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The Octane Mechanical Thrombectomy System is intended for the removal/aspiration of embolic material (thrombus/ debris) from vessels of the arterial and deep venous system, and to infuse/deliver diagnostic or therapeutic agents.

The Octane Mechanical Thrombectomy System consists of two components: the Octane mechanical thrombectomy catheter and the Octane hand pump. The Octane mechanical thrombectomy catheter has a working length of 115cm, is compatible with introducer sheaths ≥ 8F and it is intended for use in vessels ≥ 3 mm in diameter. The catheter has a rapid exchange design and includes sliding, co-axial inner and outer lumens. The rapid exchange guidewire lumen is compatible with guidewires ≤ 0.018" in diameter and the 6F inner catheter lumen is compatible with guidewires ≤ 0.038" in diameter. The catheter inner lumen tip has three side wall slot ports and the catheter's outer lumen has a beveled radiopaque tip. To alleviate plugging of the catheter tip caused by thrombus, the actuator on the proximal end of the catheter slides the catheter's outer lumen back and forth over the inner lumen distal tip. The actuator on the proximal end of the catheter is also used to control the directionality of the torque-able catheter. Directionality is further achieved through the gradual curve in the shaft materials at the distal end. The Octane hand pump provides suction to the inner lumen of the Octane mechanical thrombectomy catheter and is manually operated using a spring-loaded handle. It consists of a pump handle fitted with a 30ml piston syringe, tubing, a series of one-way valves, and a 500ml collection bag. The hand pump tubing has a standard luer fitting for connection to the Octane mechanical thrombectomy catheter hub. The Octane Mechanical Thrombectomy System has been sterilized with ethylene oxide.

The provided text describes the Octane Mechanical Thrombectomy System (K182232) and compares it to a predicate device, the Octane Aspiration System (K173266). The submission claims substantial equivalence based on the device's design, intended use, materials, and operating mechanisms.

However, the document does not include a table of acceptance criteria or details of a study that proves the device meets specific acceptance criteria in the manner usually associated with clinical performance or algorithm-based devices. Instead, it focuses on bench testing to demonstrate substantial equivalence to a predicate device following a labeling change.

Therefore, for aspects related to specific acceptance criteria, statistical performance, and ground truth establishment, the information is not present in the provided text.

Here's a breakdown of the available information based on your request:

1. Table of Acceptance Criteria and Reported Device Performance

Not explicitly provided in the document.

The document states: "The results of the verification test met the specified acceptance criteria and did not raise different questions of safety and effectiveness." However, the specific acceptance criteria themselves (e.g., specific metrics like effectiveness rates, aspiration volume, etc.) and the reported device performance against those criteria are not detailed in the text. The evaluation method described is "bench tests" to evaluate technological differences and "concomitant device compatibility tests" to support labeling modifications.

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

Not applicable/Not provided.

This document describes bench testing, not a clinical trial with a "test set" in the context of patient data. The "sample size" would refer to the number of devices or test conditions, which is not specified. The concept of "data provenance" (country of origin, retrospective/prospective) is not relevant for bench testing.

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

Not applicable/Not provided.

As this was bench testing for substantial equivalence, the concept of establishing ground truth by medical experts for a "test set" (e.g., imaging studies) is not relevant. The "ground truth" would be engineering specifications and measurements, overseen by engineers and quality assurance personnel.

4. Adjudication Method for the Test Set

Not applicable/Not provided.

Adjudication methods (e.g., 2+1, 3+1) are typically used in clinical studies or studies involving expert consensus on medical data. This information is not relevant for the bench testing described.

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

No.

The document does not mention an MRMC study. The study described is bench testing for substantial equivalence to a predicate device, not a comparative effectiveness 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 device is a mechanical thrombectomy system, not an AI algorithm. Therefore, the concept of "standalone performance" for an algorithm is not relevant.

7. The Type of Ground Truth Used

Engineering Specifications and Bench Test Measurements.

For bench testing of a medical device, the "ground truth" refers to established engineering specifications, mechanical properties, and performance benchmarks measured in a controlled environment. The document states "The results of the verification test met the specified acceptance criteria," indicating that the device's performance was measured against predetermined engineering and design standards.

8. The Sample Size for the Training Set

Not applicable/Not provided.

