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The WATCHDOG™ Hemostasis Valve is intended to maintain hemostic interventional procedures. The WATCHDOG™ Hemostasis Valve is indicated for maintaining a seal around diagnostic/ interventional devices with combined outer diameters of up to 8F [0.105 in (2.67 mm)] during diagnostic/ interventional procedures.

The Insertion Tool is used to facilitate the introduction of a guidewire during general intravascular procedures.

The Torque Device is used for guidewire manipulation during general intravascular procedures.

The WATCHDOG™ Hemostasis Valve kit includes the WATCHDOG™ Hemostasis Valve, an Insertion Tool and a Torque Device. The WATCHDOG™ Hemostasis Valve is designed to reduce blood loss and to facilitate pressure injections during interventional procedures. This device is intended to maintain hemostasis during the use of diagnostic or interventional devices by maintaining a seal around these devices. The WATCHDOG ™ Hemostasis Valve has two seals; the low-pressure (Proximal) seal and the high-pressure (Distal) seal. The body of the device has two luer fittings, one on the main body and one on the side port. The side port has a female luer fitting and is used for connecting pressure monitoring and manual infusion equipment. The main body has a rotating male luer for connecting to guide or diagnostic catheters.
The insertion tool is intended for use at the proximal end of the WATCHDOG™ Hemostasis Valve, which is attached to a guiding catheter hub. The insertion tool is used to facilitate the introduction of a guidewire through the WATCHDOG™ device, into the lumen of a guiding catheter, without damaging the guidewire distal tip. It may also be used to introduce a guidewire into an over-the-wire type balloon dilatation catheter.
The Torque Device is a non-patient contacting accessory device used to apply torsional and/or axial force to the guidewire to manipulate its distal end in the vasculature. It is designed to accommodate guidewire with diameters from 0.010 to 0.018 inches.

The provided text describes the 510(k) summary for the WATCHDOG™ Hemostasis Valve Kit, which includes a Hemostasis Valve, an Insertion Tool, and a Torque Device. The document details the device's intended use, comparison to predicate devices, and a summary of non-clinical tests. However, it does not include specific quantitative acceptance criteria or detailed results of a study proving the device meets these criteria in the format requested.

The document primarily focuses on establishing substantial equivalence to previously cleared devices through design, material, and performance testing, rather than reporting on a clinical study with detailed performance metrics against predefined acceptance criteria for AI/ML performance.

Therefore, the requested information elements such as a table of acceptance criteria and reported device performance, sample size for test sets, data provenance, number and qualifications of experts, adjudication method, MRMC study details, standalone performance, type of ground truth, and training set details are not present in this document.

The document lists performance tests completed, but doesn't provide the quantitative acceptance criteria or the specific numerical results from these tests. These tests are:

For the WATCHDOG™ Hemostasis Valve Kit:

• Sterile Barrier Strength
• Sterile Barrier Seal Width
• Sterile Barrier Integrity
• Sterile Barrier Integrity, Visual
• Shelf Carton Condition, Visual
• Label Adhesion and Print Quality
• Ease of Opening - Tyvek
• Design Validation

For the Insertion Tool:

• Corrosion Resistance
• Insertion Tool Length
• Insertion Tool ID Measurement (Guidewire Compatibility)
• Insertion Tool Hub to Hypotube Tensile Test
• Particulate Testing
• Design Validation

Biocompatibility and Chemical Characterization Tests (for the Kit including Insertion Tool):

• Minimum Essential Medium (MEM) Elution (Cytotoxicity)
• Guinea Pig Sensitization (Maximization Method)
• Intracutaneous Reactivity
• Systemic Toxicity (Acute)
• Material Mediated Pyrogenicity (Rabbit Pyrogen Test)
• Hemolysis Test - Extraction Method
• Chemical Characterization - Analytical Testing

The conclusion states that based on these tests, the WATCHDOG™ Hemostasis Valve Kit and the Insertion Tool are substantially equivalent to their respective predicate devices. This implies that the device "meets acceptance criteria" by demonstrating equivalence to devices already proven safe and effective, rather than meeting novel performance metrics.

