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510(k) Data Aggregation
(84 days)
DPD-12PCC
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.
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