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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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The Raycell X-ray Blood Irradiator is intended for use in the irradiation of blood and blood products (packaged in transfusion bags) to inactivate T-lymphocytes for the prevention of Graft Versus Host Disease according to applicable FDA, AABB, Health Canada, and European guidelines.

The Raycell X-ray Blood Irradiator is also intended for use in the irradiation of intra-operatively salvaged blood for cancer patients undergoing surgery to assist in the prevention of metastasis.

The Raycell is a self-contained shielded cabinet X-Ray Blood Irradiator. The device consists of a lead shielded chamber containing two vertically opposed x-ray tubes with provision for a sample canister holder between them, dual power supplies and a operator control panel. The operator places the blood products to be irradiated in the canister, opens the drawer, places the canister in the holder, closes the drawer and starts the irradiation cycle at the Operator Panel. The design of this device is substantially equivalent to the predicate device.

The provided text describes a 510(k) premarket notification for the Raycell Mk2 X-Ray Blood Irradiator. This document focuses on demonstrating substantial equivalence to a legally marketed predicate device (Raycell, K051065) rather than presenting a clinical study to prove the device meets specific acceptance criteria based on patient outcomes or diagnostic performance.

Therefore, many of the requested elements for describing an acceptance criteria study (like sample size for test sets, number of experts, adjudication methods, MRMC studies, standalone performance with ground truth) are not applicable or not present in this type of regulatory submission.

However, I can extract the information related to the device's technical specifications and safety/effectiveness testing against functional specifications, as this is the "study" referred to in the document.

1. Table of Acceptance Criteria and Reported Device Performance:

The document doesn't provide a direct table of quantitative acceptance criteria for clinical performance or diagnostic metrics. Instead, it focuses on demonstrating that the modified aspects of the Raycell Mk2 are equivalent or better than the predicate device's performance in terms of safety and technical functionality.

2. Sample size used for the test set and the data provenance:

• Sample Size: Not specified as a number of patient cases or blood samples in the context of a clinical study. The "test set" refers to the device itself undergoing engineering and safety validation.
• Data Provenance: The testing was likely conducted in a controlled laboratory or manufacturing environment by the manufacturer (Best Theratronics, Canada). It is not clinical data from patients or blood products in a real-world setting, but rather engineering verification and validation testing.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

• Not Applicable. As this is an engineering and safety validation of an irradiator, not a diagnostic or AI-based device, there were no clinical experts establishing "ground truth" for patient data. The "ground truth" here would be the physical and electrical parameters of the device meeting established engineering and safety standards.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

• Not Applicable. No clinical adjudication method was used. The device's performance was evaluated against technical specifications and regulatory standards by engineers and quality assurance personnel.

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 is an X-ray blood irradiator, not an AI-assisted diagnostic device. No MRMC study was conducted.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

• Not Applicable. This is a standalone medical device (X-ray blood irradiator). The "standalone performance" refers to the device's technical operation as described in the "Safety & Effectiveness" section against functional specifications and regulatory standards. There is no "algorithm only" performance to evaluate in the context of AI.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

• The "ground truth" for the device's acceptable performance was based on engineering specifications, international safety standards (IEC 60601 series), and comparison to the predicate device's proven functionality and safety. The device's ability to irradiate blood effectively for its stated purpose is an established physical principle and was likely assumed to be met based on using the same core X-ray technology as the predicate, with increased power.

8. The sample size for the training set:

• Not Applicable. This device does not use machine learning or AI models that require a "training set."

9. How the ground truth for the training set was established:

• Not Applicable. As there is no training set for an AI model, this question is not relevant.

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The Raycell" X-ray Blood Irradiator is intended for use in the irradiation of blood and blood products (packaged in transfusion bags) to inactivate T-lymphocytes for the prevention of Graft Versus Host Disease (GVHD) in accordance with applicable FDA, AABB, Health Canada, and European guidelines.

The Raycell" X-ray Blood Irradiator is also intended for use in the irradiation of intra-operative (between three) blood for cancer patients undergoing surgery to assist in the prevention of metastasis.

Not Found

The provided text describes the regulatory approval of the Raycell™ X-ray Blood Irradiator and its intended uses. However, it does not contain any information about acceptance criteria or a study proving that the device meets those criteria.

Therefore, I cannot extract the information you requested. The document is a 510(k) clearance letter, which means the FDA has determined the device is substantially equivalent to a legally marketed predicate device. This process does not typically involve the presentation of acceptance criteria or performance studies in the way you've outlined for an AI/diagnostic device.

To directly answer your questions based only on the provided text, I would have to state that the information is not present.

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The Raycell™ Shielded Cabinet X-ray System is intended for the irradiation of blood and blood products packaged in transfusion bags when irradiation to reduce the risk of Graft versus Host Disease is indicated, and is used in accordance with "Recommendations Regarding License Amendments and Procedures for Gamma Irradiation of Blood Products" (22 July 1993 memorandum from Acting Director, Office of Blood Research and Review, Center for Biologics Evaluation and Research, FDA to all registered blood establishments).

The Raycell Shielded Cabinet X-ray System consists of a sample holder (canister) between the two (2) x-ray tubes, dual power supplies, radiation shielding, control electronics, cooling assemblies and operator controls. The radiation source of the Raycell™ Shielded Cabinet X-ray System includes of two vertically opposed xray tubes contained in a shielded enclosure. It is identical to the predicate device with the exception of labeling changes to reflect the new product name and identify MDS Nordion as the manufacturer.

The provided document describes a 510(k) submission for the Raycell™ Shielded Cabinet X-ray System. This submission is for a medical device that irradiates blood and blood products. It is a declaration of substantial equivalence to an existing predicate device, the RS 3000 Shielded Cabinet X-Ray Blood Irradiator (K974210).

The document does not contain information about studies to prove device performance against acceptance criteria in the context of AI/ML or diagnostic performance. Instead, the "acceptance criteria" here refers to the device's technological characteristics remaining the same as the predicate device, which is the basis for claiming substantial equivalence.

Therefore, many of the requested fields are not applicable to this type of regulatory submission.

Here's an attempt to fill out the information based on the provided text, with clarifications where the requested information is not available or relevant:

Acceptance Criteria and Study Details for Raycell™ Shielded Cabinet X-ray System

1. Table of Acceptance Criteria and Reported Device Performance

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