Search Results
Found 1 results
510(k) Data Aggregation
(53 days)
RALCO, MODEL R225 ACS
Model R225 ACS Automatic X-RAY Collimator is intended for use in diagnostic radiographic/fluoroscopic applications.
This x-ray collimator Multilayer, square-field, automatic collimation system. Stepper motors control the movements of shutters and the additional filter. There is a mounting plane at 80 mm (3.15") from the focus. A microprocessor circuit controls the stepper motors and provides the stepless adjustment of the square field dimensions at variable FFD (SID). The field dimensions may be decreased and increased to the set value by two knobs placed on the collimator front panel.
The provided text describes a submission for a 510(k) premarket notification for the RALCO Model R225 ACS Automatic X-RAY Collimator. This device is a collimator, which is a component of an X-ray system, and therefore, the assessment criteria and study design are different from those for AI-powered diagnostic devices.
The submission focuses on establishing substantial equivalence to a predicate device (K072780, Ralco Model R302DACS Automatic Collimator) rather than demonstrating a specific performance metric against a "ground truth" in the way an AI diagnostic algorithm would.
Based on the provided text, here's a breakdown of the requested information:
1. Table of acceptance criteria and the reported device performance:
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Safety and Effectiveness Equivalence to Predicate Device: The new device must be as safe and effective as the predicate device (K072780, Ralco Model R302DACS Automatic Collimator). | "The results of bench, safety test, and laboratory testing indicates that the new device is as safe and effective as the predicate device." |
| Conforms to US Performance Standards: The device must meet applicable US performance standards. | "The new device conforms to US Performance Standards." |
| CSA Listed to US Standards for safety for medical devices: The device must be listed by CSA to US safety standards. | "and is CSA Listed to US Standards for safety for medical devices." |
| Identical Indications for Use: The new device must have the same indications for use as the predicate device. | "and has identical indications for use" (Indications for Use: Intended for use in diagnostic/fluoroscopic applications.) |
| Technological Differences: Differences should be minimal and not raise new questions of safety or effectiveness. | "has few technological differences" (The primary described difference is that the predicate employs a round field, similar to the new device, but the new device also features "Multilayer, square-field, automatic collimation system" which suggests an enhancement over the predicate's possibly singular "round field" description; however, the conclusion emphasizes "few technological differences.") |
2. Sample size used for the test set and the data provenance:
- Test Set Sample Size: Not applicable in the context of this submission. The submission relies on "bench, safety test, and laboratory testing" rather than a clinical dataset with a specific "test set" for performance evaluation against a diagnostic ground truth.
- Data Provenance: Not explicitly stated as clinical data from specific countries or retrospective/prospective studies. The testing is described as "bench, safety test, and laboratory testing," which typically refers to engineering and quality assurance activities conducted by the manufacturer (RALCO srl in Biassono, Italy).
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 consensus for a diagnostic "ground truth." The evaluation focuses on the engineering performance and safety of the collimator itself, which are assessed through engineering tests and adherence to standards.
4. Adjudication method for the test set:
- Not applicable. There is no specific "test set" requiring adjudication in the context of this 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:
- No MRMC comparative effectiveness study was done. This device is a hardware component (an X-ray collimator), not an AI algorithm intended to assist human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is a hardware device, not an algorithm.
7. The type of ground truth used:
- Not applicable in the sense of clinical diagnostic ground truth (e.g., pathology, patient outcomes). The "ground truth" here is adherence to engineering specifications, safety standards (e.g., CSA Listed to US Standards), and functional equivalence to the predicate device as demonstrated through "bench, safety test, and laboratory testing."
8. The sample size for the training set:
- Not applicable. This is a manufactured hardware device, not a machine learning model that requires a training set.
9. How the ground truth for the training set was established:
- Not applicable. As noted above, this device does not involve a training set or associated ground truth in the context of machine learning.
Ask a specific question about this device
Page 1 of 1