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The safety winged blood collection set is single-use, sterile, winged venipuncture needle bonded to a flexible tubing with or without a luer adapter and/or tube holder. The device is used for blood collection and/or the short-term infusion of intravenous fluids (up to 2 hours under direct clinical supervision). The blood-collection needle is designed to be covered with a safety mechanism, which can be activated to cover the needle immediately following venipuncture to aid in the protection against accidental needlestick injury.

The Promisemed Safety Blood Collection sets are single-use, sterile, venipuncture needles used for blood collection or short-term infusion of intravenous fluids (up to 2 hours under direct clinical supervision). The blood-collection needle is designed to be covered with a safety mechanism, which can be activated to cover the needle immediately following venipuncture to aid in the protection against accidental needlestick injury.

This document is a 510(k) summary for a medical device called "Safety Winged Blood Collection Sets" (K243806) from Promisemed Hangzhou Meditech Co., Ltd. It declares substantial equivalence to a predicate device (K211293).

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present a table of acceptance criteria and reported device performance in the format usually seen for AI/ML performance. This is because the device is a physical medical device (blood collection set), not an AI/ML diagnostic system. The "acceptance criteria" here are implied by adherence to recognized international standards and successful completion of non-clinical tests.

However, based on the provided text, we can infer some "acceptance criteria" and "performance" statements related to the modifications made (specifically the addition of model RBC and changes in needle sizes/materials).

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

• Sample size: The document does not specify a numerical sample size for any of the non-clinical tests conducted. Statements like "Visual inspections were conducted on unit packaging" and "Full performance was tested" indicate tests were performed but don't provide the number of units tested.
• Data provenance: The data provenance is from the manufacturer's internal non-clinical testing. It is implicitly "prospective" in the sense that the tests were conducted specifically to demonstrate the performance of the modified device for this 510(k) submission. No specific country of origin for the data is mentioned other than the manufacturer's location in China.

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

This section is not applicable as this is a 510(k) for a physical medical device (blood collection set), not an AI/ML device that generates diagnostic outputs requiring expert interpretation or ground truth labeling in that sense. The "ground truth" for these types of devices is established by adherence to engineering specifications and international performance standards.

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

This is not applicable for the same reason as above. No "adjudication" or consensus reading by experts is required for the non-clinical performance and design verification tests reported.

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 is not applicable as the device is not an AI/ML system, nor does it involve human readers or cases in an interpretive diagnostic context.

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

This is not applicable as the device is not an algorithm or AI system.

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

The "ground truth" for this medical device is adherence to established technical specifications, engineering drawings, and relevant international performance standards (ISO 6009, ISO 8536-4, ISO 9626, ISO 23908). Biocompatibility is "ground-truthed" by ISO 10993 series testing (e.g., in vitro cytotoxicity).

8. The sample size for the training set

This is not applicable as there is no AI/ML algorithm requiring a training set.

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

This is not applicable as there is no AI/ML algorithm requiring a training set or its associated ground truth establishment.

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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.

