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RadGil2 US is an X-Ray irradiation device intended for use in the irradiation of blood products packaged in transfusion bags to inactivate lymphocytes for the prevention of graft vs host disease (GVHD)

The RADGIL 2 US x-ray blood irradiator is for use in Hospitals, Medical Centers and blood banks. The RADGIL 2 US x-ray blood irradiator consists of one lead-shielded cabinet containing one monoblock with one X-ray tube inside, one irradiation chamber, one control electronics, one computer for data management and one operator controls panel for the X-ray settings. The RADGIL 2 US x-ray blood irradiator is designed to accommodate a rotating canister of approximately 2.5 litres, to accommodate up to six standard 300 mL blood bags provided the bags are not frozen and the blood bag tubing is not an obstruction. The RADGIL 2 US x-ray blood irradiator is capable of irradiating the blood products to a central dose of 30 Gy, granting a minimum dose >15 Gy and a maximum dose

The provided text is a 510(k) Summary for the RadGil2 US X-ray blood irradiator. It focuses on demonstrating substantial equivalence to a predicate device (SANGRAY) based on technical characteristics and non-clinical performance tests.

Crucially, the document explicitly states "Clinical Performance Test Summary None". This indicates that no clinical studies (which would involve human participants or human-in-the-loop performance evaluations) were conducted to prove the device meets specific acceptance criteria based on human performance or diagnostic accuracy.

Therefore, the requested information regarding acceptance criteria, study that proves the device meets the acceptance criteria (specifically performance metrics like sensitivity, specificity, AUC, or reader improvement), sample sizes for test sets, data provenance, expert ground truth establishment, adjudication methods, MRMC studies, standalone algorithm performance, or ground truth for training data cannot be extracted from this document. These types of data are typically found in clinical validation reports for AI/CADe devices, not premarket notifications for radiation-emitting medical devices like blood irradiators.

The acceptance criteria and performance data provided in this document relate solely to the physical specifications and non-clinical performance of the blood irradiator itself, such as:

• Dose Delivery: Central dose of 30 Gy, minimum dose >15 Gy, maximum dose 15 Gy |
  | | Maximum Dose |

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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 SANGRAY is an x-ray irradiation system intended for use in the irradiation of blood products packaged in transfusion bags to inactivate lymphocytes for the prevention of graft versus host disease (GVHD).

The X-ray irradiation system SANGRAY consists of a power supply (high-voltage generation unit), controller panel (console), and a shielded protection unit which contains two vertically opposed X-ray tube assemblies that generate X-ray beams. Blood products are placed into a tray and irradiated with the X-rays in a sample chamber. The system has a built-in dosimeter which measures the exposure dose in real time and ensures that the X-ray irradiation is stopped automatically when the preset dose is reached. If the power supply fails during the X-ray irradiation, the dosimeter keeps the integral dose value in memory, which allows the operator to continue the X-ray irradiation after power is recovered.

The provided text describes a 510(k) submission for the SANGRAY X-ray irradiation system. The document focuses on demonstrating substantial equivalence to predicate devices for regulatory clearance, rather than presenting a clinical study to prove the device meets specific performance criteria through a traditional clinical trial or AI algorithm validation study. Therefore, most of the requested information regarding acceptance criteria and studies proving the device meets them, especially in the context of AI, cannot be extracted from this document.

Here's what can be gathered, addressing your points where possible:

1. A table of acceptance criteria and the reported device performance

The document does not explicitly state acceptance criteria in the format of a clinical study or AI performance metrics. Instead, it presents a comparison of technological characteristics between the SANGRAY and two predicate devices (Rad Source X-ray Blood Irradiator, Model RS-3400 and Raycell X-ray Blood Irradiator). These characteristics serve as points of comparison to demonstrate substantial equivalence, rather than strict performance acceptance thresholds for a new, independent claim.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document explicitly states: "6.8 Clinical Performance Test Summary: None." This indicates that no clinical performance study was conducted or presented in this submission. The "test set" in this context refers to non-clinical performance and safety tests, not a clinical data set for evaluating an AI algorithm or human reader performance. The provenance of such non-clinical test data is not detailed beyond compliance with specified safety standards.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not applicable. As no clinical performance study was conducted, there were no experts used to establish ground truth for a clinical test set.

