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The POWERWAND® Safety Introducer with an Extended Dwell Catheter is used to gain access to the vascular system to sample blood and administer fluids intravenously. May be used for power injection of contrast media at a rate of 5 ml/sec at up to 300 psi fluid pressure.

The POWERWAND® Safety Introducer with an Extended Dwell Catheter is an all-in-one preassembled intravascular catheter introducer with intravascular catheter that consists of the following basic components: Introducer Needle, Guidewire, Dilator and an Extended Dwell Catheter. It is intended to provide the clinician with a safe, simple and accelerated approach, using the Accelerated Seldinger Technique, to place an in-dwelling intravascular catheter through the skin into the circulatory system. The Extended Dwell Catheter allows for withdrawal of blood and the administration of fluids, including power injection of contrast media. The device includes a Fast-flash™ feature that provides the clinician with feedback that the introducer needle is in the intraluminal position within the blood vessel. The device also incorporates a safety mechanism to guard against accidental needle stick.

This is a 510(k) summary for a medical device (a catheter introducer), which is primarily focused on demonstrating substantial equivalence to a predicate device rather than presenting a study proving performance against explicit acceptance criteria in the way an AI/software as a medical device (SaMD) study would.

Therefore, many of the requested categories (2-9) which are typical for SaMD studies involving machine learning or sophisticated algorithms are not directly applicable or extractable from this document. The document describes engineering and design verification testing against internal product specifications for a physical device, not "performance" in the sense of diagnostic accuracy or clinical outcomes of an AI system.

Here's a breakdown based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state quantitative "acceptance criteria" in a pass/fail format with corresponding "reported device performance" values for a clinical or diagnostic outcome as would be common for AI/SaMD. Instead, it lists various engineering tests performed to confirm the device's physical properties and functionality. The "acceptance criteria" here are implicitly tied to meeting the design specifications and demonstrating equivalence to the predicate device. The "reported performance" is that the device "satisfies performance requirements" and "is equivalent to the predicate device."

• Resistance to Breakage | Meet specified strength and breakage resistance. | Equivalent to predicate; satisfies requirements. |
  | 0.012" Guidewire| - Fracture Test
• Flex Test
• Strength of Union: Core-to-Coil
• Strength of Union: Wire-to-Cap | Meet specified resistance to fracture, flex, and union strength. | Equivalent to predicate; satisfies requirements. |
  | Dilator | - Distal Tip Columnar Strength
• Strength of Union: Tube-to-Hub
• Insert Leak | Meet specified columnar strength, union strength, and no leaks. | Equivalent to predicate; satisfies requirements. |
  | 4 Fr IV Catheter – Standard Testing | - Collapse Pressure
• Distal Tip Columnar Strength
• Flow Rate
• Tensile Strength
• Priming Volume
• Burst Pressure
• Leakage Test - Liquid
• Leakage Test - Air
• Catheter Tip Movement during Power Injection | Meet specified pressures, strengths, flow rates, volumes, and leakage integrity. | Equivalent to predicate; satisfies requirements. |
  | 4 Fr IV Catheter – after Pre-Conditioning | - Visual Inspection
• Fatigue Test
• Power Injection
• Elongation
• Burst Pressure | Maintain integrity and performance after pre-conditioning, meet power injection specs. | Equivalent to predicate; satisfies requirements. |
  | Introducer System | - Axial Forces
• Fast-flash™ Evaluation
• Insertability
• Needle-Stick safety
• Particulate Test | Meet specified axial forces, fast-flash feedback, ease of insertion, needle-stick safety, and particulate limits. | Equivalent to predicate; satisfies requirements. |

Overall Conclusion: "The results of testing demonstrate that the modified POWERWAND® Safety Introducer with an Extended Dwell Catheter (4 Fr Model) is substantially equivalent to the predicate device in design, function, and indications for use."

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

The document specifies "Prospective testing conducted for the 4 Fr Model POWERWAND®" (Table 11.2) for the listed physical and performance tests. However, it does not provide specific sample sizes (e.g., number of devices tested for each parameter) for these engineering tests. It also does not mention data provenance in terms of country of origin or whether it's retrospective/prospective clinical data because this is not a clinical study, but rather engineering verification.

