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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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The Elekta Medical Linear Accelerator is indicated to assist a licensed practitioner in the delivery of radiation to defined target volumes (e.g. lesions, arterio-venous malformations, malignant and benign tumors), whilst sparing surrounding normal tissue and critical organs from excess radiation 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.

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 Infinity and Versa HD.

This document (K182138) is a 510(k) Premarket Notification for a Medical Linear Accelerator, which is a radiation therapy device. The document primarily focuses on demonstrating substantial equivalence to a predicate device, rather than detailed performance study results against specific acceptance criteria for a new AI/software component.

Therefore, many of the requested details, such as specific acceptance criteria for AI performance, sample sizes for test/training sets, expert qualifications, ground truth establishment methods for a new AI, or MRMC studies, are not applicable or not provided in this document. This submission appears to be about software updates (control software, Integrity™) to an existing device, which mostly focuses on safety and existing functionality, rather than introducing a new AI-powered diagnostic or therapeutic capability that would require such extensive AI performance validation.

However, I can extract the information that is present and explain why other information is missing.

Acceptance Criteria and Device Performance (Based on the provided document)

Since this submission is for software changes to an existing medical linear accelerator and focuses on substantial equivalence, the "acceptance criteria" discussed are primarily related to general device safety, performance, and adherence to regulatory standards, rather than specific diagnostic or therapeutic efficacy metrics that would be evaluated for a novel AI algorithm.

Detailed Study Information (Based on the Provided Document):

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

   • As detailed in the table above, the acceptance criteria are generally qualitative and refer to adherence to regulatory standards (e.g., QSR, ISO standards, IEC standards) and the successful completion of verification and validation testing. The "reported device performance" is a confirmation that these standards were met and testing was successfully completed, leading to a determination of substantial equivalence.
   • Specific quantitative metrics for an AI algorithm's performance (e.g., AUC, sensitivity, specificity for a diagnostic task) are not present because the submission is for software updates to a linear accelerator, not a new AI diagnostic/therapeutic algorithm.

2. Sample sizes used for the test set and the data provenance:

   • N/A. This document describes "module, integration and system level verification" and "validation of the integrated system under clinically representative conditions." This is typical for a software update to an existing medical device. It does not mention a "test set" in the context of an AI algorithm's performance evaluation on a separate dataset of patient cases.
   • Data Provenance: Not specified as it's not a dataset-driven AI validation. The testing is described generally as "clinically representative conditions."

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

   • N/A. Ground truth establishment for an AI test set is not applicable here as the submission is for control software updates, not AI performance validation.
   • Validation was performed by "competent and professionally qualified personnel," but their specific number or qualifications are not provided for the purpose of "ground truth" establishment in an AI context.

4. Adjudication method (e.g. 2+1, 3+1, none) 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, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

   • No. This type of study is not mentioned as it's not relevant to the nature of this submission (software update for a linear accelerator control system, not an AI assisting human interpretation).

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

   • N/A. No specific AI algorithm performance in a standalone capacity is evaluated or described. The software changes are to the control system of a device that assists a licensed practitioner.

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

   • N/A. The concept of "ground truth" in the context of an AI algorithm's performance is not discussed here. The validation described is against technical design specifications and safety/performance standards for a medical device's control system.

8. The sample size for the training set:

   • N/A. No AI training set is mentioned or implied for this submission. The software changes are described as "tighter error detection" and codebase merging, which likely comes from software development and testing cycles rather than machine learning training.

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

   • N/A. Not applicable as there is no mention of an AI training set. Grounds for validation are based on established engineering principles, regulatory standards, and clinical representativeness as opposed to a data-driven AI training methodology.

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