Search Results

The Aperta NSE PTA Balloon Dilatation Catheter is indicated for percutaneous transluminal angioplasty (PTA) of lesions in peripheral arteries, including iliac, femoral, ilio-femoral, popliteal and infra-popliteal arteries, and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae. This device is also indicated for treatment of in-stent restenosis of balloon expandable and self-expanding stents in the peripheral vasculature. This device is not for use in the coronary or neuro-vasculature including carotid arteries.

The Aperta NSE™ PTA Balloon Dilatation Catheter (Aperta NSE PTA) is an over-the-wire (OTW) type catheter used for percutaneous transluminal angioplasty of lesions in peripheral arteries and obstructive lesions of arteriovenous dialysis fistula. The Aperta NSE PTA catheter is designed with protruding polymer elements parallel to the balloon to aid dilatation of stenotic lesions that are difficult to expand with a conventional balloon.

The provided FDA 510(k) Clearance Letter for the Aperta NSE PTA Balloon Dilatation Catheter describes a device that is substantially equivalent to a predicate device. This document does not contain acceptance criteria for performance of the device in a clinical setting (e.g., success rates, complication rates) nor does it describe a study proving such performance.

Instead, the document focuses on demonstrating substantial equivalence through non-clinical testing (bench testing, biocompatibility, and packaging) in comparison to the predicate device. The acceptance criteria described are for these non-clinical tests.

Therefore, many of the requested sections (e.g., sample size for test set, data provenance, number of experts, MRMC study, ground truth type, training set size) are not applicable to this document as it does not report on clinical performance or AI algorithm development.

Here's the information that can be extracted based on the provided document:

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

The document states that non-clinical testing was performed "After meeting all acceptance criteria." However, it does not provide the specific numerical acceptance criteria for each test or the detailed numerical "performance" results. It primarily indicates that the tests passed.

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

This information is not applicable as the document describes non-clinical (bench and lab-based) testing, not a clinical study on a test set of patient data.

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 non-clinical testing.

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

This information is not applicable as the document describes non-clinical testing.

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

A MRMC comparative effectiveness study was not reported. This document is for a medical device (a catheter), not an AI-powered 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 is for a medical device (a catheter), not an AI algorithm.

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

For the non-clinical tests, the "ground truth" would be established by the expected performance characteristics based on engineering specifications, regulatory standards (e.g., ISO, ASTM), and the predicate device's performance. For biocompatibility, it's based on established biological safety endpoints. The document does not specify the exact methods for establishing these "truths" for each individual test, but implies adherence to the FDA Guidance Document titled "Peripheral Percutaneous Transluminal Angioplasty (PTA) and Specialty Catheters issued on April 14, 2023."

8. The sample size for the training set

This information is not applicable as the document describes non-clinical testing of a physical medical device, not an AI algorithm requiring a training set.

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

This information is not applicable as the document describes non-clinical testing of a physical medical device, not an AI algorithm.

Ask a specific question about this device

The D-KuttingTm LL Peripheral Scoring Balloon Dilatation Catheter is indicated for Percutaneous Transluminal Angioplasty (PTA) in the peripheral vasculature, including the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae. This catheter is not for use in the coronary vasculature.

The Peripheral Scoring Balloon Dilatation Catheter is an over the wire (OTW) catheter. It features a non-compliant balloon with 3 scoring elements mounted longitudinally on its outer surface. The scoring element is attached on the surface of balloon by adhesive. The scoring elements were tightly circled by a nitinol wire and the cross section of the scoring element is a triangular. The length of the scoring element is according to effective length of balloon. The catheter has two radiopaque marker bands, which fluoroscopically indicates the expanded part of the balloon and aid in the placement of the balloon and scoring element and to facilitate proper placement. The two radiopaque marker bands are located on the inner-lumen which is underneath the balloon. The catheter includes a tapered tip to facilitate advancement of the catheter to and through the inflation site. A lubricious coating is applied at from the distal tip to shaft tubing to enhance insertion and withdrawal performance. The inner lumen in the shaft tubing and ends in a Y-connector manifold hub with 2 Luer lock fittings. The straight manifold port is used to pass the catheter over the suitable guidewire. The second side port communicates with the balloon and is used to inflate and deflate the balloon during the procedure. The diameter and length of the balloon and the diameter of the compatible guide wire are printed on the hub. The balloon is folded an inserted in a PTFE casing to protect the balloon and scoring element. The Peripheral Scoring Balloon Dilatation Catheter is offered in balloon diameters ranging from 2.5mm-7.0mm and lengths are from 20mm to 150mm. The catheter length is 90cm, 135cm and 150cm and is compatible with 0.014″ or 0.018″ guide wires accordingly.

