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This device is used to dilate strictures in the pancreatobiliary systems and to dilate openings via the transgastric or transduodenal wall. This device is indicated for adult use only.

The Tornus ES is a rotary-operated dilator designed for use in bile duct/pancreatic duct strictures and via transgastric/transduodenal dilation of openings. The Tornus ES is comprised of stainless-steel coils and polymeric materials. The Dilation and Shaft segments are composed of coils materials that are welded together. The Tornus ES is available for prescription use only.

The provided text describes the performance data for the Tornus ES device, specifically focusing on non-clinical testing and biocompatibility assessments. It does not detail a study involving human subjects or AI assistance, which would typically involve acceptance criteria related to accuracy, sensitivity, specificity, or reader performance metrics. Therefore, several points of your request cannot be fulfilled as they are not applicable to the information provided.

Based on the provided text, primarily pages 8 and 9, here's the information regarding the device's acceptance criteria and the study that proves it meets those criteria:

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

The document provides acceptance criteria specifically for biocompatibility testing, and a general "Pass" for non-clinical performance tests.

Table 1: Non-Clinical Testing Performance

Table 2: Biocompatibility Testing Acceptance 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)

The document refers to "Non clinical laboratory testing" and "in vitro bench tests". This indicates that the testing was performed on units of the device itself and not on patient data. No specific sample sizes for these tests are provided, nor is the country of origin of the data or whether it was retrospective or prospective, as these terms are generally applicable to clinical trials or studies involving patient data, which is not the case here.

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. The testing was non-clinical and benchtop, not requiring human expert interpretation or ground truth establishment in the context of imaging or clinical diagnosis.

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

Not applicable, as this refers to adjudication of ground truth in clinical data, not bench testing.

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

Not applicable. This document describes a medical device (a catheter) and its non-clinical performance and biocompatibility. It does not involve AI or human image readers.

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

Not applicable. This device is a physical medical instrument, not an algorithm or AI.

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

For the non-clinical tests, the "ground truth" would be the engineering specifications and performance standards established for the device. For biocompatibility, the ground truth is established by the methods and criteria defined in the ISO 10993 series of standards.

8. The sample size for the training set

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

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

Not applicable.

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The ClotTriever Thrombectomy System is indicated for:

• · The non-surgical removal of thrombi and emboli from blood vessels.
• · Injection, infusion, and/or aspiration of contrast media and other fluids into or from a blood vessel.

The ClotTriever Thrombectomy System is intended for use in the peripheral vasculature including deep vein thrombosis (DVT).

The ClotTriever Thrombectomy System is a single-use, sterile medical device designed for use in the peripheral vasculature. The ClotTriever Thrombectomy System consists of the ClotTriever Sheath and the ClotTriever Catheter. The ClotTriever Sheath comprises a reinforced polymeric sheath equipped with a self-expanding distal mesh funnel, a flush/aspiration port, and a proximal hemostatic valve. The ClotTriever Catheter is comprised of reinforced polymeric coaxial shafts terminating in an expandable coring element and thrombus collection bag. Three ports terminating in stopcocks are provided for de-airing the catheter shafts. To aid in fluoroscopic visualization, the Sheath dilator and ClotTriever Catheter distal tips are radiopaque. Other provided accessories include a pre-dilator, the funnel loading tool and a Large Bore 60 cc syringe

The provided document is a 510(k) premarket notification for the ClotTriever Thrombectomy System. This type of submission is for demonstrating substantial equivalence to a legally marketed predicate device, primarily through non-clinical performance data. It does not typically involve extensive clinical studies with human subjects in the same way a PMA (Premarket Approval) submission would, especially for an AI/ML-driven device.

Therefore, many of the requested elements for describing acceptance criteria and a study proving a device meets acceptance criteria in an AI/ML context (e.g., sample size for test/training sets, experts for ground truth, MRMC studies, standalone performance) are not applicable to this specific document. This document focuses on the mechanical and functional performance of a medical device (a thrombectomy system with a pre-dilator) through non-clinical testing.

Here's the information based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

The document states: "Test results demonstrated that all acceptance criteria were met; therefore, the device conforms to established product specifications." However, it does not explicitly list the quantitative acceptance criteria for each test. It only lists the types of non-clinical testing performed.

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

The document does not specify the exact sample sizes (number of units tested) for each type of non-clinical test. The data provenance is internal testing performed by Inari Medical, Inc. The nature of the testing (bench, in-vitro, and potentially in vivo animal/cadaver for functional testing) indicates it's likely prospective data collection for the purpose of this submission. The origin of the data is the manufacturer's testing facility.