This refers to bench testing for device performance and substantial equivalence, not the training of an AI algorithm. Therefore, a "training set" in this context is not applicable.

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

Not applicable/Not provided.

As there is no mention of a "training set" for an algorithm, this question is not relevant. The "ground truth" for the device's performance relies on engineering design specifications and test methods.

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The Bandit guidewire is intended for use in percutaneous procedures to introduce and position catheters and other interventional devices within the coronary and peripheral vasculature.

The Bandit guidewire is a 0.014" diameter stainless steel core guidewire with a 0.008" diameter tapered distal tip. It is available in 200 cm and 300 cm lengths. The 200 cm length is compatible with a guidewire extension. The distal portion of the guidewire includes a radiopaque coil and is covered with a polymer jacket and hydrophilic coating. The proximal portion has a PTFE coating.

The provided text is a 510(k) summary for the Bandit guidewire, which is a medical device. This document describes the device, its intended use, and how it was determined to be substantially equivalent to a predicate device.

Crucially, this document describes a medical device (a guidewire), not a software or AI-powered medical device. Therefore, many of the requested categories in your prompt (such as sample size for test/training sets, number of experts, adjudication methods, MRMC studies, or standalone algorithm performance) are not applicable to this type of device and study. The "acceptance criteria" here refer to standard engineering and biocompatibility tests for a physical device, not performance metrics of a diagnostic or AI algorithm.

Here's a breakdown of the information that is available, and why other parts are not:

1. Table of Acceptance Criteria and Reported Device Performance

The study that proves the device meets the acceptance criteria:

The study refers to a series of bench performance tests and biocompatibility tests. This is a pre-clinical study (laboratory-based testing), not a clinical trial involving human subjects for performance evaluation in the context of AI.

The document states: "The technological differences between the subject and predicate device have been evaluated through bench tests to provide evidence that the Bandit guidewire is substantially equivalent to the predicate device. The device design was verified through the following tests: [list of bench tests]. The results of the verification tests met the specified acceptance criteria and did not raise different questions of safety and effectiveness."

For biocompatibility, it states: "The biocompatibility evaluation for the Bandit guidewire was conducted in accordance with the International Standard ISO 10993-1... The battery of tests included the following: [list of biocompatibility tests]. Passing results from biomaterial tests demonstrate that the Bandit guidewire is non-cytotoxic, non-sensitizing, non-irritating, non-systemically toxic, non-pyrogenic, non-hemolytic, not an activator of the complement system, and thromboresistant."

Information Not Applicable or Not Provided for this Device Type:

• 2. Sample sized used for the test set and the data provenance: Not applicable. These were laboratory bench and biocompatibility tests on physical device samples, not studies on "test sets" of data.
• 3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for a physical guidewire is established through engineering and biological testing standards and measurements, not expert consensus on medical images or patient data.
• 4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
• 5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable. This is a physical medical device, not an AI or diagnostic tool.
• 6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable.
• 7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): The "ground truth" for this device, in the spirit of your question, is established by engineering specifications and international standards (e.g., ISO 10993-1) for physical performance and biological safety.
• 8. The sample size for the training set: Not applicable.
• 9. How the ground truth for the training set was established: Not applicable.

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VSI Micro-Introducer Kits are intended for use in percutaneous introduction of up to a 0.018 inch guidewire or catheter into the vascular system following a small gauge needle stick.

The VSI micro-introducer kits consist of a sheath and are available in lengths of 10 cm to 30 cm. The sheath is available with either a 2.3 F, 4 F or 5 F outer diameter (O.D.) and with a straight or angled tip. The dilator is available with regular flexibility or in a 'stiffen' version. The sheath and dilator consist of a high-density polyethylene shaft and hub; the sheath shaft has a tapered distal tip that provides a smooth transition to the distal tip of the dilator. A rotating luer lock on the distal end of the dilator hub can be locked on to the sheath hub. The stiffen dilator shaft contains a stainless steel hypotube.

The VSI Micro-Introducer Kit's acceptance criteria and the study proving it meets these criteria are detailed below, based on the provided text.

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size for Test Set: Not explicitly stated. The document mentions "The results of the design verification tests," implying a test set was used, but does not quantify its size.
• Data Provenance: The study was conducted by Vascular Solutions, Inc. for the VSI Micro-Introducer Kit. It is a prospective study in the sense that new tests were performed on the subject device. However, some tests were "leveraged" from the predicate device, K101604, meaning past data from that device was used to support the subject device, which could be considered retrospective in nature for those specific tests. The origin of the data is the U.S. (Minneapolis, MN, USA).

