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The Elekta Medical Linear Accelerator (EMLA) is intended to be used for external beam radiation therapy (EBRT) treatments as determined by a licensed medical practitioner.

It is intended to assist a licensed medical practitioner in the defined target volumes, while sparing surrounding normal tissue and critical organs from excess radiation.

-Elekta Synergy and Elekta Harmony are the default entry-level configurations. They are intended to be used for single or multiple fractions using standard dose fractionation, and hypofractionation in all areas of the body where such treatment is indicated.

-Elekta Infinity is the default mid-level configuration. It is intended to be used for single or multiple fractions using standard dose fractionation, hypofractionation and stereotactic delivery (stereotactic body radiation therapy - SBRT; stereotactic ablative radiotherapy - SABR) in all areas of the body where such treatment is indicated.

-Versa HD is the default high-level configuration. It is intended to be used for single or multiple fractions using standard fractionation, hyperfractionation and stereotactic delivery (stereotactic body radiation therapy - SBRT; stereotactic ablative radiotherapy – SABR; stereotactic radio surgery - SRS) in all areas of the body where such treatment is indicated and for the treatment of functional disorders, such as trigeminal neuralgia.

The EMLA is indicated for the delivery of curative and palliative intent EBRT to Adult and Pediatic with primary benign and malignant tumor and metastasis (or secondaries) anywhere in the body.

The Elekta Medical Linear Accelerator (EMLA) system is an image guided Radiation Therapy device to assist a licensed practitioner in the delivery of ionizing radiation to a defined target volume. The system consists of components of the accelerator, such as, beam shaping, with imaging and accessories for patient positioning and set-up to deliver therapeutic treatments. The Elekta Harmony being introduced with this premarket notification submission.

The EMLA offers multiple treatment modalities including photon energies in the range of 4 – 25 MV and electron energies in the range of 4 – 22 MeV. Un-flattened and flattened photon energies are available. A treatment table, located in the treatment room, allows the patient to be accurately positioned to receive the prescribed radiotherapy and supports the patient during treatment. The table is capable of linear and rotational movements. The EMLA is equipped with a MV portal imaging subsystem, i.e. iViewGT, and an optional kV imaging sub-system, i.e. XVI. The user interface controlling devices are located partly in the treatment room and partly in the control room.

This 510(k) summary describes a premarket notification for the Elekta Medical Linear Accelerator (EMLA) system, including the new Elekta Harmony variant. This submission is for a medical device that assists in delivering external beam radiation therapy and is classified as a Class II device. The document does not contain acceptance criteria or a study demonstrating the device meets such criteria for performance. The non-clinical testing performed focuses on design, risk management, and compliance with various standards related to safety, essential performance, and software development.

Therefore, many of the requested details, such as a table of acceptance criteria, reported device performance, sample sizes for test sets, data provenance, expert qualifications, adjudication methods, multi-reader multi-case studies, standalone performance, and ground truth information are not available in the provided text.

Here's a breakdown of what can be extracted:

• Device Name: Elekta Synergy, Elekta Harmony, Elekta Infinity, Versa HD (all fall under Elekta Medical Linear Accelerator - EMLA)
• Regulation Number: 21 CFR 892.5050
• Regulation Name: Medical charged-particle radiation therapy system
• Regulatory Class: Class II
• Product Code: IYE

Summary of available information based on your request categories:

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

   • Not provided. The document states "The verification and validation non-clinical test results demonstrate compliance with the applicable consensus standards and that the functional and performance requirements defined by Elekta are met." However, it does not specify what those functional and performance requirements (acceptance criteria) are, nor does it quantify the reported device performance against them.

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

   • Not provided. The document mentions "non-clinical testing" and "formal validation of the clinical workflows has been performed on a clinically representative production equivalent system," but does not give sample sizes, data provenance, or whether the study was retrospective or prospective.

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):

   • Not provided. The document mentions "competent and professionally qualified personnel" performed validation but does not specify the number or qualifications of these individuals, nor their role in establishing a "ground truth" for a test set.

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

   • Not provided.

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/Not provided. This device is a linear accelerator for radiation therapy delivery, not an AI-assisted diagnostic or interpretation tool for human readers. No MRMC study is mentioned.

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

   • Not applicable/Not provided. While the device contains software, the testing described is of the integrated system and its components, focusing on safety, essential performance, and compliance with standards. It's not a standalone algorithm with a specific performance metric of clinical output in the context of diagnostic AI. The device's function is to deliver radiation, not to independently make diagnostic or treatment decisions without human input.

