(25 days)
The EOS iViewGT™ Electronic Portal Imaging Device (EPID), as with the predicate iView, is intended to be used with radiation therapy treatments of malignant neoplastic diseases, as determined by a licensed medical practitioner.
The iViewGT™ EPID is an enhancement to the existing iView Electronic Portal Imaging Device which has previously been cleared for commercial distribution under D.C. K981790. These devices have an established and proven track record for safety. The primary reason for this modification to support solid state detectors for image acquisition. The iViewGTTM EPID does not raise additional types of safety or effectiveness considerations.
The provided text is a K012289 Summary of Safety & Effectiveness for the Elekta Oncology Systems iViewGT™ Electronic Portal Imaging Device (EPID). This document primarily focuses on demonstrating that the iViewGT™ EPID is substantially equivalent to a previously cleared device (iView K981790) and meets relevant safety and quality standards.
Crucially, the provided text does NOT contain information about specific acceptance criteria or a study that rigorously proves the device meets such criteria in terms of analytical or clinical performance (e.g., accuracy, sensitivity, specificity).
The document highlights the device's adherence to quality management systems, safety standards, and its intended use as an enhancement to an existing, cleared device. It asserts that the iViewGT™ EPID "does not raise additional types of safety or effectiveness considerations" compared to its predicate. This implies that the 'acceptance criteria' in this context are primarily related to regulatory compliance, manufacturing quality, and substantial equivalence, rather than a clinical performance study with specific metrics.
Therefore, many of the requested sections about acceptance criteria and study details cannot be answered based solely on the provided text.
Here's an attempt to answer the questions based on the available information, noting where information is absent:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Device is an enhancement to a previously cleared device. | The iViewGT™ EPID is an enhancement to the existing iView Electronic Portal Imaging Device, which was previously cleared for commercial distribution under D.C. K981790. |
| Does not raise new types of safety or effectiveness concerns. | Elekta Oncology Systems has conducted hazard analysis and concluded that the iViewGT™ EPID does not introduce hazards that raise new types of safety or effectiveness considerations. |
| "The iViewGT™ EPID does not raise additional types of safety or effectiveness considerations." | |
| Compliance with international safety standards. | The iViewGT™ EPID is subject to compliance testing as defined in IEC 60601-1 and IEC 60601-2-1. Proprietary IT equipment is procured to IEC 60950 and/or UL 1950. |
| Compliance with European Directives (CE mark). | The iViewGT™ EPID is designed to bear the CE mark affirming compliance with all relevant European Directives in force, particularly the European Medical Device Directive and the European Electromagnetic Compatibility Directive. |
| Developed under an established Quality Management System. | The Elekta Oncology Systems Software Quality System has been established to satisfy ISO 9001, EN 46001, ISO 13485, Medical Device Directive 93/42/EEC Annex II, and US 21 CFR 820 GMP. The iViewGT™ EPID was developed using an established and documented Quality Management System. |
| The Quality System is subject to periodic internal Quality Audits and regular, planned, and documented GMP audits by external auditors (SGS Yarsley and FDA). | |
| Intended use aligns with predicate device. | "The EOS iViewGT™ Electronic Portal Imaging Device (EPID), as with the predicate iView, is intended to be used with radiation therapy treatments of malignant neoplastic diseases, as determined by a licensed medical practitioner." |
| Documents provided for the user ensure safe and effective use. | "The accompanying documents provided for the user contain comprehensive information to ensure safe and effective use." |
| Substantial equivalence to predicate device. | The FDA determined the device is "substantially equivalent" to devices marketed in interstate commerce prior to May 28, 1976, or reclassified in accordance with the Act. |
Regarding a "study that proves the device meets the acceptance criteria," the provided document does not describe a performance study with specific metrics for the iViewGT™ EPID's effectiveness. Instead, it relies on:
- Substantial Equivalence: The primary assertion is that the iViewGT™ EPID is an "enhancement" to the already cleared iView (K981790) and "does not raise additional types of safety or effectiveness considerations."
- Compliance with Standards: Adherence to established safety standards (IEC 60601-1, IEC 60601-2-1, IEC 60950, UL 1950) and quality management systems (ISO 9001, EN 46001, ISO 13485, Medical Device Directive 93/42/EEC Annex II, 21 CFR 820 GMP).
- Hazard Analysis: A hazard analysis was conducted, concluding no new hazards.
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- No information provided. The document does not describe a test set or data related to clinical or analytical performance.
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)
- No information provided. No test set or ground truth establishment is described.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- No information provided. 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 information provided. The document does not describe an MRMC study, nor does it mention AI assistance. The device is an EPID, primarily for image acquisition, not an AI diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable / No information provided. The iViewGT™ EPID is an image acquisition device for radiation therapy. Its "performance" would likely be in terms of image quality, detector sensitivity, and integration with the treatment system, rather than an algorithm performing a standalone diagnostic task. The document does not mention any standalone algorithmic performance evaluation.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Not applicable / No information provided. Since no performance study is described, there's no mention of a "ground truth" for clinical or analytical performance.
8. The sample size for the training set
- No information provided. The document does not describe a training set. The device is not an AI/ML algorithm in the context of typical training/test sets.
9. How the ground truth for the training set was established
- Not applicable / No information provided. No training set or ground truth for it is mentioned.
§ 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.