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The AngioSculpt PTA Scoring Balloon Catheter is intended for dilatation of lesions in the illiac, femoral, ilio-femoral, popliteal, infra popliteal, and renal arteries, and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae. Not for use in the coronary or neuro-vasculature.

The AngioSculpt PTA Scoring Balloon Catheter with HydroCross™ Coating is a standard twolumen catheter with a scoring balloon near the distal end of the catheter has a conventional nylon-blend balloon with a scoring element that wraps around the balloon. The scoring element creates focal concentrations of dilating force which minimizes balloon slippage and assists with luminal expansion of stenotic arteries. The balloon has radiopaque markers to aid in positioning the balloon in the stenosis, and is designed to provide an expandable segment of known diameter and length at a specific pressure. As shown below, the catheter has a segment which is coated with a hydrophilic coating (HydroCross™ Coating).

This section describes the acceptance criteria and study proving the device meets said criteria for the "AngioSculpt® PTA Scoring Balloon Catheter with HydroCross™ Coating" based on the provided text.

Based on the provided document, the device described is a medical device, and the information presented is a 510(k) summary for premarket notification to the FDA, demonstrating substantial equivalence to a predicate device. This document does not describe the acceptance criteria and a study in the context of an AI/algorithm-driven device's performance metrics (e.g., sensitivity, specificity) against a ground truth established by experts.

Instead, the "acceptance criteria" discussed are related to the safety and effectiveness of a physical medical device, primarily through mechanical testing and biocompatibility testing, to demonstrate its substantial equivalence to a previously cleared predicate device.

Therefore, many of the requested categories for AI/algorithm performance studies are not applicable to this document. I will fill in the applicable information based on the provided text.

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present a table of acceptance criteria with specific numerical targets and corresponding device performance values for each criterion in the manner typical for AI/algorithm validation. Instead, it describes categories of tests performed to verify design outputs met design requirements and to confirm proper function and durability. The general outcome is that the device "demonstrated adequate device performance," and is "non-sensitizing, non-irritating, not systemically toxic, non-hemolytic, and non-mutagenic."

Note: The document states that "Design verification and validation testing demonstrated adequate device performance and confirmed that no new questions of safety or effectiveness for peripheral balloon angioplasty devices were raised."

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

• Sample Size for Test Set: The document refers to "Test articles consisted of finished sterilized catheters" for bench testing. It does not specify the exact number of devices tested for each mechanical or biocompatibility test. For biocompatibility, it indicates studies were conducted, including a GLP animal study for thrombogenicity.
• Data Provenance: The studies were conducted by Spectranetics, Inc. (the submitter). The context implies these were internal tests conducted to support the 510(k) submission. No information on country of origin of data (beyond the applicant being US-based) or retrospective/prospective nature is explicitly stated, though a GLP animal study would be prospective.

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

• This is not applicable to this type of device submission. The "ground truth" for a physical medical device's performance is established by standardized testing methods and regulatory requirements, not expert consensus on diagnostic interpretations.

4. Adjudication method for the test set:

• Not applicable for this type of device validation. Adjudication methods are typically for evaluating human or AI performance against a "truth" in diagnostic settings.

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 physical medical instrument (a balloon catheter), not an AI diagnostic tool that assists human 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 AI algorithm.

7. The type of ground truth used:

• The "ground truth" for the performance of this physical medical device is based on engineering specifications, established standards, and regulatory requirements for mechanical integrity, functional performance, and biocompatibility. For example, for biocompatibility, the ground truth is "non-toxic," "non-irritating," etc., as defined by ISO 10993-1:2009 and FDA GLP regulations. For mechanical tests, the ground truth is that the device must meet predefined design requirements and exhibit proper function and durability.

8. The sample size for the training set:

• Not applicable. This is not an AI/ML device requiring a training set.

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

• Not applicable. This is not an AI/ML device requiring a training set.

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The AngioSculpt PTA.Scoring Balloon Catheter is intended for dilatation of lesions in the iliac, femoral, lito-femoral, popliteal, infra popliteal, and renal arteries, and for the treatment of obstructive lestons of native or synthelic anteriovenous dialysis fistulae. Not for use in the coronary or neuro-vasculature.

