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The ArtPix Mobile EZ2GO, is intended for use in general radiographic examinations by qualified/trained doctors or technicians, wherever conventional screen-film systems may be used, excluding fluoroscopy, angiography and mammography.

ArtPix Mobile EZ2GO allows imaging of the skull, chest, shoulders, spine, abdomen, and extremities. Applications can be performed with the patient sitting, standing, or lying in the prone or supine position.

The modified ArtPix Mobile EZ2GO is a flexible high-resolution Digital Radiography (DR) system that is designed to provide fast and smooth radiography examinations of sitting, standing or lying patient Imaging. The modified ArtPix Mobile EZ2GO consists of the following components: Tablet Computer, Flat Panel Detectors, Detector Removable batteries & Charger, and other optional components such as External Monitor for Docking Station, USB HUB, Bluetooth DAP device and Fix Room Access Point Support. Images may be transferred via a network using DICOM protocol for printing and storage in PACS.

The modified ArtPix Mobile EZ2GO can be used in combination with any conventional analog radiography system currently using film screen or CR, fixed or mobile, or other system capable of producing general radiography exposures.

The modified Artpix Mobile EZ2GO detector can be shared between multiple Artpix Mobile EZ2GO systems.

Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text.

Based on the provided document, the device described is ArtPix Mobile EZ2GO, an X-ray system. The document is a 510(k) summary for a Special 510(k) submission, indicating modifications to a previously cleared predicate device, PrestoDR 4143 [K110849](https://510k.innolitics.com/search/K110849).

It's important to note that this document is a 510(k) submission summary, which primarily aims to demonstrate substantial equivalence to a predicate device rather than providing a detailed report of a new clinical trial. Therefore, information regarding certain aspects like "sample size used for the test set," "number of experts used to establish ground truth," "adjudication method," and "MRMC comparative effectiveness study" are not typically part of a 510(k) summary for this type of device and are not present in the provided text. These elements are more common for AI/CADe devices or those requiring de novo classification with novel claims.

The "study" proving the device meets the acceptance criteria is primarily a verification and validation (V&V) process focused on demonstrating that the modified device's performance is equivalent to or better than the predicate device and that it meets established engineering and functional requirements, without raising new safety or effectiveness concerns.

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

The document focuses on comparing the modified device (ArtPix Mobile EZ2GO) to its predicate (PrestoDR 4143 [K110849](https://510k.innolitics.com/search/K110849)) across various technical specifications and performance characteristics rather than explicitly stating acceptance criteria in table form for each parameter and then listing the observed performance. Instead, it provides a comparative table and a general conclusion of acceptance.

However, we can infer some "acceptance criteria" from the comparison table (Section 1.9.2) and the V&V section (1.10). The primary acceptance criterion for this 510(k) is substantial equivalence to the predicate device in terms of fundamental scientific technology, indication for use, safety, and effectiveness.

Here's an inferred table based on the provided comparison:

Conclusion from the document: "The modified ArtPix Mobile EZ2GO system passed its acceptance criteria and is recommended for release."

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 does not specify a "sample size" in terms of patient data or images for testing the device's diagnostic performance, as it is a technical modification to an existing X-ray system rather than a new AI/CAD device. The "test set" in this context refers to the device itself being subjected to engineering verification and validation.

• Sample Size for Test Set: Not applicable in the context of patient data or clinical images. The testing refers to the system hardware and software.
• Data Provenance: Not applicable. The V&V focused on the device's technical specifications and functionality.

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 and is generally not required for a 510(k) summary concerning technical modifications to an X-ray imaging system. Establishing ground truth by experts is relevant for assessing diagnostic accuracy, which is not the primary focus of this type of submission (since the diagnostic capability relies on the predicate's established performance and the fundamental imaging physics).

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

This information is not provided and is not typically relevant for this type of 510(k) submission. Adjudication methods are used in clinical trials, particularly for diagnostic algorithms, where there might be disagreement among reviewers regarding the ground truth.

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 comparative effectiveness study was done or reported. This type of study is specific to devices, especially AI/CAD, that assist human readers in making diagnoses. The ArtPix Mobile EZ2GO is an X-ray imaging system itself, not an AI software. The submission focuses on demonstrating that the new hardware and software components maintain diagnostic image quality and system functionality equivalent to the predicate.

