective shields, and beam-limiting devices.
• IEC 60601-1, IEC 60101-1-2, and IEC 60601-1-3: These are international safety standards for medical electrical equipment, including general requirements, electromagnetic compatibility, and requirements for diagnostic X-ray equipment.
• CE Marking requirements: European conformity mark, indicating compliance with relevant EU directives.
• UL 60601-1 and CAN/USA C22.2 No.601.1-M90: Safety standards for medical electrical equipment for the U.S. and Canada, respectively.

Conclusion from the document: The manufacturer asserts that the Omega R605 FACS collimator "does not introduce any new indications for use" and is "substantially equivalent with the predicate devices." This substantial equivalence, coupled with the declared compliance to established safety and performance standards, is the basis of the 510(k) clearance, rather than a detailed performance study like those conducted for AI/ML devices. The FDA's letter confirms they determined the device to be substantially equivalent based on the information provided in the 510(k) premarket notification.

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To support the Diagnostic Source Assembly & Image Receptor used in performing general-purpose diagnostic fluoroscopic procedures.

The B-400 Ceiling Mounted C-Positioner is a device intended to hold an X-Ray tube and an image intensifier 180° apart in a "C" configuration for the purpose of verforming general purpose diagnostic fluoroscopic procedures. The C-Positioner allows variable positioning of the X-Ray tube/Image Intensifier from +145 degrees Left Anterior Oblique (LAO) to 55 degrees Left Posterior Oblique (LPO). The device will maintain isocenter throughout its full range of motorized movement. The entire assembly is mounted to a set of ceiling rails.

The provided text is a 510(k) summary for the OMEGA MEDICAL IMAGING, INC. B-400 Isocentric Ceiling Mounted C-Positioner, a device intended to hold an X-Ray tube and an image intensifier for general purpose diagnostic fluoroscopic procedures. The document establishes substantial equivalence to predicate devices, rather than presenting a study of the device's performance against specific acceptance criteria.

Therefore, many of the requested sections (2, 3, 4, 5, 6, 7, 8, 9) cannot be answered because the document details a regulatory submission based on substantial equivalence, not a performance study as would be typical for an AI/ML device.

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

The provided document does not explicitly state acceptance criteria in the typical sense of a performance study with numerical targets for metrics like accuracy, sensitivity, or specificity. Instead, the "acceptance criteria" are based on demonstrating substantial equivalence to existing legally marketed predicate devices. The "reported device performance" is essentially a comparison of its technological characteristics and intended use to these predicate devices.

Here's a table based on the substantial equivalence comparison:

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To support the Diagnostic Source Assembly & the Image Receptor used in performing general purpose diagnostic fluoroscopic procedures.

The B-350 Ceiling Mounted C-Positioner is a device intended to hold an X-Ray tube and an image intensifier 180° apart in a "C" configuration for the purpose of performing general purpose diagnostic fluoroscopic procedures.

The C-Positioner allows variable positioning of the X-Ray tube/Image Intensifier from 30 degrees Left Anterior Oblique (LAO) to 120 degrees Left Posterior Oblique (LPO). The device will maintain isocenter throughout its full range of motorized movement. The entire assembly is mounted to a set of ceiling rails with a detent provided to lock the unit into place for use in creating a common isocenter between the Anterior/Posterior (A/P) and lateral planes. A microswitch controlled interlock system independently prevents X-Ray exposure anywhere outside the detent position.

This document is a 510(k) summary for a medical device called the B-350 Isocentric Ceiling Mounted C-Positioner. It describes the device's function and claims substantial equivalence to previously marketed devices. However, it does not contain any information regarding acceptance criteria, device performance studies, or clinical trial data.

Therefore, I cannot provide the requested information. The document focuses on establishing substantial equivalence based on technological characteristics and intended use, rather than presenting performance metrics against predefined acceptance criteria.

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