(29 days)
The Auto-Fill® Syringe Kit is indicated for the introduction of dilute lidocaine solutions into subcutaneous tissues for the purposes of tumescent local anesthesia.
The Auto-Fill Syringe Kit contains disposable components that may be used to deliver dilute lidocaine solutions into subcutaneous tissues for the purposes of local anesthesia. The kit provides an extension tubing mechanism to conveniently refill a 12cc syringe from an IV bag eliminating the need for multiple reconnections to the solution container.
The kit contains the following items:
- 12cc Control Syringe .
- IV tubing with spike, dual check valve, and roller clamp .
- Extension line (various lengths ranging from 6" to 48") .
The provided text describes a 510(k) premarket notification for the "Auto-Fill® Syringe Kit". This type of submission is for medical devices and focuses on demonstrating substantial equivalence to a predicate device, rather than performing de novo clinical studies with specific acceptance criteria that an AI/ML device would typically face.
Therefore, the information requested regarding acceptance criteria, study design for proving device performance, sample sizes, expert involvement, and ground truth establishment, which are standard for AI/ML device evaluation, is not applicable to this submission.
Here's why and what information is available:
- No AI/ML Device: The "Auto-Fill® Syringe Kit" is a physical medical device (syringe kit, tubing) used for delivering lidocaine. It is not an AI/ML device, and as such, the concepts of algorithms, training sets, test sets, ground truth established by experts, or MRMC studies do not apply.
- 510(k) Pathway: The 510(k) pathway for medical devices primarily relies on demonstrating substantial equivalence to a legally marketed predicate device. This involves comparing indications for use, technological characteristics, and performance data.
What information can be extracted from the provided text, re-framed for clarity:
1. A table of acceptance criteria and the reported device performance:
| Acceptance Criteria (Design Requirements/Performance) | Reported Device Performance |
|---|---|
| Extension tubing static pressure capabilities | Met specified design and performance requirements |
| Extension tubing dynamic pressure capabilities | Met specified design and performance requirements |
| Biocompatibility of components | Demonstrated to be biocompatible through testing by original manufacturers |
2. Sample sized used for the test set and the data provenance:
- Test Set Sample Size: Not applicable. The "testing" mentioned is engineering performance testing (static and dynamic pressure, biocompatibility) rather than a clinical "test set" in the AI/ML context. Specific sample sizes for these engineering tests are not provided.
- Data Provenance: The engineering performance testing was conducted by the submitter (Vascular Solutions, Inc.) or "original manufacturers" for biocompatibility. There is no mention of country of origin or whether it was retrospective or prospective, as these are not relevant for this type of device and testing.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. Ground truth establishment for a test set by human experts is not a component of the engineering performance testing described for this device.
4. Adjudication method for the test set:
- Not applicable. There was no "test set" in the AI/ML sense requiring 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:
- Not applicable. This is not an AI device, and no MRMC studies were performed.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is not an algorithm.
7. The type of ground truth used:
- Not applicable in the AI/ML sense. The "ground truth" for this device's performance would be the physical properties and functionality of the materials and assembled kit components meeting their design specifications.
8. The sample size for the training set:
- Not applicable. This is not an AI/ML device, therefore no training set exists.
9. How the ground truth for the training set was established:
- Not applicable. No training set.
Summary of Clinical Testing:
- "No clinical evaluations of this product have been performed." This explicitly states that no human studies of the device (clinical trials) were conducted, as the 510(k) submission relied on substantial equivalence.
§ 880.5860 Piston syringe.
(a)
Identification. A piston syringe is a device intended for medical purposes that consists of a calibrated hollow barrel and a movable plunger. At one end of the barrel there is a male connector (nozzle) for fitting the female connector (hub) of a hypodermic single lumen needle. The device is used to inject fluids into, or withdraw fluids from, the body.(b)
Classification. Class II (performance standards).