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The Prelude Planning Software for the electron beam IORT treatment can be used for any malignant and benign tumor. For Prelude no limitation is given to the patient population. Local/Regional recommendations or guidelines may indicate patient who will benefit from IORT more than from other treatment modalities.

In general, since Prelude is tailored for the planning with the Mobetron®, it can be used for IORT treatment planning, if a patient is prescribed to be treated with the Mobetron®.

The Prelude software supports the IORT treatment workflow. Prelude Dosimetric measurement data of the radiation device can be displayed by selecting the machine parameters. Upon that information the user can easily plan the treatment and the software calculate the required parameters for the IORT devices.

For quality assurance the machines parameters can be recorded and visualized.

For the calculation of the output factors or the monitor units either the IAEA or AAPM protocol is followed.

The software is intended to be used by medical professionals in the area of radiation therapy.

The main purpose is to plan the technical parameters required to perform an electron beam IORT to treat both malignant and benign tumors

This document describes the MedCom GmbH Prelude planning software, K180308, for electron beam Intraoperative Radiation Therapy (IORT) treatment planning.

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

The provided text does not contain a specific table of acceptance criteria with corresponding device performance metrics in the format typically used for AI/ML device submissions (e.g., sensitivity, specificity, AUC, FROC analysis). Instead, the document focuses on general software safety, effectiveness, and usability assessments, emphasizing that the software meets its intended use and is safe and effective.

The performance details are described qualitatively rather than quantitatively against specific acceptance criteria. Key performance aspects reported include:

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

• Sample Size for Test Set: The document states that "Clinical patient data was simulated." It does not specify a numerical sample size for this simulated data.
• Data Provenance: The data used for testing was "dosimetric measurement data from a Mobetron® device" and "simulated" clinical patient data. The country of origin for the simulated data or the Mobetron® device's data is not explicitly mentioned, but MedCom GmbH is located in Germany. The study appears to be a retrospective analysis of simulated data and device performance.

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)

The concept of "ground truth" as typically defined for AI/ML diagnostic devices (e.g., truth established by pathology or expert consensus on a test set) is not directly applicable here in the same way. The device is a planning software, not a diagnostic one.

Instead, the "truth" or correctness of the outputs was assessed through:

• Comparison to "expected parameters" for the simulated input data.
• Usability testing with "users" and "Mobetron users and other experts in that field" who provided feedback.
• Risk assessment team included "application specialists and a medical expert besides the development team and quality managers with risk management experience." Specific numbers and detailed qualifications of these individuals are not provided, beyond stating they were "medical expert" and "experts in that field."

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

No formal adjudication method (like 2+1 or 3+1 for resolving disagreements among multiple readers) is described for a test set in the context of diagnostic decision-making. The testing involved verification that the software produced "expected parameters" for simulated data and that users could successfully create plans and approve them, and that the software assisted in optimizing the treatment delivery.

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 multi-reader multi-case (MRMC) comparative effectiveness study comparing human readers with and without AI assistance is mentioned. The software is a planning tool, not an AI diagnostic assistant. Its purpose is to support medical professionals in radiation therapy by assisting in treatment planning and QA, not to be a diagnostic aid that would typically involve an MRMC study.

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

The evaluation described is intrinsically "human-in-the-loop" as Prelude is a planning software intended to be used by medical professionals. The software assists in calculations and visualizations, but the user defines parameters, approves plans, and interprets outputs. The testing included assessing user interaction and ability to create and approve plans.

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

The "ground truth" for evaluating this planning software was based on:

• Expected parameters: For the simulated clinical patient data, the software's calculated output parameters were compared against "expected parameters" for a treatment.
• Usability Feedback/Expert Opinion: Evaluation of whether users could successfully create treatment plans, define parameters, and whether the workflow was understandable. This suggests expert review of the software's functionality and output.
• Established Radiation Therapy Protocols: The software follows IAEA or AAPM protocols for calculation methods, implying adherence to recognized standards.

