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The Welch Allyn Basic Image Management system is intended to capture, display, save, export, and print images obtained from the Welch Allyn video colposcope. The images captured, displayed, saved, exported, and printed from the Basic Image Management system are not intended for diagnostic purposes. The provider shall use the image on the colposcope monitor for clinical diagnosis.

The Welch Allyn Image Management System is intended for use with the Welch Allyn Integorient by 510(k) number K955635. This system enables a customer to save an image to the customer's electronic file system for future reference and visit date. The file image may be imported into or based on patient lacklifer and tiertronic medical record/electronic health record if desired. The third-party DV Converter attaches to the Welch Allyn Colposcope through an Svideo connection. The Octposed on prected digitizes the image and sends it to through the Ovideo Intended "The IEEE 1394B connection supplies the TO over an iEE_ sampling frequency of 48kHz/16bit/2ch. Minimum 50 framestoos with a requirements to run the software will be specified. The images captured, displayed, saved, exported, and printed from the Basic Image Management byetem and the colposcope monitor for clinical diagnosis.

The provided text does not contain detailed acceptance criteria or a specific study proving the device meets acceptance criteria in the manner typically expected for medical device performance evaluation (e.g., sensitivity, specificity, accuracy metrics). Instead, it focuses on demonstrating substantial equivalence to a predicate device.

Here's an analysis based on the available information:

1. Table of acceptance criteria and the reported device performance:

The document doesn't provide a quantitative table of acceptance criteria with corresponding performance metrics. The "Summary of Effectiveness" section vaguely states: "The Welch Allyn Image Management System is effective for its intended use. Testing and evaluation indicate that the system meets the needs of the users of the device."

The core of the submission is a comparison of technological characteristics to a predicate device. This comparison implicitly defines the "acceptance criteria" as being substantially equivalent in function and safety to the predicate.

2. Sample sized used for the test set and the data provenance:

The document does not specify a quantitative "test set" and a sample size in the context of clinical performance evaluation (e.g., number of patients or images). The evaluation seems to be based on engineering and functional testing to ensure the system performs its intended technical functions (capture, display, save, export, print) correctly. There is no mention of data provenance (e.g., country of origin, retrospective/prospective).

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. The device's images are explicitly stated as "not intended for diagnostic purposes," which means no diagnostic "ground truth" (e.g., clinical diagnosis) was likely established for performance evaluation with respect to diagnostic accuracy. The ground truth, if any, would be related to the accurate capture and representation of the video feed.

4. Adjudication method for the test set:

Not applicable, as no clinical test set requiring expert adjudication for ground truth is described.

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:

No, an MRMC comparative effectiveness study was not done. The device is an "Image Management System" and is not an AI-assisted diagnostic tool.

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

The device itself is a standalone system for image capture and management. Its performance is evaluated on its ability to correctly perform these functions, not on an algorithm's diagnostic output.

7. The type of ground truth used:

The concept of "ground truth" as it pertains to diagnostic accuracy is not relevant here, as the device is not for diagnostic purposes. The ground truth for its functional performance would be that the captured, displayed, saved, exported, and printed images accurately represent the video signal from the colposcope. This would be established through technical validation and user testing.

8. The sample size for the training set:

Not applicable. This device is not an AI/machine learning system that requires a training set.

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

Not applicable, as there is no training set for an AI/machine learning algorithm.

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The Leisegang Video Colposcope is intended for magnified viewing of the tissues of the vagina, cervix and external genitalia in order to diagnose abnormalities and select areas for biopsy. The image can be viewed only on a color monitor.

The Galileo Leisegang Video Colposcope is intended for magnified viewing of the tissues of the vagina, cervix and external genitalia in order to diagnose abnormalities and select areas for biopsy. The image can be viewed only on a color monitor.

The Leisegang Video Colposcope consists of a CCD camera with a halogen light source, green filter and is mounted on a mobile base.

This 510(k) summary (K981958) is for the Leisegang Video Colposcope. It describes the device's intended use and compares it to predicate devices. However, it does not contain any information regarding acceptance criteria or a study that proves the device meets such criteria.

Therefore, I cannot provide the requested information. The document focuses on regulatory equivalence rather than performance data. The device is a direct viewing instrument, not an AI/algorithm-driven device, which means the requested parameters (e.g., sample size for training set, MRMC studies, ground truth) are not applicable to the information provided in this 510(k) summary.

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