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CT Colonography is a CT image analysis software package which allows the visualization of 2D and 3D medical image data of the colon derived from DICOM 3.0 compliant CT scans for the purpose of screening of a colon to detect polyps, masses, cancers, and other lesions. It provides functionality for 2D/3D rendering, bookmarking of suspected lesions, synchronized viewing of supine & prone data sets, and an object oriented endoluminal display. In comparison to colonoscopy, this tool has an advantage of depth penetration due its 3D presentation capability. It is intended for use by Radiologists, Clinicians, and referring Physicians to process, render, review, archive, print, and distribute colon image studies.

CT Colonography is an image analysis software package that includes all the required software that allows the user to study the inside, wall, and outside of the colon using CT-acquired helical images. The tool is laid out to facilitate the detection of colonic lesions. CT Colonography is an advanced visualization software option that provides endoluminal views of anatomical structures. The flexibility of this software allows the user to move interactively from air paths to inner vessels visualization and thus, it is not limited to inner navigation of structures as lungs and sinuses. Volume Analysis (includes both. CT/MR Windows Workstation, K913770 and 3D & Dentascan for Windows K923077) provides the base for Colonography, CTC/Nav2 and Nav2 alone, which allows an increase in the ease of use and productivity. Colonography, CTC/Nav2 and Nav2 alone, also use some options of Volume Rendering (AW Volume Render Option K972399), which allows the user to quickly isolate structure of interest and render volumetric data in three dimensions.

The provided text does not contain detailed information about specific acceptance criteria or a dedicated study proving that the device meets those criteria. Instead, it focuses on establishing substantial equivalence to previously cleared devices.

Here's an analysis based on the available information:

1. Table of Acceptance Criteria and Reported Device Performance:

The document does not explicitly state quantitative acceptance criteria or provide a table of reported device performance metrics against such criteria. The "Conclusions" section in {1} states: "The CT Colonography option (K023943) does not result in any new potential safety risks and performs as well as devices currently on the market." This suggests that the performance standard is to be equivalent to the predicate devices, rather than meeting specific numerical thresholds.

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

The document does not mention a specific test set, its sample size, or its data provenance (e.g., country of origin, retrospective or prospective nature). The safety and effectiveness claim is based on substantial equivalence to predicate devices, implying that their established performance is sufficient.

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

This information is not provided. Since no specific test set or study validating device performance is described, the process of establishing ground truth for such a set is not detailed.

4. Adjudication Method for the Test Set:

This information is not provided.

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

The document does not indicate that an MRMC comparative effectiveness study was conducted. The focus is on demonstrating that the CT Colonography software provides similar functionality and safety as the predicate devices.

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

The document does not explicitly state whether a standalone algorithm performance study was done. The device is described as an "image analysis software package" intended for "Radiologists, Clinicians, and referring Physicians to process, render, review, archive, print, and distribute colon image studies," implying it is used with human interaction, not as a standalone diagnostic tool.

7. The Type of Ground Truth Used:

The document does not specify the type of ground truth used for any performance evaluation, as no such evaluation is detailed. Given the nature of CT Colonography for lesion detection, a typical ground truth would likely involve colonoscopy with biopsy/histopathology or surgical pathology.

8. The Sample Size for the Training Set:

The document does not mention a training set or its sample size.

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

This information is not provided, as no training set is discussed.

Summary of Device Acceptance Rationale:

The core of the acceptance for the "CT Colonography" (K023943) device is its substantial equivalence to two predicate devices:

• CT Colonography/Navigator2 (K012313)
• V3D-Colon (K020658)

The manufacturer, GE Medical Systems, asserts that their CT Colonography option "does not result in any new potential safety risks and performs as well as devices currently on the market." This suggests that the acceptance criteria are met by demonstrating that the new device shares fundamental technological characteristics, intended use, and performance characteristics (as understood from the predicate devices) without raising new questions of safety and effectiveness. The "Conclusions" section acts as the primary statement on how the device meets "acceptance criteria" by equating its performance to already cleared devices.

The FDA's clearance letter (pages {2} and {3}) confirms this approach, stating they "have determined the device is substantially equivalent... to legally marketed predicate devices." This regulatory pathway does not typically require extensive new clinical studies to prove performance against novel acceptance criteria, but rather a demonstration of similarity to existing safe and effective devices.

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CT Colonography/Navigator2 is an image analysis software package that contains CT Colonogarphy and Navigator2.

CT Colonography allows the user to study the inside, wall and outside of the colon. It provides the user with an ability to view datasets from both, prone and supine positions, facilitating detection of colonic lesions. In comparison to colonoscopy, this tool has an advantage of non-invasive depth penetration due to its 3D presentation capability.