• ISO 9626 Second edition 2016-08-01: Stainless steel needle tubing for the manufacture of medical devices - Requirements and test methods
• ISO 7864 Fourth edition 2016-08-01: Sterile hypodermic needles for single use -Requirements and test methods
• ISO 80369-7 First edition 2016-10-15: Small-bore connectors for liquids and gases in healthcare applications - Part 7: Connectors for intravascular or hypodermic applications
• ISO 80369-20 First edition 2015-05-15: Small-bore connectors for liquids and gases in healthcare applications part 20: common test methods.
• ISO 23908 First edition 2011-06-11: Sharps injury protection - Requirements and test methods - Sharps protection features for single-use hypodermic needles, introducers for catheters, and needles used for blood sampling | "All the pre-determined acceptance criteria were met." |
  | Biocompatibility | - ISO10993-5: 2009: In Vitro Cytotoxicity
• ISO10993-10: 2021: Skin Sensitization
• ISO10993-23: 2021: Intracutaneous Reactivity Test
• ISO10993-11: 2017: Acute Systemic Toxicity
• ISO10993-4:2017: Coagulation test
• ISO10993-4: 2017: Complement activity (SC5b-9) Test
• ISO10993-4: 2017: Hemolytic Properties Test
• ISO10993-3: Ames Test
• ISO10993-3: Mammalian Chromosome Aberration Test | "All the pre-determined acceptance criteria were met." |
  | Sterilization | - ISO11135-1: Sterilization of health care products ethylene oxide part 1
• ISO11737-1: Sterilization of medical devices-Microbiological Methods-Part 1
• ISO11737-2: Sterilization of medical devices -- Microbiological methods - Part 2
• ISO10993-7: Biological evaluation of medical devices - Part 7: Test of Ethylene Oxide Residuals.
• ANSI/AAMI ST72: Bacterial endotoxins - Test methods | "All the pre-determined acceptance criteria were met." |
  | Packaging &
  Shelf Life | - ISO 11607-1:2006/(R) 2010: Packaging for terminally sterilized medical devices
• ASTM F1929-15: Standard Test Method for Detecting Seal Leaks in Porous Medical Packaging by Dye Penetration
• ASTM F1980-16: Standard Guide for Accelerated Aging of Sterile Barrier Systems for Medical Devices
• ASTM D3078-02 (2021): Standard Test Method for Determination of Leaks in - Flexible Packaging by Bubble Emission.
• ASTM F88/F88M-15: Standard Test Method for Seal Strength of Flexible Barrier Materials | "All the pre-determined acceptance criteria were met." |

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 Surflo Winged Infusion Set is indicated for venipuncture and intravenous administration of fluids for up to 24 hours using compatible/appropriate disposable infusion devices for medical purposes. It may be used for any patient population with consideration given to patient size.

The Surflo Winged Infusion Set consists of a protector, needle, wing, tubing, connector, and connector cap. The connector is 6% female Luer. It is primarily made from medical grade PVC (the whole device uses TOTM as plasticizer instead of DEHP) and medical grade stainless steel. The Surflo Winged Infusion Set is operated manually. The device is intended to be used by trained healthcare professionals in a healthcare facility. The Surflo Winged Infusion Set is available in different gauge sizes and tubing lengths. The Surflo Winged Infusion Set is a disposable device intended for single use only. The device is packaged and sterilized by ethylene oxide gas.

This document is a 510(k) Premarket Notification for the Surflo Winged Infusion Set, seeking substantial equivalence to a legally marketed predicate device. As such, it describes performance testing conducted to demonstrate product safety and effectiveness, rather than a study proving a device meets acceptance criteria for an AI/ML product. Therefore, several points in your requested output, such as those related to AI/ML specific criteria (e.g., sample size for training set, number of experts for ground truth establishment, MRMC study, standalone performance) are not applicable to this type of medical device submission.

However, I can extract and present the relevant information regarding acceptance criteria and performance testing for this traditional medical device:

Acceptance Criteria and Device Performance for Surflo Winged Infusion Set

The Surflo Winged Infusion Set underwent non-clinical performance testing to ensure it met predetermined specifications, conformed to applicable ISO and non-ISO standards, and demonstrated substantial equivalence to its predicate device.

1. Table of Acceptance Criteria (Standard Compliance) and Reported Device Performance

For tests conducted against specific standards, the document implies that compliance with the standard is the acceptance criterion. For additional performance tests, the acceptance criterion was "Meets acceptance criteria," established based on the predicate device's performance.

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

The document does not explicitly state the sample sizes used for each performance test. It only mentions that "Performance testing was conducted to ensure the Surflo Winged Infusion Set met the predetermined specifications." The data provenance is implied to be from the manufacturer's internal testing facilities in Hangzhou, China, as it is manufactured by "Terumo Medical Products (Hangzhou) Co., Ltd." The testing is described as non-clinical, implying a prospective testing approach conducted specifically for this 510(k) submission.

3. Number of Experts Used and Qualifications

Not applicable. This is a non-clinical performance test for a traditional medical device, not a study requiring expert readers for ground truth establishment.

4. Adjudication Method for the Test Set

Not applicable. This is a non-clinical performance test for a traditional medical device, not a study requiring adjudication of expert readings.

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

Not applicable. This is a non-clinical performance test for a traditional medical device, not a study evaluating human reader performance with or without AI assistance.

6. Standalone Performance (Algorithm Only)

Not applicable. This is a traditional medical device, not an AI/ML algorithm.

