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BAT can be used for the positioning of patients that are prescribed external beam radiation treatments to organs which are readily identifiable on ultrasound images. BAT can be used for general imaging for small organs (breast, thyroid, testes), abdominal, trans-esophageal (noncardiac), trans-rectal, trans-vaginal, and musculo-skeletal (superficial and conventional) applications.

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I am sorry, but the provided text does not contain the acceptance criteria or a study proving the device meets those criteria. The document is an FDA 510(k) clearance letter for the BAT device, indicating that the device has been found substantially equivalent to a legally marketed predicate device for its indicated uses.

The letter lists the device name, regulation numbers, regulatory class, product codes, and the indications for use, but it does not detail:

• Specific acceptance criteria.
• Results of a performance study that quantitatively demonstrates the device meets certain metrics.
• Information about sample sizes, data provenance, expert qualifications, adjudication methods, MRMC studies, standalone performance, or ground truth establishment.

Therefore, I cannot provide the requested table and information based on the text provided.

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The nomosSTAT device is intended to provide 3-dimensional conformal treatments in radiation therapy when used with an external beam photon therapy syment.

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The provided text is a 510(k) clearance letter from the FDA for a device called "nomoSTAT". It confirms that the device is substantially equivalent to a predicate device for its indicated use, which is to provide 3-dimensional conformal treatments in radiation therapy when used with an external beam photon therapy system.

However, the letter does not contain any information about acceptance criteria, specific studies proving the device meets those criteria, sample sizes, data provenance, expert involvement, adjudication methods, multi-reader multi-case studies, standalone performance, or details about the training set.

Therefore, I cannot provide the requested information based on the given text. The provided document is a regulatory clearance letter, not a scientific study report or clinical trial summary.

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The nTRAK Patient Positioning and Monitoring System is Intended for use with a linear accelerator in Radiation Therapy(RT)/ stereotactic Radiosurgery(RS) to position a patient relative to the isocenter of the linear accelerator and to monitor the patient's location relative to that position.

The Navigator System utilizes a high resolution optical tracking system to determine and monitor the position of optical markers attached to the patient as the means to locate and monitor the position and orientation of the patient, relative to treatment isocenter. The Navigator System consists of the following major components: a. A high resolution optical camera array and illuminator. b. A computer workstation. c. An optical positioning device. d. An optical calibration device.

Based on the provided text, there is no information available regarding specific acceptance criteria, a study that proves the device meets acceptance criteria, or any of the detailed study parameters requested.

The document is a 510(k) summary for a medical device (Navigator Patient Head/Neck Positioning and Position Monitoring System), which focuses on demonstrating substantial equivalence to predicate devices rather than presenting detailed performance study results against predefined acceptance criteria.

Here's why the requested information cannot be provided from the given text:

• No Acceptance Criteria or Device Performance: The document explicitly states under "Performance Standards" that "Performance standards for this type of system have not been established by the FDA under Section 514 of the Food, Drug, and Cosmetic act." This indicates there are no official, pre-defined quantitative acceptance criteria discussed or met in this submission.
• No Study Details: The summary does not describe any specific performance study with a test set, ground truth, expert involvement, or sample sizes. The substantial equivalence is established by "comparison of functions and features and the use of an essentially identical optical position location device from the same commercial manufacturer," not by a detailed performance study.
• No Mention of AI or MRMC: The device description does not involve artificial intelligence, and therefore an MRMC comparative effectiveness study with AI assistance is not mentioned or relevant to this submission.
• No Standalone Performance: Since no studies are described, there is no mention of standalone (algorithm-only) performance.
• No Training Set Information: There is no discussion of a training set, as the submission relies on substantial equivalence.

Therefore, the table and other requested details cannot be populated from the provided text. The document is primarily a regulatory filing demonstrating equivalence, not a scientific publication detailing performance evaluation.

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The indications for use for the CORVUS Radiation Therapy Planning System have not changed as a result of this modification.

