(106 days)
Hitachi's PROBEAT is a medical device designed to produce and deliver a proton beam for the treatment of patients with localized tumors and other conditions susceptible to treatment by radiation.
The PROBEAT is a proton beam irradiation system, which provides a therapeutic proton beam for clinical treatment. It is designed to deliver a proton beam with the prescribed dose and dose distribution to the prescribed patient treatment site. The equipment is comprised of two main components. One is a beam delivery system whose primary responsibility is to ensure that the above listed prescription parameters are properly delivered. The other is the equipment necessary to generate the proton beam and direct it to the beam delivery system.
The provided text describes Hitachi's PROBEAT, a proton beam therapy system, and its 510(k) submission for FDA clearance. However, it does not contain detailed information about specific acceptance criteria or a study designed to prove the device meets those criteria in the way typically required for AI/ML-based medical devices (e.g., performance metrics like sensitivity, specificity, or AUC against a ground truth).
The document is a 510(k) summary, which focuses on demonstrating substantial equivalence to predicate devices rather than providing a detailed performance study with quantitative results against established acceptance criteria.
Here's an attempt to answer your questions based only on the provided text, highlighting where information is absent:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Specific quantitative performance criteria (e.g., accuracy, precision, dose delivery uniformity) are NOT provided in the document. The document states "The submission includes performance testing that Hitachi conducted to demonstrate that the device meets its performance specifications." However, what those specifications are, and the exact results of meeting them, are not detailed. | The document broadly states that the PROBEAT meets its performance specifications. Specific metrics are not presented. It implies successful demonstration of: Producing and delivering a proton beam.Delivering the prescribed dose and dose distribution to the prescribed patient treatment site. |
2. Sample Size Used for the Test Set and Data Provenance
Information regarding a specific "test set" with a defined sample size for evaluating the PROBEAT's performance as a medical device is not provided. The document mentions general "performance testing" but does not detail the nature of this testing (e.g., patient data, phantom studies) or its provenance.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
Information about experts establishing ground truth for a test set is not provided. This type of detail is usually relevant for diagnostic devices or those involving human interpretation, which is not the primary focus of this submission for a radiation therapy delivery system.
4. Adjudication Method for the Test Set
Information on an adjudication method for a test set is not provided.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Its Effect Size
A Multi-Reader Multi-Case (MRMC) comparative effectiveness study, which typically evaluates human reader performance with and without AI assistance, was not mentioned and is not relevant for this type of device (a proton beam therapy delivery system). This device delivers the therapy, it does not assist human readers in making diagnoses or interpretations of images in the same way an AI diagnostic tool would.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
The document refers to "performance testing" conducted by Hitachi but does not explicitly describe it as a "standalone" algorithm-only performance study in the context of AI. The PROBEAT is a physical system, not primarily a software algorithm for interpretation. The performance testing would be focused on the hardware's ability to create and deliver the proton beam accurately and safely.
7. The Type of Ground Truth Used
The document does not specify the type of ground truth used for the "performance testing." For a proton beam therapy system, ground truth would likely involve:
- Physical measurements using dosimeters in phantoms to verify dose distribution and accuracy against planned treatment.
- Engineering specifications and calibration standards.
- Possibly pre-clinical studies or simulations.
8. The Sample Size for the Training Set
Information about a "training set" is not provided. As this is a proton beam therapy delivery system, and not an AI/ML-based diagnostic or predictive algorithm, the concept of a "training set" for the device's core function (beam generation and delivery) is not applicable in the same way it would be for an AI algorithm. Its design and engineering would be based on physics principles and engineering validation, not statistical learning from a large dataset.
9. How the Ground Truth for the Training Set Was Established
Information about how ground truth for a "training set" was established is not provided, as the concept of a training set is not applicable to the description of the device's validation in this document.
§ 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.