This 510(k) clearance letter pertains to a medical device, the D·Kutting™ LL Peripheral Scoring Balloon Dilatation Catheter, rather than an AI/ML-driven device. As such, many of the requested categories related to AI/ML device testing (e.g., sample size for test set, number of experts for ground truth, adjudication method, MRMC study, standalone performance) are not applicable or cannot be extracted from this document.

However, I can provide the acceptance criteria and a summary of the study results for the non-clinical tests performed to demonstrate the device's substantial equivalence to a predicate device.

Acceptance Criteria and Reported Device Performance

The document states that "The subject device, the Peripheral Scoring Balloon Dilatation Catheter, met all predetermined acceptance criteria of design verification and validation as specified by applicable standards, guidance and test protocols." However, the specific quantitative acceptance criteria for each test are not explicitly detailed in this summary. The reported performance is generally stated as having met these unquantified criteria.

Study that Proves the Device Meets Acceptance Criteria

The study performed to prove the device meets acceptance criteria consists of a comprehensive set of non-clinical tests, including bench testing, biocompatibility testing, animal testing, sterilization validation, and packaging/shelf-life testing. The document states that these tests were performed "in accordance with the FDA Guidance Document titled Peripheral Percutaneous Transluminal Angioplasty (PTA) and Specialty Catheters (April 14, 2023)".

1. A table of acceptance criteria and the reported device performance:
See table above. The document generally states that the device "met all predetermined acceptance criteria" for each category of tests but does not provide the quantitative criteria themselves.

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

• Test Set Sample Size: The document does not specify the sample sizes used for the individual bench tests, biocompatibility tests, or animal tests.
• Data Provenance: The document does not explicitly state the country of origin for the data or whether it was retrospective or prospective. Given the submitter is "DK Medical Technology Co., Ltd." located in "Suzhou Industrial Park, Jiangsu, China", it is highly probable that the testing, or at least the data generation, occurred in China. The animal study is prospective by nature.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
Not applicable. This is a medical device (catheter) clearance, not an AI/ML device, so "ground truth" established by experts in the context of image interpretation or diagnosis is not relevant here. The "ground truth" for these tests would be objective measurements and observations determined by validated methods and trained technical personnel.

4. Adjudication method for the test set:
Not applicable. See 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:
Not applicable. This is a medical device (catheter) clearance, not an AI/ML device.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Not applicable. This is a medical device (catheter) clearance, not an AI/ML device.

7. The type of ground truth used:
For the non-clinical tests:

• Bench Testing: Objective measurements (e.g., dimensions, forces, times), visual inspections, and functional performance outputs, compared against engineering specifications and regulatory standards.
• Biocompatibility Testing: Laboratory results from in-vitro and in-vivo tests based on standardized toxicology and biological evaluation protocols (e.g., ISO 10993 series), indicating the biological safety of materials.
• Animal Testing: Clinical observations, procedural success rates, and potentially histological findings from acute and chronic animal models, compared against a control device.

8. The sample size for the training set:
Not applicable. This is a medical device (catheter) clearance, not an AI/ML device. There is no AI model "training set" mentioned or implied.

9. How the ground truth for the training set was established:
Not applicable. See point 8.

Ask a specific question about this device

Tri-Wedge PTA Scoring Balloon Dilatation Catheter is indicated to dilate stenoses in the illac, femoral, iliofemoral, popliteal, and renal arteries, and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae.

