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This device is intended to be used in radiology. This collimator is to be used in conjunction with an x-ray generator and x-ray tube to limit the area of radiation that is emitted to a confined field of view. This limits the potential for radiation to the general population in the exam area. This device is for diagnostic use.

This collimator is to be used in conjunction with an x-ray generator and x-ray tube to limit the area of radiation that is emitted to a confined field of view.

The provided text is a 510(k) premarket notification letter from the FDA to Shimadzu Corporation regarding their R-300 device, a diagnostic x-ray beam-limiting device (collimator).

This document does not contain any information about acceptance criteria or a study that proves the device meets specific performance criteria.

Instead, it's a letter stating that the FDA has reviewed the 510(k) submission and determined the device is substantially equivalent to legally marketed predicate devices. This means the FDA believes the new device is as safe and effective as a device already on the market without requiring new clinical trials or extensive performance studies.

Therefore, I cannot provide the requested information in the table format or answer the specific questions about sample sizes, ground truth, expert qualifications, or MRMC studies, as this document does not contain that level of detail. The information presented is focused on regulatory approval based on substantial equivalence to existing devices, not on de novo performance testing against specific acceptance criteria.

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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 R-30H is used to take the radiography of patients. The intended for use of the R-30H are also the same as of the predicate beam limiting device R-30H (K031771).

Not Found

I am sorry, but the provided text does not contain information about acceptance criteria, device performance, or any studies conducted on the R-30H. The document is an FDA 510(k) clearance letter for the R-30H, an angiographic x-ray system. It states that the device is substantially equivalent to a predicate device and can be marketed, but it does not detail any performance studies, acceptance criteria, or specific metrics.

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Model R225 ACS Automatic X-RAY Collimator is intended for use in diagnostic radiographic/fluoroscopic applications.

This x-ray collimator Multilayer, square-field, automatic collimation system. Stepper motors control the movements of shutters and the additional filter. There is a mounting plane at 80 mm (3.15") from the focus. A microprocessor circuit controls the stepper motors and provides the stepless adjustment of the square field dimensions at variable FFD (SID). The field dimensions may be decreased and increased to the set value by two knobs placed on the collimator front panel.

The provided text describes a submission for a 510(k) premarket notification for the RALCO Model R225 ACS Automatic X-RAY Collimator. This device is a collimator, which is a component of an X-ray system, and therefore, the assessment criteria and study design are different from those for AI-powered diagnostic devices.

The submission focuses on establishing substantial equivalence to a predicate device (K072780, Ralco Model R302DACS Automatic Collimator) rather than demonstrating a specific performance metric against a "ground truth" in the way an AI diagnostic algorithm would.

Based on the provided text, here's a breakdown of the requested information:

1. Table of acceptance criteria and the reported device performance:

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

• Test Set Sample Size: Not applicable in the context of this submission. The submission relies on "bench, safety test, and laboratory testing" rather than a clinical dataset with a specific "test set" for performance evaluation against a diagnostic ground truth.
• Data Provenance: Not explicitly stated as clinical data from specific countries or retrospective/prospective studies. The testing is described as "bench, safety test, and laboratory testing," which typically refers to engineering and quality assurance activities conducted by the manufacturer (RALCO srl in Biassono, Italy).

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

• Not applicable. This is not a study requiring expert consensus for a diagnostic "ground truth." The evaluation focuses on the engineering performance and safety of the collimator itself, which are assessed through engineering tests and adherence to standards.

4. Adjudication method for the test set:

• Not applicable. There is no specific "test set" requiring adjudication in the context of this submission.

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. This device is a hardware component (an X-ray collimator), not an AI algorithm intended to assist human readers.

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

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

7. The type of ground truth used:

• Not applicable in the sense of clinical diagnostic ground truth (e.g., pathology, patient outcomes). The "ground truth" here is adherence to engineering specifications, safety standards (e.g., CSA Listed to US Standards), and functional equivalence to the predicate device as demonstrated through "bench, safety test, and laboratory testing."

8. The sample size for the training set:

• Not applicable. This is a manufactured hardware device, not a machine learning model that requires a training set.

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

• Not applicable. As noted above, this device does not involve a training set or associated ground truth in the context of machine learning.

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Model R605DASM Automatic X-RAY Collimator is intended for use in diagnostic radiographic/fluoroscopic applications.

This device is a compact radiological automatic collimating system for round and elliptic fields designed to operate with a mobile "C" arm Image Intensifier cquipment. The round and elliptical fields are defined as follows: The round field by 8 lead shutters located near the exit window and a brass cone near the x-ray focus; the elliptical field by the round field and two pairs of lead rectangular shutters located near the collimator entrane window. Round and elliptical field shutters are controlled by 5 stepping motors. The circlinator features a microprocessor circuit built into the collimator to control the 5 stepping-motornia external signal source with CanBus protocol. The circuits return a CanBus protocol signal to indicate correct motor positioning. The two pairs of lead rectangular shutters move isignify and both rotate ± 360° ..

This document is a 510(k) summary for the Ralco Model R605DASM Automatic X-RAY Collimator. It describes the device, its intended use, and argues for its substantial equivalence to a predicate device.

