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The MXU-125 or TMX-125 is a Mobile x-ray Unit intended for use in general radiographic medical procedures by a licensed professional.

The Mobile X-ray Unit is a portable, battery-powered, self-propelled - unit - designed - for - making - film radiographs in a hospital environment. The unit is capable of generating diagnostic x-rays according to the technique factor combinations selected and controlled by the operator.

The provided text describes a 510(k) summary for a Mobile X-ray Unit (MXU-125 or TMX-125) and discusses its substantial equivalence to predicate devices. However, it does not contain any information regarding acceptance criteria or a study proving the device meets said criteria.

The document focuses on:

• General Information: Manufacturer, contact, device name.
• Performance Standard: Compliance with 21 CFR Subchapter J (Diagnostic X-ray Equipment Standard).
• Substantial Equivalence: Listing predicate devices (LORAD RT-125, GE Medical Systems AMX-3) with their 510(k) numbers.
• Indications for Use: "intended for use in general radiographic medical procedures by a licensed professional."
• Technological Characteristics: Describing it as a portable, battery-powered, self-propelled unit for film radiographs in a hospital environment, capable of generating diagnostic x-rays. It also mentions compliance with Part 1020, Performance Standards for Ionizing Radiation Emitting Products, and voluntary standards for electrical safety, electromagnetic compatibility, and radiation safety.
• FDA Clearance Letter: Confirming the review of the 510(k) notification and a finding of substantial equivalence based on the stated indications for use.

Therefore, I cannot populate the requested table or answer questions 2 through 9, as the necessary information is not present in the provided text.

The document only states that the device "conforms to 21 CFR Subchapter J (21 CFR 1020.30, 1020.31 and 1020.32 Diagnostic Xray Equipment Standard)" and "complies with Part 1020, Performance Standards for Ionizing Radiation Emitting Products and conforms to recognized voluntary standards for electrical safety, electromagnetic compatibility of medical equipment and radiation safety." These are regulatory compliance statements, not specific acceptance criteria with performance metrics from a study.

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THE PROFILE 2000 MAMMOGRAPHY SysTEM, MODEL PRO-2000, 15 A DEDICATED MANMOGRAPHIC IMAGING SysTEM USED FOR MAMMOGRAPHIC EXAMINATIONS.

The Bennett Profile 2000 Mammographic System, Model PRO-1. 2000, is a dedicated mammographic imaging system used as an x-ray source in the performance of mammographic examinations. The PRO-2000 is adaptable to performing screening and/or biopsy procedures with the addition of either a film-based or digital-based image receptor device attached. It consists of the following components; an x-ray generator cabinet, Model M-2000G (single-phase input) or Model M-2000G-3P (three-phase input); a tube stand with a non-tilting c-arm; mammographic collimator (DM-2000) and tube; an operator control panel, Model M-2000C; and image receptor (film cassette holder or bucky).
The Profile 2000 Mammography System is a microprocessor-controlled x-ray source requiring single-phase 200-240 VAC, 50/60 Hz or three-phase 208-440 VAC, 50/60 Hz for operation. The Profile 2000 system's c-arm is fully counterbalanced and is locked in position using electro-mechanical locks. The c-arm has a fixed source-to-image distance (SID) of 76 cm.

The provided text describes a 510(k) submission for a mammography system, not an AI/algorithm-based device. Therefore, the questions related to AI/algorithm performance (such as sample sizes for test and training sets, ground truth establishment for AI, MRMC studies, or standalone performance) are not applicable.

The submission focuses on demonstrating substantial equivalence of the Bennett Profile 2000 Mammography System to predicate mammography systems. The acceptance criteria for this type of device are primarily related to safety, operational performance, and functional equivalence compared to existing devices.

Here's an attempt to answer the relevant questions based on the provided text, while acknowledging the limitations due to the nature of the device:

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

Based on the provided text, the acceptance criteria are implicitly tied to demonstrating substantial equivalence to predicate devices in terms of basic features, operation, and functionality, and meeting safety functions. The document does not provide specific quantitative acceptance criteria or detailed performance metrics in a tabular format as one might find for an AI algorithm's sensitivity/specificity.

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

Not applicable. This is a medical imaging hardware device (X-ray system), not an algorithm or AI. There is no "test set" of clinical images as there would be for an AI diagnostic device. The "testing" referred to is related to the hardware's safety and functional performance.