Navigator2 provides endoluminal views of anatomical structures. Navigator2 is designed to enhance and modify current image quality, tools, speed and user interface of Navigator for improved productivity. Navigator2 provides a visualization tool to investigate structures (such as polyps, tumors, stones, calcification etc.) within anatomy, airways and organs. Thus. its viewing capability of the inner and outer surfaces of organs as well as within their walls provides additional supplemental information, complementing endoscopy/colonoscopy, to support interpretation and treatment planning. Navigation2 is applicable to X-ray as well as CTMR.

CT Colonography/Navigator2 (CTC/Nav2) is an image analysis software package that allows the user to study the inside, wall, and outside of the colon using CT-acquired helical images. The tool is laid out to facilitate the detection of colonic lesions. CT Colonography requires Navigator2 for its operation however, Navigator2 can also be utilized as a stand-alone option. Navigator2 is an advanced visualization software option that provides endoluminal views of anatomical structures. The flexibility of this software allows the user to move interactively from air paths to inner vessels visualization and thus, it is not limited to inner navigation of structures as lungs and sinuses. Volume Analysis (includes both, CT/MR Windows Workstation, K913770 and 3D & Dentascan for Windows K923077) provides the base for CTC/Nav2 and Nav2 alone, which allows an increase in the ease of use and productivity. CTC/Nav2 and Nav2 alone, also use some options of Volume Rendering (AW Volume Render Option K972399), which allows the user to quickly isolate structure of interest and render volumetric data in three dimensions.

While the document describes the device, its intended use, and its equivalence to a predicate device, it does not contain information regarding specific acceptance criteria for a study or the results of such a study proving the device meets those criteria.

The document is a 510(k) summary for regulatory clearance, which focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than providing detailed performance study data against defined acceptance criteria.

Therefore, I cannot provide the requested information. The sections you asked for (acceptance criteria table, sample sizes, expert qualifications, adjudication, MRMC study, standalone performance, ground truth types, training set size, and ground truth establishment for training set) are not present in the provided text.

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The device, brand name AkroTech 4000T Kinetic Turning Low Air Loss (LAL) System, is substantially equivalent to the AkroTech 4000 Dynamic Low Air Loss (LAL) (K923077) (K923977). Both Low Air Loss support systems consist of two operating components: 1. The electromechanical, computer controlled Air Control unit (ACU) 2. The Air Floatation Mattress. Both Systems promote pressure reduction by redistributing patient weight over a surface area / medium or by shifting patient we in a area / medium or by shifting patient weight of redistributing patient weight over a

The provided text is a 510(k) summary for the AkroTech 4000T Kinetic Turning Low Air Loss (LAL) System. This document focuses on demonstrating substantial equivalence to a previously cleared device (AkroTech 4000 Dynamic Low Air Loss (LAL) - K923077/K923977), rather than presenting a study with specific acceptance criteria and performance metrics in the way a clinical trial or algorithm validation study would.

Therefore, many of the requested items (e.g., sample size for test set, number of experts, adjudication method, effect size of human readers with AI assistance, standalone performance, training set data) are not applicable to this type of regulatory submission.

However, I can extract information related to the device's features and safety standards, which serve as the implicit "acceptance criteria" for substantial equivalence.

Here's a breakdown based on the provided text:

1. Table of Acceptance Criteria (Implicit) and Reported Device Performance

Since this is a submission for substantial equivalence, the "acceptance criteria" are not predefined performance metrics in the traditional sense. Instead, the device needs to demonstrate that it is as safe and effective as the predicate device. The performance is reported in terms of feature comparison and adherence to safety standards.

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

• Not Applicable. This document describes a comparison to a predicate device based on features and specifications, not a clinical study or performance test involving a specific test set of data.

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

• Not Applicable. See point 2. The "ground truth" here is the established safety and effectiveness of the predicate device, against which the new device's features are compared by the engineers and regulatory reviewers.

4. Adjudication method for the test set

• Not Applicable. See point 2.

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 medical bed system, not an AI-assisted diagnostic tool.

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

• Not Applicable. This device is a medical bed system, not an algorithm.

7. The type of ground truth used

• The "ground truth" in this context is the established safety and effectiveness of the predicate device (AkroTech 4000 Dynamic Low Air Loss (LAL) - K923077/K923977) as determined by its previous FDA clearance. The new device demonstrates "substantial equivalence" by having similar intended use, technological characteristics, and safety/effectiveness profile, potentially with some differences that do not raise new questions of safety or effectiveness.

8. The sample size for the training set

• Not Applicable. This device is a medical bed system. There is no "training set" in the context of an algorithm. Development would involve engineering design, testing, and verification, not machine learning model training.

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

• Not Applicable. See point 8.

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