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The GaltTWS Stylet is a percutaneous catheter stylet placed inside a catheter, lead, or cannula to stiffen the device for placement or extraction.

The GaltTWS stylet is comprised of a stainless steel twisted/braided wire of varying diameters (0.012-0.015 inch), and varying length (30-72cm). The GaltTWS stylet can be configured as a Twisted/Braided wire bonded to a hub, flushable hub, or connected to a flushable adjustable hub using the Galt Gateway Hemostasis Valve (K152528).

This document is a 510(k) premarket notification decision letter for a medical device called the "GaltTWS Stylet." As such, it does not contain the information requested regarding acceptance criteria and the study proving the device meets those criteria in the context of an AI/ML-based medical device.

The requested information (acceptance criteria for AI performance, sample sizes for test/training sets, expert qualifications, ground truth establishment, MRMC studies, etc.) is specific to studies proving the performance of AI/ML algorithms. This FDA letter pertains to a non-AI medical device (a catheter stylet) and focuses on demonstrating substantial equivalence to predicate devices through bench testing and biocompatibility.

Therefore, I cannot fulfill the request using the provided text. The document describes:

• Device: GaltTWS Stylet (a percutaneous catheter stylet)
• Purpose: Stiffen a catheter, lead, or cannula for placement or extraction.
• Regulatory Pathway: 510(k) for substantial equivalence.
• Testing: Bench testing (Particulate, Mechanical Properties, Leak, Tortuous Path) and Biocompatibility testing (Cytotoxicity, Sensitization, Irritation, Systemic Toxicity, Hemolysis, Pyrogen, EO Residuals).
• Conclusion: Device is substantially equivalent to marketed predicate devices.

This information is relevant to traditional medical device clearance, not the evaluation of AI/ML performance.

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The Zenith Flex System, including the Zetheter, Aspiration Tubing Set, and VC-701 Cliq Aspirator Pump, is indicated in the revascularization of patients with acute secondary to intracranial large vessel occlusive disease (within the internal carotid, middle cerebral – M1 and M2 segments, basilar, and vertebral arteries) within 8 hours of symptom onset. Patients who are ineligible for intravenous tissue plasminogen activator (IV t-PA) or who failed IV t-PA therapy are candidates for treatment.

The InNeuroCo 074 Zenith Flex Catheter is a variable stiffness catheter that has a catheter shaft reinforced with Stainless-Steel and Nitinol to provide support. The Stainless-Steel is wound as a double coil in the proximal section and the Nitinol is a single coil in the distal section. It has a radiopaque Platinum/lridium marker band on the distal 25 cm of the 074 Zenith Flex Catheter has a hydrophilic coating. The 074 Zenith Flex Catheter is available with an internal diameter of 0.074 inches. The outer diameter is of 0.089 inches along its proximal shaft, and 0.083 inches along its distal shaft. The 074 Zenith Flex Catheter is available in three workinq lengths: 115 cm, 125 cm, and 132 cm. The 074 Zenith Flex Catheter has a PTFE lined lumen. Accessories included with the device are a Tuohy-Borst Hemostasis Valve, two peel-away Introducers, and a Scout introducer. The Scout may be used to introduce the 074 Zenith Flex Catheter into distal vasculature, thereby helping the device reach the target anatomy.

The provided text describes the Zenith Flex System (074 Zenith Flex Catheter) and its non-clinical data for demonstrating substantial equivalence. It does not describe a study involving an AI/Machine Learning device or algorithm. Therefore, I cannot provide details regarding acceptance criteria, sample size, ground truth, or adjudication methods in the context of an AI study.

However, I can extract the acceptance criteria and observed performance described for the non-clinical (bench and animal) testing of the Zenith Flex Catheter.

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 exact sample sizes for each benchtop or animal test. It refers to "test samples" for bench testing and does not provide numerical counts.

For animal testing: "Clot was used to create occlusions within several arteries of swine. One side of each swine was treated with the subject Zenith Flex system and the contralateral side was treated with the reference device." The exact number of swine used is not provided.

Data provenance: The non-clinical data is generated from laboratory (bench) and animal (swine) studies. The country of origin for the studies is not specified.

