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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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The Colposcope System is intended for magnified viewing of the vagina, cervix and external genitalia in order to assist doctors in diagnosing abnormalities and select areas for biopsy. It is intended to be used only by trained and qualified personnel in hospitals, clinics and private offices, and not intended for home use.

The Colposcope System is intended for magnified viewing of the vagina, cervix and external genitalia in order to diagnose abnormalities and select areas for biopsy. The Colposcope System has two kinds of colposcopes, a video colposcope and a binocular colposcope.

The video colposcope system is a non-patient contacting image capture device (CCD color camera) with a digital magnification of up to x16, working distance supporting 200mm, and a green filtered light source mounted on a vertical stand, swing arm stand or trolley. Tissue is magnified and viewed directly via the LCD screen attached to the capture device or on the commercially available color monitor. The video colposcope system has four models, including KN-2200A, KN-22001 and KN-2200I(H).

The binocular colposcope system is designed based on an optical colposcope. Its imaging system consists of optical imaging and CCD imaging. It permits viewing of the vagina, cervix and external genitalia by a telescopic system and the CCD camera captures digital images. The binocular colposcope system has two models, including KN-2200B and KN-2200BI. The two models have the same binoculars, CCD camera, cables except for the light source size and the stand type.

Both video colposcope system and binocular colposcope come with image management software, which is provided on a CD-ROM. The image management software allows the viewer to view, compare, record and print the image by series peripheral units, such as computer, monitor and printer.

The provided document is a 510(k) Summary for the Xuzhou Kernel Medical Equipment Co., Ltd. Colposcope System. It focuses on demonstrating substantial equivalence to predicate devices rather than providing a detailed study proving the device meets specific acceptance criteria in the manner an AI device might.

Therefore, the information required to fully answer the request, particularly regarding specific performance metrics (like sensitivity, specificity, accuracy), sample sizes for test and training sets, expert qualifications, ground truth establishment for a diagnostic AI, or MRMC studies, is not present in this document.

However, I can extract the available information related to non-clinical tests and performance specifications that are analogous to acceptance criteria in this context.

Acceptance Criteria and Device Performance (Derived from Non-Clinical Tests and Specifications)

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The Cooper Surgical Leisegang Colposcope Systems are intended for the magnified viewing of the tissues of the vagina, cervix, and external genitalia in order to assist doctors in diagnosing abnormalities such as lesions or cancer, and selecting areas for biopsy. The images from Cooper Surgical Leisegang Colposcope Systems may be viewed directly and/or on a color monitor (if so equipped). The Cooper Surgical Leisegang Colposcope Systems are intended for use in hospitals, clinics, and doctor's offices.

The Cooper Surgical Leisegang Colposcope(s) and accessories are optical colposcopes designed for non-contact visualization of the tissues of the cervix, vulva, vagina, and anogenital areas. Depending on the model and/or mode selected, they provide direct visual, photographic, and/or high resolution color imaging of the selected area.

The provided text describes the Cooper Surgical Leisegang Colposcope System, a medical device for magnified viewing of tissues. The document is a 510(k) summary, which focuses on demonstrating substantial equivalence to a predicate device rather than presenting a performance study with acceptance criteria in the typical sense for an AI/CADe device.

Therefore, the information typically requested for AI/CADe devices (such as clinical study sample sizes, expert ground truth establishment, MRMC studies, standalone performance, and training set details) is not applicable or available in this document. The "Performance Data" section specifically states "Non-clinical testing and attribute comparisons have been used to establish that the features and performance of the subject devices are substantially equivalent to the predicates."

The acceptance criteria here are implicitly met if the device's technical specifications and non-clinical performance are deemed substantially equivalent to the predicate devices, and if it complies with relevant electrical safety and electromagnetic compatibility standards.

Here's a breakdown based on the information provided, recognizing that it pertains to a traditional medical device and not an AI/CADe system:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample size used for the test set and the data provenance:
Not applicable. This is a traditional optical device, not an AI/CADe system. Testing involved non-clinical attribute comparisons and compliance with electrical/EMC standards. No patient data or test set in the AI/CADe sense was utilized.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
Not applicable. No ground truth based on expert medical review was established for the technical performance of this optical colposcope for the purpose of regulatory submission. The document refers to "non-clinical testing."

4. Adjudication method for the test set:
Not applicable. No expert adjudication process was described for this type of device submission.

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 colposcope, an optical instrument for direct viewing, not an AI or CADe system. No MRMC study was performed.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Not applicable. This device is not an algorithm or AI system.

7. The type of ground truth used:
For the technical specifications, the "ground truth" was derived from measurements against engineering and performance standards (e.g., USAG Chart NBS 1963A for resolution, direct measurements for depth of field, distortion, and illumination properties). For regulatory purposes, the primary "ground truth" for substantial equivalence was the performance and characteristics of the predicate devices.

8. The sample size for the training set:
Not applicable. This device does not involve a training set as it is not an AI/machine learning system.

9. How the ground truth for the training set was established:
Not applicable. No training set was used.

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