The AngioSculpt PTA Scoring Balloon Catheter with HydroCross™ Coating is a standard twolumen catheter with a scoring balloon near the distal end of the catheter has a conventional nylon-blend balloon with a scoring element that wraps around the balloon. The scoring element creates focal concentrations of dilating force which minimizes balloon slippage and assists with luminal expansion of stenotic arteries. The balloon has radiopaque markers to aid in positioning the balloon in the stenosis, and is designed to provide an expandable segment of known diameter and length at a specific pressure. As shown below, the catheter has a segment which is coated with a hydrophilic coating (HydroCross™ Coating).

The provided text describes a medical device, the AngioSculpt® PTA Scoring Balloon Catheter with HydroCross™ Coating, and its clearance process with the FDA. However, the document does NOT contain information about acceptance criteria or a study proving the device meets specific performance criteria in the way typically expected for an AI/ML medical device submission (e.g., sensitivity, specificity, F1-score, AUC, etc., derived from clinical data).

Instead, this document is a 510(k) summary for a physical medical device (a balloon catheter) seeking substantial equivalence to already marketed devices. The "studies" described are primarily bench testing (mechanical, material properties) and biocompatibility testing, and an animal study to demonstrate safety and deliverability. These types of tests are standard for physical devices to ensure they perform as intended and are safe for use.

Therefore, many of the requested fields regarding acceptance criteria related to a device's performance in diagnosing or predicting (like sensitivity/specificity) and specific details about ground truth, expert readers, MRMC studies, or training sets for AI algorithms are not applicable to this document.

Here's a breakdown based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

As this is a physical medical device, the "acceptance criteria" are not reported as statistical performance metrics like sensitivity or specificity. Instead, they are defined by successful completion of various engineering and biological tests, demonstrating the device meets design requirements and safety standards. The "reported device performance" is the successful outcome of these tests.

2. Sample Size for Test Set and Data Provenance

• Bench Testing: "Test articles consisted of finished sterilized catheters." The exact number of catheters tested for each bench test is not specified in this summary.
• Biocompatibility Testing: The number of biological samples or animals used for each specific biocompatibility test (e.g., L-929 Mouse Fibroblast cells for cytotoxicity, Guinea pigs for sensitization) is not specified.
• Animal Study: The sample size (number of animals) for the acute GLP animal study is not explicitly stated.
• Data Provenance: The document does not specify country of origin for the data; it refers to tests conducted in accordance with FDA GLP regulations (21 CFR Part 58) and ISO standards for biocompatibility. The animal study was conducted as a GLP study. Given the company is US-based (Fremont, CA), it's highly likely the testing was performed in the USA or by labs adhering to these international/US standards. All studies sound prospective as they were specifically designed to characterize this device.

3. Number of Experts and Qualifications for Ground Truth

• Not Applicable: This type of information is generally relevant for studies establishing clinical ground truth (e.g., presence of a disease from imaging) for interpretive devices. For this physical device, "ground truth" is established by direct physical, chemical, and biological measurements, and observed adverse events (or lack thereof) in an animal model. The "experts" are likely laboratory technicians and veterinarians performing and assessing the animal study, certified in their respective fields, but not defined in terms of their role as "ground truth adjudicators" in a clinical sense.

4. Adjudication Method for Test Set

• Not Applicable: Adjudication methods like 2+1 or 3+1 are used to resolve disagreements among multiple human readers when establishing ground truth, typically in the context of diagnostic performance studies. This is not descriptive of the testing performed for a physical device. Outcomes of bench tests are based on objective measurements against specifications. The animal study outcomes would be assessed by the study's veterinary and pathology team.

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

• No: No MRMC study was performed or described. This type of study is relevant for comparing the diagnostic performance of an AI system, with and without human assistance, against human readers. The AngioSculpt catheter is a physical interventional device, not an AI diagnostic tool.

6. Standalone (Algorithm Only) Performance Study

• Not Applicable: There is no algorithm-only performance study because this is a physical medical device, not a software algorithm.