The Tri-Wedge PTA Scoring Balloon Dilatation Catheter is an over-the-wire (OTW) peripheral balloon dilatation catheter. The catheter working length is 50cm, 75cm, 90cm and 150cm. Balloon diameters range from 3.0mm to 8.0mm. The balloon is made of a minimally compliant material with rated burst pressure of 20atm for Ø3.0-6.0mm and 16atm for Ø7.0-8.0mm. A coaxial double lumen catheter for balloon inflation and guide wire insertion is bonded to a female luer connector to form the proximal shaft. The balloon and the coaxial double lumen are welded to compose the distal of the catheter surface is coated with hydrophilic coating from the tip to the distal shaft. A scoring element with three parallel struts wraps around the balloon has radiopaque markers for positioning the balloon relative to the stenosis. The guide wire lumen is compatible with a standard 0.018-inch or 0.035-inch guide wire that enters from the catheter and extends out from the hub. The catheter is sterilized with EO and for single use only.

The provided text describes a 510(k) summary for the Tri-Wedge PTA Scoring Balloon Dilatation Catheter, a medical device. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than providing detailed clinical study results typical of drug approvals or novel device PMAs. The document focuses on bench testing and an animal study. Therefore, some of the requested information, particularly regarding human clinical trial data (e.g., sample size for test sets, number of experts for ground truth, MRMC studies, standalone performance, training set details for AI), is not applicable or available in this submission.

Here's a breakdown of the available information:

1. Table of Acceptance Criteria and Reported Device Performance

The submission states that "The test results met all acceptance criteria," but it does not provide a table detailing specific numerical acceptance criteria for each test and the corresponding reported device performance values. It only lists the types of tests performed.

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

• Test Set (Bench Testing): The document does not specify the exact sample sizes (N) for each individual bench test. It mentions that "Standard bench performance tests were conducted."
• Test Set (Animal Study): The document refers to "the test group and the control group" in the animal study, but the specific sample size (number of animals) for each group is not provided.
• Data Provenance: Not specified in the document. Likely refers to internal laboratory testing conducted by BrosMed Medical Co., Ltd.

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

Not applicable. The reported studies are bench tests and an animal study, which do not typically involve human expert adjudication for ground truth in the same way clinical trials for diagnostic devices do.

4. Adjudication Method for the Test Set

Not applicable for bench and animal studies.

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

Not applicable. This device is a physical medical device (scoring balloon catheter), not an AI-powered diagnostic or assistive tool for human readers. Therefore, an MRMC study related to AI assistance is not relevant.

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, not a software algorithm.

7. The Type of Ground Truth Used

• Bench Testing: The "ground truth" would be established by the specifications and engineering requirements for the device. For example, a balloon's rated burst pressure is a predefined specification the device must meet.
• Animal Study: The "ground truth" for the animal study (safety evaluation) was based on histological examination for inflammation, injury, and endothelialization scores, as well as observations of device performance (passage, dilation, withdrawal, coordination).

8. The Sample Size for the Training Set

Not applicable. This device does not involve a "training set" in the context of machine learning or AI.

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

Not applicable.

Summary of Device Acceptance Criteria and Study Findings (Based on Provided Text):

The acceptance criteria for the Tri-Wedge PTA Scoring Balloon Dilatation Catheter were met through a series of bench tests and an animal study.

Conclusion from the document: The studies demonstrated that the Tri-Wedge PTA Scoring Balloon Dilatation Catheter met all acceptance criteria, showing substantial equivalence to the predicate device and raising no new questions of safety or effectiveness.

Ask a specific question about this device

The XO Constrain Percutaneous Transluminal Angioplasty Constraining Catheter is intended to be used in conjunction with a PTA balloon to facilitate dilation and apposition of the scoring/constraining surface to the stenal in the iliac, femoral, ilio-popliteal, infra-popliteal, and renal arteries, and for treatment of obstructive or synthetic arteriovenous dialysis fistulae. Not for use in the coronary or neuro-vasculature.

