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The InPath™ e² Collector™ is intended for the collection of cervical cytology specimens for Pap test analysis. The InPath™ e² Collector™ should not be used after the first 10 weeks of gestation in pregnant patients.

The InPath e2 Collector (e2 Collector) is a multi-component assembly for the collection and transport of exfoliated cervical epithelial cells. The major e2 Collector components are a balloon that provides the conformal surface upon which the cells are collected, and a handle that provides a means of manipulating and expanding the balloon during the sampling process. The balloon consists of a medical grade silicone and colorant. The tip of the balloon is designed to be expanded during sampling by at least a factor of two over its resting diameter to accommodate the range of endocervical canal diameters commonly encountered in clinical practice. The body of the balloon is sized to collect cells from an area of the ectocervix, centered on the cervical canal, which is approximately 23 mm-diameter. The balloon tip measures about 3 mm in diameter, and 12 mm in length when uninflated, and it can be introduced without difficulty to the endocervix.

The provided text describes the "InPath™ e2 Collector™" and its substantial equivalence to predicate devices, but it does not contain detailed information about specific acceptance criteria or a dedicated study that proves the device meets such criteria.

The text focuses on the device description, intended use, and a conclusion of substantial equivalence based on "essentially identical indications for use, substantially equivalent principles of operation, and clinical trial results that demonstrate performance equal to, or better than, the predicate devices." However, it does not elaborate on these "clinical trial results" or define the acceptance criteria used.

Therefore, many of the requested items cannot be definitively answered from the provided text.

Here is a breakdown of what can and cannot be extracted:

1. Table of Acceptance Criteria and Reported Device Performance:

The document does not provide a specific table of acceptance criteria or detailed reported device performance metrics. It only states: "clinical trial results that demonstrate performance equal to, or better than, the predicate devices." Without the actual performance metrics or defined criteria, this table cannot be populated.

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

• Sample size for test set: Not specified in the provided text.
• Data provenance (country of origin, retrospective/prospective): Not specified in the provided text.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

Not specified in the provided text.

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

Not specified in the provided text.

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:

• MRMC study: Not explicitly mentioned. Given the device is a collection tool and not an AI-assisted diagnostic, an MRMC study with AI assistance is unlikely to be relevant to this specific device. The device is for collection of samples for Pap test analysis, not for the analysis itself.
• Effect size of human reader improvement with AI: Not applicable, as this is a collection device, not an AI-driven diagnostic.

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

Not applicable. The device is a physical collection tool, not an algorithm. Performance would inherently involve human use (collecting the sample).

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

Not specified. The clinical trial results are broad and not detailed. For a collection device for cervical cytology, ground truth would typically relate to the quality and adequacy of the collected sample for subsequent Pap test analysis, which can involve expert cytopathologist review or correlation with follow-up pathology. However, this is not stated.

8. The sample size for the training set:

Not applicable. This is a physical device, not a machine learning algorithm 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 this type of device.

Summary of available information:

The document primarily acts as a 510(k) summary, establishing substantial equivalence to predicate devices (Digene Cervical Brush and Rovers Cervex-Brush) based on:

• Identical indications for use.
• Substantially equivalent principles of operation.
• "Clinical trial results that demonstrate performance equal to, or better than, the predicate devices."

However, the specific details of these "clinical trial results," the acceptance criteria they met, and the methodologies used (sample sizes, ground truth establishment, expert involvement, etc.) are not present in the provided text. This document is a high-level summary for regulatory clearance, not a detailed study report.

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