8. The sample size for the training set

The document does not describe the use of machine learning models requiring a distinct "training set." Prelude is a treatment planning software that performs calculations based on measured dosimetric data and established physical principles (IAEA/AAPM protocols), rather than a system trained on a large dataset of patient images or outcomes. Therefore, the concept of a "training set" in the context of AI/ML is not applicable here.

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

As there is no mention of a training set for machine learning, the question of how its ground truth was established is not applicable. The software's calculations leverage "dosimetric measurement data of the radiation device," which serves as input to its algorithms based on physics principles, not as training data for a learning model.

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The X-PSI Knee System is indicated as an orthopedic instrument system to assist in the positioning of knee replacement components. It involves surgical planning software used pre-operatively to plan the surgical placement of the components on the basis of provided patient radiological images and 3-D reconstructed bones with identifiable placement anatomical landmarks, and surgical instrument components that include patient specific or customized guides fabricated on the basis of the surgical plan to precisely reference the placement of the implant components intra-operatively per the surgical plan. The X-PSI Knee system is indicated for patients without severe bone deformities, such as a HKA greater than 15° or deformities due to prior fracture of the distal femur or proximal tibia.

The X-PSI Knee System is to be used with the following fixed bearing knee replacement systems in accordance with their indications and contraindications: NexGen® CR, NexGen CR-Flex Gender, NexGen LPS, NexGen LPS-Flex, NexGen LPS-Flex Gender, Persona® CR, Persona PS, Vanguard® CR and Vanguard PS.

The patient specific guide components are intended for single-use only.

The present Zimmer Biomet® X-PSI Knee System is an instrumentation system that includes customized surgical guides to mate each patient's bony and articular surface topographies to reference the location and orientation of the implant system's instruments which in turns sets the position and alignment of the femoral and tibial implant components.

It involves the following:

• A CAS X-PSI Knee Software Suite used in preparation for the surgery to sequentially construct 3-D surface models of each patient's knee joint bony structures and articular surfaces from the patient's X-Ray images, plan the location and orientation of the knee replacement implant components upon the patient's model, and create the corresponding specification models for the patient specific surgical guides (PSI Guides) with surfaces and elements to uniquely fit each patient topographical features and set or reference the placement of the implant system components per the plan,
• . The Zimmer Biomet ® X-PSI Guides (also called jigs) that are manufactured per the above models and plan, for intra-operative and single use, which include one to set the placement of the distal femoral cut guides which set the resection depth, the varus/valgus and the flexion of the distal cut and one to set the placement of the tibial cut guides which set the resection depth, the varus/valgus, and the posterior slope of the proximal cut.
• . Each patient's Zimmer Biomet ®3-D Bone Models (femur and tibia components) that are fabricated and provided along with the PSI Guides for use intra-operatively to provide the surgeon with an intra-operative visual reference of the planned location of the PSI Guides in order to help guide their locations on the patient's actual joint,
• Zimmer Biomet X-PSI Reusable Surgical Instrumentations are provided both sterile . and non-sterile and are reusable for intra-operative use, which include femoral stylus, and femoral and tibial cut block instrumentations to allow setting the resection level and performing the bone cuts as defined by the PSI Guides.
• Fixation Pins are accessories for use of the guides, these accessories are Class I devices under the classification "Orthopedic manual surgical instrument (21 CFR § 888.4540)".

The Zimmer Biomet® X-PSI Knee System is compatible for use with the following class II Zimmer Biomet Nexgen, Persona and Vanguard total knee replacement implant systems:

• . NexGen®family: NexGen CR, NexGen CR-Flex, NexGen CR-Flex Gender, NexGen LPS, NexGen LPS-Flex, NexGen LPS-Flex Gender
• . Persona® family: Persona CR, Persona PS
• Vanguard® family: Vanguard CR, Vanguard PS

Finally, the following accessories are used for the acquisition of the x-ray images:

• X-Ray Marker 3D Zimmer Biomet ® X-PSI (re-usable) ●
• X-Ray Calibration Straps, Short and Long (single-use)

The provided document is a 510(k) premarket notification for the Zimmer Biomet X-PSI Knee System. It details the device, its indications for use, and a summary of performance data used to establish substantial equivalence to predicate devices.

