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Y-Connector hemostasis valve is intended to minimize blood loss during the introduction, withdrawal and use of devices that have an outer diameter of 8F catheter during diagnostic and interventional procedures.

The Insertion Tool facilitates introduction of a guidewire through the Y-Connector and into the guiding catheter.

The Torque Device attaches to guidewires and provides a handle to assist in manipulation of the guidewire.

The Y-connector kit is single use disposable device. It including Y connector, Insertion tool and torque device. It is mainly use for PTCA or PTA procedures to create the entrance and minimize blood loss when intervention device are inserted into the human vascular system.

The Y connector with a rotating luer lock, a sidearm and a hemostasis valve that is designed to provide a port for interventional system. The seal of hemostasis valve can be opened by pushing the switch cap, and closed by releasing switch cap.

The insertion tool is used to facilitate placement of a guide wire tip through the Y connector.

The torque device is designed to hold the guide wire and provide a handle for manipulating, so the doctor can control the guide wire to the right position.

The provided text describes a 510(k) premarket notification for a medical device called the "Y-connector Kit." This submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than a de novo clinical study proving novel performance criteria. Therefore, the information regarding acceptance criteria and a study proving device meeting those criteria will be based on the substantial equivalence claims and bench testing performed.

Here's an analysis of the provided text:

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

The document does not explicitly present a table of acceptance criteria with corresponding performance data in a quantitative manner as one might find in a clinical trial. Instead, it describes compliance with design specifications and recognized standards. The "acceptance criteria" are implied by the standards and performance characteristics of the predicate device.

Implied Acceptance Criteria and Reported Device Performance:

Study that Proves the Device Meets Acceptance Criteria:

The document describes "Bench tests were conducted to verify that the proposed device met all device specification as were substantially equivalent (SE) to the predicate device." It also mentions "Biocompatibility testing and reference standards."

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 specify the sample sizes for the bench tests. It only states that "Bench tests were conducted."

• Sample size: Not specified.
• Data provenance: The tests were conducted internally by Shanghai Kindly Medical Instruments Co., Ltd. (China). The data is presumably prospective (i.e., designed specifically for this 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 type of information (experts, their qualifications, and ground truth establishment) is typically relevant for clinical studies, especially those involving subjective interpretation (e.g., imaging diagnosis). Since this submission primarily relies on bench testing and substantial equivalence, there is no mention of experts establishing a ground truth for a test set in the context of clinical performance. The "ground truth" for the bench tests would be the established engineering and biological standards.

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

Not applicable for a submission based on bench testing and substantial equivalence, which does not involve subjective human interpretation of clinical data requiring adjudication.

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

Not applicable. This is a medical device submission for a physical y-connector kit, not an AI software/algorithm, and no MRMC study was performed or needed.

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

Not applicable. This is a medical device submission for a physical y-connector kit, not an algorithm.

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

For the bench tests, the "ground truth" would be the established scientific and engineering principles codified in the referenced ISO standards (ISO 594-1, ISO 594-2, ISO 10993 series) and the functional performance characteristics of the predicate device. For biocompatibility, the ground truth is defined by the acceptable levels of biological response as outlined in the ISO 10993 standards.

8. The sample size for the training set

Not applicable. This is a physical medical device, not an AI/machine learning model 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 a physical medical device.

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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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Merit's Rotating Adapters are indicated for use in interventional, diagnostic, surgical, and therapeutic applications to interconnect tubing, catheters, or other devices.

Merit's Rotating Adapters are marketed in two configurations: Male-Male Adapter (MMA) and Male-Female Adapter (MFA). The adapters are comprised of a stand-alone rotator assembly bonded to a polycarbonate male or female luer lock, using a UV cured adhesive. The stand-alone rotator assembly is comprised of individually molded polycarbonate parts (housing connector, retaining collar, hub) and an

The provided text describes a 510(k) premarket notification for a medical device, the Merit Rotating Adapter. This type of submission is for demonstrating "substantial equivalence" to a predicate device, rather than proving safety and effectiveness through extensive clinical trials. Therefore, the information provided focuses on comparative testing against standards and the predicate device's characteristics, not on AI model performance or deep learning studies.

