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The TSK Syringe is a low dead volume syringe intended for use in patients that need injection and withdrawal of substances for examination, treatment, diagnosis or prevention.

The TSK Syringe is a syringe intended for use with a needle to inject or withdraw substances, for general use. The TSK Syringe leaves a low volume of fluid when the plunger is fully depressed.

There are two model numbers for the TSK Syringe. The technological differences are as follows:

The provided text is a 510(k) Clearance Letter and 510(k) Summary for the TSK Syringe. It details the device's characteristics, indications for use, and a comparison to a predicate device. However, it does not contain the specific information required to answer your request about acceptance criteria and a study proving device performance in the context of an AI/human reader study.

This document describes a physical medical device (syringe), not a software or AI-powered medical device that would involve AI performance metrics, human reader studies, ground truth establishment, or training/test set sample sizes in the way you've outlined.

Therefore, I cannot provide the requested information from this document. The details about acceptance criteria and study design for AI-based performance evaluation are not present.

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The Small Volume 0.2mL Syringe is intended to be used for medical purposes to inject fluids into or withdraw fluids from the body.

The Small Volume 0.2mL Syringe is intended for manual, single use. It is a small volume 0.2 mL syringe. It is comprised of a PP barrel, ABS plunger, TPE plunger stopper, PP plunger shield and PP Luer protective cap. The device has a Luer lock connection type that enables connection to a hypodermic needle for liquid injection or withdrawal. The device has a plunger stopper to prevent any liquid residual from remaining in the syringe barrel, maximizing the efficiency of liquid usage. The feature is called Low Dead Space/Volume. The Luer protective cap serves to safeguard the small Luer connector from potential damage during transportation. Similarly, the plunger shield is utilized to ensure the small plunger remains undamaged during transportation. The Luer protective cap and the plunger shield are optional to be used. The device has been manufactured without any silicone oil. The device has six models, each equipped with a 0.2 mL Luer lock syringe. Among these models, three include an additional feature for enhanced dosing technology (EDT), which comprises a colored reference line on the plunger surface to improve visibility. These include identifying markings to distinguish the EDT models from the regular 0.2 mL syringe.

The provided FDA 510(k) clearance letter and summary for the "Small Volume 0.2mL Syringe" do not contain any information related to AI/ML or software-driven medical devices. The submission is for a physical medical device (syringe) and, as such, the acceptance criteria and study descriptions are entirely focused on the physical and material properties, performance, biocompatibility, and sterility of the syringe itself.

Therefore, I cannot provide details on:

• A table of acceptance criteria for AI/ML performance
• Sample sizes for a test set or data provenance for AI/ML
• Number of experts and their qualifications for establishing AI/ML ground truth
• Adjudication methods for AI/ML test sets
• MRMC comparative effectiveness study for AI with human readers
• Standalone AI algorithm performance
• Type of ground truth for AI/ML
• Training set sample size for AI/ML
• How ground truth for AI/ML training was established

The document explicitly states "9. Clinical testing: Not applicable for this submission." This further confirms that no studies involving human interaction or clinical performance for a software/AI component were conducted or required for this purely mechanical device.

If the request was intended to be about the acceptance criteria and studies for the physical device as described in the 510(k) summary, here is the relevant information extracted:

Acceptance Criteria and Study for the "Small Volume 0.2mL Syringe" (Physical Device)

The device, a "Small Volume 0.2mL Syringe," is a physical medical device. The acceptance criteria and the studies proving it meets these criteria are related to its mechanical performance, material safety, and sterility, in accordance with recognized medical device standards. There is no AI/ML component described in this 510(k) submission.

1. Table of Acceptance Criteria and Reported Device Performance

The 510(k) summary references compliance with specific standards, rather than providing explicit numerical acceptance criteria directly in a table. The device performance is generally stated as "met the standards' requirements."

