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The EVA (Enhanced Visual Assessment) System is intended to provide magnified viewing of the vagina, cervix and external genitalia in order to aid in diagnosing abnormalities and selecting areas for biopsy. The device is intended for use in hospitals, doctor's offices, and remote and rural clinics.

The EVA (Enhanced Visual Assessment) System is a handheld device in which a smartphone is fitted and consists of a colposcope body, lens, smartphone upper and lower brackets, LED electronics, CervDx app for image capture, and online portal for image transfer and remote viewing. The device also includes the strap, carrier case, and instruction manual. During colposcopy, the operator may mount the EVA System on a tripod for hands free imaging, turn on the LED light for improved viewing, see a magnified view of the vagina and cervix on a smartphone screen resting at the back of the device, annotate and save images on the CervDx app, and upload images to the portal. The EVA System is compatible with Motorola G2 and Motorola G3 smartphones.

The EVA System is capable of working for ten hours before recharging. The EVA System weighs about 0.5 kg and is light enough that the device can be operated for 10 minutes at a time without any fatiguing.

The device operates at a working distance of 22.5 - 42.5 cm with an optical magnification up to 4.0x and ultimately up to 16x, with digital zoom.

The provided text describes the EVA (Enhanced Visual Assessment) System, a colposcope, and its substantial equivalence to a predicate device. However, it does not contain information about a study that proves the device meets specific acceptance criteria in terms of clinical performance metrics like sensitivity, specificity, or accuracy for diagnosing abnormalities.

The document focuses on non-clinical performance testing to verify design specifications and compliance with standards, and a comparison with a predicate device based on technical characteristics.

Here's a breakdown of the information that is and is not available based on your request:

1. A table of acceptance criteria and the reported device performance

The document lists several technical specifications for the EVA System and compares them to the predicate device. It also states that "Non-clinical tests were conducted to verify that the EVA System met all design specifications." However, it does not explicitly define "acceptance criteria" as target performance for clinical endpoints (e.g., a specific sensitivity or specificity for abnormality detection). Instead, the "performance" discussed relates to technical aspects.

Note: The document only states that "Non-clinical tests were conducted to verify that the EVA System met all design specifications." It doesn't explicitly list the acceptance criteria thresholds for each of these technical specifications, only the reported performance. The underlying assumption is that the reported performance meets the internal design specifications.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Not Applicable (N/A). The document explicitly states "Clinical Performance Data: Not Applicable." The non-clinical tests mentioned do not involve a "test set" of patient data in the sense of clinical performance evaluation. The "Cervical Model Image Quality" test likely used a physical model, not patient data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not Applicable (N/A). As no clinical performance study involving a test set of patient data was conducted, there was no need for experts to establish ground truth for such a set.

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

Not Applicable (N/A). No clinical test set requiring adjudication was used.

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 (N/A). The document does not describe any MRMC study, nor does it mention AI assistance. The EVA system, as described, is a colposcope for magnified viewing, not an AI-powered diagnostic tool.

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

Not Applicable (N/A). The EVA System is described as a device that "aids in diagnosing abnormalities and selecting areas for biopsy" and provides "magnified viewing." It is a tool for human use, not a standalone algorithm performing diagnoses.

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

Not Applicable (N/A). Since no clinical performance study for diagnosing abnormalities was conducted, no clinical ground truth (like pathology or outcomes data) was established or used for the purpose of proving diagnostic performance. The ground truth for non-clinical tests would be the known properties of the physical testing apparatus (e.g., known resolutions of test charts for optical resolution tests).

8. The sample size for the training set

Not Applicable (N/A). The device as described does not involve a "training set" in the context of machine learning or AI.

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

Not Applicable (N/A). As there is no training set for an AI/ML algorithm involved, this question is not relevant.

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