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

Not applicable in this context. The non-clinical studies rely on objective measurements and observations in laboratory and animal settings, not on expert ground truth for interpretation of images or clinical outcomes. For 'Simulated Use - Bench' and 'Simulated Use Testing - Usability', a physician's assessment was used, but details on the number or qualifications of these physicians are not provided.

4. Adjudication Method for the Test Set

Not applicable, as the tests involve objective measurements and direct observation rather than 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

Not applicable. This is a medical device (catheter), not an AI/ML device for diagnostic interpretation. There was no MRMC study involving human readers and AI assistance.

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

Not applicable. This is a medical device (catheter), not an AI/ML device.

7. The Type of Ground Truth Used

For bench testing, the ground truth is based on physical and chemical properties measured against established specifications (e.g., ISO, ASTM standards).
For animal testing, the ground truth for effectiveness was "angiographic assessment of revascularization," and for safety, "angiographic assessment and histopathological assessment."

8. The Sample Size for the Training Set

Not applicable. This is a medical device (catheter); there is no "training set" in the context of an AI/ML algorithm.

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

Not applicable.

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The Zenith Support Catheter is indicated for the introduction of interventional devices into the peripheral and neuro vasculature.

The InNeuroCo Zenith Support product consists of a catheter, a hemostasis valve, and a split sheath introducer. The Zenith Support catheter is a single lumen, variable stiffness catheter that has an outer polymer shaft and is reinforced with a Stainless Steel cross coil. The Zenith Support catheter has a radiopaque Platinum/Iridium marker band on the distal end. The Zenith Support is available with an internal diameter of 0.074 inches and a nominal outer diameter of 0.086 inches. There are three working lengths available: 95 cm, 105 cm, and 115 cm in either diameter. The Zenith Support catheter has a PTFE-lined lumen throughout the catheter shaft. The catheter is flexible and has a hydrophilic coating. The Zenith Support catheter is inserted through a guide catheter or vascular sheath, provides access to the target site, and once in place, provides a reinforcing conduit for other intravascular devices. Accessories included with the device are a Tuohy-Borst hemostasis valve with an extension luer and a split sheath introducer. The Zenith product line is supplied sterile, non-pyrogenic, and intended for single use only.

This request concerns the InNeuroCo Zenith Support Catheter, a percutaneous catheter used for introducing interventional devices into the peripheral and neuro vasculature. The provided document is a 510(k) premarket notification summary, which focuses on demonstrating substantial equivalence to a predicate device rather than a comprehensive study for novel device acceptance criteria.

The information primarily revolves around non-clinical data and justifications for not re-testing certain parameters due to the device's similarity to its predicate. Therefore, detailed information on ground truth establishment, expert qualifications, adjudication methods, or MRMC studies is not available as this type of submission typically relies on a comparison to an already approved device.

Here's an analysis based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

The document provides a "SUMMARY OF NON-CLINICAL DATA" (page 8, "Table 1: Non-Clinical Testing Analysis") which serves this purpose. Many tests were not re-tested for the Zenith Support Catheter because no material changes were made from the predicate device (Zenith 074) and manufacturing processes were identical or within the predicate's tolerance.

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

Due to the nature of a 510(k) summary relying on substantial equivalence, specific sample sizes for re-tested parameters (like Simulated Use - Bench) are not explicitly stated. For most tests, the data provenance is essentially inherited from the predicate device (Zenith 074) and another reference device (InNeuroCo SDA) because the new device's materials and manufacturing are identical or within tolerance. The document indicates these are non-clinical studies (benchtop and animal models for predicate devices). The geographical origin of the data is not specified beyond the manufacturer being based in Florida, USA. All studies are retrospective in relation to the current device's testing, as they refer to data from predicate devices.

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

This information is not provided. For non-clinical tests, "ground truth" is typically established by laboratory procedures and measurements against defined standards (e.g., ISO, ASTM). For the "Simulated Use - Bench" test, it states it was conducted "by a physician," implying at least one expert, but qualifications and number are not detailed.

4. Adjudication Method for the Test Set

Not applicable/not provided. This type of detail (e.g., 2+1, 3+1 consensus) is typical for clinical studies, especially those involving expert interpretation of medical images, which is not the focus of this non-clinical submission.

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 (catheter), not an AI/Software as a Medical Device (SaMD) product. Therefore, MRMC studies and AI-assisted performance metrics are not relevant or performed for this submission.