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

Not applicable. This summary relates to the clearance of a physical medical device (catheter introducer) based on engineering performance testing, not an AI/SaMD device that requires expert-established ground truth for diagnostic accuracy. The "ground truth" for these tests would be the measurement against a defined engineering specification or standard.

4. Adjudication method for the test set

Not applicable. See point 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 physical medical device; no human readers or AI assistance are involved in its operation or assessment in a diagnostic context.

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

Not applicable. This is a physical medical device; there is no algorithm in this context.

7. The type of ground truth used

The "ground truth" for this device's testing would be defined by engineering specifications, industry standards, and regulatory requirements (e.g., ISO standards for medical devices, ASTM standards for material properties, etc.). For example, a "burst pressure" test would have an internal specification for the minimum pressure it must withstand, which serves as the ground truth.

8. The sample size for the training set

Not applicable. This is not an AI/SaMD device; there is no "training set."

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

Not applicable. See point 8.

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The POWERWAND® Safety Introducer with an Extended Dwell Catheter is used to gain access to the vascular system to sample blood and administer fluids intravenously. May be used for power injection of contrast media at a rate of 5cc/sec at up to 300 psi fluid pressure.

The POWERWAND® Safety Introducer with an Extended Dwell Catheter is an all-in-one preassembled intravascular catheter introducer with intravascular catheter that consists of the following basic components: Introducer Needle, Nitinol Guidewire. Dilator and an Extended Dwell Catheter. It is intended to provide the clinician with a safe, simple and accelerated approach, using the Accelerated Seldinger Technique, to place the in-dwelling intravascular catheter through the skin into the circulatory system. The Extended Dwell Catheter allows for withdrawal of blood and the administration of fluids, including power injection of contrast media. The device includes a Fast-flash™ feature that provides the clinician with feedback that the introducer needle is in the intraluminal position within the blood vessel. The device also incorporates a safety mechanism to guard against accidental needle stick.

The provided text describes a 510(k) premarket notification for a medical device called "the POWERWAND® Safety Introducer with an Extended Dwell Catheter." The submission aims to demonstrate substantial equivalence to a legally marketed predicate device.

Here's an analysis of the acceptance criteria and the study that proves the device meets them, based solely on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Important Note: The provided text summarizes the testing and conclusions. It does not provide the specific numerical acceptance criteria (e.g., minimum separation force in Newtons) or the quantitative results achieved by the device. It states that testing was conducted to "qualify" the modifications and that the results "demonstrate substantial equivalence."

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

• Sample Size: The document does not specify the sample size used for any of the performance tests (Needle Hub to Dilator Separation Force, Removal Force, Removal Testing).
• Data Provenance: The document does not specify the country of origin of the data or whether the studies were retrospective or prospective. It only mentions "Design verification testing was conducted."

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

This question is not applicable in the context of this device and submission. This is a medical device for vascular access, and the performance testing described relates to the physical and mechanical characteristics of the device (e.g., forces, removal). There is no mention of a "test set" requiring expert-established ground truth in the way it would apply to, for example, an AI diagnostic imaging device. Ground truth for mechanical testing would typically be established by calibrated instruments and engineering specifications.

4. Adjudication Method for the Test Set

This question is not applicable for the same reasons as point 3. Adjudication methods (like 2+1, 3+1) are typically used in studies involving human assessment or interpretation where there might be disagreements, such as in image analysis or clinical endpoint determination. The testing described here is for physical device performance.

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

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done based on the provided text. This type of study is relevant for diagnostic devices where human readers (e.g., radiologists) interpret cases with and without AI assistance to measure the AI's impact on their performance. The submitted device is a physical medical instrument, not a diagnostic imaging or AI-driven interpretative system.

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

This question is not applicable as the device is a physical medical instrument, not an algorithm or AI system. Therefore, there is no "standalone" algorithm performance to be evaluated.

