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PLPT LDV (Low Dead Volume) LC(Luer-Cone) Sterile Syringe / PLPT LDV (Low Dead Volume) LL(Luer-Lock) Sterile Syringe is intended for use by health care professionals for general purpose aspiration of fluid from vials, ampoules and liquid injection below the surface of the skin.

PLPT LDV LC Sterile Syringe / PLPT LDV LL Sterile Syringe is a device intended to inject fluids into, or withdraw fluids from, parts of the body the surface of the skin. The device consists of a calibrated barrel (cylinder) with plunger, and metal tube that is sharpened at one end and at the other end joined to a female connector (hub). This device is intended for various medical applications and is not dedication administration. At the distal end of the barrel has a Luer-Cone or Luer-lock connector for the attachment to a hypodermic needle or an administration set. Attached needle has covered by the protective cap which is intended to provide physical protection to the needle tube. Attached needle may have safety guard that protect the user after use. This product is packed by sterile paper and sterilized by EO gas, and single-use device.

This document describes the regulatory approval for a medical device, specifically a Low Dead Volume (LDV) Sterile Syringe (PLPT LDV LC/LL Sterile Syringe). The provided text is an FDA 510(k) Premarket Notification, which focuses on demonstrating substantial equivalence to a predicate device, rather than proving novel effectiveness or clinical superiority through extensive comparative clinical trials.

Therefore, the information about acceptance criteria and study proving the device meets those criteria will be focused on bench testing and biocompatibility assessments demonstrating equivalence to established standards and predicate devices, rather than complex multi-reader, multi-case studies typically seen for AI/ML devices.

Here's the breakdown based on the provided text:

Device: PLPT LDV (Low Dead Volume) LC (Luer-Cone) Sterile Syringe and PLPT LDV (Low Dead Volume) LL (Luer-Lock) Sterile Syringe.

Indications for Use: Intended for use by healthcare professionals for general purpose aspiration of fluid from vials, ampoules, and liquid injection below the surface of the skin.

Acceptance Criteria and Reported Device Performance

The acceptance criteria are primarily based on established international standards for medical devices and comparison to predicate devices. The device's performance is demonstrated through adherence to these standards and the fulfillment of specific regulatory requirements.

These standards define the acceptable performance characteristics for syringes and needles.

8. The sample size for the training set:

Not applicable. This device is a physical product and does not involve AI/ML requiring a "training set" in the computational sense.

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

Not applicable for the same reason as above.

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This product is intended for use to inject fluid into or withdraw fluids from parts of the surface of the skin.

Sterile single use needle is a device intended to inject fluids into, or withdraw fluids from, parts of the body below the surface of the skin. The device consists of a metal tube that is sharpened at one end and at the other end joined to a female connector (hub). The needle cap covers intended to provide physical protection to the needle tube. This product is packed by sterile paper and sterilized by EO gas.

The safety guard is placed around the needle after using the product for safety and to prevent reuse. EZ-Injec LDV Sterile Safety Needle helps to decrease fluid volume loss because of its smaller hub inner size.

The provided text describes a 510(k) premarket notification for a medical device, the EZ-Injec LDV Sterile Safety Needle. It details the device's characteristics, comparison to a predicate device, and the performance testing conducted to demonstrate substantial equivalence.

However, the information provided does not contain details about acceptance criteria, study methodologies, or performance results in the context of an AI/ML powered device. Specifically, it lacks:

• A table of acceptance criteria and reported device performance (in terms of AI metrics like sensitivity, specificity, AUC, etc.).
• Sample sizes for test sets, data provenance, ground truth establishment, expert qualifications, or adjudication methods for an AI/ML study.
• Any mention of Multi-Reader Multi-Case (MRMC) studies or standalone algorithm performance.
• Information on training set size or how its ground truth was established for an AI/ML model.

The document focuses on the physical and functional aspects of a hypodermic needle, including:

• Mechanical properties: Gauge, length, dead space, sharps prevention function.
• Material composition: Polypropylene, SUS304, Epoxy.
• Sterilization: EO gas.
• Biocompatibility testing: Cytotoxicity, Sensitization, Irritation, Acute Systemic Toxicity, Material-Mediated Pyrogenicity, Hemocompatibility, Particulate Matter.
• Shelf-life validation.

The "Performance Testing" section refers to conformance with recognized ISO standards for hypodermic needles and tests for low dead space capability and sharps injury protection. These are engineering and safety standards for the physical device, not performance benchmarks for an AI/ML algorithm.

Therefore, it is not possible to provide the requested information regarding acceptance criteria, study details, and performance for an AI/ML device based on the provided text, as the device in question (EZ-Injec LDV Sterile Safety Needle) is a traditional medical device, not an AI/ML-powered one.

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