Given this context, I cannot fulfill all the requested points (especially those related to AI algorithm performance, human reader improvement with AI, ground truth establishment for AI, or training set details) because the document describes a traditional medical device submission, not an AI/ML medical device submission.

However, I can extract information related to the device's functional and safety testing as described.

Acceptance Criteria and Device Performance for Merit Rotating Adapter (K140475)

The device, Merit Rotating Adapter, is a Class II medical device (Product Code DTL) and is intended for use in interventional, diagnostic, surgical, and therapeutic applications to interconnect tubing, catheters, or other devices. The submission focuses on demonstrating substantial equivalence to a predicate device (Merit Rotator, K932251). The performance testing was conducted based on risk analysis and
requirements of international standards.

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly list distinct "acceptance criteria values" for each test. Instead, it states that "The results of the testing demonstrated that the Rotating Adapters met the predetermined acceptance criteria applicable to the safety and efficacy of the device." The tests conducted are listed, implying that passing these tests according to the relevant standards constitutes meeting the acceptance criteria.

• Merit Hydrostatic Pressure Test
• Merit Vacuum Leak Test
• ISO 8536-10 Particulate
• ISO 8536-10 Leakage | Met "predetermined acceptance criteria applicable to the safety and efficacy of the device." (No specific values or thresholds reported). |
  | Chemical | - ISO 8536-4 Chemical Requirements | Met "predetermined acceptance criteria applicable to the safety and efficacy of the device." |
  | Biocompatibility | - Cytotoxicity (based on ISO 10993-5:2009)
• Sensitization (based on ISO 10993-10:2010)
• Irritation (based on ISO 10993-10:2010)
• Systemic Toxicity (based on ISO 10993-11:2006)
• Systemic Injection (based on ISO 10993-11:2006)
• Pyrogenicity (based on USP 36, NF 31, 2013 )
• Hemocompatibility (based on ISO 10993-4:2002 (Amd.1:2006) and ASTM F756-08:2008)
• Chemical Characterization (based on ISO 10993-1:2009 and FDA guidance) | Met "predetermined acceptance criteria applicable to the safety and efficacy of the device" for all biocompatibility aspects. (No specific results). |
  | Sterilization | - ANSI/AAMI/ISO 11135-1:2007 (Sterilization of health care products - routine control of a sterilization process for medical devices) | Test conducted, implies successful meeting of criteria. |

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

The document does not specify the sample sizes (number of units tested) for each of the performance or biocompatibility tests.
Data provenance is not applicable in the context of this device's testing, as it involves physical and chemical tests of the device itself, not data derived from patients or clinical sources. The tests are laboratory-based.

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

This is not applicable. The "ground truth" for this type of device (a mechanical adapter) is adherence to engineering and biological safety standards, not expert interpretation of clinical data or images. The "experts" involved would be engineers and scientists performing the tests and assessing compliance with the standards.

4. Adjudication Method for the Test Set

This is not applicable. Adjudication methods like "2+1" or "3+1" are relevant for expert consensus on clinical data (e.g., in MRMC studies), which is not the nature of the testing described for this device.

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

This is not applicable. MRMC studies are performed for diagnostic devices (e.g., imaging AI) to assess the impact of a device on human reader performance. This device is a physical adapter for fluid management, not a diagnostic tool requiring human interpretation.

6. Standalone Performance

The "standalone performance" for this device is essentially its ability to meet the specified mechanical, chemical, and biocompatibility standards independently. The document states that "The results of the testing demonstrated that the Rotating Adapters met the predetermined acceptance criteria applicable to the safety and efficacy of the device." This implies successful standalone performance in the context of the device's function.