Here's a breakdown of the requested information based on the provided text:

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

The document states that a non-significant risk clinical study was performed to evaluate the proper positioning of the Zimmer Biomet X-PSI Knee guides. The primary metric measured was the resulting frontal Hip-Knee-Ankle (HKA) alignment angle versus the surgically planned HKA alignment angle.

Note: The document states "satisfactory performance" but does not provide specific numerical thresholds or a statistical comparison for the HKA alignment angle, which would typically be included in detailed acceptance criteria. It also mentions "substantial equivalence in cut accuracy with regards to femoral and tibial frontal and sagittal angles, as well as femoral rotation and resection depth" based on full system validation tests, but no specific acceptance criteria for these were detailed.

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

The document does not explicitly state the sample size for the clinical study (test set) or the data provenance (country of origin, retrospective/prospective). It only refers to it as a "Non-Significant Risk Clinical Study."

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)

The document does not provide details on the number of experts or their qualifications for establishing the ground truth in the clinical study.

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

The document does not describe any adjudication method used for the clinical study's test set.

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

The document does not mention a multi-reader multi-case (MRMC) comparative effectiveness study or any assessment of human reader improvement with AI assistance. The device is an orthopedic instrument system that assists in surgical planning and guiding, not a diagnostic AI tool that human readers would interpret.

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

The document describes "Software System Tests" which were performed to "ensure that no hazardous anomalies were present in the system software components" and "consisted of testing software features and functionalities in correspondence to software design requirements." This implies a standalone evaluation of the software's functional performance, but not in terms of diagnostic accuracy or clinical outcomes in isolation. The "Full System Validation Tests" using cadaver specimens and bone models involved "multiple surgeons," indicating a human-in-the-loop component for these tests, rather than purely standalone algorithm performance on clinical metrics.

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

For the clinical study, the ground truth was implied by surgically planned HKA alignment angle against which the "resulting frontal Hip-Knee-Ankle (HKA) alignment angle" was compared. This implies the surgical plan served as the reference for evaluating positioning accuracy. For the "Full System Validation Tests," the ground truth for "cut accuracy" (femoral/tibial angles, rotation, resection depth) would typically be established by precise measurements from the bone models or cadaver specimens, likely compared against the planned surgical cuts.

8. The sample size for the training set

The document does not specify a sample size for the training set for the software or any AI/ML components. It mentions that the software "sequentially construct[s] 3-D surface models of each patient's knee joint bony structures and articular surfaces from the patient's X-Ray images," but it doesn't detail how this software was trained or validated in terms of data volume.

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

The document does not provide information on how the ground truth for any potential training set was established.

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The PIPSpro QA Software System displays, enhances and analyses portal images, and is used in conjunction with commercially available electronic portal imaging detectors (EPIDs). PIPSpro provides numerous measurement tools, image processing routines, statistical analysis and capabilities that are not available in the standard software provided by the EPID suppliers. These include the processing of simulator and portal verification images, analyzing patient registration errors, measuring of image quality from an EPID during installation tests, providing a platform for quality assurance programs in radiation therapy, and tools for writing and editing notes attached to images for easy communication. In this capacity, it can only import images and information.

PIPSpro QA Software System (Portal Imaging Processing System, professional version) is a stand-alone software program for use on PC computers running under Microsoft Windows 9x/Me/2000/NT/XP. The PC is not supplied with PIPSpro, and must be provided by the user. PIPSpro is supplied on a CD together with a software security key ("dongal" or hard lock) which is inserted into a parallel or USB port on the computer to allow the software to work. PIPSpro does not use, control, or operate any hardware, it is purely a stand-alone software program.