The CORVUS system is a radiation treatment planning package designed to allow medical physicists, dosimetrists, and radiation oncologists to create conformal treatment plans using photon (x-ray) external beam radiation therapy. The treatment plans generated by CORVUS are based upon treatment machinespecific data and are intended to provide a quide to delivering external beam radiation therapy which conforms to the target volume defined by the radiation oncologist.

The CORVUS System is valid for use only with external beam photon therapy; calculations for electrons and intracavitary sources (Brachytherapy) are not supported.

The CORVUS system is a radiation treatment planning package designed to allow medical physicists, dosimetrists, and radiation oncologists to create conformal treatment plans using photon (x-ray) external beam radiation therapy. The treatment plans generated by CORVUS are based upon treatment machine-specific data and are intended to provide a guide to delivering external beam radiation therapy which conforms to the target volume defined by the radiation oncologist.

The CORVUS System is valid for use only with external beam photon therapy; calculations for electrons and intracavitary sources (Brachytherapy) are not supported.

The modification described in this premarket notification consists of a change to the operating system upon which the device operates. The currentlymarketed CORVUS System utilizes the NextStep operating system, while the modified device runs on the Macintosh OS X (Mac OSX) operating system. This change did not modify the intended use of the device or the fundamental scientific technology of its design. Testing performed demonstrates that the modified device produces clinically equivalent results. Therefore, this change does not affect the safe and effective use of the device within its prescribed indications.

The provided text describes a 510(k) premarket notification for the NOMOS CORVUS 5.0M System, which is a Radiation Therapy Treatment Planning System. The core of this submission is a modification to the operating system from NextStep to Macintosh OS X (Mac OSX), with the claim that this change did not modify the intended use or fundamental scientific technology, and that testing demonstrates clinically equivalent results.

Here's an analysis of the acceptance criteria and study information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document states that the modification to the CORVUS system (changing the operating system) did not modify the intended use, fundamental scientific technology, or performance specifications. Therefore, the "acceptance criteria" are implicitly that the new system performs at least equivalently to the predicate device (the currently marketed CORVUS System) and adheres to its existing performance specifications.

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

The document does not explicitly state the sample size used for the test set or the data provenance (e.g., country of origin, retrospective or prospective nature of the test data). It generally refers to "testing performed" and "hazard analysis and testing" without providing specific details about the dataset or methodology.

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

The document does not specify the number of experts used or their qualifications to establish ground truth for any testing. Given the nature of the device (a treatment planning system), expert review would typically involve medical physicists and radiation oncologists, but this is not explicitly mentioned.

4. Adjudication Method for the Test Set

The document does not mention any specific adjudication method (e.g., 2+1, 3+1, none) used for the test set.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

A Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not conducted. This is not a diagnostic device where human readers interpret images, but rather a treatment planning software. The focus is on the equivalence of the software's output to the previous version, not on human interpretive improvement.

6. Standalone (Algorithm Only Without Human-in-the-loop Performance) Study

Yes, a standalone performance study was implicitly done. The "testing performed" to demonstrate clinical equivalence would involve comparing the output of the CORVUS 5.0M (algorithm only on the new OS) against the output of the predicate CORVUS system (algorithm only on the old OS). The claim is that the device itself, functioning on the new OS, produces equivalent results. There is no mention of a "human-in-the-loop" component to this specific performance evaluation, as the change is at the operating system level, not the core algorithms or user interaction for treatment planning.

7. Type of Ground Truth Used

The "ground truth" in this context is the performance of the predicate CORVUS System. The new CORVUS 5.0M System's performance was compared against the established, accepted performance of the previous version. This is a case of device-to-device equivalence, where the "truth" is what the previously cleared device produces, and the goal is to show the modified device produces the same "truth." This would involve comparing the treatment plans (e.g., dose distributions, conformality indices, etc.) generated by both systems for the same input data.

8. Sample Size for the Training Set

The document does not refer to a "training set" in the context of machine learning or AI models. This device is a treatment planning system based on algorithms, not a machine learning model that undergoes a training phase with a dataset. The system uses "treatment machine-specific data" for its calculations, which is more akin to calibration data for physics models than a training set for an AI.