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

   • Not provided. The term "ground truth" in this context is generally for diagnostic or interpretive AI systems. For a linear accelerator, "ground truth" would relate to the accuracy of beam delivery, dose distribution, and patient positioning. The document states validation was done against "functional and performance requirements defined by Elekta" and "applicable consensus standards," which serve as the "ground truth" for engineering and safety performance, but not in the sense of a clinical diagnostic truth.

8. The sample size for the training set:

   • Not applicable/Not provided. This is not a submission for an AI/ML algorithm that is "trained" on a dataset in the typical sense of diagnostic AI. The software development and verification are described as following IEC 62304 for medical device software.

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

   • Not applicable/Not provided. See point 8.

Conclusion:

The provided 510(k) summary focuses on demonstrating substantial equivalence through non-clinical testing regarding safety, essential performance, and compliance with regulatory standards for a medical linear accelerator system. It does not contain the detailed performance study information typically requested for diagnostic or interpretive AI/ML devices, such as specific acceptance criteria, quantitative performance metrics, test set characteristics, or ground truth methodologies for clinical outcomes.

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Elekta Unity using Magnetic Resonance Imaging is indicated for radiation therapy treatments and stereotactic radiation treatments of malignant and benign diseases anywhere in the body as determined by a licensed medical practitioner in accordance with a defined treatment plan. Elekta Unity is intended for use with the compatible Treatment Planning and Oncology Information Systems.

The Elekta Unity 1.5T MR scanner is a magnetic resonance imaging system that produces cross-sectional images in any orientation of the internal structure of the whole body before, during, and after the radiotherapy treatment. When interpreted by a trained physician magnetic resonance images acquired before, during, and after the radiotherapy treatment yield information that can be useful in diagnosis and may assist therapy planning, patient positioning and treatment delivery related to radiation oncology.

Elekta Unity is a multifunctional digital linear accelerator designed to assist licensed medical practitioners in the delivery of ionizing radiation to defined volumes (e.g. malignant and benign tumors). Elekta Unity is capable of both intensity modulated radiation therapy (IMRT) and image guided radiation therapy (IGRT).

The Elekta Unity 1.5T MRI scanner is a magnetic resonance imaging sub-system that produces cross-sectional images in any orientation of the internal structure of the whole body before, during, and after the radiotherapy treatment.

When interpreted by a trained physician the images acquired before, during, and after the radiotherapy treatment yield information that can be useful in diagnosis and may assist therapy planning, patient positioning and treatment delivery related to radiation oncology.

In addition to the MRI sequences cleared with the predicate device, the current Elekta Unity configuration has the ability to generate images using following techniques, before, during or after treatment for Off-line review:

• Single-shot EPI diffusion imaging (DWI) with 3 diffusion directions and up to 16 b-values.
• . Diffusion imaging processing with automatic generation of the ADC and/or eADC maps.

Here's a breakdown of the acceptance criteria and the study details for the Elekta Unity device, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

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

• The document does not specify a numerical sample size for the "test set" used in the image validation study. It only mentions "anonymized images" from Elekta Unity.
• Data Provenance: The images were "obtained on Elekta Unity," implying they were internally generated or acquired from the device itself. Given the context of a 510(k) summary, it's highly likely these were retrospective images produced during internal testing or early clinical use for device characterization, rather than a prospective, formal diagnostic study with patient consent for external use. The country of origin is not specified, but the submission is from Elekta Limited in the UK.

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

• Number of Experts: More than one expert, specified as "US Board Certificated Diagnostic Radiologists." The exact number is not provided, but it implies a panel.
• Qualifications of Experts: "US Board Certificated Diagnostic Radiologists." No specific experience level (e.g., 10 years) is given.

4. Adjudication Method for the Test Set

• The adjudication method was consensus. The document states, "There was consensus among the expert reviewers that imaging with Elekta Unity met the clinical criteria for diagnostic MRI."

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

• No, an MRMC comparative effectiveness study was not explicitly stated or described. The study focused on the standalone performance and image quality of the Elekta Unity's MR imaging capabilities. It did not compare human readers with and without AI assistance; rather, it evaluated the diagnostic quality of the images generated by the device itself.

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

• Yes, a standalone performance evaluation of the imaging component was done. The image validation study assessed the quality of images produced by the Elekta Unity's MR scanner, interpreted by radiologists without any indication of AI assistance in the interpretation loop for the purpose of validating the device's inherent imaging capabilities. The main purpose of this 510(k) is the device itself (hardware and core software), not an AI diagnostic algorithm. The new features for diffusion imaging (DWI and ADC/eADC maps) are outputs of the device's imaging capabilities, which are then evaluated for their standalone image quality.

