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Intended Purpose: The K-Pack Embrace™ Active Safety Needle, being a hypodermic needle with safety shield, is intended to inject fluids into, or withdraw fluids from, parts of the body below the surface of the skin. The safety shield shall be manually locked (activated), after use, to cover the needle to minimize the risk of accidental needle stick.

Indications: The K-Pack Embrace™ Active Safety Needle is for general application – for treatment (injection of fluids) or diagnosis (withdrawal of fluids).

The K-Pack Embrace™ Active Safety Needle is a hypodermic single lumen needle, for single use consisting of stainless steel cannula that is sharpened at one end and at the other end joined to a female luer connector (hub) made of polycarbonate designed to be connected with a male luer connector (nozzle) of a hypodermic syringe. The K-Pack Embrace™ Active Safety Needle is compatible for use with standard luer slip and luer lock syringes. The K-Pack Embrace™ Active Safety Needle is packed in a hard plastic container (cap and case) made of polypropylene and sealed with a label.

This device features a hinged safety shield, made of polycarbonate, attached to the needle hub. The safety feature is activated when the safety shield is manually pressed over the needle immediately after use and prior to disposal to minimize the risk of accidental needle stick injuries. The safety shield is activated with a one-handed operation, using the finger, thumb, or surface activation.

The K-Pack Embrace™ Active Safety Needle is sterilized by ethylene oxide.

I am sorry, but the provided text from the FDA 510(k) Clearance Letter for the K-Pack Embrace™ Active Safety Needle does not contain the specific information required to describe the acceptance criteria and the study that proves the device meets those criteria in the way you've requested (e.g., details about AI studies, sample sizes for training/test sets, expert adjudication, MRMC studies, and nuanced ground truth establishment).

The document is a standard 510(k) clearance letter for a medical device (a hypodermic needle with a safety shield) that demonstrates substantial equivalence to a predicate device. The "Non Clinical Test" section focuses on:

• Performance testing: Verification of the device's design against recognized international standards (ISO 7864, ISO 9626, ISO 80369-7, ISO 6009, ISO 23908, ISO 11607-1, USP , and FDA guidance on sharps injury prevention). These standards define various physical and functional requirements for hypodermic needles and their safety features.
• Biocompatibility testing: Evaluation of the materials in contact with the body according to ISO 10993.
• Sterilization and shelf-life testing: Validation of the sterilization method (Ethylene Oxide) according to ISO 11135 and shelf-life studies according to ASTM F1980.

The document does not describe an AI/ML-based device or a study involving human readers, AI assistance, ground truth established by experts, or any of the elements typically associated with the kind of acceptance criteria you've detailed in your prompt (e.g., sensitivity, specificity, AUC for an AI model).

Therefore, I cannot populate the table or answer the specific questions related to AI/ML study design and expert review methodology based on the provided text. The device described is a physical medical device, not a diagnostic AI system.

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The purpose of this Guideline is to provide clarity and guidance regarding the use of a digital pathology system which utilizes artificial intelligence (AI)-based image analysis algorithms. It describes the intended use of the system and covers relevant considerations related to its functionality, setup, and use in a pathology laboratory environment. This includes the following:

• Clear indications for use, including the patient population, sample type, purpose of the analysis, and interpretation of the results.
• Description of the AI algorithms used, including their validation and performance characteristics.
• Guidelines for system setup and configuration, including hardware and software requirements, calibration procedures, and quality control measures.
• Recommendations for training and competency assessment of users.
• Instructions for data management and archiving.
• Considerations for potential limitations and risks associated with the use of the system.
• Reporting of results, including integration with laboratory information systems.
• Post-market surveillance and system updates.
• Adherence to relevant regulatory requirements and standards.

By following this Guideline, pathology laboratories can ensure the safe and effective use of AI-based image analysis in digital pathology, contributing to improved diagnostic accuracy and patient care.

