(168 days)
The MASCT device is intended for use in the collection of nipple aspirate fluid for laboratory cytological testing.
The Nastech MASCT device is similar to the non-powered breast pumps Manufactured by Windy Hill Technology used to elicit and collect nipple aspirate fluid (NAF) from the excretory ducts (tubuli lactiferi or galactophori). The device is comprised of a rigid polycarbonate cup in which the sample collection container is inserted. Negative pressure (vacuum) is produced by non-powered (hand) actuations of a lever like handle. The expressed NAF sample is collected on a membrane filter and washed into the sample container using an appropriate fixative solution.
The provided text describes a 510(k) summary for the Nastech Mammary Aspiration Specimen Cytology Test (MASCT) device. However, it does not contain the detailed information necessary to fully answer all aspects of your request regarding acceptance criteria and the comprehensive study that proves the device meets those criteria. The document explicitly states that "Nastech conducted in-vitro and clinical studies to verify and validate the device design. The results of that testing supported the conclusion that the MASCT device is safe and effective for its intended use." However, it does not provide specific details about the acceptance criteria, the reported device performance, the study design (e.g., sample sizes, ground truth establishment, expert qualifications, adjudication methods), or any comparative effectiveness studies with human readers.
Therefore, the following response will reflect the information available and indicate where details are missing.
Description of Acceptance Criteria and Proving Study for the Nastech Mammary Aspiration Specimen Cytology Test (MASCT)
The provided 510(k) summary indicates that Nastech conducted studies to support the safety and effectiveness of the MASCT device and its substantial equivalence to a predicate device. However, the document does not explicitly define specific numerical acceptance criteria and does not detail the results of the studies in terms of specific performance metrics against such criteria. The basis for acceptance appears to be the successful demonstration of substantial equivalence to a legally marketed predicate device (Windy Hill Technology DucPrep™ Breast Aspirator).
1. Table of Acceptance Criteria and Reported Device Performance
As the document does not present specific acceptance criteria or quantitative performance metrics, a table cannot be fully populated. The primary "acceptance criterion" implied by the 510(k) process is demonstrating substantial equivalence to a predicate device in terms of safety, effectiveness, and technological characteristics.
| Acceptance Criterion | Reported Device Performance |
|---|---|
| Safety | Demonstrated safe in in-vitro and clinical studies. (Specific metrics not provided) |
| Effectiveness | Demonstrated effective for its intended use in in-vitro and clinical studies. (Specific metrics not provided) |
| Substantial Equivalence (to Windy Hill Technology DucPrep™ Breast Aspirator) | Demonstrated to share similar design, material, and operating characteristics, and intended use as the predicate device. |
| Intended Use Fulfilled | Successfully collects nipple aspirate fluid for laboratory cytological testing. (Specific success rates not provided) |
2. Sample Size Used for the Test Set and Data Provenance
The document states that "Nastech conducted in-vitro and clinical studies," but does not provide any specific sample sizes for these studies, nor does it detail the data provenance (e.g., country of origin, retrospective or prospective nature).
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
The document does not provide any information regarding the number of experts used, their qualifications, or how ground truth was established for any test sets.
4. Adjudication Method for the Test Set
The document does not provide any information regarding an adjudication method for the test set.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
The document does not mention or describe a Multi-Reader Multi-Case (MRMC) comparative effectiveness study. Given the nature of a device for collecting biological samples, such a study focusing on human reader improvement with AI would not be directly applicable, as the device's function is collection, not interpretation via AI.
6. Standalone (Algorithm Only) Performance Study
The document does not describe a standalone performance study. The MASCT device is a physical instrument for sample collection, not an algorithm. Therefore, an "algorithm only" performance study is not relevant to this device.
7. Type of Ground Truth Used
The document does not specify the type of ground truth used for any studies. For a device collecting samples for cytological testing, relevant ground truth might involve the clinical diagnosis, pathology reports from biopsies, or long-term patient outcomes, but this is not detailed.
8. Sample Size for the Training Set
The document does not provide any information regarding a training set or its sample size. This is consistent with the device being a physical collection instrument rather than an AI/ML-based diagnostic algorithm.
9. How Ground Truth for the Training Set Was Established
As no training set is mentioned or implied for this device, the document does not provide information on how ground truth for a training set was established.
§ 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.