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

Not applicable. This is a medical device submission based on non-clinical engineering and performance testing, not an AI/ML algorithm requiring expert review for ground truth establishment.

4. Adjudication method for the test set

Not applicable. This is not an AI/ML study requiring expert adjudication of outputs. The tests are typically conducted according to standardized protocols with defined acceptance criteria.

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 thrombectomy system, not an AI-assisted diagnostic or therapeutic device.

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

Not applicable. This device does not involve an algorithm. The testing described is for the mechanical and functional performance of the device itself.

7. The type of ground truth used

For the non-clinical tests, the "ground truth" is defined by the product specifications and performance standards for the device, and established engineering principles for evaluating medical device safety and effectiveness. For example:

• Visual and Dimensional Inspection: Comparison against engineering drawings and design specifications.
• Leak Testing: Absence of fluid egress under specified pressure.
• Tensile Testing: Measurement against predefined force resistance requirements.
• In Vivo Functional Testing: Successful and safe operation in a relevant biological model (e.g., animal or cadaver model, though the document does not specify which was used or the exact endpoints, only that the test was conducted).

8. The sample size for the training set

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

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

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

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Intended to be used for dilating puncture sites or catheter tracts for percutaneous placement of devices for vascular applications in the arterial system.

Endovascular Dilator and Sets are manufactured from vinyl radiopaque dilator tubing and consist of either one or two dilators that are used percutaneously to dilate puncture sites or catheter tracts, thereby facilitating the placement of other therapeutic or diagnostic devices into an artery for vascular clinical applications that require percutaneous access. The serial dilator components are designed with long, gradual tapers and include hydrophilic coating, and are available in various inner and outer diameter and length combinations.

The provided text is a 510(k) Premarket Notification from the FDA for a medical device called "Endovascular Dilator and Sets." This type of document is a regulatory submission for medical devices, not a study report or clinical trial. Therefore, it does not contain the detailed information about acceptance criteria, study methodologies, or performance results that would be found in a clinical study publication.

Specifically, the document states:
"There are no device, material, or design changes to any of the devices included in the Endovascular Dilator and Sets. Since there is no design change to the device subject of this submission, the testing that was provided for the predicate device in submission K183036 remains to support this submission. No additional testing or design control activities or risk assessment are required to support substantial equivalence."

This indicates that the FDA clearance for this device (K210734) is based on its substantial equivalence to a previously cleared predicate device (K183036), meaning no new performance studies were conducted for this specific submission to demonstrate the device meets acceptance criteria. The original testing for the predicate device (K183036) would contain such information.

Therefore, I cannot provide the requested information from this document because it is not a study report. The document asserts that no new testing was performed specific to this submission (K210734) as the device itself hasn't changed.

To address your request, one would need access to the 510(k) submission for the predicate device, K183036, as that is where the original performance data and testing details would be described.

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The Cook Unimpregnated Central Venous Catheter (Non-Power Injectable) is used for:

1. Continuous or intermittent drug infusions
2. Central venous blood pressure monitoring (CVP)
3. Acute hyperalimentation
4. Blood sampling
5. Delivery of whole blood or blood products
6. Simultaneous, separate infusion of drugs for multi-lumen catheters only
   The device is a short-term use catheter, intended for less than 30 days.
   The Cook dilator is used for dilating puncture sites or catheter tracts.
   The Cook Unimpregnated Central Venous Catheter (Non-Power Injectable) is intended for adult and pediatric populations.

The Cook Unimpregnated Central Venous Catheter with power injection is used for:

1. Continuous or intermittent drug infusions
2. Central venous blood pressure monitoring (CVP)
3. Acute hyperalimentation
4. Blood sampling
5. Delivery of whole blood or blood products
6. Simultaneous, separate infusion of drugs for multi-lumen catheters only
7. Power injection of contrast media*
   *The flow rate may not exceed 3 mL/sec for 4.0 and 5.0 French catheters and 10 mL/sec for 7.0, 8.0, 9.0, and 10.0 French catheters. Verify prior to use that the maximum safety cut-off pressure limit is set at or below 250 psi for 4.0 and 5.0 French catheters and 325 psi for 7.0, 8.0, 9.0, and 10.0 French catheters.
   The device is a short-term use catheter, intended for less than 30 days.
   The 9.0 and 10.0 French catheters include an inner catheter to facilitate insertion of the main catheter.
   The Cook dilator is used for dilating puncture sites or catheter tracts.
   The Cook Unimpregnated Central Venous Catheter with power injection is intended for adult and pediatric populations.