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The Attachable Cath Lab Hemostasis Valve is indicated to minimize blood loss during the introduction of catheters, guidewires and other intravascular devices into the vasculature.

The Galt Medical Attachable Cath Lab Hemostasis Valve assembly consists of a molded hub with an integrated hemostasis valve, sideport tubing with 3 way stopcock. The design of the Attachable Cath Lab Hemostasis Valve is derived directly from the current line of Galt Medical Cath Lab Introducer Sheath (K043525). The subject and predicate device are both have an integrated hemostasis valve, and side port tubing with stopcock.

The provided text describes a 510(k) submission for a medical device, the "Attachable Cath Lab Hemostasis Valve." However, it does not detail a study that proves the device meets specific acceptance criteria in the manner typically associated with AI/CADe devices, which would involve metrics like sensitivity, specificity, or AUC, established through a rigorous ground truth determination process.

Instead, this document focuses on demonstrating substantial equivalence to predicate devices through a comparison of technological characteristics and functional testing. The "acceptance criteria" here are essentially the performance specifications, and the "study" is the non-clinical functional testing performed.

Here's an analysis based on the information provided:

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

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

   • Sample Size: Not explicitly stated as a number of units tested. The functional testing states it was performed on "4-year aged product," implying a set of devices and potentially new devices.
   • Data Provenance: The functional testing was conducted by Galt Medical Corp. on their own manufactured devices. The text does not specify the country of origin of the data beyond being from the manufacturer's internal testing. It is prospective in the sense that the testing was performed for this submission.

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

   • This question is not applicable in the context of this device and submission type. The "ground truth" for these functional tests is the defined engineering specification (e.g., 7 PSI pressure withstand). The tests themselves are designed to objectively measure whether the device meets these specifications, not to interpret complex medical data requiring expert consensus.

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

   • This is not applicable as the tests are objective functional measurements against engineering specifications, not subjective interpretations requiring adjudication.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

   • This is not applicable because the device is a physical medical instrument (hemostasis valve), not an AI/CADe system.

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 the non-clinical functional tests is derived from engineering specifications and established performance standards relevant to the function of such a valve (e.g., ability to withstand a certain pressure, secure insertion of guidewires, pull force thresholds). For biocompatibility and sterilization, the ground truth refers to meeting pre-defined biological safety standards and sterility assurance levels.

8. The sample size for the training set

   • This is not applicable as the device is a physical medical instrument and does not involve AI or machine learning models that require 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 this type of device.

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The Passage Hemostasis Valve is recommended for maintaining a fluid-tight seal around percutaneous transluminal angioplasty catheters and guidewires.

The Passage Hemostasis Valve minimizes blood loss during diagnostic and interventional procedures. The Merit Passage Hemostasis Valve consists of a Y-adaptor with a hemostasis valve which also incorporates a female luer lock connector and a male luer lock rotator. The polycarbonate used to manufacture the adaptor is transparent to aid in visualizing entrapped air. The hemostatic valve adjusts between 0 to 0.097" (approximately 7 French). The Y-body design allows both injection of contrast and placement of interventional devices.

The Passage Hemostasis Valve is comprised of a stand-alone rotator assembly bonded to the polycarbonate Y-body, using a UV cured adhesive. The seal and washer are inserted into the Y-body valve port. A thin coat of silicone is applied to the threaded portion of the Y-body and the cap is assembled. The standalone rotator assembly is comprised of individually molded polycarbonate parts(housing connector, retaining collar, hub) and an EPDM(Ethylene Propylene Diene Monomer) O-Ring.

This document is a 510(k) premarket notification for the "Passage Hemostasis Valve" and primarily focuses on demonstrating substantial equivalence to a predicate device rather than detailing a comparative effectiveness study involving AI or human reader performance. Therefore, many of the requested items related to AI device performance and human studies are not present.