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

Not applicable. No clinical performance study was conducted.

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. The SANGRAY is an X-ray irradiation system, not an AI-powered diagnostic or assistive tool for human readers. No MRMC study was conducted.

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

Not applicable. SANGRAY is a medical device for irradiating blood, not an AI algorithm.

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

For the non-clinical performance tests mentioned (Section 6.7), the "ground truth" would be established by physical measurements and engineering standards, comparing the device's output (e.g., dose, dose rate, leakage) against pre-defined specifications and regulatory limits. For example, radiation leakage is compared against a specified maximum (e.g., less than 1 µSv/h). There's no clinical ground truth in the sense of disease diagnosis or outcomes.

8. The sample size for the training set

Not applicable. SANGRAY is not an AI algorithm that requires a training set.

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

Not applicable. SANGRAY is not an AI algorithm.

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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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Intended for the irradiation of blood or blood products packaged in transfusion bags 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 of Biologics Evaluation and Research, FDA to all registered blood establishments) when irradiation to reduce the risk of Graft Versus Host Disease is indicated.

The RS 3400 Rad Source X-ray Blood Irradiator consists of a shielded enclosure containing one x-ray tube capable of emitting radiation in a 360 degree output around its cylindrical design, a power supply and controller. A carousel capable of holding 5 cylindrical containers rotates those cylinders around the cylindrical x-ray tube radiation source causing the blood products contained therein to be irradiated.

Here's a breakdown of the acceptance criteria and the study information based on the provided document:

The document describes a 510(k) premarket notification for the RS 3400 Rad Source X-ray Blood Irradiator, seeking substantial equivalence to a predicate device, the RS 3000 Shielded Cabinet X-ray Radiation Source (K974210). Since this is a submission for an X-ray irradiation device, not an AI/ML medical device, many of the standard questions regarding AI/ML acceptance criteria, reader studies, and ground truth establishment for diagnostic performance are not applicable.

Acceptance Criteria and Reported Device Performance

The acceptance criteria for this device are based on demonstrating substantial equivalence to its predicate for safety and effectiveness in irradiating blood products. This is primarily evaluated through measurable technical characteristics and the ability to achieve the required radiation dose.

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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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To irradiate cellular blood products to inactivate T-lymphocytes in order to prevent graft versus host disease.

The basic operation of an irradiator involves placing of the blood product into the beaker, loading the beaker into the gammacell, closing the safety door and pressing the 'start' button. Upon start of the cycle, the unit moved the beaker to the irradiation position. Concurrently, the timer begins to count down (irradiation time is pre-programmed by the site supervisor) from the set time and when the time reaches zero, the sample returns to the unload position and the audible alarm sounds.

This 510(k) summary describes a modification to an existing medical device, the Gammacell 1000 Elite and Gammacell 3000 Elan blood irradiators. The submission focuses on demonstrating substantial equivalence to the previously marketed versions (Gammacell 1000E and 3000E, K963497) due to a specific design change.

Acceptance Criteria and Device Performance Study:

The primary acceptance criteria for this 510(k) submission are related to demonstrating that the modified devices maintain the same safety and effectiveness as their predicate devices, despite the internal design change. Since the change is specifically to replace an obsolete PCB and its associated firmware with a new board and operating system, the performance evaluation centers on ensuring that the core functionality, safety systems, and intended use remain unaffected.

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size and Data Provenance:

• Test Set Sample Size: The document does not specify a numerical "sample size" in the context of typical clinical trials. Instead, the testing appears to be functional and engineering-based on the modified device itself. The "functional specifications" against which the device was tested constitute the "test set" in this engineering context.
• Data Provenance: The study is described as having been performed "in an environment that simulated, as much as possible, the actual operating environment." This suggests in-house testing and validation by MDS Nordion, rather than a multi-center clinical study with patient data. The country of origin of the data would be Canada, where MDS Nordion is located. The nature of the study is prospective, as it involves testing the newly modified device.