A compact USB-C hub designed to expand connectivity options, featuring multiple ports including USB-A, HDMI, SD card reader, and a passthrough charging port, ideal for laptops with limited ports.

The provided FDA clearance letter for Terumo's Hypodermic Needle (K243309) does not describe a study involving acceptance criteria for device performance in the context of an AI/ML or diagnostic imaging device. Instead, this document is a 510(k) submission for a medical device (a hypodermic needle) that demonstrates substantial equivalence to a predicate device.

The "acceptance criteria" and "study that proves the device meets the acceptance criteria" in this document refer to performance verification tests for a physical medical device (hypodermic needle), rather than the kind of AI/ML or diagnostic performance evaluation described in the prompt's request.

Therefore, the requested information (table of acceptance criteria and device performance for AI/ML, sample sizes for test/training sets, expert qualifications, ground truth establishment, MRMC studies, etc.) is not applicable to this document.

The document primarily focuses on:

• Substantial Equivalence: Demonstrating that the new needle is as safe and effective as a previously cleared predicate device, despite a minor change (increased inner diameter/thin wall vs. regular wall).
• Non-Clinical Testing: Citing compliance with various ISO standards for hypodermic needles, biocompatibility, sterilization, and shelf-life, which are the "acceptance criteria" for this type of device.
• No Clinical Testing: Explicitly stating that clinical test data was not included because the changes were supported by non-clinical performance verification.

If this were an AI/ML or diagnostic device, the document would contain sections detailing sensitivity, specificity, AUC, human reader studies, etc., none of which are present here.

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The K-Pack Enhance Needle a sterile, hypodermic needle, for single use, intended to inject fluids into, or withdraw fluids from, parts of the body below the surface of the skin. The K-Pack Enhance Needle is for general application - for injection of fluids or withdrawal of fluids.

The K-Pack Enhance Needle is a sterile hypodermic needle for single use consisting of a stainless steel cannula with nominal outside diameter of 0.33 mm or 0.40 mm and a length of 12 mm. The cannula is sharpened at one end and has 45° cut at the other end, which is joined to a female luer connector (hub) made of polycarbonate (PC) designed to be connected with a male luer connector (nozzle) of a hypodermic syringe. The K-Pack Enhance Needle is packed in a hard plastic container (cap and case) made of polypropylene and sealed with a label. The case serves as needle protector. The needle is non-toxic, nonpyrogenic and sterilized by ethylene oxide.

This document is a 510(k) clearance letter for the K-Pack Enhance Needle, which is a hypodermic single lumen needle. This device is a physical product and not an AI/ML powered medical device. Therefore, the questions related to AI/ML device performance, such as sample size for test set, data provenance, number of experts for ground truth, adjudication method, MRMC studies, standalone performance, type of ground truth, training set size, and how training set ground truth was established, are not applicable.

Here's the breakdown of the acceptance criteria and performance information that is relevant to this type of medical device:

Acceptance Criteria and Device Performance for K-Pack Enhance Needle

The K-Pack Enhance Needle is a physical medical device (hypodermic needle). Its acceptance criteria are based on various international and national standards for such devices, ensuring its safety, effectiveness, and substantial equivalence to a predicate device. The performance of the device against these standards is demonstrated through non-clinical testing.

1. Table of Acceptance Criteria and 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)

This device is a physical medical product, not an AI/ML powered device. Therefore, the concept of a "test set" in the context of data for an algorithm does not apply. Performance was evaluated through non-clinical testing (laboratory and bench testing) of the physical device as manufactured. The specific sample sizes for each non-clinical test (e.g., how many needles were tested for tensile strength, flow rate, or EO residuals) are not detailed in this summary document, but such testing would be performed on representative samples per relevant standards. Data provenance, in this case, would refer to the materials and manufacturing location (Terumo Europe N.V., Belgium) and the testing being conducted in accredited laboratories following international standards.

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. This is a physical medical device. "Ground truth" expertise would involve engineers and quality control specialists performing direct measurements and assessments against specified technical standards.