Here's a breakdown of the available information:

1. Table of Acceptance Criteria and Reported Device Performance

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

The document does not specify the exact sample sizes for each test set. It mentions that "A battery of testing was conducted" and refers to "risk analysis" for determining the extent of testing. The provenance of the data (country of origin, retrospective/prospective) is not mentioned. Given the device is manufactured by Merit Medical Systems, Inc. (with an address in South Jordan, UT, USA, and Merit Medical Ireland Ltd. in Galway, Ireland), the testing could have occurred in either location or a contracted lab.

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

Not applicable. This device is a physical medical device (hemostasis valve), not an AI imaging or diagnostic algorithm. Therefore, "ground truth" as typically defined for AI performance studies (e.g., expert consensus on image findings) is not relevant. The performance is assessed through engineering and biological testing.

4. Adjudication Method for the Test Set

Not applicable. As described above, this is a physical device and performance is assessed through objective testing against pre-defined engineering and biological criteria, not through expert adjudication of data.

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

No. This is not an AI-assisted diagnostic or imaging device, so an MRMC study is not relevant.

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

No. This is a physical medical device. "Standalone performance" in the context of AI algorithms is not applicable here. The device itself is "standalone" in its intended mechanical and fluid dynamic function.

7. The Type of Ground Truth Used

The "ground truth" in this context refers to the defined acceptance criteria for the engineering and biocompatibility tests. These criteria are based on:

• Industry standards (e.g., ISO 11070:1998, ISO 594-2:1998, ISO 11135:2014, ASTM F1980-07, ISO 10993-1:2009).
• Requirements outlined in guidance documents.
• Risk analysis.
• Comparison to the performance of the predicate device.

8. The Sample Size for the Training Set

Not applicable. This is not an AI/machine learning device; thus, there is no "training set."

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

Not applicable. Since there is no training set, there is no ground truth to be established for it.

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Guardian hemostasis valves are intended to maintain hemostasis during the use of diagnostic or interventional devices. Guardian hemostasis valves are indicated for maintaining a seal around diagnostic/interventional devices with outside diameters up to 8F (0.105" or 2.67 mm) during diagnostic/ interventional procedures.

The torque device is provided as an aid in steering the guidewire within the vascular anatomy.

The Guardian hemostasis valves are designed to be used as conduits when interventional devices with diameters up to 8 F are inserted into the human vascular system. The devices have two seals: the lowpressure seal and the high-pressure seal. Closure of the high-pressure seal, which is achieved when the nut can no longer rotate, secures the diagnostic/ interventional device in position within the vasculature and allows for pressure injections up to 600 psi (40 ATM).

A guidewire introducer and guidewire torque device may be included with the Guardian II NC hemostasis valves.

The provided text describes a 510(k) premarket notification for the Guardian® II and Guardian® II NC hemostasis valves. The key change being evaluated is an increase in the pressure injection upper limit from 150 psi to 600 psi.

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

1. Table of Acceptance Criteria and Reported Device Performance

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

The document mentions "bench testing" but does not specify the sample size used for this testing.
The data provenance is not explicitly stated in terms of country of origin but is implied to be from the manufacturer's internal testing. The study is prospective as it's evaluating a modification to an existing device.

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

Not applicable. This device is an engineering component, and its performance is evaluated against engineering specifications, not expert interpretation of medical images or conditions.

4. Adjudication Method for the Test Set

Not applicable. As this is bench testing against specified performance, there is no need for an adjudication method as would be typical for clinical studies involving human interpretation.

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

No. This is a bench test for an engineering component, not an AI or imaging device that would involve human readers.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

Not applicable. This is not an algorithm or AI device. The study performed was a standalone bench test of the physical device's performance.

7. Type of Ground Truth Used

The ground truth used is the engineering specification that the device must be capable of performing as intended at the increased pressure injection limit of 600 psi. This is a direct physical measurement.

8. Sample Size for the Training Set

Not applicable. There is no mention of a training set as this is not an algorithm that requires machine learning.

9. How Ground Truth for the Training Set Was Established

Not applicable. There is no training set for this type of device evaluation.

