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R104/A, R108 and R108 F Manual X-Ray Collimators are intended for use in diagnostic radiographic/fluoroscopic applications.

These are square-field single- or, optionally, multi-layer x-ray collimators. They are lightweight and compact, suited for installation on mobile of fired x-ray equipment. In the standard single- layer version, the x-ray field is defined by two pairs of shutters and a conc at the xray beam window. In the version mounting RO 334, he x-ray field is defined by six pairs of shutters, two of which are leadlined. The six pairs of shutters move perpendicularly within the x-ray field. Four pairs of shutters are in bronze: two are located near the focus and two are leated near the entrance window. Two leaded shutters are located near the exit window of the x-ray beam from the collimator and serve to accurately define the x-ray field edges. Shutter movements are manual and controlled by two knobs on the collimator from panel. The square-field X-ray beam Limiting Device is designed for installation on rotating or fixed anode Xray tubes (mounting RO 334) (EN 60601-1-3 par 29.202.3); manual controls provide for the adjustment of the X-ray field dimension to the size of the image receptor or to that of the anatomical area of interest. Adjustment to the area under investigation is possible by using the knobs on the front panel. Direct visualisation of the x-ray field is provided by a light beam which corresponds to the x-ray bean, within a tolerance of two percent of the selected FFD (SID) value. The light-field centre is provided by the intersection of two perpendicular lines silk-screened into the Lexan window and projected on the light field by the light beam. To activate the light field, press the area marked with the light symbol on the front of the device. The light will switch on for 30 seconds and an electronic timer will switch the lamp OFF automatically.

The provided K110856 document details the premarket notification for RALCO's R104/A, R108, and R108 F Manual X-Ray Collimators. However, it does not contain specific acceptance criteria or an explicit study report with performance metrics in the way a clinical trial or algorithm validation study would.

Instead, this submission focuses on establishing substantial equivalence to a predicate device (K030487 Ralco R72 Manual Collimator) based on bench testing and safety testing. The core argument is that the new devices are "as safe and effective" as the predicate device due to similar design, intended use, and conformance to US Performance Standards.

Here's an analysis based on the information provided, highlighting what is and is not present:

1. Table of Acceptance Criteria and Reported Device Performance

Missing Information:

• Specific quantitative metrics for "safety" and "effectiveness" are not provided. For example, there are no reported measurements of radiation leakage, field size accuracy (beyond the 2% tolerance claim), or shutter precision from the bench tests.
• The document does not elaborate on the specific "bench, safety test, and laboratory testing" that led to these conclusions.

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

• Sample Size: Not specified. The document refers to "bench, safety test, and laboratory testing" but does not provide details on the number of units tested or the specific conditions.
• Data Provenance: Not specified, but generally, bench and laboratory testing for a device like this would be conducted by the manufacturer (Ralco srl, in Italy). The testing would be prospective in nature, as it's part of the design verification and validation process for the new device.

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

• This type of information is not applicable to this submission. The device is a mechanical X-ray collimator. Its performance is evaluated through engineering and physical measurements (e.g., light field accuracy, shutter movement, structural integrity, electrical safety), not through expert interpretation of medical images or clinical outcomes. Therefore, there is no "ground truth" derived from medical experts in the context of a diagnostic reading study.

4. Adjudication Method for the Test Set

• Not applicable. See point 3. Adjudication methods (like 2+1, 3+1) are used in studies involving human interpretation or subjective assessments, typically for AI algorithms or reader performance studies. This is a physical device.

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 submission is for a physical medical device (X-ray collimator), not an AI-powered diagnostic tool. Therefore, no MRMC study or AI assistance evaluation was performed or is relevant to this submission.

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

• The "ground truth" for this device's performance would be objective physical measurements and engineering specifications, e.g., using calibrated measuring equipment to verify dimensions, light intensity, field accuracy, mechanical movement tolerances, and electrical safety parameters. It is not based on expert consensus, pathology, or outcomes data in the medical sense.

8. The Sample Size for the Training Set

• Not applicable. This is a physical device, not a machine learning model. There is no concept of a "training set" for its development or validation.

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

• Not applicable. See point 8.

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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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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 document is an FDA 510(k) clearance letter for the R-201 device, which is a diagnostic x-ray beam-limiting device (collimator).

Unfortunately, this document does not contain the detailed information necessary to answer the questions about acceptance criteria and the study that proves the device meets those criteria.

The letter primarily provides:

• Confirmation of substantial equivalence to predicate devices.
• The device's regulation number, name, and product code.
• Indications for use.
• General regulatory information and requirements for marketing the device.

It does not include:

1. A table of acceptance criteria or reported device performance.
2. Details about sample sizes, data provenance, or ground truth establishment for any studies.
3. Information on expert qualifications, adjudication methods, or MRMC studies.
4. Data on standalone algorithm performance.
5. Training set details.