7. Type of Ground Truth Used

The "ground truth" for the performance tests were adherence to established industry standards (ISO, JIS, GB) and internal company specifications derived from the predicate device's performance.

8. Sample Size for the Training Set

Not applicable. This is a traditional medical device, not an AI/ML product requiring a training set.

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

Not applicable. This is a traditional medical device, not an AI/ML product requiring a training set.

Additional Test Information:

• Biocompatibility: Tests were conducted on non-aged and accelerated-aged devices according to ISO 10993-1, with results demonstrating biocompatibility throughout the product's shelf life.
• Sterilization: The device is sterilized to a Sterility Assurance Level (SAL) of 10^-6, validated in accordance with ISO 11135:2014.
• Clinical Tests: The 510(k) submission states that it "does not include data from clinical tests."

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The safety winged blood collection set is single-use, sterile, winged venipuncture needle bonded to a flexible tubing with or without a luer adaper and/or tube holder. The device is used for blood collection and/or the short-term infusion of intravenous fluids (up to 2 hours under direct clinical supervision). The blood-collection needle is designed to be covered with a safety mechanism, which can be activated to cover the needle immediately following venipuncture to aid in the protection against accidental needlestick injury.

The Promisemed Safety Blood Collection sets are single-use, sterile, venipuncture needles used for blood collection or short-term infusion of intravenous fluids (up to 2 hours under direct clinical supervision). The blood-collection needle is designed to be covered with a safety mechanism, which can be activated to cover the needle immediately following venipuncture to aid in the protection against accidental needlestick injury.

This document describes the premarket notification (510(k)) for the Promisemed Safety Winged Blood Collection Set. The core of this submission is to demonstrate "substantial equivalence" to a legally marketed predicate device (K170276). It does not involve AI or algorithms, but rather a physical medical device. Therefore, many of the requested elements regarding AI/algorithm performance are not applicable.

Here's an analysis based on the provided document:

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

The acceptance criteria are demonstrated through adherence to various international and national standards, showing the device's conformance to established safety and performance benchmarks. The reported device performance is indicated by "passing results" for all tests.

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

The document does not specify exact sample sizes for each test listed, but it indicates "Non-Clinical bench testing" was performed. The data provenance is implied to be from the manufacturer's internal testing in China (Promisemed Hangzhou Meditech Co., Ltd., Hangzhou City, Zhejiang, China). The tests are retrospective, as they are part of the device development and verification process before submission.

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

Not applicable. This is a physical medical device. Ground truth is established through adherence to international standards and validated laboratory testing procedures for physical, chemical, and biological properties, not through expert consensus on images or interpretations.

4. Adjudication method for the test set

Not applicable. Adjudication methods like 2+1 or 3+1 are typically used in studies involving human interpretation (e.g., radiologists reading images) where disagreement might occur. For physical device testing, the results are typically quantitative or pass/fail based on established 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 product is a physical blood collection device, not an AI or imaging diagnostic tool. Therefore, MRMC studies and human reader improvement are irrelevant.

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

Not applicable. This product is a physical blood collection device, not an algorithm.

7. The type of ground truth used

The "ground truth" for this device's performance is established by the specified international and national consensus standards (e.g., ISO, USP, ASTM) for medical devices, which define acceptable physical, chemical, and biological properties. This includes:

• Physical performance metrics: Bond strength, needle dimensions, patency, kink stability, puncture force, safety mechanism activation.
• Chemical properties: Absence of harmful residues or leaching.
• Biological properties: Biocompatibility tests (cytotoxicity, sensitization, irritation, systemic toxicity, hemolysis, pyrogenicity, bacterial endotoxin) and sterility.
• Outcomes: The device is designed to prevent needlestick injuries, and its safety mechanism is tested to meet this outcome requirement.

8. The sample size for the training set

Not applicable. This is a physical medical device, not an AI/machine learning model. There is no "training set" in the context of this 510(k) submission.

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

Not applicable. As there is no training set, this question is not relevant.

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The GYNECARE TVT Device is intended to be used as a pubo-urethral sling for treatment of Stress Urinary Incontinence (SUI), for female urinary incontinence resulting from urethral hypermobility and/or intrinsic sphincter deficiency. The GYNECARE TVT Introducer and Rigid Catheter Guide are available separately and are intended to facilitate in the placement of the GYNECARE TVT Device.

