(21 days)
The DVS (Dose Verification System) is intended for use in radiation therapy to verify treatment planning and radiation dose to tissue and organs in or near the irradiated areas of a patient.
The DVS system is specifically indicated for breast and prostate cancer to measure photon beam therapy and as an adjunct to treatment planning to permit measurement of the in vivo radiation dose received at the tumor periphery, tumor bed and/or surrounding normal tissues for validation of the prescribed dose.
The DVS, Dose Verification System consists of four sub-systems: the DVS Implantable Dosimeter for measuring radiation dose in vivo, the DVS Insertion Tool for implanting the dosimeter during percutaneous procedures, the DVS Reader System (Wand and Base Station) for powering the dosimeter and providing a user interface when taking dose measurements, and the DVS Data System (Plan and Review Software and Dosimetery Database) for storing and reporting patient data and for storing dosimeter information. The dosimeters use a MOSFET, Metal Oxide Semiconductor Field Effect Transistor, as a sensing mechanism. The dosimeter is factory calibrated and powered by the Reader Wand utilizing electromagnetic energy. The dosimeter contains a transmitter, to transmit threshold voltage readings to the reader. It is radioopaque and thus registers on computed tomography scans as a point of interest whereby a point dose may be determined. Patients are implanted prior to radiotherapy. Information on the patient's therapy, dose planning, point dose at the dosimeter, dosimeter serial number and calibration files are entered into the Plan and Review software and stored in the Dosimetry Database. At each therapy fraction the dosimeter is read pre- and post-therapy using the Reader Wand and Base Station. This translates into a daily fractional dose. The patient's daily and cumulative dose may be reviewed via the Plan and Review software. Because the Plan and Review software and Dosimetry Database are designed to be stored on a server, multiple users may be logged into the system at any one time. Reports on the patient's daily and cumulative dose history may be printed using the Plan and Review software.
The provided text is a 510(k) summary for the DVS (Dose Verification System) and discusses its substantial equivalence to a predicate device. It does not contain detailed information about specific acceptance criteria, device performance metrics (other than stating "the dosimeter performance specifications are the same and have not changed"), sample sizes for testing, ground truth establishment, or clinical study designs (such as MRMC studies).
Therefore, I cannot populate the table or answer most of the questions based on the provided text.
Here is what can be inferred or stated about the information requested:
1. Table of acceptance criteria and the reported device performance:
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not specified | "The dosimeter performance specifications are the same and have not changed." |
| Not specified | "The Reader design and performance specifications are the same and have not changed." |
| Not specified | "verification and validation testing... demonstrated that the device met pre-determined acceptance criteria based on performance specifications." (Specific criteria not provided) |
2. Sample sized used for the test set and the data provenance:
- Sample size: Not specified.
- Data provenance: Not specified (e.g., country of origin, retrospective or prospective). The document mentions "verification and validation testing" but does not detail the nature of the test set.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not specified. The document does not describe the establishment of a "ground truth" using human experts for the test set.
4. Adjudication method for the test set:
- Not specified, as no expert adjudication of a test set is mentioned.
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 MRMC comparative effectiveness study is mentioned. This device is a hardware/software system for dose verification, not an AI-assisted diagnostic tool for human readers.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- This device is not an algorithm-only system. It's a physical dosimeter and reader system with accompanying software. The document states "verification and validation testing... demonstrated that the device met pre-determined acceptance criteria based on performance specifications," which implies standalone testing of the system's performance.
7. The type of ground truth used:
- The document implies that the device's measurements are validated against established physical dosimetry principles and potentially against existing clinical dose measurement standards (given its use for "verification of the prescribed dose"). However, the specific type of ground truth (e.g., gold standard phantom measurements, comparison to other validated dosimetry systems) is not explicitly detailed.
8. The sample size for the training set:
- Not applicable. This device is not an AI/ML model that requires a training set in the typical sense. It is a measurement device.
9. How the ground truth for the training set was established:
- Not applicable, as there is no training set for an AI/ML model for this device.
§ 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.