7. Type of Ground Truth Used

The "ground truth" for this device's performance is compliance with established international standards (e.g., ISO 8536-4, ISO 8536-10, ISO 10993 series, ASTM F756-08, USP 36) and internal Merit Medical test protocols (Rotational Torque, Hydrostatic Pressure, Vacuum Leak). This is essentially engineering and biomaterial testing standards compliance.

8. Sample Size for the Training Set

This is not applicable. There is no AI/ML algorithm or "training set" for this physical medical device.

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

This is not applicable as there is no training set mentioned for this type of device.

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CoLign™ The Hemostasis Valve is intended to to maintain hemostasis during the introduction/withdrawal and use of diagnostic and interventional devices up to an external diameter of 7 French or smaller.

The insertion tool facilitates introduction of the guide wire go through the hemostasis valve.

The torquer when inserted into the proximal end of the guide wire provides a handle for easier manipulation of the guide wire.

The CoLign Hemostasis Valve is a device that can be operated with only one hand through its special "push-pull" mechanism. In the pushed-down position, the valve is open for safe insertion and removal of devices. In the pulled-up position, the valve is closed and seals smoothly round the inserted devices. Once the valve is closed, devices can still be manipulated freely. CoLign eliminates the need for adjustment of the hemostasis valve by rotating during the procedure. The CoLign Hemostasis Valve is compatible with most interventional devices based on rapid exchanged and over-the-wire technology. There are three models of the CoLign Hemostasis Valve: the Standard CoLign , the CoLign 20,and the CoLign 50. The configuration of the sideport is the only difference among the three models. The sideport of the Standard CoLign ends in a male luer, while the sidearm of the CoLign 20/50 ends with a 20/50 cm extension tubing and 3-way stopcock.

Here's an analysis of the provided text regarding the CoLign™ Hemostasis Valve, focusing on the acceptance criteria and study data:

It's important to note that the provided text is a 510(k) Premarket Notification for a medical device. This type of submission aims to demonstrate substantial equivalence to a previously legally marketed device (predicate device), rather than proving safety and effectiveness de novo through extensive clinical trials. Therefore, the "acceptance criteria" and "study" information will differ significantly from what one might expect for a novel device requiring a PMA (Premarket Approval).

The "acceptance criteria" in this context refers to the performance characteristics that the CoLign™ Hemostasis Valve needed to meet to be considered substantially equivalent to its predicate device. The "study" refers to the non-clinical performance testing conducted to demonstrate these characteristics.

1. Table of Acceptance Criteria and Reported Device Performance

Given the nature of a 510(k) submission, the acceptance criteria are largely implied by the comparison to the predicate device and the typical tests for this device type. The reported device performance is presented as meeting these criteria.

Note on "Acceptance Criteria": For a 510(k), the primary "acceptance criterion" is often demonstrated substantial equivalence to the predicate device, which is shown by comparing technological characteristics and performance test results. Many of the reported performances are directly compared against the predicate's stated specifications or generally accepted industry standards for such devices. The "Met requirements" for tests like visual inspection or peel tests imply internal company-defined acceptance criteria based on good manufacturing practices and risk assessment.

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

• Sample Size: The document does not specify the exact sample sizes for each of the performance tests (e.g., how many valves were subjected to leak testing or pressure resistance testing). It is typical for such non-clinical tests to use a statistically relevant but often small number of units (e.g., N=3 to N=10 per test) to demonstrate performance.
• Data Provenance: The studies were conducted by Jilin Coronado Medical Ltd. The data is non-clinical performance test data, likely conducted in a controlled laboratory setting (in-house or third-party lab) by the manufacturer. The country of origin for the testing would be China, where the manufacturer is located. The nature of these tests makes them prospective in the sense that they were designed and executed to evaluate the new device's performance against predefined criteria.

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

• This question is not applicable to this type of submission. The ground truth for the non-clinical performance tests (e.g., pressure resistance, leak testing, material composition) is established by physical measurement, chemical analysis, and engineering standards. It does not involve human expert interpretation of data like imaging studies.

