(30 days)
Intended Use: 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.
Indications for Use: 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 does not contain specific acceptance criteria or an analytical study proving the device meets those criteria. Instead, it describes a 510(k) submission for the DVS (Dose Verification System) focusing on its substantial equivalence to predicate devices and the modifications made.
However, based on the text, we can infer some general acceptance criteria and the type of study conducted, though not its detailed results.
Inferred Acceptance Criteria and Device Performance (based on general statements in the document):
| Acceptance Criteria Category | Reported Device Performance (Inferred from "verification and validation testing") |
|---|---|
| Dose Ranges | The modified device (with DVS HFT dosimeter) expanded the dose ranges compared to the predicate device, specifically allowing for use with hypofractionated radiation treatment plans. |
| Accuracy | The modified device maintained or improved accuracy, corresponding to the new dose ranges, compared to the predicate device. |
| Safety | Verified and validated to have no negative effect on safety. |
| Efficacy/Performance | Verified and validated to have no negative effect on efficacy and demonstrated it "performs as well as the predicate device" and met "performance specifications." |
Study Information Based on the Text:
Since the provided text is a 510(k) summary, it details the submission for substantial equivalence rather than a detailed clinical or performance study with raw data and statistical analysis. The text states:
"Furthermore, verification and validation testing based on the risk analysis, provided information sufficient to determine that the modifications did not have an effect on safety or efficacv and demonstrated that the device met acceptance criteria based on performance specifications. The testing demonstrated that the modified device is substantially equivalent to the predicate device and performs as well as the predicate device. The verification and validation results are provided within the 510(k)."
This indicates that internal verification and validation testing was performed. However, the document does not provide the specific details requested for the study, such as:
- Sample size used for the test set and the data provenance: Not mentioned.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not mentioned.
- Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not mentioned.
- 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 mentioned. The device is a dosimeter, not an AI-assisted diagnostic tool.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not explicitly stated as a "standalone" study in the context of an algorithm, but the "verification and validation testing" would have assessed the device's inherent performance.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not mentioned. For a dosimeter, ground truth would typically refer to highly accurate reference dosimetry measurements (e.g., from ion chambers or calibrated phantoms).
- The sample size for the training set: Not mentioned. Dosimeters are typically calibrated, not "trained" in the machine learning sense.
- How the ground truth for the training set was established: Not mentioned. Calibration would be against known radiation doses from a calibrated source.
§ 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.