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

No standalone algorithm performance study was done or reported. The device is an integral imaging system requiring human operation (qualified/trained doctors or technicians). The submission does not claim any autonomous algorithmic diagnostic capabilities.

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

Since this is not a diagnostic AI/CAD device but an imaging system, the "ground truth" concept in the traditional sense (e.g., pathology for disease detection) is not directly applicable to the V&V described. The V&V focused on:

• Expected performance of software functions ("pass/fail" based on test protocols).
• Correctness of system integration.
• Measured image quality metrics (DQE, MTF) against expected engineering specifications which are themselves proxies for producing diagnostic quality images.
• Adherence to safety and electrical standards.

So, the "ground truth" essentially refers to engineered specifications and functional requirements.

8. The sample size for the training set

Not applicable. The ArtPix Mobile EZ2GO is an X-ray imaging device, not an AI/machine learning algorithm that requires a training set of data.

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

Not applicable. (See point 8).

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The PrestoDR 4143, is intended for use in general radiographic examinations, wherever conventional screen-film systems may be used, excluding fluoroscopy, angiography and mammography. PrestoDR 4143 allows imaging of the skull, chest, shoulders, spine, abdomen, and extremities.

The PrestoDR 4143 is a Digital Radiography system, featuring an integrated flat panel digital detector (FPD) and CMT's proprietary technology, which incorporates state of the art objectoriented software and connectivity. The legally marketed PrestoDR Portable K 100400 has been modified: To integrate the Pixium 4143 flat panel digital detector (FPD), improve its cost effectiveness, aging technologies and components (hardware and software) have been redesigned. The device major functions, intended use and principle of operation were not changed.

The provided text is a 510(k) summary for the PrestoDR 4143 device. It states that the device has been redesigned and its safety and effectiveness were verified and validated according to 21CFR 820.30 regulations. However, it does not contain the detailed information requested regarding specific acceptance criteria, study methodologies, or performance data beyond a general statement that "Tests data demonstrate that the PrestoDR 4143 meets the required specifications."

Therefore, I cannot fulfill your request for a table of acceptance criteria, device performance, sample sizes, ground truth establishment, expert qualifications, adjudication methods, or MRMC study details based solely on the provided text.

The information you are asking for typically resides in the detailed study reports submitted as part of the 510(k) premarket notification, which is not fully included in this summary.

Here's what can be extracted from the provided limited text:

• Device Name: PrestoDR 4143
• Submission Type: Special 510(k) Submission (meaning it's a modification to an already legally marketed device, K100400 PrestoDR 4143)
• Reason for Submission: To integrate a new flat panel digital detector (Pixium 4143 FPD), improve cost-effectiveness, and redesign aging technologies and components (hardware and software). The major functions, intended use, and principle of operation were not changed.
• Safety & Effectiveness Statement: "The device has been designed verified and validated complying with 21CFR 820.30 regulations. Tests data demonstrate that the PrestoDR 4143 meets the required specifications. No adverse affects have been detected."
• Substantial Equivalency: The manufacturer believes the PrestoDR 4143 is substantially equivalent in terms of safety and effectiveness to the predicate device, K100400 PrestoDR 4143.

In summary, the provided document does not contain the level of detail necessary to answer the specific questions about acceptance criteria, study design, or performance metrics.

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The Duet DRF is a digital image acquisition system to be used in conjunction with a solid state detector during radiography or fluoroscopy x-ray examination to capture, digitalize, review images and format images according to DICOM protocol to be sent through network connection. This device is not intended for mammography use

The Duet DRF is a Digital Radiography system, featuring an integrated flat panel digital detector (FPD) same as in K080859 DRF 4343, Villa sistemi medicali S.p.A. (this is the 510(k) for the system that incorporate the same flat panel detector and state of the art object-oriented software and connectivity.

The provided text describes the 510(k) submission for the Duet DRF device, a Digital Radiography system. However, it does not contain the detailed information requested regarding the acceptance criteria, specific performance study results, sample sizes for test sets or training sets, expert qualifications, or ground truth establishment methods.

The document states:
"The device has been designed verified and validated complying with 21CFR 820.30 regulations. Tests data demonstrate that the Duet DRF meets the required specifications. No adverse affects have been detected."