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

This information is not provided in the document. The study primarily involves bench testing and leveraging data from a predicate device, not clinical performance requiring expert ground truth establishment in a conventional sense (e.g., image interpretation).

4. Adjudication Method for the Test Set

This information is not applicable as the study described is primarily bench testing and direct comparison to a predicate device, not a human reader or diagnostic assessment where adjudication would typically be needed.

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

No, an MRMC comparative effectiveness study was not done. This submission focuses on engineering and biocompatibility comparisons to a predicate device and does not involve human readers assessing device performance in a clinical setting.

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

This question is not applicable as the device is a VSI Micro-Introducer Kit, a physical medical device, not an algorithm or AI system.

7. The Type of Ground Truth Used

For the bench tests, the "ground truth" was established based on the engineering specifications and performance standards for medical devices of this type, verified through laboratory testing. For the leveraged tests, the "ground truth" was the previously established performance and biocompatibility data of the predicate device (K101604).

8. The Sample Size for the Training Set

This question is not applicable as the device is a physical medical device and not an AI/ML algorithm that requires a training set.

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

This question is not applicable as the device is a physical medical device and not an AI/ML algorithm.

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The TrapLiner catheter is intended for use in conjunction with guide catheters to access discrete regions of the coronary and/or peripheral vasculature, to facilitate placement of interventional devices, and to facilitate the exchange of an interventional device while maintaining the position of a guidewire within the vasculature.

The TrapLiner catheter is a rapid-exchange guide extension catheter with a trapping balloon on the distal end of the pushrod. The stainless steel pushrod is covered on the distal end by a semi-circular polymer ('half-pipe') and transitions to a hydrophilic coated full-round polymer guide extension section. There are two radiopaque marker bands on the guide extension segment, one on the distal tip and one on the collar. The trapping balloon is located proximal to the half-pipe and has a single radiopaque gold marker under the proximal end of the balloon.

I am sorry, but the provided text does not contain information about acceptance criteria or a study that proves the device meets those criteria in the context of an AI/ML medical device.

The document is an FDA 510(k) clearance letter for a medical device called the "TrapLiner catheter." This device is a physical catheter used in interventional procedures, not an AI/ML algorithm.

The core of the document discusses:

• The FDA's determination of substantial equivalence to a predicate device.
• The intended use of the catheter.
• A comparison of technological characteristics with a predicate device, noting a "geometry improvement at the distal end of the pushrod."
• Bench tests conducted to evaluate this design change (e.g., Track Force, Guide Catheter Backup Support, Balloon Fatigue, etc.).

There is no mention of:

• Acceptance criteria for an AI/ML algorithm's performance (e.g., sensitivity, specificity, AUC).
• A sample size for a test set or training set for an AI/ML model.
• Data provenance, expert ground truth establishment, or adjudication methods for an AI/ML model.
• Multi-reader multi-case (MRMC) comparative effectiveness studies related to AI assistance.
• Standalone performance of an AI algorithm.

Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves an AI/ML device meets them based on the provided text.

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The Warrior 14 guidewire is intended for use in percutaneous procedures to introduce and position cathers and other interventional devices within the coronary and peripheral vasculature.

The Warrior 14 guidewire is a 0.014" diameter stainless steel core guidewire with a 0.009" diameter tapered distal tip. The distal 20cm of the guidewire has a spring coil, of which the distal 2.5cm is visible under fluoroscopic methods. The guidewire has a straight shapeable tip with a tip load of 14 grams. The distal portion of the guidewire has a hydrophilic coating and the proximal portion has a PTFE coating. It is available in 190cm and 300cm lengths. The proximal end of the 190cm version has a guidewire extension feature. The Warrior 14 guidewire is intended for single use and sterilized with ethylene oxide.

The provided document is a 510(k) summary for the Warrior 14 guidewire, a medical device. It does not describe an AI/ML device or a study comparing AI performance against acceptance criteria. Instead, it details the substantial equivalence determination process for a traditional medical device (a guidewire) based on biocompatibility and bench testing.

