(101 days)
The OneDose Patient Dosimetry System is intended to measure a patient's dose during radiotherapy applications.
The OneDose Patient Dosimetry System consists of the following components and accessories: (1) disposable, single use, pre-calibrated radiation dosimeters, (2) a hand held, battery powered, reader, and (3) a reader calibration test strip. The dosimeters use a metal oxide semiconductor field effect transistor as a sensing mechanism. The dosimeters are inserted into the Reader and calibrated prior to use on a patient. The dosimeters are small and have no wires. They have a medical grade adhesive and liner on the back. The adhesive side of the dosimeter is adhered to the patient. Following radiotherapy, the dosimeters are removed from the patient, re-inserted into the Reader, and the patient's dose is read and reported by the Reader. The dose records are stored on the dosimeter for future reference and in the Reader's memory.
The provided document K040687 is a 510(k) summary for the Sicel Technologies, Inc. OneDose Patient Dosimetry System. This document describes the device, its intended use, and its substantial equivalence to predicate devices. However, it does not contain a detailed study proving the device meets specific acceptance criteria in the format typically expected from a clinical performance study.
510(k) submissions primarily focus on demonstrating substantial equivalence to a legally marketed predicate device, rather than providing independent clinical performance data against pre-defined acceptance criteria for a novel device. The document states that the "data contained with the methods section demonstrates that calibrated devices perform within the stated performance specifications of the labeling." This implies that performance data was submitted, but the specific acceptance criteria and detailed study results are not explicitly provided within this summary.
Therefore, many of the requested fields cannot be filled directly from the provided text.
Here's an attempt to answer based on the available information and highlighting what is not present:
1. Table of acceptance criteria and the reported device performance:
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not explicitly stated in this 510(k) summary. The summary mentions "stated performance specifications of the labeling" but does not provide specific numerical targets or thresholds for accuracy, precision, or other performance metrics. | The document states, "the data contained with the methods section demonstrates that calibrated devices perform within the stated performance specifications of the labeling." This indicates that some performance data was provided to the FDA to show the device meets its specifications, but the specific details are not in this summary. It also mentions "The OneDose, while pre-calibrated, is calibrated for thermal fluctuations in a method similar to the methods found in the Thomson Nielsen for evaluating radiation factors using the same methods as Thomson Nielsen" and that the device is calibrated under controlled factory conditions. |
2. Sample size used for the test set and the data provenance:
- Sample Size: Not specified in this 510(k) summary.
- Data Provenance: Not specified. It can be inferred that testing was conducted by the manufacturer, Sicel Technologies, Inc., likely at their facilities in Morrisville, NC, but the specific country of origin or whether it was retrospective or prospective is not mentioned for the performance data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Number of experts: Not applicable. For dosimetry devices, "ground truth" is typically established by physical measurements using highly accurate reference equipment or established radiation physics principles, not by human expert opinion.
- Qualifications of experts: Not applicable.
4. Adjudication method for the test set:
- Not applicable. Adjudication methods like 2+1 or 3+1 are used for subjective interpretations (e.g., image reading), not for objective physical measurements from a dosimetry device.
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:
- No. This is a dosimetry device, not an AI-assisted diagnostic tool. MRMC studies are not relevant here.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Yes, implicitly. The OneDose Patient Dosimetry System is a standalone device that measures and reports patient dose. Its performance would be evaluated as such. The device's function is to objectively measure a dose, not to assist humans in interpretation.
7. The type of ground truth used:
- The ground truth would be established through highly accurate and traceable radiation measurements using established laboratory standards and reference dosimetry equipment. This could involve direct measurements in controlled radiation fields. The summary indirectly hints at this by mentioning "evaluating radiation factors" and "calibrated under controlled conditions at the factory."
8. The sample size for the training set:
- Not applicable in the typical sense for machine learning algorithms. This device is based on a MOSFET sensing mechanism, which relies on physical principles, not a "training set" in the context of AI/ML. The "calibration" performed at the factory might involve using a set of known radiation doses to ensure the device accurately converts the MOSFET response into a dose reading, but this is distinct from an AI training set.
9. How the ground truth for the training set was established:
- Not applicable for the reasons stated in point 8. The calibration process would involve exposing the devices to precisely known radiation doses and adjusting the device's internal parameters (or ensuring they meet specifications) to report these doses accurately.
§ 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.