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

Not applicable. This is a physical medical device. Performance is determined by objective physical and chemical testing against defined 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 is a physical medical device, not an AI/ML diagnostic or assistive tool.

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 concensus, pathology, outcomes data, etc)

Not applicable. For a physical device, "ground truth" equates to adherence to established engineering specifications, material properties, and performance benchmarks defined by national and international standards (e.g., ISO, USP, ASTM).

8. The sample size for the training set

Not applicable. This is a physical medical device, not an AI/ML powered device.

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

Not applicable. This is a physical medical device.

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The Terumo Injection Filter Needle is intended to inject fluids. The Terumo Injection Filter Needle is indication - for treatment - injection of fluids into parts of the body below the surface of the skin and into the vitreous.

The Terumo Injection Filter Needle is a sterile injection needle for single use consisting of a stainless steel cannula with nominal outside diameter of 0.3 mm and length of 12 mm that is sharpened at one end and at the other end joined to a female luer connector (hub) made of polymethyl methacrylate designed to be connected with a male luer connector (nozzle) of a syringe. The integrated 5u filter in the hub is intended to prevent particles from being injected. The needle is non-toxic, nonpyrogenic and sterilized by ethylene oxide. Its operation is manual. The Terumo Injection Filter Needle protector and is individually packed in a soft blister made of paper and film and sterilized by ethylene oxide.

Here's an analysis of the provided text regarding the acceptance criteria and supporting studies for the Terumo Injection Filter Needle (K230951).

Disclaimer: This device is a physical medical instrument (needle) and not an AI/software device. Therefore, many of the requested categories related to AI performance, ground truth, experts, and MRMC studies are not applicable. I will address only the relevant sections from the provided document.

1. Table of Acceptance Criteria and Reported Device Performance

As this is a physical medical device, not an AI/software device, the following points are not applicable to the provided 510(k) summary:

2. Sample size used for the test set and the data provenance: Not explicitly stated for each test, but standard compliance implies specific sample sizes. Data provenance is implied to be laboratory testing of the manufactured device.
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 a physical device's performance is typically established through direct physical and chemical testing against recognized standards.
4. Adjudication method: Not applicable.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done: No. This is for AI-assisted human reading.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: No. This is for AI algorithm performance.
7. The type of ground truth used: For this physical device, the "ground truth" is defined by the requirements of the recognized consensus standards (e.g., ISO, USP, ASTM) and the inherent physical properties and chemical composition of the materials. Performance is measured against these established quantitative and qualitative criteria.
8. The sample size for the training set: Not applicable. This is not an AI/ML device.
9. How the ground truth for the training set was established: Not applicable.

Summary of the Study Proving Device Meets Acceptance Criteria:

The Terumo Injection Filter Needle (NF-3013RBKE05M) demonstrates substantial equivalence to its predicate device (K-Pack II Needle, K192057) through a comprehensive set of non-clinical performance, biocompatibility, and sterilization tests. The key difference in the subject device is the inclusion of an integrated 5µm filter and an additional indication for use in the vitreous.

This substantial equivalence is supported by:

• Performance Verification: Adherence to established international and national standards including:
  • ISO 7864:2016 (Sterile hypodermic needle for Single use)
  • ISO 9626:2016 (Stainless steel needle tubing for the manufacturing of medical devices)
  • ISO 80369-7:2017 (Small bore connectors for liquids & gases in healthcare applications - Part 7: Connectors for intravascular or hypodermic applications)
  • ISO 6009:2016 (Color coding)
  • **USP ** (Particulate matter in injections) and **USP ** (Particulate matter in ophthalmic solutions) to evaluate particulate control and filter efficiency.
  • ISO 11607-1:2019 (Packaging for terminally sterilized medical devices) for packaging integrity.
• Biocompatibility Studies: Evaluation performed in accordance with EN ISO 10993-1:2020, targeting endpoints such as cytotoxicity, sensitization, irritation (including ocular and intraocular), acute systemic toxicity, pyrogenicity, and haemocompatibility. Chemical extraction (ISO 10993-18:2020) and toxicological assessment (ISO 10993-17:2009) were conducted to ensure material safety, particularly for ophthalmic use.
• Sterilization and Shelf Life Validation:
  • Sterilization validated using ISO 11135:2014 (Ethylene oxide sterilization), ensuring a Sterility Assurance Level (SAL) of 10^-6.
  • Bacterial endotoxin limits determined by LAL testing and aligned with FDA Guidance for ophthalmic devices.
  • Ethylene oxide residual limits addressed per ISO 10993-7:2008/Amd.1:2019, considering special situations for ocular devices.
  • Shelf life of 5 years supported by accelerated aging studies (ASTM F1980).

