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The System is intended for use in Radiographic / Fluoroscopic applications including general radiographic / fluoroscopic diagnostic, and interventional X-Ray imaging for General and Pediatric Populations.

The Soteria E-View system is classified as an interventional fluoroscopic X-ray system. The fundamental performance characteristics of the Soteria E-View interventional fluoroscopic X-ray system consists of:

• The patient table and C- arm with X-ray source on one side and the flat panel detector on the opposite side. The C-arm can be angulated in both planes, and the flat panel detector can be lifted vertically. The tabletop can be shifted from side to side and move forward/backward by an operator.
• Real-time image visualization of patient anatomy during procedures.
• Imaging techniques and tools to assist interventional procedures.
• . Post-processing functions after interventional procedures.
• Storage of reference/control images for patient records.
• Compatibility to images of other modalities via DICOM.
• . Built-in radiation safety controls-with the already FDA cleared CA-100S /FluoroShield (K182834).
  This array of functions provides the physician with the imaging information required to achieve minimally invasive interventional procedures.
  The Soteria E-View system is available as a Model GI-100 configuration. It is similar to the currently marketed predicate Soteria.Al consisting of an X-ray generator, image processor, collimator, X-ray Tube, Positioner, and patient table with CA-100S / FluoroShield Accessory, (K212336).

This document describes the Omega Medical Imaging, LLC Soteria E-View (K242488) system, which is a fluoroscopic/radiographic X-ray system. The submission aims to demonstrate substantial equivalence to its predicate device, the Soteria.AI (K212336).

The provided text details the device's technical specifications and comparisons to the predicate, as well as adherence to various safety standards and guidance documents. However, it does not contain information regarding specific acceptance criteria, corresponding device performance data, or detailed study results (including sample sizes, data provenance, ground truth establishment, expert qualifications, adjudication methods, MRMC studies, or standalone performance studies).

The document primarily focuses on demonstrating substantial equivalence through:

• Indications for Use: The Soteria E-View has similar indications, but with cardiac and vascular applications removed and gastrointestinal/ERCP applications added.
• Technological Characteristics: Changes include an updated flat panel detector (Varex Azure 3131Z CXP Detector with IGZO technology) with improved specifications like resolution and MTF, a different X-ray generator, positioner configuration, power supplies, control buttons, actuators, table size, and power unit.
• Non-Clinical Performance: States that non-clinical and "Sample clinical images" were used to validate image performance and demonstrate conformance to intended use, claims, user, and service needs. It also mentions software verification testing for functional requirements, performance, reliability, and safety.
• Safety and Effectiveness: Asserts that the differences do not raise new safety or effectiveness concerns, and the device complies with relevant 21 CFR regulations and international safety standards.

Therefore, many of the requested details about acceptance criteria and the study proving adherence cannot be extracted from this document.

Based on the provided text, here is what can be inferred or explicitly stated:

1. Table of Acceptance Criteria and Reported Device Performance

Specific, quantifiable "acceptance criteria" and direct "reported device performance" against those criteria are not explicitly laid out in a table format in the provided text. The document focuses on demonstrating substantial equivalence to a predicate device, meaning the new device performs at least as well as the predicate and does not raise new safety or effectiveness concerns.

However, some performance characteristics are compared to the predicate, implying they meet or exceed the predicate's performance, which can be seen as an indirect form of demonstrating acceptance.

Note: The table above extracts direct comparisons from Section "PRODUCT OVERVIEW" within the 510(k) summary. For other aspects like software performance, safety, and functional requirements, the document only states that "Results demonstrated that the executed verification test was passed" without providing specific criteria or data.

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 states: "Non-clinical and Sample clinical images were used to validate image performance." It also mentions: "Non- clinical and Sample clinical images were used for validation testing of the Soteria E-View system to demonstrate conformance to the intended use, claims, user, and service needs..."
However, no specific sample size for the test set (number of images, number of cases, number of patients) is provided.
The data provenance (country of origin, retrospective/prospective) is not mentioned.

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

This information is not provided in the document.

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

This information is not provided in the document.

