(84 days)
In order to ensure the day to day performance of medical devices, many quality assurance tests are performed. In all quality assurance testing a phantom or measurement device is used to either validate a system parameter or measure some aspect of system performance. These test objects/devices can easily be classified as one of two types, passive or active. An active device is one that can make a direct measurement or perform a test without user evaluation or interpretation, while a passive device merely provides an environment or condition for testing, but the result requires the user or operator to make an evaluation and determination. Examples of passive devices are test phantoms or film cassettes.
The Mick Radio-Nuclear Perma-Doc Phantom is an example of a passive device. It is designed to be placed between the source from a HDR system and a piece of film. Radiographic exposure of the film by the HDR source results in the production of an image on the film which can then be analyzed by the operator for consistency from the prior test exposure. The Perma-Doc Phantom does not alter, change or moderate the radiation field in any manner. It has a radio-opaque scale embedded into it that can be visualized on standard x-ray film when exposed to the radiation output from the HDR system. Inspection of the image on the film is then used as part of the quality assurance process.
The Mick Radio-Nuclear Perma-Doc Phantom is an example of a passive device. It is designed to be placed between the source from a HDR system and a piece of film. Radiographic exposure of the film by the HDR source results in the production of an image on the film which can then be analyzed by the operator for consistency from the prior test exposure. The Perma-Doc Phantom does not alter, change or moderate the radiation field in any manner. It has a radio-opaque scale embedded into it that can be visualized on standard x-ray film when exposed to the radiation output from the HDR system. Inspection of the image on the film is then used as part of the quality assurance process.
This submission pertains to the Perma-Doc Phantom, a radiologic quality assurance instrument. The provided document does not contain a study demonstrating the device meets specific acceptance criteria in the traditional sense of a performance study with numerical metrics for accuracy, sensitivity, or specificity. Instead, the submission focuses on establishing substantial equivalence to a predicate device.
Here's an analysis based on the provided text:
Acceptance Criteria and Reported Device Performance
The document describes the Perma-Doc Phantom as a passive device designed for quality assurance testing in High-Dose Rate (HDR) systems. Its primary function is to provide an environment for testing where the user evaluates the results.
Given the nature of the device as a "Radiologic Quality Assurance Instrument" and a "passive device," the "acceptance criteria" and "performance" are not framed in terms of clinical outcomes or diagnostic accuracy. Instead, the core acceptance criterion is substantial equivalence to a legally marketed predicate device.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Similarity in Design and Construction | "This device is similar in design and construction..." |
| Identical Materials | "...utilizes the identical materials..." |
| Same Intended Use | "...and has the same intended use..." (to be placed between an HDR system source and film to produce an image for operator analysis of consistency for quality assurance) |
| Same Performance Characteristics | "...and performance characteristics to the predicate devices." (Provides a radio-opaque scale for visualization on standard x-ray film to inspect consistency from prior test exposure, does not alter/change/moderate the radiation field). |
| No New Issues of Safety or Effectiveness | "No new issues of safety or effectiveness are introduced by using this device." (And no new issues of biocompatibility are raised). This forms the basis for demonstrating that it does not pose additional risks compared to the predicate. |
Study Information
The document is a 510(k) premarket notification, which establishes substantial equivalence rather than proving performance against specific acceptance criteria through a clinical study. Therefore, most of the requested study-related information is not applicable or not present in this type of submission.
- Sample size used for the test set and the data provenance: Not applicable. There is no formal "test set" in the context of a performance study described here. The submission relies on a comparison to a predicate device based on its design, materials, and intended use.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. No ground truth establishment by experts for a test set is described.
- Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
- 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 not an AI-assisted device, nor is an MRMC study described.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is a passive physical device, not an algorithm.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable in the context of a performance study for this device. The "ground truth" for the substantial equivalence determination is the existing regulatory status and performance profile of the predicate device (Med Tec, Inc. Iso-Align, Class I exemption).
- The sample size for the training set: Not applicable. This is a physical device, not a machine learning model requiring a training set.
- How the ground truth for the training set was established: Not applicable.
Summary of Substantial Equivalence Determination
The "study" that proves the device meets the (implied) acceptance criteria is the demonstration of substantial equivalence to the predicate device, "Med Tec, Inc. Iso-Align" (Class I exemption under registration A 743531).
The submission asserts this equivalence based on the following:
- Similar design and construction: The Perma-Doc Phantom is a passive device with a radio-opaque scale embedded within it for quality assurance of HDR systems.
- Identical materials: The materials used are stated to be identical to the predicate.
- Same intended use: Both devices serve as radiologic quality assurance instruments for evaluating system performance, specifically by providing a quantifiable image for operator analysis.
- Same performance characteristics: The device performs its intended function (providing an image for consistency analysis) without altering the radiation field, comparable to the predicate.
- No new issues of safety or effectiveness: This is a crucial point for 510(k) clearance, indicating that the device does not introduce novel risks.
The FDA's review and subsequent letter (K993960) confirm that the device is substantially equivalent to legally marketed predicate devices, thereby allowing it to be marketed. This regulatory determination serves as the "proof" that the device meets the necessary criteria for market entry under the 510(k) pathway, specifically by demonstrating it is as safe and effective as a legally marketed predicate device.
§ 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.