This is a general statement indicating that testing was performed to verify and validate the device, and that it met specifications. It does not provide the specifics needed for the requested information.

Therefore, for your current input, much of the requested information cannot be extracted. I will outline what can be gleaned and state where information is missing.

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

1. A table of acceptance criteria and the 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)

• Sample Size for Test Set: Not specified.
• Data Provenance: Not specified.

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)

• Number of Experts: Not specified.
• Qualifications of Experts: Not specified.
• Ground Truth Establishment Method for Test Set: Not specified. The document does not describe how ground truth was established for "tests data."

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

• Adjudication Method: 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

• MRMC Comparative Effectiveness Study: Not mentioned. The device is described as a "digital image acquisition system," not an AI-assisted diagnostic tool. Therefore, a study on human reader improvement with AI assistance would not be applicable based on the device description.

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

• Standalone Performance Study: Not explicitly mentioned in terms of diagnostic accuracy or a specific algorithm study. The "tests data" mentioned suggests performance tests were done for the system (hardware and software), but not specifically for a standalone algorithm's diagnostic capability. The device's primary function described is image acquisition, digitalization, review, and formatting, not automated diagnosis.

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

• Type of Ground Truth: Not specified.

8. The sample size for the training set

• Sample Size for Training Set: Not applicable/Not specified. The document primarily describes a hardware system for image acquisition. There's no indication of a machine learning model that would require a "training set" in the context of diagnostic AI.

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

• Ground Truth for Training Set Establishment: Not applicable/Not specified, as there is no mention of a training set.

Summary of Device and Safety/Effectiveness Claims from the Document:

• Device Name: Duet DRF
• Device Type: Digital Radiography system with an integrated flat panel digital detector.
• Purpose: To capture, digitalize, review, and format X-ray images during radiography or fluoroscopy examinations, sending them via DICOM protocol.
• Predicate Device: K080859 DRF 4343
• Intended Use: Not for mammography.
• Safety & Effectiveness Claim: The device has been designed, verified, and validated complying with 21CFR 820.30 regulations. "Tests data demonstrate that the Duet DRF meets the required specifications. No adverse affects have been detected." The manufacturer believes it is substantially equivalent in safety and effectiveness to the predicate device.

Conclusion:

The provided text serves as a 510(k) summary, which often focuses on substantial equivalence to a predicate device and general declarations of meeting regulatory requirements. It does not delve into the detailed technical specifications, specific acceptance criteria, or performance study methodologies and results that would typically be found in a detailed validation report. Therefore, most of the specific questions about acceptance criteria, test set details, expert involvement, and ground truth establishment cannot be answered from this document.

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The PrestoDR Portable ™, is intended for use in general radiographic examinations, wherever conventional screen-film systems may be used, excluding fluoroscopy, angiography and mammography. PrestoDR Portable ™ allows imaging of the skull, chest, shoulders, spine, abdomen, and extremities.

The PrestoDR Portable is a Digital Radiography system, featuring an integrated portable flat panel digital detector (FPD) K090625 WIRELESS PORTABLE DETECTOR FD-W17, Philips Medical Systems North America CO (this is the 510(k) for the wireless portable flat panel detector) and CMT's proprietary technology, which incorporates state of the art object-oriented software and connectivity. The legally marketed SMARTRAD K003438 has been modified: To integrate the portable flat panel digital detector (FPD) K090625, improve its cost effectiveness, aging technologies and components (hardware and software) have been redesigned. The device major functions and principle of operation were not changed.

The provided text is a 510(k) Summary and related FDA correspondence for the PrestoDR Portable, a Digital Radiography system. It focuses on establishing substantial equivalence to predicate devices rather than presenting a detailed study proving performance against specific acceptance criteria for AI or diagnostic accuracy.

The document indicates that the PrestoDR Portable is primarily a hardware and software system for general radiography, replacing conventional screen-film systems. The "Reason for 510(k) Submission" states it's a "Special 510(k) Submission" due to integration of a portable flat panel digital detector and redesign of "aging technologies and components (hardware and software)." It explicitly says, "The device major functions and principle of operation were not changed."