The GYNECARE TVT Introducer is a reusable device intended to aid in the placement of the GYNECARE TVT Device retropubically.

The GYNECARE TVT Rigid Catheter Guide is a reusable device intended to facilitate the identification of the urethra and bladder neck during the placement of the GYNECARE TVT Device.

The GYNECARE TVT Device is intended to be used as a pubo-urethral sling for treatment of stress urinary incontinence (SUI), for female urinary incontinence resulting from urethral hypermobility and/or intrinsic sphincter deficiency. The GYNECARE TVT Introducer and Rigid Catheter Guide are available separately and GYNECARE TVT Abdominal Guides and Couplers are included in each kit.

The GYNECARE TVT Abdominal Guides and Couplers are single use devices used to facilitate placement of the GYNECARE TVT Device when placed in a top-down retropubic fashion (also known as an abdominal approach).

The GYNECARE TVT EXACT Continence System is intended to be used as a pubo-urethral sling for treatment of female Stress Urinary Incontinence, resulting from urethral hypermobility and/or intrinsic sphincter deficiency.

The GYNECARE TVT EXACT Continence System Trocar is a single use device intended to aid in the placement of the GYNECARE TVT EXACT Continence System retropubically.

The GYNECARE TVT Rigid Catheter Guide is a reusable device intended to facilitate the identification of the urethra and bladder neck during the placement of the GYNECARE TVT EXACT Continence System.

The GYNECARE TVT Obturator Device is intended to be used in women as a sub-urethral sling for the treatment of stress urinary incontinence (SUI) resulting from urethral hypermobility and/or intrinsic sphincter deficiency.

The GYNECARE TVT Obturator Helical Passers and Atraumatic Winged Guide are intended to aid in the placement of the GYNECARE TVT Obturator Device.

The GYNECARE TVT ABBREVO Continence System is intended for use in women as a suburethral sling for the treatment of SUI resulting from urethral hypermobility and/or intrinsic sphincter deficiency.

The GYNECARE TVT ABBREVO Helical Passers and Atraumatic Winged Guide are intended to aid in the placement of the GYNECARE TVT ABBREVO Device.

GYNECARE TVT™ Tension-free Vaginal Tape System: Consists of PROLENE™ Polypropylene Mesh (tape) with clear plastic Sheaths and stainless steel needles. The mesh is knitted filaments of extruded polypropylene strands. GYNECARE TVT™ Reusable Introducer (available separately) is a reusable stainless steel instrument. GYNECARE TVT™ Rigid Catheter Guide (available separately) is a non-sterile reusable stainless-steel instrument.

GYNECARE TVT™ with Abdominal Guides Tension-free Support for Incontinence System: Includes GYNECARE TVT™ Abdominal Guide, a sterile disposable instrument, and GYNECARE TVT™ Coupler, a sterile disposable polypropylene connector.

GYNECARE TVT EXACT™ Continence System: A sterile, single patient use procedure kit consisting of the GYNECARE TVT EXACT Continence System Trocar Sheath / Implant Assembly (blue PROLENE™ Polypropylene Mesh with clear plastic Sheaths and white Trocar Sheaths) and the GYNECARE TVT EXACT Continence System Trocar (stainless-steel Trocar Shaft and plastic Trocar Handle).

GYNECARE TVT™ Obturator System: A sterile, single patient use procedure kit consisting of the GYNECARE TV Obturator Device (undyed or blue PROLENE™ polypropylene mesh with clear plastic sheath and plastic tube receptacles) and the GYNECARE TVT™ Obturator Helical Passers and Atraumatic Winged Guide (two stainless steel, curved wire helical passers with plastic handles and a stainless steel accessory instrument).

GYNECARE TVT ABBREVO™ Continence System: A sterile, single-patient use procedure kit consisting of the GYNECARE TVT ABBREVO Implant Assembly (blue PROLENE™ Polypropylene Mesh with clear plastic Sheaths and Helical Passer Sheaths, and Positioning Lines) and the GYNECARE TVT ABBREVO Placement Loop (PROLENE Polypropylene Monofilament loop with an attached polypropylene button). Also includes GYNECARE TVT ABBREVO™ Helical Passers and Atraumatic Winged Guide (two stainless steel, curved wire helical passers with plastic handles and a stainless steel accessory instrument).