• Cytotoxicity
• Irritation
• Sensitization
• Acute systemic toxicity
• Hemocompatibility
• Pyrogenicity
• Particulate Matter per USP
• Bacterial Endotoxins per USP | All tested endpoints met the acceptance criteria (Implied: complied with ISO 10993-1, USP , and USP ). |
  | Syringe Performance | Complies with ISO 7886-1:2017 (e.g., accuracy, force, freedom from leakage, residual volume) | Met all necessary requirements of the standard. |
  | Luer Connector Performance | Complies with ISO 80369-7:2016 and ISO 80369-20:2015 (e.g., connection integrity, leakage) | Met the standards' requirements. |
  | Dead Space Specification | ≤ 0.0058 mL (95% confidence/ 95% reliability) | Meets requirements (stated as "a lower dead space volume is achieved" compared to predicate). |
  | Sterilization | Complies with ISO 11135 (EO sterilization process validation) | Validation results confirm compliance. |
  | Ethylene Oxide (EO) & Ethylene Chlorohydrin (ECH) Residuals | Do not exceed limits according to ISO 10993-7 | Residues do not exceed the limits. |
  | Shelf-Life | Device functionality maintained through 3 years (accelerated aging per ASTM F1980-16) | Demonstrated device functionality through the claimed shelf-life of 3 years. (Real-time testing is ongoing to confirm). |
  | Packaging Integrity | Complies with ISO 11607-1, ISO 11607-2, ASTM D4169-22, ASTM F88/F88-15, ASTM F1929-15 | All packaging was deemed acceptable for protection of product and sterility maintenance. |
  | Sterile Barrier Testing | Complies with USP | Confirmed compliance. |

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

The exact sample sizes used for each specific test (e.g., biocompatibility endpoints, performance testing per ISO 7886-1) are not detailed in the 510(k) summary. The summary generally states that testing was conducted on "samples" or "unconditioned samples as well as samples aged... and samples transit conditioned."

• Data Provenance: The studies were conducted by the manufacturer, Prosum Medical Limited, and their testing partners, likely in the United Kingdom or through contract laboratories that adhere to international standards. The data is prospective as it involves new testing specifically for this device submission.

3. Number of Experts Used to Establish Ground Truth and Qualifications

Not Applicable. For a physical device like a syringe, "ground truth" as it relates to expert consensus for image interpretation or clinical outcomes is not relevant. The ground truth here is derived from objective measurements and compliance with established engineering and biological standards. Testing is performed by qualified laboratory personnel following validated protocols.

4. Adjudication Method for the Test Set

Not Applicable. Adjudication typically applies to subjective assessments (e.g., expert reads). For objective measurements on a physical device, statistical analysis of measured values against predefined acceptance limits determines compliance.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and its effect size

Not Applicable. MRMC studies are used for assessing the impact of AI/software on human performance in diagnostic tasks and do not apply to a physical syringe device.

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

Not Applicable. This refers to AI algorithm performance, which is not part of this submission.

7. The type of ground truth used

The "ground truth" for this device's performance and safety is based on objective, quantifiable measurements and compliance with internationally recognized consensus standards (e.g., ISO 7886-1 for syringe performance, ISO 10993-1 for biocompatibility). These standards define acceptable ranges for various parameters (e.g., dead space, force to push plunger, leakage, material toxicity).

8. The sample size for the training set

Not Applicable. There is no "training set" as this is not an AI/ML device.

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

Not Applicable. There is no "training set" as this is not an AI/ML device.

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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.

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This device is intended for use to inject fluids into or withdraw fluids from the body. The needle protection device covers the needle after use to help prevent needle sticks.

