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The Protura Couch Software is intended to interface between record and verify systems, linear accelerator (Linac) software systems, Linac safeguard systems, and/or image guidance systems and the Protura Couch. The Protura Couch Software is also capable of operating the Protura Couch (6 Degree Axis Couch).

The proposed device, the Protura Couch Software 1.3.0 (Part No. MT6XSM1.3.0), is patient positioning software used in radiation treatments in conjunction with an Image Guided Radiation Therapy (IGRT) system. The Protura Couch Software interfaces with the Couch Hardware (K031866) and is intended to position the patient after diagnostic decisions have been made based on results from an IGRT system. The Protura Couch Software allows the user to control patient positioning with six degrees of freedom from outside of the treatment room. The Protura Couch Software also includes the ability to interface with record and verify systems, Linac software systems, Linac safeguard systems, and/or image guidance systems.

The provided document is a 510(k) summary for the Protura Couch Software 1.3.0, a patient positioning software used in radiation treatments. It states that non-clinical performance testing was conducted, but no clinical testing was performed. Therefore, it does not contain the specific information required to complete a table of acceptance criteria and reported device performance based on a study, nor does it provide details about patient data, expert reviews, or comparative effectiveness studies.

However, based on the information provided, here's what can be extracted and inferred:

1. Table of Acceptance Criteria and Reported Device Performance:

The document lists "Non-Clinical Performance Data" areas tested and states "All testing confirmed that the Protura Couch Software 1.3.0 is safe and effective for its intended use." However, it does not provide specific acceptance criteria (e.g., numerical thresholds, error limits) or quantitative results of the device's performance against such criteria.

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

• Sample Size: Not applicable. No clinical testing with patient data was performed. The testing described is non-clinical performance testing of the software and hardware interfaces.
• Data Provenance: Not applicable, as no patient data was used.

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

• Number of Experts: Not applicable. No clinical testing or expert review of patient data was conducted.
• Qualifications of Experts: Not applicable.

4. Adjudication Method for the Test Set:

• Adjudication Method: Not applicable. No clinical testing or expert review requiring adjudication was conducted.

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

• MRMC Study: No. The document explicitly states: "No clinical testing was performed in the evaluation of this medical device." Therefore, no MRMC study, human reader improvement analysis, or AI assistance effect size was reported.

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

• Standalone Performance: The non-clinical performance testing focused on the device's functionality, interfacing, and mechanical aspects. While this could be considered a form of "standalone" testing for the software's operational characteristics, it's not in the context of diagnostic or interpretive performance where "standalone" typically refers to an AI algorithm's accuracy in analysis without human input. The document describes testing of the software's technical operation (e.g., couch movement, interfacing), not its interpretation of data.

7. The Type of Ground Truth Used:

• Ground Truth: For the non-clinical performance tests, the "ground truth" would have been established by engineering specifications, calibration standards, and expected operational parameters for the couch movement, interface communication, and alignment accuracy. For example, for "Movement of the Protura Couch," the ground truth would be the programmed movement patterns and expected physical responses of the couch hardware. For "Couch Pedestal and Isocenter Alignment," it would be the precise physical alignment specifications.

8. The Sample Size for the Training Set:

• Sample Size: Not applicable. This device is software that controls a medical device (a radiation therapy couch). It is not an AI/ML algorithm that requires a training set in the typical sense (i.e., for learning from data to perform a diagnostic or predictive task). The software is programmed based on engineering principles and specifications, not trained on a dataset of patient cases.

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

• Ground Truth for Training Set: Not applicable, as there is no "training set" in the context of an AI/ML algorithm for this device. The software functions based on its coded logic and interface protocols, not on learned patterns from a dataset.

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The Protura Couch Software is interface between a record and verify system, linear accelerator (Linac) software, Linac safeguard systems, and/or image guidance systems and the Protura Couch. The Protura Couch Software is also capable of operating the Protura Couch (6 Degree Axis Couch).

The proposed device, the Protura Couch Software (MT6XSMEU), is patient positioning software used in radiation treatments in conjunction with an Image Guided Radiation Therapy (IGRT) system. The Protura Couch Software interfaces with the Protura Couch Hardware (K031866) and is intended to position the patient after diagnostic decisions have been made based on results from an IGRT system. The Protura Couch Software allows the user to control patient positioning with six degrees of freedom from outside of the treatment room. The Protura Couch Software also includes the ability to interface with a record and verify system, Linac software, Linac safeguard systems, and/or image guidance systems.

The provided text describes a 510(k) summary for the Protura Couch Software (device name: MT6XSMEU) by MED-TEC, Inc. d/b/a CIVCO Medical Solutions. This software is designed for patient positioning in radiation therapy.

