Search Results

The Sterile Auto-Disable syringes with/without needle for single use is used for aspiration of fluids from vials and ampoules and a variety of fluid injections below the surface of the skin except phlebotomy.

The Sterile Auto-Disable syringes with/without needle for single use is a syringe with or without needle, sterile, single use hypodermic syringe with a 6% (Luer) male connector/lock fitting in various sizes. The syringe assembly consists of a lubricated polypropylene barrel with a graduated scale, a lubricated synthetic rubber stopper and a polypropylene plunger rod. The plunger rod is pulled back to aspirate fluids or depressed to inject or expel fluids. The main principle of the syringe is that after the injection is completed, the device automatically locks the plunger to prevent reuse.

The provided text describes a 510(k) premarket notification for a medical device called "Sterile Auto-Disable Syringes with/without Needle for Single Use." The submission aims to demonstrate substantial equivalence to a legally marketed predicate device. The information details the device, its intended use, and a comparison to the predicate, along with performance testing conducted.

Here's an analysis of the provided text in relation to your request for acceptance criteria and the study proving the device meets them:

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

The document does not explicitly state "acceptance criteria" with numerical targets in a tabular format as you might expect for a specific performance metric (e.g., "accuracy > 90%"). Instead, it states that the device's performance "complies with" or "conforms to" various ISO standards. For medical devices like syringes, these standards themselves define the performance requirements and test methods. Therefore, the "acceptance criteria" are implicitly the requirements set forth by these international standards, and the "reported device performance" is that the device meets those standards.

Below is a table constructed from the "Performance testing" section, indicating the relevant standards as acceptance criteria and the reported performance as compliance with these standards.

2. Sample size used for the test set and the data provenance

The document does not specify the sample size used for any of the performance tests.
The document does not specify the data provenance (e.g., country of origin of the data, retrospective or prospective). These details are typically found in the full test reports, which are summarized here.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

This information is not applicable to this type of device and study. The testing for a syringe involves physical, chemical, and biological performance against standardized criteria, not interpretation by human experts to establish a "ground truth" like in imaging or diagnostic studies. The "ground truth" is defined by the parameters and thresholds in the ISO and ASTM standards themselves.

4. Adjudication method for the test set

This is not applicable. Adjudication methods (like 2+1, 3+1) are used to resolve disagreements among human reviewers (experts) when establishing ground truth for subjective assessments. Since this study relies on objective performance against defined standards, there's no need for adjudication.

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

This is not applicable. An MRMC study is relevant for diagnostic or AI-assisted interpretation devices. This submission concerns sterile auto-disable syringes, which are physical medical devices, not diagnostic software.

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

This is not applicable. This is not an algorithmic device.

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

The "ground truth" for the performance of the syringe device is defined by the requirements and test methods specified in the cited international ISO and ASTM standards. For example, for "Seal Strength," the ISO/ASTM standard dictates the method and acceptable range, which serves as the objective ground truth. For "Biocompatibility," the ground truth is whether the device materials elicit a toxic response beyond defined limits, as determined by standardized biological tests.

8. The sample size for the training set

This is not applicable. This device does not involve machine learning or AI, and therefore does not have a "training set."

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

This is not applicable for the reason stated above.

Ask a specific question about this device