AQUA is also a stand-alone software program, consisting of a small part of the PIPSpro system. AQUA includes only those routines required for the analysis of images acquired with the QC-3 phantom, and used for quality control of electronic portal imaging devices

The PIPSpro OA Software System, which displays, enhances and analyses portal images, and is used in conjunction with commercially available electronic portal imaging detectors (EPIDs). PIPSpro provides numerous measurement tools, image processing routines, statistical analysis and capabilities that are not available in the standard software provided by the EPID suppliers. These include the processing of simulator and portal verification images, analyzing patient registration errors, measuring of image quality from an EPID during installation tests, providing a platform for quality assurance programs in radiation therapy, and tools for writing and editing notes attached to images for easy communication. In this capacity, it can only import images and information.

The provided document is a 510(k) Summary of Safety and Effectiveness Information for the Standard Imaging PIPSpro QA Software System. It describes the software's functionality and its substantial equivalence to predicate devices, but it does not contain information about acceptance criteria or a specific study proving the device meets those criteria with quantitative values.

The document states: "The Standard Imaging PIPSpro QA Software System has met its predetermined design specifications, risk analysis and validation objectives." It also mentions "nearly 10 years of evolving development and use" and lists validation activities such as "Algorithm and image transfer," "Results presentation and graphing," "Beta testing," "Interface, compatibility, use and misuse," and "Bug, Modification and/or Addition change testing." However, these are general statements about development and validation processes, not a detailed account of specific performance metrics or a study.

Therefore, I cannot provide the requested information from this document.

Summary of missing information:

• Table of acceptance criteria and reported device performance: Not provided. The document states validation objectives were met, but does not list specific criteria or performance metrics.
• Sample size used for the test set and data provenance: Not provided.
• Number of experts used to establish ground truth for the test set and qualifications: Not provided.
• Adjudication method for the test set: Not provided.
• Multi-reader multi-case (MRMC) comparative effectiveness study: Not mentioned.
• Standalone (algorithm only) performance study: Not detailed, although the software is described as "standalone."
• Type of ground truth used: Not specified.
• Sample size for the training set: Not provided.
• How the ground truth for the training set was established: Not provided.

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In order to ensure the day to day performance of medical devices, many quality assurance tests are performed. In all quality assurance testing a phantom or measurement device is used to either validate a system parameter or measure some aspect of system performance. These test objects/devices can easily be classified as one of two types, passive or active. An active device is one that can make a direct measurement or perform a test without user evaluation or interpretation, while a passive device merely provides an environment or condition for testing, but the result requires the user or operator to make an evaluation and determination. Examples of passive devices are test phantoms or film cassettes.

The Mick Radio-Nuclear Perma-Doc Phantom is an example of a passive device. It is designed to be placed between the source from a HDR system and a piece of film. Radiographic exposure of the film by the HDR source results in the production of an image on the film which can then be analyzed by the operator for consistency from the prior test exposure. The Perma-Doc Phantom does not alter, change or moderate the radiation field in any manner. It has a radio-opaque scale embedded into it that can be visualized on standard x-ray film when exposed to the radiation output from the HDR system. Inspection of the image on the film is then used as part of the quality assurance process.

The Mick Radio-Nuclear Perma-Doc Phantom is an example of a passive device. It is designed to be placed between the source from a HDR system and a piece of film. Radiographic exposure of the film by the HDR source results in the production of an image on the film which can then be analyzed by the operator for consistency from the prior test exposure. The Perma-Doc Phantom does not alter, change or moderate the radiation field in any manner. It has a radio-opaque scale embedded into it that can be visualized on standard x-ray film when exposed to the radiation output from the HDR system. Inspection of the image on the film is then used as part of the quality assurance process.

This submission pertains to the Perma-Doc Phantom, a radiologic quality assurance instrument. The provided document does not contain a study demonstrating the device meets specific acceptance criteria in the traditional sense of a performance study with numerical metrics for accuracy, sensitivity, or specificity. Instead, the submission focuses on establishing substantial equivalence to a predicate device.

Here's an analysis based on the provided text:

Acceptance Criteria and Reported Device Performance

The document describes the Perma-Doc Phantom as a passive device designed for quality assurance testing in High-Dose Rate (HDR) systems. Its primary function is to provide an environment for testing where the user evaluates the results.