3. Number of Experts and Qualifications for Ground Truth:

• The document does not mention the use of external experts or a ground truth established by medical professionals in the typical sense for analyzing diagnostic images or clinical outcomes. The "ground truth" here is the established, known performance and safety requirements of the predicate device and relevant international standards (IEC 60601-1). The validation team at MDS Nordion and the independent test house (mentioned implicitly by "Independent body concluded that the device is as safe and effective as the predicate device") would have served as the "experts" in verifying compliance against these predefined engineering and safety standards. Their qualifications would be in electrical engineering, regulatory affairs, and quality assurance.

4. Adjudication Method:

• No adjudication method (e.g., 2+1, 3+1) is mentioned or implied, as this was not a study involving human interpretation of data where consensus among multiple reviewers would be required. The "adjudication" was against predefined engineering specifications and international standards.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

• No MRMC comparative effectiveness study was done. This type of study is relevant for diagnostic devices where human readers interpret results, and the AI's impact on their performance is being evaluated. This submission is for an irradiator, a therapeutic device, and the changes are internal component replacements, not changes to the output that would require human interpretation.

6. Standalone (Algorithm Only) Performance Study:

• A standalone performance study was conducted in the sense that the modified device was tested by itself against its functional specifications and safety standards. The new embedded firmware and operating system represent the "algorithm" in this context, and its performance was directly evaluated. The text states: "The performance of the device was tested against a set of functional specifications in an environment that simulated... the actual operating environment." This describes a standalone, functional validation of the device's internal operations.

7. Type of Ground Truth Used:

• The ground truth used was a combination of:
  • Predicate Device Performance: The established safety and effectiveness profile of the legally marketed predicate devices (Gammacell 1000E and 3000E, K963497). The modified device must perform equivalently.
  • Functional Specifications: Engineering specifications detailing the required operation of the irradiator, including timing, counting, safety interlocks, and operator interface.
  • International Safety Standards: Compliance with electrical safety standards (IEC 60601-1 and IEC 60601-1-2).

8. Sample Size for the Training Set:

• The concept of a "training set" is not applicable here as this is not a machine learning or AI development project that requires data for model training. The "training" for this device's new software would have been part of its development and debugging process, not a distinct "training set" in the context of clinical or image data.

9. How the Ground Truth for the Training Set Was Established:

• As a "training set" in the AI/ML sense is not relevant, this question does not apply. The functional behavior of the device's control system (which includes the new firmware and QNX operating system) was effectively the "product" of its development. The "ground truth" for its correct operation was established by the engineering design requirements and functional specifications, which would have been based on the predicate device's proven functionality and regulatory standards.

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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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The RS 3000 Shielded Cabinet X-ray Radiation Source is intended for the irradiation of blood or blood products packaged in transfusion bags 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) when irradiation to reduce the risk of Graft Versus Host Disease is indicated.

The RS 3000 Shielded Cabinet X-ray Radiation Source consists of A shielded enclosure containing 2 vertically opposed x-ray tubes with provision for a sample holder (canister) between them, a power supply and a controller.

This document is a 510(k) premarket notification for the RS 3000 Shielded Cabinet X-ray Radiation Source, a blood irradiator. It focuses on demonstrating substantial equivalence to a predicate device (IBL 437C Blood Irradiator), rather than presenting a study with acceptance criteria and device performance in the typical sense of a diagnostic or therapeutic device that would involve a clinical study with human subjects.

Therefore, many of the requested categories for a clinical study are not applicable to this type of submission. However, I can extract information related to the device's technical specifications and how they compare to the predicate, which serves as the "performance" data in this context for demonstrating substantial equivalence.