Therefore, the submission does not contain the detailed study results, acceptance criteria for device performance (especially in a diagnostic context), or specific data regarding AI-driven diagnostic improvements as requested in the prompt. The text focuses on regulatory compliance and substantial equivalence to a predicate device, as opposed to a clinical performance study with specific diagnostic accuracy metrics.

Here's a breakdown of why most of the requested information cannot be found in the provided text:

1. Table of acceptance criteria and the reported device performance

• Not found. The document states, "Tests data demonstrate that the PrestoDR Portable meets the required specifications." However, it does not specify what those specifications or acceptance criteria are, nor does it provide a table of reported device performance against them. The focus is on safety and effectiveness through substantial equivalence and compliance with 21CFR 820.30 regulations for design, verification, and validation, rather than specific clinical performance metrics.

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

• Not found. No information is provided about any specific test set, its sample size, or data provenance. The submission describes a device modification and asserts substantial equivalence, which typically relies on demonstrating that the modified device performs similarly to the predicate, rather than new clinical trials measuring diagnostic accuracy.

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 found. Since no specific test set or clinical performance study is described, there is no mention of experts establishing ground truth.

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

• Not found. No adjudication method is described because no specific test set or study requiring such a method 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

• Not found. The document does not describe an MRMC study or any AI assistance. The device is a digital radiography system; while it uses "state of the art object-oriented software," this doesn't imply an AI-driven diagnostic aid that would require an MRMC study to show human reader improvement with AI.

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

• Not found. There is no mention of a standalone algorithm performance study.

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

• Not found. No ground truth type is specified, as no clinical performance study involving diagnostic accuracy is detailed.

8. The sample size for the training set

• Not found. There is no mention of a training set, as the document doesn't describe the development or validation of a diagnostic algorithm based on machine learning.

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

• Not found. Consequently, no information is provided on how ground truth for a training set was established.

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The SmartSPOT PrimaX enhances the quality of the fluoroscopy image, enables acquisition and display of high quality resolution (1024X1024 pixels) radiographic images and gives the user the possibility to perform advanced studies involving image digital subtraction, such as Road mapping and DSA, that were not possible with conventional technique. Fields of application of the system are: gastrointestinal examinations, interventional procedures, peripheral angiography studies, urology examinations and other routine fluoroscopy studies

The SmartSPOT PrimaX is a high-resolution digital imaging system designed for Digital Spot Imaging. The system is based on a PC Workstation running Windows XT as the operating system. The legally marketed SMARTSPOT K961307 has been modified: To improve its cost effectiveness, aging technologies and components (hardware and software) have been redesigned. The device major functions and principle of operation were not changed.

The provided S510(k) summary for the Koro890 SmartSPOT PrimaX describes the device as a high-resolution digital imaging system for Digital Spot Imaging, indicating it's an update to a previously marketed device (SMARTSPOT K961307). However, the submission does not include specific acceptance criteria or details of a study proving the device meets acceptance criteria in the format explicitly requested.

Instead, the document focuses on demonstrating substantial equivalence to a predicate device by stating: "Tests data demonstrate that the SMARTSPOT PrimaX meets the required specifications. No adverse affects have been detected." and highlighting changes made to improve cost-effectiveness and update aging technologies/components, while asserting that "The device major functions and principle of operation were not changed."

Therefore, it's not possible to populate the requested table and answer the study-related questions based on the provided text. The document is a regulatory submission for a 510(k) clearance, which primarily focuses on demonstrating substantial equivalence rather than presenting detailed performance study results with specific acceptance criteria.

Information NOT available in the provided text:

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

The document states that "The device has been designed verified and validated complying with 21 CFR 820.30 regulations," which refers to the Quality System Regulation, outlining general requirements for design controls, but does not provide the specific performance data or acceptance criteria.

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The SmartSpot 2000 is indicated for the acquisition, storage, processing (enhancement), printing and display of fluoroscopic and digital x-ray spot images.

Not Found

The provided text is a 510(k) clearance letter from the FDA for the SmartSpot 2000 Image Processing System. This document does not contain information about acceptance criteria, study details, or performance metrics for the device.

Therefore, I cannot provide the requested information. The letter primarily states that the device is "substantially equivalent" to legally marketed predicate devices, allowing its marketing. It does not elaborate on the specific studies or data that led to this determination, nor does it define acceptance criteria for the device's performance.

