(90 days)
The EOS RT Desktop, as with the predicate SL/SLi Series user interface, is intended to be used as the user interface for the SL/SLi Series Linear Accelerators that are used for the radiation therapy treatments of malignant neoplastic diseases, as determined by a licensed medical practitioner.
The RT Desktop is an enhancement to the SL/SLi Interface (Javelin) which has previously been cleared for commercial distribution. This device has an established and proven track record for safety. The enhancement contains industry standard computer components to address the issue of component obsolescence currently associated with SL/SLi interface (Javelin). The RT Desktop does not raise additional types of safety or effectiveness considerations.
The provided text is a premarket notification for the Elekta Oncology Systems RT Desktop, which is an enhancement to an existing device (SL/SLi Interface). The document focuses on demonstrating that the RT Desktop does not raise new safety or effectiveness concerns compared to its predicate device and complies with various quality and safety standards.
However, the document does NOT contain information regarding a specific study to prove the device's performance against acceptance criteria in the context of clinical efficacy or diagnostic accuracy, which would typically involve metrics like sensitivity, specificity, accuracy, or effect size for AI-assisted workflows.
The "Summary of Safety & Effectiveness" primarily asserts the device's safety and effectiveness through:
- Comparison to a predicate device: Stating the RT Desktop is an enhancement to an already cleared device with a "proven track record for safety."
- Compliance with industry standards: IEC 60601-1, IEC 60601-2-1, IEC 950, UL 1950, CE mark, ISO 9001, EN 46001, Medical Device Directive 93/42/EEC Annex II, and 21 CFR 820.
- Hazard analysis: Concluding it "does not introduce hazards that raise new types of safety or effectiveness considerations."
- Comprehensive user information: Ensuring safe and effective use.
Therefore, I cannot populate the requested table and answer the majority of the questions because the document does not describe a study involving performance metrics for a device that involves clinical outcomes or diagnostic tasks. It's a regulatory submission demonstrating substantial equivalence and safety compliance for a system enhancement, rather than a clinical performance study.
Here's what I can extract based on the provided text, highlighting the absence of the requested performance study details:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (from a performance study) | Reported Device Performance |
|---|---|
| Not specified by a performance study | Not specified by a performance study |
| Instead, the document focuses on: | |
| - Substantial equivalence to predicate device | - Stated as an "enhancement" to a previously cleared and proven device (SL/SLi Interface/Javelin) |
| - Compliance with safety standards | - IEC 60601-1, IEC 60601-2-1, IEC 950, UL 1950, CE Mark, ISO 9001, EN 46001, 93/42/EEC Annex II, 21 CFR 820 |
| - Hazard analysis | - Concluded "does not introduce hazards that raise new types of safety or effectiveness considerations." |
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
- Not applicable. The document does not describe a performance study with a test set.
3. 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 applicable. No ground truth establishment for a test set is described.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
- Not applicable. No test set or adjudication method is described.
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. The document does not describe an MRMC study or any AI component. The device is a user interface for linear accelerators.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. The device described is a user interface, not a standalone algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not applicable. No ground truth is mentioned in the context of a performance study.
8. The sample size for the training set
- Not applicable. The document does not describe an AI/ML algorithm requiring a training set.
9. How the ground truth for the training set was established
- Not applicable. No training set or ground truth for it is mentioned.
Conclusion:
The provided document is a regulatory submission for a device enhancement. It demonstrates safety and effectiveness through compliance with standards, comparison to a predicate device, and hazard analysis, rather than through a clinical performance study involving specific acceptance criteria, test sets, or ground truth. The questions posed are highly relevant for AI/ML-driven medical devices or devices where clinical performance metrics (like diagnostic accuracy) are directly being evaluated, which is not the case in this particular submission.
§ 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.