The XO Constrain Percutaneous Transluminal Angioplasty Constraining Catheter is a balloon dilation scoring/constraining catheter. It consists of a metal alloy wire shaft connected to the metal alloy expandable constraining structure (CS) at the distal atraumatic tapered tip. It works with offthe-shelf compliant and semi-compliant balloons to expand the constraining structure and is designed to facilitate uniform, atraumatic balloon expansion, vessel scoring, and rewrap within small or distal vessels and arteries. The XO Constrain catheter is designed to be used with balloons between the sizes of 6 - 20mm in length and 1.5 - 4.0mm in diameter and may work with PTA and peripheral use PTCA balloon catheters with a standard over-the-wire (OTW) or rapid exchange (RX) procedural approaches. The expansion of the CS is determined by the balloon inflation diameter. Upon deflation the CS returns to its original shape and is removed from the vessel along with the balloon catheter. The XO Constrain should not be used in the coronary or neuro-vasculature.

The device under consideration is the XO Constrain™ Percutaneous Transluminal Angioplasty Constraining Catheter.

Based on the provided text, the device's acceptance criteria are addressed through a series of Functional/Safety Testing and Animal Testing. The manufacturer, Transit Scientific, LLC, states that "All data met pre-determined acceptance criteria" for these tests and that the device is "substantially equivalent to the cited predicate device."

Here's a breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance

The document lists various tests performed to ensure the device meets predefined acceptance criteria, but it does not explicitly state specific quantitative acceptance criteria or the numerical performance results for each test. Instead, it broadly states that "All data met pre-determined acceptance criteria."

Ask a specific question about this device

The Aperta NSE PTA Balloon Dilatation Catheter is indicated for percutaneous transluminal angioplasty (PTA) of lesions in peripheral arteries, including iliac, femoral, ilio-femoral, popliteal and infra-popliteal arteries, and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae. This device is also indicated for treatment of in-stent restenosis of balloon expandable and self-expanding stents in the peripheral vasculature. This device is not for use in the coronary or neuro-vasculature including carotid arteries.

The Aperta NSE™ PTA Balloon Dilatation Catheter (Aperta NSE PTA) is an over-the-wire (OTW) type catheter used for percutaneous transluminal angioplasty of lesions in peripheral arteries and obstructive lesions of arteriovenous dialysis fistula. The Aperta NSE PTA catheter is designed with protruding polymer elements parallel to the balloon to aid dilatation of stenotic lesions that are difficult to expand with a conventional balloon.

This document is a 510(k) premarket notification for a medical device called the Aperta NSE PTA Balloon Dilatation Catheter. It is important to note that this submission does not contain information about a study proving the device meets acceptance criteria in the context of an AI/ML device. The device described is a physical medical device (a balloon catheter), and the studies mentioned are non-clinical (bench and animal testing).

Therefore, I cannot provide the information requested in the format of AI/ML device acceptance criteria and study details. The document does not describe an AI/ML device or its associated performance metrics, test sets, ground truth, or human-in-the-loop studies.

Instead, the document details the non-clinical testing performed for the physical medical device to demonstrate its substantial equivalence to a predicate device. If you are interested in the "acceptance criteria" and "study" as presented in this specific document for the physical device, here's an interpretation:

The acceptance criteria are implicitly defined by the successful completion of the listed non-clinical tests in accordance with relevant FDA guidance and standards. The "study" refers to the entire body of non-clinical testing.

Here's a breakdown of what is available in the document regarding the physical device's non-clinical studies:

1. Table of Acceptance Criteria and Reported Device Performance:

The document lists various non-clinical tests performed. The "reported device performance" is summarized by the statement: "After meeting all acceptance criteria, non-clinical testing has demonstrated that the Aperta NSE PTA is substantially equivalent to the predicate." This implies that the device successfully passed all specified tests according to predefined thresholds (acceptance criteria), though the specific numerical thresholds for each test are not explicitly detailed in this summary.