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The Guardian® II NC HV is intended to maintain hemostasis during the use of diagnostic/interventional devices. The device is indicated for maintaining a seal around diagnostic/interventional devices with outside diameters up to 8.0F (2.67 mm or 0.105") during diagnostic/interventional procedures.

The guidewire introducer is included to facilitate the guidewire's passage through the Guardian® II NC HV.

The Torque Device is included to manipulate the steering of the guidewire within the vascular regions.

The Zerusa Guardian® II NC Hemostasis Valve is designed to be used as a conduit when interventional devices with diameters up to 8.0F (2.67mm or 0.105") are inserted into the human vascular system.

The device has two seals: the low-pressure seal (or wiper seal) and the high-pressure seal. Depressing the cap opens the low-pressure seal, releasing the cap closes the seal. The high-pressure seal is operated by rotating the nut clockwise. Closure of the highpressure seal, which is achieved when the nut can no longer rotate, secures the diagnostic/interventional device in position within the vasculature and also allows for pressure injections up to 150 psi (10 ATM).

Included with the Guardian® II NC Hemostasis Valve is a Guidewire Introducer, which is used to facilitate entry of the guidewire into the Guardian® II NC Hemostasis Valve. It consists of an austenitic stainless steel tube connected to a hub constructed of polycarbonate.

Also included with the Guardian® II NC HV is a simple Guidewire Torquer which is used to manipulate the steering of a guidewire within the vascular regions.

The provided text describes a 510(k) premarket notification for the Zerusa Limited Guardian® II NC Hemostasis Valve. This document focuses on demonstrating substantial equivalence to a predicate device, not on proving device performance against specific acceptance criteria through a clinical study. Therefore, much of the requested information regarding acceptance criteria and a study proving device performance is not present in the provided text.

Here is the information that can be extracted, and where details are missing:

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

The document does not provide a table of acceptance criteria or specific quantitative performance metrics. It states: "The Guardian® II NC Hemostasis Valve was subjected to a full battery of performance testing. The results of the performance testing demonstrated the safety and effectiveness of the device." This is a general statement, not a detailed report of criteria and results.

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

This information is not provided. The document describes non-clinical "performance testing" rather than a clinical study with a test set of patient data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This information is not applicable and not provided, as the testing was non-clinical performance testing of a medical device, not a study evaluating an AI algorithm's diagnostic performance against expert-established ground truth.

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

This information is not applicable and not provided, for the same reasons as above.

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 or reported. This document pertains to a physical medical device, not an AI-assisted diagnostic tool.

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

This information is not applicable and not provided. The device is a hemostasis valve, not an algorithm.

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

For the "performance testing" mentioned, the ground truth would typically be established by engineering specifications, validated test methods, and industry standards for sealing capability, pressure resistance, material compatibility, and fluid dynamics. These specific details are not provided in the summary.

8. The sample size for the training set

This information is not applicable and not provided, as the device is not an AI algorithm requiring a training set.

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

This information is not applicable and not provided, as the device is not an AI algorithm.

In summary:

The provided 510(k) summary focuses on demonstrating the substantial equivalence of a modified hemostasis valve (Guardian® II NC Hemostasis Valve) to its predicate device (Guardian® II Hemostasis Valve). It highlights changes in the low-pressure seal activation mechanism from a "push/push" to a "spring-loaded" action. The document states that "performance testing demonstrated the safety and effectiveness of the device," but it does not detail specific acceptance criteria, quantitative results, or the methodology of a clinical study, as these are not typically required for a Special 510(k) seeking to modify a previously cleared device where the focus is on maintaining equivalence rather than proving new performance claims through extensive clinical trials.

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The Guardian™ II HV is intended to maintain hemostasis during the use of diagnostic/interventional device is indicated for maintaining a seal around diagnostic/interventional devices with outside diameters up to 8.0F (2.67 mm or 0.105") during diagnostic/interventional procedures.

The guidewire introducer is included to facilitate the guidewire's passage through the Guardian™ II HV.