7. Type of Ground Truth Used

• Bench Testing: The ground truth for bench tests is objective physical and chemical measurements against pre-defined engineering specifications and accepted industry standards.
• Biocompatibility Testing: The ground truth is based on established biological responses (e.g., cell viability, immune response, genetic mutation) as measured by validated assays against accepted toxicity limits and ISO standards.
• Animal Study: The ground truth is direct observation by trained personnel (veterinarians, histopathologists) of in-vivo events and tissue responses in an animal model, assessing for safety endpoints like dissection, perforation, embolization, and device integrity.

8. Sample Size for Training Set

• Not Applicable: No "training set" in the context of machine learning was used or described. The device's design and performance are based on engineering principles, material science, and iterative testing, not on training an AI model with data.

9. How Ground Truth for Training Set Was Established

• Not Applicable: As there is no training set, this question is not relevant.

Ask a specific question about this device

The AngioSculpt PTA Scoring Balloon Catheter is intended for dilatation of lesions in the iliac, femoral, ilio-femoral, popliteal, infra popliteal, and renal arteries, and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae. Not for use in the coronary or neuro-vasculature.

The AngioSculpt catheter is a standard two-lumen catheter with a scoring balloon near the distal tip. The distal end of the catheter has a conventional nylon-blend balloon with a scoring element that wraps around the balloon. The scoring element creates focal concentrations of dilating force which minimizes balloon slippage and assists with luminal expansion of stenotic arteries. The balloon has radiopaque markers to aid in positioning the balloon in the stenosis, and is designed to provide an expandable segment of known diameter and length at a specific pressure.

This document is a 510(k) summary for the AngioSculpt® PTA Scoring Balloon Catheter, which is a medical device. As such, it describes various tests and comparisons to predicate devices to establish substantial equivalence for regulatory approval. However, it does not contain specific acceptance criteria, reported device performance metrics in the format of a table, nor does it describe a study explicitly designed to prove device acceptance criteria in the way a clinical trial for a new diagnostic or AI-powered device would.

The document primarily focuses on bench testing, biocompatibility testing, and animal testing to demonstrate the device's safety and effectiveness in comparison to existing, already approved devices (predicate devices).

Here's an analysis based on the information provided, recognizing that some of your requested points are not applicable to this type of device submission:

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

The document does not provide a table with explicit acceptance criteria (e.g., minimum tensile strength, maximum inflation time) alongside reported numerical performance. Instead, it states that "Mechanical testing of the AngioSculpt catheter was conducted in accordance with AngioScore's Risk Analysis and all applicable FDA guidance documents and relevant standards. The following bench tests were conducted to verify that design outputs met design requirements and to confirm proper function and durability." The results are generally described as meeting requirements or demonstrating appropriate function.

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

• Bench Testing: The specific sample sizes for each bench test (e.g., Catheter Diameter, Device Burst Strength) are not explicitly stated. The data provenance would be internal AngioScore, Inc. laboratory testing, which is prospective for the purpose of this submission.
• Biocompatibility Testing: Biocompatibility tests were not conducted as part of this device modification because materials were shown to be equivalent to currently marketed AngioScore products. The original biocompatibility testing would have been prospective internal or contract lab testing.
• Animal Testing: "An acute GLP and non GLP study was conducted to determine the safety and deliverability of the AngioSculpt catheter. The studies were conducted in the llio-femoral peripheral arteries of one experimental animal." (Note: this is a very small sample size for animal testing, likely acceptable for minor device modifications and predicate device comparison). This was a prospective study. The country of origin is not specified but presumed to be where AngioScore, Inc. conducts its R&D or contracts animal studies.

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 point is not applicable as the device is a physical medical device (balloon catheter), not a diagnostic device or AI system that relies on expert interpretation for ground truth in a test set. The "ground truth" for this device's performance is determined by engineering specifications and direct physical measurements/observations in bench and animal testing.

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

This point is not applicable for the same reasons as #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 point is not applicable as the device is a physical medical device, not an AI or diagnostic tool requiring human reader studies.

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

This point is not applicable as the device is a physical medical device, not an algorithm.

