(21 days)
The Trilogy™ Radiotherapy Delivery System and Trilogy Tx Delivery System are intended to provide stereotactic radiosurgery and precision radiotherapy for lesions, tumors and conditions anywhere in the body when radiation treatment is indicated.
The Trilogy™ Radiotherapy Delivery System and Trilogy Tx Delivery System are indicated for stereotactic radiosurgery and precision radiotherapy for lesions, tumors, and conditions anywhere in the body when radiation treatment is indicated.
The Trilogy TM Radiotherapy Delivery System, K033343, is a dual-energy, high dose rate medical linear accelerator optimized for 3D conformal radiation therapy, intensity-modulated radiation therapy and stereotactic applications. The Trilogy system allows for stereotactic treatments that may be intracranial or extracranial and consist of single-session or multisession ("fractionated") treatment delivery.
The provided text is a 510(k) Summary for the Varian Medical Systems' Trilogy Radiotherapy Delivery System. It primarily focuses on demonstrating substantial equivalence to predicate devices rather than providing a detailed study description with acceptance criteria and performance metrics for the new device itself.
Therefore, many of the requested sections (e.g., sample size for test set, number of experts for ground truth, adjudication method, MRMC study, training set details) are not explicitly available in this document.
However, I can extract information related to the acceptance criteria for specific technical specifications.
Here's the breakdown of the available information:
1. Table of Acceptance Criteria and Reported Device Performance
The device demonstrates performance equivalent to its predicate device, the Varian Medical Systems' Trilogy Radiotherapy Delivery System (K033343), and the CyberKnife (K041315) for its intended use and indications. The acceptance criteria can be inferred from the specifications listed in the "Substantial Equivalence Comparison" table.
| Feature / Acceptance Criteria Category | Acceptance Criteria (from Predicate Device K033343 and K041315, and the new device) | Reported Device Performance (Trilogy Radiotherapy Delivery System & Trilogy Tx Delivery System) |
|---|---|---|
| Intended Use | To provide stereotactic radiosurgery and precision radiotherapy for lesions, tumors, and conditions anywhere in the body when radiation treatment is indicated. (Matched from predicate CyberKnife K041315) | The Trilogy™ Radiotherapy Delivery System and the Trilogy Tx Delivery System are intended to provide stereotactic radiosurgery and precision radiotherapy for lesions, tumors, and conditions anywhere in the body when radiation treatment is indicated. |
| Indications for Use | Indicated for stereotactic radiosurgery and precision radiotherapy for lesions, tumors, and conditions anywhere in the body when radiation treatment is indicated. (Matched from predicate CyberKnife K041315) | The Trilogy™ Radiotherapy Delivery System and the Trilogy Tx Delivery System are indicated for stereotactic radiosurgery and precision radiotherapy for lesions, tumors, and conditions anywhere in the body when radiation treatment is indicated. |
| Isocenter | ≤1.5mm for all three rotational axes (from predicate K033343) | ≤1.5mm for all three rotational axes |
| Energy used | 4-25MV (from predicate K033343) | 4-25MV |
| Dose rate | 3DCRT and IMRT: Up to 600MU/min. SRS: Up to 1000MU/min (from predicate K033343) | 3DCRT and IMRT: Up to 600MU/min. SRS: Up to 1000MU/min |
| Maximum field size | 3DCRT: 40cm x 40cm. IMRT: 34cm x 40cm. SRS: 15cm x 15cm (from predicate K033343) | 3DCRT: 40cm x 40cm. IMRT: 34cm x 40cm. SRS: 15cm x 15cm |
| Remote touch motion | Small, corrective motions (≤ 2cm and 2°) and large, planned rotations. Secondary position readout indicators perform secondary verification. (from predicate K033343) | Small, corrective motions (≤ 2cm and 2°) and large, planned rotations. Secondary position readout indicators perform secondary verification. |
Study Description and Specifics (Based on Available Information):
The document does not detail a specific new study to demonstrate device performance in terms of clinical outcomes or complex image analysis. Instead, it relies on demonstrating substantial equivalence to previously cleared devices (predicates). This means the "study" is primarily a comparison of technical specifications and intended use against the predicates.
2. Sample size used for the test set and the data provenance:
- Not applicable / Not explicitly stated. The document is a 510(k) summary focused on substantial equivalence by comparing technical specifications. It does not describe a clinical performance study with a "test set" in the context of image analysis or diagnostic accuracy. Data provenance would relate to the predicate devices' prior approvals.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable / Not explicitly stated. No expert panel or ground truth establishment is described for a clinical test set in this document.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not applicable / Not explicitly stated. As there is no clinical test set described in the context of diagnostic or treatment efficacy, there is no adjudication method detailed.
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 document is for a radiotherapy delivery system, not an AI-assisted diagnostic or treatment planning software requiring MRMC studies for human reader performance.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- No. This document does not describe an AI algorithm or a standalone algorithmic performance study. It's for a medical linear accelerator.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Not applicable / Not explicitly stated. The "ground truth" in this context is the established safety and effectiveness of the predicate devices and their technical specifications, to which the new device is compared. For technical specifications like "Isocenter
§ 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.