(56 days)
Model R605DASM Automatic X-RAY Collimator is intended for use in diagnostic radiographic/fluoroscopic applications.
This device is a compact radiological automatic collimating system for round and elliptic fields designed to operate with a mobile "C" arm Image Intensifier cquipment. The round and elliptical fields are defined as follows: The round field by 8 lead shutters located near the exit window and a brass cone near the x-ray focus; the elliptical field by the round field and two pairs of lead rectangular shutters located near the collimator entrane window. Round and elliptical field shutters are controlled by 5 stepping motors. The circlinator features a microprocessor circuit built into the collimator to control the 5 stepping-motornia external signal source with CanBus protocol. The circuits return a CanBus protocol signal to indicate correct motor positioning. The two pairs of lead rectangular shutters move isignify and both rotate ± 360° ..
This document is a 510(k) summary for the Ralco Model R605DASM Automatic X-RAY Collimator. It describes the device, its intended use, and argues for its substantial equivalence to a predicate device.
Here's the breakdown regarding acceptance criteria and the study, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state numerical acceptance criteria in terms of performance metrics (e.g., accuracy, precision, error rates) for the device. Instead, the "acceptance criteria" are implied to be adherence to general safety and effectiveness standards, and substantial equivalence to a legally marketed predicate device.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Safe and Effective | "The new device conforms to US Performance Standards and is CSA Listed to US Standards for safety for medical devices." |
| Substantially Equivalent to Predicate Device | "The results of bench, safety test, and laboratory testing indicates that the new device is as safe and effective as the press, and The predicate device was made for Omega Medical Imaging and in fact carries virtually the same model name as the new Ralco device. The predicate employs a round field, same as our new device." |
| Identical Indications for Use | "has identical indications for use" (compared to predicate) |
| Few Technological Differences | "has few technological differences" (compared to predicate) |
2. Sample Size Used for the Test Set and Data Provenance
The document mentions "bench, safety test, and laboratory testing" but does not provide details on the sample size used for any test sets or the data provenance (e.g., country of origin, retrospective/prospective nature). It focuses on the physical characteristics and control mechanisms of the collimator.
3. Number of Experts Used to Establish Ground Truth and Qualifications
This information is not applicable and not provided. The device described is an automatic X-ray collimator, a hardware component that limits the X-ray beam. Its performance is assessed through engineering and safety tests, not through clinical interpretation requiring expert consensus on ground truth (like in image analysis AI).
4. Adjudication Method for the Test Set
This information is not applicable and not provided. As mentioned above, the assessment is based on physical and functional testing, not on clinical adjudication of interpretations.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done
No, a MRMC comparative effectiveness study was not done. This type of study is relevant for devices that provide diagnostic interpretations or assist human readers in making decisions (e.g., AI for image analysis). The Ralco Model R605DASM is a hardware device for controlling X-ray beams.
6. If a Standalone (i.e. algorithm only without human-in-the loop performance) was done
This is not directly applicable in the typical sense of an "algorithm only" standalone performance study for an AI device. The device itself is an automatic collimator, meaning it operates autonomously to control the X-ray beam based on its internal programming and external signals. The "tests" performed would assess its standalone mechanical and electronic performance, in that sense, it is "standalone." However, this is not a standalone AI algorithm performance.
7. The Type of Ground Truth Used
The "ground truth" for this device would be established engineering specifications, safety standards, and the physical accuracy of the collimator's movements and beam-limiting capabilities. For example:
- Engineering Specifications: Whether the 5 stepping motors accurately position the shutters.
- Safety Standards: Adherence to US Performance Standards and CSA Listing for safety.
- Functional Testing: The ability to correctly define round and elliptical fields as intended.
8. The Sample Size for the Training Set
This information is not applicable and not provided. The device is a mechanical and electronic system, not an AI model that requires a "training set" in the context of machine learning.
9. How the Ground Truth for the Training Set was Established
This information is not applicable and not provided. As explained in point 8, there is no "training set" in the typical sense for this device.
§ 892.1610 Diagnostic x-ray beam-limiting device.
(a)
Identification. A diagnostic x-ray beam-limiting device is a device such as a collimator, a cone, or an aperture intended to restrict the dimensions of a diagnostic x-ray field by limiting the size of the primary x-ray beam.(b)
Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.