(89 days)
0.9% Sodium Chloride I.V. Flush Syringe for Sterile Delivery is intended for use in flushing compatible intravenous administration sets and indwelling intravenous access devices. Use according to the recommendations for the appropriate device. May be placed on a sterile field.
The 0.9% Sodium Chloride I.V. Flush Syringe for Sterile Delivery is a sterile, single-use, prefilled 12 mL syringe containing 10 mL of 0.9% Sodium Chloride Injection, USP. The pre-filled syringes are provided in two packaging configurations: 1) single syringe or 2) two (2) syringes. The device may be used in the sterile field as they are sterilized post-packaging.
The provided text is related to a 510(k) premarket notification for a medical device (0.9% Sodium Chloride I.V. Flush Syringe for Sterile Delivery). It details the device's description, indications for use, comparison to a predicate device, and a summary of non-clinical testing.
However, the questions you've asked (related to acceptance criteria and study design for proving device performance, especially concerning AI/human reader studies, ground truth establishment, training set size, etc.) are not covered in this document. This document focuses on the safety and effectiveness of a physical medical device (a pre-filled syringe with saline), not a diagnostic algorithm or AI-powered system.
Therefore, I cannot extract the information requested from the provided text. The document does not describe:
- A table of acceptance criteria and reported device performance related to diagnostic accuracy or AI performance. The table provided is for physical/chemical properties and sterility.
- Sample sizes used for a "test set" in the context of an AI study. The sample sizes mentioned are for specific non-clinical tests (e.g., cytotoxicity, sterility).
- Data provenance (country of origin, retrospective/prospective) for AI data.
- Number of experts and their qualifications for establishing ground truth.
- Adjudication methods.
- MRMC comparative effectiveness studies.
- Standalone algorithm performance.
- Type of ground truth (expert consensus, pathology, outcomes data).
- Sample size for a training set.
- How ground truth for a training set was established.
The document's "Summary of Non-Clinical Testing" section outlines the tests performed to demonstrate the device's conformance to established standards for safety and performance (e.g., biocompatibility, sterility, shelf life, chemical composition). The acceptance criteria are specified for each of these physical and chemical tests, and the results uniformly state "Pass."
§ 880.5200 Intravascular catheter.
(a)
Identification. An intravascular catheter is a device that consists of a slender tube and any necessary connecting fittings and that is inserted into the patient's vascular system for short term use (less than 30 days) to sample blood, monitor blood pressure, or administer fluids intravenously. The device may be constructed of metal, rubber, plastic, or a combination of these materials.(b)
Classification. Class II (performance standards).