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The CrossGlideTM ETS, Endometrial Tissue Sampler, is indicated for use to remove material from the uterus and from the mucosal lining of the uterus by scraping and vacuum suction in order to obtain tissue for histological biopsy.

The CrossGlide™ ETS, Endometrial Tissue Sampler, is a sterile, disposable, single-use device which enables the removal of mucosal tissue from the uterus for histological biopsy. The CrossGlide™ ETS contains a Delivery Catheter with an everting Membrane and an Inner Aspiration Catheter. The everting Membrane places the Inner Aspiration Catheter into the uterine cavity. Movement of the ETS device, after creating negative pressure with the 3cc syringe, removes material and tissue from the uterine cavity.

The provided text describes the CrossGlide™ ETS, an Endometrial Tissue Sampler, and its submission for FDA 510(k) clearance. The document focuses on establishing substantial equivalence to a predicate device rather than presenting a standalone study with detailed acceptance criteria and performance data for the device itself.

Based on the information provided, here's a breakdown of the requested elements:

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

The document does not explicitly state quantitative acceptance criteria or a specific study that proves the device meets these criteria in the context of clinical performance (e.g., diagnostic accuracy or tissue yield). Instead, it lists various tests conducted to demonstrate substantial equivalence to a predicate device and safety/functionality.

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

The document does not mention a clinical test set in the traditional sense of patient data for evaluating diagnostic or clinical performance. The "test sets" mentioned relate to engineering and safety validation:

• Biocompatibility tests: Sample sizes are typically small and determined by the specific ISO standard. Data provenance is implied to be from laboratory testing performed by the manufacturer or contracted labs.
• Sterilization validation: Sample sizes are determined by AAMI/ISO standards. Data provenance is from laboratory testing.
• Packaging, Shipping, Shelf-Life & Device Functionality: Sample sizes are determined by specific ASTM guidance. Data provenance is from laboratory testing.
• Functional testing (uterine model): The specific number of devices tested on the uterine model is not provided. Data provenance is from laboratory testing using a physical model, not human data.

There is no mention of country of origin for any human data or whether studies were retrospective or prospective, as no human studies are described in detail.

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

Not applicable. There is no described "test set" of patient cases requiring expert interpretation to establish ground truth for clinical performance. The ground truth for the engineering and safety tests would be defined by the specifications of the standards (e.g., whether a material is cytotoxic, whether a sterile barrier is maintained, whether a specific force is withstood).

4. Adjudication method for the test set

Not applicable. As no clinical test set requiring expert interpretation is described, no adjudication method is mentioned.

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 an endometrial tissue sampler, a physical medical device for tissue collection, not an AI-powered diagnostic tool. Therefore, an MRMC study related to AI performance is irrelevant to this submission.

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

Not applicable. This is not an algorithm or AI device.

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

For the engineering and safety studies described:

• Biocompatibility: Ground truth is against established limits and responses per ISO standards.
• Sterilization: Ground truth is against sterility assurance levels (SALs) defined by AAMI/ISO standards, and residual limits.
• Mechanical/Functional: Ground truth is against design specifications and functional requirements (e.g., maintaining negative pressure, correct deployment).
• Uterine Model: Ground truth for comparison would be the ability to successfully deploy and collect "specimens" from the model as intended by the device design, presumably measured by quantitative factors or visual assessment of model interaction.

8. The sample size for the training set

Not applicable. This is not an AI/algorithm device that requires a training set.

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

Not applicable.

Summary Conclusion from the Document:

The provided document (a 510(k) summary) focuses on demonstrating substantial equivalence of the CrossGlide™ ETS to a legally marketed predicate device (Marina Ampler (MAS), K021876). The "study" described is a collection of engineering and validation tests (biocompatibility, sterilization, packaging, shelf-life, and functional testing using a uterine model) to ensure the new device is safe and performs as intended, and that its differences from the predicate device do not raise new questions of safety or effectiveness. It does not present a clinical study with detailed acceptance criteria for diagnostic performance or tissue yield, as would be common for diagnostic AI tools.

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