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These are stationary x-ray systems intended for obtaining radiographic images of various portions of the human body in a clinical environment. The devices are not intended for mammography

This is a complete stationary diagnostic x-ray system employing digital x-ray panels coupled with image acquisition software. The key features are: Ceiling Tube Suspension, Motorized Movements, Auto-Positioning, Tube Mounted 10" Touch Screen, Elevating 6 Way Table Patient Load: 5501bs, Single User Interface, High Frequency Generator. This ergonomic design incorporates automatic motorized positioning, creating an efficient workflow increasing the patient throughput. Precision offers automatic stitching enhancing the workflow further. Tube, vertical wall stand and table have extended range of motion for easy patient positioning. The acquisition software is installed on a Windows compatible workstation. The high frequency generator is available in different power ratings. All components are either 510(k) exempt or previously cleared. Generators are available in 50, 65, 80 kW (High Frequency) models.

Here's an analysis of the provided text regarding the acceptance criteria and study for the Arcoma AB 0180 Intuition & 0072 Precision Stationary Digital X-Ray Systems (K140683):

1. Table of Acceptance Criteria and Reported Device Performance

The provided document does not explicitly list quantitative acceptance criteria for the device's performance. Instead, it focuses on demonstrating substantial equivalence to a predicate device (Arcoma Intuition, K073632) through functional comparisons, non-clinical tests, and a qualitative clinical evaluation.

The "acceptance criteria" can be inferred from the overall claim of substantial equivalence and the scope of the testing performed, primarily that the modified device is "as safe, as effective, and performs as well as or better than the legally marketed device."

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

• Test Set Sample Size: The document does not specify a numerical sample size for the clinical images used in the clinical study. It states only that "Clinical images were obtained."
• Data Provenance: The document does not specify the country of origin of the data or whether the study was retrospective or prospective.

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

• Number of Experts: The document states that clinical images "were evaluated by professional radiologist" (singular, though likely implying multiple, it does not specify the number).
• Qualifications of Experts: The experts are described only as "professional radiologist." No further details on their experience level (e.g., "10 years of experience") are provided.

4. Adjudication Method for the Test Set

The document does not describe any specific adjudication method (e.g., 2+1, 3+1) for the clinical image evaluation. It simply states that the images "were evaluated by professional radiologist and found to be of good diagnostic quality."

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. The study described is a qualitative evaluation of image quality by radiologists, comparing the modified device's performance to an implicit standard of "good diagnostic quality" rather than a direct comparison against the predicate by multiple readers on multiple cases. Therefore, no effect size of human readers improving with AI vs. without AI assistance is applicable or reported, as this device is a traditional x-ray system, not an AI-powered diagnostic tool.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

No, a standalone (algorithm only) performance study was not done. This device is a digital X-ray system, and its primary output is human-interpretable images, not an automated diagnostic algorithm.

7. The Type of Ground Truth Used

The ground truth for the clinical images seems to be based on expert consensus (or individual expert opinion) regarding "good diagnostic quality." The text does not mention pathology, outcomes data, or other objective ground truth measures for evaluating the images.

8. The Sample Size for the Training Set

This information is not applicable and not provided in the document. This device is a traditional digital X-ray system, not an AI or machine learning algorithm that requires a training set. The "software integration validation" mentioned refers to the system's operational software, not an AI model.

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

This information is not applicable as there is no training set for an AI/ML algorithm described.

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These Digital Radiographic Systems are intended for use by a qualified/trained doctor or technician on both adult and pediatric subjects for taking diagnostic radiographic exposures of the skall, spinal column, chest, abdomen, extremities, and other body parts. Applications can be performed with the patient sitting, standing, or lying in the prone or supine position.

These digital diagnostic x-ray systems consist of a tubehead and collimator assembly mounted on a U-Arm, along with a generator, generator control, and an xray table. Power ratings for the available generators are in the rage of 50 kw to 80 kW. Exposure voltage range varies from 40 - 125 KV or 40 - 150 kV with current of 300 - 100 mA. Exposure time is 1 ms - 10 s. This device represents a new combination of already cleared Sedecal and Canon products.