Therefore, the requested information about acceptance criteria for an AI device, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, training set details, and ground truth establishment for AI is not applicable to this document. The document focuses on the physical and material properties of the guidewire and its comparison to a predicate device.

However, I can extract the acceptance criteria and performance data for the guidewire as presented in the document, which are primarily related to safety and performance through bench and biocompatibility testing.

Here's a summary of the relevant information provided in the document:

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

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

This information is not provided in the document. The document refers to "biomaterial tests" and "verification tests" but does not specify the sample sizes (e.g., number of guidewires tested for each bench test) or data provenance. These are typically internal lab tests conducted by the manufacturer.

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

This information is not applicable as the document describes a physical medical device (guidewire) and its bench/biocompatibility testing, not an AI device requiring expert ground truth for image or data interpretation.

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

This information is not applicable for the same reasons as point 3.

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

This information is not applicable as the document describes a physical medical device (guidewire), not an AI-assisted diagnostic tool.

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

This information is not applicable as the document describes a physical medical device (guidewire), not an AI algorithm.

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

For the biocompatibility tests, the "ground truth" is established by the specified standards (ISO 10993-1) and the observed biological responses. For the bench performance tests, the "ground truth" is the established engineering specifications and measurement results. These do not involve expert consensus in the typical sense of diagnostic interpretation.

8. The sample size for the training set

This information is not applicable as the document describes the testing of a physical medical device (guidewire), not an AI/ML model that requires a training set.

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

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

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Gel-Bead embolization spheres are intended for use in embolization of hypervascular tumors.

The Gel-Bead embolization spheres product consists of biodegradable gelatin spheres pre-filled in a 20 ml syringe. The syringe contains either 1 ml or 2 ml of spheres suspended in 5 ml or 4 ml of saline, respectively. Offered in five nominal size ranges (100-300 µm, 500-700 µm, 600-800 µm, and 700-1000 um), the spheres are intended to be used with a delivery catheter with an inner diameter that is adequate for sphere delivery (not included). The finished product is sterilized by Gamma irradiation and is intended for single use only.

This document describes the acceptance criteria and supporting study for the Gel-Bead Embolization Spheres (600-800um - 1 ml and 2 ml sphere volumes) device.

The study presented focuses on demonstrating the substantial equivalence of the new 600-800 µm sphere size and new 1ml sphere volume, to previously cleared Gel-Bead embolization spheres (K133237 and K171946). This is primarily achieved through bench testing of key device characteristics.

1. Table of Acceptance Criteria and Reported Device Performance

Detailed Information on the Study:

The provided document describes a bench test study rather than a clinical study involving human or animal subjects for evaluating performance in a biological context. The primary goal of this submission is to demonstrate substantial equivalence to previously cleared predicate devices through direct comparison of technological characteristics and performance in a controlled laboratory environment.

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

   • The document does not specify the exact sample sizes used for each of the bench tests (Deliverability, Sphere Diameter, Sphericity).
   • Data Provenance: The study appears to be an in-vitro (bench) study conducted by the manufacturer, Vascular Solutions. There is no indication of country of origin for the data in the context of clinical trials, as this is a laboratory-based evaluation.

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

   • This information is not applicable to this type of study. Bench tests rely on objective measurement and predefined specifications (acceptance criteria) rather than expert interpretation of data points to establish a "ground truth." The "ground truth" for these tests is the physical measurement itself against the defined thresholds.

4. Adjudication Method for the Test Set:

   • This information is not applicable to this type of study. Adjudication methods like "2+1" or "3+1" are used in clinical studies where multiple human readers independently assess data and discrepancies need to be resolved. Bench tests involve direct measurements against predefined criteria.

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

   • No, an MRMC comparative effectiveness study was not done. This device is a physical medical device (embolization spheres), not an AI or imaging diagnostic tool that would typically involve human readers.

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

   • Not applicable. This device is not an algorithm or AI. The performance tested is the inherent physical and functional characteristics of the embolization spheres themselves.

7. Type of Ground Truth Used:

   • The "ground truth" for this study is based on pre-defined engineering specifications and measurable physical properties of the device (e.g., specific diameter ranges, mechanical properties related to deliverability, and optical properties related to sphericity). These are verified through direct measurement and laboratory testing, rather than expert consensus, pathology, or outcomes data which are typical for clinical performance evaluation.