The Cook Unimpregnated Central Venous Catheter is a single use sterile intravascular catheter designed to be inserted into a patient's vascular system. The CVC is inserted into the vasculature using the Seldinger technique. The tip of the catheter is then advanced until it is above the superior vena cava-right atrium (SVC-RA) junction. The CVC configurations include a single, dual, triple, or five-lumen shaft manufactured from polyethylene, ethylene-vinyl acetate, or polyurethane tubing. The CVC is manufactured with an outside diameter between 2.5 and 10 French and has a length between 5 and 40 centimeters dependent on the configuration. Single lumen CVCs are designed with a premolded winged hub on the proximal end. Dual, triple, and five-lumen CVCs are designed with a manifold assembly, which is comprised of a winged manifold connected to extension tubes. Each extension tube has a slide clamp and is manufactured with a proximal winged hub. Certain CVC configurations are power injectable. The CVC may be packaged as a convenience kit with various other components which may include a dilator, inner catheter, wire guide, access needle, injection caps, clamps, catheter securement device, connecting tube, and other convenience accessories. The subject device inner catheter, supplied with the 9 and 10 French subject device catheters, is used to assist advancement of the main catheter over the wire guide. The inner catheter, manufactured from nylon, is designed to lock with the hub of the polyurethane catheter. The subject device dilator, used to dilate the access site during the procedure, is designed with a radiopaque extruded polyethylene shaft and a pre-molded polyethylene proximal hub. It is manufactured with an outside diameter ranging from 3.5 to 12.0 French and has a length between 6 and 11 centimeters.

The provided text describes the acceptance criteria and the results of various performance tests for the Cook Unimpregnated Central Venous Catheter. It is a submission for a 510(k) premarket notification to demonstrate substantial equivalence to a predicate device, not an AI or algorithm-driven device. Therefore, many of the requested categories (such as sample size for test set, data provenance, ground truth establishment, expert adjudication, MRMC studies, or standalone algorithm performance) are not applicable to this document.

Here's the information that can be extracted from the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