The provided document is a 510(k) summary for the Sedecal Millennium Plus Digital Diagnostic X-Ray System. It states that the new device is substantially equivalent to legally marketed predicate devices. However, this document does not contain information about specific acceptance criteria, a study that proves the device meets those criteria, or details regarding performance metrics, sample sizes, ground truth establishment, or expert involvement in a study as requested.

The document primarily focuses on establishing substantial equivalence by comparing the new device's characteristics and intended use to those of its predicate devices (Sedecal Millennium Digital K042876 and Sedecal X Plus LP Plus K062335) and by stating that it passes bench and test laboratory evaluations to applicable standards (21 CFR 1020.30 and IEC 60601).

Therefore, I cannot provide the requested table and detailed information based on the content of this document. The document explicitly states:

"The results of bench and test laboratory indicates that the new device is as safe and effective as the predicate devices."
and
"After analyzing bench and external laboratory testing to applicable standards, it is the conclusion of Sedecal Inc that the Scdecal Millennium Plus Digital Diagnostic X-Ray Systems are as safe and effective as the predicate device, have few technological differences, and has no new indications for use, thus rendering them substantially equivalent to the predicate devices."

This indicates that general safety and effectiveness testing was conducted, but the specific details of the acceptance criteria, study design, performance metrics, sample sizes, ground truth, or expert involvement are not disclosed in this 510(k) summary.

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These Digital Radiographic Systems are intended for use by a qualified/trained doctor or technician on both adult and pediatric subjects for taking diagnostic radiographic exposures of the skull, spinal column, chest, abdomen, extremities, and other body parts. Applications can be performed with the patient sitting, standing, or lying in the prone or supine position.

These digital diagnostic x-ray systems consist of a tubehead/collimator assembly mounted on a U-Arm, along with a generator, generator control, and an x-ray table. Power ratings for the available generators are in the rage of 50 kw to 80 kW. Exposure voltage range varies from 40 - 125 KV or 40 - 150 kV, with current of 300 - 100 mA. Exposure time is 1 ms - 10 s. This device represents a new combination of already cleared Sedecal and Canon products.

The provided 510(k) summary for the Sedecal X-Plus LP Plus Digital Diagnostic X-Ray System (K090238) does not contain the information requested regarding acceptance criteria and a specific study proving the device meets those criteria, as you would typically expect for performance data of AI/CADe devices.

This submission is for a traditional X-ray system, and the approval is based on substantial equivalence to predicate devices, rather than a performance study with defined acceptance criteria for diagnostic accuracy.

However, I can extract and infer some information based on the document's content:

1. Table of Acceptance Criteria and Reported Device Performance:

• Acceptance Criteria: For this type of device, the acceptance criteria are generally related to demonstrating substantial equivalence to existing legally marketed devices, primarily focusing on safety and effectiveness through comparison of technical characteristics and adherence to relevant performance standards.
• Reported Device Performance: The document states, "The results of bench and test laboratory indicates that the new device is as safe and effective as the predicate devices."

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 in the document. The approval is based on "bench and test laboratory" results and comparison of specifications, not a clinical test set with patient data for diagnostic accuracy assessment.

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

• This information is not applicable/provided. No clinical reader study or ground truth establishment relevant to diagnostic accuracy is described.

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

• This information is not applicable/provided.

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, an MRMC comparative effectiveness study was not done. This device is a digital X-ray system, not an AI or CADe device designed to assist human readers or provide diagnostic interpretations.

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

• No, a standalone performance study was not done. This is an imaging acquisition device, not an algorithm.

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

• Not applicable. The "ground truth" for this submission revolves around engineering performance verified by "bench and external laboratory testing to applicable standards" (e.g., 21 CFR 1020.30, IEC-60601) to demonstrate the device functions as intended and is safe. It's not about diagnostic accuracy.

8. The sample size for the training set:

• Not applicable. This isn't an AI/machine learning device that requires a training set.

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

• Not applicable.

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This digital radiographic system is intended for use by a qualified/trained physician or technician on both adult and pediatric subjects for taking diagnostic x-rays.

