(40 days)
The Agility multileaf collimator is indicated for use when additional flexibility is required in conforming the radiation beam to the anatomy to be exposed.
The associated Integrity R3.0 software is the interface and control software for the Elekta medical digital linear accelerator 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 tumors), 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 the addition of the new Agility multileaf collimator beam limiting device and its associated control software to the Elekta medical linear accelerator. The new device has 160 leaves of 5mm width at isocenter, a fast leaf speed of up to 65 mm/s, low leakage (
The provided document is a 510(k) premarket notification for a medical device called "Agility™," a multileaf collimator, and its associated control software, Integrity R3.0. This type of document focuses on demonstrating substantial equivalence to a predicate device rather than a detailed comparative effectiveness study of AI versus human readers or standalone AI performance.
Therefore, many of the requested elements for describing "acceptance criteria and the study that proves the device meets the acceptance criteria" in the context of AI performance are not applicable or cannot be extracted from this specific document.
However, I can provide information based on the engineering and performance specifications detailed in the 510(k) summary.
Acceptance Criteria and Reported Device Performance
The acceptance criteria are implicitly defined by the reported performance of the device and its predicate, primarily focusing on mechanical and physics performance characteristics to demonstrate substantial equivalence. The "study" proving the device meets these criteria is described as "module, integration and system level verification," "regression testing," and "validation... under clinically representative conditions."
Table of Acceptance Criteria and Reported Device Performance:
| Attribute | Acceptance Criterion (Predicate Device Performance - K082122) | Reported Device Performance (Agility™ - This Submission) |
|---|---|---|
| Mechanical | ||
| Interdigitation capable | yes | yes |
| Number of leaves | 80 | 160 |
| Nominal leaf width at isocenter | 10 mm | 5 mm |
| Maximum field size | 40 x 40 cm | 40 x 40 cm |
| Max distance between leaves | 32.5 cm | 20 cm |
| Leaf travel over central axis | 12.5 cm | 15 cm |
| Leaf nominal height | 82 mm | 90 mm |
| Leaf positioning resolution | 0.1 mm | 0.1 mm |
| Leaf positioning verification | Optical and machine vision system | Optical and machine vision system (Rubicon) |
| Diaphragm over-travel | 0 | 12 cm |
| Dimensions / Weight / Speeds | ||
| Head rotation | 365 degrees | 365 degrees |
| Head weight | 380 kg | 420 kg |
| Radiation head diameter | 620 mm | 815 mm at widest, 694 mm at narrowest |
| Head to isocenter clearance | 45 cm | 45 cm |
| Head rotation speed (set-up) | 12°/s | 12°/s |
| Head rotation speed (dynamic) | 6°/s | 6°/s |
| Leaf speed (combined w/ guide) | 2.0 cm/sec | up to 6.5 cm/s |
| Leaf speed | 2.0 cm/sec | up to 3.5 cm/s |
| Diaphragm speed | 1.5 cm/s | up to 9 cm/s |
| Wedge | ||
| Integrated wedge size | Automatic 0-60° | Automatic 0-60° |
| Wedge field size | 30 x 40 cm | 30 x 40 cm |
| Physics Performance | ||
| Leaf position accuracy | ± 1 mm | 1 mm at isocenter, 0.5 mm RMS* |
| Leaf position repeatability | 0.5 mm | 0.5 mm |
| Avg transmission through leaf bank | 1.5% |
§ 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.