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Winged Infusion Set is indicated for the short-term infusion of intravenous fluids for 2 hours or less. It is to be used by appropriately trained healthcare professionals in accordance with the instructions.

Safety Winged Infusion Set is indicated for the short-term infusion of intravenous fluids for 2 hours or less. It is to be used by appropriately trained healthcare professionals in accordance with the instructions. The safety shield is intended to aid in the protection against accidental needle stick injury.

Blood Collection Set is indicated for venous blood collection. It is to be used by appropriately trained healthcare professionals in accordance with the instructions.

Blood Collection Set with Holder is indicated for venous blood collection. It is to be used by appropriately trained healthcare professionals in accordance with the instructions.

Safety Blood Collection Set is indicated for venous blood collection. It is to be used by appropriately trained healthcare professionals in accordance with the instructions. The safety shield is intended to aid in the protection against accidental needle stick injury.

Safety Blood Collection set with Holder is indicated for venous blood collection. It is to be used by trained healthcare professionals in accordance with the instructions. The safety shield to aid in the protection agamst accidental needle stick injury.

Needle Holder is used for the collection of blood specimen into the blood collection tubes in routine venipuncture procedures. It is used with blood collection sets, needles and tubes. It is to be used by trained healthcare professional only.

The Blood Collection Set with Holder, Blood Collection Set, and Winged Infusion Set are single-use, sterile, winged needles bonded to flexible tubing with a Luer connector. The devices are individually wrapped and sterile with a luer port. The luer port can connect FDAcleared accessories like luer adapter, holder, etc.

The Safety Blood Collection Set with Holder, Safety Blood Collection Set, and Safety Winged Infusion Set are single-use, sterile, winged needles bonded to flexible tubing with a Luer connector and a safety mechanism. The winged needle is designed with a safety mechanism, which allows for activation and ensures the needle is covered immediately following venipuncture to protect against accidental needlestick injury. The Safety Blood Collection / Infusion Set (with/without needle holder) is individually wrapped sterile with a luer port. The luer port can connect FDA-cleared accessories like luer adapter, holder, etc.

The safety feature is operated by releasing a latch mechanism whereby the user slides a winged cover over the needle as it is removed from the patient. Once the needle is covered, the safety cover locks in place. There is no ability to clean and reuse these because the safety feature cannot be deactivated without bending the needle and rendering it unusable.

The devices are used for venous blood collection and/or the short-term infusion of intravenous fluids. The product is to be used by appropriately trained healthcare professionals only in accordance with the manufacturer's instructions. It can be used with an intravascular administration set, syringe, or other device to administer fluids.

The provided document is a 510(k) Premarket Notification from the U.S. FDA, which concerns the substantial equivalency of a medical device to legally marketed predicate devices. This type of submission focuses on demonstrating that a new device is "as safe and effective" as a predicate device and often relies on comparisons to known standards and existing devices rather than extensive clinical studies.

Therefore, the document does not describe a study that aims to prove that the device meets acceptance criteria related to AI/ML performance (e.g., sensitivity, specificity, F1-score for an AI algorithm, or human reader improvement with AI assistance).

Instead, the acceptance criteria and performance data provided in this document relate to the physical and functional performance, biocompatibility, sterilization, and packaging of a medical device (Winged Infusion Sets, Blood Collection Sets, and Needle Holders).

Here's an analysis of the provided information within the context of a medical device 510(k) submission, specifically addressing the points in your request where applicable, and noting where the information is not provided due to the nature of this type of submission (i.e., it's not an AI/ML device).

Analysis of Acceptance Criteria and Study to Prove Device Meets Acceptance Criteria:

This document describes the non-clinical performance testing conducted to support the substantial equivalence claim for physical medical devices (Winged Infusion Set, Safety Winged Infusion Set, Blood Collection Set, Blood Collection Set with Holder, Safety Blood Collection Set, Safety Blood Collection Set with Holder, Needle Holder). It does not pertain to an AI/ML device, and therefore, many of your specific questions related to AI/ML performance metrics, expert adjudication, MRMC studies, or standalone algorithm performance are not applicable and are not found in this document.

The "acceptance criteria" here are compliance with recognized international and national standards for medical devices of this type. The "study" proving the device meets these criteria refers to the non-clinical performance testing conducted against these standards.

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

The document lists the standards that the device was tested against. The "reported device performance" is a blanket statement that "All the pre-determined acceptance criteria were met." There isn't a specific table with numerical performance metrics for each criterion; rather, it indicates compliance with the listed standards.

Specific tests performed for Packaging and Shelf Life: Accelerated Aging Test, Simulated shipping distribution testing, Visual inspection, Performance Inspection (Chemical performance and Physical performance), Sterile Test, Vacuum Leak Test, Dye penetration test, Tensile Seal Strength Test.

2. Sample sized 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 the sample sizes for each test mentioned (e.g., how many devices were tested for tensile strength, biocompatibility, etc.). The data provenance is not explicitly stated in terms of country of origin but is implied to be from the manufacturer's testing (Jiangsu Kangbao Medical Equipment Co., Ltd, China). The testing is non-clinical, likely conducted retrospectively for the purpose of the submission.

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)

This question is not applicable. This is not an AI/ML device that requires expert-established ground truth from, for example, medical images. The "ground truth" here is adherence to specified engineering, material, and biological standards.

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

Not applicable, as this is not an AI/ML device requiring human review/adjudication of outputs.