2. Sample Size for Test Set and Data Provenance:

• Bench Testing: Sample sizes are not specified in this summary. The tests are typically conducted in a laboratory setting.
• Animal Testing: A "porcine peripheral artery model" was used for acute (Day 0) and chronic (Day 30) safety evaluation. The number of animals (sample size) is not specified. This is prospective data generated for the submission. The "country of origin of the data" is not specified but would be from the performing lab/facility.

3. Number of Experts Used to Establish Ground Truth for Test Set and Qualifications:
Not applicable. For a physical device, "ground truth" typically refers to established engineering specifications, material properties, and biological responses observed in animal models, rather than expert consensus on data interpretation.

4. Adjudication Method for the Test Set:
Not applicable. This is typically used for clinical trials or image interpretation studies, not for bench and animal testing of a physical device.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:
No. This type of study is relevant for AI/ML diagnostic tools with human readers, which is not what this device is.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done:
No. This is not an AI/ML algorithm.

7. The Type of Ground Truth Used:
For the non-clinical tests, the "ground truth" is based on:

• Established engineering specifications and design tolerances for physical properties and dimensions.
• Industry standards and FDA guidance for biocompatibility.
• Observed biological responses and safety endpoints in an animal model.

8. The Sample Size for the Training Set:
Not applicable. This is not an AI/ML device, so there is no "training set."

9. How the Ground Truth for the Training Set was Established:
Not applicable. No training set for an AI/ML algorithm.

In summary, the provided document is a 510(k) summary for a physical medical device (balloon catheter) and outlines its non-clinical testing to demonstrate substantial equivalence to a predicate device, rather than the acceptance criteria and study details for an AI/ML product.

Ask a specific question about this device

The D Kutting™ PTA Scoring Balloon Dilatation catheters are indicated for Percutaneous Transluminal Angioplasty (PTA) of obstructive lesions of synthetic or native arteriovenous dialysis fistulae.

The D·Kutting™ PTA Scoring Balloon Dilatation Catheter is an Over-The-Wire (OTW) balloon catheter with a dual lumen shaft design. One lumen is used to pass the catheter over 0.018" or 0.035" guidewires. The second lumen communicates with the balloon and is used to inflate and deflate the balloon during the procedure. The guidewire lumen and the balloon lumen terminate at the proximal end of the catheter in a Y-connector manifold with Luer lock fillings. 3 scoring wires between the two marker bands are radially distributed every 120° and mounted on the surface of the balloon. A PVP coating is applied to the tip to enhance insertion and withdrawal performance. The D. Kutting™ PTA Scoring Balloon Dilatation Catheter will be available with balloon diameters 4.0 mm to 8.0 mm, balloon lengths 20 mm to 80 mm and with catheter lengths of 50 cm, 90 cm, and 130 cm. The diameter and length of the balloon and the diameter of the compatible guide wire are printed on the hub.

The provided document is a 510(k) summary for the D.Kutting™ PTA Scoring Balloon Dilatation Catheter. It focuses on demonstrating substantial equivalence to a predicate device through various performance, biocompatibility, sterility, and animal studies. However, the document does not describe a study involving an AI/Machine Learning (ML) component, nor does it provide acceptance criteria and performance data in the context of AI/ML.

Therefore, I cannot extract the information requested for an AI/ML device from this document. The document primarily concerns the safety and effectiveness of a physical medical device (a balloon dilatation catheter) and its equivalence to a similar, previously cleared device.

Ask a specific question about this device

The XO Score LP Percutaneous Transluminal Angioplasty Scoring Catheter is intended to be used in conjunction with a PTA balloon to facilitate dilation and apposition of the scoring surface to the stenotic material in the iliac, femoral, iliofemoral, popliteal, infra-popliteal, and renal arteries, and for treatment of obstructive lessions of native or synthetic arteriovenous dialysis fistulae. Not for use in the coronary or neuro-vasculature.

