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Used to temporarily occlude the ureteropelvic junction to prevents from entering the ureter during percutaneous lithotripsy, and for injection of contrast medium.

The UPJ Occlusion Balloon Catheter is composed of a balloon catheter, a removable inflation/injection adapter, a 1 mL syringe, and a wire guide assembly. The UPJ Occlusion Balloon Catheter is manufactured from a double lumen polyurethane radiopaque tubing with a working length of 75 centimeters. The smaller lumen is designed for balloon inflation, while the larger lumen fits over the wire guide assembly. The distal balloon is manufactured from silicone and has an approximate inflation volume of 4 mL. The inflation/injector adapter is removable, allowing for a cystoscope to be removed after the catheter is in place. The wire guide assembly is manufactured in 0.028- or 0.038-inch diameter stainless steel coils. The stainless-steel coils are coated with polytetrafluoroethylene and measure 80 centimeters. The wire guide assembly is designed to be placed through the small lumen of the balloon catheter. The UPJ Occlusion Balloon Catheter is supplied sterile, intended for one-time use only, and packaged in a peel-open pouch with a shelf-life of 3 years.

This document describes the Cook Incorporated UPJ Occlusion Balloon Catheter (K183323). This is a physical medical device, not an AI/ML powered device. As such, the information you requested about acceptance criteria and studies is not applicable in the context of an AI/ML device.

Here's a breakdown based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance:

The document does not provide a table with specific acceptance criteria and reported device performance in the manner typically seen for AI/ML models (e.g., sensitivity, specificity, AUC). Instead, it lists performance data in the form of engineering and material testing.

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

This information is not explicitly provided. The "testing" mentioned is for a physical device, and typically involves a certain number of manufactured units or material samples. The document does not specify quantities or data provenance (e.g., country of origin, retrospective/prospective) because these concepts are not applicable to the engineering tests described.

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

This information is not applicable. For physical devices, "ground truth" is established through engineering and material standards, not expert consensus on medical images or clinical data.

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

This information is not applicable as the testing involves physical device properties, not diagnostic interpretations.

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

This information is not applicable as the device is a physical catheter, not an AI/ML diagnostic or assistive tool.

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

This information is not applicable as the device is a physical catheter, not an AI/ML algorithm.

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

The "ground truth" for this physical device is based on established engineering and material standards, and compliance with the device's design specifications and intended use. This is demonstrated through various physical and material performance tests.

8. The sample size for the training set:

This information is not applicable as the device is a physical catheter and does not involve an AI/ML training set.

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

This information is not applicable as the device is a physical catheter and does not involve an AI/ML training set.

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The Scepter Mini Occlusion Balloon Catheter is intended:

For use in the peripheral and neuro vasculature where temporary occlusion is desired. The balloon catheter provides temporary vascular occlusion which is useful in selectively stopping or controlling blood flow. The balloon catheter also offers balloon assisted embolization of intracranial aneurysms.

For use in the peripheral vasculature for the delivery of diagnostic agents, such as contrast media, that have been approved or cleared for use in the peripheral vasculature and are compatible with the inner lumen of the Scepter Mini Occlusion Balloon Catheter.

For neurovascular use for the delivery of diagnostic agents, such as contrast media, and liquid embolic agents that have been approved or cleared for use in the neurovasculature and are compatible with the inner lumen of the Scepter Mini Occlusion Balloon Catheter.

Scepter Mini Occlusion Balloon Catheter is a dual co-axial lumen balloon catheter. The catheter is designed to track over a steerable guidewire. The outer lumen is used for the inflation of the balloon independent of guidewire position. The inner lumen can be used to deliver diagnostic agents or liquid embolics to distal locations in tortuous anatomy. Radiopaque marker bands are located at each end of the balloon to facilitate fluoroscopic visualization. The outer surface of the catheter is coated with a hydrophilic polymer to increase lubricity. A luer fitting on the microcatheter hub is used for the attachment of accessories. The catheter is packaged sterile for single use only.

