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The Marie Imaging System is indicated for the acquisition of CT images and the precise positioning of human patients to facilitate delivery of external beam radiation when integrated with a separate therapy treatment delivery device.

The Marie System is intended to acquire CT images and enable the precise positioning of human patients to facilitate delivery of external beam radiation when integrated with a separate therapy treatment delivery device.

The Marie System is intended to be used by healthcare professionals to image patients in an upright position rather than conventional supine treatments, to enable precise treatment planning and patient positioning for radiotherapy.

Specifically, it is intended to:

• Image the patient to provide image-guided radiation therapy
• Image the patient to acquire images for the purpose of treatment planning
• Immobilize patients in an upright position for upright radiotherapy.

The Marie System is comprised of two major sub-systems: a computed tomography (CT) imaging system that performs pretreatment imaging and treatment simulation in the upright positions and a beam agnostic, patient positioning system that supports the patient in the upright positions.

The Marie Imaging System is used with compatible devices for treatment delivery and patient immobilization. The positioning system is designed with six degrees of freedom of motion and a patient positioning system to provide the desired posture for each cancer site to achieve accurate, reproducible patient setups, while the imaging system acquires helical scans by translating and rotating up the patient.

The provided text solely describes the Leo Cancer Care Marie System as a Computed Tomography X-ray System with its features, safety, and performance details. It outlines the regulatory clearance (FDA 510(k)) based on substantial equivalence to a predicate device (P-ARTIS K160611). It describes the device's characteristics and the non-clinical tests performed to demonstrate its performance and functionality against design and risk management requirements.

Crucially, the provided text does not contain any information about acceptance criteria for AI performance, clinical study design, sample sizes for test or training sets, ground truth establishment using experts, or any MRMC comparative effectiveness studies. The document is a 510(k) clearance summary for a medical device (a CT imaging and patient positioning system), not for an AI diagnostic or assistive software. The "performance testing" section refers to hardware and software system performance, not AI model performance.

Therefore, I cannot answer most of your questions based on the provided input. The questions you've asked are typically relevant for AI/ML-based medical devices or diagnostics that involve image interpretation and require rigorous validation against human expert performance. The Marie System, as described, is a physical imaging system for patient positioning and CT image acquisition, not an AI software.

If this were an AI device, the answers would need to be extracted from sections detailing clinical performance studies, AI model validation, or similar. Since those sections are absent, I am unable to provide the requested information.

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The Marietta Contact Lens (polymacon), Tinted Contact Lens for daily wear is indicated for the correction of visual acuity in aphakic and not aphakic persons with non-diseased eyes with myopia or hyperopia, and to enhance and/or alter the apparent eye color. The lens may be worn by persons who exhibit refractive astigmatism of 0.75 diopters or less where the astigmatism does not interfere with visua acuity.

The lens may be cleaned and disinfected using a chemical (not heat) lens care system.

Eyecare practitioners may prescribe the lenses for frequent/planned replacement wear, with cleaning, disinfection and scheduled replacement. When prescribed for frequent/planned replacement wear, the ler may be cleaned and disinfected using a chemical (not heat) lens care system.

The Marietta Contact Lens (polymacon), Tinted Daily Wear Contact Lens is available as a single vision spherical lens. The hydrophilic nature of this material allows the lens to become soft and pliable when immersed in an aqueous solution.

The nonionic lens material, (polymacon) is a hydrophilic polymer of 2- Hydroxyethyl methacrylate (2-HEMA) and cross-linked with ethylene glycol dimethacrylate (EGDMA), plus an initiator. The copolymer consists of 62% polymacon and 38% water by weight when immersed in normal buffered saline solution.

Lenses that contain a unique tinting pattern are subsequently processed to incorporate the 'listed' color additives, and contain only the amount of color additive needed to accomplish the intended coloring effect.

As part of the manufacturing process, the lenses containing the color additives are thoroughly washed to remove unbound color additives. The manufacturing process alters and/or changes the specifications to the clear version of a contact lens by affixing a listed color reactive additive on that portion of the anterior (front) surface of the lens that corresponds to the iris. The color additive effect is formed by reacting one or more of the color additives listed in this paragraph with (poly hydroxyethyl methacrylate). The reactive color additives that may be used either alone or in combination are: reactive black 5, reactive blue 19, reactive blue 4, reactive blue 163, reactive red 11, reactive red 180, reactive yellow 15, reactive yellow 86, or reactive orange 78. The color additives used are not removed by lens handling and cleaning/disinfecting procedures. Except for affecting the amount of light transmittance through the lens, the coloring process does not alter the original characteristics of the pre-tinted lens.