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

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

The document does not explicitly state quantitative acceptance criteria in a table format. Instead, it describes performance testing conducted. The reported device performance is that "All testing confirmed that the Protura Couch Software is safe and effective for its intended use" and that it is "substantially equivalent to the predicate device in regards to safety, effectiveness, and performance."

The characteristics tested include:

• Movement of the Protura Couch
• Interfacing with External Systems
• Couch Pedestal and Isocenter Alignment
• Patient Record Handling

Without specific numerical targets for these characteristics, a precise table of acceptance criteria and reported performance cannot be generated. The document indicates these tests were performed and passed.

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

The document does not specify a sample size for the test set. It mentions "non-clinical performance testing" but does not detail the number of test cases, simulated patients, or data points used. Data provenance is also not mentioned, as no clinical data or data from human subjects was used for testing.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)

This information is not applicable and hence not provided. As the testing was "non-clinical" and involved evaluating software functionality and interface, there was no need for experts to establish ground truth in the context of medical image interpretation or patient outcomes.

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

This information is not applicable and hence not provided. The non-clinical performance data described does not involve expert adjudication as it pertains to software functionality and system interfaces, not diagnostic or prognostic outcomes requiring consensus.

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 study was performed or is mentioned. The device is software for controlling a radiation therapy couch, not an AI for image interpretation or diagnosis that would typically be evaluated with human readers.

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

Yes, based on the description, the performance testing appears to be a standalone evaluation of the software's functionality and its ability to interface with other systems and control the couch. The "non-clinical performance data" section describes testing conducted on the software itself and its interactions, without human-in-the-loop performance being a primary evaluation point for its safety and effectiveness.

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

The concept of "ground truth" as typically applied in AI/clinical studies (e.g., expert consensus for diagnosis, pathological findings) is not relevant here. For this device (software controlling a medical couch), the "ground truth" would be the expected functional behavior and precise physical movements of the couch, as defined by engineering specifications and safety standards. The testing verified that the software met these operational specifications.

8. The sample size for the training set

This information is not applicable and not provided. The Protura Couch Software is described as an interface and control system, programmed in C#. It is not an AI/machine learning model that typically requires a distinct "training set" in the sense of labeled data for learning.

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

This information is not applicable and not provided, for the same reasons as in point 8.

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Interface between treatment planning system and the MED-TEC Pro Series Couch; or: Software for MED-TEC Pro Series Couch (6 Degree Axis Couch) .

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This FDA 510(k) letter for the "Pro Series Couch Software" by MED-TEC, Inc. (K034054) is a regulatory clearance document. It does not contain the information required to describe the acceptance criteria and the study that proves the device meets those criteria.

The letter explicitly states that the device is determined to be "substantially equivalent" to legally marketed predicate devices. This means that the FDA has not conducted a de novo review of performance or efficacy in the way that would typically involve acceptance criteria and detailed study results. Instead, the focus is on whether the new device is as safe and effective as devices already on the market.

Therefore, I cannot provide answers to the requested points based on the provided document. The document pertains to regulatory clearance based on substantial equivalence, not a detailed performance study with acceptance criteria.

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The intended use of this device is to support a patient during radiation therapy; or The intended use of the MED-TEC 6 degree axis couch is to support and aid in positioning a patient during radiologic, radiation therapy, and other medical procedures.

The 6 degree axis couch adds Pitch and Roll to the normal X, Y, Z. and Yaw motions. The additional Pitch and Roll make patient alignment simpler without the need to manually move the patent on the table.

MED-TEC 6 degree axis couch

The provided document is a 510(k) cleared by the FDA for the "MED-TEC 6 degree axis couch." This type of document primarily focuses on demonstrating substantial equivalence to a predicate device, rather than presenting a detailed study proving the device meets specific acceptance criteria in the manner you've outlined for performance studies.

Therefore, most of the information you've requested regarding acceptance criteria, a specific study proving those criteria, sample sizes, expert involvement, and ground truth types is not available within this 510(k clearance letter and its attached "Indications For Use" statement.

The 510(k) process for a Class II device like this couch generally involves submitting information about the device's design, intended use, materials, manufacturing processes, and how it compares to a legally marketed predicate device. The "acceptance criteria" here are typically tied to the device's ability to perform its intended function safely and effectively, similar to the predicate, and to comply with general controls and any special controls applicable to its device class.

Here's what can be inferred or stated based on the provided text, and where your requested information is not present:

1. Table of Acceptance Criteria and Reported Device Performance

• Acceptance Criteria: Not explicitly stated in terms of measurable performance metrics within this document. The implicit acceptance criteria are that the device performs its intended function (patient support and positioning during radiation therapy and other medical procedures) safely and effectively, and is substantially equivalent to a predicate device. This would typically involve demonstrating mechanical stability, range of motion, load bearing capacity, and safety features in testing, but these specific criteria and their target values are not detailed here.
• Reported Device Performance: The document states the device "supports and aids in positioning a patient during radiologic, radiation therapy, and other medical procedures" and that the "6 degree axis couch adds Pitch and Roll to the normal X, Y, Z, and Yaw motions. The additional Pitch and Roll make patient alignment simpler without the need to manually move the patent on the table." This describes the functionality and benefit of the device but doesn't provide quantitative performance data against specific acceptance criteria.