The XO Score LP (Low Profile) Percutaneous Transluminal Angioplasty Scoring Catheter is a 2.2 Fr (0.76 mm) and 3.8 Fr (1.27 mm) diameter, single-lumen, metal alloy shaft, a proximal polymer outer jacket and a balloon expandable scoring element at the distal tip. Designed to work with a standard PTA balloon catheter. The XO Score LP catheter essentially adds the lesion scoring / cutting capability to a standard PTA balloon catheter with the scoring element at its distal end. It is available in the one catheter length (150 cm), and longitudinal scoring element length (23cm).

The provided text is a 510(k) summary for the XO Score LP Percutaneous Transluminal Angioplasty Scoring Catheter. It focuses on demonstrating substantial equivalence to a predicate device through comparative analysis and functional/safety testing, rather than an AI-driven medical device requiring a study with acceptance criteria for a new clinical indication or improved diagnostic performance.

Therefore, the document does not contain the information requested regarding acceptance criteria related to device performance in a clinical or diagnostic context, a study proving the device meets that criteria, sample sizes for test/training sets, expert involvement, adjudication methods, MRMC studies, standalone performance, or ground truth establishment relevant to an AI/diagnostic device.

The "acceptance criteria" referred to in the document are for bench testing to validate and verify that the device is substantially equivalent to a predicate device, focusing on physical and functional characteristics of the catheter. This is different from the type of acceptance criteria and study design you're asking for, which typically apply to AI/software as a medical device (SaMD) or diagnostic devices that provide clinical information or assist human readers.

To be specific, the document explicitly states:
"The following testing was conducted to validate and verify that the subject device was substantially equivalent to the predicate devices. All data met pre-determined acceptance criteria."
The listed tests are all bench tests (e.g., Biocompatibility, Kink Radius, Tensile Testing, Retrieval Force Testing, Device Recovery, Accessory PTA Balloon Catheter burst pressure, Torque, Cycling, Scoring Capability Assessment).

In summary, the provided text does not describe the type of study and acceptance criteria you've requested for an AI-driven or diagnostic device.

Ask a specific question about this device

The Serranator® PTA Serration Balloon Catheter is intended for dilatation of lesions in the iliac, femoral, illofemoral, popliteal, infrapopliteal arteries and for the treatment of native or synthetic arteriovenous dialysis fistulae. Not for use in the coronary or neuro-vasculature.

The Serranator® PTA Serration Balloon Catheter is an over-the-wire (OTW) balloon dilatation catheter designed to perform percutaneous transluminal angioplasty (PTA) for peripheral indications as described in the Indication for Use statement. The Serranator® has a nylon semicompliant balloon with multiple embedded external metal strips or scoring elements. The unique scoring elements are serrated, designed to modify the plaque by creating linear, interrupted scoring along the endoluminal surface. This occurs during balloon inflation and is designed to aid arterial expansion.

The provided text describes a 510(k) premarket notification for the Serranator® PTA Serration Balloon Catheter. This notification is a "consolidation (i.e., bundling) of previously cleared 510(k) indication statements and labeling." The key takeaway is that the device described in this submission (K220704) is identical to previously cleared devices (K213728 and K203437) in terms of "purpose, design, materials, energy source, function, or any other feature." Therefore, no new performance data or studies were conducted for this specific submission.

The document does not contain any information about acceptance criteria or a new study proving the device meets new acceptance criteria for this K220704 submission. It explicitly states: "No new data are included in this bundled 510(K) application. The Serranator® PTA Serration Balloon Catheters represented in this bundled submission do not differ in purpose, design, materials, energy source, function, or any other feature. Performance data previously provided in K213728 and K203437 demonstrate that the devices function as intended."

Therefore, based solely on the provided text, I cannot complete the requested information regarding acceptance criteria and a study that proves the device meets them, as no new study was performed for this specific submission to demonstrate compliance with new acceptance criteria. The device's substantial equivalence is based on its identity to previously cleared devices and the previous performance data.