8. Sample Size for the Training Set:

   • This concept is not applicable to this study. "Training set" refers to data used to train machine learning models. This study is a bench test verification of a physical device against engineering specifications.

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

   • Not applicable, as there is no training set for this type of device and study.

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The Raider guidewire is intended for use in percutaneous procedures to introduce and position catheters and other interventional devices within the coronary and peripheral vasculature.

The Raider guidewire is a stainless steel core guidewire with a maximum outer diameter of 0.014″ and a straight, shapeable tip. It is available in 190 cm and 300 cm length is compatible with a guidewire extension. The distal portion of the guidewire includes a radiopaque coil and is covered with a polymer jacket and hydrophilic coating. The proximal portion has a PTFE coating.

The provided text is a 510(k) summary for the Raider Guidewire. It outlines the device's indications, technological characteristics, and testing performed to demonstrate substantial equivalence to a predicate device. However, this document does not contain the kind of detailed information about acceptance criteria or a study design (like sample size for test sets, data provenance, expert demographics, adjudication methods, MRMC studies, or standalone algorithm performance) that you would typically find for an AI/ML medical device.

The Raider Guidewire is a physical medical device (a catheter guide wire), not an AI/ML software device. Therefore, the questions posed in the prompt, which are highly specific to the evaluation of AI/ML diagnostic or predictive algorithms, are not applicable to the information provided in this 510(k) summary.

The document discusses "acceptance criteria" in a general sense through performance testing for mechanical properties and biocompatibility.

Here's the information that can be extracted or inferred from the provided text, while acknowledging that many of your questions cannot be answered because they pertain to a different type of device:

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

The document doesn't provide specific numerical acceptance criteria for each test (e.g., "Tensile strength > X Newtons"). Instead, it states that "Device samples passed the following biocompatibility tests" and "The device design has been verified through the following tests." This implies that predefined acceptance criteria were met, but the specific values are not detailed.

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

This information is not provided in the document. For mechanical and biocompatibility testing of a physical device, samples are typically manufactured batches tested in a lab setting, not "test sets" in the AI/ML sense. Data provenance (country of origin, retrospective/prospective) is not relevant for this type of testing.

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

This information is not applicable/provided. "Ground truth" in the context of this device refers to objective measurements derived from physical and chemical tests, not expert interpretation of data.

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

This information is not applicable/provided. Adjudication methods are relevant for human interpretation tasks, not for the objective testing of physical device properties.

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 information is not applicable/provided. MRMC studies and AI assistance are relevant for AI/ML diagnostic devices, not for a guidewire.

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

This information is not applicable/provided. This refers to AI algorithm performance, which is not relevant for this physical device.

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

The "ground truth" for this device's performance is based on objective measurements from standard mechanical, material, and biological tests (e.g., tensile strength testing, chemical assays for biocompatibility, dimensional measurements). It is not based on expert consensus, pathology, or outcomes data in the way an AI/ML diagnostic system would be evaluated.

8. The sample size for the training set:

This information is not applicable/provided. Training sets are for AI/ML models. This device is a physical product.

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

This information is not applicable/provided. (See #8).

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The Octane aspiration system is intended for the removal/aspiration of embolic material (thrombus/debris) from vessels of the arterial and deep venous system, and to infuse/deliver diagnostic or therapeutic agents.

The Octane aspiration system consists of two components: the Octane catheter and the Octane hand pump. The Octane aspiration catheter has a working length of 115cm, is compatible with introducer sheaths ≥ 8F, guidewires ≤ 0.018" in diameter, and it is intended for use in vessels ≥ 3 mm in diameter. The catheter has a rapid exchange design and includes sliding, co-axial inner and outer lumens. The catheter inner lumen tip has three side wall slot ports and the catheter's outer lumen has a beveled radiopaque tip. To alleviate plugging of the catheter tip caused by thrombus, the actuator on the proximal end of the catheter slides the catheter's outer lumen back and forth over the inner lumen distal tip. The actuator on the proximal end of the catheter is also used to control the directionality of the torque-able catheter. Directionality is further achieved through the gradual curve in the shaft materials at the distal end. The Octane hand pump provides suction to the inner lumen of the Octane aspiration catheter and is manually operated using a spring-loaded handle. It consists of a pump handle fitted with a 30ml piston syringe, tubing, a series of one-way valves, and a 500ml collection bag. The hand pump tubing has a standard luer fitting for connection to the Octane aspiration catheter hub. The Octane aspiration system has been sterilized with ethylene oxide.