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

• Not available. The document does not describe a clinical or performance "test set" in the context of, for example, image analysis or diagnostic accuracy. For a device like a patient support assembly, testing would likely involve engineering and bench testing rather than human subject testing in the traditional sense of a "test set."

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

• Not applicable/Not available. There is no mention of "experts" establishing "ground truth" for a test set in this 510(k documentation, as it's not a study involving expert assessment of data (e.g., medical images).

4. Adjudication method for the test set

• Not applicable/Not available. No test set or adjudication method is described.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

• Not applicable. This device is a mechanical patient support assembly, not an AI-driven diagnostic or imaging device. Therefore, an MRMC study comparing human reader performance with and without AI assistance is not relevant or described.

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

• Not applicable. This device is a mechanical patient support assembly and does not involve an algorithm with standalone performance.

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

• Not applicable/Not available. Ground truth, in the context of the type of studies implied by your questions, is not relevant to this mechanical device's 510(k. The "truth" for this device would be its mechanical specifications, safety, and functionality conforming to engineering standards and its intended use.

8. The sample size for the training set

• Not applicable/Not available. There is no "training set" relevant for a mechanical device like this couch.

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

• Not applicable/Not available. As there is no training set, this question is not applicable.

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The intended use of this device is to act as a quality assurance device to check for the presence of a brachytherapy seed and give indication of dose rate by an audible tone or digital readout on a standard multi meter. The SDF will be used for 'relative' dosimetry.

The SDF will be used for 'relative' dosimetry.

Scintillating Fiber Dosimeter (SFD)

This document is a 510(k) clearance letter for the Scintillating Fiber Dosimeter (SFD). It does not contain information about acceptance criteria or a study proving the device meets said criteria. The letter primarily focuses on the FDA's determination of substantial equivalence to a predicate device and regulatory compliance.

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

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The intended use of this device is to provide a cutout for displacement of the small bowel from the treatment area. The belly board can be used by it's self or with MED-TEC's HipFix system. The MED-TEC bellyboard is placed on the treatment table and has a cutout that aids in the displacement of the small bowel from the treatment area.

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I am sorry, but the provided text does not contain information about acceptance criteria or a study proving device performance. The document is a 510(k) clearance letter from the FDA for a device called "Bellyboard," stating that it has been found substantially equivalent to legally marketed predicate devices. It discusses regulatory matters, but no performance studies or acceptance criteria are detailed.

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Software translates the ASCII output from a treatment plan to G code for use on a milling machine.

Works with various treatment plan outputs and translates the treatment plan into G code that can be used on a milling machine to produce a compensating shield.

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I am sorry, but the provided text does not contain the information required to answer your request. The document is an FDA 510(k) clearance letter for the MED-TEC Compensator Block Cutter Software, which indicates the device is substantially equivalent to legally marketed predicate devices. However, it does not include details on acceptance criteria, specific device performance, study methodology, sample sizes, ground truth establishment, or expert qualifications. The attachment only provides the "Indications For Use" for the software.

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The intended use of this device is to help provide dose uniformity for electron beam profile.

MED-TEC, INC. has a Block, Beam-Shaping, Radiation system to be manufactured by MED-TEC, INC.

This document is an FDA 510(k) clearance letter for the "Electron Wedge MT-EW-1000" by Med-Tec, Inc. It indicates that the device has been found substantially equivalent to a predicate device and can therefore be marketed.

However, this document does not contain any information about acceptance criteria, device performance studies, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, or training set details. It is purely a regulatory clearance notice.

Therefore, I cannot provide the requested information from the given input.

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The intended use of this device is to provide an additional aid to the fast and accurate repeat positioning of the patient for radiation or other treatment. The device forms to the back of the patient's head and eliminates the usual range of movement of ordinary head cups.

MoldCare Head & Neck Cushion Model # MT-ACL-14242. A Radiographic head holder System to be manufactured by MED-TEC, INC.

This document is a 510(k) premarket notification decision letter from the FDA regarding the Moldcare Head & Neck Cushion. It does not contain information about acceptance criteria or a study proving that the device meets such criteria.

The letter explicitly states that the device is substantially equivalent to legally marketed predicate devices. This means that the FDA determined the device is as safe and effective as a device already on the market, usually without requiring new clinical studies to prove efficacy.

Therefore, I cannot extract the requested information from the provided text. The document focuses on regulatory approval based on substantial equivalence, not on performance criteria and validation studies.

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