The Scepter Mini has similar indications for use as the predicates, however, incorporates several minor design differences. The Scepter Mini has a slightly longer length and a slightly smaller diameter. The balloon of the Scepter Mini is slightly shorter. The distal tip of the Scepter Mini extends a shorter distance from the distal end of the balloon than that of the Scepter C and XC. For the Scepter Mini, the purge hole is covered by a semi-permeable membrane designed to allow air to escape while preventing liquids from passing. The predicate Scepter C and XC incorporate 3 radiopaque marker bands, while the design of the Scepter Mini allows for visualization under fluoroscopy with only 2 radiopaque marker bands (due to shorter distal tip segment). All Scepter catheters have a hydrophilic coating.

This document is a 510(k) Pre-market Notification for the Scepter Mini Occlusion Balloon Catheter, seeking to demonstrate its substantial equivalence to previously cleared predicate devices. The study detailed is a set of verification and validation tests, and a summary of an animal study, used to support this claim.

Here's a breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance:

The document provides a comprehensive table of "Verification Test Summary" where each test description implicitly defines the acceptance criteria by stating the desired outcome (e.g., "does not break," "does not leak," "pass") and then reports that the subject device "Pass"ed. For many tests, it explicitly states that the device "meets the same specification as predicates Scepter C/XC (K121785)."

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

• Verification Tests: The document doesn't explicitly state the sample sizes for each individual mechanical or physical verification test. However, it indicates these tests were performed on the "subject device" (Scepter Mini Occlusion Balloon Catheter). The provenance of this data is MicroVention, Inc.'s internal testing/laboratories. This data is likely prospective, generated specifically for this submission.
• Animal Study (In Vivo Testing): The animal study used for the "In Vivo Testing" was performed using the predicate device Scepter C in an "acute swine animal model." The exact number of swine used is not explicitly stated in this summary, but it implies multiple animals ("compared with a commercially equivalent device"). The data provenance is from this predicate device study. This would be prospective data for the predicate, but retrospective in its application to the subject device.

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

• The document does not mention expert involvement in establishing ground truth for the mechanical, physical, or biocompatibility tests. These are objective, quantitative tests with defined pass/fail criteria.
• For the animal study, the "histopathologic evaluation" implies assessment by a qualified pathologist. However, the exact number of experts or their specific qualifications (e.g., "veterinary pathologist with X years of experience") are not specified in this summary.

4. Adjudication Method for the Test Set:

• For the technical verification tests, the results are objective (numerical values meeting specifications, or physical observations like "no leak," "no break"). An adjudication method is not applicable in the sense of expert consensus on ambiguous findings, as the tests produce clear pass/fail outcomes against predefined criteria.
• For the animal study's histopathologic evaluation, it's not specified if multiple pathologists reviewed slides or if an adjudication method was used for discrepancies.

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 study was performed. This submission is for a physical medical device (balloon catheter), not an artificial intelligence (AI) or software as a medical device (SaMD) that typically relies on human reader performance. Therefore, there is no AI component, and no effect size regarding human reader improvement with AI assistance is relevant or reported.

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

• Does not apply. This is a physical medical device; there is no AI algorithm to evaluate.

7. The Type of Ground Truth Used:

• Verification Tests (Mechanical, Physical, Chemical): The ground truth for these tests is based on engineering specifications, industry standards (e.g., ISO), and regulatory requirements (e.g., USP). These are objective, measurable outcomes.
• Biocompatibility Tests: Ground truth is established based on pre-defined biological responses (e.g., lack of cytotoxicity, non-irritating, non-pyrogenic) as per ISO 10993-1:2009 and FDA guidelines.
• Animal Study (In Vivo Testing): The ground truth for the efficacy and safety during the in-vivo performance characteristics and histopathology evaluation is based on direct observation in the animal model and subsequent pathological examination of tissues for injury or adverse events. This could be considered pathology and in-vivo observational data.

8. The Sample Size for the Training Set:

• Does not apply. This is a physical medical device, not a machine learning model; therefore, there is no "training set."

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

• Does not apply. There is no training set for this type of device submission.

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The Occlusion Balloon Catheter is indicated for temporary occlusion of large vessels, including the superior vena cava, in applications including perioperative occlusion and emergency control of hemorrhage.