To answer these questions, one would need to review the original 510(k) submission (K101036) document, which would contain the performance data and testing methodology used to demonstrate substantial equivalence. The provided FDA letter is merely the agency's response to that submission.

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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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Model R 72B Manual X-RAY Collimator is intended for use in diagnostic radiographic or fluoroscopic applications fluoroscopic applications.

This is a compact collimator with an external cover in ABS plastic. It is a single-layer, square field radiological collimator. Its light weight and compact size allow cass. positioning and make it ideal for mobile and portable units. The X-ray field size is limited by two pairs of lead shutters controlled by two knobs located on the sides of the collimator and by o yead disc near the x-ray focus to reduce scattered radiation. An indexed scale provides information on the field set with the knobs.

This 510(k) summary describes a manual X-ray collimator (Model R 72B) and primarily focuses on demonstrating its substantial equivalence to a predicate device rather than presenting a performance study with acceptance criteria in the typical sense for algorithm-based devices.

Here's an analysis based on the provided text, addressing the points where information is available or noting where it's not applicable for this type of submission:

1. Table of Acceptance Criteria and Reported Device Performance

Summary of Device Performance: The device (Model R 72B Manual X-Ray Collimator) was determined to be substantially equivalent to the predicate device (Ralco Model R72, K030487) based on bench, safety, and laboratory testing. It is reported to be identical in components and specifications, conforms to US Performance Standards, is CSA Listed, has few technological differences, and shares identical indications for use.

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

This information is not applicable in the context of this 510(k) submission. This submission is for a physical medical device (an X-ray collimator) and focuses on engineering specifications, safety testing (bench, electrical, mechanical), and comparison to a predicate device. It does not involve a "test set" of clinical data to evaluate an algorithm's performance.

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

This information is not applicable. Since there is no "test set" in the context of a clinical performance study involving image interpretation by experts, there is no ground truth established by experts.

4. Adjudication Method for the Test Set

This information is not applicable for the reasons stated above.

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

No. This submission is for a physical X-ray collimator, not an AI or imaging software device that would typically undergo an MRMC study to evaluate human reader performance with or without AI assistance.

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

No. This device is a manual X-ray collimator; there is no embedded algorithm to evaluate in a standalone capacity.

7. The Type of Ground Truth Used

The "ground truth" for this device relates to its engineering specifications, safety features, and performance as a physical component in an X-ray system. This would be established through:

• Engineering specifications and drawings: Defining the design, materials, and dimensions.
• Bench testing: Verifying mechanical function, field size accuracy, light field/X-ray field congruence, leakage radiation, etc.
• Safety testing: Ensuring electrical safety, radiation safety (e.g., leakage radiation limits), and compliance with relevant standards (e.g., CSA listing).
• Comparison to predicate device: Direct comparison of features and performance characteristics to the legally marketed predicate.

8. The Sample Size for the Training Set

This information is not applicable. There is no "training set" in the context of an AI or algorithm development for this physical device.

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

This information is not applicable for the reasons stated above.

In summary: K093596 is a 510(k) for a manual X-ray collimator. The approval is based on demonstrating substantial equivalence to a predicate device (Ralco Model R72, K030487) through bench, safety, and laboratory testing, confirming identical components, specifications, and indications for use, and adherence to relevant performance and safety standards. The concepts of clinical test sets, ground truth by experts, and AI performance evaluations are not relevant to this type of device submission.

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The VeriSuite patient position system is used for verification and correction of the patient's position during a radiotherapy treatment with external beams or charged particles. It is based on stereoscopic X-ray images and DRRs calculated from a CT image series of the treatment region of the patient and information from the treatment planning.

VeriSuite is an image processing system for verification and correction of the patient position during a radiation therapy treatment. The verification or correction is performed by a comparison of X-ray images that are acquired during the treatment with DRRs (digital reconstructed radiographs) calculated from a CT image series of the patient and information from the radiation therapy planning, The correction can also be based on fiducial, radio-opaque markers that are implanted in the patient.

VeriSuite is a system of devices consisting of the VeriSuite software and a number of hardware devices:

• Beam limiting collimator device (Ralco 302)
• X-ray generator (Sedecal XHF 835) -
• X-ray tubes (Varian A277 or A272)
• Flat panel digital imager (Varian 4030E -
  Optional:
  All these hardware devices are legally marketed in the US as listed in previous section D.

This document, a 510(k) submission for VeriSuite 1.8, does not contain information regarding detailed acceptance criteria, the methodology of a study to prove device performance against these criteria, or specific data pertaining to ground truth establishment, expert qualifications, or sample sizes for training and test sets.

