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The Avanza patient positioning table is used as a universal patient support to accurately and reproducibly position patients for radiation therapy and simulation. The Avanza is used with THERATRON® Equinox™ units and is also adaptable to third party radiation therapy treatment devices.

The Avanza Patient Positioning Table is a powered radiation therapy patient support assembly that is substantially equivalent in functionality and performance as the previously cleared Precise Treatment Table.

The Avanza Patient Positioning Table is supported by a mechanism and features several functions including isocentric rotation, column rotation, longitudinal, lateral, and vertical motions. The computer-controlled table can be activated by using the table mounted control panels or by using an optional hand control.

This K060870 510(k) submission describes the Avanza Patient Positioning Table, a device used to position patients for radiation therapy. The submission focuses on demonstrating substantial equivalence to a predicate device, the Precise Treatment Table (K983678). There is no information provided about acceptance criteria or a study demonstrating the device meets those criteria in the provided text.

Therefore, I cannot fulfill the request as the essential information for acceptance criteria and study details is missing from the provided document. The document primarily identifies the device, its intended use, and its substantial equivalence to a predicate device, which is a regulatory filing, not an performance evaluation study.

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A Cobalt Teletherapy unit is a device by which gamma radiation is delivered for the treatment of cancer under the direction of health care professionals in a radiation therapy clinic.

The Theratron Equinox consists of a source head, collimator, gantry, main frame, base, controls and a pendulum or beam-stopper style counterweight. The design of this device is similar to predicate device Theratron Elite 80 and 100.

The provided document describes the MDS Nordion Theratron Equinox 80 and 100, which are Cobalt Teletherapy Devices. The submission is a 510(k) for substantial equivalence to a predicate device, the Theratron Elite 80 and 100. The device is a "Radionuclide Radiation Therapy System" intended for delivering gamma radiation for cancer treatment.

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

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state specific quantitative acceptance criteria in terms of numerical performance thresholds for the device. Instead, the acceptance criteria are implicitly defined by compliance with a set of international safety and performance standards for medical electrical equipment and radiotherapy devices, and by demonstrating equivalence to the predicate device.

The reported device performance primarily focuses on the design changes and equivalence to the predicate device, rather than new quantitative performance metrics for the Theratron Equinox itself.

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

The document does not provide details on a "test set" in the context of patient data or clinical images for algorithm performance. This is a 510(k) submission for a physical radiotherapy device, not an AI/software as a medical device (SaMD) that typically involves diagnostic or prognostic algorithms.

The "testing" mentioned refers to engineering verification and validation of the device's functional specifications and safety compliance. The data provenance would be internal engineering test data generated during the device's development and testing phases, presumably in Canada (MDS Nordion is based in Ottawa, Ontario) and is prospective testing against design requirements.

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

This information is not applicable in the context of this 510(k) submission. The ground truth for this type of device (a radiation therapy machine) is established through engineering design specifications, adherence to international standards, and physical measurements of performance (e.g., radiation output accuracy, gantry movement precision, safety mechanism functionality) conducted by engineers and physicists, not by medical experts interpreting clinical data.

4. Adjudication Method for the Test Set

The concept of an "adjudication method" (like 2+1 or 3+1) is not applicable here. This method is typically used in clinical studies where multiple human readers independently assess data, and a consensus or tie-breaking mechanism is needed for ground truth establishment. For a physical device like a teletherapy unit, performance is objectively measured against pre-defined engineering and safety criteria.

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

An MRMC comparative effectiveness study is not applicable to this device. This type of study assesses the impact of AI on human diagnostic or interpretative performance. The Theratron Equinox is a treatment delivery device, not a diagnostic tool or an AI assistant for human readers.

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

A standalone algorithm performance study is not applicable to this device. While the device contains a control system and GUI, it is not an "algorithm-only" device intended for diagnostic or predictive functions. It is a machine that performs a physical action (delivering radiation) under human operation.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)

The "ground truth" for this device's performance would be established through:

• Engineering Specifications: The design parameters the device is intended to meet (e.g., dose accuracy, mechanical precision, safety interlock response times).
• International Standards: Compliance with the enumerated EN 60601 and EN 61217 standards serves as a benchmark for safety and performance.
• Physical Measurements: Direct measurements taken during manufacturing and testing to verify that the device meets its specifications (e.g., using dosimeters to measure radiation output, calipers/sensors to measure gantry/collimator movement accuracy).
• Predicate Device Performance: The predicate device, Theratron Elite, serves as a de facto "ground truth" for acceptable performance for this class of device, given the 510(k) pathway for substantial equivalence.

8. The Sample Size for the Training Set

The concept of a "training set" in the context of machine learning is not applicable to this device. The device's control system and operational logic are developed through traditional software engineering and hardware design, not by training an AI model on a dataset.

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

As stated above, the concept of a "training set" is not applicable here. The "ground truth" for the device's functional design and safety is established through engineering principles, regulatory standards, and validated manufacturing processes.

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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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DCM is a three-dimensional radiotherapy dose engine for radiation dose planning of patients undergoing external beam treatment in the oncology clinic.

Based on quality assured radiation therapy input data Dose Calculation Module is used to plan radiation treatment with:

• Linear accelerators with X-ray energies from 4 to 50MV and electron energies from 6 . to 25 MeV
• Cobalt-60 units .

DCM will calculate dose for 3D radiotherapy treatment approaches of combined modality plans, asymmetric and non-coplanar fields; total body irradiation; multi-leaf collimators;

motorized and dynamic wedges; customized blocking and bolus.

DCM 2.0 is intended for calculations of dose plans, the calculations are based on DICOM objects and other information conveyed by a control communication protocol from the THERAPLAN treatment planning system.