Given the nature of the device as a "Radiologic Quality Assurance Instrument" and a "passive device," the "acceptance criteria" and "performance" are not framed in terms of clinical outcomes or diagnostic accuracy. Instead, the core acceptance criterion is substantial equivalence to a legally marketed predicate device.

Study Information

The document is a 510(k) premarket notification, which establishes substantial equivalence rather than proving performance against specific acceptance criteria through a clinical study. Therefore, most of the requested study-related information is not applicable or not present in this type of submission.

1. Sample size used for the test set and the data provenance: Not applicable. There is no formal "test set" in the context of a performance study described here. The submission relies on a comparison to a predicate device based on its design, materials, and intended use.
2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. No ground truth establishment by experts for a test set is described.
3. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
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: Not applicable. This device is not an AI-assisted device, nor is an MRMC study described.
5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is a passive physical device, not an algorithm.
6. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable in the context of a performance study for this device. The "ground truth" for the substantial equivalence determination is the existing regulatory status and performance profile of the predicate device (Med Tec, Inc. Iso-Align, Class I exemption).
7. The sample size for the training set: Not applicable. This is a physical device, not a machine learning model requiring a training set.
8. How the ground truth for the training set was established: Not applicable.

Summary of Substantial Equivalence Determination

The "study" that proves the device meets the (implied) acceptance criteria is the demonstration of substantial equivalence to the predicate device, "Med Tec, Inc. Iso-Align" (Class I exemption under registration A 743531).

The submission asserts this equivalence based on the following:

• Similar design and construction: The Perma-Doc Phantom is a passive device with a radio-opaque scale embedded within it for quality assurance of HDR systems.
• Identical materials: The materials used are stated to be identical to the predicate.
• Same intended use: Both devices serve as radiologic quality assurance instruments for evaluating system performance, specifically by providing a quantifiable image for operator analysis.
• Same performance characteristics: The device performs its intended function (providing an image for consistency analysis) without altering the radiation field, comparable to the predicate.
• No new issues of safety or effectiveness: This is a crucial point for 510(k) clearance, indicating that the device does not introduce novel risks.

The FDA's review and subsequent letter (K993960) confirm that the device is substantially equivalent to legally marketed predicate devices, thereby allowing it to be marketed. This regulatory determination serves as the "proof" that the device meets the necessary criteria for market entry under the 510(k) pathway, specifically by demonstrating it is as safe and effective as a legally marketed predicate device.

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In order to ensure the day to day performance of radiation generating equipment, many quality assurance tests are performed. This testing includes such tests as machine output, beam alignment, distance indicators. In all quality assurance testing a test object or measurement device is used to either validate a system parameter or measure some aspect of system performance. These test objects/devices can easily be classified as one of two types, passive or active. An active device is one that can make a measurement or perform a test without user evaluation or interpretation, while a passive device merely provides an environment or condition for testing, but the result requires the user or operator to make an evaluation and determination. Examples of passive devices are test phantoms or film cassettes.

The Mick Radio-Nuclear Isocentric Beam Checker is a passive device, designed to be placed between the incident radiation beam and a piece of film. Radiographic exposure of the Isocentric Beam Checker results in the production of an image on the film which can then be analyzed by the operator for consistency from the prior test exposure. The Isocentric Beam Checker does not alter, change or moderate the radiation field in any manner. It has radio-opaque objects embedded into it that are visualized on standard x-ray film when inserted in a radiation beam. The inspection of the radio-opaque marks on the film is then used in quality assurance.

The Mick Radio-Nuclear Isocentric Beam Checkers are a passive device, designed to be placed between the incident radiation beam and a piece of film. Radiographic exposure of the Isocentric Beam Checker results in the production of an image on the film which can then be analyzed by the operator for consistency from the prior test exposure. The Isocentric Beam Checker does not alter, change or moderate the radiation field in any manner. It has radio-opaque objects embedded into it that are visualized on standard xray film when inserted in a radiation beam. The inspections of the radio-opaque marks on the film are then used in quality assurance.

