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The DucPrep Breast Aspirator device is used to elicit fluid from multiple ductal orifices for subsequent cytological evaluation and/or to identify ductal orifices for subsequent cannulation with the WHT Fuji Catheter.

The Windy Hill Technology DucPrep breast aspirator device is similar to nonpowered breast pumps used to express mill in lactating women. The device is comprised of a rigid polycarbonate cup which is connected to a small piece of polymer tubing. A flexible, silicone insert is placed inside of the rigid polycarbonate cup prior to device placement around the breast nipple. The tubing is attached to a standard syringe which is used to pull a gentle vacuum to express breast ductal fluid. The device is packaged in a Tyvek® pouch.

The provided text describes a medical device, the Windy Hill Technology DucPrep™ Breast Aspirator, and its clearance process, but it does not contain acceptance criteria or detailed study results that prove the device meets specific acceptance criteria.

The document states:

• "WHT conducted laboratory and clinical testing to demonstrate the safe and effective use of the WHT Device."
• "Laboratory testing was conducted to evaluate specific device performance parameters."
• "Clinical testing was conducted to evaluate human use of the device in human subjects. This testing supported that use of the Windy Hill Technology DucPrep Breast Aspirator is both safe and effective for its intended use."

However, it does not provide any quantitative or qualitative acceptance criteria (e.g., "device must reliably express fluid in X% of cases," or "flow rate must be Y ml/min") nor does it present the reported device performance data against any such criteria. It also does not explicitly describe the studies in a way that allows for the extraction of the requested information (sample sizes, ground truth, expert qualifications, etc.).

Therefore, I cannot fully complete the table or answer all your questions as the specific details are not present in the provided text.

Here's what can be inferred or stated based on the available information:

Acceptance Criteria and Reported Device Performance

Study Information

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

   • Sample Size: Not specified.
   • Data Provenance: Clinical testing was conducted in "human subjects." The country of origin and whether it was retrospective or prospective is not specified.

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

   • Not specified. The purpose of the device is for "subsequent cytological evaluation" and "to identify ductal orifices for subsequent cannulation," implying that the end analysis would involve medical experts (e.g., pathologists for cytology, and clinicians for cannulation), but the document does not detail how ground truth was established for the device's performance in its own studies.

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

   • Not specified.

4. 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/Not mentioned. This device is a physical aspirator, not an AI-powered diagnostic tool engaging human readers for interpretation.

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

   • Not applicable. This is a physical medical device.

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

   • The document implies that the device enables the collection of samples for "cytological evaluation" (pathology) or for "identifying ductal orifices" (clinical observation/procedure). However, it does not explicitly state what ground truth was used to validate the aspirator's own performance (e.g., its ability to elicit fluid, or its safety).

7. The sample size for the training set:

   • Not applicable/Not specified. This is a physical device, and the concept of a "training set" as understood in AI/algorithm development does not apply here.

8. How the ground truth for the training set was established:

   • Not applicable.

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The Fuji Catheter is designed to perform contrast enhanced radiography of breast milk ducts. It may also be used for the collection of cells and/or fluid for cytological analysis.

The Windy Hill Technology Fuii Catheter is a dual lumen device with a flexible shaft. The hub located at the proximal end of the Fuii Catheter has two branches which each correspond with a single port. The entry port is used for saline or contrast infusion and is marked with an arrow pointing in the distal direction of the catheter. The corresponding entry lumen is located at the distal end of the catheter, adjacent to the 1 cm marker. The exit port is used for fluid collection and for quidewire introduction and is marked with an arrow pointing in the proximal direction of the catheter. The corresponding exit lumen is located at the distal tip of the catheter. The device is provided sterile and is intended for single use only.

This document describes a medical device, the Windy Hill Technology Fuji Catheter, submitted for 510(k) clearance, which is a premarket submission made to FDA to demonstrate that the device is at least as safe and effective as a legally marketed device (predicate device). Therefore, the provided text does not contain information about acceptance criteria or a study designed to prove a device meets specific performance criteria in the way a clinical trial for a new drug or a novel AI diagnostic device would.

Based on the provided text, here’s a breakdown of the information that is available, and what is not:

1. A table of acceptance criteria and the reported device performance: Not applicable. This document is for a 510(k) submission for a manual surgical instrument, not a device with quantifiable performance metrics like sensitivity/specificity that would require acceptance criteria in this format. The submission relies on demonstrating substantial equivalence to predicate devices through laboratory, preclinical, and clinical testing in terms of safety and effectiveness for its intended use.

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

   • Test Set Sample Size: Not explicitly stated. The document mentions "clinical testing was conducted to evaluate human use of the device in pre-mastectomized or lumpectomized breasts," but the number of subjects is not provided.
   • Data Provenance: The preclinical testing used a "human cadaver model." The clinical testing was on "pre-mastectomized or lumpectomized breasts" (implying human subjects, and likely prospective data collection for the study). Country of origin is not specified, but the applicant (Windy Hill Technology, Inc.) is based in Menlo Park, California, USA, suggesting the studies likely occurred in the USA.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable/not provided. For a manual surgical instrument, "ground truth" in the context of diagnostic accuracy (like for an imaging AI) is not the relevant paradigm. The "clinical testing" would likely focus on ease of use, safety, and ability to perform the intended function (e.g., successful contrast delivery, successful fluid collection), which would be observed and assessed by medical professionals during the procedure, rather than establishing a diagnostic ground truth against which the device's output is compared.

4. Adjudication method for the test set: Not applicable/not provided. Since this is not a diagnostic reader study, an adjudication method for reconciling expert opinions on diagnostic outcomes is not relevant here.

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 a "manual surgical instrument," not an AI or imaging device designed to be read by human readers. Therefore, an MRMC study and AI assistance are not relevant to this submission.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is a manual surgical instrument, not an algorithm.

7. The type of ground truth used: For the clinical testing, the "ground truth" would be related to the successful performance of the device's intended functions (contrast enhanced radiography of breast milk ducts, collection of cells/fluid for cytological evaluation) and safety observations, rather than a diagnostic 'ground truth' in the sense of a disease state. Pathology or cytological evaluation of collected samples would be considered the ground truth for the use of the device in collecting samples, but not for the device's intrinsic function itself.

8. The sample size for the training set: Not applicable. This is a physical medical device, not a machine learning algorithm that requires a training set. The "testing" mentioned refers to traditional engineering, preclinical, and clinical evaluations.

9. How the ground truth for the training set was established: Not applicable, as there is no training set for this type of device.

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