The company asserts that the differences in intended use (no fluid withdrawal, added vitreous injection) and technological characteristics (integrated filter) are adequately supported by these performance validations and do not raise new or different questions of safety or effectiveness compared to the predicate device. No clinical tests were included in this 510(k) submission.

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The TERUMO SurGuard®3 SAFETY HYPODERMIC NEEDLE is intended for use in the aspiration and injection of fluids for medical purposes. The Terumo Safety Hypodermic Needle is compatible for use with standard luer lock syringes. Additionally, after withdrawal of the needle from the body, the attached needle safety sheath can be manually activated to cover the needle immediately after use to minimize risk of accidental needlestick.

The SurGuard®3 Safety Hypodermic Needle is a hypodermic single lumen needle, for single use consisting of stainless steel cannula that is sharpened at one end at the other end joined to a female luer connector (hub) made of polypropylene designed to be connected with a male luer connector (nozzle) of a hypodermic syringe. The SurGuard®3 Safety Hypodernic Needle is compatible for use with standard luer slip and luer lock syringes. This device features a hinged safety sheath attached to the needle hub. The safety sheath contains two locking mechanisms, the tooth-cannula and sheath-collar which are simultaneously activated when manually pressed over the needle immediately after use and just prior to disposal to minimize the risk of accidental needlestick. The safety sheath is activated with a one-handed operation, using the finger, thumb, or surface activation.

The SurGuard®3 Safety Hypodermic Needle will be individually packaged and sterilized by ethylene oxide.

This document focuses on the Terumo SurGuard®3 Safety Hypodermic Needle (K212095).

Based on the provided text, this is a 510(k) summary for a medical device that claims substantial equivalence to previously cleared devices. It describes design and manufacturing aspects and non-clinical performance testing. It explicitly states that no clinical tests were performed or included in this 510(k) submission. Therefore, the information requested regarding acceptance criteria and studies that prove the device meets these criteria in a clinical context (e.g., sample sizes, expert ground truth, MRMC studies, standalone performance) is not applicable or cannot be extracted from this document.

The acceptance criteria and supporting studies mentioned pertain to non-clinical performance and substantial equivalence to predicate devices.

1. Table of Acceptance Criteria and Reported Device Performance

The device is evaluated against recognized consensus standards and general performance requirements for hypodermic needles. The "acceptance criteria" are implied by compliance with these standards and the "reported device performance" is the statement of this compliance.

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

• Sample Size: Not specified in the document for any individual test. The document states that "The design... has been validated... in accordance with the Design Control Requirements and recognized consensus standards." These standards typically define sample sizes for specific tests.
• Data Provenance: The testing was "validated by Terumo Europe N.V." and conducted to "recognized consensus standards." The nature of these standards suggests laboratory-based, non-clinical engineering and biological safety tests. No country of origin for the explicit test data is mentioned beyond Terumo Europe N.V. performing the validation. All testing is retrospective to the device design.

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

• Not applicable. This document describes non-clinical performance testing against technical standards for a hypodermic needle, not a diagnostic or AI device that requires expert-established ground truth.

4. Adjudication method

• Not applicable, for the same reasons as #3.

