(79 days)
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
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not specified in the document | Not specified in the document (Simply stated that testing "supported that use... is both safe and effective") |
Study Information
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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.
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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.
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Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not specified.
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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.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is a physical medical device.
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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).
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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.
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How the ground truth for the training set was established:
- Not applicable.
§ 876.1075 Gastroenterology-urology biopsy instrument.
(a)
Identification. A gastroenterology-urology biopsy instrument is a device used to remove, by cutting or aspiration, a specimen of tissue for microscopic examination. This generic type of device includes the biopsy punch, gastrointestinal mechanical biopsy instrument, suction biopsy instrument, gastro-urology biopsy needle and needle set, and nonelectric biopsy forceps. This section does not apply to biopsy instruments that have specialized uses in other medical specialty areas and that are covered by classification regulations in other parts of the device classification regulations.(b)
Classification. (1) Class II (performance standards).(2) Class I for the biopsy forceps cover and the non-electric biopsy forceps. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.