The Occlusion Balloon Catheter is a multi-lumen catheter which has a compliant polyurethane balloon with a maximum diameter of 32mm at 60cc inflation volume. The balloon has a nominal length of 80mm. The device is constructed with a blended PEBA shaft and is available in two models; one model is compatible with 8Fr (or larger) introducer sheaths and one model is compatible with 10Fr (or larger) introducer sheaths. Both models provide the same balloon performance with respect to sizing and occlusion. The two models are intended for individual physician preference for patient-specific sheath selection. The device has an effective length of 90cm and is compatible with 0.035" diameter guidewires. Three (3) platinum-iridium radiopaque marker bands are placed on the shaft to facilitate balloon placement in the anatomy prior to inflation. The proximal end of the catheter has an integral PEBA bifurcation manifold with female luer ports to allow communication with the balloon inflation lumen and guidewire lumen. A PVC extension tube (with stopcock) is connected to the balloon inflation port to facilitate handling. The device is a single use, sterile device.

The provided text describes a 510(k) premarket notification for an Occlusion Balloon Catheter. The document focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study proving a device meets specific acceptance criteria and reporting its performance.

Therefore, many of the requested items (e.g., acceptance criteria table, sample size for test set, number of experts for ground truth, MRMC study, training set details) are not applicable and cannot be extracted from this document because the submission method relies on demonstrating equivalence through non-clinical testing and comparison to predicate devices, not through a clinical trial with specific performance metrics against acceptance criteria.

Here's what can be extracted based on the provided text:

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

• Not Applicable. The document does not provide specific quantitative acceptance criteria or reported performance metrics against such criteria in the context of a clinical study. It lists a series of non-clinical tests performed to ensure the device meets established performance criteria and will perform as intended for substantial equivalence.

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

• Not Applicable. No clinical test set or data provenance is detailed, as clinical evaluation was not required. The tests performed were non-clinical (mechanical, performance, biocompatibility).

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. No ground truth for a test set was established using experts, as no clinical study requiring such ground truth was conducted.

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

• Not Applicable. No adjudication method for a test set is mentioned, as no clinical study requiring this was conducted.

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. No MRMC study was done, nor does the device involve AI.

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

• Not Applicable. This device is a physical medical catheter, not an algorithm.

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

• Not Applicable. No ground truth of this nature was used, as clinical studies involving such data were not performed. The "ground truth" for this submission was based on successful completion of non-clinical performance and mechanical tests to demonstrate substantial equivalence to the predicate device.

8. The sample size for the training set

• Not Applicable. No training set is mentioned, as this is a medical device submission based on substantial equivalence and non-clinical testing, not a machine learning model.

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

• Not Applicable. No training set or ground truth for it was established.

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The GORE® Molding and Occlusion Balloon Catheter is intended for temporary occlusion of large vessels or to assist in the expansion of selfexpanding endovascular prostheses (stent grafts).

The GORE® Molding and Occlusion Balloon Catheter is a sterile (EtO), single use, single-lobed polyurethane balloon catheter. The compliant polyurethane balloon is mounted on the leading end of a 3 lumen catheter shaft (two inflation lumens and one quidewire lumen). Termination of the leading end of the catheter is an atraumatic catheter leading tip for smooth transition from the quidewire to catheter transition. Radiopaque markers (approximately 40 mm apart) indicate the proximal and distal end of the balloon which aid in proper balloon placement under fluoroscopy. Both of the (2) inflation lumens are in communication with each end of the balloon to facilitate balloon catheter preparation, inflation and deflation. At the trailing end of the balloon catheter is a dual port (balloon inflation and quidewire) yarm. The inflation port of the y-arm is in communication with both of the balloon inflation lumens and is affixed with a luer lock and three way stopcock via an extension tube. The quidewire lumen of the v-arm allows introduction of a 0.035" (0.89 mm) diameter guidewire for over-the-wire access. The trailing end of the quidewire lumen is affixed with a flushing / guidewire port with luer lock used for flushing the guidewire lumen. The balloon catheter proximal y-arm is provided within a housing which contains markings of the balloon length and inflation range diameter. The balloon can be inflated to diameters of 10 mm to a maximum inflation diameter of 37 mm. The balloon catheter profile is 10 Fr introducer sheath compatible.

