(109 days)
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:
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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.
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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.
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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.
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Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not provided.
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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.
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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.
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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.
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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.
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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.
§ 892.5050 Medical charged-particle radiation therapy system.
(a)
Identification. A medical charged-particle radiation therapy system is a device that produces by acceleration high energy charged particles (e.g., electrons and protons) intended for use in radiation therapy. This generic type of device may include signal analysis and display equipment, patient and equipment supports, treatment planning computer programs, component parts, and accessories.(b)
Classification. Class II. When intended for use as a quality control system, the film dosimetry system (film scanning system) included as an accessory to the device described in paragraph (a) of this section, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.