The Hypodermic Needle-Pro® EDGE™ Safety Device with Syringe is intended for injection or aspiration of fluids using a Luer lock (LL) or Luer slip syringe. The device is provided sterile and is for single use only. The Hypodermic Needle-Pro® EDGE™ Safety Device with Syringe is an extension of Smiths Medical's Hypodermic Needle-Pro® EDGE™ product portfolio. The Low Dead-Space (LD) Syringe new component - is added to form new device combo with the previously cleared Hypodermic Needle-Pro® EDGE™ Safety Device. The device combo is intended to offer an optimization of the volume of fluids injected to patients, and thus reduce the amount of medical product remaining in the needle and the syringe's hub after injection. The Needle-Protection (Needle-Pro) EDGE™ safety device covers the needle after use to help prevent needle sticks. The device features a one-viece design of polypropylene needle hub and protective sheath with a living hinge. The stainless-steel needle cannula is permanently affixed into the hub. After a procedure is completed, the needle is pressed into the sheath using a one-handed technique and the needle is contained within the sheath. The Low Dead-Space (LD) Syringe is a new component to be used along with the Hypodermic Needle-Pro® EDGE™ Safety Device. The LD Syringe is designed with luer lock (LL) connection to provide a secure and leak-free connection between the syringe and the needle and maintain a continuous lumen for fluid flow. The LD Syringe plunger is designed for less product waste without changing the use of the device. The Syringe plunger tip extends into the syringe neck reducing fluid waste. The fluid waste is about 0.010 mL (10 µL), max = 0.015 mL (15 µL) for the LD syringe.

This document is a 510(k) Premarket Notification from the FDA regarding a medical device, specifically a hypodermic needle and syringe. It does not contain information about acceptance criteria or a study that proves the device meets those criteria in the context of an Artificial Intelligence (AI) or software-based medical device.

The document primarily focuses on demonstrating "substantial equivalence" of a new physical device (Hypodermic Needle-Pro® EDGE™ Safety Device with Low Dead Space Syringe) to a previously cleared predicate device. The performance data mentioned (biocompatibility, sterilization, shelf-life, non-clinical bench testing) refers to the physical properties and safety of the needle and syringe, not the performance of an AI algorithm.

Therefore, I cannot extract the requested information regarding AI device acceptance criteria and study details from this document. The provided text does not describe an AI medical device or its performance studies.

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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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TopFine® LDS (Low Dead Space) Syringe is intended for use to inject fluid into or withdraw fluids from the parts of body below the surface of the skin.

The TopFine® LDS (Low Dead Space) 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 hypodermic single lumen needle which is a permanently attached. The device is used to inject fluids into, or withdraw fluids from, the body. It is made of plastic and silicone materials that allows for smooth plunger movement, and is manually operated. This is a single-use device. This product is packed by sterile paper and sterilized by Ethylene Oxide gas.

The proposed device has 2 models depending on the diameter of the needle.

The provided document is a 510(k) premarket notification for a medical device, specifically a syringe. It does not contain information about an Artificial Intelligence/Machine Learning (AI/ML) device. Therefore, it is not possible to describe acceptance criteria or a study related to AI/ML device performance.

The document focuses on demonstrating substantial equivalence of the "TopFine® LDS (Low Dead Space) Syringe" to a predicate syringe through various performance tests and material comparisons.

Here's an analysis based on the information provided, specifically addressing the technical performance of the syringe, not AI/ML:

Acceptance Criteria and Reported Device Performance (Non-AI/ML Syringe)

The document details various performance criteria for the syringe. There isn't a single table explicitly labeled "Acceptance Criteria and Reported Device Performance" with detailed numerical results for each criterion. However, the "Comparison of technological characteristics with the predicate device" section (page 5) and "Performance data" section (page 7) implicitly define the acceptance criteria by stating compliance with recognized standards and providing general results.

Here's an attempt to construct a table based on the provided information, focusing on criteria where reported performance is available, even if only generally stated as "Same" or "Complies."

Since this is concerning a non-AI/ML medical device, the following points are not applicable or cannot be answered from the provided text:

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

   • The document does not specify exact sample sizes for each physical or biological test. It only mentions that tests were "conducted."
   • Data provenance (country of origin, retrospective/prospective) is not mentioned for the testing data.

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 as this is not an AI/ML device requiring expert ground truth for image/data interpretation. This refers to standard performance testing.

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

   • Not applicable. Adjudication methods are typically for clinical studies involving human interpretation or AI/ML output.

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/ML device. "Clinical studies were not required to support substantial equivalence."

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

   • Not applicable. This is not an AI/ML device.

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

   • For the syringe, "ground truth" would be established by direct physical measurements, chemical analyses, and biological assays according to the specified international and national standards (e.g., ISO, USP, ASTM). For example, the "dead space" measurement itself would be the ground truth for that specific characteristic, and the acceptance criterion is a predefined maximum value (≤ 0.03 ml).

