(90 days)
The EOS iCom/QuickMode Software Options, as with the predicate SLi Series system, is intended to be used for radiation therapy treatments of malignant neoplastic diseases, as determined by a licensed medical practitioner.
The EOS iCom/QuickMode Software Options are improvements to the existing SLi Series Linear Accelerators which have previously been cleared for commercial distribution.
The provided text is a summary of safety and effectiveness information for the Elekta Oncology Systems iCom/QuickMode Software Options, along with the FDA's 510(k) clearance letter and Indications for Use statement. This documentation does not contain details about specific acceptance criteria or an analytical study with performance metrics for the software options themselves. Instead, it focuses on the equivalence to a predicate device and compliance with regulatory standards.
Therefore, I cannot provide a table of acceptance criteria and reported device performance, or details about sample size, expert ground truth, adjudication methods, MRMC studies, or training data for the iCom/QuickMode Software Options based on the input.
However, I can extract the information that is present regarding the device's regulatory pathway and safety/effectiveness claims:
1. A table of acceptance criteria and the reported device performance
Based on the provided documents, specific quantitative acceptance criteria or reported device performance metrics for the QuickMode Software Options are not present. The main claim for effectiveness and safety is based on substantial equivalence to a predicate device and adherence to quality systems and standards.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Safety | Established and proven track record with existing SLi Series Linear Accelerators. No additional safety concerns introduced. Compliance with IEC 601-1, IEC 601-2-1, IEC 950, UL 1950, CE mark (European Medical Device Directive, Electromagnetic Compatibility Directive). Hazard analysis concluded no new safety or effectiveness considerations. |
| Effectiveness | Functionally an "enhancement to the existing SLi Series Linear Accelerators." Substantially equivalent to predicate devices (SLi Series Linear Accelerators) cleared prior to May 28, 1976. Intended for radiation therapy treatments of malignant neoplastic diseases. |
| Quality | Developed using an established and documented Software Quality Management System (ISO 9001, EN 46001, Medical Device Directive 93/42/EEC Annex II, US 21 CFR 820 GMP). Subject to internal and external Quality Audits (SGS Yarsley, FDA). |
Missing Information (Not available in the provided text):
- 2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- 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)
- 4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- 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
- 6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- 7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- 8. The sample size for the training set
- 9. How the ground truth for the training set was established
The provided FDA clearance and accompanying summaries primarily demonstrate regulatory compliance and substantial equivalence to existing, already-cleared devices, rather than presenting a performance study of the software options against specific acceptance criteria. The "effectiveness information" refers to the device's intended use and the fact that it doesn't introduce new effectiveness concerns compared to the predicate device, which has an "established and proven track record for safety."
§ 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.