The Torque Device is included to manipulate the steering of the guidewire within the vascular regions.

The Zerusa Guardian™ II Hemostasis Valve is designed to be used as a conduit when interventional devices with diameters up to 8.0F (2.67mm or 0.105") are inserted into the human vascular system.

The device has two seals: the low-pressure seal (or wiper seal) and the highpressure seal. Depressing the cap engages the Quikloc " to open the low-pressure seal, depressing the cap again closes the seal. The high-pressure seal is operated by rotating the nut clockwise. Closure of the high-pressure seal, which is achieved when the nut can no longer rotate, secures the diagnostic/interventional device in position within the vasculature and also allows for pressure injections up to 150 psi (10 ATM).

Included with the Guardian™ II Hemostasis Valve is a Guidewire Introducer, which is used to facilitate entry of the guidewire into the Guardian IIM II Hemostasis Valve. It consists of an austenitic stainless steel tube connected to a hub constructed of polycarbonate.

Also included with the Guardian™ II HV is a simple Guidewire Torquer which is used to manipulate the steering of a guidewire within the vascular regions.

This is a 510(k) premarket notification for the Guardian™ II Hemostasis Valve. The provided text describes the device, its intended use, and indicates that performance testing was conducted. However, the document does NOT contain the specific acceptance criteria or the detailed results of the study that proves the device meets those criteria.

The document states: "The Guardian™ II Hemostasis Valve was subjected to a full battery of performance testing. The results of the performance testing demonstrated the safety and effectiveness of the device." This is a general statement and does not provide the specific information requested in your prompt.

Therefore, I cannot extract the information you requested regarding:

1. A table of acceptance criteria and the reported device performance
2. Sample sized used for the test set and the data provenance
3. Number of experts used to establish the ground truth... and the qualifications
4. Adjudication method
5. Multi reader multi case (MRMC) comparative effectiveness study information
6. Standalone (algorithm only) performance information
7. The type of ground truth used
8. The sample size for the training set
9. How the ground truth for the training set was established

The provided text focuses on the administrative aspects of a 510(k) submission (submitter, device classification, predicate device comparison, intended use, indications for use) and the FDA's response, rather than the detailed technical performance study results.

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The Guardian Hemostasis Valve is intended to maintain hemostasis during the introduction, withdrawal and use of diagnostic/interventional devices during vascular procedures. The Guardian HV is intended to maintain hemostasis during the use of diagnostic/interventional devices. The device is indicated for maintaining a seal around diagnostic/interventional devices with outside diameters up to 8.0F (2.67 mm or 0.105") during diagnostic/interventional procedures. The guidewire introducer is included to facilitate the guidewire's passage through the Guardian HV. The Torque Device is intended to manipulate the steering of the guidewire within the vascular regions.

The Zerusa Guardian™ Hemostasis Valve is designed to be used as a conduit for which interventional devices with diameters up to 8.0F are inserted into the human vascular system. The device has two seals: the low-pressure seal and the high-pressure seal. Depressing the cap engages the Quikloc TM to open the low-pressure seal, depressing the cap again closes the seal. The high-pressure seal is operated by rotating the nut clockwise. Closure of the high-pressure seal secures the diagnostic/interventional device in position within the vasculature and also allows for pressure injections. The two independently operated seals allow for minimal blood loss during vascular procedures. When the low pressure seal is open, it allows the device to be flushed. During the procedure, the low pressure seal is opened in order to allow the advancement/withdrawal of diagnostic/interventional devices. Included with the Guardian™ Hemostasis Valve is a Guidewire Introducer, which is used to facilitate entry of the guidewire into the hemostasis valve. The Guidewire Introducer has an effective length of 125mm (4.9") and an inside diameter of 0.6mm (or 0.023"). A Guidewire Torquer, intended to manipulate the steering of the guidewire within the vascular regions, is also included.

