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510(k) Data Aggregation
(29 days)
Veenstra Instruments VDC-506 Dose Calibrator
The Veenstra Instruments VDC-506 Dose Calibrator is designed to measure the amount of radioactive material in vials, syringes and capsules. It is used to measure the amount of activity used to prepare radiopharmaceutical kits, measure the activity in syringes of radiopharmaceuticals prior to injection and to quantify the activity remaining in the syringe following injection. It is indicated for use in the preparation of radiopharmaceuticals and verification of the activity prior to patient administration.
The Veenstra Instruments VDC-506 Dose Calibrator (VDC-506) is a software application installed on a personal computer (PC) running Windows XP, and is used in conjunction with the Veenstra Instruments VIK-202 ionization chamber (VIK-202) to measure the radioactive strength of radioactive material in vials, syringes and ampoules placed inside the ionization chamber.
The VDC-506 software, in conjunction with the PC, serves as the control mechanism and display for the VIK-202 ionization chamber. The PC on which the VDC-506 software is installed is connected to the VIK-202 ionization chamber using a RS-232 cable.
It is recommended that the PC includes a touchscreen display for convenient navigation within the software; however, a touchscreen is not necessary.
The document provided describes the Veenstra Instruments VDC-506 Dose Calibrator, a radionuclide dose calibrator designed to measure radioactive material. The information focuses on demonstrating substantial equivalence to a predicate device, rather than providing a detailed study proving the device meets specific acceptance criteria in a clinical setting in terms of diagnostic accuracy.
The acceptance criteria provided are primarily related to technical specifications and compliance with electrical safety, electromagnetic compatibility (EMC), and software standards, rather than performance metrics like sensitivity, specificity, or reader improvement in a clinical diagnostic context. The document confirms that the device meets these technical criteria.
Here's a breakdown of the requested information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
Given that the document is a 510(k) submission for a non-diagnostic device, the "acceptance criteria" are predominantly technical specifications and regulatory compliance. The "reported device performance" refers to the device meeting these specifications and complying with relevant standards.
| Acceptance Criterion (Technical Specification / Standard Compliance) | Reported Device Performance (as stated in document) |
|---|---|
| Overall Accuracy | ± 3% dependant of specific calibration source and geometric variations |
| Electrometer Accuracy | ± 1% |
| Temperature Coefficient | 0.1 % / °C between 10°C and 40°C at 5 MBq and up |
| Reproducibility | ± 1% over 24 hours, stable conditions |
| Linearity | ± 1% between 1 MBq and 200 GBq (Tc-99m) |
| Electrical Safety (IEC 60601-1: 2005) | Complies with the Standards. |
| Electromagnetic Compatibility (IEC 60601-1-2: 2007) | Complies with the Standards. |
| Software Development (FDA guidance, IEC 62304: 2006) | Complies with its predetermined specification and the Standards and guidance documents. |
| Performance (IEC 61145: 1992, IEC 61303: 1994, IEC 62366: 2007) | Complies with predetermined specification and with the applicable Standards. |
| Readout Range | 0.001 MBq – 200 GBq; 0.01 µCi – 6000 mCi |
| Ionization Chamber Model | Veenstra Instruments VIK-202 |
| Chamber Type | Argon-filled, pressurized, well chamber |
| Ionization Voltage | 150 V lithium battery |
| Geometry of Sensitive Volume (Well Size) | Height: 250 mm (~9.84 in), Diameter: 60 mm (~2.36 in) |
2. Sample Size Used for the Test Set and Data Provenance
The document does not describe a clinical "test set" in the traditional sense of a diagnostic device evaluating patient data. The performance testing conducted was against technical specifications and international standards for radionuclide dose calibrators. Therefore, there is no patient-specific sample size or data provenance (e.g., country of origin, retrospective/prospective) for a clinical test set for diagnostic accuracy.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
This device is a dose calibrator, not a diagnostic imaging device that requires interpretation by medical experts (like radiologists). Therefore, no experts were used to establish ground truth for a test set in a diagnostic context. The "ground truth" for the device's accuracy would be established by reference standards or highly accurate measurement techniques in a physics or engineering lab setting.
4. Adjudication Method for the Test Set
As there is no clinical "test set" requiring expert interpretation, no adjudication method was employed.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study is typically conducted for diagnostic imaging devices to assess the impact of AI on human reader performance. The Veenstra Instruments VDC-506 Dose Calibrator is a measurement device for radioactive materials, not a diagnostic interpretation tool, and it does not involve human-in-the-loop diagnostic tasks.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
The device itself is a standalone system for measuring radionuclide activity. The "performance testing" described in the document (electrical safety, EMC, software, and general performance testing against standards) is essentially standalone performance evaluation of the device's technical specifications. It's not an "algorithm only" performance in the context of AI diagnostic applications, but rather the performance of the integrated hardware and software system as a whole.
7. The Type of Ground Truth Used
The ground truth used for performance verification would be:
- Reference standards/Calibrated sources: For evaluating the accuracy, linearity, and reproducibility of the dose measurements.
- International standards: For assessing compliance with electrical safety, EMC, and specific performance characteristics for radionuclide calibrators (e.g., IEC 60601-1, IEC 60601-1-2, IEC 61145, IEC 61303).
- Predetermined specifications: Internal specifications set by the manufacturer against which the device's performance is verified.
8. The Sample Size for the Training Set
The document describes a physical device with software, not a machine learning or AI model that requires a "training set" of data in the common sense. The software development and testing follow standard engineering practices. Therefore, there is no "training set sample size" as would be applicable to an AI algorithm.
9. How the Ground Truth for the Training Set Was Established
As there is no "training set" for an AI algorithm, this question is not applicable to the VDC-506 Dose Calibrator. The "ground truth" for software robustness and functionality is established through verification and validation activities based on software requirements and design specifications.
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