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 hypodermic needle and not an AI-assisted diagnostic device. The document explicitly states "This 510(k) does not include data from clinical tests."

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

• Not applicable. This is a physical medical device (hypodermic needle), not an algorithm or AI system.

7. The type of ground truth used

• For non-clinical performance and safety testing, the "ground truth" is established by the specifications and requirements defined within the referenced international and national consensus standards (e.g., ISO, USP, ASTM). For example, a needle's sterility is "ground truth" if it achieves a SAL of 10⁻⁶ as per ISO 11135:2014. Biocompatibility is confirmed by meeting the biological endpoints outlined in ISO 10993-1.

8. The sample size for the training set

• Not applicable. This is a physical medical device, not an AI or machine learning model. There is no concept of a "training set."

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

• Not applicable, for the same reasons as #8.

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The K-Pack II Needles - 27G x 1/2" Extra Thin Wall, 27G x 1/2" Ultra Thin Wall, 30G x 1/2" Extra Thin Wall and 30G x 1/2" Ultra Thin Wall being Hypodermic Single Lumen Needles are sterile medical devices for single use intended to inject fluids into, or withdraw fluids from, parts of the body below the surface of the skin.

The subject K-Pack II Needles are hypodermic single lumen needles, for single use consisting of stainless steel that is sharpened at one end and at the other end joined to a female luer connector (hub) made of polypropylene designed to be connected with a male connector (nozzle) of a hypodermic syringe. The needle is packed in a hard pack (cap-case) made of polypropylene. The K-Pack II Needles - 27G x 1/2" Extra Thin Wall, 27G x 1/2" Ultra Thin Wall, 30G x 1/2" Extra Thin Wall and 30G x 1/2" Ultra Thin Wall will be an extension of the existing K-Pack II Needles product family.

The K-Pack II Needles are subject to a Special 510(k) submission due to the introduction of new product codes with increased cannula's inner diameter, resulting in different cannula wall types (ultra and extra thin wall versus thin wall). The device's performance was evaluated against several recognized consensus standards for hypodermic needles.

Here is a breakdown of the information requested:

1. Table of Acceptance Criteria and Reported Device Performance

The device performance is reported as meeting the acceptance criteria outlined by the specified standards.

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The "Syringe with fixed needle - For use only with GONAL-f Multi-Dose 600 IU/mL FSH" is a hypodermic syringe with fixed needle intended for manual aspiration of GONAL-f Multi-Dose and for the solution into parts of the body below the surface of the skin.

The syringes designed for manual use are intended for use soon after filling, as they are not suitable for containing GONAL-f Multi-Dose over extended periods of time.

The "Syringe with fixed needle – For use only with GONAL-f Multi-Dose 600 IU/mL FSH" is comprised of a standard piston syringe with a permanently attached (fixed) hypodermic single lumen needle designed for the manual aspiration and injection of GONAL-f Multi-Dose. The needle is covered by a protective cap. The graduated scale is specifically designed for GONAL-f Multi-Dose. This syringe is a 1 ml syringe with 27G x 12" fixed needle. This is a single use syringe.

The provided text is a U.S. FDA 510(k) Premarket Notification for a medical device (a syringe). It details the device's characteristics, intended use, and comparison to a predicate device, along with summaries of verification and validation activities.

However, the request asks for information relevant to the acceptance criteria and study proving a device meets acceptance criteria for an AI/ML-driven medical device. The furnished document does not describe an AI/ML device. It describes a physical medical device (syringe) and its physical, mechanical, and biological performance characteristics. Therefore, many of the specific questions regarding AI/ML device testing (e.g., sample size for test/training sets, data provenance, number/qualifications of experts for ground truth, MRMC studies, standalone performance, etc.) are not applicable to the content provided.

