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The ETO sterilized MAS w/ Syringe is used to obtain a sample of differential endometrial tissue. The MAS w/ syringe is a 3mm (O.D.) endometrial suction device that has a Randall-like cutting edge at its distal end and is packaged with a twist-and-lock syringe. The syringe will provide a vacuum or suction during the procedure. The MAS w/ syringe is sterile unless the package is opened or damaged and designed for single patient use only.

The ETO sterilized MAS without syringe is used to obtain a sample of differential endometrial tissue. The MAS is a m 3.5mm (O.D.) endometrial suction curette that has a fenestration on the wall at its distal end and a tight fitting piston that will provide a vacuum or suction during the procedure as it is pulled proximally. The MAS is sterile unless the package is opened or damaged and designed for single patient use only.

The provided text describes a 510(k) summary for the "Marina Ampler Sampler (MAS) with and without syringe," which is an endometrial suction curette. The document aims to demonstrate substantial equivalence to a predicate device, the "Curelle from Bioteque Corporation" (510k #K915491).

However, the submission does not contain acceptance criteria for a device's performance that would require a study to prove it meets those criteria. Instead, it focuses on demonstrating substantial equivalence in technological characteristics to a legally marketed predicate device.

Therefore, the requested information cannot be fully provided as it pertains to a different type of validation and performance evaluation than what is presented in this 510(k) summary.

Here's an breakdown of why the requested information isn't available in this document:

1. Acceptance criteria and reported device performance (Table): Not applicable. This document is a 510(k) summary for a Class II device, where the primary goal is to show the new device is as safe and effective as a predicate device, not necessarily to meet specific, quantifiable performance thresholds with a new, standalone study. The table provided (paragraph 14) compares technological characteristics to the predicate device, not performance against pre-defined acceptance criteria. The performance is stated as "Identical" to the predicate.

2. Sample size, data provenance for test set: Not applicable. No clinical outcome or diagnostic performance test set is described. The comparison is based on design, materials, and intended use as compared to the predicate device.

3. Number of experts and qualifications for ground truth: Not applicable. Ground truth, as typically used in the context of diagnostic accuracy studies (e.g., for AI/imaging devices), is not established or discussed here.

4. Adjudication method: Not applicable. No test set requiring expert adjudication for ground truth is present.

5. Multi-reader multi-case (MRMC) comparative effectiveness study: Not applicable. This is a medical device (endometrial suction curette), not an AI/imaging diagnostic device that would typically undergo such a study to evaluate human reader improvement with AI assistance.

6. Standalone (algorithm only) performance: Not applicable. This device is a manual medical instrument not an algorithm.

7. Type of ground truth used: Not applicable. As explained above, ground truth in the context of performance evaluation of diagnostic algorithms is not part of this submission. The "ground truth" for this 510(k) is the established safety and effectiveness of the predicate device.

8. Sample size for training set: Not applicable. This is not an AI/machine learning device. No training set is involved.

9. How ground truth for training set was established: Not applicable.

Summary of Device Equivalence (from Paragraph 14):

The submission demonstrates substantial equivalence by comparing the Marina Ampler Sampler (MAS) with and without syringe to the predicate device, Curelle from Bioteque Corporation (510k #K915491), based on technological characteristics.

The study described here is a comparison of technological characteristics to demonstrate substantial equivalence to a legally marketed predicate device, rather than a performance study against predefined acceptance criteria for a novel device or an AI algorithm.

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