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The AIO Solution 3.0 is a positioning and immobilization system to set-up and reproduce the supine and prone position of belly & pelvic patients and the prone position of breast patients during radiation therapy.

The AIO Solution 3.0 with accessories provides the immobilization and positioning system necessary to set-up and reproduce the position of a patient for supine and prone belly & pelvic treatments or prone breast treatments in radiation therapy.

For belly & pelvic treatments, the AIO solution 3.0 base plates (already cleared: K191158) can be used in combination with the green AIO 3.0 belly & pelvic positioning cushions and accessories. Depending on the anatomy of the patient, 2 different sizes of belly inserts are available to make sure the intestines can be pulled out of the treatment area when in prone position. The arms of the patient are positioned above the head to bring them out of the treatment field. A full belly insert should be used in supine position while the arms of the patient can be positioned on the chest to bring them out of the treatment field. The legs of the patient are supported by the grey AIO 3.0 knee & leg positioning cushions and/or the AIO 3.0 indexable feet support (already cleared; K191158). For increased precision, the set-up can be combined with an Orfit thermoplastic EFFICAST mask.

For prone breast treatments, the AIO solution 3.0 base plates (already cleared; K191158) can be used in combination with the yellow AIO 3.0 prone breast positioning cushions and accessories. The arms of the patient are positioned above the head to bring them out of the treatment field. The legs of the patient are supported by the grey AIO 3.0 knee & leg positioning cushions (already cleared; K191158). For increased precision, the set-up can be combined with an Orfit thermoplastic EFFICAST mask.

The provided text describes a medical device, "The AIO Solution 3.0," and its substantial equivalence determination by the FDA. However, the document does not contain any information regarding acceptance criteria or the study details typically associated with AI/ML-driven medical devices, such as performance metrics (e.g., sensitivity, specificity), ground truth establishment, expert adjudication, or training/test set sample sizes.

The "PERFORMANCE DATA" section of the document primarily focuses on:

• Sterilization and Shelf Life: Stating devices are non-sterile and made of durable polymers with low degradation.
• Biocompatibility: Emphasizing that materials are identical to the predicate device, thus no new testing is needed.
• Electrical Safety, EMC, Software, Cybersecurity: Stating the device contains no active components, software, or ports, rendering these categories irrelevant.
• MRI Safety: Confirming material compatibility with MR environments.
• "Performance Testing": This solely refers to dosimetry testing (measurement of radiation attenuation and water equivalent thickness), not clinical performance or diagnostic accuracy. It states, "The test data meets the A/R criteria predetermined for the device," but does not define what those A/R criteria are or what the actual reported performance values were.

Therefore, based only on the provided input, I cannot answer the questions related to AI/ML device performance, acceptance criteria, study design for diagnostic accuracy, or ground truth establishment. The device in question appears to be a physical positioning and immobilization system for radiation therapy, not an AI/ML diagnostic or predictive tool.

If this was a misunderstanding and the request was for a hypothetical AI/ML device, I would need more specific attributes to invent a plausible scenario. However, as per the input, the device's assessment focuses on material properties and physical radiation attenuation, not AI/ML performance.

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The Aerial Couchtop for proton therapy is intended to support, position and immobilize patients during proton radiotherapy treatments.

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I am sorry, but the provided document describes a 510(k) clearance letter for a medical device called "Orfit Aerial Couchtop," which is a couchtop for proton therapy. It does not contain any information regarding acceptance criteria, device performance, clinical study details, or AI/algorithm performance. Therefore, I cannot generate the requested response.

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The AIO Breast and Lung Board Solution is a positioning and immobilization system to set-up and reproduce the supine position of a breast or lung patient during radiation.

The AIO Head and Neck Solution is indicated to aid in supporting the knees or ankles of patients undergoing radiation therapy in the supine or prone position. The device is also used during image acquisition to support treatment planning.

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The provided text is a 510(k) premarket notification letter for a medical device (The AIO Solution) and its Indications for Use. It does not contain information about acceptance criteria, device performance studies, sample sizes, ground truth establishment, expert qualifications, or MRMC studies.

