(45 days)
The intended use of the PRIMUS™ is to deliver x-ray radiation for therapeutic treatment of cancer. The intended use of the PRIMUS™ is the same as the MEVATRON™ M and has not changed as a result of the modification.
The PRIMUS™ is a dual energy, high dose medical linear accelerator. The PRIMUS™ includes dual dose rate, asymmetric jaws, and either Virtual Wedge™ or standard cross-plane wedges.
This submission K993425 is for a conventional medical device (Linear Accelerator) and not an AI/ML device. Therefore, the requested information elements related to AI/ML device performance studies (such as sample sizes for test/training sets, ground truth establishment, expert qualifications, MRMC studies, and standalone performance) are not applicable and are not present in the provided document.
The document focuses on demonstrating substantial equivalence to a predicate device (MEVATRON™ M Class, K882729) based on intended use and technological characteristics, particularly the advancement in Faster Intensity Modulated Radiation Therapy (FIMRT).
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Primary Claim: Substantial Equivalence to Predicate Device (MEVATRON™ M Class, K882729) | The PRIMUS™ linear accelerator does not have significant changes in materials, energy source, or performance characteristics compared to the predicate devices. The intended use and the performance characteristics are the same as the predicate device. |
| Intended Use: Deliver x-ray radiation for therapeutic treatment of cancer. | The intended use of the PRIMUS™ is to deliver x-ray radiation for therapeutic treatment of cancer, which is the same as the MEVATRON™ M. |
| Technological Characteristics: | The main difference between the existing MEVATRON™ M system and the PRIMUS™ is new covers, name, and inclusion of FIMRT (Fast Intensity Modulated Radiation Therapy). FIMRT offers up to 40% faster delivery. |
| Performance Standards: Compliance with applicable performance standards. | No applicable performance standards have been established by FDA under section 514 of the Food, Drug and Cosmetic Act. |
Study Proving Device Meets Acceptance Criteria:
The study proving the device meets the acceptance criteria is a substantial equivalence comparison to the predicate device, MEVATRON™ M Class (K882729).
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. This is a conventional medical device submission based on substantial equivalence to a predicate device, not an AI/ML device requiring a test set for performance evaluation in artificial intelligence terms. The "test set" in this context refers to the comparison of technological specifications and intended use against the predicate device.
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. Ground truth establishment by experts in the context of diagnostic or interpretive AI/ML is not relevant here. The evaluation relies on engineering and regulatory assessment of the device's design and function compared to a legally marketed predicate.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not Applicable. Adjudication methods are relevant for resolving discrepancies in expert interpretations, typically in diagnostic studies. This submission is for a therapeutic medical device with a focus on engineering equivalence.
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
- Not Applicable. MRMC studies are used to assess the impact of AI on human interpretative performance. This device is a linear accelerator for radiation therapy, not a diagnostic imaging AI/ML device that assists human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not Applicable. This question pertains to standalone performance of an AI/ML algorithm. The PRIMUS™ is a physical medical device, a linear accelerator, and does not operate as a standalone algorithm in the sense implied by this question.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not Applicable (in the AI/ML sense). The "ground truth" for this device's acceptance is its demonstrated equivalence in intended use and performance characteristics to the predicate device, as assessed by engineering specifications and regulatory review.
8. The sample size for the training set
- Not Applicable. There is no "training set" in the context of an AI/ML model for this conventional medical device submission.
9. How the ground truth for the training set was established
- Not Applicable. As there is no training set, there is no ground truth established for it.
§ 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.