(95 days)
ERGO++ is a treatment planning system. It is an accessory to linear accelerators used for radiation therapy. It is indicated for use in the planning of 3 dimensional radiation therapy.
description of the device such as might be found in the labeling or promotional material for the device, including an explanation of how the device functions, the scientific concepts that form the basis for the device, and the significant physical and performance characteristics of the device, such as device design, material used, and physical properties is in Appendix 2 and Appendix 3 of this notification.
This document is a 510(k) submission for the ERGO++ Treatment Planning System. It does not contain information about acceptance criteria or a study that proves the device meets those criteria for the reasons outlined below.
This 510(k) submission is for a Traditional 510(k) for ERGO++, a modification of existing devices (ERGO, ERGO SRS, and ERGO EVTOOL). The submission states in the cover letter that the modifications are "not eligible for the Special 510(k) process" and that "the conclusions drawn from the nonclinical tests that demonstrate that the device is as safe, as effective, and performs as well as or better than the predicate device are in Appendix 6 of this notification."
The provided text does not include Appendix 6, nor does it describe specific acceptance criteria or performance results from any studies. The FDA's letter in response confirms that the device is "substantially equivalent" to predicate devices, which means it relies on the safety and effectiveness of those previously cleared devices rather than requiring new clinical studies with defined acceptance criteria.
Therefore, I cannot provide the requested information from the given text.
The document does not contain the following information:
- A table of acceptance criteria and the reported device performance.
- Sample size used for the test set and the data provenance.
- Number of experts used to establish the ground truth for the test set and their qualifications.
- Adjudication method for the test set.
- If a multi-reader multi-case (MRMC) comparative effectiveness study was done, or the effect size of how much human readers improve with AI vs. without AI assistance. (This device is a Treatment Planning System, not an AI-assisted diagnostic tool, so this type of study is unlikely to be relevant or included).
- If a standalone (i.e., algorithm only without human-in-the-loop performance) was done.
- The type of ground truth used.
- The sample size for the training set.
- How the ground truth for the training set was established.
§ 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.