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

As there is no mention of a "training set" in the context of an AI/ML model, this question is not applicable. The device's calculations are based on "treatment machine-specific data," which would be established through appropriate calibration and commissioning procedures for the radiation therapy machines it interfaces with.

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The NOMOS Motorized CRANE II is intended to be used as an accessory to powered radiation therapy patient support tables. The NOMOS Motorized CRANE II verifies and describes, via a set of Z and X coordinates, the set-up of the table/patient prior to treatment.

The NOMOS Motorized CRANE II is a powered version of the manual NOMOS CRANE II. It is an accessory to radiation therapy patient support tables. Like the NOMOS CRANE II, the Motorized CRANE II attaches to the stationary base Elle the NOWOO OF through a permanently installed interface plate and clamps to the accessory rails of the moveable table top. The Motorized CRANE II can be the acod from the treatment table when its use is not required, leaving only the interface plate remaining on the stationary base of the treatment table. The Motorized CRANE II uses precision ball screw drive positioning mechanisms (one for the Z-axis and one for the X-axis) to position the table top relative to the stationary base of the treatment table. While these positioning mechanisms retain the small hand cranks employed in the predicate CRANE II to allow manual operation when needed, the primary drive force is provided by two electric motors – one for each axis of movement. These motors le provided and operator interface is provided through two touch screen are ooltware oon. One located on the device and one remote panel that can be placed in the treatment control room. The control panels display the position of the patient treatment table, and allow the operator to specify and initiate movement in the Z and X axes. Using the NOMOS CRANE II, the operator can move the treatment table over a range of 300 mm in each axis. When attached to a treatment table loaded to a maximum weight of 300 ounds, the NOMOS Motorized Crane II is capable of +/- 0.1 mm accuracy in the Zaxis, and +/- 0.4 mm accuracy in the X-axis. The Motorized CRANE II retains the battery-powered digital scales from the Crane II as an independent means of position verification.

Here's an analysis of the provided text regarding the acceptance criteria and study for the NOMOS Motorized CRANE II:

The document provided (K013036) is a 510(k) summary for the NOMOS Motorized CRANE II, which focuses on demonstrating substantial equivalence to a predicate device (NOMOS CRANE II). Crucially, this document does not contain a detailed study report with methods, results, or statistical analysis. Instead, it states the specifications and claims equivalence.

Therefore, I cannot populate all the requested fields with specific study details. I will extract the available information and explicitly state when information is not provided in the document.

Acceptance Criteria and Reported Device Performance

Study Details (Based on available information)

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

   • Sample Size: Not specified. The document states "When attached to a treatment table loaded to a maximum weight of 300 pounds," implying a specific loading condition for testing, but does not detail the number of tests performed or readings taken.
   • Data Provenance: Not specified. As this is a 510(k) summary focusing on equivalence, it doesn't describe originating data, but rather claims to meet specifications. It's likely internal engineering testing by NOMOS Corporation. The country of origin would presumable be USA, given the applicant's address.
   • Retrospective or Prospective: Not specified.

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

   • Number of Experts: Not applicable. This device's performance is objective (positional accuracy), not subjective (like image interpretation). Ground truth would be established by high-precision measurement tools (e.g., laser interferometers, precision calipers, etc.), not human experts.
   • Qualifications of Experts: Not applicable.

3. Adjudication method for the test set:

   • Adjudication method: Not applicable. As the ground truth is objective measurement of mechanical precision, human adjudication is not relevant.

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:

   • MRMC Study: No. This is a mechanical positioning device, not an AI-assisted diagnostic tool.

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

   • Standalone Performance: The claims regarding +/- 0.1 mm and +/- 0.4 mm accuracy are standalone specifications of the device's mechanical and control system performance. While operators control the movement, the inherent accuracy is a characteristic of the device itself. The document does not describe a formal "standalone study" with methodology, but rather states the device "is capable of" this performance. No algorithm performance is described beyond the basic controls for movement.

