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510(k) Data Aggregation
(90 days)
This instrument is intended for the purpose of calibrating and measuring the ionizing radiation outputs from medical therapy machines.
The Model 580-006 Radiation Therapy Ionization Chamber is modeled after the traditional 0.6cm Farmer-type chamber used for absolute dosimetry measurements of medical linear accelerators and 900 machines. Each chamber includes an energy response chart, a PMMA 600 buildup cap, a convenient low noise one meter cable with triaxial BNC connector and a custom carrying case.
The provided document is a 510(k) Premarket Notification Summary for a medical device, the Model 580-006 Radiation Therapy Ionization Chamber. This type of document is for demonstrating substantial equivalence to a predicate device, not for a study proving device performance against acceptance criteria in the way a clinical trial or AI algorithm validation would.
Therefore, many of the requested categories (such as sample size for test/training sets, data provenance, expert ground truth, adjudication methods, multi-reader multi-case studies, standalone performance for AI, and ground truth establishment for training) are not applicable to this type of regulatory submission for a physical medical device like an ionization chamber. The "study" here is essentially the comparison of specifications and characteristics to a predicate device.
Here's an attempt to answer the questions based only on the provided text, indicating where information is not present or not applicable to this type of device submission:
Acceptance Criteria and Device Performance Study Summary
1. A table of acceptance criteria and the reported device performance
The document provides a "Specification Comparison Table" where the new device (Model 580-006) specifications are presented alongside the predicate device (Model 500-6) specifications. In the context of a 510(k) submission, the "acceptance criteria" are generally that the new device's specifications and performance fall within an acceptable range, demonstrating substantial equivalence to the predicate device, or that any differences do not raise new questions of safety or effectiveness. The table below presents the new device's specifications as its "reported performance" and the predicate device's specifications as the "benchmark" for substantial equivalence.
| Feature | Predicate Device (Model 500-6) (Acceptance/Benchmark) | New Device (Model 580-006) (Reported Performance) |
|---|---|---|
| Volume | 0.6 cm³ | 0.61 cm³ |
| Sensitivity | 2 x 10⁻¹⁰ A/R/s | 2.0 x 10⁻⁸ cGy⁻¹ |
| Leakage | < 10⁻¹⁵ A | < 4 x 10⁻¹⁵ A |
| Wall Material | Tissue equivalent plastic | PMMA acrylic with graphite layer |
| Wall area material density | 58 mg/cm² | 78.5 mg/cm² |
| Collector | Tissue equivalent plastic | Pure aluminum, 1mm diameter x 20.0mm long |
| Cable length | 15 meters | 1 meter |
| Range of Temperature | +10°C to +40°C | +10°C to +40°C |
| Relative air humidity | 20% to 75%, non-condensing | 75%, non-condensing |
| Build-up cap material | Acrylic 1.2 g/cm³ | PMMA for ⁶⁰Co |
| Chamber length | 24.4 mm | 23.6 mm |
| Chamber diameter | 7.1 mm | 5.95 mm |
| Build-up cap diameter | 13.3 mm | 16.3 mm |
| Probe length | 124 mm | 157 mm |
| Energy Range without build-up cap | 70keV to 662 keV | 21keV to 662 keV |
| Energy Range with build-up cap | 1.2 MeV to 1.5 MeV | 662 keV to 1.5 MeV |
| Maximum exposure range for 99.5% efficiency @ 300 V | 4000 R/min | 3.0Gy s⁻¹ |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample size for test set: Not applicable. This document describes a physical device and its specifications, not a study involving a test set of data/patients. The "test" is the device's adherence to its own design specifications and comparison to a predicate device.
- Data provenance: Not applicable.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not applicable. Ground truth in this context would refer to the physical and electrical properties of the device, which are established through engineering design, manufacturing, and calibration, not by expert consensus on a test set of data. The document mentions manufacturing in compliance with standards and calibration by an approved calibration lab.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable. There is no test set or adjudication process in the sense of expert review of data for this device submission.
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 is not an AI/software device and does not involve human readers interpreting data.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This is not an algorithm or AI device. The device's "standalone" performance is its ability to meet its technical specifications, which are implicitly demonstrated by the specification table and the claim of substantial equivalence.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- The "ground truth" for this device, regarding its performance, is its physical and electrical specifications as measured and calibrated against established physical standards (e.g., NIST techniques M50, M250, Cesium 137, and Cobalt 60, as mentioned under "Calibration"). The substantial equivalence is based on engineering and performance characteristics compared to the predicate device.
8. The sample size for the training set
- Not applicable. This is not an AI/machine learning device.
9. How the ground truth for the training set was established
- Not applicable. This is not an AI/machine learning device.
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