This document is a 510(k) Summary for the Octane Aspiration System, a medical device intended for the removal of embolic material from blood vessels. The summary describes the device, its intended use, and the studies conducted to demonstrate its substantial equivalence to a predicate device (Pronto XL). However, it does not contain information about acceptance criteria and device performance in a format that directly addresses the user's request for AI/algorithm-related performance metrics or human reader studies.

The document specifies bench testing and biocompatibility testing to demonstrate substantial equivalence, focusing on the physical and material properties of the device, rather than the diagnostic or interpretative performance of an AI system.

Therefore, many of the requested categories related to AI performance, ground truth, expert opinions, and sample sizes for AI training/testing sets cannot be directly answered from the provided text.

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

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

The document broadly states: "The results of the verification tests met the specified acceptance criteria and did not raise new safety or performance issues." However, it does not provide a specific table detailing the numerical acceptance criteria for each test and the corresponding reported device performance values. It only lists the tests performed.

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

• The document does not specify sample sizes for each bench or biocompatibility test. These tests typically involve a certain number of device units.
• Data provenance (e.g., country of origin, retrospective/prospective) is not applicable or provided as these are bench and lab tests, not clinical or image-based studies.

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

• This is not applicable. The studies described are physical and material tests of a medical device, not diagnostic or AI-driven interpretations requiring expert consensus for ground truth.

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

• This is not applicable. These are objective engineering and laboratory tests, 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:

• No MRMC or comparative effectiveness study involving human readers or AI assistance was performed or reported in this document. The device is an aspiration catheter, not an AI diagnostic tool.

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

• No standalone algorithm performance study was done as the device is a physical medical instrument, not an AI algorithm.

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

• The "ground truth" for the bench tests would be established by engineering specifications, physical measurements, and standardized laboratory procedures. For biocompatibility, it's defined by the ISO 10993 standards. It's not based on expert consensus, pathology, or outcomes data in the way an AI diagnostic would be.

8. The sample size for the training set:

• Not applicable, as this device does not involve an AI algorithm that requires a training set.

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

• Not applicable, as this device does not involve an AI algorithm.

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The Langston dual lumen catheter is indicated for delivery of contrast medium in angiographic studies and for simultaneous pressure measurement from two sites. This type of pressurement is useful in determining transvalvular, intravascular, and intraventricular pressure gradients.

The Langston dual lumen catheter consists of a coaxial tube (outer lumen) mounted over a braided catheter shaft (inner lumen) and an extension line with a 3-way stopcock. The extension line with stopcock connects to the outer lumen. The outer lumen, and extension line are joined by an over molded manifold. The manifold also includes a luer that connects to the inner lumen. The manifold is printed with the Langston catheter length, French size, maximum guidewire diameter, and product logo ("Langston"). The Langston dual lumen catheter tip terminates in either a pigtail or multipurpose tip configuration.

The provided text describes a medical device, the Langston Dual Lumen Catheter, and its substantial equivalence to predicate devices, but it does not contain details about acceptance criteria or a study designed to prove the device meets specific performance criteria in the context of an AI/ML model for diagnosis or prediction.

The document is a 510(k) summary for a medical device (a catheter) seeking FDA clearance, demonstrating substantial equivalence to already cleared predicate devices. The "studies" mentioned are bench tests and biocompatibility tests to show that the new device's modifications (e.g., in manufacturing, materials) do not negatively impact its safety and performance compared to the previously cleared versions. These are not clinical studies in the sense of evaluating diagnostic accuracy or predictive performance through human reader evaluations or ground truth comparisons.

Therefore, I cannot provide the requested information about acceptance criteria for an AI/ML model's performance, sample sizes for test sets, expert qualifications, adjudication methods, MRMC studies, standalone performance, or ground truth establishment for training sets, because this information is not present in the provided text.

The closest relevant information from the document is related to the performance verification of the physical medical device, not an AI component.

Here's a breakdown of what is available in the document, framed in the context of device performance, but noting its irrelevance to AI/ML model evaluation:

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

The document broadly states: "The results of the verification tests met the specified acceptance criteria and did not raise new safety or performance issues." It does not provide a table with specific quantitative acceptance criteria or detailed reported performance figures for each test. Instead, it lists the types of tests performed.