6. The type of ground truth used:

   • Type of Ground Truth: Objective mechanical measurement using high-precision metrology tools (e.g., highly accurate encoders, laser measurement systems, etc.) to verify the actual position of the table.

7. The sample size for the training set:

   • Sample Size: Not applicable. This device utilizes electric motors and software controls for mechanical movement, not a machine learning or AI algorithm that requires a "training set" in the typical sense. The software would be developed and tested through traditional software engineering verification and validation (V&V) processes.

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

   • How Ground Truth Established: Not applicable, as there is no "training set" in the AI/ML sense. The "ground truth" for the device's control system development would be the desired mechanical behavior and accuracy specifications, which are translated into software requirements and tested against using established engineering principles.

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The PEREGRINE™ Radiation Therapy Dose Calculation System is intended to be used for radiation therapy in conjunction with a Radiation Treatment Planning system to calculate dose distributions. It is to be used by the physician and/or other competent health aooo alombation clinical review and judgement of radiation treatment plans. The goal of the protections is to produce consistent highly accurate dose calculations using the Monte Carlo algorithms.

The PEREGRINE™ Radiation Therapy Dose Calculation System is used in conjunction with a radiation treatment planning system to provide the dose distribution for radiation therapy treatments employing radiation sources and associated beam modifiers for clinical review and judgement prior to treating the patient. The PEREGRINE™ Radiation Therapy Dose Calculation System is intended to be used by a competent health professional such as a radiation oncologist, medical physicist, radiation therapist, or dosimetrist.

The PEREGRINE Radiation Therapy Dose Calculation System is a 3-D Monte Carlo radiation transport system designed to provide accurate dose calculations for radiation therapy treatment planning. PEREGRINE combines Monte Carlo-based modeling of the accelerator beam production system, Monte Carlo simulation of treatment-specific beam modifiers and Monte Carlo transport in the patient to provide a robust and accurate representation of the radiation source, beam modifiers and heterogeneities in the patient. PEREGRINE has been designed to provide highly accurate, high resolution radiation dose calculations rapidly on economical, commercially available computer microprocessors and to be easily integrated with commercial radiation treatment planning systems. In order to ensure its accuracy, PEREGRINE has been verified against a comprehensive set of clinical measurements designed to stress the physics algorithms for a full range of clinically relevant materials, densities and beam energies for open, blocked, wedged and compensated fields incident on both simple phantoms and phantoms with a variety of surface and sub-surface heterogeneities.

Here's an analysis of the acceptance criteria and study information for the PEREGRINE™ Radiation Therapy Dose Calculation System, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The provided text does not contain explicit, quantitative acceptance criteria or a direct table comparing them to reported device performance. It generally states that the device "meets the design criteria and user needs" and that "Test completion shows that the device performs and is substantially equivalent to the predicate system."

However, we can infer the intent of the acceptance criteria from the device description and the non-clinical tests. The overarching criterion is accuracy of dose calculations.

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

• Sample Size: The text states that the device was "verified against a comprehensive set of clinical measurements." It does not specify a numerical sample size for this test set (e.g., number of patients, number of phantom configurations).
• Data Provenance: The measurements are referred to as "clinical measurements," implying they reflect a real-world clinical context, but it doesn't specify the country of origin. The study appears to be prospective in the sense that the measurements were likely taken specifically for the verification of the PEREGRINE system, rather than retrospectively collected from existing patient data.

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

The text does not provide information on the number of experts used or their qualifications for establishing ground truth for the test set. The ground truth appears to be based on "clinical measurements" and the physics principles inherent in Monte Carlo simulations.

4. Adjudication Method for the Test Set

The text does not specify any adjudication method (e.g., 2+1, 3+1, none) for the test set. The verification seems to rely on the direct comparison of the system's calculations against the "comprehensive set of clinical measurements."