The hydrophilic characteristics allow aqueous solutions to enter the lens and in its fully hydrated state the lens is approximately 38% water by weight.

This document is a 510(k) summary for a contact lens (Marietta Contact Lens (polymacon), Tinted Daily Wear Contact Lens). The 510(k) pathway is for demonstrating substantial equivalence to a legally marketed predicate device, rather than proving a new device meets acceptance criteria through a clinical study with specific performance metrics like those for AI/ML devices. Therefore, the provided text does not contain explicit acceptance criteria and a study demonstrating performance against those criteria in the way you might expect for an AI/ML device.

However, I can extract the relevant information from the document to infer the acceptance criteria and how the device demonstrated "performance" for its regulatory pathway.

Here's an attempt to answer your request based on the provided document, adapting the terminology to fit the context of a 510(k) for a contact lens:

Description of Acceptance Criteria and Study for the Marietta Contact Lens (polymacon), Tinted Daily Wear Contact Lens

This submission is a 510(k) for a modified contact lens, demonstrating substantial equivalence to pre-existing predicate devices. As such, the "acceptance criteria" are primarily established by the characteristics and safety profile of the predicate devices, and the "study" is a comparison and verification that the modified device maintains these characteristics.

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are essentially the characteristics of the predicate devices. The "reported device performance" is a demonstration that the modified device meets or is comparable to these characteristics.

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

Since this is a 510(k) for a contact lens, the "test set" does not refer to a dataset for an algorithm. Instead, it refers to the physical lenses and potentially human subjects used in biocompatibility, physical property, and clinical performance testing (though detailed clinical study results are not provided in this summary). The document does not specify a sample size for any in vivo testing. The data provenance would be from Marietta Vision's internal testing and comparison to their own predicate devices. It is implicit that any human subject testing would be prospective, though details are not provided.

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

This concept is not applicable here. "Ground truth" in the context of AI/ML evaluation (e.g., expert consensus on medical images) is not relevant for this medical device submission. The "truth" for physical and chemical properties of a contact lens is established through validated laboratory testing methods. Clinical performance and safety are typically assessed by optometrists/ophthalmologists, but no specific "ground truth" expert panel is mentioned as would be for an AI diagnostic device.

4. Adjudication Method for the Test Set

This concept is not applicable. There's no interpretive test set requiring adjudication in the way an AI diagnostic device would.

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

This is not applicable. The device is a contact lens, not an AI-powered diagnostic tool. There are no "human readers" or "AI assistance" involved in its direct function.

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

This is not applicable as the device is a physical contact lens, not an algorithm.

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

The "ground truth" for this device's characteristics is based on established physical, chemical, and biological testing methods for contact lenses, and comparison to the known properties and safety profiles of previously cleared predicate devices (their own Addvantage 38 (Polymacon), K942302 and Marietta Contact Lens, color enhanced, K002647). For safety and clinical performance, the ground truth would be based on clinical observations and established ophthalmic standards.

8. The Sample Size for the Training Set

This is not applicable as the device is a contact lens, not an AI model requiring a training set.

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

This is not applicable as the device is a contact lens, not an AI model.

Summary of the "Study" from the Document:

The "study" or justification for equivalence in this 510(k) is primarily a technological characteristics comparison (as presented in the table on page 3) between the modified device and its predicate devices. This comparison demonstrates that:

• The Intended Use, Functionality, Indications, Production Method, FDA Group #, USAN Name, and Water Uptake (%) are identical to the predicate devices.
• The Sterility Assurance Level (SAL) is $10^{-6}$, which aligns with one predicate and indicates a sterile product, satisfying safety requirements.
• The material composition (polymacon, 2-HEMA, EGDMA, initiator, 38% water) is the same.
• The modification strictly involves the incorporation of specific, listed reactive color additives to the anterior surface, which are stated to be thoroughly washed and not to alter the original characteristics of the lens except for light transmittance.
• New physical properties for the tinted version (Light Transmission >90%, Oxygen Permeability 8.4 X 10-11) are provided, implicitly demonstrating that these are within acceptable ranges for a safe and effective contact lens of this type.

The core argument for acceptance is substantial equivalence to existing, legally marketed predicate devices, meaning the modified device is as safe and effective as the predicates and does not raise new questions of safety or effectiveness.

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