8. The sample size for the training set

   • Not applicable. This is not an AI/ML device with a training set.

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

   • Not applicable. This is not an AI/ML device.

In summary, the document addresses a traditional medical device (syringe) and demonstrates its substantial equivalence to a predicate device through adherence to manufacturing standards, material comparisons, and performance testing against established physical, chemical, and biological criteria, rather than through AI/ML performance metrics.

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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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FEELject LDV(Low dead volume) Syringe is intended for use to inject fluid into or withdraw fluids from the parts of body below the surface of the skin.

A Disposable Syringe with Needle 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 hypodermic single lumen needle which is permanently attached. The device is used to inject fluids into, or withdraw fluids from, the body. It is made of plastic and silicone materials that allows for smooth plunger movement, and manually operated. This is a single-use device. This product is packed by sterile paper and sterilized by E.O gas.

The provided text describes the 510(k) summary for the FEELject LDV (Low dead volume) Syringe, a medical device. This document focuses on demonstrating substantial equivalence to a predicate device, rather than proving a new medical device meets specific acceptance criteria through a clinical study or AI performance evaluation.

Therefore, the information required to answer your specific questions about acceptance criteria, AI performance, ground truth establishment, sample sizes for training/test sets, expert adjudication, or MRMC studies for an AI/device is not available in this document.

The document discusses bench testing and biocompatibility testing to show that the device performs in a substantially equivalent manner to the predicate device. These tests demonstrate the physical and biological properties of the syringe, not the performance of an AI algorithm or a diagnostic device.

Here's a breakdown of what can be extracted from the document, and why the other requested information is absent:

Information Available from the Document:

This document is a 510(k) summary for a medical device (syringe), not an AI algorithm. Therefore, the requested information about AI-related acceptance criteria, study design (MRMC, standalone), ground truth establishment for AI, and sample sizes for AI training/test sets is not applicable and not found in this text.

The closest equivalent to "acceptance criteria" here is compliance with ISO standards and passing various bench tests and biocompatibility tests to show substantial equivalence to the predicate device.

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

While not "AI performance" criteria, the document lists various requirements/tests for the syringe and their results (Pass). These serve as the "acceptance criteria" for the syringe's physical and biological properties.

Information Not Applicable or Not Present:

The following information is specifically requested for AI/Software as a Medical Device (SaMD) performance studies, which are not described in this 510(k) summary for a physical medical device (syringe). Therefore, the answers are "Not Applicable" or "Not Provided" in this context.

• 2. Sample sized used for the test set and the data provenance: Not applicable. The tests are bench tests of physical characteristics, not data-driven AI test sets with specific sample sizes from a clinical population.
• 3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for an AI algorithm is not established for a physical syringe.
• 4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable. This is for AI performance evaluation.
• 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 for AI performance evaluation.
• 6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is for AI performance evaluation. The device is a physical syringe.
• 7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable. This is for AI performance evaluation. The "ground truth" for the syringe is its compliance with specified physical and biological standards.
• 8. The sample size for the training set: Not applicable. There is no AI training set for a syringe.
• 9. How the ground truth for the training set was established: Not applicable. There is no AI training set for a syringe.

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STERILE SINGLE USE LDV SYRINGE/CHOICARE STERILE SINGLE USE LDV 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.

A Disposable Syringe with Needle 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 hypodermic single lumen needle which is permanently attached. The device is used to inject fluids into, or withdraw fluids from, the body. This is a single-use device. This product is packed by sterile paper and sterilized by E.O gas.

This document is an FDA 510(k) Premarket Notification for a medical device (Sterile Single-use LDV Syringe, CHOICARE Sterile Single-use LDV Syringe). The provided text describes the device, its intended use, performance data, and a comparison to a predicate device to demonstrate substantial equivalence.