Here's the breakdown of the information provided in the input, tailored to what's available for this specific type of device submission:

1. Table of "Acceptance Criteria" (Predicate Device Specifications) and Reported Device Performance (RS 3000)

In the context of a 510(k) for a blood irradiator, "acceptance criteria" are effectively the specifications and performance characteristics of the predicate device, which the new device (RS 3000) aims to meet or be substantially equivalent to.

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The intended use of the modified Gammacell with version 1.0 control system remains unchanged. Both the improved and the predicate device effectively irradiate blood components to inactivate leukocytes and lymphocytes.

The modified Gammacell E- series Blood Irradiator models, the 1000 Elite and the 3000 Elan use the new software version 1.0 control system. With the exception of the modified control system, the 1000 Elite and 3000 Elan are identical to previously cleared models.

The basic operation of an irradiator involves placing of the blood product into the beaker, loading the beaker into the Gammacell, closing the safety door and pressing the "start" button. Upon start of the cycle, the unit moves the beaker to irradiate position and rotates the blood product continuously at a uniform speed to provide a consistent dose of irradiation. Concurrently, the timer begins to count down (irradiation time is pre-programmed by the site supervisor) from the set time and when the time reaches zero, the sample returns to unload position and the audible alarm sounds. If the cycle is completed as pre-programmed the message "cycle completed OK." is displayed. Any problems in the irradiation cycle will be displayed specifically and clearly.

This document describes a 510(k) summary for a modified Gammacell E-series Blood Irradiator, specifically the 1000 Elite and 3000 Elan models with a new software version 1.0 control system. The primary goal of the submission is to demonstrate substantial equivalence to previously cleared versions (Version 2.09).

Here's an analysis of the provided information regarding acceptance criteria and the study:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not present a formal table of acceptance criteria with specific quantitative thresholds. Instead, it describes general functional requirements and claims of equivalence to the predicate device.

2. Sample Size Used for the Test Set and Data Provenance

The document does not specify a numerical sample size for the test set. It mentions "Validation testing results" but does not detail the number of units or test cases involved.

• Data Provenance: The testing appears to be internal validation by the manufacturer, Nordion International Inc., based in Canada. The document states, "The performance of the device was tested against a set of functional specifications in an environment which simulated, as much as possible, the actual operating environment." This suggests controlled, internal testing rather than external clinical data. It is retrospective in the sense that it's based on internal validation performed by the developer.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications

This information is not provided in the document. The validation testing seems to be based on engineering and functional testing against predetermined specifications, rather than a clinical assessment requiring expert consensus on ground truth. The "predetermined specifications" may have been established by internal experts, but their number and qualifications are not disclosed.

4. Adjudication Method for the Test Set

This information is not provided and is likely not applicable given the nature of the validation described. The validation appears to be against functional requirements and engineering specifications rather than a subjective assessment requiring adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size

No, an MRMC comparative effectiveness study was not done. The document focuses on demonstrating substantial equivalence through functional and safety testing, not a comparative clinical study involving human readers or clinicians.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study Was Done

The device described is a blood irradiator, not a diagnostic algorithm. Therefore, the concept of an "algorithm only, standalone performance" study as typically applied to AI/ML diagnostic devices is not applicable. The "algorithm" here is the software control system of a physical medical device. The validation described is of this control system's functional performance.

7. The Type of Ground Truth Used

The "ground truth" for this device's validation is the functional specifications and engineering requirements for the blood irradiator's control system. This includes aspects like security functions, safety functions, operational features, timing, counting, and interface behavior, as well as compliance with electrical safety and EMC standards. It is not based on clinical outcomes, pathology, or expert consensus on diagnostic interpretations.

8. The Sample Size for the Training Set

The concept of a "training set" as understood in machine learning is not explicitly applicable here. The software control system was likely developed and verified using standard software engineering practices. No "training set" of data for an AI/ML model is mentioned or implied.

9. How the Ground Truth for the Training Set Was Established

As the concept of a training set for an AI/ML model is not applicable here, the method for establishing its ground truth is not relevant or described. The "ground truth" for engineering and functional validation is the set of design specifications and regulatory standards.

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