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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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The Elekta Synergy®, Elekta Synergy® S, and XVI R3.5 are intended to be used for radiation therapy treatment of malignant neoplastic diseases, as determined by a licensed medical practitioner.

This Premarket Notification Special 510(k) describes modifications to the Elekta Synergy® System; a combination of the specially prepared Elekta medical linear accelerator, Elekta Synergy® Platform, with the XVI on-board kV imaging accessory. The primary reasons for the modifications to this product are to provide:

• Hardware & software support for increased patient throughput
• Easier selection of parameters & provision of clinical presets to improve efficiency
• Improved image quality and image management
• Improved tools for device set-up and image processing
• Improved connectivity with other systems through DICOM

This 510(k) summary does not contain the information needed to answer the request. The document describes modifications to an existing medical linear accelerator system, Elekta Synergy®, Elekta Synergy® S, and XVI R3.5, and focuses on substantial equivalence to a predicate device (K032996).

Specifically, the document lacks:

• Acceptance criteria: No specific performance metrics or thresholds are mentioned for the device.
• Study details: There is no description of any new study conducted to prove the device meets acceptance criteria. The document states "There has been no change made to the underlying technological characteristics of the product." which suggests that performance evaluation beyond verifying the modifications function as intended may not have been required or specifically detailed for this 510(k). The focus is on the modifications providing "Hardware & software support," "Easier selection of parameters & provision of clinical presets," "Improved image quality and image management," "Improved tools for device set-up and image processing," and "Improved connectivity." These are feature improvements rather than specific quantitative performance criteria.
• Sample size, data provenance, expert ground truth, adjudication methods, MRMC studies, standalone performance, training set details, or ground truth establishment for a study.

The document is a regulatory submission focused on demonstrating substantial equivalence of a modified device, rather than a detailed report of a performance study against specific acceptance criteria.

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The Elekta Synergy™ System is intended to be used for radiation therapy treatment of malignant neoplastic diseases, as determined by a licensed medical practitioner.

The Elekta Synergy™ System is an enhancement to the previously reported Precise Treatment Systems Digital Accelerator (formally designated the SL/SLi Series, D.C. K963624) and its commercially available options.

The provided text describes the Elekta Synergy™ System as an enhancement to a previously reported device (Precise Treatment Systems Digital Accelerator, K963624) and its commercially available options. However, it does not include detailed information regarding specific acceptance criteria, device performance, a study conducted to prove it meets acceptance criteria, sample sizes, expert qualifications, or ground truth establishment methods in the way typically expected for a detailed product validation.

Instead, the document focuses on:

• Safety and Effectiveness Justification: Stating that the device does not raise new safety or effectiveness concerns compared to its predicate device and is considered an enhancement.
• Compliance with Standards: Highlighting compliance with international safety standards (IEC 60601-1, IEC 60601-2-1), CE mark, ISO 9001, ISO 13485, Medical Device Directive 93/42/EEC Annex II, and US 21 CFR 820.
• Quality Management System: Describing established and documented Quality Management System, internal audits, and external GMP audits by SGS Yarsley and FDA.
• Hazard Analysis: Concluding that the device does not introduce new hazards, and the level of concern for the device is "Major."
• Substantial Equivalence: The FDA letter confirms the device's substantial equivalence to legally marketed predicate devices, allowing it to be marketed.

Given the information, a table of acceptance criteria and reported device performance cannot be generated with specific numerical values for performance metrics. The document generally asserts safety and effectiveness without providing quantitative clinical study results for the new components of the Elekta Synergy™ system.

Therefore, many sections of your request cannot be fulfilled due to the absence of this information in the provided text.

Here's what can be extracted and what information is missing:

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

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 does not describe a specific test set or clinical study for the new device components, but rather relies on the predicate device's established safety and effectiveness and compliance with regulatory standards.

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. No explicit "ground truth" establishment for a test set is mentioned.

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

• Not provided. 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 provided. This is not an AI-assisted device; it's a radiation therapy system. No MRMC study is mentioned.

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

• Not applicable. This isn't an algorithm-only device.

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

• Not explicitly stated for the "Elekta Synergy™ System" components. The safety and effectiveness are based on the proven track record of the predicate device (Precise Treatment Systems Digital Accelerator) and compliance with regulatory/quality standards.

8. The sample size for the training set

• Not applicable / Not provided. The document doesn't describe a machine learning model with a training set.

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

• Not applicable / Not provided. The document doesn't describe a machine learning model with a training set or ground truth establishment for it.

In summary, the provided text is a summary of safety and effectiveness for a 510(k) submission, emphasizing regulatory compliance and substantial equivalence to a predicate device, rather than detailed performance metrics from a comparative clinical trial for a novel device.

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