Therefore, I cannot provide the requested information based on the input text. The letter primarily states that the device has been reviewed and determined to be substantially equivalent to legally marketed predicate devices.

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The HP PRO Positioning Device is indicated to assist in the proper positioning of patients for radiation therapy and radiosurgery and treatment with protons.

The HP PRO Positioning Device is used by first attaching the base plate to the couch top utilizing the appropriate indexing. Then the health care provider positions the immobilization devices on to the HP PRO Positioning Device. Next the patient is helped onto the couch and positioned onto HP PRO Positioning Device in the appropriate immobilization device. An example of an immobilization device is the overlay base plate of the Proton Immobilization Solution.

The HP PRO Positioning Device is a device that assists in the proper positioning and repositioning of patients for radiation therapy and radiosurgery with protons. It is an accessory to the Proton Immobilization Solution. The HP PRO Positioning Device is typically attached to the treatment table and supports the patient during treatment. The proposed HP PRO Positioning Device is essentially an extension of the treatment table.

The HP PRO Positioning Device is made up of 4 components: Base Plate (PMMA and Carbon Fiber), Interface (Aluminum), Indexing Pins (POM (Polyoxymethylene)), and Sheet Screws (Stainless Steel).

The provided document describes the HP PRO Positioning Device and its substantial equivalence to a predicate device, K151207 Proton Immobilization Solution. The study focuses on demonstrating that the new device performs comparably to the predicate device across various physical and dosimetric properties.

Here's an analysis of the acceptance criteria and study details based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Note on "SE" (Substantially Equivalent): The document frequently uses "SE" to indicate that the performance of the proposed device is considered substantially equivalent to the predicate device, even if the numerical values are different (e.g., sag, creep, WET). The justification for "SE" for these differences is provided in the "SE Discussion" column or within the "SE Summary Statement."

Study Information & Acceptance Criteria Details:

The study described is not a clinical effectiveness study, but rather a set of engineering and physical performance tests designed to demonstrate substantial equivalence to a predicate device for regulatory clearance (510(k)). Therefore, many of the typical clinical study parameters (like test sets, ground truth from experts, MRMC, or standalone performance for an AI algorithm) are not applicable here.

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

• See the table above. The acceptance criteria for many parameters are implicitly defined by the performance of the predicate device, or by general engineering/safety standards (e.g., IEC60601-1). The document states that the HP PRO Positioning Device is "SE" based on these comparisons and justifications.

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

• This is not a clinical study involving patient data. The "test set" consists of physical tests and measurements performed on the device itself. The document does not specify a "sample size" in the traditional sense for these engineering tests. Each test (e.g., sag, creep, mechanical strength, dosimetric properties) would have been performed on one or more units of the HP PRO Positioning Device and compared against the predicate's known performance or against established engineering limits.
• Data provenance is not explicitly stated in terms of country, but the applicant (Orfit Industries NV) is based in Belgium, implying the tests may have been conducted internally or by a contracted lab. The data is prospective in the sense that these tests were conducted on the new device for the purpose of this submission.

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 this is not a clinical study involving expert interpretation of data or images. The "ground truth" for the physical and dosimetric properties would be established through calibrated measuring equipment and standard testing methodologies.

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

• Not applicable. There is no human adjudication process involved in these physical and dosimetric measurements. The evaluation is based on direct comparison to predicate device performance or engineering standards.

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 device is a patient positioning accessory, not an AI-powered diagnostic or treatment planning system that would involve human readers or AI assistance.

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

• Not applicable as this is a physical medical device, not an algorithm.

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

• The "ground truth" in this context refers to the measured physical properties and dosimetric characteristics of the device, obtained through standardized engineering and radiation physics tests. The predicate device's established performance served as a primary reference for substantial equivalence.

8. The sample size for the training set:

• Not applicable. This device does not involve a "training set" as it is not an AI or machine learning model.