This represents the straightforward interconnection of two FDA cleared devices: The MinXray HF120/60H PowerPlus™ (K040046) and the Canon CXDI-50G Solid State Imager (K031447). MinXray HF120/60H PowerPlus™ is a portable unit which operates from 120 V 50-60~ AC. The generator unit utilizes a high frequency inverter and can be mounted to a tripod or support arm. The usual safety precautions regarding the use of x-rays must be observed by the operator. The digital panel features Canon's large-area flat panel technology in a sleek and compact unit. The portable CXDI-50G provides digital X-ray image capture for a wide range of applications. The lightweight design, generous imaging area, and fast processing times of the detector make it easy to capture high quality diagnostic images for routine diagnosis, as well as challenging trauma and bedside exams. It's a portable solution for a faster, more streamlined approach to digital radiography.

The provided text describes a 510(k) submission for the MinXray CMDR-1S Digital Diagnostic X-Ray System (Mobile). This submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than providing a detailed study proving the device meets specific acceptance criteria through clinical performance metrics.

Therefore, the information required to fully answer your request regarding acceptance criteria and a study proving those criteria are met is not present in the provided text. The document primarily discusses the device's technical specifications and intended use in comparison to a predicate device, concluding substantial equivalence based on bench testing.

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 does not define specific performance acceptance criteria for image quality, diagnostic accuracy, or clinical effectiveness. It focuses on demonstrating equivalence to predicate devices through technical characteristics and bench testing.

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. The text only mentions "bench testing" and does not refer to any human or clinical test sets, their sample sizes, or data provenance.

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 involving expert review or ground truth establishment is mentioned.

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

• Cannot be provided. No clinical test set is described, so no 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

• No MRMC study was done, and no AI component is described. The device is a digital X-ray system, not an AI-powered diagnostic tool. The document states it is "the straightforward interconnection of two FDA cleared devices."

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

• Not applicable. This device is a hardware system for acquiring X-ray images, not an algorithm.

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

• Cannot be provided. No clinical ground truth is established or referenced. The "ground truth" for the substantial equivalence claim is the performance and safety of the predicate device.

8. The sample size for the training set

• Not applicable, no training set for an algorithm is mentioned.

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

• Not applicable, no training set for an algorithm is mentioned.

Summary of what the document focuses on:

The MinXray CMDR-1S Digital Diagnostic X-Ray System (Mobile) achieved 510(k) clearance by demonstrating substantial equivalence to a previously cleared predicate device (K042361 DIGITAL PORTABLE X-RAY UNITS, MODEL SP-HF-4.0 D, SEDECAL USA, INC). This approach to regulatory clearance typically relies on technical comparisons and non-clinical testing rather than extensive clinical performance studies with specific acceptance criteria as you might see for a novel diagnostic algorithm.

The core of the "study" demonstrating this equivalence is:

• Bench testing: The document states, "The results of bench testing indicates that the new device is as safe and effective as the predicate devices. Proper system operation is fully verified upon installation."
• Comparison of Characteristics: A table comparing characteristics like intended use, configuration, generator type, and performance standard confirmed that the new device is largely "SAME" or has minor technological differences (e.g., generator made by a different company and different MHz).

The acceptance criteria for this type of submission would generally be that the new device does not raise different questions of safety and effectiveness and performs comparably to the predicate device in terms of its technical specifications and typical operation (as verified by bench testing). The document concludes that "the MinXray CMDR-1S Digital Diagnostic X-Ray System is as safe and effective as the predicate device, have few technological differences, and has no new indications for use, thus rendering it substantially equivalent to the predicate device."

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Vidar Vision 3000 and Vidar Vision 4000 X-Ray Systems are indicated for use in generating radiographic images of human anatomy. It has a Solid State X-ray Imaging system intended to replace radiographic film/screen systems in all general-purpose diagnostic procedures. The Vidar Vision 3000 and Vidar Vision 4000 is not indicated for diagnostic X-ray mammography.