Here's an analysis of the provided text regarding the acceptance criteria and study for the GORE Molding and Occlusion Balloon Catheter:

1. Table of Acceptance Criteria and Reported Device Performance:

The document describes a series of "Design Verification Testing" activities as the performance data. While specific pass/fail criteria (e.g., a numerical range for "Inflation Time") are not explicitly listed in this summary, the document states that these tests "demonstrated the subject device performed as intended and was substantially equivalent to the predicate device." This implies that the device met internal specifications and expectations derived from the predicate device's performance.

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

The document does not specify the exact sample sizes for each of the "Design Verification Testing" activities. It only references "bench study" data.

• Sample Size: Not specified.
• Data Provenance: The studies were "bench studies," which are laboratory-based tests. The country of origin is not explicitly stated, but the company (W.L. Gore & Associates) is based in the U.S. (Flagstaff, Arizona), suggesting the studies were likely conducted in the U.S. These are retrospective tests performed to verify design specifications.

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

Not applicable. This device is a physical medical device, and the "ground truth" for its performance is established through objective engineering and materials testing, not through expert human interpretation of data like in an AI/imaging device.

4. Adjudication Method for the Test Set:

Not applicable, as the tests are objective bench tests.

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 imaging diagnostic tool that would involve human readers.

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

Not applicable. This is a physical medical device.

7. The Type of Ground Truth Used:

The ground truth used for this device's performance evaluation is based on objective engineering specifications, material properties, and functional requirements for a balloon catheter intended for occlusion and stent graft expansion. These are derived from established medical device standards and comparison to a predicate device. For example, "Burst Volume" would have a defined expected value, and the tested device's performance would be compared against that.

8. The Sample Size for the Training Set:

Not applicable. There is no concept of a "training set" for physical medical device bench testing in the same way there would be for an AI algorithm. The design and manufacturing processes are refined based on general engineering principles and iterative development, not a specific training dataset.

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

Not applicable, as there is no training set in the context of this device. The "ground truth" for the device's design and manufacturing is derived from industry standards, regulatory requirements, scientific principles, and iterative design and testing.

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The Embolx Occlusion Balloon Catheter is intended for use in the peripheral vasculature where temporary occlusion is desired and offers a vessel selective technique of temporary vascular occlusion for selectively stopping or controlling blood flow. The Embolx Occlusion Catheter is also intended to assist in the delivery of diagnostic agents such as contrast media and therapeutic agents into the peripheral vasculature.

The Embolx Occlusion Balloon Catheter is a coaxial dual lumen device that consists of an occlusion balloon at the distal end with two embedded radiopaque bands to allow for visualization and positioning of the device under fluoroscopic guidance. The proximal hub consists of two ports: one port for use by the guidewire and delivery of fluids and the second port for inflation and deflation of the balloon. The low profile balloon is manufactured of a compliant material that allows ease of insertion and withdrawal from the vasculature and conforms to the vessel wall. The balloon is inflated and deflated with a hand held syringe. The device is supplied sterile by EtO and is intended for single use. The occlusion catheter has an outside diameter of 2.9F proximally and 2.2F distally. The occlusion balloon on the distal end can be inflated up to 5mm in diameter and 11mm in length. The usable length of the device is 110cm. The device can withstand an infusion pressure up to 900 psi.

This document is a 510(k) premarket notification for a medical device called the Embolx Occlusion Balloon Catheter. It is a submission to the FDA seeking to demonstrate substantial equivalence to a legally marketed predicate device. Therefore, the information provided focuses on comparative testing rather than detailed novel performance criteria and studies as would be expected for a de novo submission or a device with new indications.

Based on the provided text, here's a breakdown of the requested information:

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

The document does not explicitly state acceptance criteria in a quantitative, pass/fail manner for many of the tests listed. Instead, it states that "all testing was conducted on sterilized and aged test articles" and that "Substantial equivalence was demonstrated through the following non-clinical testing." This implies that the device met whatever internal or recognized standard criteria existed for each test to demonstrate equivalence.

Here's a table based on the "Summary of Supporting Data" with reported performance being that the device "demonstrates substantial equivalence" or "is as safe, as effective, and performs as well as or better than the predicate device."