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

Not applicable. The device is a physical catheter, not an algorithm.

7. The Type of Ground Truth Used

For the majority of the non-clinical tests not re-performed, the "ground truth" (or accepted performance) is based on:

• Established performance of the predicate device (Zenith 074): This implies that the predicate device previously met these standards.
• International Standards (ISO 10993, ISO 10555-1, ISO 594-1, ISO 594-2, ISO 11135) and ASTM standards (ASTM F1929-12, ASTM F88-09, ASTM F1980): These standards define methodologies and acceptable ranges for material properties, biocompatibility, and device functionality.
• USP 788: For particulates.

For the re-tested "Simulated Use - Bench" test, the ground truth was "predetermined user needs," likely established through design validation or clinical input.

8. The Sample Size for the Training Set

Not applicable. The Zenith Support Catheter is a physical medical device. The concept of "training set" is relevant for AI/machine learning models, which this device is not.

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

Not applicable as there is no "training set" for this physical device.

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The Galt Medical Corp Elite HV Radial is indicated to facilitate placing a catheter through the skin into a vein or artery including but not limited to the radial artery.

The Galt Medical Corp Elite HV product has been on the market since February of 2005, and was cleared under 510(k) K043525. The clearance included sizes from 4-9FR, and lengths from 5-110 cm with the following indication for use: The Sheath Introducer system is indicated for use in percutaneous procedures to introduce catheters and other intravascular devices into the vasculature. The purpose of this 510(k) is to expand that indication for use for the Elite HV products to include radial placement. There were no design changes required as the current Galt offering included sizes which are appropriate for radial placement. The only limitation of the Radial placement claim is that the range of sizes is more limited due to the target anatomy. The Elite HV and Elite HV Radial consists of an introducer (valved sheath with sidearm and stopcock and dilator), which are packaged together with a guide wire. The Elite HV product is configured with a silicone valve or a TPE valve cleared under 510(k) K152528. Some product configurations also include an entry needle, guide wire inserter and a flushing syringe. The Elite HV Radial is used to facilitate placing a catheter through the skin into a vein or artery including but not limited to the radial artery. The sheath is coated with hydrophilic coating to minimize frictional resistance when inserting or removing the sheath from the patient's blood vessel. In addition, the sheath and dilator contain barium sulfate, making these devices visible under fluoroscopy.

Here's an analysis of the provided text regarding the acceptance criteria and study information for the Galt Medical Corp. Elite HV Radial device:

1. Table of Acceptance Criteria and Reported Device Performance

The provided text does not explicitly state specific quantitative acceptance criteria for each test. Instead, it describes what types of tests were performed to establish substantial equivalence. It implies that the results of these tests demonstrated substantial equivalence to the predicate device, which is the primary "acceptance criterion" for a 510(k) submission.

Therefore, the table will reflect the types of tests performed and the conclusion reached regarding substantial equivalence.

• Particulate Test
• Mechanical Properties Test
• Lubricity Test
• Durability of coating
• Dimensional comparison test
  Accelerated aging to an equivalent age of 4 years was also performed, and the functional testing was repeated, with the implication that results remained acceptable. The submission concludes: "The technological differences between the subject device and predicate device have been evaluated through bench and biocompatibility tests to provide evidence of substantial equivalence." |
  | Biocompatibility: Device materials are safe for human contact. | Biocompatibility Testing Results: Performed in accordance with ISO 10993-1, including:
• Cytotoxicity (MEM Elution)
• Sensitization (Magnusson - Kligman)
• Irritation (Intracutaneous injection)
• Systemic Toxicity (Systemic injection)
• Hemolysis (Direct Contact)
• Hemocompatibility (Complement Activation)
• In-Vitro Hemocompatibility (Dog Thrombogenicity)
• Systemic Toxicity (Materials Mediated Pyrogen)
• EO Residuals (EO, ECH, & EG)
  This was done "to update the biocompatibility testing to current standards" and the conclusion of substantial equivalence implies these tests were met. |
  | Sterilization Efficacy: Device is effectively sterilized. | Sterilization Efficacy: The subject device was "adopted into the existing ethylene oxide sterilization cycle for the Galt product cleared under K043525 & K152528." This implies the cycle is validated and effective for the new device. |
  | Shelf-Life Stability: Device maintains integrity over shelf life. | Shelf-Life Stability: "Current packaging shelf life testing was provided in the predicate submission." This indicates reliance on previous validation, implying stability for the Elite HV Radial in its unchanged packaging. |
  | Safety and Effectiveness: No new questions regarding safety and effectiveness are raised by the differences to predicate devices. | Conclusion: "It will be shown in this 510(k) submission that the differences between the Galt Elite HV Radial and the predicate devices do not raise any new questions regarding safety and effectiveness. The Galt Elite HV Radial as designed and manufactured is determined to be substantially equivalent to the current marketed predicate device." |