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

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not mentioned or described in the provided text. The evaluation focuses on the standalone performance of the dose calculation system, not on its impact on human reader performance.

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

Yes, a standalone (algorithm only) performance evaluation was done. The description of the verification process—"verified against a comprehensive set of clinical measurements designed to stress the physics algorithms"—directly pertains to the algorithm's performance in generating dose calculations. The system is designed to "provide accurate dose calculations" and its "accuracy" was verified. There is no mention of physician interaction being part of this core verification.

7. The Type of Ground Truth Used

The primary type of ground truth used was clinical measurements. These measurements were used to stress the physics algorithms, implying they represent real-world physical dose distributions, likely obtained from dosimetric equipment in phantoms.

8. The Sample Size for the Training Set

The text does not specify a sample size for the training set. It refers to the system's development using "design controls" and "Quality system design control and product release procedures," indicating a structured development process, but no details on training data are provided. As a dose calculation system based on physical models (Monte Carlo), it may not have a "training set" in the same way a machine learning algorithm would, but rather internal physics parameters and models derived from fundamental principles and potentially calibrated against general physical data.

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

The text does not explicitly describe how ground truth for any "training set" was established. Given the nature of a Monte Carlo radiation transport system, its core "ground truth" for development would likely be based on fundamental physics laws, established physical constants, and potentially extensive experimental data from various radiation sources and materials, rather than a specific "training set" with established ground truth by human experts in the context of typical AI/ML development. The "modeling of the accelerator beam production system" and "simulation of treatment-specific beam modifiers" would rely on established physics and engineering data.

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The RAPTOR® Radiation Treatment Planning System is intended to be used by radiation oncology professionals for clinical review and judgement of radiation treatment plans and dose estimates based on computation, output and displays. The goal of the system is to produce consistent results using well-documented algorithms. It will provide outputs for radiation delivery equipment including documented and released multileaf collimators [MLCs] for planning, optimization, delivery and reporting of treatments. The device provides output data in the form of displays, hardcopy prints and / or plots, set-up instructions and other control information to guide the physician and / or other competent health care professional in selecting the optimum patient treatment plan.

The RAPTOR® Treatment Planning System is used to generate computation, display, evaluation and output radiation dose estimates for clinical review and judgement prior to treating the patient. It uses well-documented algorithms to provide output data in the form of displays, hardcopy prints, plots and treatment instructions to guide the radiation oncology professional and / or physician to select the optimum treatment plan. The MLC module is used to generate plans and instructions for documented and released multileaf collimators.

The RAPTOR Treatment Planning System is a collection of software modules that execute known and documented algorithms to produce radiation dose estimations. All data is user controlled and is a table look-up formation is presented graphically on CRT screens and hardcopy reports. Various models are available based on the specific features desired by the customer (e.q., asymmetric jaws, electron pencil beam calculations, etc.) to best meet their clinical needs. The software is designed to run on a PC platform utilizing the Microsoft Windows NT® operating system. The RAPTOR Treatment Planning System includes modules for the development of instructions and controls for multileaf collimators. It is designed to upgradable in both hardware and software features. All dates are four digit numbers so the system is year 2000 compliant.

This looks like a 510(k) premarket notification for a medical device called the RAPTOR® Treatment Planning System. Unfortunately, the provided document does not contain the detailed information required to answer your request about acceptance criteria and the comprehensive study that proves the device meets those criteria.

Here's why and what information is missing:

• No specific acceptance criteria table: The document states that the system "has a product specification, which was used as the basis for the development of verification and validation plans, tests and acceptance criteria." However, it does not explicitly list these acceptance criteria.
• No detailed study results or performance metrics: While it mentions "Validation and verification testing... demonstrate that the software is safe and effective" and that it "performs and is equivalent to the predicate systems," it does not provide any quantitative performance data (e.g., accuracy percentages, precision values, specific metrics like sensitivity, specificity, AUC) or a comparison against predefined acceptance thresholds.
• Missing information on sample size, data provenance, ground truth, experts, MRMC studies, or standalone performance.