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

• For bench testing, the "ground truth" is based on engineering specifications, established industry standards, and regulatory guidance documents. Performance is measured directly against these specified values (e.g., correct diameter, sufficient burst strength, acceptable inflation time).
• For biocompatibility testing, the "ground truth" is based on the results of standardized biological assays (e.g., cytotoxicity, sensitization, irritation, systemic toxicity, hemolysis, thrombosis) against predefined acceptable limits according to ISO 10993 standards and FDA guidance.
• For animal testing, the "ground truth" is based on direct observation of device performance (deliverability, trackability, passability, inflation/deflation parameters, radiopacity, ease of removal) and lack of adverse events (dissection, perforation, embolization, thrombosis, loss of components) within the animal model, as interpreted by the study investigators.

8. The sample size for the training set

This point is not applicable as the device is a physical medical device, not an AI/machine learning system that requires a training set.

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

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

In summary, this 510(k) submission demonstrates "substantial equivalence" of the AngioSculpt® PTA Scoring Balloon Catheter to its predicate devices through rigorous bench testing, biocompatibility evaluations, and acute animal studies. While it confirms that the device "met design requirements" and "demonstrated adequate device performance," it does so within the context of regulatory comparison to existing devices rather than proving a novel acceptance threshold through specific clinical performance metrics.

Ask a specific question about this device

The AngioSculpt PTA Scoring Balloon Catheter is intended for dilatation of lesions in the iliac, femoral, ilio-femoral, popliteal, infra popliteal, and renal arteries, and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae. Not for use in the coronary or neuro-vasculature.

The AngioSculpt catheter is a standard two-lumen catheter with a scoring balloon near the distal tip. The distal end of the catheter has a conventional nylon-blend balloon with a scoring element that wraps around the balloon. The scoring element creates focal concentrations of dilating force which minimizes balloon slippage and assists with luminal expansion of stenotic arteries. The balloon has radiopaque markers to aid in positioning the balloon in the stenosis, and is designed to provide an expandable segment of known diameter and length at a specific pressure.

The provided text is a 510(k) summary for the AngioSculpt PTA Scoring Balloon Catheter, which is a medical device. This document describes the device, its intended use, and the testing performed to demonstrate its safety and effectiveness for substantial equivalence to predicate devices. It does not provide information relevant to the acceptance criteria and study design for a software algorithm/AI device. Therefore, I cannot extract the requested information.

Ask a specific question about this device

The AngioSculpt PTA Scoring Balloon Catheter is intended for dilatation of lesions in the iliac, femoral, ilio-femoral, popliteal, infra popliteal, and renal arteries, and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae. Not for use in the coronary or neuro-vasculature.

The AngioSculpt catheter is a standard two-lumen catheter with a scoring balloon near the distal tip. The distal end of the catheter has a conventional nylon-blend balloon with a nitinol scoring element that wraps around the balloon. The scoring element creates focal concentrations of dilating force which minimizes balloon slippage and assists with luminal expansion of stenotic arteries. The balloon has radiopaque markers to aid in positioning the balloon in the stenosis, and is designed to provide an expandable segment of known diameter and length at a specific pressure.

The modified AngioSculpt PTA catheter has very similar technological characteristics as the cleared AngioSculpt PTA catheter. The modified AngioSculpt PTA Catheter is exactly the same device as the cleared AngioSculpt PTA catheter, except for minor differences to the distal bond and intermediate bond of the 0.018" OTW platform, 20mm balloon length catheters.

Here's the information regarding the acceptance criteria and the study for the AngioSculpt® PTA Scoring Balloon Catheter, based on the provided document:

This document is a 510(k) summary for a modification to an already cleared device, the AngioSculpt PTA Scoring Balloon Catheter. Therefore, the "study" described focuses on demonstrating that the modified aspects of the device still meet expectations, not on a full-scale clinical trial to prove initial efficacy or safety for a new device.

1. Table of Acceptance Criteria and Reported Device Performance

The document doesn't provide specific numerical acceptance criteria (e.g., "Bond Tensile Strength >= X N") or precise numerical performance results (e.g., "Bond Tensile Strength = Y N"). Instead, it states that the modified design was evaluated against specifications and met them.

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

The document provides no explicit sample sizes for the non-clinical performance testing. It generally refers to "design verification testing" and "application of risk analysis and a change impact assessment."

The data provenance is non-clinical bench testing conducted by the manufacturer, AngioScore, Inc. Details such as country of origin for the data are not specified beyond the manufacturer's location in Fremont, CA, USA. This testing is retrospective in the sense that it's evaluating a modification to an existing design.

