Search Results

The Luer Lock/Slip Tip Syringe (Low Dead Space) without needle is to inject fluids into, or withdraw fluids from, the body.
The Luer Lock/Slip Tip Syringe (Low Dead Space) with exchangeable is used to inject fluids into, or withdraw fluids from, the body.
The Luer Lock Syringe (Low Dead Space) with Safety needle is used to inject fluids into, or withdraw fluids from, the body. The safety mechanism covers the needle after use. In the activated position, the protective arm guards against accidental needle stick during normal handling and disposal of the used needle/syringe combination.

The Luer Lock and Slip Tip syringe (Low Dead Space) without Needle is a sterile, single-use, standard 3-piece piston hypodermic syringe.
The Luer lock and Slip Tip syringe (Low Dead Space) with exchangeable needle is a sterile, single-use, standard 3-piece piston syringe with a detachable pre-attached needle.
The Luer Lock Syringe (Low Dead Space) with Safety Needle is a Low Dead Space syringe in combination with a safety needle. The safety needle contains a mechanism that covers the needle point after use. In the activated position, the needle cover guards against accidental needle stick during normal handling and disposal of the used needle/syringe combination.

The provided document is a 510(k) Premarket Notification from the FDA for a medical device (syringes). It details the device description, indications for use, comparison to a predicate device, and summaries of non-clinical testing.

However, it does not contain information related to an AI/ML powered device, acceptance criteria or a study proving that an AI/ML meets these criteria.

Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device (AI/ML based) meets the acceptance criteria using this document.

The document discusses performance testing against established ISO standards for medical devices like sterile hypodermic syringes and needles, biocompatibility testing, sterility, and shelf life for physical devices, not AI/ML model performance.

Ask a specific question about this device

The Sol-M Luer Lock Syringe is intended for aspiration of medications and fluids into the body.

The Sol-M Luer Lock Syringe is used to aspirate and inject fluid/medication into the body. The syringe is a sterile, single-use, 3-part syringe with luer lock conical connection. The Sol-MTM Luer Lock Syringe consists of the following components: Barrel, Plunger, Gasket. In addition to being used manually, the Sol-MTM Luer Lock Syringe can also work with a powerdriven syringe pump, with the luer lock tip connected to the IV administration line to deliver specific volume of fluid/medication. The syringe is individually blister packaged, and EtO sterilized with SAL of 10-6. The Sol-M™ Luer Lock Syringe is provided in 1, 3, 5, 10, 20, 30, and 60ml volume.

The provided text describes the Sol-M Luer Lock Syringe (K222744) and its acceptance criteria, particularly focusing on its suitability for use with power-driven syringe pumps.

Here's an analysis of the provided information, framed by your requested criteria:

The study primarily focuses on demonstrating the suitability of the Sol-M Luer Lock Syringe for use with power-driven syringe pumps, referring to ISO 7886-2 as the key standard.

1. Table of Acceptance Criteria and Reported Device Performance

The submission states that the device was tested according to ISO 7886-2:2020. The acceptance criteria are implicitly those defined by this standard. The reported performance is that the device met these criteria.

2. Sample Size Used for the Test Set and Data Provenance

• Sample Size: The document does not explicitly state the specific number of syringes used for each test (e.g., for critical dimensions, flow rate, compliance tests). It only refers to "testing per ISO 7886-2."
• Data Provenance: Not explicitly stated, but based on the context of a 510(k) submission, this would be prospective testing conducted by the manufacturer, Sol-Millennium Medical Inc. The country of origin of the data is generally where the manufacturer performs their testing, which for Sol-Millennium Medical Inc. is based in Suwanee, Georgia.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications

Not applicable. This is a bench testing (non-clinical) submission involving a physical medical device (syringe). "Ground truth" in this context refers to standardized measurements and performance specifications outlined in ISO 7886-2, not expert consensus on diagnostic images or clinical outcomes.

4. Adjudication Method for the Test Set

Not applicable. Adjudication methods like 2+1 or 3+1 are typically used in clinical studies, especially those involving human interpretation of data where consensus is needed to establish a "ground truth" or resolve disagreements. For bench testing against a standard like ISO 7886-2, objective measurements are taken, compared against predefined limits, and either pass or fail.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No, a MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic devices where human readers interpret data (e.g., radiologists reading images) and the AI aims to improve their performance. This submission is for a physical medical device (syringe) and focuses on engineering performance.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

Not applicable. This is for a physical medical device, not an algorithm or AI. The testing described is "standalone" in the sense that the syringe's performance is measured directly, not in conjunction with human interpretation of its output.

7. Type of Ground Truth Used

The "ground truth" for the test set is established by international standards and specifications, specifically ISO 7886-2:2020 (for use with power-driven syringe pumps) and ISO 7886-1:2017 (for manual use). These standards define acceptable ranges for dimensional requirements, flow rate error, pump forces, and syringe compliance.

8. Sample Size for the Training Set

Not applicable. There is no AI/algorithm component requiring a training set mentioned in this submission. This is a traditional medical device (syringe) bench test.

9. How the Ground Truth for the Training Set Was Established

Not applicable, as there is no training set for an algorithm.

Ask a specific question about this device