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The Pocket Colposcope is a digital video colposcope intended for gynecological examination. It provides a portable means of magnified visualization of the tissues of the vagina, cervix and external genitalia in order to aid in diagnosing abnormalities and selecting areas for biopsy. The image system is intended to provide documentation of the image in the field of view of the colposcope. The Pocket Colposcope System is intended to be inserted into the vagina via a speculum by trained medical personnel in hospitals, clinics, and private offices, and is not intended for home use.

The Pocket Colposcope is a reusable, high-definition video colposcope intended to be used in a hospital / clinical environment for examination of the tissues of the vagina, cervix and external female genitalia in order to aid in diagnosing abnormalities and selecting areas for biopsy. The Pocket Colposcope can be used outside of the body to capture images of the vagina and external genitalia or can be inserted through a vaginal speculum to capture images of the cervix and surrounding tissue. The Pocket Colposcope it is not intended to come into direct contact with the body.

The Pocket Colposcope utilizes a ring or single loop of LED lights to illuminate the target tissue. The digital color image generated by the Pocket Colposcope is intended to be used to aid in diagnosing abnormalities and selecting areas for biopsy. Users can switch between the white and green light illumination and zoom in or out to capture images at different working distances.

The Pocket Colposcope has a 5 MP CMOS camera with a 0° angled lens. The Pocket Colposcope uses a computer-based software program to display the camera output on a computer screen and to capture images. Together, the Pocket Colposcope and the software comprise the Pocket Colposcope System.

The provided text does not contain detailed acceptance criteria or a study directly comparing the device's performance against specific clinical efficacy metrics. Instead, it focuses on demonstrating safety, essential performance, and technological equivalence to a predicate device.

However, based on the Summary of Performance Testing section, we can infer some general "acceptance criteria" through the standards the device was tested against and the statement "All test results met pre-determined acceptance criteria."

Here's an attempt to answer your request based on the available information:

1. Table of Acceptance Criteria and Reported Device Performance

Since specific numerical acceptance criteria (e.g., minimum sensitivity/specificity for a diagnostic claim) are not provided, the table below reflects what can be inferred from the regulatory submission document. The "Reported Device Performance" here refers to the outcome of the testing mentioned, which is that the device complied or met the standards.

2. Sample Size for Test Set and Data Provenance

The document does not specify a "test set" in terms of cases (e.g., patient images for diagnostic performance). The performance testing described is primarily engineering and usability-focused.

• Sample Size for Test Set: Not applicable in the context of clinical diagnostic performance. For the "Design Validation" where medical professionals evaluated the device, the sample size is referred to as "several trained medical professionals," which is not a specific number.
• Data Provenance: Not applicable for engineering and usability testing as described. If "Design Validation" involved patient interaction, the provenance is not specified.

3. Number of Experts and Qualifications for Ground Truth

• Number of Experts: "several trained medical professionals"
• Qualifications of Experts: "trained medical professionals (intended users)" - no specific experience level (e.g., "10 years of experience") or specialization (e.g., "radiologist") is given. They are described as "intended users."

4. Adjudication Method for Test Set

Not applicable. The performance testing described does not involve a multi-reader, multi-case adjudication process for establishing ground truth for diagnostic accuracy, as it's not a diagnostic AI device requiring such. The "Design Validation" focused on user satisfaction and device function, not diagnostic accuracy.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

• Was an MRMC study done? No, the document does not mention an MRMC comparative effectiveness study where human readers improve with AI vs. without AI assistance. The Pocket Colposcope System is a physical imaging device, not an AI diagnostic aid for human readers in the described context.
• Effect size of improvement: Not applicable.

6. Standalone (Algorithm Only) Performance

• Was a standalone performance study done? No. The device itself is an imaging tool. The "Software Verification and Validation Testing" focused on the software within the device meeting regulatory requirements, not on a standalone diagnostic algorithm's performance on a dataset.

7. Type of Ground Truth Used

• For the engineering and usability tests, the "ground truth" was compliance with established industry standards (e.g., IEC, ISO, ANSI/NEMA, CISPR) and, for design validation, user feedback on device function and meeting needs.
• The document does not describe a ground truth derived from expert consensus, pathology, or outcomes data in the context of clinical diagnostic accuracy testing for the device.

8. Sample Size for Training Set

Not applicable. This device is an imaging system, not a machine learning algorithm that requires a training set for diagnostic classification.

9. How Ground Truth for Training Set was Established

Not applicable, as there is no mention of a training set or machine learning components that would require such ground truth.

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