7. The Type of Ground Truth Used

• Expert Consensus. For the image validation, the ground truth was established by the "consensus among the expert reviewers that imaging with Elekta Unity met the clinical criteria for diagnostic MRI." For the device's overall safety and performance, the ground truth was established through conformance with recognized consensus standards and internal design and risk management requirements.

8. The Sample Size for the Training Set

• The document does not provide any information regarding a training set size. This submission is for the Elekta Unity hardware and its associated imaging capabilities, not primarily an AI/ML algorithm that would typically have a separate training set. The mention of "Diffusion imaging processing with automatic generation of the ADC and/or eADC maps" implies some algorithmic processing, but no details on training data for this specific processing are given.

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

• As no training set is mentioned for the direct evaluation described, no information is provided on how its ground truth would have been established.

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Entry-level EMLA (Synergy Platform/Synergy)
• The Elekta Medical Linear Accelerator (EMLA) is intended to be used for external beam radiation therapy (EBRT) treatments as determined by a licenced medical practitioner.
• It is intended to assist a licenced medical practitioner in the delivery of EBRT to defined target volumes, while sparing surrounding normal tissue and critical organs from excess radiation. It is intended to be used for single or multiple fractions using standard dose fractionation, and hypofractionation in all areas of the body where such treatment is indicated.
• The EMLA is indicated for the delivery of curative and palliative intent EBRT to Adult and Pediatic with primary benign and malignant tumor and metastasis (or secondaries) anywhere in the body.

Mid-level EMLA (Infinity)
• The Elekta Medical Linear Accelerator (EMLA) is intended to be used for external beam radiation therapy (EBRT) treatments as determined by a licenced medical practitioner.
• It is intended to assist a licenced medical practitioner in the delivery of EBRT to defined target volumes, while sparing surrounding normal tissue and critical organs from excess radiation. It is intended to be used for single or multiple fractions using standard dose fractionation, hypofractionation and stereotactic delivery (stereotactic body radiation therapy – SBRT: stereotactic ablative radiotherapy – SABR) in all areas of the body where such treatment is indicated.
• The EMLA is indicated for the delivery of curative and palliative intent EBRT to Adult and Pediatric patients with primary benign and malignant tumor and metastasis (or secondaries) anywhere in the body.

High-level EMLA (Versa HD)
• The Elekta Medical Linear Accelerator (EMLA) is intended to be used for external beam radiation therapy (EBRT) treatments as determined by a licenced medical practitioner.
• It is intended to assist a licenced practitioner in the delivery of EBRT to defined target volumes, while sparing surrounding normal tissue and critical organs from excess radiation. It is intended to be used for single or multiple fractions using standard fractionation, hypofractionation and stereotactic delivery (stereotactic body radiation therapy - SBRT: stereotactic ablative radiotherapy - SABR; stereotactic radio surgery - SRS) in all areas of the body where such treatment is indicated.
• The EMLA is indicated for the delivery of curative and palliative intent EBRT to Adult and Pediatic with primary benign and malignant tumor and metastasis (or secondaries) anywhere in the body and for the treatment of functional disorders, such as trigeminal neuralgia.

The Elekta Medical Linear Accelerator system is an image guided Radiation Therapy device to assist a licensed practitioner in the delivery of ionizing radiation to a defined target volume.
The system consists of components of the accelerator, such as, beam shaping, with imaging and accessories for patient positioning and set-up to deliver therapeutic treatments.
The Elekta Medical Linear Accelerator System is currently available in the following model variants - Precise Treatment System, Elekta Synergy Platform, Elekta Synergy, Elekta Infinity and Versa HD.

This document, K192242, is an FDA 510(k) premarket notification for an Elekta Medical Linear Accelerator system. It outlines the device's indications for use and asserts its substantial equivalence to a predicate device (EMLA K182138).

Crucially, this document does not describe a study that proves the device meets specific acceptance criteria based on performance metrics (e.g., accuracy, sensitivity, specificity) for an AI/ML component. Instead, the notification primarily concerns restructuring and clarifying the Indications for Use statements for different models of the linear accelerator.

The "Summary of performance testing (non-clinical)" section explicitly states: "Since no changes to the hardware or software was made in this submission, no additional non-clinical testing has been conducted." Similarly, for "Summary of performance testing (clinical)", it mentions, "The only change in this submission concern Indications for Use. An extensive literature search was conducted to collect and analyze available clinical evidence in order to support new Indications for Use."

Therefore, based on the provided text, it is not possible to complete the requested information about acceptance criteria and a study demonstrating device performance for an AI/ML component. The document does not contain such a study or performance metrics.