7. The Type of Ground Truth Used

For the performance testing mentioned ("Needle Hub to Dilator Separation Force and Removal Force," "Removal Testing"), the ground truth would be based on engineering specifications and measurements from calibrated testing equipment. For instance, a "separation force" would have a defined minimum or maximum value that the device must meet, measured by a force gauge, which serves as the "ground truth" reference. The document does not explicitly state the specific ground truth values or methods but implies they are part of the "product design specification."

8. The Sample Size for the Training Set

This question is not applicable. The device is a physical medical instrument, not an AI or machine learning model. Therefore, there is no "training set" in the context of algorithm development.

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

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

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The PICC WAND® Peelable Safety Introducer is used to facilitate the placing of an intravascular catheter through the skin into the circulatory system.

The PICC WAND® Peelable Safety Introducer is an all-in-one preassembled intravascular catheter introducer that consists of the following basic introducer components: Introducer Needle, Nitinol Guidewire. Dilator and a peelable Sheath Introducer. It is intended to provide the clinician with a safe, simple and accelerated approach, using the Accelerated Seldinger Technique, to place an in-dwelling intravascular catheter through the skin into the circulatory system. The peelable Sheath Introducer allows for the placement of peripherally inserted central catheters (PICC) and midline catheters. The device includes a Fast-flash™ feature that provides the clinician with feedback that the introducer needle is in the intraluminal position within the blood vessel. The device also incorporates a safety mechanism to guard against accidental needle stick.

Here's an analysis of the provided text regarding the acceptance criteria and study for the PICC WAND® Peelable Safety Introducer, structured to answer your questions:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state acceptance criteria in a quantitative, pass/fail manner. Instead, it describes a series of performance tests conducted to confirm that the modified device satisfies "performance requirements" and is "equivalent to the predicate device." The reported performance is implicitly the successful completion of these tests, demonstrating substantial equivalence.

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

The document does not provide specific sample sizes (e.g., number of devices tested for each parameter) for the test set. It merely lists the types of tests conducted.

The data provenance is internal to the manufacturer (Access Scientific, Inc.) and is prospective in the sense that these tests were performed on the modified device to demonstrate its performance for this specific 510(k) submission. There is no mention of external data, clinical data, or data provenance in terms of country of origin.

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

This information is not provided. The testing described appears to be primarily engineering and physical performance testing (e.g., force, dimensional, seal integrity, shelf life) rather than subjective evaluation requiring clinical experts to establish ground truth.

4. Adjudication Method for the Test Set

This is not applicable and not mentioned. The tests are objective physical and functional measurements, not requiring adjudication by multiple readers or reviewers in the traditional sense of clinical studies.

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. The submission focuses on demonstrating substantial equivalence through direct performance testing and comparison to a predicate device, not on assessing human reader performance with or without AI assistance.

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

No, this is not applicable. The device is a physical medical introducer, not a software algorithm or AI-driven system. Therefore, standalone algorithm performance is not relevant.

7. The Type of Ground Truth Used

The ground truth used for these tests is implicitly the engineering specifications and performance characteristics of the predicate device, as well as relevant industry standards and design specifications for such devices. The goal was to show that the modified device "satisfies performance requirements" and is "equivalent to the predicate device." The "truth" is whether the measured physical properties and functional performance meet pre-defined benchmarks or match those of the predicate.

8. The Sample Size for the Training Set

This is not applicable. The device is a physical medical device, not an AI/ML algorithm that requires a "training set."

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

This is not applicable, as there is no training set for a physical device.

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The Power WAND™ Safety Introducer with an Extended Dwell Catheter is used to gain access to the vascular system to sample blood and administer fluids intravenously. May be used for power injection of contrast media at a rate of 5cc/sec at up to 300 psi fluid pressure.

The Power WAND™ Safety Introducer with an Extended Dwell Catheter is an all-in-one pre-assembled device that combines the functionality of a catheter introducer system with an extended dwcll (> 72 hours but

This document, K101422, describes the Power WAND™ Safety Introducer with an Extended Dwell Catheter. It focuses on demonstrating substantial equivalence to predicate devices through various testing. Here's an analysis of the provided information, specifically addressing the requested points regarding acceptance criteria and study details:

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

The document lists numerous tests conducted, but it does not explicitly state specific numerical acceptance criteria for each test. Instead, it generally concludes that the device "satisfied the acceptance criteria" or "satisfy performance requirements of the product specification and are equivalent to the predicate device."