Here's a breakdown of the requested information based on the provided text:

Important Note: The provided document is a 510(k) submission for a syringe, which is a relatively low-risk medical device. The types of acceptance criteria and studies are primarily focused on bench testing and adherence to existing international standards, rather than complex clinical studies or AI/software performance evaluations. Therefore, many of the requested points related to AI, MRMC studies, and expert ground truth establishment for complex image analysis are not applicable or detailed in this document.

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are primarily defined by adherence to various ISO standards and specific quantitative thresholds for certain tests. The reported device performance is consistently "Pass" for all tested criteria, indicating the device met the acceptance criteria.

2. Sample Size for the Test Set and Data Provenance

• Sample Size for Test Set: The document does not explicitly state the numerical sample sizes for each bench test conducted. However, for a 510(k) submission, testing is typically performed on a statistically relevant number of units as required by the referenced ISO standards.
• Data Provenance: The document indicates that the tests were performed by Jeil Tech Co., Ltd. (Republic of Korea). The studies are "bench tests," which are laboratory tests, not clinical studies involving human patients. The nature is prospective in the sense that the tests were performed specifically for this submission to verify the device's adherence to standards and safety.

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

This information is not applicable to this type of device and study. Bench testing for a syringe relies on objective measurements against engineering specifications and international standards (e.g., ISO, USP). There isn't "ground truth" to be established by human experts in the context of diagnostic interpretation or clinical outcomes. The "experts" involved would be qualified lab technicians and engineers performing and verifying the tests.

4. Adjudication Method for the Test Set

This is not applicable. Since the tests are objective bench measurements against quantitative or qualitative (Pass/Fail based on standard adherence) criteria, there is no need for an adjudication method. The results are either within specification or not.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done, What was the Effect Size of How Much Human Readers Improve with AI vs without AI Assistance

This is not applicable. This submission is for a physical medical device (syringe), not an AI-powered diagnostic or assistive tool. Therefore, no MRMC comparative effectiveness study was performed or required.

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

This is not applicable. As stated above, this is not an AI/algorithm device.

7. The Type of Ground Truth Used

The "ground truth" for this device's performance is the adherence to established international standards (ISO 7886-1, ISO 7864, ISO 9626, ISO 23908, ISO 10993 series, ISO 11135, ISO 11737-2) and specific quantitative requirements (e.g., dead volume, endotoxin limits). This is an engineering specification and regulatory standard conformance type of ground truth.

8. The Sample Size for the Training Set

This is not applicable. There is no "training set" as this is not an AI or machine learning device. The device is manufactured based on design specifications, and tested to ensure it meets those specifications and relevant standards.

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

This is not applicable as there is no training set for this device.

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

The LDV (Low Dead Volume) Syringe is consistent with the calibrated syringe and permanent needle intended to be used for injection or withdrawal of fluids to or from the human body. The needle is fixed that cannot be removed. The needle cap is colored to differentiate the different types of needle models. The syringe plunger is well-designed to reduce the fluid waste, called low dead volume or low dead space. The LDV (Low Dead Volume) Syringe has various colors, syringe volumes, needle gauge sizes, and needle length sizes, which could be applied in different clinic-use scenarios. Meanwhile, the device is sterilized with ethylene oxide and without any pyrogen. Therefore, this is a single-use device that should be immediately discarded after use.

The provided text is a 510(k) summary for the LDV (Low Dead Volume) Syringe, a medical device. It details the device's characteristics, comparison to predicate devices, and non-clinical performance testing.

However, the information requested in your prompt (acceptance criteria, study details, expert involvement, and ground truth for an AI/algorithm-driven device) is not present in this document. The LDV Syringe is a physical medical device (syringe with a fixed needle), not an AI/algorithm-based diagnostic or therapeutic tool. Therefore, the concepts of acceptance criteria for algorithm performance, test sets, training sets, human reader studies, and expert ground truth establishment for algorithm output do not apply to this specific device submission.

The document discusses "acceptance criteria" and "performance testing" in the context of physical device standards (e.g., ISO standards for sterility, needle performance, dead space volume, biocompatibility). These are mechanical, material, and sterilization performance criteria, not related to the performance of an algorithm.

Therefore, I cannot provide the requested information from the given text because the text describes a physical medical device, not an AI/algorithm-driven one.

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