(84 days)
The DPD-12PC Direct Patient Dosemeter is used
- to monitor radiation dosage to a patient during radiotherapy procedure
- for quality control measurements of therapeutic radiation devices
The Scanditronix Medical DPD-12PC, Direct Patient Dosemeter is a device modification of DPD-3, Direct Patient Dosemeter, FDA K9420921, 510(k) July 1994 used for In Vivo Dosimetry in radiation therapy. It consists of a 12 channel electrometer, display unit (personal computer) semiconductor detectors, detector support, extension cable, communication cable.
The provided text describes a 510(k) summary for the DPD-12PC Direct Patient Dosemeter. According to the document, the device is a modification of a predicate device (DPD-3 and DPD-510) and is intended for in-vivo dosimetry in radiation therapy and quality control measurements of therapeutic radiation devices.
Here's an analysis of the acceptance criteria and the study as described:
1. Table of Acceptance Criteria and Reported Device Performance:
The document does not explicitly state quantitative acceptance criteria in a numerical or statistical format, nor does it provide specific reported device performance metrics against such criteria. Instead, it relies on a comparison to a predicate device and compliance with established standards.
| Acceptance Criterion | Reported Device Performance |
|---|---|
| Similar operational characteristics to predicate device (DPD-3) | "Comparison of operational characteristics for the Scanditronix Medical DPD-12-PC and the predicate product show similar results that are suitable for their intended purpose." |
| Safety against electrical hazards | "Scanditronix Medical adheres to recognized and established industry practice, and all devices are subject to final performance testing." |
| Conformance with IEC 601-1 standards for electrical isolation and leakage current | "The Scanditronix Medical DPD-12PC is designed for conformance with IEC 601-1 standards for electrical isolation and leakage current" |
| Meets electrical performance standards for CSA and UL | "and meets electrical performance standards for CSA and UL." |
| Semiconductor detectors fulfill IEC-601-2-9 standard | "all semiconductor detectors fulfills the IEC-601-2-9 standard." |
| Electromagnetic compatibility according to IEC 601-1-2 | "The electrometer of Scanditronix Medical DPD-12PC has been tested and found to fulfil the requirements concerning electromagnetic compatibility according to the standard IEC 601-1-2." |
| Performance as good as or better than predicate device (DPD-3) | "Testing of operational parameters indicates that the DPD-12PC is safe, it fulfils the intended use and performs as well as or better than the previously released DPD-3." |
2. Sample Size Used for the Test Set and Data Provenance:
The document does not describe a "test set" in the context of clinical data or patient samples. The tests performed were non-clinical, focusing on engineering specifications and comparison to a predicate device. Therefore, information about sample size for a test set and data provenance (country of origin, retrospective/prospective) is not applicable or provided.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications:
No ground truth established by experts for a test set is mentioned, as no clinical testing or performance evaluation against specific clinical outcomes was conducted. The evaluation primarily relied on engineering standards and comparison with a predicate device.
4. Adjudication Method for the Test Set:
Not applicable, as no test set requiring expert adjudication for ground truth was used.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:
No, an MRMC comparative effectiveness study was not done. The document explicitly states: "Due to the fact that the system is a quality assurance device in radiation treatment (In Vivo Dosimetry) not directly involved in the delivery of the treatment radiation, no clinical testing was performed."
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done:
The device is not an algorithm or AI system. It is a physical medical device (direct patient dosemeter). Therefore, the concept of "standalone performance" in the context of an algorithm is not applicable. The device's performance was evaluated through non-clinical technical tests comparing it to its predicate.
7. The Type of Ground Truth Used:
The "ground truth" for the non-clinical tests was adherence to established industry practices, international standards (IEC 601-1, IEC 601-2-9, IEC 601-1-2), and observed operational characteristics of a legally marketed predicate device (DPD-3). There was no ground truth derived from expert consensus, pathology, or outcomes data as no clinical testing was performed.
8. The Sample Size for the Training Set:
Not applicable. The device is not an AI/ML model that requires a training set.
9. How the Ground Truth for the Training Set Was Established:
Not applicable, as there is no training set for this type of 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.