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

Not applicable. This was non-clinical bench testing of device attributes, not a clinical study requiring expert assessment of patient data. The "ground truth" was established by engineering specifications and testing protocols.

4. Adjudication Method for the Test Set

Not applicable. This was non-clinical bench testing. Results would typically be evaluated against pre-defined engineering specifications, not through a consensus or adjudication process involving multiple human reviewers.

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

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This document describes non-clinical engineering testing, not a clinical study involving human readers or patient cases.

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 (a balloon catheter), not an algorithm or AI system.

7. The Type of Ground Truth Used

The "ground truth" for this non-clinical testing was engineering specifications and established testing methodologies to measure physical properties like bond strength and profile.

8. The Sample Size for the Training Set

Not applicable. This involves non-clinical bench testing for a physical device, not a machine learning model that requires a training set.

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

Not applicable. As above, this is about a physical device, not an AI/ML system.

Ask a specific question about this device

The AngioSculpt PTA Scoring Balloon Catheter is intended for dilatation of lesions in the iliac, femoral, ilio-femoral, popliteal, infra popliteal, and renal arteries, and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae. Not for use in the coronary or neuro-vasculature.

The AngioSculpt catheter is a standard two-lumen catheter with a scoring balloon near the distal tip. The distal end of the catheter has a conventional nylon-blend balloon with a nitinol scoring element that wraps around the balloon. The scoring element creates focal concentrations of dilating force which minimizes balloon slippage and assists with luminal expansion of stenotic arteries. The balloon has radiopaque markers to ald in positioning the balloon in the stenosis, and is designed to provide an expandable segment of known diameter and length at a specific pressure.

The provided document is a 510(k) summary for the AngioSculpt® PTA Scoring Balloon Catheter. It focuses on demonstrating substantial equivalence to a previously cleared predicate device (K100303) rather than presenting a de novo study with specific clinical acceptance criteria for effectiveness.

Therefore, the document does not contain the acceptance criteria or a study proving the device meets those criteria for clinical effectiveness in the way typically expected for a new medical device seeking marketing authorization based on clinical performance.

Instead, the document details bench testing and animal testing to demonstrate safety and performance characteristics for substantial equivalence to a predicate device. These tests are designed to show that the new device performs as expected and does not raise new safety or effectiveness concerns compared to the predicate.

Here's a breakdown of what is in the document related to testing, formatted to address your questions where applicable, but highlighting that no clinical acceptance criteria or human clinical study results are presented:

Description of Acceptance Criteria and Study to Prove Device Meets Acceptance Criteria

Disclaimer: This 510(k) summary focuses on demonstrating substantial equivalence to a predicate device through non-clinical testing (bench and animal studies), rather than establishing clinical effectiveness against specific clinical acceptance criteria in a human study. Therefore, the requested information regarding human-in-the-loop performance, multi-reader multi-case studies, effect sizes, specific clinical ground truth, and training set details are not applicable and not found in this regulatory submission.

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

Since this is a 510(k) for substantial equivalence based on bench and animal testing, there are no "acceptance criteria" in the sense of clinical performance metrics for a human study. Instead, the document lists various bench tests and their purpose (e.g., to verify design outputs met design requirements, confirm proper function and durability) and describes the findings from animal testing.

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

• Bench Testing: "Test articles consisted of finished sterilized catheters." (Specific sample sizes for each test are not provided in this summary). Data provenance is from AngioScore, Inc. (Fremont, CA, USA). These are prospective tests performed as part of device development and verification.
• Biocompatibility Testing: Specific sample sizes for each in vitro or in vivo test are not explicitly provided in this summary. The thrombogenicity evaluation was part of a GLP animal study.
• Animal Testing: The study involved one experimental animal (a single animal). The study was acute and conducted in the femoral peripheral arteries. It was a prospective, GLP (Good Laboratory Practice) study.

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 human clinical study or test set requiring expert ground truth for diagnostic accuracy (common in AI/imaging devices) was conducted. Evaluations were based on physical measurements, biological assays, and observational findings in an animal model by study personnel.