To answer your request, one would need to refer to the original 510(k) submissions (K213728 and K203437) to find the acceptance criteria and study details.

Ask a specific question about this device

The Serranator® PTA Serration Balloon Catheter is intended for dilatation of lesions in the illac, femoral, and poplited arteries for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae. Not for use in the coronary or neuro-vasculature.

The Serranator® PTA Serration Balloon Catheter is an Over-The-Wire (OTW) balloon dilatation catheter designed to perform Percutaneous Transluminal Angioplasty (PTA) for peripheral indications as described in the Indication for Use statement. The Serranator® has a nylon semicompliant balloon with embedded external metal strips or scoring elements. The unique scoring elements are serrated, designed to modify the plaque by creating linear, interrupted scoring along the endoluminal surface. This occurs during balloon inflation and is designed to aid arterial expansion.

The provided text is a 510(k) Premarket Notification for a medical device called the Serranator® PTA Serration Balloon Catheter. It discusses the device's indications for use, description, and comparison to predicate and reference devices to demonstrate substantial equivalence. Crucially, this document does not contain information about clinical acceptance criteria (e.g., sensitivity, specificity, accuracy) or the results of a clinical study that proves the device meets these criteria.

The "NON-CLINICAL TESTING/PERFORMANCE DATA" section states that "bench tests were performed" and "In vitro bench testing demonstrated that the subject device performed as intended and similar to the predicate device." This refers to laboratory tests, not human clinical trials. There is no mention of an AI component, human readers, or ground truth establishment relevant to AI performance.

Therefore, I cannot provide the requested information. The document focuses on demonstrating substantial equivalence to a predicate device through non-clinical testing rather than proving clinical performance against specific acceptance criteria in a human study.

Ask a specific question about this device

The Serranator® PTA Serration Balloon Catheter is intended for dilatation of lesions in infrapopliteal arteries. Not for use in the coronary or neuro-vasculature.

The Serranator® PTA Serration Balloon Catheter is an over-the-wire (OTW) balloon dilatation catheter designed to perform percutaneous transluminal angioplasty (PTA) for peripheral indications as described in the Indication for Use statement. The Serranator® has a nylon semicompliant balloon with three embedded external metal strips or scoring elements. The unique scoring elements are serrated, designed to modify the plaque by creating linear, interrupted scoring along the endoluminal surface. This occurs during balloon inflation and is designed to aid arterial expansion.

The provided text is a 510(k) summary for the Serranator® PTA Serration Balloon Catheter and focuses on demonstrating substantial equivalence to a previously cleared predicate device. It does not describe a clinical study or detailed acceptance criteria for device performance based on clinical outcomes. Instead, it relies on non-clinical bench testing to demonstrate that the new device performs as intended and is comparable to the predicate.

Therefore, many of the requested sections (2, 3, 4, 5, 6, 7, 8, 9) regarding a study with human subjects, ground truth, and training sets are not applicable to the information provided.

Here's a breakdown of what can be extracted from the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document mentions "acceptance criteria" generally for non-clinical testing but does not provide specific quantitative criteria or detailed performance results in a table format. It states generally that "The subject device meets all acceptance criteria" and "In vitro bench testing demonstrated that the subject device performed as intended."

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

Not applicable. The study was non-clinical bench testing, not involving a test set of human data.

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

Not applicable. Ground truth for human data is not relevant for this non-clinical bench testing.

4. Adjudication Method for the Test Set

Not applicable. No test set involving human data or expert review.

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-powered diagnostic tool.

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, not an algorithm.

7. The Type of Ground Truth Used

Not applicable. Ground truth as typically defined for clinical or AI studies (e.g., pathology, outcomes data) is not relevant for this non-clinical bench testing. The "ground truth" for these engineering tests would be the established engineering specifications and performance standards which the device was tested against.

8. The Sample Size for the Training Set

Not applicable. This is not referring to an AI device or a study with a training set of data.

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

Not applicable. See point 8.

Ask a specific question about this device