(231 days)
The 1D Water Phantom WP-3840 and WP-3040 is used to position various radiation detectors in water or air. It consists of a cubic acrylic tank and a precision one-dimensional hand crank. By design it is suitable to act as a phantom according to various protocols such as the AAPM's TG-51protocol.
The Water Phantom WP-3840 and WP-3040 comprises of a one-dimensional precision mechanism attached to an Acrylic water tank. Various radiation detectors can be positioned along a vertical guide rail in different depths according to the application needs. The WP-3840 and WP-3040 consist of the basic acrylic water tank phantom, equipped with a hand crank to move the detector. That hand crank is coupled to a mechanical counter, reset-able position indicator that displays the depth.
This document, a 510(k) Premarket Notification Summary (K173848) for the CNMC Model WP-3840 and WP-3040, primarily focuses on demonstrating substantial equivalence to a predicate device, rather than proving the device meets specific acceptance criteria through a clinical study or performance evaluation with a dedicated test set and ground truth.
Therefore, many of the requested details about acceptance criteria, study design, expert involvement, and ground truth establishment are not present in this type of regulatory submission.
However, based on the provided text, we can infer the "acceptance criteria" through the comparison made to the predicate device and the "study" by the comparison table and conclusion.
Here's how we can address the questions based on the available information:
1. Table of Acceptance Criteria and Reported Device Performance:
The "acceptance criteria" for equivalency are implicitly defined by the characteristics of the predicate device (Medtec, Inc. - K943199, Model MT-150). The "reported device performance" is a statement of the CNMC Model WP-3840/WP-3040's characteristics.
| Acceptance Criteria (Predicate Device MT-150) | Reported Device Performance (CNMC WP-3840/WP-3040) |
|---|---|
| How the device is used: 1D stand-alone water phantom for absolute dose measurements according to TG-51 and IAEA TRS-398 dosimetry protocols. | How the device is used: Comprises a one-dimensional precision mechanism attached to an Acrylic water tank. Various radiation detectors can be positioned along a vertical guide rail in different depths according to the application needs. |
| Intended use: Radiation dosimetry | Intended use: Radiation dosimetry |
| Detectors: ion chambers, diodes | Detectors: ion chambers, diodes |
| Manual Control: Yes | Manual Control: Yes |
| Travel Range: 0 – 25cm | Travel Range: 0 – 25cm |
| Resolution: 0.1mm | Resolution: 0.1mm |
| Position Indicator: Yes (Mechanical) | Position Indicator: Yes (Mechanical) |
| Position Indicator Resettable: Yes | Position Indicator Resettable: Yes |
| Acrylic Tank Dimensions: 38cm W x 38cm L x 38cm H; 30.5cm W x 38cm L x 38cm H | Acrylic Tank Dimensions: WP3840: 38cm W x 40cm L x 38cm H; WP3040: 30cm W x 40cm L x 38cm H |
| Drain Valve: Yes | Drain Valve: Yes |
| Manufacturing Material: Same as predicate | Manufacturing Material: Exact material as predicate |
| Protocol Compatibility: AAPM TG-51 protocol | Protocol Compatibility: AAPM TG-51 protocol |
Note: The "acceptance criteria" here are not numerical thresholds for performance metrics but rather a qualitative comparison to the established characteristics of the predicate device for demonstrating substantial equivalence.
2. Sample size used for the test set and the data provenance:
This document describes a comparison of device specifications and intended use, not a study involving a "test set" of data or patient samples. Therefore, there is no information about sample size or data provenance (country of origin, retrospective/prospective). The "test" is a comparison of product specifications against a predicate.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
Not applicable. This is not a study requiring expert-established ground truth on a test set. The "ground truth" for the comparison is the published specifications of the predicate device and the design specifications of the new device.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
Not applicable. There is no test set or adjudication process described as this is a comparison of technical specifications.
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 device is a water phantom used for radiation dosimetry, not an AI-assisted diagnostic device for human readers. No MRMC study was performed.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Not applicable. This is a physical medical device (water phantom), not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
The "ground truth" in this context is the technical specifications and intended use of the legally marketed predicate device (Medtec, Inc. - K943199, Model MT-150), along with the design and manufacturing specifications of the new device (CNMC WP-3840/WP-3040). There's no biological or clinical ground truth involved.
8. The sample size for the training set:
Not applicable. This document does not describe a machine learning or AI device that requires a training set.
9. How the ground truth for the training set was established:
Not applicable. No training set is described.
In summary:
This 510(k) notification demonstrates substantial equivalence to a predicate device based on comparison of engineering specifications and intended use, rather than a clinical performance study with defined acceptance criteria and a test set like those typically used for diagnostic or AI-based medical devices. The "study" is the comparative analysis presented in the "Similarities/Differences" table.
§ 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.