• ≥ 5 N for 2.5 and 3 Fr catheters
• ≥ 10 N for 4 and 5 Fr catheters
• ≥ 15 N for catheters > 5 Fr
  (In accordance with BS EN ISO 10555-1:2013) | The acceptance criteria were met. |
  | Catheter Sideport Tensile (Aged) | Peak tensile load for the sideport section of the catheter shall be:
• ≥ 10 N for 4 and 5 Fr catheters
• ≥ 15 N for catheters > 5 Fr
  (In accordance with BS EN ISO 10555-1:2013) | The acceptance criteria were met. |
  | Catheter Shaft-to-Hub Tensile (Aged) | Peak tensile load for the shaft-to-hub section of the catheter shall be:
• ≥ 5 N for 2.5 and 3 Fr catheters
• ≥ 10 N for 4 and 5 Fr catheters
• ≥ 15 N for catheters > 5 Fr
  (In accordance with BS EN ISO 10555-1:2013) | The acceptance criteria were met. |
  | Catheter Shaft-to-Manifold Tensile (Aged) | Peak tensile load for the shaft-to-manifold section of the catheter shall be:
• ≥ 10 N for 4 and 5 Fr catheters
• ≥ 15 N for catheters > 5 Fr
  (In accordance with BS EN ISO 10555-1:2013) | The acceptance criteria were met. |
  | Catheter Manifold-to-Extension Tube Tensile (Aged) | Peak tensile load for the manifold-to-extension tube section of the catheter shall be:
• ≥ 10 N for 4 and 5 Fr catheters
• ≥ 15 N for catheters > 5 Fr
  (In accordance with BS EN ISO 10555-1:2013) | The acceptance criteria were met. |
  | Catheter Extension Tube-to-Hub Tensile (Aged) | Peak tensile load for the extension tube-to-hub section of the catheter shall be:
• ≥ 10 N for 4 and 5 Fr catheters
• ≥ 15 N for catheters > 5 Fr
  (In accordance with BS EN ISO 10555-1:2013) | The acceptance criteria were met. |
  | Catheter Liquid Leakage (Aged) | No part of the catheter shall leak liquid when tested in accordance with Annex C of BS EN ISO 10555-1. | The acceptance criterion was met. |
  | Catheter Air Leakage (Aged) | No air shall enter the hub when tested in accordance with Annex D of BS EN ISO 10555-1. | The acceptance criterion was met. |
  | Catheter Kink Radius (Aged) | The catheter shall not kink (flowrate reduced by 50%) at a specified kink (circumferential) length when tested in accordance with Annex B of BS EN 13868. | The acceptance criterion was met. |
  | Catheter Gravity Flow Rate (Time-Zero) | The flow rate of the test articles will be characterized when tested in accordance with Annex E of BS EN ISO 10555-1. | The acceptance criterion was met. |
  | Catheter Static Burst (Aged) | The catheter failure pressure during static burst was characterized for the test articles when tested in accordance with Annex F of BS EN ISO 10555-1. | The acceptance criterion was met. |
  | Catheter Hub Pressure (Power Injection) (Aged) | The peak hub pressure of the power injectable lumen for each specimen type for the test articles when tested in accordance with Annex G of BS EN ISO 10555-1. | The acceptance criterion was met. |
  | Inner Catheter Shaft Tensile (Time-Zero) | Peak tensile load for the shaft section of the inner catheter shall be:
• ≥ 5 N for 3 Fr catheters
• ≥ 10 N for 4 Fr catheters
  (In accordance with BS EN ISO 10555-1:2013) | The acceptance criteria were met. |
  | Inner Catheter Hub-to-Shaft Tensile (Time-Zero) | Peak tensile load for the hub-to-shaft section of the inner catheter shall be:
• ≥ 5 N for 3 Fr catheters
• ≥ 10 N for 4 Fr catheters
  (In accordance with BS EN ISO 10555-1:2013) | The acceptance criteria were met. |
  | Dilator Hub-to-Shaft Tensile (Aged) | Peak tensile load for the hub-to-shaft section of the dilator shall be:
• ≥ 5 N for 3.0 Fr dilators
• ≥ 10 N for 3.5, 4.0, 5.0, and 5.5 Fr dilators
• ≥ 15 N for dilators > 5.5 Fr
  (In accordance with BS EN ISO 11070) | The acceptance criterion was met. |
  | Dilator and Wire Guide Compatibility Analysis | Each unique dilator French size shall be compatible with the correlating wire guide. | The acceptance criteria were met (implied by "The acceptance criterion was met"). |
  | Catheter Hub Luer Compatibility Analysis | Tested in accordance with the test methods specified in ISO 594-1:1986 and ISO 594-2:1998. | The acceptance criterion was met (implied by "The acceptance criterion was met"). |
  | Packaging: Dye penetration testing | Per ASTM F1929-15. | Performed (stated "Performed to assure design and performance"). |
  | Packaging: Seal strength testing | Per ASTM F88/F88M-15. | Performed (stated "Performed to assure design and performance"). |
  | Sterilization validation testing | Per ISO 11135-1:2014. | Performed (stated "Performed to assure design and performance"). |
  | Biocompatibility Testing | Testing for cytotoxicity, sensitization, intracutaneous irritation, acute systemic toxicity, material-mediated pyrogenicity, subacute/subchronic toxicity, genotoxicity, implantation, and hemocompatibility were performed per ISO 10993-1 and FDA guidance. | Performed (stated "Performed to ensure the biocompatibility of the subject device set"). |

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

The document does not specify the exact sample sizes used for each performance test. It mentions "each specimen type" for some tests, implying multiple samples were tested for each variation. Data provenance is not explicitly stated in terms of country of origin or whether it was retrospective/prospective, but these are laboratory-based performance tests, not clinical studies involving patient data.

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

Not applicable. This document describes laboratory performance testing of a physical medical device, not a diagnostic or AI-driven system that requires expert ground truth.

4. Adjudication method for the test set

Not applicable. This is not a study requiring adjudication of interpretations.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done

No, this is about the mechanical and material performance of a central venous catheter, not a diagnostic or AI system.

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

Not applicable, as this is not an algorithm or AI device.

7. The type of ground truth used

For the performance tests, the "ground truth" is defined by the objective physical and chemical standards and test methods specified by the referenced international standards (e.g., BS EN ISO 10555-1, BS EN 13868, ISO 594-1, ISO 594-2, ASTM F1929-15, ASTM F88/F88M-15, ISO 11135-1, ISO 10993-1). These standards outline the methods to objectively measure and verify the device's characteristics.

8. The sample size for the training set

Not applicable, as this is not an AI or algorithm-driven device that requires a training set.

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

Not applicable.

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