However, if we were to infer the types of information that would be present in such a study, and filling in with "N/A" or "Not provided" for elements not found in the text, here's how the table and subsequent points would be structured:

Acceptance Criteria and Device Performance Study Information (Based on the supplied document, which does not contain this data):

As the provided FDA 510(k) notification (K192242) for the Elekta Medical Linear Accelerator focuses on clarifying Indications for Use and asserts substantial equivalence without new performance testing, the specific details regarding acceptance criteria and a study proving an AI/ML device meets these criteria are not available in the document. The document explicitly states no changes were made to hardware or software and no additional non-clinical testing was conducted for this submission.

Therefore, the following table and subsequent points will indicate "Not Provided" or "N/A" for the requested information, as it is not present in the given text.

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size for Test Set: Not provided. The submission states that no new non-clinical testing was conducted, and for clinical "performance," an extensive literature search was performed, not a new clinical study with a defined test set.
• Data Provenance: The document refers to "extensive literature search" for clinical evidence, but does not detail the origin (e.g., country of origin, retrospective/prospective nature) of data within that literature.

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

• Not applicable as no specific test set requiring expert-established ground truth for an AI/ML component's performance is described in this submission. The "ground truth" for the current submission is based on existing clinical literature supporting the general use of linear accelerators for radiation therapy.

4. Adjudication Method for the Test Set

• Not applicable as no specific test set requiring adjudication is described.

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

• Was an MRMC study done? No. The document does not describe any MRMC study.
• Effect size of human reader improvement with AI vs. without AI assistance: Not applicable.

6. Standalone (Algorithm Only) Performance Study

• Was a standalone study done? No. The document refers to the Elekta Medical Linear Accelerator system as a whole, not a specific standalone AI algorithm, and states no new non-clinical testing was performed.

7. Type of Ground Truth Used for the Test Set

• Not applicable for a performance study of an AI/ML component. The current submission's "ground truth" for its claims relates to the well-established clinical indications for external beam radiation therapy, supported by existing literature.

8. Sample Size for the Training Set

• Not applicable as no AI/ML training set is described in this submission, which focuses on device indications and substantial equivalence rather than a new AI component's development or validation.

9. How Ground Truth for the Training Set Was Established

• Not applicable.

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Elekta Unity using Magnetic Resonance Imaging is indicated for radiation therapy treatments and stereotactic radiation treatments of malignant and benign diseases anywhere in the body as determined by a licensed medical practitioner in accordance with a defined treatment plan. Elekta Unity is intended for use with compatible Treatment Planning and Oncology Information Systems.

The Elekta Unity 1.5T MR scanner is a magnetic resonance imaging system that produces cross-sectional images in any orientation of the internal structure of the whole body before, during and after the radiotherapy treatment. Images provide information that may assist the therapy planning, patient positioning and treatment delivery related to radiation oncology.

Elekta Unity is a multifunctional digital linear accelerator designed to assist licensed medical practitioners in the delivery of ionizing radiation to defined volumes (e.g. malignant and benign tumors). Elekta Unity is capable of both intensity modulated radiation therapy (IMRT) and image guided radiation therapy (IGRT). Elekta Unity consists of a gantry-mounted 7MV linear accelerator sub-system which rotates around a 1.5T Magnetic Resonance Imaging (MRI) sub-system and a Patient Positioning Sub-system (PPS). It is controlled by dedicated system software, which incorporates patient positioning, imaging, and treatment delivery functions, and it is designed for use in conjunction with approved compatible Oncology Information and Treatment Planning systems. The Elekta Unity 1.5T MRI scanner is a magnetic resonance imaging sub-system that produces cross-sectional images in any orientation of the internal structure of the whole body before, during and after the radiotherapy treatment.

The provided text describes the Elekta Unity device, a medical charged-particle radiation therapy system. However, it does not contain specific acceptance criteria, reported device performance data, detailed information about study designs (like sample sizes for test or training sets, data provenance, expert adjudication, or MRMC studies), or how ground truth was established for the training set.

The document is a 510(k) premarket notification summary, which focuses on demonstrating substantial equivalence to a predicate device rather than providing a detailed clinical study report with performance metrics against predefined acceptance criteria.

Therefore, I cannot fulfill your request for a table of acceptance criteria and reported device performance, nor can I provide information regarding sample sizes, data provenance, expert qualifications, adjudication methods, MRMC studies, standalone performance, or ground truth details.