Here's an attempt to present the information as requested, with the caveat that specific numerical acceptance criteria are not provided in the document:

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

The document does not provide specific sample sizes for any of the tests mentioned. It only states that a "program of design verification testing" was conducted.

• Sample Size: Not specified.
• Data Provenance: The studies are described as "design verification testing," "biocompatibility testing," and "in vitro bench testing." This indicates they were prospective tests conducted by the manufacturer, Access Scientific, Inc., which is based in San Diego, CA, USA. The country of origin for the data is implicitly the USA.

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 section is not applicable as the described studies are physical and chemical bench tests (biocompatibility and performance testing) of a medical device, not diagnostic studies requiring expert interpretation or ground truth establishment in a clinical context.

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

This section is not applicable for the same reasons as point 3. No clinical interpretation or adjudication by multiple experts was required for these types of engineering and biocompatibility tests.

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 section is not applicable. This submission is for a physical medical catheter and introducer system, not an AI-powered diagnostic or assistive device. Therefore, no MRMC study or assessment of human reader improvement with AI assistance was performed or relevant.

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

This section is not applicable. As stated above, this is not an AI algorithm but a physical medical device.

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

For the biocompatibility tests, the "ground truth" is defined by adherence to specific ISO standards (e.g., ISO 10993 series) and their respective criteria for non-toxicity, non-pyrogenicity, etc.

For performance tests, the "ground truth" or reference is defined by product specifications and comparison to the performance characteristics of the predicate devices. The goal was to show that the new device "satisfy performance requirements of the product specification and are equivalent to the predicate device."

8. The sample size for the training set

This section is not applicable. There is no "training set" as this is not an AI/machine learning device. The "training" in a manufacturing context refers to manufacturing process development and validation, not data-driven model training.

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

This section is not applicable as there is no training set or ground truth in the context of AI/machine learning.

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The PICC WAND™ Peelable Safety Introducer is used to facilitate the placing of an intravascular catheter through the skin into the circulatory system.

The PICC WAND™ Peelable Safety Introducer is an all-in-one preassembled intravascular catheter introducer that consists of the following basic introducer components: Introducer Needle, Nitinol Guidewire, Dilator and a peelable Sheath Introducer. It is intended to provide the clinician with a safe, simple and accelerated approach, using the Accelerated Seldinger Technique, to place an in-dwelling intravascular catheter through the skin into the circulatory system. The peelable Sheath Introducer allows for the placement of peripherally inserted central catheters (PICC) and midline catheters. The device includes a Fast-flash™ feature that provides the clinician with feedback that the introducer needle is in the intraluminal position within the blood vessel. The device also incorporates a safety mechanism to guard against accidental needle stick.

The provided text describes a 510(k) premarket notification for a medical device, the PICC WAND™ Peelable Safety Introducer. The document focuses on demonstrating substantial equivalence to a predicate device, rather than defining and proving acceptance criteria for a novel AI or diagnostic device. Therefore, much of the requested information (e.g., sample size for test set, data provenance, ground truth establishment, MRMC study, training set details) is not applicable or cannot be extracted from this type of regulatory submission.

However, I can extract information related to the device performance and the study conducted to demonstrate equivalence.

Here's a summary based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

The document doesn't explicitly state "acceptance criteria" in a quantitative, pass/fail form for a new device's performance. Instead, it focuses on demonstrating equivalence to a predicate device. The "performance characteristics" and "requirements of the product design specification" serve as the de facto acceptance criteria, implying that the modified device must perform at least as well as, or be equivalent to, the predicate and meet established design requirements.

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

• Sample Size for Test Set: Not specified in the document. The testing was "in vitro bench testing," implying laboratory-based testing rather than patient data.
• Data Provenance: Not applicable in the context of patient data, as the tests were in vitro bench tests.