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

The document mentions "non-clinical testing" which typically refers to bench testing, in-vitro (e.g., cytotoxicity, hemolysis), and animal studies (in-vivo thrombogenicity in canine).

• Sample sizes: Specific sample sizes for each test are not provided in this summary.
• Data provenance: Not specified. Given it's a 510(k) for a US market, the testing likely adheres to US or international standards (e.g., ISO for biocompatibility). The in-vivo thrombogenicity study was done using canine models, which is an animal model. All tests appear to be prospective in nature, as they were conducted to support the 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 is a medical device submission, not an AI software submission. Therefore, the concept of "ground truth" as established by human experts (e.g., radiologists) for a test set of images or data relevant to an AI algorithm does not apply here. The "truth" for these tests is based on objective laboratory measurements, physical testing parameters, and established biocompatibility standards.

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

This question is also not applicable as it pertains to expert consensus for data labeling (ground truth) relevant to AI/diagnostic software. The testing outlined for this medical device involves physical, mechanical, and biological evaluations, not expert adjudication of clinical cases.

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

This question is not applicable. This is a submission for a physical medical device (an occlusion balloon catheter), not an AI-powered diagnostic tool, and therefore no MRMC study or assessment of human reader improvement with AI assistance would have been performed or relevant.

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

This question is not applicable. No algorithm performance is being evaluated for this physical medical device.

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

As explained in point 3, the concept of "ground truth" for expert consensus on images or outcomes data for an AI algorithm is not applicable. The "truth" in this context is defined by:

• Physical measurements: For dimensional verification, tensile strength, burst pressures, flow rates.
• Chemical/Biological assays: For cytotoxicity, sensitization, irritation, acute systemic toxicity, complement activation, LAL (pyrogenicity), PTT/PT.
• In-vivo observations/histopathology: For in-vivo thrombogenicity in canine models.
• Industry/Regulatory Standards: Adherence to recognized standards for sterility, packaging, and biocompatibility.

8. The sample size for the training set

This question is not applicable. This is a physical medical device, not an AI algorithm that requires a training set.

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

This question is not applicable. No training set or associated ground truth for an AI algorithm is involved in this medical device submission.

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Equalizer™ Occlusion Balloon Catheter is indicated for use for temporary vessel occlusion in applications including arteriography, preoperative occlusion, emergency control of hemorrhage, chemotherapeutic drug infusion and renal opacification procedures.

Any use for procedures other than those indicated in the instructions is not recommended.

The Equalizer™ Occlusion Balloon Catheter is constructed of a soft compliant latex balloon mounted near the tip of a dual-lumen nylon catheter shaft. Radiopaque markers are placed adjacent to the balloon to provide visual reference points for balloon positioning within the vessel. The catheter shaft is radiopaque, maximizing fluoroscopic visibility. Proximal to the bifurcation, the two lumens of the catheter are marked to differentiate their use. The tubing marked 'BALLOON' is the balloon inflation lumen. The tubing marked 'DISTAL' is the central lumen of the catheter, which terminates at the distal tip. This lumen is used to pass the catheter over a guidewire. The lumen can also be used for the infusion of contrast media or therapeutic drugs. Each lumen ends in a luer fitting hub for attachment to ancillary devices.

The provided K140273 510(k) Summary describes a medical device, the Equalizer™ Occlusion Balloon Catheter, and its performance evaluation. However, it does not involve an AI/ML device, and therefore several of the requested categories are not applicable. The study primarily relies on bench testing and biocompatibility testing rather than clinical performance data related to diagnostic accuracy or AI model performance.

1. Table of Acceptance Criteria and Reported Device Performance

Notes on Acceptance Criteria: The document primarily states that testing was performed to "support a determination of substantial equivalence" and provide "reasonable assurance that the proposed device has been designed and tested to assure conformance to the requirements for its intended use." Specific quantitative acceptance criteria are not detailed in this summary for each test, but they would typically reference established industry standards (e.g., ISO for biocompatibility) or internal specifications benchmarked against the predicate device (Equalizer™ Occlusion Balloon Catheter K021721).