DCM is a three-dimensional radiotherapy dose engine for radiation dose planning of patients undergoing external beam treatment in the oncology clinic.

Based on quality assured radiation therapy input data Dose Calculation Module (DCM) is used to plan radiation treatment with:

• Linear accelerators with X-ray energies from 4 to 50MV and electron energies from 6 . to 25 MeV
• . Cobalt-60 units

DCM will calculate dose for 3D radiotherapy treatment approaches of combined modality plans, asymmetric and non-coplanar fields; total body irradiation; multi-leaf collimators; motorized and dynamic wedges; customized blocking and bolus.

Here's an analysis of the provided text to extract information about the acceptance criteria and the study conducted for the DCM 2.0 device:

Important Note: The provided text is a 510(k) summary and FDA clearance letter. It describes the device, its intended use, and its substantial equivalence to predicate devices, but does not contain detailed information about specific acceptance criteria or a comprehensive study report as would be found in a clinical trial or validation study. The FDA clearance process for this type of device typically relies on demonstrating substantial equivalence to a legally marketed predicate, often through performance testing that is not fully detailed in this summary. Therefore, many of the requested fields below will indicate "Not explicitly stated in the provided text."

Acceptance Criteria and Device Performance

Study Details

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

   • Sample Size: Not explicitly stated in the provided text. The submission focuses on substantial equivalence based on technological characteristics and intended use.
   • Data Provenance: Not explicitly stated.
   • Retrospective or Prospective: Not explicitly stated.

2. 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 explicitly stated in the provided text. The ground truth for dose calculation systems is typically against established physics models, experimental measurements, or other gold-standard dose calculation software, rather than expert human interpretation in the same way an image analysis AI would be evaluated.

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

   • Not applicable/explicitly stated. This type of adjudication is typically for subjective assessments (e.g., image interpretation), not direct dose calculation comparisons.

4. 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. DCM 2.0 is a dose calculation system, not an AI-assisted diagnostic tool that humans interact with for interpretation.

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

   • Yes, implicitly. As a dose calculation engine, DCM 2.0's primary function is to perform calculations independently based on input parameters. The validation for such a device would focus on the accuracy of these calculations compared to established standards (e.g., experimental measurements, other validated physics models). The text states it uses the Voxel Monte Carlo (VCM++) algorithm for electron calculations, indicating an algorithmic, standalone function.

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

   • Not explicitly stated, but for a dose calculation engine, the ground truth would typically be established through:
     • Physics-based models: Comparison to highly accurate physics simulations (e.g., full Monte Carlo simulations).
     • Experimental measurements: Physical measurements using phantoms and dosimeters (e.g., ion chamber, film, TLDs) in controlled environments.
     • Comparison to predicate device: Implicit in the 510(k) process, the device's calculations are compared to those of the legally marketed predicate device (DCM 1.0 and Helax-TMS v 5.1).

7. The sample size for the training set:

   • Not applicable/explicitly stated. Dose calculation algorithms like Voxel Monte Carlo are typically based on deterministic physics principles or experimentally derived beam models, rather than machine learning models that require "training sets" in the conventional sense. While beam models might be "tuned" or "configured" using experimental data, this is different from a machine learning training set.

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

   • Not applicable, as a training set in the machine learning sense is not described or implied for this type of device. The "ground truth" for developing the underlying Voxel Monte Carlo algorithm and electron beam model would be physical measurements and established physics principles.

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Helax-TMS is a 3D radiotherapy treatment planning system for radiation dose planning, but not treatment, of patients undergoing external beam or brachytherapy treatment in the oncology clinic. The system is designed to lead the user through a logical flow planning process.

Based on quality assured radiation therapy input data Helax-TMS is used to plan radiation treatments with:

• Linear accelerators with X-ray energies from 4 to 50MV and electron energies from 4 to 50 MeV, proton energies from 1 to 275 MeV as well as cobalt-60 units. Helax-TMS will plan 3D radiotherapy treatment approaches of combined modality plans, asymmetric and non-coplanar fields; total body irradiation; multi-leaf collimators; motorised and dynamic wedges; customised blocking; compensating filters; and bolus.
• Brachytherapy units for patients undergoing interstitial or intracavitary treatment in the oncology clinic.

Export capabilities exists as part of Helax-TMS to verify beam and patient data, dose planning results, and provide on-line information to block-cutting devices and milling machines, multi-leaf collimator control units, as well as record and verify systems.

Helax TMS is a 3D Radiotherapy Treatment Planning (RTP) system for radiation dose planning of patients undergoing external beam and brachytherapy treatment in the Oncology clinic. Helax-TMS is a 3-D system, using modern algorithms for dose calculations. The user has the option of selecting either a convolution/superposition pencil beam or a Collapsed Cone algorithm for photons, a Gaussian pencil beam model for electrons, and a proton dose calculation. A brachytherapy module is integrated into Helax-TMS for treatment modeling of interstitial and intracavity brachytherapy techniques. The system software is designed to lead the user through a logical flow planning process.

This document does not contain the information required to populate the table and fully answer the questions. The provided text is a 510(k) summary for a medical device (Helax-TMS Proton Functionality), which focuses on the device's description, intended use, and substantial equivalence to predicate devices, rather than detailed performance studies and acceptance criteria.

Specifically, the document lacks details on:
* Specific acceptance criteria for device performance (e.g., accuracy thresholds for dose calculations).
* Any quantitative performance results from a study.
* Sample sizes for test or training sets.
* Data provenance, expert qualifications, or adjudication methods for ground truth establishment.
* Comparisons with human readers or standalone performance studies.
* The type of ground truth used.

Therefore, I cannot complete the table or answer most of the questions based on the provided text.

Below is a table showing the information that is not available in the provided text.

Acceptance Criteria and Study Details (Information Not Available in Document)

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