Here's the breakdown regarding acceptance criteria and the study, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state numerical acceptance criteria in terms of performance metrics (e.g., accuracy, precision, error rates) for the device. Instead, the "acceptance criteria" are implied to be adherence to general safety and effectiveness standards, and substantial equivalence to a legally marketed predicate device.

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

The document mentions "bench, safety test, and laboratory testing" but does not provide details on the sample size used for any test sets or the data provenance (e.g., country of origin, retrospective/prospective nature). It focuses on the physical characteristics and control mechanisms of the collimator.

3. Number of Experts Used to Establish Ground Truth and Qualifications

This information is not applicable and not provided. The device described is an automatic X-ray collimator, a hardware component that limits the X-ray beam. Its performance is assessed through engineering and safety tests, not through clinical interpretation requiring expert consensus on ground truth (like in image analysis AI).

4. Adjudication Method for the Test Set

This information is not applicable and not provided. As mentioned above, the assessment is based on physical and functional testing, not on clinical adjudication of interpretations.

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

No, a MRMC comparative effectiveness study was not done. This type of study is relevant for devices that provide diagnostic interpretations or assist human readers in making decisions (e.g., AI for image analysis). The Ralco Model R605DASM is a hardware device for controlling X-ray beams.

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

This is not directly applicable in the typical sense of an "algorithm only" standalone performance study for an AI device. The device itself is an automatic collimator, meaning it operates autonomously to control the X-ray beam based on its internal programming and external signals. The "tests" performed would assess its standalone mechanical and electronic performance, in that sense, it is "standalone." However, this is not a standalone AI algorithm performance.

7. The Type of Ground Truth Used

The "ground truth" for this device would be established engineering specifications, safety standards, and the physical accuracy of the collimator's movements and beam-limiting capabilities. For example:

• Engineering Specifications: Whether the 5 stepping motors accurately position the shutters.
• Safety Standards: Adherence to US Performance Standards and CSA Listing for safety.
• Functional Testing: The ability to correctly define round and elliptical fields as intended.

8. The Sample Size for the Training Set

This information is not applicable and not provided. The device is a mechanical and electronic system, not an AI model that requires a "training set" in the context of machine learning.

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

This information is not applicable and not provided. As explained in point 8, there is no "training set" in the typical sense for this device.

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Model R302DACS/A Automatic X-RAY Collimator is intended for use in diagnostic radiographic/fluoroscopic applications.

Model R302DACS/A Automatic X-RAY Collimator is an Automatic X-ray beam-limiting system with a multilayer square field collimator. Stepper motors drive shutter movements as well as additional filters and the round field if these two features are mounted. A microprocessor circuit controls the stepper motors and provides the stepless adjustment of the square field dimensions at variable FFD (SID). The two stepper motors that provide shutter control may also be manually adjusted by the two knobs or by the pushbuttons located on the front panel. Two boards built into the collimator allow direct control of the system via CAN-Bus protocol.

The provided text is a 510(k) summary for the RALCO srl Model R302DACS/A Automatic X-RAY Collimator. It describes the device, its intended use, and claims substantial equivalence to predicate devices. However, the document does not contain specific acceptance criteria, detailed study designs, or reported device performance metrics that would allow for the comprehensive completion of the requested table and study information.

The document primarily focuses on establishing substantial equivalence based on safety and effectiveness compared to predicate devices, rather than presenting a performance study with defined acceptance criteria and quantitative results for the new device.

Therefore, I cannot populate the table or provide the requested study details as the information is not present in the provided text.

Here is an explanation of why the requested information cannot be extracted:

• Acceptance Criteria and Reported Device Performance: The document states, "The results of bench, safety test laboratory and user testing indicates that the new device is as safe and effective as the predicate device." It also mentions "analyzing both bench and safety testing data." However, it does not define what these "results" or "data" actually are, what specific performance metrics were measured (e.g., accuracy of collimation, field size precision), nor what the predefined "acceptance criteria" for these metrics were.
• Sample Size, Data Provenance, Expert Ground Truth, Adjudication, MRMC, Standalone, Training Set Details: None of this information is available in the provided text. The submission focuses on regulatory compliance and comparison to predicate devices, not on a detailed clinical or technical performance study with these elements.
• Type of Ground Truth: While it mentions "bench, safety test laboratory and user testing," it doesn't specify if this involved expert consensus, pathology, or other forms of "ground truth" as typically understood in a performance study for AI/diagnostic devices. For an X-ray collimator, ground truth would likely relate to the actual dimensions and alignment of the X-ray field versus the device's output, but this is not detailed.

In summary, the provided 510(k) pertains to a hardware device (X-ray collimator) and emphasizes regulatory equivalence based on general safety and effectiveness. It does not include the type of detailed performance study data, acceptance criteria, or ground truth establishment typically found for AI/software-based diagnostic devices.

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The Collimare "Collimator Family" and/or variations is used to control the x-ray beam for use on diagnostic imaging equipment during radiographic and fluoroscopic procedures. It is designed to be adapted to various x-ray systems.