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

Not applicable. The "ground truth" for this device's performance is determined by physical measurements and functional tests in a laboratory setting, not by expert interpretation of data or images.

4. Adjudication Method for the Test Set

Not applicable. This device's performance is assessed through objective physical and functional tests, not by human adjudication of ambiguous results.

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

No, an MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic devices that involve human interpretation of results, often with AI assistance. The PICC WAND™ is a medical instrument, and its performance is evaluated through engineering and functional bench tests.

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

Not applicable. The PICC WAND™ is a physical medical device, not an algorithm, so the concept of "standalone performance" in this context does not apply.

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

The "ground truth" for this product is derived from engineering specifications, established physical testing methodologies, and performance standards for such introducer devices. For instance, "columnar strength" would be determined by a force gauge, and "Fast-flash function and timing" would be measured with a stopwatch or similar timing device under controlled conditions.

8. The Sample Size for the Training Set

Not applicable. This is not an AI or machine learning device, so there is no 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 PICC WAND® Peelable Safety Introducer is used to facilitate the placing of an intravascular catheter through the skin into the circulatory system.

The PICC WAND® Peelable Safety Introducer is an integrated sterile, single-use intravascular catheter introducer. It is designed to incorporate a combination of devices into an all-in-one device that provides the clinician with a safe and simple approach to the Modified Seldinger technique, and thereby accelerate the procedure required to place indwelling intravascular catheters. The device includes an Introducer Needle, Guidewire, Dilator, and a Peelable Sheath Introducer in a single integrated device, and incorporates a safety mechanism to guard against accidental needlestick.

The provided document describes the 510(k) premarket notification for the PICC WAND® Peelable Safety Introducer. The information primarily focuses on establishing substantial equivalence to a predicate device through biocompatibility and performance testing. There is no information regarding AI-based devices or studies that would involve AI models. Therefore, many of the requested categories are not applicable to this submission.

Here's an analysis based on the provided text:

Acceptance Criteria and Device Performance

Study Details (Focus on Safety and Performance, Not AI)

1. Sample size used for the test set and the data provenance:
   The document does not specify the sample sizes for the biocompatibility or in vitro bench testing. The data provenance is not explicitly mentioned (e.g., country of origin), but it is implied to be from studies conducted by Access Scientific, Inc. for regulatory submission in the USA. These tests are prospective.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
   This information is not applicable. The studies described are laboratory/bench tests and biocompatibility assessments, not clinical studies requiring expert ground truth for interpretation of medical images or data.

3. Adjudication method for the test set:
   This information is not applicable as the studies are not clinical trials that would require adjudication for outcomes.

4. 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 medical device (catheter introducer), not an AI-powered diagnostic or assistive tool. No MRMC study was performed.

5. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
   Not applicable. This device does not involve an algorithm or AI.

6. The type of ground truth used:
   For biocompatibility, the ground truth would be established by validated test methods adhering to ISO standards (e.g., ISO 10993 series) for biological safety, with results compared against predetermined safety thresholds. For biomechanical performance, the ground truth would be established by engineering specifications and performance requirements derived from the predicate device and intended use, measured through in vitro bench testing.

7. The sample size for the training set:
   Not applicable. This device does not involve a training set as it is not an AI/ML product.

8. How the ground truth for the training set was established:
   Not applicable (no training set).

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The WAND™ MicroAccess Safety Introducer is used to facilitate the placing of an intravascular catheter through the skin into the circulatory system.

The WAND™ MicroAccess Safety Introducer is an integrated sterile, single-use intravascular catheter introducer. It is designed to incorporate a combination of devices into an all-in-one device that provides the clinician with a safe and simple approach to the Modified Seldinger technique, and thereby accelerate the procedure required to place indwelling intravascular catheters. The device includes an Introducer Needle, Guidewire, Dilator, and Introducer Sheath in a single integrated device, and incorporates a safety mechanism to guard against accidental needlestick.

