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The Strait'Map is intended to permit digital x-ray systems to produce distortion-free images for stereotaxy without the use of a film changer. Strait' Map corrects the geometric distortion in the digital images caused by the image intensifier. The corrected images are then sent to a laser imager for use in neuroangiographic examinations requiring the use of a stereotactic frame. The correction procedure can be used in either monoplane or biplane configuration.

This optional software is run after the acquisition of patient images is completed and has no affect on the acquisitions. Two orthogonal acquisitions are required to obtain accurate localization in the region of interest. The image correction is based on distortion calibration using a straight grid image, with the patient removed from the imaging field. A separate callbration is performed for each patient series to be corrected.

Here's an analysis of the provided text regarding the Strait'Map device and its acceptance criteria, focusing on the lack of a detailed study:

The provided 510(k) summary for the Strait'Map device does not contain the details of a study with specific acceptance criteria and reported device performance in the way a clinical or technical validation study would typically be presented. Instead, it focuses on demonstrating substantial equivalence to predicate devices and outlining a risk management plan.

Therefore, many sections of your requested output cannot be directly extracted from the provided text.

Here's what can be inferred or explicitly stated based on the given information:

1. Table of Acceptance Criteria and Reported Device Performance

No explicit acceptance criteria or reported device performance metrics (e.g., accuracy, precision values) are provided in the document. The document states a qualitative goal: "Strait Map permits the production of images free of the geometrical distortion which are comparable to those produced by film changers."

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

• Sample Size: Not specified.
• Data Provenance: Not specified. The document mentions "external evaluation by different hospitals," but doesn't detail what data or how much was used for this evaluation.

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

• Number of Experts: Not specified.
• Qualifications: Not specified. The term "external evaluation by different hospitals" suggests medical professionals, but no specific roles or years of experience are mentioned.

4. Adjudication Method for the Test Set

• Adjudication Method: Not specified.

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

• No, an MRMC study is not mentioned or described. The document focuses on the technical capability of the software to correct distortion, not on human reader performance with or without AI assistance.

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

• Yes, implicitly. The device is described as "optional accessory consisting of a software program" that "is run after the acquisition of patient images is completed and has no affect on the acquisitions." It performs image correction automatically. The performance described is the technical capability of the algorithm to produce distortion-free images. However, no specific metrics of this standalone performance (e.g., distortion reduction percentage, measurement accuracy improvement) are quantified within the provided text.

7. The Type of Ground Truth Used

• Inferred based on the comparison: The "ground truth" seems to be the geometric accuracy and "distortion-free" nature of images produced by film changers that do not utilize an image intensifier. The Strait'Map is designed to make digital x-ray images (which use intensifiers and thus suffer distortion) comparable to these film-changer images.

8. The Sample Size for the Training Set

• Sample Size: Not specified.

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

• Not specified. Given the nature of distortion correction, it would likely involve known geometric patterns or phantoms imaged with and without distortion, but the document does not detail this.

Summary of Limitations from the Document:

The provided 510(k) summary is a regulatory filing, not a detailed scientific publication of a study. It outlines the device's function, indications for use, and a qualitative comparison to predicate devices, along with a high-level statement about risk management. It does not include the detailed methodological and results sections one would expect from a formal study proving the device meets specific, quantifiable acceptance criteria. The "study" referenced in the prompt (if one exists beyond the general "external evaluation") is not described in detail within this document.

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