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)

Not applicable, as there is no "test set" or "ground truth" to establish in the context of an AI/algorithm for this device. The evaluation would involve engineering tests and potentially clinical performance assessments by users, but not ground truth establishment for diagnostic accuracy.

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

Not applicable, as there is no "test set" requiring adjudication of diagnostic findings.

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 a standalone imaging system, not an AI-assisted diagnostic tool designed to improve human reader performance.

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

The device itself is a standalone mammography system. "Standalone performance" in the AI context would refer to an algorithm making a diagnosis without human intervention. This device is the imaging equipment, which serves as a component in a diagnostic process that involves a human reader (radiologist).

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

Not applicable. Ground truth, in the context of diagnostic accuracy, is not relevant for the submission of an X-ray hardware device.

8. The sample size for the training set

Not applicable. This is a hardware device, not an AI algorithm requiring a training set.

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

Not applicable. This is a hardware device, not an AI algorithm.

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The Contour 2000 Mammography system, Model CTR-2000, is used for dedicated mammographic examination.

The Bennett Contour 2000 Mammographic System, Model CTR-1. 2000, is a dedicated mammographic imaging system used as an x-ray source in the performance of mammographic examinations. The CTR-2000 is adaptable to performing screening and/or biopsy procedures with the addition of either a film-based or digital-based image receptor device attached. It consists of the following components; an x-ray generator cabinet, Model M-2000G (single-phase input) or Model M-2000G-3P (three-phase input); a tube stand with a tilting c-arm; mammographic collimator (DM-2000) and tube; an operator control panel, Model M-2000C; and image receptor (film cassette holder or bucky).
The Contour 2000 Mammography System is a microprocessor-controlled x-ray source requiring single-phase 200-240 VAC, 50/60 Hz or three-phase 208-440 VAC, 50/60 Hz for operation. The Contour 2000 system's c-arm is fully counterbalanced and is locked in position using electro-mechanical locks. The c-arm has a fixed source-to-image distance (SID) of 76 cm.

The provided text describes a 510(k) submission for the "Bennett Contour 2000 Mammography System, Model CTR-2000." This document asserts substantial equivalence to predicate devices and focuses on the system's technical specifications and safety rather than a clinical performance study with specific acceptance criteria and reported device performance.

Therefore, the requested information regarding acceptance criteria and a study proving the device meets them cannot be fully extracted as structured in the prompt because the available text does not contain details about a clinical performance study with specific acceptance criteria, test sets, ground truth establishment, or expert evaluations.

The document is a 510(k) summary, which primarily aims to demonstrate substantial equivalence to legally marketed predicate devices based on design, intended use, operation, and safety testing (e.g., conformance to requirements, hazard analysis). It does not present data from a clinical trial or a standalone algorithm performance study.

Here's a breakdown of what can and cannot be answered based on the provided text:

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

• Cannot be provided. The document states that "The safety functions of the Contour 2000 Mammography System have been rigorously tested and analyzed for conformance to requirements. In each case, these functions have performed as required, ensuring that each identified hazardous condition would not occur under simulated conditions. The Contour 2000 Mammography System fulfills its design requirements by providing the operator with the ability to perform safe and effective mammographic examinations." However, it does not specify quantitative acceptance criteria (e.g., sensitivity, specificity, accuracy for a diagnostic task) or reported performance metrics from a clinical study. The focus is on technical and safety conformance, not diagnostic accuracy.

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

• Cannot be provided. No clinical test set or data provenance is mentioned. The testing described is related to the device's technical and safety functions, likely using engineered test cases or simulated conditions, not patient data in a clinical study context.

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

• Cannot be provided. No clinical test set or ground truth establishment by experts is mentioned.

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

• Cannot be provided. No clinical test set or adjudication method 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

• Cannot be provided. The device described is a mammography imaging system (hardware), not an AI algorithm. Therefore, an MRMC study comparing human readers with and without AI assistance is not applicable and not mentioned.

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

• Cannot be provided. The device is a mammography imaging system (hardware), not a standalone algorithm.

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

• Cannot be provided. No clinical ground truth is mentioned. The "ground truth" for this device's evaluation would relate to its technical specifications and safety performance (e.g., x-ray output accuracy, mechanical stability), not diagnostic outcomes.