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

The document does not mention an MRMC study or any AI components for human reader assistance. The device is an X-ray system, and while the predicate device is named "Soteria.AI", the specific AI functionality (automatic region of interest to reduce exposure) is a built-in feature of the system and not framed as an AI-assistance tool for human readers in the context of comparative effectiveness for diagnosis. The focus is on the device's technical performance and safety.

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

This information is not provided in the document, as the device is a complete X-ray system, not a standalone algorithm. The "FluoroShield / CA-100S device to provide an automated Region of interest that reduces exposure to the patient and operator" is described as an integrated hardware/software component of the system.

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

This information is not provided in the document. The text only mentions "Sample clinical images" were used for validation testing, but how their "ground truth" was established is not detailed.

8. The sample size for the training set

The document primarily discusses validation and substantial equivalence, not the development of a specific algorithm requiring a "training set." Therefore, no information on a training set size is provided.

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

As no training set is described, this information is not applicable/provided.

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The Omega Medical Imaging, LLC CS-series-FP (SSXI) systems with optional accessory device CA-100S as a modification device to provide an automated Region of interest that reduces exposure to the patient and operator. The system is intended for use in Radiographic/fluoroscopic applications including cardiac, vascular, general radiographic/fluoroscopic diagnostic, and interventional x-ray imaging for General Populations. At no time will the CA-100S be considered as a replacement for the primary collimator shall always be used, in accordance with good medical practice, to define a Region of Interest

This 510(k) submission is for the addition of an optional secondary fast collimator system (Model: CA-100S / FluoroShield™ K182834 cleared 02/18/19). The CA-100S/ FluoroShield™ will be used with the following FDA cleared device: Omega's CS-series-FP ( K100102) which utilizes a Varex 2020 Flat Panel Detector. (Note: the only difference between this submission and the predicate is the size of the FPD. The predicate device utilizes a Varex 3030 Flat Panel Detector)

The-CA-100S/ FluoroShield™ system is composed of a Shutter, a ROI Electronics Unit, an Auto-ROI Processor, two ROI Control Panels and a Monitor.

The CA-100S / FluoroShield™ is a secondary collimator that can only be used in conjunction with the primary collimator. When using the CA-100S / FluoroShield™, the primary collimator shall be used to manually define a region of interest. Once this ROI has been established by the primary collimator, the CA-100S / FluoroShield™ can be used to further reduce the size of the ROI beyond the ROI initially established with the primary collimator.

I am sorry, but based on the provided text, there is no information about specific acceptance criteria and detailed study that proves the device meets those criteria for the CS-series-FP Radiographic / Fluoroscopic Systems with Optional CA-100S / FluoroShield™ mentioned in the document.

The document is a 510(k) premarket notification and primarily focuses on demonstrating substantial equivalence to a predicate device and outlining the device's description, function, and safety compliance. While it mentions that "Additional testing for this submission was performed utilizing a DAP meter to demonstrate the dose reduction results utilizing the CA-100S / FluoroShield™ accessory" and "A clinical study was conducted sampling 100 patients as well to demonstrate the dose reduction to patients and staff," it does not provide the specific acceptance criteria for these tests or detailed results in a table format.

Here's what can be extracted regarding some of your questions, but it's not a complete answer to all:

• Study Objective: The clinical study aimed to compare and measure radiation exposure to patients using Dose Area Product (DAP) and scatter radiation to endoscopy personnel using Landauer Luxel personal dosimetry badges.
• Performance Claim (from clinical study conclusion): "When using FluoroShield, unnecessary radiation can be reduced up to 61.8% in patients and 59.4% to the staff."
• Sample size for test set: 100 patients for the clinical study.
• Data provenance: The clinical study was a "prospective study of 100 consecutive patients who underwent fluoroscopy-guided endoscopic procedure." It doesn't specify the country of origin.
• Training set: No information available about a training set. The descriptions of "segmentation model" and "motion detection module" being updated or based on trained images from the 2020 system imply a training process, but details on sample size or ground truth establishment for this training are not provided.
• Ground truth: For the clinical study, the ground truth appears to be measured radiation exposure (DAP for patients, dosimetry badges for staff).
• Other details: Questions 1 (table of acceptance criteria), 3 (experts), 4 (adjudication), 5 (MRMC study), and 6 (standalone performance) are not addressed in the provided text.

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