This 510(k) premarket notification describes the Zerusa Limited Guardian™ Hemostasis Valve, which is designed to maintain hemostasis during vascular procedures when interventional devices up to 8.0F are inserted. This submission specifically adds a Guidewire Torquer. The device is deemed substantially equivalent to the previously marketed Zerusa Limited Guardian Hemostasis Valve (K052381).

Here's an analysis of the provided information regarding acceptance criteria and supporting studies:

1. Table of Acceptance Criteria and Reported Device Performance

The provided document does not explicitly state specific quantitative acceptance criteria for performance parameters. Instead, it makes a general statement about performance testing.

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

The document does not specify the sample size used for the test set or the data provenance (e.g., country of origin, retrospective/prospective nature). It only mentions "a full battery of performance testing."

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

This information is not provided in the document. The device is a medical accessory, and ground truth in the context of clinical outcomes or diagnostic accuracy (which would typically involve expert review) is not discussed. Performance testing likely refers to engineering and functional tests rather than clinical evaluation with human subjects and expert-established ground truth.

4. Adjudication Method for the Test Set

The document does not mention any adjudication method as it does not describe a study involving human interpretation or clinical endpoints that would require adjudication.

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

A Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done or is not reported in this document. Such studies are typical for diagnostic imaging devices where human interpretation is a key component, which is not the primary function of this hemostasis valve.

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

This device is a medical accessory and does not involve any algorithm or AI for standalone performance. Therefore, this type of study is not applicable and was not performed.

7. The Type of Ground Truth Used

The term "ground truth" as typically understood in studies involving diagnostic accuracy (e.g., pathology, outcomes data) is not applicable to the performance testing described for this device. The testing likely focused on physical and functional characteristics such as:

• Hemostasis effectiveness: Ability to seal around devices of specified diameters to minimize blood loss.
• Ease of use: Smooth introduction and withdrawal of interventional devices.
• Leakage: Absence of leakage during pressure injections.
• Durability and material compatibility: Ensuring the device withstands procedural stresses and is biocompatible.
• Sterility and packaging integrity.

The "ground truth" for these tests would be established by engineering specifications and industry standards.

8. The Sample Size for the Training Set

This question is not applicable as the device does not involve machine learning or AI, and hence, there is no "training set."

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

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

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The Hemostasis Valve is intended to maintain a fluid-tight seal around interventional and diagnostic devices during use.

The Hemostasis Valve is a valve consisting of a clear polycarbonate body, silicone valve, polyacetal actuation lever, and polycarbonate and EPDM o-ring rotating male Luer lock connector and female Luer lock.

This document, a 510(k) Premarket Notification for a Hemostasis Valve, does not contain the level of detail regarding acceptance criteria and study design that would be found in a clinical trial report or a more extensive study. The information provided focuses on demonstrating substantial equivalence to a predicate device rather than a comprehensive evaluation against specific performance metrics for a novel technology like an AI-powered device.

Therefore, many of the requested categories cannot be populated from the provided text.

Here's a breakdown of what can be extracted and what cannot:

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

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

• Not explicitly stated. The document refers to "performance data provided" but does not detail the sample size or the nature of the tests conducted (e.g., in-vitro, ex-vivo, in-vivo studies). Data provenance is also not mentioned.

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/Not stated. This type of information is relevant for studies involving qualitative assessments, such as image interpretation by medical professionals, which is not the case for this mechanical device.

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

• Not applicable/Not stated. Adjudication methods are typically used when there's subjective interpretation or disagreement among experts, which doesn't seem to be relevant for the mechanical performance testing of a valve.

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 device is a mechanical hemostasis valve, not an AI-powered diagnostic or assistive tool for human readers. Therefore, an MRMC study is irrelevant.

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

• Not applicable. This device is a mechanical hemostasis valve, not an algorithm or AI system.

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

• Implied engineering and performance standards. For a mechanical device like a hemostasis valve, the "ground truth" would likely be established through engineering specifications, validated test methods (e.g., leakage tests, pressure tests, material compatibility tests), and comparison to the predicate device's established performance. The document states that the technological characteristics are "similar in design and technology" to the predicate.

