(184 days)
To irradiate cellular blood products to inactivate T-lymphocytes in order to prevent Graft Versus Host Disease.
The Raycell Mk1 x-ray blood irradiator consists of one cabinet containing one x-ray tube, one highvoltage power supply, one radiation shielding chamber, control electronics, an internal cooling system, two removable shielding access panels to the irradiation chamber, a touch-based Graphical User Interface, and additional operator controls. The operator places the blood products to be irradiated in the canister or syringe holder, opens the door, places the canister or syringe holder on the turntable, closes the door and indicates the irradiation cvcle on the Graphical User Interface. The Operator then uses the Operator controls to start the irradiation cycle. The design of this device is substantially equivalent to the predicate device.
This document describes the Raycell MK1, an x-ray blood irradiator. However, the provided text does not contain acceptance criteria or study details in the format requested, relating to AI/device performance metrics, sample sizes, expert ground truth, or MRMC studies.
The document is a 510(k) summary for the Raycell MK1, which is a medical device for irradiating cellular blood products. The primary aim of a 510(k) submission is to demonstrate substantial equivalence to a legally marketed predicate device, not necessarily to prove specific performance metrics against pre-defined acceptance criteria in the manner often associated with AI/software performance studies.
Here's a breakdown of what is and isn't in the provided text, in relation to your request:
What is present (partial information):
- Device Name: Raycell MK1
- Intended Use: To irradiate cellular blood products to inactivate T-lymphocytes in order to prevent Graft Versus Host Disease.
- Predicate Device: Raycell MK2 (K161324)
- Safety & Effectiveness Statement: "The safety of the Raycell is equivalent or better than the predicate device." and "Validation testing demonstrated that the device is as safe and effective as the predicate device."
- Compliance Standards: IEC 60601-1-2:2014-02 and IEC 60601-1:2012-08 (These are general medical electrical equipment safety and performance standards, not specific performance metrics for the irradiation itself).
- Testing Method (general): "The performance of the device was tested against a set of functional specifications in an environment that simulated, as much as possible, the actual operating environment."
What is NOT present in the provided text, and therefore cannot be answered from this document:
- A table of acceptance criteria and reported device performance (in terms of specific metrics like sensitivity, specificity, accuracy, etc.): The document only generally states that "validation testing demonstrated that the device is as safe and effective as the predicate device." It does not provide quantitative performance metrics.
- Sample size used for the test set and data provenance: No information on the number of samples (e.g., blood bags) tested, or where the data came from.
- Number of experts used to establish the ground truth for the test set and their qualifications: This device is not an AI/diagnostic device that typically relies on expert interpretation for ground truth. Ground truth for an irradiator would be related to the actual dosage delivered and its biological effect.
- Adjudication method: Not applicable for this type of device and study description.
- If a multi reader multi case (MRMC) comparative effectiveness study was done, and its effect size: Not applicable/not mentioned. This is a physical device, not an AI assistance tool for human readers.
- If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable/not mentioned.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc.): While the device's function is to inactivate T-lymphocytes, the document doesn't detail how the effectiveness of this inactivation was rigorously measured or what constituted "ground truth" for its performance validation.
- The sample size for the training set: Not applicable, as this is not an AI/machine learning device requiring a training set in that context.
- How the ground truth for the training set was established: Not applicable.
Conclusion based on the provided text:
The provided 510(k) summary focuses on demonstrating substantial equivalence to a predicate device by describing design changes and compliance with general safety standards. It does not provide the specific performance metrics, study designs (like MRMC), sample sizes, or ground truth details typically associated with the type of acceptance criteria and studies you've asked about for an AI-powered diagnostic/analysis device. The "performance of the device was tested against a set of functional specifications," but these specifications and their results are not detailed.
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