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

• Not applicable.

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The Raycast MammoRx Carbon Fibre Breast Board is a positioning and immobilization system to set-up and reproduce the supine position of a breast patient during radiation therapy.

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This document is a 510(k) premarket notification decision letter from the FDA for the "Raycast MammoRx Carbon Fibre Breast Board." It informs the manufacturer that their device has been found substantially equivalent to a predicate device.

This document does not contain information about the acceptance criteria and study results for the device's performance.

The provided text focuses on the regulatory approval process (510(k)), classification of the device, applicable regulations, and administrative details. It includes the device name, its intended use (positioning and immobilization for breast radiation therapy), and the 510(k) number (K162355).

Therefore, I cannot provide the requested information from this document. To answer your query, a different document, such as the actual 510(k) submission or a performance study report, would be necessary.

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The Raycast High Precision Lung Board Solution is a patient positioning device intended to be used for the positioning and re-positioning of patients undergoing or receiving a course of external beam radiation therapy for the treatment of cancer and other diseases. It is intended to be used by or under the direction of a licensed physician.

The Raycast High Precision Lung Board is used to position the patient supine on the treatment couch with the arms lifted above the head. This will keep the arms outside of the treatment field, which is the thorax in this case. The Raycast High Precision Lung Board is attached to the treatment couch with a 2-vin indexing bar in order to reproduce the same position each day. The Raycast High Precision Lung Board should be fully supported by the treatment couch. Then the patient is asked to lie down on the couch with his head in a head support that is attached to the Raycast High Precision Lung Board. Once the patient is lying down, he can lift up his arms until the elbows rest against the 'wings' of the board and the hands can reach the T-shaped handgrip.

The position of the T-shaped handgrip can be adjusted both in height and length according to the patient's anatomy. To adjust the height of the handgrip, pull the white knob on the side and move the grip pole up or down. To adjust the length of the handgrip, pull the white knob at the cranial side and slide the handgrip more caudally or cranially. Various head supports can be placed on the Raycast High Precision Lung Board depending on the physician's preference. The standard set-up will be with an Orfit Head Support, but it is also possible to use a Silverman or Timo Head Support which they might already have available in their department.

Once the patient is set-up correctly, the arms should not be treatment field anymore, which is the thorax area in this case. This allows the physician to irradiate the thorax from various angles, including laterally without passing through the arms of the patient. The Raycast High Precision Lung Board itself will not be in the treatment field and as such will not be irradiated through.

The provided text is a 510(k) summary for a medical device called the "Raycast High Precision Lung Board Solution". This document focuses on demonstrating substantial equivalence to a predicate device, rather than proving the device meets specific acceptance criteria through a clinical study. Therefore, most of the requested information regarding acceptance criteria, sample sizes, expert involvement, and ground truth establishment cannot be directly extracted from this document.

The document primarily relies on a comparative analysis with a previously cleared predicate device (K040773 Extended Butterfly Board, Bionix Development Corp.) to establish substantial equivalence.

Here's an analysis based on the information provided:

1. Table of Acceptance Criteria and Reported Device Performance:

The document doesn't define explicit acceptance criteria in the typical sense of a clinical study (e.g., target sensitivity/specificity). Instead, it demonstrates equivalence to a predicate device across various attributes. The "acceptance criteria" are implied by the features and performance of the predicate device.

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

• Sample Size: Not applicable. This is not a clinical study involving a "test set" of patients or data in the typical sense. The primary "test" is a comparative analysis of the device's characteristics against a predicate device.
• Data Provenance: Not applicable. The data is primarily derived from the technical specifications and performance testing of the proposed device and comparison to the predicate device's known characteristics. No mention of country of origin or retrospective/prospective data collection in a clinical context.

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

• Not applicable. There is no "ground truth" establishment in a clinical setting as this is a device comparison for substantial equivalence. The "truth" is established by the specifications and performance of the proposed device and the predicate.