4. Adjudication Method for the Test Set

• This question is not applicable. Adjudication methods (like 2+1 or 3+1) are used in clinical studies where multiple human readers interpret patient data and discrepancies need to be resolved. Performance testing of a physical device against engineering specifications does not involve such human "readings" or adjudication. The results are typically quantitative measurements or qualitative observations that conform to a standard.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done, If So, What was the Effect Size of How Much Human Readers Improve with AI vs Without AI Assistance

• This question is not applicable. An MRMC study is relevant for evaluating the impact of AI on human performance in diagnostic tasks (e.g., radiology). The CoLign™ Hemostasis Valve is a physical medical device (hemostatic valve), not an AI-powered diagnostic tool. Therefore, no MRMC study was performed or is relevant here.

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

• This question is not applicable. This device is a physical, mechanical medical device. It does not involve any algorithm or AI component, so the concept of "standalone algorithm performance" is irrelevant.

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

• The "ground truth" for the non-clinical performance tests is based on established engineering standards, material specifications, and validated test methods. For example:
  • Pressure Resistance: Ground truth is a measured pressure, compared against a specified bar value.
  • Biocompatibility: Ground truth is determined by compliance with ISO 10993 standards, involving quantitative and qualitative lab tests (e.g., cell culture assays for cytotoxicity, chemical analyses for extractables).
  • Leak Test: Ground truth is the absence of fluid leakage under defined conditions.
  • Material Composition: Ground truth is the chemical identity of the materials (e.g., polycarbonate, silicone) as confirmed by material testing.

8. The Sample Size for the Training Set

• This question is not applicable. "Training set" refers to data used to train machine learning models. As established, this device is a physical medical component and does not involve AI or machine learning.

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

• This question is not applicable for the same reason as point 8. There is no training set for a device of this type.

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Flexible Luer Lock Adapters are indicated for use in connecting tubing and/or devices during cardiopulmonary bypass procedures up to 6 hours in duration.

The flexible luer lock adapters are single use only devices that consist of a flexible tubing segment with an inner diameter of 0.32 cm (0.125 in) with a male luer adapter on one end and a female luer adapter on the other end. This device is currently packaged with the Affinity Pixie Cardiotomy/Venous Reservoir device. It is also available as a standalone device (subject of this submission).

The provided text describes a 510(k) submission for the Medtronic Affinity® Flexible Luer Lock Adapters. This submission focuses on demonstrating substantial equivalence to a predicate device, primarily through performance testing of the updated packaging for a device that was previously an accessory.

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

1. Table of Acceptance Criteria and Reported Device Performance

Note: The core product (the luer lock adapter itself) is stated to be identical to the predicate device in terms of design, materials, intended use, and principles of operation. Therefore, there are no specific performance criteria for the adapter's function (e.g., fluid flow, connection strength) in this submission, as those were already established for the predicate device. The focus is solely on the new packaging configuration.

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

• Test Set Sample Size: The document does not specify the exact number of samples used for the packaging tests (e.g., how many blister trays were tested for dye penetration or peel strength). It refers to "packaged samples."
• Data Provenance: Not explicitly stated regarding country of origin. The study appears to be retrospective in the sense that the device itself largely pre-exists as part of another product, and the study is for demonstrating the adequacy of the new packaging for standalone distribution. It's a lab-based performance study, not a clinical trial involving human patients.

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

• Not applicable (N/A). This study is a physical and mechanical performance test of packaging, not a diagnostic or AI-driven device requiring expert-established ground truth. The "ground truth" for packaging integrity is defined by compliance with ISO and ASTM standards and visual/mechanical tests (dye penetration, peel strength).

4. Adjudication Method for the Test Set

• Not applicable (N/A). As this is a physical performance study, there is no need for expert adjudication in the traditional sense. The results are objectively measured against established criteria (e.g., successful dye penetration vs. no penetration, peel strength within a range).

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. This is not an AI/imaging device. It's a medical device accessory whose performance evaluation focuses on packaging integrity.