8. The sample size for the training set

• Cannot be provided. This is a hardware device, not a machine learning model, so there is no "training set" in the AI sense.

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

• Cannot be provided. Not applicable as this is a hardware device.

Summary of Device and its Evaluation (Based on provided text):

The "Bennett Contour 2000 Mammography System, Model CTR-2000" is a dedicated mammographic imaging system used as an x-ray source for mammographic examinations. Its 510(k) clearance (K984091) was based on demonstrating substantial equivalence to legally marketed predicate devices, including the Bennett Contour M-CTR, LORAD M-IV, Instrumentarium Alpha IQ, GE Senographe 800T, and Planmed Sophie Classic mammographic imaging systems.

The evaluation process described in the 510(k) summary focused on:

• Comparison of basic features, operation, and functionality to predicate devices.
• Rigorous testing and analysis of safety functions to conform to requirements and ensure identified hazardous conditions would not occur under simulated conditions.
• Fulfilling design requirements to provide safe and effective mammographic examinations.

Key takeaway: This document pertains to the clearance of a medical imaging hardware device, not a diagnostic AI algorithm. Therefore, the assessment criteria and study design are fundamentally different from what would be expected for an AI-based diagnostic tool.

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The XRE Collimator with spectral filter is designed to be the primary X-ray beam limiting device as part of an angiographic imaging system and is controllable manually and automatically. It also provides a means of manual or automatic selection of filtration designed to reduce the xray dose applied to the patient while still providing high quality images. It is designed to be operated by professional medical personnel only.

Not Found

This document is a 510(k) clearance letter from the FDA for the "XRE Collimator with Spectral Filter" and an "Indications for Use Statement". It does not contain any information about acceptance criteria, device performance studies, sample sizes, expert qualifications, ground truth, or adjudication methods.

Therefore, I cannot provide the requested information based on the input text. The provided text only confirms that the device has received FDA clearance for marketing based on substantial equivalence to a predicate device.

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TREX Tilt-C, Integrated C-Arm/Table multipurpose radiographic/fluoroscopic positioning system. It is an all-digital multi-purpose system designed to address a broad variety of radiographic/fluoroscopic, interventional and limited angiographic procedures.

Integrated C-Arm/Table multipurpose radiographic/fluoroscopic positioning system, Model TREX Tilt-C. It is an all-digital multi-purpose system designed to address a broad variety of radiographic/fluoroscopic, interventional and limited angiographic procedures.

This 510(k) premarket notification is for a conventional medical device (TREX Tilt-C, Integrated C-Arm/Table multipurpose radiographic/fluoroscopic positioning system), not an AI/ML powered device. As such, the concept of "acceptance criteria" and "device performance" in the context of an AI model's metrics (like accuracy, sensitivity, specificity) is not directly applicable here.

The letter primarily focuses on the substantial equivalence determination for regulatory clearance based on the device's adherence to general controls and existing regulations. It does not contain information about studies proving performance against specific acceptance criteria in the manner requested for AI/ML devices.

Therefore, I cannot provide the requested information.

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Digital Imaging System, Model DigiTREX-X000 is a digital video processing system and is intended to be produced by the radiographic, fluoroscopic, or special procedure systems, excluding mamography.

Digital Imaging System, Model DigiTrex-1000 and DigiTrex-2000 is a digital video processing system.

I am sorry, but the provided text does not contain the detailed information necessary to answer your request about acceptance criteria and a study proving device performance. The document is an FDA clearance letter for the DigiTrex-1000 and DigiTrex-2000 digital imaging systems, indicating substantial equivalence to a predicate device.

It mentions that the device is cleared based on the information provided in the 510(k) submission and that it passed general controls provisions and compliance with good manufacturing practices. However, it does not include:

• A table of acceptance criteria and reported device performance.
• Details about sample size, data provenance, number or qualifications of experts, or adjudication methods for any test set.
• Information on MRMC comparative effectiveness studies or standalone algorithm performance.
• The type of ground truth used.
• Sample size or ground truth establishment methods for a training set.

To answer your questions, I would need access to the actual 510(k) submission document or a summary thereof, which would contain the study details and acceptance criteria.

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