(242 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 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 radioopague 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, up to 25 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 detailed information about acceptance criteria or a specific study proving the device meets acceptance criteria. The document is a 510(k) summary for regulatory submission, focusing on device description, predicate device comparison, and indications for use. It mentions performance studies and preclinical studies were conducted, and that the performance data demonstrates that calibrated devices perform within the stated performance specifications of the labeling, but does not provide the specifics of these studies or the quantitative acceptance criteria.
Therefore, many of the requested sections cannot be filled from the provided text.
Here's a breakdown of what can be extracted and what information is missing:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not specified in text | Performance data demonstrates that calibrated devices perform within the stated performance specifications of the labeling. |
2. Sample size used for the test set and the data provenance
- Sample Size (Test Set): Not specified.
- Data Provenance: Not specified (e.g., country of origin, retrospective/prospective). The document mentions "performance studies, pre-clinical studies, and clinical studies" were conducted, but gives no details about them.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not specified. The device is a dosimeter, so the "ground truth" would likely be a known radiation dose, rather than expert interpretation of images.
4. Adjudication method for the test set
- Not specified. This is typically relevant for studies involving human interpretation or subjective assessments, which isn't directly applicable to a dosimeter's primary function as 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
- Not applicable. This device is a patient radiation dosimeter, 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
- No specific standalone algorithm performance study is detailed. The device itself (the DVS implantable dosimeter and reader system) performs the measurement and relies on factory calibration. The text states "performance data section demonstrates that calibrated devices perform within the stated performance specifications of the labeling." This implies internal testing of the device's accuracy.
7. The type of ground truth used
- The ground truth would be precise, known radiation dose values, provided by calibrated radiation sources. The text mentions "The DVS, Dose Verification System is calibrated at the factory using the same method as the Thomson Nielsen for evaluating radiation units/volts" and that an external ADCL lab verifies factory calibration for similar devices. This suggests a rigorous calibration process against established standards.
8. The sample size for the training set
- Not applicable. This device is a hardware dosimeter with associated software; it's not described as a machine learning algorithm that requires a "training set" in the conventional sense. Its "training" is its factory calibration.
9. How the ground truth for the training set was established
- Not applicable as it's not an ML system. For its calibration (analogous to training), the ground truth is established through "controlled conditions at the factory" using methods similar to predicate devices, and potentially validated by an "external ADCL lab." The "factory calibration procedure is described in sufficient detail within the 510(k) to demonstrate the methods used to assure calibration."
Summary of Missing Information:
The document is a high-level regulatory summary and does not delve into the specifics of the actual performance studies, including:
- Quantitative acceptance criteria (e.g., accuracy percentages, dose deviation limits).
- Detailed results of the performance studies.
- Protocols and methodologies of the pre-clinical and clinical studies.
- Sample sizes for any testing or validation.
- Specific ground truth methodologies beyond general statements about calibration.
§ 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.