The VIDAR VISION 3000 Digital Radiography system is an affordable DR (Digital Radiographic) solution designed for smaller radiography environments, including imaging centers, orthopedic practices, small hospitals, and outpatient areas of hospitals. The VIDAR VISION 3000 is the first truly affordable, full-featured DR system. providing a total solution for all digital radiographic examinations. The VIDAR VISION 3000 features high image quality, rapid image acquisition, improved productivity, and ease of use. The flexible system features a 3K detector for the high-resolution imaging needs of busy radiology centers, orthopedic practices, and hospitals. VIDAR's new VISION DR product line also includes the VISION 4000 system, with a 4K detector that is ideal for higher volume settings.

The provided text describes a 510(k) premarket notification for a medical device, which focuses on demonstrating substantial equivalence to a predicate device rather than presenting a detailed study proving the device meets specific acceptance criteria in a quantitative manner. Therefore, much of the requested information (such as sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, and training set details) is not available in the provided document.

However, based on the provided text, we can infer some details related to the evaluation.

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria here are implicitly related to demonstrating "substantial equivalence" to the predicate device, meaning the new device is as safe and effective and has no new indications for use. The performance is reported in terms of functional equivalence and technological specifications.

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

The document states "bench, user, and standards testing" were conducted. However, no specific sample sizes or details about data provenance (e.g., country of origin, retrospective/prospective) are provided in the given text for these tests.

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

Not applicable/Not provided. The testing appears to be primarily focused on technical specifications and functionality as compared to the predicate device, rather than diagnostic accuracy against a ground truth assessed by experts.

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

Not applicable/Not provided. As there's no mention of expert evaluation of diagnostic images for ground truth, adjudication methods are not relevant here.

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

Not applicable. This device is an X-ray system, not an AI-powered diagnostic tool. Thus, MRMC studies and AI-assisted improvements are not relevant.

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

Not applicable. This device is an X-ray system, not an algorithm. Standalone algorithm performance is not relevant.

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

Not applicable/Not provided. The "ground truth" in this context is the performance and safety established for the predicate device, against which the new device's technical specifications and functional capabilities are compared. This is a comparison of device characteristics, not a diagnostic accuracy study requiring a clinical ground truth.

8. The sample size for the training set

Not applicable/Not provided. This is a hardware device (X-ray system), not an algorithm that requires a training set.

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

Not applicable/Not provided. As above, this is a hardware device.

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DIGITAL RADIOGRAPHY CXDI-40EC 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. This device is not intended for mammography applications.

The Canon digital radiography CXDI-40EC is used to directly capture and convert conventional projection Xray 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 DICOM compatible digital network for printing. The device provides digital image capture for conventional film/screen radiographic examinations.

The provided text describes a 510(k) summary for the Canon CXDI-40EC digital radiography device. It focuses on demonstrating substantial equivalence to predicate devices and does not contain information about acceptance criteria, specific device performance metrics, or details of a study proving the device meets acceptance criteria in the manner requested (e.g., sample sizes, ground truth establishment, expert qualifications, MRMC studies, or standalone performance).

The summary primarily discusses:

• Device Description: The CXDI-40EC is a digital radiography device for capturing and converting X-ray images. Its key difference from a predicate (CXDI-40EG) is the use of CsI (Cesium Iodide) as the fluorescent screen material, leading to higher X-ray absorption, lower dose requirements, and approximately double the DQE (Detective Quantum Efficiency) compared to the GOS (Gadolinium Oxy Sulfide) used in CXDI-40EG. It is similar to CXDI-40C in sensor characteristics but differs in the control PC interface.
• Intended Use: Replaces radiographic film/screen systems in all general-purpose diagnostic procedures, excluding mammography.
• Substantial Equivalence: The submission asserts substantial equivalence based on similar amorphous silicon array specifications, imaging principle, intended use, and design control activities, despite the differences in fluorescent screen material and control PC interface.

Therefore, I cannot provide the requested information from the given text because it is not present in the document. The document is a regulatory submission focused on substantial equivalence to predicate devices, not a detailed performance study with explicit acceptance criteria and corresponding results.

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