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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 below the skin. The device consists of a calibrated barrel (cylinder) with a 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. 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. The attached needle is covered by the protective cap which is intended to provide physical protection to the needle tube. The attached needle may have a safety guard that protects the user after use. This product is packed by sterile paper and sterilized by EO gas, and is a single-use device.

This document is a 510(k) summary for the PLPT LDV (Low Dead Volume) LC (Luer-Cone) Sterile Syringe and PLPT LDV (Low Dead Volume) LL (Luer-Lock) Sterile Syringe. It outlines the performance data and equivalence comparison to a predicate device.

1. Table of Acceptance Criteria and Reported Device Performance:

The document primarily relies on compliance with established ISO standards and USP requirements rather than defining specific acceptance criteria values with corresponding measured performance values in a single table. Instead, it states that tests were "passed" or "met requirements." This is typical for medical device submissions demonstrating substantial equivalence to a predicate device by adhering to recognized consensus standards.

Here's a summary of the acceptance criteria (standards/test criteria) and reported performance:

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

The document mentions "Bench tests for the device's performance were conducted." and "Performance testing was conducted for this change". However, it does not specify the sample sizes used for the test sets for any of the performance or biocompatibility evaluations.

The data provenance is not explicitly stated in terms of country of origin, but the manufacturer is "Poonglim Pharmatech Inc." located in "Gunsan, 54001, Republic of Korea." The nature of the tests (bench, biocompatibility, sterility) implies prospective testing on manufactured devices, not retrospective data analysis.

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

This information is not applicable and not provided in the document. The tests performed are objective, laboratory-based physical, chemical, and biological tests governed by international standards (ISO, USP). They do not require interpretation by a panel of human experts in the way clinical diagnostic or AI-based image analysis studies might.

4. Adjudication Method for the Test Set:

This information is not applicable as the tests are objective, laboratory-based evaluations against predetermined criteria. There is no human subjective assessment that requires 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 information is not applicable and not provided. This document pertains to the market clearance of a sterile syringe, which is a physical medical device. It does not involve any artificial intelligence (AI) component or human diagnostic interpretation that would warrant an MRMC study.

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

This information is not applicable and not provided. This device is a physical syringe and does not have an algorithm or AI component.

7. The Type of Ground Truth Used:

The "ground truth" for the performance criteria and biocompatibility assessments is based on established international consensus standards (ISO) and pharmacopeial monographs (USP). For instance, cytotoxicity is evaluated against requirements of ISO 10993-5, sterility against ISO 11737-2, and mechanical properties against ISO 7886-1 and ISO 23908. These standards define the acceptable limits and methodologies, which serve as the "ground truth" for compliance.

8. The Sample Size for the Training Set:

This information is not applicable and not provided. This device is a physical syringe and does not involve machine learning or a training set.

9. How the Ground Truth for the Training Set was Established:

This information is not applicable and not provided as there is no training set for this type of device.

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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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PLPT LDV (Low Dead Volume) Sterile Syringe is intended to be used for medical purpose to inject fluid into or withdraw fluid from body.

A sterile device consisting of a calibrated barrel (cylinder) with plunger intended to be used for injection/withdrawal of fluids/gas (e.g., medication) to/from a medical device or the body (i.e., capable of both); a needle is not included. It is intended for various medical applications and is not dedication administration. At the distal end of the barrel is a Luer-lock connector for the attachment to a hypodermic needle or an administration set. This is a single-use device.

The PLPT LDV (Low Dead Volume) Sterile Syringe is designed to reduce the fluid waste because of its plunger design.

The provided FDA 510(k) summary for the PLPT LDV (Low Dead Volume) Sterile Syringe describes its performance testing but does not contain information typically associated with studies for AI/algorithm-driven medical devices.

This document describes a traditional medical device (a syringe) and focuses on engineering, material, and biological compatibility testing, not on algorithm performance, human reader studies, or ground truth establishment for AI.

Therefore, many of the requested sections (2, 3, 4, 5, 6, 7, 8, 9) are not applicable or cannot be answered from the provided text.

Here's a breakdown of the relevant and irrelevant information based on your request:

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

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Not applicable / Not provided. This information is for AI/algorithm studies. The document describes bench testing for a physical device. While specific sample sizes for tests like dead space measurement, biocompatibility, or sterility validation would have been used, they are not detailed in this summary.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

• Not applicable / Not provided. This information is for AI/algorithm studies. The "ground truth" for a physical device is typically established through direct measurement against established standards or validated laboratory methods, not expert consensus.

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

• Not applicable / Not provided. This information is for AI/algorithm studies involving human readers or interpretation.

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

• No. This is not an AI-assisted device. The device is a physical syringe.

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

• Not applicable / No. This is not an algorithm-only device.

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

• The "ground truth" for the performance testing of this physical device relied on established international and national standards, laboratory methods, and physical measurements. For example:
  • Dead space: Measured directly against the specified quantitative limit.
  • Biocompatibility: Evaluated through laboratory tests like cytotoxicity, sensitization, and irritation following ISO standards.
  • Sterility: Determined through microbiological testing according to USP and ISO standards.
  • Particulate Matter: Measured using methods described in USP .

8. The sample size for the training set

• Not applicable / Not provided. This information is for AI/algorithm studies. This document describes a physical medical device.

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

• Not applicable / Not provided. This information is for AI/algorithm studies.