The provided document is a 510(k) summary for the GYNECARE TVT™ System and related devices. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than proving safety and efficacy through new clinical studies against specific acceptance criteria.

Therefore, the document does not contain information about:

• Clearly defined acceptance criteria for device performance.
• A standalone study proving the device meets specific acceptance criteria.
• Sample sizes for test sets, data provenance, number of experts, adjudication methods, MRMC studies, standalone algorithm performance, or ground truth for test and training sets.

Instead, the document states:

• Substantial Equivalence: The primary assertion is that "the subject devices are substantially equivalent to their respective predicate devices."
• Technological Characteristics: "The subject devices and their respective predicate devices are identical and therefore have the same technological characteristics."
• Differences from Predicates: The only stated differences are in "labeling (Instructions for Use)" which have been "revised to meet the new European Union (EU) Medical Device Regulation (MDR) requirements" and include additional information such as warnings, adverse events, safety information, and information for patients. Minor clarifications to "Indications and Contraindications statements" were also made.
• Performance Data: "No performance data are needed to evaluate these labeling changes." This explicitly states that no new performance studies were conducted or required for this particular submission.

In summary, there is no study described in this document that proves acceptance criteria because the submission's purpose is to demonstrate substantial equivalence based on identical technological characteristics and updated labeling, not new performance data.

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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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The Surflo Winged Infusion Set with Needle Protection (Surshield) is intended to access the peripheral vasular system, for intravenous administration of fluids and/or withdrawal of blood specimens using a syringe, fuer adapter, or other compatible/ appropriate devices. Additionally, after withdrawal of 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 Needle Protection (Surshield), are sterile, single use devices consisting of a needle attached to a winged hub, standard or microbore tubing, adapter and adapter cap, and a hinged shield cover that attaches to the wing just below the needle-towing 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 standard or microbore tubing.

The document provides information on the Surflo Winged Infusion Set with Needle Protection (Surshield). It details the acceptance criteria and summarizes verification activities to demonstrate substantial equivalence to previously cleared predicate devices.

1. Table of Acceptance Criteria and Reported Device Performance:

Device Performance Note: The document explicitly states: "The Surflo Winged Infusion Sets with Needle Protection (Surshield), with standard and microbore tubing, meet all acceptance criteria as indicated in table above. None of the obtained data raises any new issue of safety and effectiveness."

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

• Sample Size for Test Set: The document does not specify the exact sample sizes used for each individual verification test. It generally refers to "all necessary verification and validation tests" having been performed.
• Data Provenance: The document was prepared by Terumo Europe N.V. in Belgium. The tests were performed to demonstrate substantial equivalence to predicate devices cleared by the FDA (K052887, K072894, K100946). The nature of these tests (e.g., physical, mechanical, functional) suggests they were conducted prospectively to evaluate the modified device's performance.

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

This information is not applicable as the verification activities are focused on the physical, mechanical, and functional performance of a medical device (infusion set) against defined engineering and safety standards (e.g., ISO standards), rather than diagnostic accuracy or interpretation by human experts. Therefore, there is no "ground truth" in the clinical diagnostic sense established by experts.

4. Adjudication Method for the Test Set:

This information is not applicable for the same reasons as point 3. The testing involves objective measurements against predefined acceptance criteria, not subjective interpretation requiring adjudication among experts.

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. The device is an intravenous administration set, not an AI-powered diagnostic or interpretive tool. Therefore, no MRMC study or AI assistance evaluation was performed or is relevant.

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

This information is not applicable. The device is a physical medical instrument, not an algorithm or AI system.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.):

The "ground truth" for the verification activities comprises pre-defined acceptance criteria based on established engineering standards (e.g., ISO 594-1, ISO 594-2, EN ISO 11135-1, EN ISO 10993-7) and internal specifications. These criteria are objective and measurable, ensuring the device's physical, mechanical, and sterile properties.

8. The Sample Size for the Training Set:

This information is not applicable. The device is a physical medical instrument and does not involve a "training set" in the context of machine learning or AI.

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

This information is not applicable for the same reasons as point 8.