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

• Not applicable (N/A). This is not an AI/algorithm-based device. The device itself (the luer lock adapter) is a standalone accessory, but its performance in this submission relates to its packaging.

7. The type of ground truth used

• Defined by International Standards and Objective Physical Measurements: The "ground truth" for the packaging performance is compliance with ISO 11607-1 and 11607-2, 2006, and ASTM D4169-08. Performance is assessed through objective measurements like visual inspection, dye penetration, and peel tests.

8. The Sample Size for the Training Set

• Not applicable (N/A). There is no "training set" as this is not an AI or machine learning product.

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

• Not applicable (N/A). There is no training set or associated ground truth for this type of device submission.

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Medtronic Connector Components with Balance™ Biosurface are indicated for use in the extracorporeal circuit during cardiopulmonary bypass surgical procedures.

Medtronic Comector Components with Balance Biosurface are intended for use in the extracorporeal circuit during cardiopulmonary bypass surgery. These components are primarily used to interconnect tubing and the primary devices of the bypass circuit. The lumen of the Connector Components with Balance Biosurface consist of smooth blood-contacting surfaces which provide a continuous pathway for the flow of blood and/or other fluids during cardiopulmonary bypass surgical procedures. The Connector Components with Balance Biosurface are comprised of polycarbonate and Balance Biosurface materials and provided in Ytype, straight, reducer and adapter (luer) configurations.

This K122811 submission is for "Connector Components with Balance Biosurface" intended for use in extracorporeal cardiopulmonary perfusion bypass circuits. This device is a component, specifically tubing connectors, and not an AI/ML powered device. As such, the information requested in the prompt related to acceptance criteria, study details, expert involvement, and AI performance is not typically found in the documentation for such a device. This submission focuses on demonstrating substantial equivalence to a predicate device.

However, I can extract the relevant information available from the provided document regarding substantial equivalence.

1. Table of Acceptance Criteria and Reported Device Performance:

The document implicitly uses "substantial equivalence" as the acceptance criterion. The performance is reported in terms of equivalence to the predicate device K113845.

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

• Not applicable for an AI/ML device. This document does not detail a "test set" in the context of AI/ML evaluation. The safety and effectiveness are established through comparative testing and material characterization against the predicate. The document doesn't specify the sample sizes for these comparative tests (e.g., for biological safety, material properties, or performance tests).

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

• Not applicable for an AI/ML device. This information is for AI/ML performance evaluation and is not relevant to this device's regulatory submission.

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

• Not applicable for an AI/ML device. This is relevant for AI/ML performance evaluation and is not detailed for this type of device.

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 for an AI/ML device. This is for AI/ML performance evaluation and is not relevant to this device.

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

• Not applicable for an AI/ML device. This is for AI/ML performance evaluation and is not relevant to this device.

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

• Not applicable for an AI/ML device. The "ground truth" for this device's submission is effectively the established performance and safety profile of the predicate device (K113845), as well as compliance with recognized standards for material properties and biological safety.

8. The sample size for the training set:

• Not applicable for an AI/ML device. This device does not involve a training set as it is not an AI/ML product.

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

• Not applicable for an AI/ML device. This device does not involve a training set.

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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 Mediane Stopcock and Manifold are indicated to serve as flow controls and conduit devices for IV fluid delivery to the patient's vascular system.

Medline Stopcock and Manifold

This document is an FDA 510(k) clearance letter for the "Medline Stopcock and Manifold." It primarily concerns the regulatory approval of a medical device and does not contain information about a clinical study with acceptance criteria and device performance data in the context of AI/ML or diagnostic performance.

Therefore, I cannot provide the requested information, which typically pertains to studies evaluating the diagnostic accuracy, sensitivity, specificity, or other performance metrics of a device, especially those involving AI/ML components.

