Search Results

The 0.9% Sodium Chloride Injection, USP BD Pre-Filled Flush Syringes are intended for use in maintaining patency of vascular access devices (VAD'S).

A comparison between the new 0.9% Sodium Chloride Injection, USP BD Pre-Filled Flush Syringe and the existential BD Preefil Normal Saline Flush Syringe is provided in the table below:

| Component/
Characteristic | 0.9% Sodium Chloride
Injection, USP BD Pre-
Filled Flush Syringe | BD Preefil Normal
Saline Flush Syringe |
|------------------------------|------------------------------------------------------------------------|-------------------------------------------|
| Barrel, Plunger Rod, Tip cap | Polypropylene | Polypropylene |
| Lubricant | Medical Grade Silicone | Medical Grade Silicone |
| Plunger Tip (stopper) | Latex Free Synthetic
Rubber | Latex Free Synthetic
Rubber |
| Syringe Tip | Luer Lok | Luer Lok |
| Saline Solution | 0.9% Sodium Chloride
Injection, USP | 0.9% Sodium Chloride
Injection, USP |
| Process | Aseptic Fill | Aseptic Fill |

The provided text describes a 510(k) Premarket Notification for a medical device: the "0.9% Sodium Chloride Injection, USP BD Pre-Filled Flush Syringe". This type of submission is for demonstrating substantial equivalence to a predicate device, not for proving that a device meets specific performance acceptance criteria through clinical studies as would typically be described in an AI/ML context.

Therefore, the requested information regarding acceptance criteria, study details, sample sizes, expert ground truth, adjudication methods, MRMC studies, standalone performance, and training set details cannot be extracted from this document because:

• The document is a 510(k) submission, not a performance study report. It focuses on comparing the new device to a legally marketed predicate device to demonstrate that it is "substantially equivalent" in terms of intended use, technological characteristics, and safety and effectiveness.
• The device is a pre-filled flush syringe, not an AI/ML device. The questions you've asked are highly specific to the evaluation of AI/Machine Learning models, which use algorithms and data to make predictions or classifications. A pre-filled syringe is a physical medical product.

Here's what can be extracted and why the other information is not present:

1. A table of acceptance criteria and the reported device performance:

• Not applicable in the typical sense for a 510(k) submission of this type of device. The "acceptance criteria" here is primarily the demonstration of substantial equivalence to the predicate device, especially regarding design, materials, manufacturing process, and intended use. There are no performance metrics like sensitivity, specificity, accuracy, etc., for a product like a saline flush syringe in this document.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Not applicable. This document does not describe a "test set" in the context of an AI/ML algorithm evaluation. The comparison is based on materials, design, and manufacturing processes, not empirical data from a clinical trial or performance study with a "test set" of patient data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

• No experts used for "ground truth" in this context. The "ground truth" for a device like a syringe is its compliance with specifications, sterility, material properties, and functionality, which are assessed through engineering and quality control tests, not expert human review of data.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

• Not applicable. No adjudication method is described because there is no "test set" or diagnostic/interpretive task involved.

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

• Not applicable. MRMC studies are for evaluating the performance of diagnostic imaging devices or AI tools that assist human readers. This device is a saline flush syringe.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

• Not applicable. This pertains to AI algorithms.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

• Not applicable/Different definition of "ground truth". For this device, "ground truth" would be established by physical and chemical testing of the syringe and its contents (e.g., sterility tests, particulate matter tests, chemical analysis of saline, dimensional checks, functional tests for plunger movement and seal integrity, biocompatibility tests for materials). This document does not detail those specific test methods or their results as it is merely a summary for substantial equivalence.

8. The sample size for the training set

• Not applicable. This pertains to AI algorithms.

9. How the ground truth for the training set was established

• Not applicable. This pertains to AI algorithms.

In summary: The provided document is a regulatory submission demonstrating substantial equivalence for a physical medical device (a pre-filled saline flush syringe). It is not a clinical study report for an AI/ML device, hence the absence of information related to AI-specific evaluation criteria.

Ask a specific question about this device

Ask a specific question about this device