The document focuses on:

• Physical performance tests: Cleanliness, visual appearance, gasket position, needle length, blister dimensions, peel behavior, integrity of sterile barrier, seal strength, package burst, air/liquid leakage, mobility force, graduated capacity tolerance, dead space volume, plunger-gasket assembly, stopper function strength, barrel printing resistance, protector fitting strength, bonding strength of cannula, needle penetration resistance, and transport simulation tests.
• Biocompatibility tests: Cytotoxicity, hemolysis, systemic (acute) toxicity, intracutaneous reactivity, sensitization, pyrogenicity, and LAL testing.
• Sterilization validation: Ethylene oxide sterilization to SAL 10-6, and residuals compliance.
• Shelf life: 5 years.

Assuming the request is a general template for AI/ML devices and I must derive the closest equivalent answers from the provided syringe document:

Here's an interpretation based on the provided document, although it explicitly does not relate to an AI/ML device:

1. Table of acceptance criteria and the reported device performance:

The document provides a table of "Verification Activities" with "STANDARD OR INTERNAL ACCEPTANCE CRITERIA." While specific "reported device performance" values are not listed for each test (only that the tests were performed and the device met the criteria), the acceptance criteria themselves are explicitly stated.

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

• The document states, "All necessary verification and validation tests have been performed by testing the "Syringe with fixed needle - For use only with GONAL-f Multi-Dose 600 IU/mL FSH"." It does not specify the sample size for each test.
• Data provenance: Not explicitly stated, but as the company is Terumo Europe N.V. (Belgium), the testing would likely have been conducted within their quality system, potentially in Belgium or at their manufacturing sites. It's a "prospective" test in the sense that the new device was manufactured and then subjected to these validation tests.

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

• This question is irrelevant to the type of device described. Ground truth for a physical syringe's performance is established by objective measurements against engineering specifications and international standards, not by expert consensus on, for example, diagnostic images.

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

• This question is irrelevant to the type of device described. No adjudication methods are mentioned as it's not applicable to the physical/mechanical and biological testing of a syringe.

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 question is irrelevant as the device is a physical syringe, not an AI-assisted diagnostic tool.

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

• This question is irrelevant as the device is a physical syringe, not an algorithm.

7. The type of ground truth used:

• The "ground truth" for this device's performance is based on International Standards (EN ISO) and internal acceptance criteria derived from engineering specifications and regulatory requirements. For example, ISO 8537 for "Syringes for insulin" and ISO 11607-1 for "Sterilization of health care products - Packaging for terminally sterilized medical devices." Biocompatibility is against ISO 10993 series.

8. The sample size for the training set:

• This concept is not applicable as the device is not an AI/ML model that requires training data.

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

• Not applicable as there is no training set for a physical syringe.

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The 29G x 5/16" Thin Wall K-Pack II Needles being Hypodermic Single Lumen Needles are sterile medical devices for single use, intended to inject fluids into, or withdraw fluids from, parts of the body below the surface of the skin.

Comprised of a stainless steel tube that is sharpened at one end and at the other end joined to a female luer connector (hub) designed to be connected with a male connector (nozzle) of a piston syringe.

Acceptance Criteria and Device Performance Study for K-Pack II Needle - 29G x 5/16" Thin Wall

This document describes the acceptance criteria and a summary of verification activities conducted for the K-Pack II Needle - 29G x 5/16" Thin Wall, as presented in the provided 510(k) summary. The study aims to demonstrate substantial equivalence to predicate devices (K-Pack II Needles (K984576) and 29G x 1/2" Thin Wall K-Pack II Needles (K082820)).

1. Table of Acceptance Criteria and Reported Device Performance

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The 21G x 2" K-Pack II Needle being a Hypodermic Single Lumen Needle is a sterile medical device for single use, intended to inject fluids into, or withdraw fluids from, parts of the body below the surface of the skin.

Comprised of a stainless steel tube that is sharpened at one end and at the other end joined to a female luer connector (hub) designed to be connected with a male connector (nozzle) of a piston syringe.