Based on the provided text, I cannot complete the table or answer the specific questions about the study design and results. The document focuses on the regulatory submission process, the device's intended use, and its general technological characteristics, rather than the detailed validation study methodology and outcomes.

However, I can extract the following relevant information:

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

Missing Information:

• Specific quantitative acceptance criteria (e.g., accuracy within X%, dose calculation deviation within Y%).
• Quantitative results from the verification and validation tests (e.g., actual measured accuracies, deviations, etc.) that demonstrate the device met these criteria.

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

Missing Information:

• Sample size (number of cases/patients used) for the test set.
• Data provenance (e.g., country of origin, retrospective/prospective nature of the data).

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)

Missing Information:

• Number of experts.
• Qualifications of experts. This document is about a treatment planning system, so "ground truth" would likely relate to the accuracy of dose calculations or treatment plan parameters, which might be compared against established physics models, phantom measurements, or potentially consensus among medical physicists/radiation oncologists.

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

Missing Information:

• Adjudication method for establishing ground truth or resolving discrepancies.

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

Missing Information:

• There is no indication of an MRMC comparative effectiveness study being performed. This device is a treatment planning system, not an AI-assisted diagnostic tool, so such a study might not be directly applicable in the typical sense of "human readers."

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

Missing Information:

• While the validation and verification tests would inherently be "standalone" in evaluating the software's calculations, the specific results and metrics of this standalone performance are not provided. The device focuses on "producing radiation dose estimations" and "output and displays," which implies an algorithm-only component.

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

Missing Information:

• The document does not specify the method for establishing "ground truth," which for a radiation therapy planning system would likely involve physical measurements in phantoms, comparison to established analytical models, or potentially simulations.

8. The sample size for the training set

Missing Information:

• The document does not mention a training set, as it describes a system involving "known and documented algorithms" and "table look-up." This suggests a more deterministic, physics-based approach rather than a machine learning model that requires a separate training set.

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

Missing Information:

• As there's no mention of a training set, this information is not applicable.

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The NOMOS® CRANE II is intended to be used as an accessory to powered, radiation therapy patient support assemblies. The CRANE II verifies and describes, via a set of X, Y and Z coordinates, the set-up of the couch/patient prior to treatment.

The NOMOS CRANE II is an accessory to powered radiation therapy patient support assemblies. The NOMOS CRANE II attaches to the stationary base of the treatment table through a permanently installed interface plate and clamps to the accessory rails of the moveable couch top. A treatment table foot brake is also installed, if not already part of the treatment table, to further stabilize the stationary base. The treatment table foot brake is typically an accessory that can be purchased from the treatment table original equipment manufacturer (OEM). In cases where the foot brake is not an OEM accessory, one will be adapted or custom designed for the application. The CRANE II can be removed from the treatment table with only the interface plate remaining on the stationary base of the treatment table.

The CRANE II uses precision ball screw drive positioning tables, one for the Y-axis and one for the X-axis, to position the couch top relative to the stationary base of the treatment table. The positioning tables are operated using a small hand crank.

Each axis of the CRANE II incorporates a battery powered digital scale that measures the movement of the positioning table and therefore, the movement of the couch top itself. The digital scale may be set to display the value in inches, however, the operator's manual instructs the user to set the digital scale to display millimeters With the CRANE II attached, the couch top can be manipulated over a range of 12 inches (304.8 mm) in both the Y and X axis with no impedance on the couches range of travel in the Z-axis.

Here's an analysis of the provided text regarding the NOMOS® CRANE II, focusing on the acceptance criteria and study details:

Acceptance Criteria and Device Performance for NOMOS® CRANE II

1. Table of Acceptance Criteria and Reported Device Performance:

2. Sample Size and Data Provenance:

The document does not explicitly state the sample size used for the test set or the data provenance (e.g., country of origin, retrospective/prospective nature). It only mentions that validation data for the more precise accuracy claim was included in "Appendix 5 of this submission."