The Collimare "Collimator Family" and/or variations is used to control the x-ray beam for use on diagnostic imaging equipment. The intended usage is all portable/fixed, manual and automatic, Radiographic, Fluoroscopic, rectangular, square and/or circular shuttering. It can encompass a light simulation, spectral filters, wedge filters, input port shuttering, dose measurement, laser alignment indicating lines and/or mechanical or digital SID measurement.

The provided text describes a 510(k) premarket notification for the Collimare "Collimator Family" device, which is an X-ray beam limiting device. However, it does not contain any information about acceptance criteria or a study proving the device meets those criteria, device performance, sample sizes, ground truth establishment, or any details related to AI/human reader studies.

The document primarily focuses on:

• Submission details: Submitter, contact, common/trade/classification names, predicate devices.
• Device description and intended use: Control of X-ray beams for diagnostic imaging.
• Performance standards / Safety Information: References existing regulatory standards (21 CFR Section 1020.30, .31 & .32; UL 60601-1; IEC 60825-1).
• FDA correspondence: The FDA's determination of substantial equivalence to predicate devices.
• Indications for Use statement.

Therefore, I cannot provide the requested information in the table or answer the specific questions as the input text does not contain it. This type of document, a 510(k) summary and FDA decision letter, typically attests to compliance with established safety and performance standards rather than presenting novel clinical study data with specific acceptance criteria as you might see for a diagnostic AI device.

In summary, none of the requested information regarding acceptance criteria, device performance, study details, sample sizes, ground truth, or MRMC/standalone studies is present in the provided text.

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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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The Dunlee "FORMAT" collimator family restricts the dimensions of the diagnostic X-rav field by limiting the size of the primary X-ray beam.
The Dunlee manual "FORMAT M" collimators are intended for use in diagnostic X-ray systems during radiographic examinations.
The Dunlee automatic "FORMAT A" collimators are intended for use in diagnostic X-ray systems during radiographic and fluoroscopic examinations.

The Dunlee "FORMAT" collimator family is a family of Beam-Limiting Devices, which comprises both manual and automatic collimators. The manual collimators are to be used in diagnostic radiographic X-ray systems, and the automatic collimators are to be used in both diagnostic fluoroscopy X-ray systems and diagnostic radiographic X-ray systems.

This 510(k) summary describes a device called the "Dunlee 'FORMAT' collimator family," which comprises both manual and automatic collimators for diagnostic X-ray systems. The submission asserts that this device is substantially equivalent to legally marketed predicate devices.

Here's an analysis of the provided text in relation to your request:

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

The provided document does not explicitly state specific quantitative acceptance criteria or detailed device performance metrics in a table format. Instead, it focuses on general compliance with safety and performance standards and substantial equivalence to predicate devices.

However, based on the Safety Information section, we can infer the acceptance criteria are compliance with:

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

The document does not mention a traditional "test set" sample size or data provenance in the context of a clinical performance study. The evaluation presented is one of compliance with standards and substantial equivalence to predicate devices, not direct performance data from a specific patient cohort.

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 or provided in the document. The substantial equivalence determination for this type of device (X-ray collimator) typically relies on engineering specifications, safety standards, and comparison to existing devices, rather than a "ground truth" derived from expert image interpretation or patient outcomes.

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

This information is not applicable or provided. There is no mention of a test set that would require an adjudication method.

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:

This document does not describe an MRMC comparative effectiveness study. The device is an X-ray beam-limiting device (collimator), not an AI-powered diagnostic or assistive tool for human readers. Therefore, this section is not relevant.

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

This document does not describe a standalone performance study in the context of an algorithm. The device is hardware (a collimator), not a software algorithm.

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

As discussed, a traditional "ground truth" for clinical performance is not applicable to the submission for an X-ray collimator. The "truth" in this context is adherence to engineering specifications, regulatory standards, and the demonstrated functionality of the device in limiting X-ray beams as intended.

8. The sample size for the training set:

The document does not mention a "training set" sample size. This is not an AI/machine learning device that undergoes a training phase with data.

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

This information is not applicable as there is no "training set" for this type of device.

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The Philips NICOL Collimator is intended for use in diagnostic x-ray systems during radiographic and fluoroscopic examinations. The collimator restricts the dimensions of the diagnostic x-ray field by limiting the size of the primary x-ray beam.

The NICOL collimator family of Beam Limiting Devices which may be used in all Philips Radiographic, Universal Radiographic/Fluoroscopic, Cardio and Vascular systems. It will provide rectangular shuttering, circular shuttering, or a combination of both. It will provide a light simulation of the X-ray field, spectral filtering, wedge filtering, dose measurement, and mechanical or electronic SID measurement.

This document is a 510(k) summary for the Philips NICOL Collimator Family. It provides information about the device's intended use and compliance with safety standards, but it does not contain details about acceptance criteria, specific device performance metrics, or any studies involving test sets, ground truth establishment, or human reader performance.

Therefore, I cannot provide the requested information. The provided text is a regulatory submission summary, not a clinical or performance study report.

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