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

The study described is bench testing and biocompatibility testing, not a clinical study involving human data. Therefore:

• Sample Size for Test Set: Not specified in terms of human subjects or clinical cases. For bench tests, it would refer to the number of devices or components tested. For biocompatibility, it refers to the samples tested in vitro or in animal models (though details are not provided).
• Data Provenance: Not applicable as it's not clinical data. The tests were performed in a laboratory setting, likely at the manufacturer's facilities or a contract research organization.

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. This device is a physical medical device (catheter), and its performance evaluation involves engineering and biocompatibility testing, not interpretation of medical images or diagnostic outputs for which ground truth would be established by medical experts.

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

Not applicable. Adjudication methods are used in clinical studies or studies involving human readers/interpreters to resolve discrepancies in ground truth, which is not relevant for bench and biocompatibility testing of a physical device.

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

Not applicable. This is not an AI/ML device and no MRMC study was performed.

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

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

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

The concept of "ground truth" as typically applied to diagnostic AI/ML devices is not directly applicable here. Instead, the "ground truth" for this device's performance can be considered:

• Biocompatibility Standards: Established international standards (e.g., ISO 10993 series) define acceptable biological responses.
• Engineering Specifications: Predetermined design specifications and performance requirements (e.g., burst pressure, inflation time, tensile strength) established by the manufacturer and benchmarked against the predicate device.
• Predicate Device Performance: The performance characteristics of the legally marketed predicate device (Equalizer™ Occlusion Balloon Catheter K021721) served as the reference for establishing substantial equivalence.

8. The sample size for the training set

Not applicable. There is no AI/ML component; therefore, no training set is relevant.

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

Not applicable. There is no AI/ML component; therefore, no ground truth for a training set was established.

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The Occluder™ Occlusion Balloon Catheters are indicated for use for temporary Ureteral occlusion and applications including, renal opacification, dislodgment of calculi and preventative calculi migration.

Occluder Occlusion Balloon Catheters are designed for use for temporary occlusion of the ureter and applications including renal opacification, dislodgement of calculi and preventative calculi migration. The devices are provided sterile and are intended for single use. The Occluder Occlusion Balloon Catheters are constructed of a soft compliant latex balloon mounted on the tip of a catheter shaft. Catheter shafts are radiopaque, maximizing fluoroscopic visibility. The Occluder Occlusion Balloon Catheters have two lumens that are marked and color-coded. The balloon tubing, marked BALLOON is a balloon inflation lumen. The tubing marked DISTAL, is the essential lumen of the catheter, which terminates at the distal tip. This lumen is used to pass the catheter over a guidewire. This lumen can also be used for infusion of contrast medium.

This document describes the Boston Scientific Occluder™ Occlusion Balloon Catheter, which is cleared through the 510(k) pathway as substantially equivalent to a predicate device. As such, the study focuses on demonstrating this substantial equivalence rather than establishing new acceptance criteria or conducting a multi-reader multi-case comparative effectiveness study in the way one might for an AI/ML diagnostic device.

Here's an analysis of the provided text in the context of your request:

1. Table of Acceptance Criteria and Reported Device Performance

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

The document does not specify a "test set" in the context of clinical data or patient samples. The performance testing mentioned is a bench evaluation.

• Sample Size: The document mentions "samples aged at T=0 and 7-months Accelerated Aging." The specific number of samples tested is not provided.
• Data Provenance: The data is from "Boston Scientific" and is generated through "performance testing (Bench Evaluation)." There is no mention of country of origin of data or whether it is retrospective or prospective, as it does not involve human subjects or historical patient data.

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

This information is not applicable to this submission. The "ground truth" for a substantial equivalence claim based on bench testing does not involve expert consensus on clinical findings. Instead, the "truth" is established by direct measurement against engineering specifications and comparison to the predicate device's known performance/specifications.

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

This information is not applicable. Adjudication methods are typically used in clinical studies or when interpreting complex images/data to establish ground truth for diagnostic devices, which is not the case here.

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

No, an MRMC comparative effectiveness study was not done. This type of study is relevant for AI-powered diagnostic devices involving human interpretation, not for a medical device like an occlusion balloon catheter, especially when seeking 510(k) clearance based on substantial equivalence.