4. Adjudication Method for the Test Set:

• Not applicable. No clinical test set requiring adjudication in this context.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done:

• No. This type of study is not mentioned or implied because the device is a patient positioning board, not an imaging or diagnostic AI device that would involve human readers.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:

• Not applicable. This device is not an algorithm or AI. It's a physical medical device. Performance testing for a physical device typically involves bench testing, which was done for dosimetry (attenuation, water thickness) and MR safety.

7. The Type of Ground Truth Used:

• The "ground truth" in this context is the technical specifications, material properties, and physical performance data of both the proposed device and the predicate device. For example, material composition (Acrylic, POM, Nylon), dimensions, weight, and results of physical bench tests such as dosimetry and MR safety. The "truth" is effectively the established characteristics of the predicate device against which the new device is compared.

8. The Sample Size for the Training Set:

• Not applicable. This is a physical device, not an AI or machine learning model that requires a training set.

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

• Not applicable. No training set for this type of device.

Additional Study Information from the Text:

• Bench Testing: "Bench testing was performed and includes a dosimetry test report for the device including device attenuation and water thickness, which have been validated to demonstrate SE to the predicate in safety and effectiveness."
• MR Safety Studies: "Additional studies performed are the MR safety studies performed in order to demonstrate that the device tested as MR safe."

In summary, the provided document is a 510(k) submission focused on demonstrating substantial equivalence for a physical patient positioning device. It directly compares the proposed device to a legally marketed predicate based on technical specifications and bench testing, rather than reporting on a clinical study with acceptance criteria and a test set against a clinical ground truth.

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The Proton IMMOBILIZATION Solution is indicated to assist in the proper positioning and repositioning of patients for radiation therapy and radiosurgery and treatment including electron, photon, and proton treatments.

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This document is a 510(k) premarket notification decision letter from the FDA for the "Proton Immobilization Solution" device. It does not contain any information regarding acceptance criteria, device performance, study details, or ground truth establishment.

The letter confirms that the device is substantially equivalent to legally marketed predicate devices and can be marketed subject to general controls. The "Indications for Use" section (page 2) describes the intended purpose of the device but does not include any performance metrics or study results.

Therefore, I cannot provide the requested information based on the provided text.

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The SAGITTL is indicated to assist in the proper positioning and re-positioning of patients for radiation therapy and radiosurgery simulation and treatment including electron, photon and proton treatments.

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I am sorry, but the provided text does not contain the detailed information necessary to describe the acceptance criteria and the study proving the device meets those criteria, as requested. The document is an FDA 510(k) clearance letter for a medical device called SAGITTILTTM, indicating that it has been found substantially equivalent to a predicate device.

Specifically, the document does not include:

• A table of acceptance criteria and reported device performance.
• Details about sample sizes, data provenance, number of experts, their qualifications, or adjudication methods for any test set.
• Information on a multi-reader multi-case (MRMC) comparative effectiveness study or its effect size.
• Details about a standalone algorithm performance study.
• The type of ground truth used.
• Sample size for training data or how its ground truth was established.

The document primarily focuses on the regulatory clearance for the device, its intended use (positioning and re-positioning patients for radiation therapy), and general FDA compliance information. It does not delve into the specifics of performance studies or acceptance criteria beyond indicating that it was deemed "substantially equivalent" to a legally marketed predicate device.

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The NANOR and NANOR/EFFICAST Hybrid Thermoplastic materials are used to retain and reproduce a patient's position during radiation therapy.

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I am sorry, but the provided text is a 510(k) premarket notification document from the FDA regarding "NANOR and EFFICAST/NANOR Hybrid Thermoplastic Materials". This document is an approval letter and an "Indications for Use" statement.

It describes the device as thermoplastic materials used to retain and reproduce a patient's position during radiation therapy. It establishes the device's regulatory classification and that it is substantially equivalent to legally marketed predicate devices.

However, the document does not contain any information about acceptance criteria, device performance studies, sample sizes, expert involvement, ground truth, or adjudication methods. Therefore, I cannot extract the requested information as it is not present in the provided text.

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