The document states that:

• Non-clinical testing was performed to evaluate device performance and functionality against design and risk management requirements at sub-system, integration, and system levels.
• Software verification testing was conducted in accordance with FDA's "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices that pose a major level of concern (Class C per IEC 62304).
• Basic safety and essential performance have been satisfied through conformance with device-specific recognized consensus standards (listed in the table on page 7), as well as applicable general and collateral safety and essential performance standards for medical devices.
• Validation and usability testing of the integrated system was performed in accordance with FDA guidance on human factors and usability engineering under clinically representative conditions by competent and professionally qualified personnel.
• The results from verification testing demonstrate device conformance to stated design specifications and standards.

While these statements indicate that testing was done to ensure safety and performance, the specific data, acceptance criteria, and study details you've asked for are not present in this document.

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iViewDose is a standalone software tool, available as an optional accessory of the linear accelerator. It is intended to assist in reducing the clinical risk in the delivery of radiotherapy treatments and does not alter the treatment delivery, or impact the clinical workflow.

The software is to be used for the purposes of detecting gross errors during the delivery of radiation therapy. The software acquires data using the iViewGT Electronic Portal Imaging Device at the time of treatment) and subsequently processes it. The processed data is compared with data calculated by the treatment planning system. The comparison is derived from the application of dose conversion and reconstruction algorithms to the EPID data, which is back-projected to a plane normal to a beam (2D) or multiple planes (3D) inside the patient (in vivo) or phantom (pretreatment).

iViewDose is not a treatment planning system, and provides an independent means of checking the dose delivered to the patient.

iViewDose therefore provides an added level of treatment assurance, thus giving clinicians greater confidence especially when complex treatment techniques are employed.

iViewDose is intended to support decision making in relation to the delivery of radiation to defined target volumes performed with Elekta linear accelerators only.

This Traditional 510(k) describes a new standalone software to be used with the Elekta range of medical linear accelerators, to further enhance the existing functionality.

The iViewDose program uses iViewGT™ images to reconstruct the dose in 3D in the volume (patient or phantom). The program then uses a gamma analysis to compare the reconstructed dose with the TPS dose in 3D. iViewDose uses a dose reconstruction algorithm to calculate the dose in the patient from the dose delivered to the MV detector panel. The algorithm corrects for scattered radiation from the patient and the MV detector panel. You can use iViewDose in vivo to make an estimate of the delivered dose to a patient. You can also use iViewDose for pre-treatment checks to make an estimate of the delivered dose to a phantom.

The provided text is a 510(k) summary for the Elekta iViewDose R1.0 device. While it describes the device's functionality and its comparison to predicate devices, it does not contain a detailed study report with specific acceptance criteria or an analysis of its performance against those criteria in a formal study.

The document states: "Validation of the system under clinically representative conditions has been performed by competent and professionally qualified personnel. Results from verification and validation testing demonstrate that conformance to applicable technical design specification have been met and safety & effectiveness have been achieved." However, it does not provide the specifics of these tests.

It also mentions: "Although no clinical testing has been performed as part of the development, it can be shown that the algorithm at the core of the iViewDose product has been used extensively for a number of years. The data reviewed as part of this evaluation has been obtained from clinical sites. The data is presented in section 11 of this submission." This indicates that while there's no new clinical study specifically for this device, existing clinical data related to the underlying algorithm was reviewed. The specifics of "section 11 of this submission" are not included in the provided text.

Therefore, I cannot provide the requested information in a table format with specific metrics because the detailed acceptance criteria and performance study results are not present in the given document.

Here's what I can extract from the text regarding the nature of the evaluation, even without specific numbers:

Device Overview:

• Device Name: iViewDose R1.0
• Intended Use: A standalone software tool to assist in reducing clinical risk in radiotherapy treatments by detecting gross errors during delivery. It acquires data from the iViewGT Electronic Portal Imaging Device (EPID), processes it, and compares it with data calculated by the treatment planning system. It provides an independent means of checking delivered dose (in vivo or pre-treatment) and offers an added level of treatment assurance.
• Functionality: Reconstructs 2D or 3D dose from EPID images, uses gamma analysis to compare reconstructed dose with TPS dose, generates reports, shows % difference, volume analysis, total dose assessment, dose profiles, and EPID images. It's compatible initially with Monaco and Pinnacle TPS and Elekta linear accelerators.

Evaluation Information (based on general statements, not specific study data):

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

   • Acceptance Criteria: Not explicitly stated in the provided text. The document broadly mentions "conformance to applicable technical design specification have been met and safety & effectiveness have been achieved."
   • Reported Device Performance: Not numerically reported in the provided text. The document states "This testing has shown that iViewDose is safe in use... Also, the use of iViewDose has been shown to have equivalent clinical efficacy when compared to the predicate devices..."

