(95 days)
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
| Acceptance Criteria Category | Specific Metric | Acceptance Threshold | Reported Device Performance |
|---|---|---|---|
| Device Performance | N/A | N/A | N/A |
| Safety | N/A | N/A | N/A |
| Effectiveness | N/A | N/A | N/A |
| Clinical Efficacy | N/A | N/A | N/A |
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.
§ 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.