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The SMARTSPOT enhances the quality of the fluoroscopy image, enables acquisition and display of high resolution (1024 x 1024 pixels) radiographic images and gives the user the possibility to perform advanced studies involving image digital subtraction, such as Roadmapping and DSA, that were not possible with conventional techniques.

Fields of application of the system are: gastrointestinal examinations, interventional procedures, peripheral angiography studies, urology examinations and other routine fluoroscopy studies.

The SMARTSPOT is a high resolution digital system for Digital Spot Imaging in Radiography/Fluoroscopy (R/F) X-ray rooms. It is designed to reduce (and even replace) the use of cassette filming and 105 mm spot cameras, and in this way reduce overall patient radiation exposure and examination time.

The system is based on a computer workstation running Windows NT as the operating system. The other main components are: a high resolution CCD camera, an advanced video processor, operation room and control room monitors, X-ray and TV interfaces, Hardcopy Laser Camera interface and a 2 GBytes internal hard disk.

This 510(k) summary does not contain information about acceptance criteria or a study proving the device meets acceptance criteria in the way typically expected in modern regulatory submissions for AI/ML devices. The "SMARTSPOT" device from CMT Medical Technologies Ltd. (K961307) is a high-resolution digital imaging system, not an AI/ML device in the contemporary sense. The document primarily focuses on its intended use, comparison to a predicate device, and safety information based on general medical device standards.

Here's an analysis based on the provided text, highlighting the absence of the requested information:

Analysis of Provided Information:

The document describes the SMARTSPOT as a "high resolution digital system for Digital Spot Imaging," designed to "reduce (and even replace) the use of cassette filming and 105 mm spot cameras, and in this way reduce overall patient radiation exposure and examination time." Its primary function is to "enhance the quality of the fluoroscopy image, enable acquisition and display of high resolution (1024 x 1024 pixels) radiographic images and gives the user the possibility to perform advanced studies involving image digital subtraction, such as Roadmapping and DSA."

The comparison to the predicate device (S&S Inficon Inc.'s FC 2000, K911454) states: "Both systems have the same intended use. They have almost identical features, same spatial resolution and same digitization depth." The main difference highlighted is the camera type (digital CCD vs. Pick-up tube), with CCD cameras noted for "comparable spatial resolution and dynamic range" and outperforming in "cost-effectiveness and long term stability."

Absence of Requested Information:

The provided 510(k) summary does not contain any of the following information relevant to acceptance criteria or a study proving performance as typically understood for AI/ML devices:

1. A table of acceptance criteria and the reported device performance: There are no specific quantitative performance metrics (e.g., sensitivity, specificity, AUC) or defined acceptance thresholds for such metrics presented. The document states a general goal of "enhancing image quality" and enabling higher resolution, but no measurable criteria are given.

2. Sample size used for the test set and the data provenance: No test set is described, nor is any sample size, country of origin, or whether the data was retrospective/prospective.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: No ground truth establishment for a test set is mentioned because no test set analysis is presented.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable as no test set analysis 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: Not applicable. This is not an AI-assisted diagnostic device. The comparison is between a new digital imaging system and existing conventional methods (cassette filming, 105mm spot cameras) or a predicate digital imaging system. The "effect" described is primarily related to image quality, resolution, and procedural efficiency (reduced radiation, examination time), not human reader performance with AI.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable. This is an imaging hardware and software system, not an AI algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable as no specific performance evaluation based on ground truth is described.

8. The sample size for the training set: Not applicable as it's not an AI/ML device that undergoes training on image data in the described manner.

9. How the ground truth for the training set was established: Not applicable.

Summary Conclusion based on the document:

The 510(k) summary for the SMARTSPOT device (K961307) focuses on establishing substantial equivalence to a predicate device (FC 2000, K911454) based on similar intended use, features, spatial resolution, and digitization depth, while highlighting improvements in technology (CCD camera) and efficiency. It does not provide the type of detailed performance data, acceptance criteria, ground truth methodology, or study design typically associated with AI/ML devices, as those concepts were not applicable to this type of device and regulatory submission in 1996. The "study" mentioned is primarily related to compliance with general medical device safety standards (IEC 601-1) and internal "beta testing to meet specifications," rather than a clinical performance study with defined endpoints and statistical analysis as would be expected for a diagnostic AI.

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