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

No, a standalone algorithm-only performance study was not done. This 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 this submission is based on engineering specifications and direct measurements/observations from bench testing. The goal was to show that the new device's physical and functional characteristics (e.g., balloon inflation, shaft properties, radiopacity) meet predetermined criteria and are equivalent to the predicate device. This essentially means the "ground truth" is adherence to design specifications and performance metrics established from the predicate.

8. The sample size for the training set

This information is not applicable. There is no "training set" as this is not an AI/ML device.

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

This information is not applicable as there is no training set.

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Occlusion Balloon Catheters are indicated for temporary vessel occlusion in applications including arteriography, preoperative occlusion, emergency control of hemorrhage, chemotherapeutic drug infusion and renal opacification procedures.

The Occlusion Balloon Catheter product line consists of two specific designs - Standard Occlusions Balloon Catheters and Berenstein™ Occlusion Balloon Catheter.

Only the Berenstein Occlusion Balloon Catheter has been designed for coaxial delivery of small catheters or embolic agents.

The Occlusion Balloon Catheters are a compliant latex balloon mounted on the distal tip of a dual lumen, radiopaque catheter shaft to which two luer fittings are attached proximally. In addition to the balloon inflation lumen, the central lumen is used to pass the catheter over the guidewire as well as infusion of contrast medium, and in the case of the Berenstein™ Occlusion Balloon Catheter, coaxial delivery of small catheters or embolic agents.

I am sorry, but I cannot fulfill your request to describe the acceptance criteria and study for the provided text. The document describes a medical device, specifically an Occlusion Balloon Catheter, and its 510(k) submission to the FDA. However, the provided text does not contain explicit numerical acceptance criteria or detailed study results that would allow me to construct the specified table and answer all your questions.

The "Performance Data" section and the "Biocompatibility" and "Bench" testing sections generally state that testing was performed and that the results provide "reasonable assurance that the proposed device has been designed and tested to assure conformance to the requirements for its intended use." It also concludes that the device is "substantially equivalent" to a predicate device.

Key Missing Information:

• Specific, quantifiable acceptance criteria: For example, what was the minimum tensile strength required for the proximal bond, or what was the maximum allowable balloon deflation time?
• Reported device performance values: The document states what tests were done (e.g., "Proximal Bond Tensile"), but not the results (e.g., "Proximal Bond Tensile = X N").
• Sample sizes for test sets (for specific tests): While the tests are listed, the number of units tested for each specific bench test is not provided.
• Data provenance, expert qualifications, adjudication methods, MRMC studies, standalone algorithm performance, or ground truth details: These types of information are typically associated with performance studies for AI/ML devices or diagnostic accuracy studies, which are not described in this document for an occlusion balloon catheter. This device appears to be a physical medical instrument, not an AI/ML diagnostic tool.

Therefore, I cannot generate the table or answer questions 2, 3, 4, 5, 6, 7, 8, or 9 as the necessary information is not present in the provided text.

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The Stryker Neurovascular TransForm™ Occlusion Balloon Catheters (Compliant and Super Compliant) are indicated for use in the neuro and peripheral vasculature to temporarily stop or control blood flow and for balloon assisted embolization of intracranial aneurysms.

Stryker Neurovascular's TransForm Occlusion Balloon Catheters (Compliant and Super Compliant) are compliant, variable stiffness reinforced balloon catheters. The outer surface of the catheter's distal segment is coated with a lubricious hydrophilic coating designed to reduce friction. Each balloon catheter has two radiopaque markers to facilitate fluoroscopic visualization. The proximal end of the balloon catheter incorporates a strain relief and a standard luer fitting to facilitate the attachment of accessories.

Here's an analysis of the provided 510(k) summary for the TransForm™ Occlusion Balloon Catheter, detailing acceptance criteria and proof of their fulfillment.

1. Table of Acceptance Criteria and Reported Device Performance:

The provided 510(k) summary focuses on demonstrating substantial equivalence to a predicate device through non-clinical performance data (bench testing, shelf life, packaging, and biocompatibility). The "acceptance criteria" for this type of submission are typically that the new device meets the performance requirements for its intended use and is proven safe and effective for that use, typically demonstrated by showing it performs comparably or better than the predicate for relevant attributes.