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 Data: No clinical study is included in this submission."

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)

The "ground truth" for this device is physical and material science standards (e.g., ISO, ASTM standards for materials, performance, sterilization, and packaging). Compliance with these established industry standards constitutes the "ground truth" for device safety and effectiveness in this context.

8. The sample size for the training set

Not applicable. This is not an AI/ML device, so there is no training set in the AI sense. The manufacturing processes and designs would be "trained" in an engineering sense over time and through quality control, but this is not data for an algorithm.

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

Not applicable, as there is no AI/ML training set. The "ground truth" for manufacturing and design would be engineering specifications and quality control parameters.

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The Antineedle Stick Protector is an integral, active safety device intended to minimize accidental needle stick injuries when used to shield needles for Kawasumi products manufactured with a wing and needle assembly for solution infusion and blood sampling.

The Small Vein Infusion Set with Antineedle Stick Protector is a single use, sterile device used for peripheral venous access for solution administration or blood collection. The Antineedle Stick Protector is an integral, active safety device intended to minimize accidental needle stick injuries when used to shield needles.

The Winged Collection Set with Multi-Sample Luer Adapter and Antineedle Stick Protector is a single use, sterile, blood collection device used for peripheral venous access for blood sampling. The Antineedle Stick Protector is an integral, active safety device intended to minimize accidental needle stick injuries when used to shield needles.

The Antineedle Stick Protector is a polymeric device designed to be used integral with winged needle sets and shields the needle when the needle with hub and wing assembly is removed from the patient

Here's an analysis of the provided text regarding the acceptance criteria and study for the device:

1. Table of Acceptance Criteria and Reported Device Performance

Based on the provided K023917 510(k) Summary, the acceptance criteria are implicitly tied to the performance of the predicate device and the prevention of needlestick injuries. The document does not explicitly state quantitative acceptance criteria with specific thresholds (e.g., "99% activation rate"). Instead, it focuses on achieving the same results as the predicate device regarding needle tip protection.

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

• Test Set Sample Size: Not specified. The document mentions "a successful simulated use study" but does not provide details on the number of units or uses tested.
• Data Provenance: The study was conducted by Kawasumi Laboratories, Inc., located in Tokyo, Japan. The study is described as a "simulated use study," implying it was conducted in a controlled environment, likely within their facility. It is a prospective study as it was conducted specifically to demonstrate the device's performance for this 510(k) submission.

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

This information is not provided in the given text. The study is described as a "simulated use study" but does not mention the involvement of experts in establishing ground truth or evaluating the results. The determination of "success" likely relied on internal assessment criteria by Kawasumi Laboratories.

4. Adjudication Method for the Test Set

This information is not provided in the given text. There is no mention of independent reviewers or an adjudication process for the "simulated use study."

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study is typically associated with diagnostic imaging devices or algorithms where human readers interpret medical images with or without AI assistance. The device in question is a medical device designed to prevent needlestick injuries, and such a study would not be applicable.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

This question is not applicable to the device described. The device is a physical product (winged needle set with an antineedle stick protector), not an algorithm or software. Its performance inherently involves human interaction during its use to activate the protector.

7. The Type of Ground Truth Used

The "ground truth" for this device's performance would likely be a direct observation of whether the needle tip was successfully shielded or retracted after simulated use, thereby preventing accidental needlestick. The text states: "In both devices, the needle tip is protected inside the device after use." This implies the ground truth for success was the successful physical enclosure of the needle tip.

8. The Sample Size for the Training Set

This question is not applicable as there is no "training set" for this type of physical medical device. Training sets are relevant for machine learning algorithms.

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

This question is not applicable as there is no "training set."

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This winged needle holder is indicated for use in securing and positioning a hypodermic needle during the administration of a peribulbar nerve block.

The winged needle holder is fabricated from polyethylene.

This document describes a 510(k) submission for a "Removable Wings" device, also referred to as a "Winged needle holder." The submission focuses on demonstrating substantial equivalence to a predicate device already on the market. Consequently, the study described does not involve performance criteria and a study to prove they are met in the manner of a typical medical device with measurable outcomes (e.g., accuracy, sensitivity, specificity for a diagnostic device, or efficacy for a therapeutic device).

Instead, the "acceptance criteria" here are based on the comparison of attributes to a legally marketed predicate device. The "study" is a comparison table rather than a clinical trial or performance study.

1. Table of Acceptance Criteria and Reported Device Performance

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

This is not applicable in the traditional sense for this type of submission. There is no "test set" of patient data or clinical samples. The "test" is a direct comparison of physical and functional attributes of the submitted device against a predicate device.

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

Not applicable. The "ground truth" for this substantial equivalence submission is the attributes of the legally marketed predicate device. No expert consensus on a test set was required.

4. Adjudication Method for the Test Set

Not applicable. There was no test set 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 not an AI-assisted device, nor is it a diagnostic imaging device that would typically undergo an MRMC study.

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

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

7. The Type of Ground Truth Used

The "ground truth" used for this submission is the characteristics and functionality of a legally marketed predicate device (Becton Dickinson and Company's removable winged needle holder). This is a regulatory "ground truth" for substantial equivalence rather than a clinical one.

8. The Sample Size for the Training Set

Not applicable. There is no training set as this is not an algorithm or AI-powered device.

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

Not applicable, as there is no training set. The "ground truth" for the comparison was established by the existence and characteristics of the predicate device, presumably through manufacturer specifications and its established market use.

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