8. The sample size for the training set

• Not applicable. This information pertains to machine learning models, not the development of a mechanical device.

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

• Not applicable. This information pertains to machine learning models, not the development of a mechanical device.

Summary based on the provided text:

The provided document describes a 510(k) premarket notification for a Hemostasis Valve. The acceptance criteria are implicitly that the device is safe and effective for its intended use, specifically to "maintain a fluid-tight seal around interventional and diagnostic devices during use," and that its component materials are biocompatible. The study proving this involves "performance data provided" and biocompatibility statements, along with a comparison of its design and technology to a legally marketed predicate device (Merit Passage® Hemostasis Valve, K925419).

The document is a regulatory submission for a traditional medical device, not an AI/ML-powered device. Therefore, many of the questions related to AI-specific study design (e.g., training sets, expert ground truth, MRMC studies) are not applicable to this context and are not addressed in the provided text. The "study" here refers to the testing and comparison performed by the manufacturer to demonstrate substantial equivalence, rather than a clinical trial with human subjects or a formal AI performance evaluation.

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The Guardian HV is intended to maintain hemostasis during the use of diagnostic/interventional devices. The device is indicated for maintaining a seal around diagnostic/interventional devices with outside diameters up to 8.0F (2.67 mm or 0.105") during diagnostic/interventional procedures. The guidewire introducer is included to facilitate the guidewire's passage through the Guardian HV.

The Zerusa Guardian™ Hemostasis Valve is designed to be used as a conduit for which interventional devices with diameters up to 8.0F are inserted into the human vascular system. The device has two seals: the low-pressure seal and the high-pressure seal. Depressing the cap engages the Quikloc TM to open the low-pressure seal, depressing the cap again closes the seal. The high-pressure seal is operated by rotating the nut clockwise. Closure of the high-pressure seal secures the diagnostic/interventional device in position within the vasculature and also allows for pressure injections. The two independently operated seals allow for minimal blood loss during vascular procedures. When the low pressure seal is open, it allows the device to be flushed. During the procedure, the low pressure seal is opened in order to allow the advancement/withdrawal of diagnostic/interventional devices. Included with the Guardian™ Hemostasis Valve is a Guidewire Introducer, which is used to facilitate entry of the guidewire into the hemostasis valve. The Guidewire Introducer has an effective length of 125mm (4.9") and an inside diameter of 0.6mm (or 0.023").

The provided text describes a 510(k) summary for the Zerusa Limited Guardian Hemostasis Valve with Guidewire Introducer. It states that the device was subjected to a "full battery of performance testing" and that the "results of the performance testing demonstrated the safety and effectiveness of the device."

However, the document does not provide specific details on:

• Acceptance Criteria: What specific thresholds or metrics were defined for acceptable performance.
• Reported Device Performance: The actual quantitative results from the performance tests.
• Study Design Details: Information regarding sample sizes, data provenance, ground truth establishment, expert involvement, or specific types of studies (MRMC or standalone).

Therefore, based only on the provided text, I cannot answer the questions comprehensively. The document focuses on demonstrating substantial equivalence to predicate devices and receiving FDA clearance, rather than detailing the specifics of the performance study itself.

Here's what can be inferred and what is missing:

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

• Acceptance Criteria: Not specified in the document. It only broadly states that testing "demonstrated the safety and effectiveness of the device," implying that the device met internal Zerusa Limited criteria.
• Reported Device Performance: Not specified in the document. No quantitative results from any performance testing are included.

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

• Sample Size: Not specified.
• Data Provenance: Not specified (e.g., country of origin, retrospective/prospective).

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

• This type of detail (expert involvement for ground truth) is typically associated with studies involving subjective interpretation, like imaging. For a hemostasis valve, testing would likely involve objective, measurable parameters (e.g., leak rate, burst pressure, force to advance/withdraw devices). Therefore, the concept of "experts establishing ground truth" in this context might not apply or is not described. No information is provided about experts.