3. Number and Qualifications of Experts for Ground Truth:

The document does not mention the number or qualifications of experts used to establish the ground truth for the test set.

4. Adjudication Method:

The document does not specify any adjudication method (e.g., 2+1, 3+1, none) for the test set.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

No mention of a Multi-Reader Multi-Case (MRMC) comparative effectiveness study is made in the provided text. Therefore, no effect size of human readers improving with AI vs. without AI assistance can be determined. This device is a caliper, not an AI system.

6. Standalone Performance Study:

A standalone performance study was done to validate the accuracy claim of ± 0.1 mm. The specific details of this study are not provided in the summary but are referenced as being in "Appendix 5 of this submission." The device itself acts as a measurement tool, so its "standalone" performance refers to its ability to accurately measure without human interpretation of images.

7. Type of Ground Truth Used:

The type of ground truth used is not explicitly stated, but given the nature of the device (a caliper for measuring positioning), it would most likely be a reference standard measurement obtained through a highly precise and validated alternative method, or an established physical dimension.

8. Sample Size for the Training Set:

The concept of a "training set" is not applicable to this device, as it is a mechanical measuring tool and not an AI/machine learning system. Therefore, no information on training set sample size is provided.

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

As the device is not an AI/machine learning system, there is no "training set" or corresponding ground truth establishment process in that context.

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BAT is intended for use in external beam Radiation Therapy (RT)/Radiosurgery (RS) to locate internal anatomy that moves relative to external or bony landmarks, so as to position that anatomy correctly for the delivery of conformal radiation.

BAT can be used for the positioning of all patients that are prescribed external beam radiation treatments to organs which are readily identifiable on ultrasound images.

BAT permits its user to align the isocenter crosshairs, structure contours or calculated dose (the latter 2 imported from a treatment planning system) with perpendicular ultrasound images acquired at treatment time. The BAT system then guides couch motion to achieve the desired patient alignment with the treatment beam. Additional ultrasound images can be taken to confirm proper positioning.

The provided document K981424 does not contain information on acceptance criteria, a study proving the device meets acceptance criteria, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, or details regarding the ground truth for training or test sets.

The document primarily focuses on the device's classification, intended use, and a summary of substantial equivalence to predicate devices, as required for a 510(k) submission in 1998. It states that "Performance standards for this type of device have not been established by the FDA under Section 514 of the Food, Drug and Cosmetic Act." Therefore, no specific acceptance criteria or associated studies are detailed within this summary.

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The NOMOS Slit Collimator (BEAK™) is intended for use in Radiosurgery/Radiation Therapy to secondarily collimate the width of the radiation beam after it passes through the MIMiC® Multileaf Intensity Modulating Collimator (K940412). Several sizes of collimators will be provided with a slit width, at isocenter, ranging from 1 mm to 8 mm.

The Slit Collimator (BEAK) is tungsten block whose purpose is to provide secondary collimation for the radiation beam exiting from the NOMOS MIMiC (K940412). The MIMiC has the capability of delivering treatment slices whose width is either 8 mm or 16 mm. The Slit collimator, by providing secondary collimation of the 8 mm beam, allows slices to be delivered that are 1 - 8 mm in thickness without the need to modify the control mechanisms built into the MIMiC that ensure that leaf (vane) movement is functioning correctly. In this sense, the Slit Collimator serves the same purpose as the secondary collimators provided with radiosurgical systems or the secondary collimators, commonly called blocks, that are used with radiation therapy linear accelerators.

This document does not contain a description of acceptance criteria or a study proving device performance against such criteria. The provided text is a 510(k) summary for the NOMOS Slit Collimator (BEAK™), which focuses on demonstrating substantial equivalence to predicate devices rather than a detailed performance study with acceptance criteria.

Therefore, I cannot populate the table or answer the questions as the required information is not present in the provided text. The document primarily describes the device, its intended use, and argues for its substantial equivalence to existing devices based on design, materials, and intended purpose without detailing specific performance metrics or clinical study results.

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