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

• Not Applicable. No human clinical study or test set requiring adjudication 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. This device is a physical medical device (balloon catheter), not an AI/imaging device that would involve human readers or AI assistance.

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

• Not Applicable. This device is a physical medical device (balloon catheter), not an AI/algorithm device.

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

• For bench testing, ground truth is based on established engineering principles, material specifications, and regulatory standards.
• For biocompatibility testing, ground truth is based on standard ISO 10993-1 methods and 21 CFR Part 58 GLP regulations, relying on established biological endpoints.
• For animal testing, the "ground truth" (i.e., evaluation of device performance, integrity, and lack of adverse events) was established through direct observation, examination (e.g., for dissection, perforation, embolization), and assessment by the trained GLP study personnel.

8. The sample size for the training set

• Not Applicable. This device is a physical medical device. There is no concept of a "training set" as would be used for an AI/machine learning model.

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

• Not Applicable. As above, no training set for an AI model. For physical device development, "ground truth" is typically defined by design specifications and regulatory standards against which performance is measured.

Ask a specific question about this device

The AngioSculpt PTA Scoring Balloon Catheter is intended for dilatation of lesions in the iliac, femoral, ilio-femoral, popliteal, infra popliteal, and renal arteries, and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae. Not for use in the coronary or neuro-vasculature.

The AngioSculpt catheter is a standard two-lumen catheter with a scoring balloon near the distal tip. The distal end of the catheter has a conventional nylon-blend balloon with a nitinol scoring element that wraps around the balloon. The scoring element creates focal concentrations of dilating force which minimizes balloon slippage and assists with luminal expansion of stenotic arteries. The balloon has radiopaque markers to aid in positioning the balloon in the stenosis, and is designed to provide an expandable segment of known diameter and length at a specific pressure.

This document is a 510(k) Premarket Notification for the AngioSculpt® PTA Scoring Balloon Catheter, seeking substantial equivalence to previously cleared devices. It describes the device, its intended use, and compares it to predicate devices. However, the document does not contain specific acceptance criteria, study details, or performance data in the format requested.

Therefore, I cannot provide the requested table and detailed information based on the provided text. The document focuses on demonstrating substantial equivalence rather than presenting a performance study with acceptance criteria.

Information not available in the provided document:

• A table of acceptance criteria and reported device performance.
• Sample sizes used for test sets.
• Data provenance (country of origin, retrospective/prospective).
• Number and qualifications of experts for ground truth.
• Adjudication method for the test set.
• Results of a multi-reader multi-case (MRMC) comparative effectiveness study or any effect size of human reader improvement with AI assistance (as this is a medical device, not an AI product).
• A standalone algorithm performance study (as this is a medical device, not an AI algorithm).
• Type of ground truth used (pathology, outcomes data, etc.).
• Sample size for the training set.
• How the ground truth for the training set was established.

The document states: "Design verification and validation testing demonstrated adequate device performance and confirmed that no new questions of safety or effectiveness for peripheral balloon angioplasty devices were raised." However, it does not provide the specifics of these tests, their acceptance criteria, or the results.

Ask a specific question about this device

The AngioSculpt PTA Scoring Balloon Catheter is intended for dilatation of lesions in the iliac, femoral, ilio-femoral, popliteal, and infra popliteal arteries, and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae. Not for use in the coronary or neuro-vasculature.

The AngioSculpt catheter is a standard two-lumen catheter with a scoring balloon near the distal tip. The distal end of the catheter has a conventional nylon-blend balloon with a nitinol scoring element that wraps around the balloon. The sconng element creates focal concentrations of dilating force which minimizes balloon slippage and assists with luminal expansion of stenotic arteries. The balloon has radiopaque markers to aid in positioning the balloon in the stenosis, and is designed to provide an expandable segment of known diameter and length at a specific pressure.

This document is a 510(k) summary for the AngioSculpt PTA Scoring Balloon Catheter (K091966). It does not contain the detailed acceptance criteria or the study results that would be needed to fill out a table of acceptance criteria and reported device performance. It focuses on demonstrating substantial equivalence to previously cleared devices rather than presenting novel clinical study data against defined acceptance criteria.