4. Adjudication method for the test set:

• Not applicable/not specified, as the type of ground truth and existence of expert involvement is not mentioned.

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. An MRMC study is not mentioned. This type of study is relevant for AI systems in image interpretation. The device described is a physical medical device (hemostasis valve), not an AI-powered diagnostic tool. Therefore, this question is not applicable.

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

• Yes, indirectly. The "full battery of performance testing" would be considered standalone testing of the device itself (not an algorithm) without a human-in-the-loop, as it's a physical device. However, no details of these tests are provided.

7. The type of ground truth used:

• For physical device testing like a hemostasis valve, the "ground truth" would likely be defined by engineering specifications and validated test methods. For example, a leakage test would have a "ground truth" of zero leakage or a maximum allowable leakage rate. A force measurement for device insertion/withdrawal would have a "ground truth" of acceptable force ranges. The document does not explicitly state these, but this is the implied type of "ground truth" for such a device.

8. The sample size for the training set:

• Not applicable/not specified. A "training set" typically refers to data used to train a machine learning algorithm. This is a physical device, not an AI system.

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

• Not applicable/not specified. See point 8.

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The Guidant Hemostasis Valve is used to maintain hemostasis around catheters percutaneously introduced into the vasculature.
The Rotating Hemostasis Valve is intended for maintaining a fluid- tight seal around devices, including implantable coronary venous leads, during the implant procedure.

The RAPIDO™ Cut-Away Rotating Hemostasis Valve is recommended for use during vascular procedures in conjunction with interventional and/or diagnostic devices such as balloon catheters, wires, and pacemaker and defibrillation leads. The RAPIDO™ Cut-Away Rotating Hemostasis Valve has a single adjustable seal that provides control over fluid loss.
The seal is a Tuohy-Borst type that may be adjusted by rotating the cap clockwise to close, and counterclockwise to open. The seal is adjusted to control leakage and device movement. An open RHV seal allows air and fluid to be purged while allowing the advancement/withdrawal of diagnostic/ interventional devices

I am sorry, but the provided text does not contain the detailed information needed to fill out all aspects of your request. The document is a 510(k) summary for a medical device and primarily focuses on establishing substantial equivalence to a predicate device.

Here's what can be extracted and what is missing:

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

The document states: "The results of the verification testing demonstrate that the modified Rotating Hemostasis Valve meets the established acceptance criteria and perform in a manner equivalent to the predicate device." However, it does not provide a specific table of acceptance criteria or the reported performance data. It only makes a general statement of compliance.

What is available form the text:

What is missing: The specific quantitative or qualitative acceptance criteria used for the device and the detailed results of the performance testing against these criteria.

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

The document does not specify the sample size used for any testing. It also does not mention data provenance (e.g., country of origin, retrospective/prospective).

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

This information is not present in the provided text. The document describes a medical device, and the "ground truth" concept as typically applied to AI/imaging studies (e.g., expert consensus on image interpretation) is not relevant in this context of a physical device's performance testing.

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

This information is not present and is not typically relevant for the type of device testing described.

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 type of study is not mentioned in the document. An MRMC study is relevant for AI-assisted diagnostic tools, not for a physical hemostasis valve.

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

This is not applicable as the device is a physical hemostasis valve, not an algorithm.

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

The concept of "ground truth" as typically used in AI/diagnostic studies is not applicable here. For a physical device, testing typically involves engineering tests, material compatibility tests, and functional performance tests against predefined specifications. The "ground truth" would be the direct measurement or observation of the device's physical properties and functional performance.

8. The sample size for the training set:

There is no mention of a training set as this is a physical medical device, not an AI model.

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

Not applicable, as there is no training set.

In summary, the provided text is a 510(k) summary for a physical medical device. It focuses on demonstrating substantial equivalence to a predicate device through verification testing, but it does not disclose the specific details of that testing (e.g., acceptance criteria, test results, sample sizes) that would be needed to answer most of your detailed questions. The concepts of "ground truth," "training set," "experts," and "AI performance" are not relevant to this type of regulatory submission for this device.

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