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The Intermed Zoom Colposcope is intended for direct magnified viewing of the cervix, vagina, and external genitalia for the purpose of diagnosing abnormalities and selecting areas for biopsy.

The Intermed Zoom Colposcope consists of a stereo zoom microscope mounted to a mobile floor stand. A halogen light source with an integrated green filter is also mounted to the stand providing subject illumination.

The provided 510(k) summary for the Intermed Zoom Colposcope (K031639) does not contain information about acceptance criteria or a study proving the device meets specific performance criteria through a clinical or technical study using a test set with established ground truth.

Instead, this 510(k) relies on a demonstration of substantial equivalence to predicate devices. This means the manufacturer is asserting that their device is as safe and effective as a device already legally marketed, based on technological similarities, rather than presenting novel performance data from a new study.

Therefore, most of the requested information (acceptance criteria table, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth types, and training set details) is not applicable in the context of this 510(k) submission.

Here's a breakdown of what can be extracted based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

The provided document does not specify quantitative acceptance criteria or report specific performance metrics for the Intermed Zoom Colposcope. Instead, it states: "Non-clinical testing has demonstrated that any differences in technological characteristics, does not adversely affect the intended use, performance, or safety of the device." This implies the "acceptance criteria" were met by demonstrating that the device functions comparably to predicate devices in terms of its intended use.

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

Not applicable. The submission does not describe a test set or a study with performance data. The "non-clinical testing" mentioned is not detailed, but generally, for substantial equivalence, it would involve internal engineering verification and validation, not a formal clinical test set with human subjects and ground truth for performance evaluation in the way a new AI/diagnostic device would be studied.

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

Not applicable. No test set requiring expert-established ground truth is described.

4. Adjudication Method for the Test Set:

Not applicable. No test set is described.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done:

No. An MRMC study was not done. This submission focuses on technological equivalence, not comparative effectiveness with human readers.

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

Not applicable. This device is a colposcope, a medical instrument operated by a human, not an algorithm.

7. The Type of Ground Truth Used:

Not applicable. No ground truth is described in the context of device performance evaluation in the provided summary. The "purpose of diagnosing abnormalities and selecting areas for biopsy" refers to the intended clinical use by a medical professional, not a ground truth for evaluating the device itself.

8. The Sample Size for the Training Set:

Not applicable. This device is a hardware medical instrument, not a machine learning algorithm that requires a training set.

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

Not applicable. No training set is described.

Summary of the basis for device acceptance:

The Intermed Zoom Colposcope's acceptance, as indicated by the 510(k) clearance (K031639), is based on substantial equivalence to legally marketed predicate devices: Accuscope (K913365), Wallach Zoom Colposcope (K853389), and LM1Z Zoom Scope (K902313).

The submission states:

• Technological Similarity: The Intermed Zoom Colposcope utilizes "technologically similar, commercially available optical systems configured in a like manner" and "technologically similar 150watt halogen light sources with integrated green filters" compared to the predicate devices.
• Non-clinical Testing: "Non-clinical testing has demonstrated that any differences in technological characteristics, does not adversely affect the intended use, performance, or safety of the device." This implies that internal tests confirmed the device's basic functionality and safety were comparable.
• Intended Use: The intended use is identical to the predicate devices: "direct magnified viewing of the cervix, vagina, and external genitalia for the purpose of diagnosing abnormalities and selecting areas for biopsy."

In essence, the "study" demonstrating the device meets "acceptance criteria" here is the analysis of technological characteristics and intended use compared to predicate devices, and the conclusion that any differences do not negatively impact safety or effectiveness. This is a common pathway for medical device clearance when a new device is very similar in design and function to existing ones.

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