2. Sample sized used for the test set and the data provenance: Not specified in the provided text. It mentions "data reviewed as part of this evaluation has been obtained from clinical sites," but details about the size or nature (retrospective/prospective, country of origin) of this data are absent.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not specified in the provided text. However, it indicates "Validation of the system under clinically representative conditions has been performed by competent and professionally qualified personnel."

4. Adjudication method for the test set: Not specified in the provided text.

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 mentioned as performed. The device is described as a "standalone software tool" for checking dose, not primarily as an AI assistant for human reading.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Yes, the device is explicitly described as a "standalone software tool" and its function is to objectively compare reconstructed dose with planned dose. The performance claims ("conformance to applicable technical design specification have been met") likely refer to this standalone performance.

7. The type of ground truth used:

   • The primary comparison is between the dose calculated by the device (reconstructed from EPID data) and the data calculated by the treatment planning system (TPS dose).
   • The TPS dose serves as the reference or "ground truth" for the comparison within the iViewDose system's operation.

8. The sample size for the training set: Not specified in the provided text. The document refers to the algorithm having "been used extensively for a number of years" and data being "obtained from clinical sites," but does not provide details on training set size.

9. How the ground truth for the training set was established: Not specified in the provided text. Given the device's function, it's likely that the "training" (or calibration/validation) of the dose reconstruction algorithm would involve comparisons to established dosimetry measurements (e.g., ionization chambers, film, TPS calculations on phantoms), but this is not detailed.

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The Elekta X-Ray Volume Imaging system, XVI, is an electronic imaging device (EID), designed to be used with the Elekta range of medical linear accelerators and intended to be used as part of the radiation therapy treatment process for single or multiple fractions, of static and/or dynamic treatments, in gated or un-gated deliveries, in all areas of the body where such image guidance is determined by a licensed physician.

It provides real-time 2D, 3D & 4D image guidance before, during and after treatment delivery, and is intended to support confirmation of patient positioning, monitoring and management of internal motion, and decision making in response to target position, size. shape and displacement resulting from organ deformation and anatomical movement in relation to surrounding critical structures.

X VI facilitates precise and accurate dose placement, and patient set-up correction, through visualization of internal anatomy including target, critical structures and soft tissue with or without the use of implanted markers.

Symmetry™ is a software option within XVI that can be used to acquire and display volumetric images of sequential phases of the breathing cycle for the evaluation of respiration induced motion, to assist in identification of appropriate target locations within anatomical structures in motion.

The Elekta digital linear accelerator can be used for treatment that includes but is not limited to malignant and benign brain tumors, brain metastases, spine lesions treated using SRS, squamous cell carcinoma of the head and neck, lung, breast, pancreatic, hepatic malignancies treated using SBRT, prostate, and bone metastases.

This Traditional 510/k) describes modifications made to the XVI kilo-voltage imaging accessory of the Elekta range of digital linear accelerators. The primary reason for these modifications is to further enhance the imaging tools to support the monitoring and management of motion, by allowing visualization of tumor and surrounding critical structures during treatment delivery.

Improvements have also been made to the operator interface connectivity with other systems to support distributed workflow and in the provision of licensable options to tailor individual features.

The XVI system consists of a kV radiation source mounted onto the linac gantry drum and a kV radiation image detector. Incorporation of the kV imaging system onto the same structure as the treatment system allows high quality images of the patient anatomy to be acquired at the point of treatment and their content to be spatially related to the planned MV treatment, as previously cleared under Control Number (K100115)

There has been no change made to the underlying technological characteristics of the product.

Here's a breakdown of the acceptance criteria and study information for the Elekta XVI R5.0, based on the provided document:

This 510(k) summary (K131965) for Elekta XVI R5.0 does not contain specific acceptance criteria with numerical targets and reported device performance values nor details of a formal clinical study to prove these criteria. It focuses on demonstrating substantial equivalence to predicate devices and describes non-clinical performance testing.

Therefore, many of your requested points cannot be fully answered from this document. I will fill in what can be inferred or is explicitly stated and note where information is absent.

Acceptance Criteria and Device Performance

This document does not specify quantitative acceptance criteria (e.g., in terms of sensitivity, specificity, accuracy, precision, or detection rates) for the XVI R5.0. Instead, it relies on demonstrating that the device's functionality and performance are substantially equivalent to its predicates and that it meets internal requirement specifications and voluntary consensus safety standards.

Study Details

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

   • Sample Size: Not specified. The document mentions "clinically representative conditions" and "testing... at hospital sites," but no specific number of patients, cases, or images is provided for any test set.
   • Data Provenance: Not specified. The company is based in the UK, but where the "hospital sites" are located for testing is not mentioned. It is unclear if data was retrospective or prospective.