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

The document describes bench testing and biocompatibility testing. It does not specify a "test set" in terms of patient data.

• Sample Size for Functional/Biocompatibility Tests: The document does not provide specific sample sizes (e.g., number of devices tested for particulate, mechanical properties, etc.). It only mentions that testing was conducted "according to protocols based on international standards and Galt Medical requirements."
• Data Provenance: The data provenance is from bench laboratory testing and in vitro biocompatibility studies, not human patient data. There is no mention of country of origin for the data as it's not clinical data. It is inherently retrospective in the sense that the testing was performed, and then the results were compiled for the 510(k) submission.

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

• This question is not applicable to this submission. The "ground truth" for this type of device (a medical introducer) in a 510(k) context is established through compliance with recognized standards (e.g., ISO for biocompatibility, internal engineering specifications for functional tests). There isn't a "ground truth" established by human experts in the same way an AI diagnostic device would have radiologists establishing ground truth for images. The "experts" involved would be the engineers, toxicologists, and quality assurance personnel who designed the tests, conducted them, and interpreted the results against established standards.

4. Adjudication Method for the Test Set

• This question is not applicable. Adjudication methods like "2+1" or "3+1" are typically used in clinical studies where multiple human readers interpret data (e.g., medical images) and their disagreements need to be resolved. For bench testing and biocompatibility, the results are typically quantitative or qualitative (pass/fail) based on pre-defined criteria in the test protocols and standards.

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 AI-powered diagnostic devices where the AI assists human readers. The Elite HV Radial is a physical medical device (catheter introducer) and does not involve AI or human interpretation in its function.

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

• No, a standalone performance study was not done. This term also applies to AI algorithms. The Elite HV Radial is a physical device, not an algorithm.

7. The Type of Ground Truth Used

The "ground truth" for this device's performance in the context of the 510(k) submission is derived from:

• Compliance with International Standards: e.g., ISO 10993-1 for biocompatibility.
• Internal Engineering Specifications/Requirements: Derived from design control processes and the intended function of the device, often benchmarked against predicate device performance.
• Predicate Device Performance: The underlying assumption of the 510(k) pathway is that the predicate device is safe and effective when used as labeled. By demonstrating "substantial equivalence," the new device inherits this established "ground truth" of safety and effectiveness.

8. The Sample Size for the Training Set

• This question is not applicable as there is no "training set" in the context of a physical medical device. This term is used for machine learning models.

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 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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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 SunmedTM Haemostatic Valves is intended to maintain hemostasis during the introduction/withdrawal and use of diagnostic and interventional devices up to an external diameter of 7 Fr, 8 Fr or 9 Fr; The insertion tool facilitates introduction of guide wire through the haemostatic valves 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.

Hemostatic valves is composed of single Y connector, insertion tool and torquer. There are four models of the Hemostatic valves: Push-pull Y Connector, Screw Y Connector, Y click Connector and Double Screw Y Connector. Each single Y connector has two different structures: one is that the end of sideon is female luer; Another is that the end of sideon is the tubing and a stopcock. The Sunmed TM Hemostatic Valvesis designed to three external diameter of 7F, 8F, 9F for through different specifications of guide wire or catheter according to clinical need.

I am unable to provide a description of acceptance criteria and a study proving device meets acceptance criteria, as the document does not contain information on device performance or clinical study results for the Sunmed™ Haemostatic Valves.

The document is a 510(k) premarket notification for a medical device (Sunmed™ Haemostatic Valves) and primarily focuses on demonstrating substantial equivalence to predicate devices through non-clinical bench testing and biocompatibility. It explicitly states in section 8 that "Clinical Evaluation was not applicable." Therefore, there is no information about acceptance criteria for device performance or a study proving the device meets said criteria.

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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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