The following points are explicitly NOT present in the provided text, as they relate to AI/ML model evaluation, which is not the subject of this 510(k) summary:

2. Sample size used for the test set and the data provenance: Not applicable, no AI/ML test set mentioned.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable, no AI/ML ground truth mentioned.
4. Adjudication method: Not applicable.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done: "Clinical testing was not performed to validate the performance of the subject device." Therefore, no MRMC study for AI assistance.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable, no algorithm.
7. The type of ground truth used: Not applicable, no AI/ML ground truth mentioned.
8. The sample size for the training set: Not applicable, no AI/ML training set mentioned.
9. How the ground truth for the training set was established: Not applicable, no AI/ML training set mentioned.

In summary, the provided document details the regulatory clearance process for a physical medical catheter through non-clinical bench and biocompatibility testing, not the evaluation of an AI-powered diagnostic or predictive device.

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Gel-Bead embolization spheres are intended for use in embolization of hypervascular tumors.

The Gel-Bead embolization spheres (Gel-Bead) consists of biodegradable gelatin spheres prefilled in a 20 ml syringe. The syringe contains 2 ml of spheres suspended in 4 ml of saline. Gel-Bead is offered in four nominal size ranges: 100-300 um, 300-500 um, 500-700 um and 700-1000 um. The spheres are intended to be used with a delivery catheter with an inner diameter that is adequate for sphere delivery (not included). The finished product is sterilized by Gamma irradiation and is intended for single use only.

Here's an analysis of the provided text regarding the acceptance criteria and study for the Gel-Bead device, based on the requested information:

This device is a medical device (embolization spheres), not an AI/ML device. Therefore, many of the requested fields pertinent to AI/ML device studies (like those related to AI effectiveness, ground truth for training sets, etc.) are not applicable in this context and will be marked as such.

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 sample sizes used for each of the bench tests (sphere suspension, pepsin digestion, supplied volume, deliverability, glutaraldehyde residuals). It also does not explicitly mention the data provenance in terms of country of origin or whether it was retrospective or prospective, as these are bench tests rather than clinical studies with patient data.

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

Not applicable. These are bench tests measuring physical and chemical properties of the device, not diagnostic interpretations requiring expert ground truth in the context of AI/ML.

4. Adjudication Method for the Test Set

Not applicable, as ground truth establishment by experts is not relevant for these bench tests. The acceptance criteria were likely objective measurements defined by the manufacturer based on regulatory guidelines and validated methods.

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

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

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

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

7. The Type of Ground Truth Used

The "ground truth" for these bench tests would be the established scientific and engineering principles, regulatory standards, and internal specifications for the physical and chemical properties of the embolization spheres. For example, for "supplied volume," the ground truth would be the expected nominal volume (2 ml) and acceptable deviation from that volume. For "glutaraldehyde residuals," the ground truth would be the acceptable safe limit for residuals.

8. The Sample Size for the Training Set

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

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

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

Summary of the Study Proving Device Meets Acceptance Criteria:

The device, "Gel-Bead" embolization spheres (2 ml fill), underwent a series of bench tests to demonstrate substantial equivalence to its predicate device (Gel-Bead, K133237). The studies focused on evaluating the device's functionality and technological characteristics.

The specific tests conducted were:

• Sphere suspension in contrast: This likely assesses how well the spheres remain suspended in a contrast agent, which is crucial for their navigability and visualization during clinical use.
• Pepsin digestion: This test evaluates the biodegradability of the gelatin spheres, confirming they break down as intended over time after embolization.
• Supplied volume: This verifies that the actual volume of spheres provided in the syringe meets the specified amount (2 ml).
• Deliverability: This assesses the ability of the spheres to be successfully delivered through compatible catheters without clumping or clogging, which is critical for clinical efficacy.
• Glutaraldehyde residuals: This measures any residual glutaraldehyde (a cross-linking agent sometimes used in gelatin products), ensuring it is below safe limits.

The document states that "The results of the verification tests met the specified acceptance criteria and did not raise new safety or performance issues." This indicates that for each of these measured characteristics, the device performed within the predefined acceptable ranges or thresholds. The exact numerical acceptance criteria are not provided in this document, but the overall conclusion is that they were successfully met.

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