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

   • Number of experts: Not specified.
   • Qualifications: "Competent and professionally qualified personnel" performed validation, but their specific qualifications (e.g., radiologists, oncologists, number of years experience) are not detailed.

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

   • Not specified. The document does not describe any expert adjudication process for establishing ground truth for a test set.

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 performed/Not applicable. This document describes a device that provides image guidance for radiation therapy, not an AI-assisted diagnostic tool for human readers in the traditional sense. It's an imaging accessory for a linear accelerator. There is no mention of an MRMC study comparing human reader performance with and without this device's assistance.

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

   • Partially. The product itself is an "electronic imaging device (EID)" and its functions (image acquisition, 3D/4D registration, etc.) operate algorithmically. Non-clinical performance testing validated the "performance and functionality of the new and existing features against the requirement specification," which implies testing the algorithm's standalone capabilities. However, clinical performance in terms of patient outcomes or diagnostic accuracy without human intervention is not described, as the device is intended for human use "as part of the radiation therapy treatment process." The term "standalone" in this context might refer to testing the imaging and processing capabilities independently of patient treatment.

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

   • Not explicitly stated. Given the context of medical device testing for functionality and safety, ground truth for validation likely refers to:
     • Technical specifications/phantoms/known values: For verifying image quality, geometric accuracy, registration capabilities.
     • Clinical observation/expert verification during "clinically representative conditions": For assessing whether the visualization and motion management features operate as intended for patient positioning and internal motion.
   • There is no mention of pathology, post-treatment outcomes data, or a formal expert consensus process as "ground truth" for a performance study.

7. The sample size for the training set:

   • Not applicable. This document describes a medical imaging device that acquires and processes images, not a machine learning model that requires a training set in the conventional sense (e.g., for classification or detection tasks). While the device's algorithms would have been developed and refined, the document does not refer to a "training set" for the purpose of a regulatory submission.

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

   • Not applicable (as per point 7).

Summary of Limitations in the Provided Document:

The provided 510(k) summary is typical for a device demonstrating substantial equivalence, especially for modifications to an existing device (XVI R4.5) and expanding functionalities already present in predicate devices (Varian TrueBeam and Brainlab ExacTrac Vero). It emphasizes:

• Technological characteristics: Demonstrating that changes are minor or equivalent to predicates.
• Non-clinical performance testing: Verifying that the device meets its own functional and safety specifications.
• Compliance with standards: Adhering to relevant industry and safety standards.

It does not include the detailed clinical study data, quantitative acceptance criteria, or robust ground truth methodologies that would be expected for a novel device or an AI/CADe (Computer-Aided Detection) device undergoing a de novo or PMA pathway, or for an AI device where improved diagnostic performance is the primary claim.

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Integrity™ is the interface and control software for the Elekta range of medical digital linear accelerators and is intended to assist a licensed practitioner in the delivery of radiation to defined target volumes (e.g. lesions, arterio-venous malformations, malignant and benign tumours), whilst sparing surrounding normal tissue and critical organs from excess radiation. It is intended to be used for single or multiple fractions, delivered as static and/or dynamic beams of radiation, in all areas of the body where such treatment is indicated

This Traditional 510(k) describes enhancements to the integral software performing the interface and machine control functions for the Elekta Limited range of medical digital linear accelerators. These modifications provide improvements to beam delivery, compatibility with a wider range of Elekta products and the provision of diagnostic tools to assist service engineers

The provided 510(k) summary for Integrity™ R1.1 discusses a software enhancement to an existing medical linear accelerator control system. This submission does not describe a study in the traditional sense with acceptance criteria, sample sizes, expert ground truth, or an MRMC study related to diagnostic accuracy. Instead, it focuses on verifying the software's functionality and safety and establishing substantial equivalence to a predicate device.

The "acceptance criteria" here are essentially the successful completion of various engineering and validation tests, ensuring the new software features and changes do not negatively impact safety or effectiveness.

Here's a breakdown of the requested information based on the provided text, recognizing that many categories are not applicable to this type of submission which focuses on software changes to a control system, rather than a diagnostic AI device.

1. Table of Acceptance Criteria and Reported Device Performance

Given the nature of this 510(k) (software update for a control system), the "acceptance criteria" are implied to be the successful execution and verification of functional and safety requirements, and demonstrating substantial equivalence to the predicate device. The "reported device performance" refers to the system meeting these established criteria.

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

The document does not specify a "test set" in terms of patient data or clinical images, as this is a software update for a control system. Testing was performed on "production equivalent systems at Elekta and at customer sites." There is no mention of data provenance (e.g., country of origin, retrospective/prospective) because the testing is related to the functionality of the control system software, not analysis of patient data.

