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510(k) Data Aggregation
(87 days)
The MASCT device is intended for use in the collection of nipple aspirate fluid for cytological testing. The collected fluid can be used in the determination and/or differentiation of normal versus premalignant versus malignant cells.
The Nastech MASCT device is similar to the non-powered breast aspirators manufactured by Nastech Pharmaceutical Company, Inc. and Pro-Duct Health, Inc. 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 nonpowered (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.
Here's an analysis of the provided text regarding the acceptance criteria and supporting study for the Nastech Pharmaceutical Company, Inc. Mammary Aspiration Specimen Cytology Test (MASCT) device:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are implicitly derived from the study's stated objective to demonstrate the device's ability to collect sufficient samples for cytological analysis and to support the claim that the collected cells can be used to identify differences associated with premalignant or malignant conditions.
| Acceptance Criteria Category | Specific Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Sample Collection Success | All breasts evaluated yield nipple aspirate fluid (NAF). | 100% of breasts evaluated yielded nipple aspirate fluid. |
| Sample Sufficiency for Cytological Analysis | All collected samples are clinically useful and sufficient for cytological analysis by a pathologist. | All samples were sufficient for cytological analysis; the pathologist was able to read all samples and obtain cytology results. |
| Cytological Data Quality | The device enables the collection of cells that can be used to identify differences (normal, premalignant, malignant) through cytological examination. | 97% of samples were Class I (normal/benign); 3% were Class IIa (benign). These results support the claim for identifying cell differences. |
| Sample Weight (Implicit) | While not an explicit "acceptance criterion," the viability of collecting samples above a minimal weight threshold for practical handling/analysis is implied. | Mean sample weight was 6.6 mg, range <1 to 37 mg. Even samples reported as <1 mg due to weighing variability were sufficient for cytological analysis. |
2. Sample Size Used for the Test Set and Data Provenance
- Test Set Sample Size: 60 samples (from 30 patients, right and left breasts).
- Data Provenance: The study was a "clinical study conducted by Nastech," implying it was prospective and likely conducted in the country where Nastech is based (USA, as inferred from the address). No specific country of origin for the data is explicitly stated beyond "clinical study by Nastech."
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
- Number of Experts: One pathologist is explicitly mentioned as reading all samples.
- Qualifications of Experts: The text only states "pathologist" and "trained individuals" for cytological examinations. No specific experience level (e.g., "10 years of experience") is provided.
4. Adjudication Method for the Test Set
- Adjudication Method: Not applicable/Not explicitly stated. The text indicates that "the pathologist was able to read all of the samples and cytology results were obtained," implying a single pathologist's assessment formed the basis of the results. There is no mention of multiple experts or an adjudication process for resolving discrepancies.
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
- MRMC Study: No. This device is a fluid collection device, not an AI or image analysis tool. Therefore, an MRMC comparative effectiveness study comparing human readers with and without AI assistance is not relevant or applicable to the stated purpose of this device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Standalone Performance: No. This device is a manual fluid collection tool. Standalone algorithm performance is not applicable. The device's output (nipple aspirate fluid) requires human intervention (a pathologist) for interpretation.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Type of Ground Truth: The ground truth for the interpretability of the samples was established by pathological evaluation (cytological analysis) of the collected nipple aspirate fluid. The study primarily aimed to prove that the device successfully collects samples suitable for such analysis, not to validate the accuracy of cytological interpretation against a "true" disease state (e.g., biopsy). It showed that the yielded cytology results were either Class I or Class IIa (both benign).
8. The Sample Size for the Training Set
- Training Set Sample Size: The document does not mention a training set. This is not an AI/machine learning device, so the concept of a "training set" for algorithm development is not applicable. The clinical study described served as the validation (test) set for the device's performance in collecting samples.
9. How the Ground Truth for the Training Set was Established
- Ground Truth for Training Set: Not applicable, as there was no training set for an algorithm.
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