Since specific numerical acceptance criteria (e.g., "Deflation time must be

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For use in the blood vessels of the peripheral and neurovasculature where temporary occlusion is desired. These catheters offer a vessel selective technique of temporary vascular occlusion which is useful in selectively stopping or controlling blood flow and for balloon assisted embolization of intracranial aneurysms.

For use in the peripheral vasculature for the infusion of diagnostic agents, such as contrast media, and therapeutic agents, such as embolization materials.

For neurovascular use for the infusion of diagnostic agents, such as contrast media, and therapeutic agents, such as embolization materials, that have been approved or cleared for use in the neurovasculature and are compatible with the inner diameter of the Scepter C/XC Balloon Catheter.

The Scepter C and XC Occlusion Balloon Catheter is a dual coaxial lumen catheter with a nondetachable low inflation pressure compliant balloon attached to the distal end of the catheter. The catheter is designed to track over a steerable guidewire. The inner lumen can be used for infusion/delivery of diagnostic and therapeutic agents. The outer lumen is used for the inflation and deflation of the balloon independent of guidewire position. Radiopaque marker bands are located at ends of the balloon and distal tip of the catheter to facilitate fluoroscopic visualization. The outer surface of the catheter is coated with a hydrophilic polymer to increase lubricity. A luer fitting on the microcatheter hub is used for the attachment of accessories. The catheters are packaged sterile for single use only.

The Scepter C and XC Occlusion Balloon Catheter is intended for temporary occlusion in peripheral and neurovasculature, controlling blood flow for balloon-assisted embolization of intracranial aneurysms, and infusing diagnostic and therapeutic agents in peripheral and neurovascular applications.

Here's an analysis of the provided text regarding acceptance criteria and the study that proves the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance:

The document describes pre-clinical testing performed on the Scepter C and XC Occlusion Balloon Catheter. The acceptance criterion for each test is implicitly "Pass," indicating that the device must meet the specified performance standards for each category.

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

The document does not explicitly state the sample sizes used for each pre-clinical test. The testing is referred to as "Pre-clinical Testing," which typically involves laboratory-based assessments rather than human or animal studies with large sample sizes.

• Sample Size for Test Set: Not explicitly stated.
• Data Provenance: The document does not specify the country of origin for the data or whether the studies were retrospective or prospective. Given it's pre-clinical testing for a 510(k) submission, it's virtually certain to be prospective, laboratory-based testing conducted by the manufacturer, MicroVention, Inc., based in Tustin, California, U.S.A.

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

Not applicable. For pre-clinical engineering and biocompatibility tests, ground truth is established by standardized test methods and criteria, not by expert consensus on clinical images or patient outcomes. The "ground truth" is defined by the physical or chemical properties being measured against established regulatory standards (e.g., ISO standards for biocompatibility).

4. Adjudication Method for the Test Set:

Not applicable. Adjudication methods like 2+1 or 3+1 are used in clinical trials or image interpretation studies where there's variability in expert assessment. For pre-clinical engineering tests, results are typically objective measurements against defined pass/fail criteria.

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

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study is relevant for evaluating diagnostic devices, especially those involving human interpretation of medical images (e.g., radiologists reading scans with and without AI assistance). The Scepter C and XC Occlusion Balloon Catheter is an interventional device, not a diagnostic one.

6. Standalone (Algorithm Only) Performance Study:

No, a standalone (algorithm only) performance study was not done. This type of study is specifically for evaluating the performance of AI algorithms without human intervention. The Scepter C and XC Occlusion Balloon Catheter is a physical medical device, not an AI algorithm.

7. Type of Ground Truth Used:

The ground truth used for these pre-clinical tests is based on engineering specifications, standardized test methods, and regulatory requirements (e.g., ISO 10993 for biocompatibility). For example, "Tensile strength Pass" implies the device met a pre-defined tensile strength threshold established by engineering design and industry standards; "Cytotoxicity (ISO 10993-5) Pass" means the device met the criteria outlined in that specific ISO standard for cytotoxicity.

8. Sample Size for the Training Set:

Not applicable. The Scepter C and XC Occlusion Balloon Catheter is a physical medical device, not an AI/ML algorithm 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 this device.

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