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The SafeTouch PSV Winged Infusion Set with/without filter is intended to be used for insertion into a patient's vascular system for single use as an indwelling device to administer fluids intravenously. Secondly it is designed with an active sharp feature that requires physical action by the clinician to prevent accidental needlesticks.

The SafeTouch PSV winged Infusion Set with/without filter consists of a winged needle (25 gauge x 3/4 inch) with an integrated safety mechanism connected to PVC tubing and a female luer connector with cap. An optional filter has been added to prevent the flow of particulate matter.

The provided text describes a 510(k) submission for the "SafeTouch PSV winged Infusion Set with/without filter." This submission focuses on demonstrating substantial equivalence to a predicate device through non-clinical performance testing. It explicitly states that no clinical testing was required or performed.

Therefore, many of the requested categories related to clinical studies, ground truth establishment, expert adjudication, multi-reader studies, and training/test set details are not applicable to this submission.

Here's the information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

The document lists the types of performance tests conducted but does not provide specific acceptance criteria or quantitative results for each test in a table format. It only states that "The results and conclusions of these tests are included in this submission" and that these tests "verify that the device is safe and effective for its intended use" and "demonstrate that the SafeTouch PSV performs equivalent to the predicate device."

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

• Sample Size: Not specified in the provided text, as the testing was non-clinical (bench testing).
• Data Provenance: Not applicable, as no human data was used. The testing was non-clinical bench testing.

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. Ground truth was established through non-clinical test methods and device specifications, not expert human evaluation.

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

• Not applicable. There was no human adjudication for a test set.

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. A multi-reader multi-case (MRMC) comparative effectiveness study was not done. This submission is for a medical device (infusion set), not an AI-assisted diagnostic tool.

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

• No. This is not an algorithm or AI device. The testing was standalone in the sense that it was non-clinical bench testing of the physical device.

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

• The "ground truth" for this device's performance was based on engineering specifications and established test methods for medical devices (e.g., penetration force, leakage, material strength).

8. The sample size for the training set:

• Not applicable. There was no training set, as this is not an AI/machine learning device.

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

• Not applicable. There was no training set.

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The SafeTouch PSV Winged Infusion Set with/without filter is intended to be used for insertion into a patient's vascular system for single use as an indwelling device to administer fluids intravenously or to sample blood. Secondly it is designed with an active sharp feature that requires physical action by the clinician to prevent accidental needlesticks.

The SafeTouch PSV winged Infusion Set with/without filter consists of a winged needle (25 gauge x 3/4 inch) with an integrated safety mechanism connected to PVC tubing and a female luer connector with cap. The tubing material is DEHP-free PVC and the filter has been added to prevent the flow of particulate matter.

Here's a breakdown of the acceptance criteria and study information for the Nipro SafeTouch PSV winged Infusion Set with/without filter, based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

Note: The document states that "The results and conclusions of these tests are included in this submission," and concludes that the device is "safe and effective when used as intended," implying that the device met the acceptance criteria for all listed tests. Specific numerical acceptance criteria and performance values are not provided in this summary.

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

• Sample Size: Not specified in the provided summary.
• Data Provenance: The tests conducted are "Non-clinical tests," implying bench testing. The country of origin for this testing is not specified, but the applicant (Nipro Medical Corporation) is located in Miami, FL, USA. The data is retrospective in the sense that it was generated for the purpose of the 510(k) submission, not as a continuous monitoring process.

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

• Number of Experts: Not applicable. This was bench testing, not a study requiring expert clinical assessment for ground truth.
• Qualifications of Experts: Not applicable.

4. Adjudication Method for the Test Set

• Not applicable, as this was bench testing.

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 MRMC comparative effectiveness study was done. The document explicitly states: "No clinical testing was required or performed in support of this 510k submission." This is not an AI-based device, so a human-reader improvement metric is irrelevant.

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

• Not applicable. This device is a medical instrument (infusion set), not an algorithm or AI system. Its performance is evaluated through physical and functional bench tests.

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

• The "ground truth" for the bench tests would be the pre-defined engineering specifications, industry standards, and established test methodologies for medical devices of this type. It's based on engineering validated criteria rather than clinical ground truth (like pathology or outcomes data).

8. The sample size for the training set

• Not applicable. This device is not an AI/ML algorithm that requires a training set.

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

• Not applicable, as there is no training set for this device.