Here's an analysis of the provided text regarding the acceptance criteria and study for the WAND™ MicroAccess Safety Introducer:

It's important to note that this 510(k) summary is for a medical device, specifically a catheter introducer, not an AI/ML-based diagnostic device. Therefore, many of the requested categories (like MRMC studies, AI effect size, ground truth for training sets, etc.) are not applicable to this type of submission. The performance evaluation for this device focuses on physical and biological characteristics, not diagnostic accuracy.

Acceptance Criteria and Device Performance

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

Based on the provided text, the acceptance criteria are implicitly defined by demonstrating equivalence to predicate devices and meeting established biomechanical and biocompatibility requirements for the intended use. Specific numerical acceptance criteria are not detailed in this summary; rather, it refers to a full application (K081697) for the details.

Predicate devices listed: Arrow International Emergency Infusion Device (K840455), BD Introsyte Precision Introducer (K020834), Stiffer Coaxial Micro-Introducer Set (K071574). |

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

• Sample Size: Not specified in this summary. The summary refers to the original 510(k) application (K081697) for details on device performance evaluation and testing.
• Data Provenance: Not specified, but generally, bench and biocompatibility testing are conducted in laboratories according to established 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 medical device for facilitating catheter placement, not a diagnostic AI/ML device requiring expert interpretation for ground truth establishment. Performance is evaluated through engineering and biological testing, not clinical reads by experts.

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

• Not Applicable. This is a medical device, not a diagnostic AI/ML device requiring adjudication of interpretations.

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 system, so an MRMC study and AI assistance effect size are irrelevant.

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

• Not Applicable. This question typically applies to AI/ML software. The device itself is "standalone" in the sense that its physical functionality is tested, but it's not an algorithm.

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

• For biocompatibility: Ground truth is typically based on established biological safety standards, in vitro testing (e.g., cytotoxicity, sensitization, irritation), and in vivo animal studies, rather than expert clinical consensus.
• For biomechanical performance: Ground truth is based on engineering specifications, industry standards, and functional testing to ensure the device performs as intended (e.g., strength, integrity, flow rates).

8. The sample size for the training set

• Not Applicable. This device does not involve machine learning algorithms that require a "training set."

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

• Not Applicable. This device does not involve machine learning algorithms and therefore has no "training set" or associated ground truth establishment.

Summary of Relevant Information from the K090372 Summary:

• Device Type: Catheter Introducer (physical medical device).
• Performance Evaluation: Focused on biocompatibility, in vitro bench testing for biomechanical performance, and sterility.
• Key Conclusion: Substantial equivalence to predicate devices (Arrow International Emergency Infusion Device, BD Introsyte Precision Introducer, Stiffer Coaxial Micro-Introducer Set) in design, function, and indications for use.
• Missing Details: Specific test protocols, numerical results, and sample sizes for the performance studies are not included in this summary but are referenced as being in the original 510(k) application K081697.

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The WAND™ MicroAccess Safety Introducer is used to facilitate the placing of an intravascular catheter through the skin into the peripheral circulatory system.

The WAND™ MicroAccess Safety Introducer is an integrated sterile, single-use intravascular catheter introducer. It is designed to incorporate a combination of devices into an all-in-one device that provides the clinician with a safe and simple approach to the Modified Seldinger technique, and thereby accelerate the procedure required to place indwelling intravascular catheters. The device includes an Introducer Needle, Guidewire, Dilator, and Introducer Sheath in a single integrated device, and incorporates a safety mechanism to guard against accidental needlestick.

The provided 510(k) summary for "The WAND™ MicroAccess Safety Introducer" does not contain information about acceptance criteria or a study proving that a device meets those criteria in the context of an AI-powered system. The document describes a traditional medical device (catheter introducer) and its premarket notification rather than an AI/ML diagnostic or assistive device.

Therefore, I cannot extract the requested information such as test set sample size, data provenance, number of experts for ground truth, adjudication methods, MRMC studies, standalone performance, training set size, or how ground truth for training was established, as these concepts are not relevant to the described device and its regulatory submission.

The document primarily focuses on demonstrating substantial equivalence to predicate devices through biocompatibility and in vitro bench testing. It does not involve AI or algorithms that would require evaluation against clinical performance metrics like sensitivity, specificity, or reader improvement.

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