The provided document details:

• Device Name: Medline Stopcock and Manifold
• Regulation Number and Name: 21 CFR 870.4290 (Cardiopulmonary Bypass Adaptor), 21 CFR 870.4270 (Stopcock, Manifold or Fitting)
• Regulatory Class: Class II
• Product Code: DTL
• Indications for Use: To serve as flow controls and conduit devices for IV fluid delivery to the patient's vascular system.
• 510(k) Number: K120069
• Date of Clearance: April 3, 2012

This is a traditional medical device clearance, not a submission involving the kind of performance evaluation typically described by your prompt's questions (e.g., test sets, ground truth, expert adjudication, MRMC studies, AI/ML performance, etc.).

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The E-Pass is intended to maintain hemostasis during the introduction/withdrawal and use of diagnostic and interventional devices up to an external diameter of 7 French.

The guide wire insertion tool helps the guide wire go through the hemostasis valve to reach the guiding catheter.

The torquer provides a handle for easier manipulation of the guide wire when inserted into the proximal end of the guide wire.

The E-Pass is a unique one-hand operated, "push-pull" hemostatic valve system. It consists of two pieces of silicone hemostasis valve. The quick open-close valve reduces the patient blood loss significantly during endovascular procedures. In the push forward position the valves is 100% open for safe insertion and removal of devices. In the pulled back position the valve is 100% closed and seals smoothly around the inserted devices. Once the valve is closed, devices can still be manipulated freely. E-Pass eliminates the need for rotating hemostatic valve adjustments during the procedure. The E-Pass hemostatic valve system is compatible with most interventional devices based on rapid exchanged and over-the-wire technology. There are three models of the E-Pass: the standard E-Pass and the E-Pass20/E-Pass50. The configuration of the sideport is the only difference among the three models. The sideport of the standard E-Pass ends in a female luer, while the sidearm of the E-Pass 20/ 50ends with a 20/50 cm extension tubing and 3-way stopcock.

The provided text describes a 510(k) summary for the E-Pass™ Hemostasis Valve. However, it does not include detailed acceptance criteria or a comprehensive study report with specific performance metrics to fill a table and address all the requested points.

The document states:

• "The results of the performance testing demonstrated the safety and effectiveness of the E-Pass TM Hemostatic Valve."
• "Performance testing mainly includes the following tests: Visual Inspection for Pouch Integrity, Pouch Peel Test, E-Pass Visual Inspection, Leak Test without products inserted, E-Pass Alarm pressure leak rate, Tensile test on assembly of Extention tube/Y-hub."

This lists the types of tests performed but does not provide the acceptance criteria or reported results for these tests. Therefore, I cannot construct the requested table or answer many of the specific questions.

Here's what can be inferred or stated based on the provided text, and where information is missing:

1. Table of Acceptance Criteria and Reported Device Performance

Missing Information:

The provided 510(k) summary is very high-level and does not contain the detailed study information regarding acceptance criteria, sample sizes, expert qualifications, adjudication methods, or specific quantitative results typically found in full test reports. This type of detail is usually in the appendices or a more comprehensive submission, not in the summary document provided.

Therefore, for the remaining points, most answers are "Not specified" or "Not applicable" based solely on the provided text.

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

• Sample Size: Not specified.
• Data Provenance: Not specified (e.g., retrospective or prospective, country of origin). This involves physical testing of the device, not clinical data that would typically have country of origin.

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

• Not applicable. This device is a hemostatic valve, and the testing described consists of engineering/physical performance tests (e.g., leak tests, tensile tests, visual inspections), not clinical studies requiring expert image interpretation or ground truth establishment in a diagnostic sense.

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

• Not applicable. As above, this is physical performance testing, not a diagnostic study requiring adjudication of expert 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 device is a hemostatic valve, not an AI-powered diagnostic tool.

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

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

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

• Not applicable. The "ground truth" for this device's performance would be the specifications and requirements for mechanical and sealing integrity, based on engineering standards and design validation.

8. The sample size for the training set:

• Not applicable. This is not a machine learning or AI device that would have a "training set."

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

• Not applicable. As above.

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