(75 days)
Dey Vial Sodium Chloride 3% and 10% are used in conjunction with a nebulizer for the induction of sputum production where specimen collection is indicated.
DEY-PAK® Sodium Chloride Solution 3% and 10% solutions are contained in a 15 mL polyethylene vial. The vials have a tear-off top and a lower tab for displaying the lot number and expiration date. One side of the vial has pressure sensitive label and the other side is blank. The vials are supplied in cartons of 50 vials.
The provided document is a 510(k) premarket notification for a medical device (DEY-PAK® Sodium Chloride Solution 3% and 10%). This type of document focuses on demonstrating substantial equivalence to a predicate device, rather than proving performance against specific acceptance criteria through clinical studies. Therefore, the document does not contain the information requested for a detailed study description or acceptance criteria and reported device performance in the context of an algorithm or AI system.
Here's a breakdown of why the requested information cannot be extracted from this document:
- Type of Device: The device is a sodium chloride solution used with a nebulizer, a pharmaceutical product, not an AI/algorithm-based diagnostic or treatment system.
- Regulatory Pathway: A 510(k) submission primarily establishes that a new device is "substantially equivalent" to a legally marketed predicate device. This typically involves comparing design, materials, chemical composition, energy source, manufacturing processes, and performance (if applicable, through bench testing or non-clinical data) to the predicate. It does not generally require or present the type of clinical trial data with acceptance criteria, ground truth, and reader studies that would be associated with AI or imaging devices.
- Lack of AI/Algorithm: There is no mention of any AI component, algorithm, or software in the device description or intended use.
Therefore, I cannot provide the requested information from this document.
If this were a document for an AI-powered medical device, the following information would typically be present and could be extracted:
- Table of Acceptance Criteria and Reported Device Performance: This would specify metrics like sensitivity, specificity, AUC, or F1-score with corresponding thresholds and the device's actual performance against those thresholds in a test set.
- Sample Size and Data Provenance for Test Set: Details on the number of cases (e.g., images, patient records) used for testing, their origin (e.g., specific hospitals, geographical regions), and whether the data was collected retrospectively or prospectively.
- Number and Qualifications of Experts for Ground Truth: Information about how many human experts (e.g., radiologists, pathologists) reviewed the test cases to establish the definitive diagnosis, and their experience levels (e.g., board-certified, years of experience).
- Adjudication Method: How disagreements among experts were resolved (e.g., majority vote, senior expert arbitration).
- Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study: If human reader performance with and without AI assistance was evaluated, and the statistical effect size of improvement.
- Standalone Performance: Data on the algorithm's performance without any human intervention.
- Type of Ground Truth: Whether the truth was established by expert consensus, histological pathology, long-term patient outcomes, or another definitive method.
- Sample Size for Training Set: The total number of cases used to train and validate the AI model.
- Ground Truth Establishment for Training Set: How the labels or diagnoses for the training data were determined.
None of these elements are present in the provided 510(k) summary for the DEY-PAK® Sodium Chloride Solution.
§ 868.5630 Nebulizer.
(a)
Identification. A nebulizer is a device intended to spray liquids in aerosol form into gases that are delivered directly to the patient for breathing. Heated, ultrasonic, gas, venturi, and refillable nebulizers are included in this generic type of device.(b)
Classification. Class II (performance standards).