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The K-Shield Winged Collection Set with Multisample Luer Adapter and Antineedle Stick Protector intended use is for the access of peripheral veins for blood collection. The antineedle stick protector is an integral, active safety device intended to minimize accidental needle stick injuries when used to shield the needle.

The K-Shield Small Vein Infusion Set with Antineedle Stick Protector intended use is for the access of peripheral veins for solution infusion. The antineedle stick protector is an integral, active safety device intended to minimize accidental needle stick injuries when used to shield the needle.

The K-Shield Small Vein Infusion Set with Antineedle Stick Protector and the K-Shield Winged Collection Set with Multisample Luer Adapter and Antineedle Stick Protector are sterile, single use devices commonly used to access a patient's veins for blood collection or solution infusion. Both devices are comprised of a needle and wing assembly with tubing and a female luer connector. The Multisample Luer Connector is used to transfer blood from the Winged Collection Set to a vacuum tube. Both devices incorporate an integral antineedle stick protector used to prevent accidental needlestick injuries.

The provided document details a 510(k) premarket notification for a medical device (Kawasumi Laboratories Small Vein Infusion Set with Antineedle Stick Protector and Winged Collection Set with Multisample Luer Adapter and Antineedle Stick Protector). This is for a device modification summary, not an AI/ML device, and therefore the provided document does not contain information typically associated with AI/ML model evaluations such as:

• Acceptance criteria and reported device performance in terms of AI metrics (e.g., sensitivity, specificity, accuracy).
• Sample sizes for test sets in an AI context (e.g., number of images, patient cases).
• Data provenance for AI/ML training/test sets.
• Number and qualifications of experts for ground truth establishment for AI/ML.
• Adjudication methods for AI/ML ground truth.
• Multi-reader multi-case (MRMC) comparative effectiveness studies for AI.
• Standalone performance for an AI algorithm.
• Type of ground truth (beyond product testing results).
• Training set sample size for an AI model.
• How ground truth for a training set was established for an AI model.

Instead, the document focuses on the mechanical and functional performance of a medical device (a winged collection set and small vein infusion set with an antineedle stick protector) and its substantial equivalence to predicate devices.

Based on the provided text, here is an analysis of the acceptance criteria and study for this physical medical device:

1. Table of Acceptance Criteria and Reported Device Performance

Note: The document implicitly defines "PASS" as meeting the acceptance criteria for the internal tests. For the simulated use study, the stated "successful" outcome and specific results serve as the performance and meet the implied acceptance criteria.

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

• Test Set: Not explicitly stated as a numerical sample size. The "simulated clinical observations" involved a "simulated use study," but the number of participants or simulated uses is not provided.
• Data Provenance: The tests were "Kawasumi Internal Test" and "Simulated Clinical Observations" conducted by Kawasumi Laboratories, indicating an internal, prospective study environment for the modification assessment. The country of origin for the data is Japan (Kawasumi Laboratories, Inc. is based in Tokyo) for the internal tests, and potentially the US for the simulated use study (Kawasumi Laboratories America, Inc. is in Tampa, FL), though this is not explicitly stated.

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

There were no "experts" in the sense of medical professionals establishing a diagnostic ground truth for an AI/ML model. The "ground truth" here is the physical performance and safety features of the device, assessed through internal engineering tests and a simulated use study. The "ground truth" was established by the test results themselves as outlined in the table above.

4. Adjudication Method for the Test Set

Not applicable as this is not an AI/ML model evaluation requiring expert consensus or adjudication. The internal tests have objective Pass/Fail criteria, and the simulated use study collected observations directly.

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. The study involves a physical medical device and its safety features.

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

Not applicable. This is not an AI/ML algorithm.

7. The Type of Ground Truth Used

The ground truth used was based on:

• Objective measurements and outcomes from internal engineering tests (e.g., verifying wing activation, deactivation, and defeat locking mechanism).
• Direct observation of events during a simulated clinical use study (e.g., absence of needle sticks).
• User feedback collected via questionnaires during the simulated use study.

8. The Sample Size for the Training Set

Not applicable. This is not an AI/ML device, so there is no "training set." The device was modified and then tested.

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

Not applicable, as there is no training set for an AI/ML model. The "ground truth" for the device's design and intended function was established through engineering specifications, previous predicate device performance, and the modifications made.

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