Here's an analysis of the acceptance criteria and study information provided in the document:

Device: K-Pack II Needle - 21G x 2"
General Type of Device: Hypodermic Single Lumen Needle

Acceptance Criteria and Reported Device Performance

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The Surflo Winged Infusion Set with Filter and Needle Protection (Surshield) is intended to access the peripheral vascular system, for single-dose or short-term intravenous administration of fluids using a syringe or other compatible/appropriate devices. Additionally, after withdrawal of the needle from the patient's vein, the shield cover can be manually activated to cover the needle to minimize risk of accidental needle stick.

The 23G and the 25G Terumo Surflo Winged Infusion Sets with Filter and Needle Protection (Surshield), are sterile, single use devices consisting of a needle attached to a winged hub, microbore tubing, adapter with integrated 20 um filter and adapter cap, and a hinged shield cover that attaches to the wing just below the needle-to-wing junction. The shield cover can be turned 180 degrees on the hinge. As the needle is removed from the patient's vessel, the user's finger actively pushes the shield cover until it latches onto the needle using a one- or two- handed technique. An audible click is noted upon activation. The shield cover is designed to allow the user's finger to remain behind the needle point so that the risk of needle stick injury is minimized. The shield cover is transparent for easy confirmation of the needle held in it. The device possesses a 350 mm length microbore tubing.

The provided text describes the acceptance criteria and a summary of verification activities for the SURFLO® Winged Infusion Set with Filter and Needle Protection (Surshield®). This device is a medical product, and the study described is a series of engineering and performance tests, not a clinical study involving human patients or algorithmic performance. Therefore, many of the requested categories (e.g., sample size for test set, data provenance, number of experts for ground truth, adjudication method, MRMC study, training set information) are not applicable to this type of device submission.

Here's a breakdown of the available information:

1. Table of Acceptance Criteria and Reported Device Performance

The document states: "The Surflo Winged Infusion Sets with Filter and Needle Protection (Surshield), meet all acceptance criteria as indicated in table above."

2. Sample size used for the test set and the data provenance
The document does not specify the exact sample sizes (number of units tested) for each individual test. It only states that "All necessary verification and validation tests have been performed." Data provenance is not explicitly mentioned as "country of origin," but the submission is from "TERUMO EUROPE N.V." in Leuven, BELGIUM, so the testing likely occurred in Europe. The tests are prospective in nature, as they are performed on the newly designed devices to verify their performance against established criteria.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. These are engineering and performance tests of a physical medical device, not a diagnostic algorithm requiring expert interpretation of medical images or data. The "ground truth" is defined by the technical specifications and international standards (e.g., ISO 594-1, ISO 594-2, EN ISO 11135-1, EN 556-1, EN ISO 10993-7).

4. Adjudication method for the test set
Not applicable. There is no adjudication method described as these are quantitative and qualitative engineering tests against predefined specifications.

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 diagnostic device.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an algorithm.

7. The type of ground truth used
The ground truth for these tests is established by international standards and technical specifications for sterile medical devices for intravascular administration. Examples include:

• ISO 594-1: Conical fittings with a 6% (Luer) taper for syringes, needles and certain other medical equipment — Part 1: General requirements
• ISO 594-2: Conical fittings with a 6% (Luer) taper for syringes, needles and certain other medical equipment — Part 2: Lock fittings
• EN ISO 11135-1: Sterilization of health care products - Ethylene oxide - Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices
• EN 556-1: Sterilization of Medical Devices - Requirements for medical devices to be designated "STERILE" - Part - I: Requirements for terminally sterilized medical devices
• EN ISO 10993-7: Biological evaluation of medical devices - Part 7: Ethylene oxide sterilization residuals
• FDA General Program Memorandum #G95-1: Use of International Standard ISO-10993, "Biological Evaluation of Medical Devices Part-1: Evaluation and testing"

8. The sample size for the training set
Not applicable. There is no "training set" as this is not a machine learning or AI device.

9. How the ground truth for the training set was established
Not applicable.

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