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

The device consists of a metal tube that is beveled at one end and at the other end join to a female connector (hub). The needle cap covers intended to provide physical protection to the needle tube. This product is packed by blister paper and sterilized by E.O. gas.

The provided document describes the acceptance criteria and the study that proves the EZ-Inject Single Use Needle device meets these criteria.

1. Table of Acceptance Criteria and Reported Device Performance

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

The document does not explicitly state the sample sizes for each specific test or the provenance (country of origin, retrospective/prospective) of the data, as these are typically bench tests performed on manufactured devices. The studies are described as "Bench test" and "The performance tests," suggesting these were conducted in a laboratory setting by the manufacturer (POONGLIM Pharmatech Inc., Korea).

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

The document describes bench testing, biocompatibility testing, and sterility testing according to international standards (ISO, USP). For these types of tests, ground truth is established by objective measurements and adherence to specified standard limits rather than expert human interpretation in the way, for example, a radiologist would interpret an image. Therefore, there is no mention of "experts" in the context of establishing ground truth for individual test cases as it would apply to a clinical study. The tests are conducted by qualified laboratory personnel following established protocols.

4. Adjudication Method for the Test Set

Given that the performance evaluation relies on bench tests against objective, quantitative standards (e.g., ISO and USP standards), an adjudication method like "2+1" or "3+1" (common in clinical trials with subjective endpoints) is not applicable. The results are binary (Pass/Fail) based on whether the device meets the specified criteria in the relevant standards.

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

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. The device is a single-use hypodermic needle, and its performance evaluation focuses on physical, chemical, and biological safety and efficacy aspects through bench testing, not on comparative effectiveness with human readers or AI assistance.

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

Not applicable. The EZ-Inject Single Use Needle is a physical medical device, not a software algorithm or an AI system. Therefore, the concept of a "standalone algorithm" performance study is irrelevant to this submission.

7. Type of Ground Truth Used

The ground truth for evaluating the device's performance is based on International Standards and Pharmacopeial Monographs. Specifically, the document references:

• ISO 7864: Sterile hypodermic needles for single use.
• ISO 9626: Stainless steel needle tubing for the manufacture of medical devices.
• ISO 80369-7: Small-bore connectors for liquids and gases in healthcare applications - Part 7: Connectors for intravascular or hypodermic applications.
• ISO 6009: Hypodermic needles for single use - Colour coding for identification.
• USP 41, : United States Pharmacopeia for Bacterial Endotoxin Test.
• ISO 10993-5, -10, -11, -4, -7: Biological evaluation of medical devices (for Cytotoxicity, Irritation/Sensitization, Systemic Toxicity, Interaction with blood, Ethylene oxide residuals).
• ISO 11135:2014: Sterilization of health-care products - Ethylene oxide.
• ISO 11737-2: Sterilization of medical devices - Microbiological methods - Part 2: Tests of sterility performed in the definition, validation and maintenance of a sterilization process.

These standards define the acceptable physical properties, material safety, sterility, and functional performance limits, which serve as the "ground truth" for each test.

8. Sample Size for the Training Set

Not applicable. This device is a physical medical device. It does not involve a training set as would be used for machine learning or AI models. There is no algorithm being "trained."

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

Not applicable. As there is no training set involved for this physical medical device, the concept of establishing ground truth for a training set is not relevant.

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

The device consists of a metal tube that is beveled at one end and at the other end join to a female connector (hub). The needle cap covers intended to provide physical protection to the needle tube. This product is packed by blister paper and sterilized by E.O. gas.

The provided text describes the acceptance criteria and performance data for the Kopac Sterile Needle as part of its 510(k) submission (K172483) to the FDA.

Here's the breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance

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

The document does not specify the exact sample sizes for each of the bench tests. It broadly states “Bench test were performed.” and lists various types of tests. Data provenance is not explicitly mentioned (e.g., country of origin, retrospective/prospective), but these are standard bench tests typically performed in a laboratory setting by the manufacturer (Poonglim Pharmatech Inc., Korea).

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 submission. The "ground truth" for a device like a hypodermic needle is established through objective physical, chemical, and biological measurements against international standards (ISO, USP) and predefined specifications, not through expert consensus on interpretation.

4. Adjudication method for the test set

Not applicable. The tests are quantitative or qualitative assessments against defined standards, not subjective interpretations 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 a submission for a medical device (hypodermic needle), not an AI/software as a medical device (SaMD) that involves human readers or AI assistance.

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

Not applicable. This is a physical medical device.

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

The "ground truth" for the performance tests relies on:

• International Standards: Primarily ISO 7864 (Hypodermic needles for single use), ISO 9626 (Stainless steel needle tubing for the manufacture of medical devices — Requirements and test methods), ISO 10993 series (Biological evaluation of medical devices), ISO 11135 (Sterilization of health-care products — Ethylene oxide), ISO 11737-2 (Sterilization of medical devices — Microbiological methods), and USP39 (Bacterial Endotoxins Test).
• Defined Specifications: Manufacturer's internal specifications for dimensions, material properties, and visual characteristics.
• Objective Measurements: Using instruments like digital vernier calipers, digital thickness gauges, protractors, tension and compression testers, and laboratory analyses for chemical and biological properties.

8. The sample size for the training set

Not applicable. This is a physical medical device, not an AI model requiring a training set.

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

Not applicable. No training set for an AI model was used.

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