The provided text is a 510(k) summary for the "Isocentric Beam Checker." This document does not describe a study that establishes acceptance criteria or proves the device meets them. Instead, it describes a device that is a passive quality assurance tool and asserts its substantial equivalence to a predicate device.

Here's why the requested information cannot be extracted from this document:

• Nature of the Device: The Isocentric Beam Checker is a passive device. It doesn't have an "algorithm" or "AI" that analyzes images or makes determinations. It provides radio-opaque objects that are visualized on X-ray film, and then a human operator analyzes the film.
• Regulatory Context: This is a 510(k) premarket notification, which focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving performance against specific acceptance criteria through a standalone study in the way a novel diagnostic software might.
• Contents of the Document: The document outlines the device's classification, intended use, description, and claims substantial equivalence. It explicitly states, "No new issues of safety or effectiveness are introduced by using this device." There is no mention of a performance study with a test set, ground truth, experts, or any of the other details requested for proving device performance in the context of an algorithm or AI. It also notes that "Performance standards for radiologic quality assurance instruments have not been established by the FDA under Section 514 of the Food, Drug and Cosmetic Act."

Therefore, I cannot populate the table or answer the specific questions about acceptance criteria, study details, sample sizes, ground truth, or expert involvement because this information is not present in the provided 510(k) summary.

The document refers to "performance characteristics" in the context of substantial equivalence, but it does not define specific metrics or a study to evaluate them for this particular device.

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In Radiation Therapy and Diagnostic Radiology, an ongoing quality assurance program is essential for ensuring the overall quality of patient care. As part of the overall quality assurance program daily, monthly and annual tests to validate machine output, field size indicators, and general machine geometry are performed. In order to obtain reproducible results, these tests must be Since machine with the same conditions, with the same physical parameters. Since machine output and field size are directly related to the geometry of the test conditions it is important that the distance from the beam source to the test device is consistent. The Aktina Medical Physics Corporation Mechanical Frontpointer is designed to provide this ability. By utilizing the fixed geometry of the accessory mount system on a linear accelerator, a rigid based for measuring distance can be obtained. The Mechanical Frontpointer presented in this notification functions exactly as a standard mechanical tape measure however by being attached to a frame which slides into the accessory mount a reproducible setup is ensured.

The AKTINA Medical Physics Corporation Mechanical Frontpointer is intended for use in Medical Physics Quality Assurance. The intended use of this device is to provide a reproducible and accurate mechanism for the setup of test objects and equipment used in quality control and calibrations by medical physicists. The Mechanical Frontpointer is mounted in the accessory slot of the treatment machine and is not in contact with the patient at any time when in use.

The provided text does not contain information about acceptance criteria, device performance metrics, or a study demonstrating the device meets such criteria. The document is a 510(k) summary for the "Mechanical Frontpointer," which is a device for medical physics quality assurance, used to provide a reproducible and accurate mechanism for the setup of test objects and equipment.

The document focuses on:

• General Provisions: Trade name, common name, applicant information.
• Predicate Devices: Sears Tape Measure and Elekta Oncology Systems Mechanical Frontpointer K874558.
• Classification: Class I and Class II device classifications.
• Performance Standards: Notes that FDA has not established performance standards for Mechanical Frontpointers.
• Intended Use and Device Description: Explains its function in medical physics quality assurance for reproducible setup of test objects and equipment.
• Biocompatibility: States no studies were undertaken as the device does not contact the patient.
• Summary of Substantial Equivalence: Claims similarity in design, construction, materials, intended use, and performance to predicate devices without introducing new safety/effectiveness issues.
• FDA Clearance Letter: Official communication from FDA stating clearance based on substantial equivalence.
• Indications for Use: Details its role in radiation therapy and diagnostic radiology quality assurance for reproducible setup.

Therefore, I cannot provide the requested information regarding acceptance criteria, device performance, study details, sample sizes, ground truth establishment, or MRMC studies, as these details are not present in the provided text. The document is a regulatory submission for substantial equivalence, not a detailed performance study report.

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