Therefore, I cannot provide the requested information from the given text. The provided document states:

• No specific acceptance criteria are listed. The document focuses on demonstrating substantial equivalence to predicate devices.
• No specific study is described with performance metrics. The document mentions "Design verification and validation testing demonstrated adequate device performance," but does not detail the nature, sample size, or specific results of these tests, particularly in a way that aligns with "device performance" as might be measured in a clinical study (e.g., success rates, complication rates).

The remaining sections of your request (sample size for test set, data provenance, number of experts, adjudication method, MRMC study, standalone performance, type of ground truth, training set sample size, how training set ground truth was established) require information that would typically be found in a detailed clinical study report or a more comprehensive premarket submission, which is not present in this 510(k) summary.

A 510(k) summary is a high-level overview intended to demonstrate substantial equivalence, not a full clinical study report.

Ask a specific question about this device

The AngioSculpt PTA Scoring Balloon Catheter is intended for dilatation of lesions in the iliac, femoral, ilio-femoral, popliteal, and infra popliteal arteries, and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae. Not for use in the coronary or neuro-vasculature.

The AngioSculpt catheter is a standard two-lumen catheter with a scoring balloon near the distal tip. The distal end of the catheter has a conventional nylon-blend balloon with a nitinol scoring element that wraps around the balloon. The scoring element creates focal concentrations of dilating force which minimizes balloon. slippage and assists with luminal expansion of stenotic arteries. The balloon has radiopaque markers to aid in positioning the balloon in the stennsis, and is designed to provide an expandable segment of known diameter and length at a specific pressure.

Unfortunately, the provided document K082059 is a 510(k) premarket notification correcting a previous letter for the AngioSculpt® PTA Scoring Balloon Catheter. This type of document, particularly for a device that is substantially equivalent to a predicate, typically focuses on demonstrating equivalence rather than detailing a specific clinical study with acceptance criteria and a comprehensive study report as you've requested.

Therefore, the document does not contain the following information:

• A table of acceptance criteria and the reported device performance.
• Sample size used for the test set and the data provenance.
• Number of experts used to establish the ground truth for the test set and their qualifications.
• Adjudication method for the test set.
• If a multi-reader multi-case (MRMC) comparative effectiveness study was done, or its effect size.
• If a standalone performance (algorithm only) study was done.
• The type of ground truth used (expert consensus, pathology, outcomes data, etc).
• The sample size for the training set.
• How the ground truth for the training set was established.

The document states that "Design verification and validation testing demonstrated adequate device performance and confirmed that no new questions of safety or effectiveness for peripheral balloon angioplasty devices were raised." However, it does not provide the specifics of these tests, including the acceptance criteria or detailed results in a format that would allow me to populate the requested table or answer the specific questions about study design and ground truth.

In summary, this document is a regulatory approval letter based on substantial equivalence to existing devices, not a detailed clinical study report.

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The AngioSculpt PTA Scoring Balloon Catheter is intended for dilatation of lesions in the iliac, femoral, ilio-femoral, popliteal, and infra popliteal arteries, and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae. Not for use in the coronary or neuro-vasculature.

The AngioSculpt catheter is a standard two-lumen catheter with a scoring balloon near the distal tip. The distal end of the catheter has a conventional nylon-blend balloon with a nitinol scoring element that wraps around the balloon. The scoring element creates focal concentrations of dilating force which minimizes balloon slippage and assists with luminal expansion of stenotic arteries. The balloon has radiopaque markers to aid in positioning the balloon in the stenosis, and is designed to provide an expandable segment of known diameter and length at a specific pressure.

This document is a 510(k) premarket notification from AngioScore, Inc. to the FDA for their AngioSculpt PTA Scoring Balloon Catheter. The purpose of this notification is to demonstrate that the device is substantially equivalent to legally marketed predicate devices, not to conduct a study proving acceptance criteria for a new AI/software device.

Therefore, the requested information regarding acceptance criteria and a study proving device meets acceptance criteria, in the context of AI/software performance, cannot be extracted from this document. The document describes a medical device, a physical balloon catheter, and the 510(k) summary focuses on demonstrating substantial equivalence to existing devices through a comparison of design, indications for use, and performance, rather than a clinical trial with acceptance criteria for an AI algorithm.

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