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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.

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

The document does not explicitly state the numerical sample sizes for each specific test (e.g., how many syringes were tested for each mechanical property, or how many biological samples were used for biocompatibility tests). However, for medical devices cleared via 510(k), it is expected that sufficient samples were used to meet the statistical requirements of the referenced ISO standards for design verification and validation.

• Data Provenance: The studies were bench tests and biocompatibility evaluations. The data would be prospective, generated specifically for this 510(k) submission, likely conducted at the manufacturer's facilities or accredited testing labs. The country of origin for the data generation is not explicitly stated, but the manufacturer is based in Republic of Korea.

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

This type of information is generally not applicable for a 510(k) submission for a physical medical device like a syringe. The "ground truth" for these tests comes from adherence to established international engineering and biological standards (ISO, USP). There isn't a subjective "ground truth" established by human experts in the way there would be for an AI-based diagnostic tool. The "experts" are the engineers and scientists conducting the tests according to the specified protocols.

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

Not applicable. Adjudication methods like 2+1 or 3+1 are used for establishing consensus "ground truth" in human-in-the-loop diagnostic studies, typically involving image interpretation. For physical device performance, the results are quantitative measurements against predefined pass/fail criteria established by engineering standards.

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 device is a physical syringe, not an AI-assisted diagnostic tool. No MRMC study was conducted.

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

Not applicable. This device is a physical syringe, not an algorithm.

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

The "ground truth" for this device's performance is based on objective measurements and results from standardized bench tests and validated biological assays as defined by:

• International Organization for Standardization (ISO) standards (e.g., ISO 7886-1, ISO 80369-7, ISO 10993 series, ISO 11135, ISO 11607, ISO 23908).
• United States Pharmacopeia (USP) guidelines (e.g., USP <85>, USP <788>).

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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