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

N/A. This is a software control system update, not a diagnostic device requiring expert interpretation for ground truth establishment.

4. Adjudication Method for the Test Set

N/A. Not applicable for this type of submission.

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

No. An MRMC study is not relevant for this type of device (a linear accelerator control system software update). The device's primary function is to control radiation delivery, not to interpret diagnostic images.

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

The device itself is a standalone algorithm (a control system software). Its performance was evaluated through verification and validation testing, as described in the "Summary of non clinical performance testing." This is effectively "standalone" performance testing for the software's functionality.

7. The Type of Ground Truth Used

N/A. For a control system, "ground truth" is defined by the technical specifications and desired operational parameters. Successful operation according to these specifications (e.g., accurate beam delivery, proper system responses) constitutes meeting the "ground truth." There is no patient-level ground truth (like pathology or outcomes data) involved for this type of submission.

8. The Sample Size for the Training Set

N/A. This 510(k) is for a software update to a control system. It does not involve machine learning or AI in the sense of being "trained" on a dataset like an image analysis algorithm would be.

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

N/A. As there is no "training set" in the context of an AI/ML algorithm that learns from data, this question is not applicable.

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Apex is an add-on microMLC system. It is an accessory to the linear accelerator used for radiation therapy and it is intended to shape the X-ray field both in static (fixed) or dynamic mode with rotating gantry as a function of the gantry angle. It is provided to assist the radiation oncologist to deliver radiation to the target tissue while sparing the surrounding normal tissues.

This Traditional 510(k) describes modifications made to the add-on DMLC accessory for the Elekta range of digital linear accelerators. The primary reason for these enhancements is to improve the leaf resolution - Apex 11 has a reduced leaf width of 2.5mm and increased field size. The add-on MLC Apel M consist of a 112 leaves individually controlled and monitored having a 2.5mm thickness at the isocenter and a field size of 120 mm x 140 mm.

The provided document {0} is a 510(k) summary for the Elekta Apex microMLC, an add-on accessory for linear accelerators used in radiation therapy. This submission focuses on modifications to improve leaf resolution (2.5mm leaf width and increased field size) compared to its predicate device, the DMLC IV (K001163). The core of the submission revolves around demonstrating substantial equivalence to the predicate device.

Based on the information provided, the document describes the device, its intended use, and its technological characteristics but does not contain information about specific acceptance criteria, performance studies, sample sizes, ground truth establishment, or comparative effectiveness studies (MRMC or standalone) in the manner typically associated with clinical performance evaluation of medical devices where diagnostic accuracy or similar metrics are assessed.

The document is a regulatory submission for a device that shapes radiation beams. The evaluation of such devices primarily focuses on their technical performance in shaping the beam accurately and safely, rather than a clinical study evaluating diagnostic accuracy or treatment efficacy as might be seen with an AI-powered diagnostic tool.

Therefore, for most of the requested points, the answer derived from the provided text will indicate that the information is "Not provided in the document."

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

Acceptance Criteria and Device Performance

Study Details

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

   • Not provided in the document. The 510(k) summary provided here is a technical and regulatory declaration of substantial equivalence, not a report of a clinical performance study with a test set of data. The "study" mentioned mainly refers to the comparison against the predicate device based on technical specifications and functional equivalence.

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

   • Not applicable / Not provided in the document. There is no indication of a "test set" with a ground truth established by experts. The device's function is to shape radiation beams, and its performance is typically evaluated through engineering tests and phantom studies rather than expert-labeled clinical data.

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

   • Not applicable / Not provided in the document. No test set or expert adjudication is described.

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

   • No MRMC study was done, or at least, it is not mentioned in this document. This device is a radiation therapy accessory (a microMLC), not an AI-powered diagnostic tool that assists human readers. Its function is mechanical beam shaping.

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

   • Not applicable / Not provided in the document. The device is a physical component (microMLC) that operates as an accessory to a linear accelerator, not a standalone algorithm. Its performance is inherent to its mechanical and control accuracy.

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

   • Not applicable / Not provided in the document. No such "ground truth" as typically understood for diagnostic or prognostic AI devices is relevant or described for this device in this submission. The "ground truth" for a microMLC would relate to its physical accuracy in beam shaping, measured through dosimetry and mechanical verification, not clinical outcomes or expert consensus on clinical images/data.

7. The sample size for the training set:

   • Not applicable / Not provided in the document. This document describes a physical medical device, not an AI/ML algorithm that requires a training set.

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

   • Not applicable / Not provided in the document. As above, no training set or its associated ground truth is relevant or described for this device submission.

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