The document primarily focuses on:

• Device Identification: Trade names, common names, classification, and product codes of VeriSuite and its components.
• Predicate Device: Details of VeriSuite 1.6 and other predicate devices (X-Ray Generator, X-Ray Tubes, Flat Panel Digital Imager, Collimator).
• Device Description: VeriSuite is an image processing system for verifying and correcting patient position during radiation therapy by comparing X-ray images with DRRs or fiducial markers. It's a system comprising software and legally marketed hardware components.
• Intended Use: Verification and correction of patient position during radiation therapy using stereoscopic X-ray images and DRRs. Emphasizes evaluation and approval by an authorized person, and notes it's not for diagnostic purposes.
• Summary of Technical Considerations: States substantial equivalence to the predicate device.
• FDA Communication: A letter from the FDA confirming the review of the 510(k) premarket notification and determining substantial equivalence for the stated indications for use.
• Indications for Use Statement: A formal statement on the intended use of the VeriSuite patient position system.

Therefore, I cannot provide the requested information as it is not present in the provided text.

To answer your request, the document would need to include sections on:

1. Clinical Performance Study, Validation Study, or Bench Testing: Describing the study design, objectives, and methods for evaluating the device's accuracy and performance.
2. Acceptance Criteria: Specific quantitative thresholds for performance metrics (e.g., accuracy, precision, repeatability) that the device must meet to be considered safe and effective.
3. Study Results: The measured performance of the device against the established acceptance criteria.
4. Sample Size and Data Provenance: Details on the number of cases/patients used, where the data originated (e.g., specific hospitals, countries), and whether it was collected retrospectively or prospectively.
5. Ground Truth Establishment: How the "true" patient position or correction vector was determined for the study data, including the number and qualifications of experts involved, and their adjudication method (e.g., consensus, majority vote).
6. Standalone vs. Reader Study: Whether the device's performance was evaluated independently (algorithm only) or as part of a human-in-the-loop study (MRMC). If MRMC, the effect size of AI assistance on human readers.
7. Training Data: Information on the size and characteristics of the dataset used to train the VeriSuite algorithm (if applicable, as this is an older device submission, specific AI/ML training details might not be explicit in this format).
8. Training Ground Truth: How the ground truth for the training set was established.

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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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The VeriSuite patient position verification system is used for verification and correction of the patient's position during a radiotherapy treatment with external beams or charged particles. It is based on stereoscopic X-ray images and DRRs calculated from a CT image series of the treatment region of the patient and information from the treatment planning.

Not Found

Here's a breakdown of the acceptance criteria and study information for the VeriSuite device, based on the provided text.

Note: The provided document is a 510(k) premarket notification summary, which primarily focuses on demonstrating substantial equivalence to a predicate device. It does not contain the detailed study protocols, results, or comprehensive acceptance criteria that would typically be found in a full clinical or performance study report. Therefore, much of the requested information (like specific sample sizes for test sets, expert qualifications, adjudication methods, MRMC studies, or detailed ground truth establishment for training data) is not present in this document. The information provided below is extracted directly from the available text.

Acceptance Criteria and Device Performance (Limited Information)

The document states: "We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices..." This indicates that the primary acceptance criterion for the 510(k) submission was demonstrating substantial equivalence to existing predicate devices (specifically, EXACTRAC 5.5 / ExacTrac X-RAY 6D K072506).

Table of Acceptance Criteria and Reported Device Performance

Study Information (Based on Available Text)

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

   • Sample Size: Not specified in the provided document.
   • Data Provenance: Not specified in the provided document. The document primarily focuses on the regulatory review rather than detailed study methodology. It is likely that testing data would have been generated internally by the manufacturer during development and validation, but specific details are absent here.

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

   • Number of Experts: Not specified.
   • Qualifications of Experts: Not specified.

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

   • Not specified.

4. 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 evidence of an MRMC study related to human readers or AI assistance in this document. The VeriSuite system is described as a "patient position verification system" based on X-ray images, implying an automated or semi-automated system for patient positioning rather than an AI-assisted diagnostic tool that would typically involve human readers and diagnostic accuracy studies.

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

   • The description "patient position verification system... It is based on stereoscopic X-ray images and DRRs calculated from a CT image series..." suggests that the system operates in a standalone capacity to perform its verification function. However, the document does not explicitly present a "standalone performance study" with specific metrics or results. The FDA's determination of substantial equivalence implies they reviewed performance data, but the details are not included in this summary.

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

   • The document implies that the "ground truth" for patient position verification would be the actual patient position or a carefully measured, validated reference position. This would likely be established through precise physical phantoms or highly accurate imaging modalities. However, the exact method for establishing ground truth for any testing is not specified in this regulatory filing summary.

7. The sample size for the training set:

   • Not specified. The document does not describe a training set as would be relevant for machine learning models. If the system uses algorithms that were "trained," the details are not in this summary.

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

   • Not applicable/Not specified, as no training set is described in the provided text.

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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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