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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.

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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.

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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.

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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.

This document is a 510(k) summary for the Serranator® PTA Serration Balloon Catheter. It describes non-clinical testing performed to demonstrate that the device meets design input requirements and is substantially equivalent to predicate devices. It does not contain information about acceptance criteria or a study with human readers with or without AI assistance. It also does not discuss standalone algorithm performance, or ground truth for training data in the context of an AI-powered device.

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

Based on the provided document, the acceptance criteria are implicit in the "Pass" results for various tests. The reported device performance is that it met all these acceptance criteria.

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

• Non-Clinical Testing/Performance & Biocompatibility: The document states that "Bench testing... was performed on sterile, unaged (Time Zero) and accelerated aged (Time Aged) test samples" and "Biocompatibility testing was conducted on sterile, finished devices". Specific sample sizes for each bench or biocompatibility test are not provided. The data provenance is from laboratory testing, not human subjects or real-world clinical data.
• Animal Studies: A total of two porcine test subjects were used for the animal study. This is a prospective animal study.
• Cadaver Studies: A diseased cadaver study was not performed for this specific device. However, a cadaver study was performed for the reference device (Serranator® Alto PTA Serration Balloon Catheter, K163380) to determine medial thickness of non-diseased infrapopliteal arteries. The sample size for this cadaver study is not specified, nor is the provenance beyond "cadaver artery assessment."
  • Data Provenance for device performance: Lab/bench testing, animal studies, and cadaver studies (for reference device). No country of origin is specified for the animal or cadaver 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 device is not an AI/ML device, and therefore, there is no mention of experts establishing ground truth for a test set in the context of diagnostic or interpretive performance. The "ground truth" for the non-clinical and animal studies would be the objective measurements and observations made by laboratory personnel and veterinarians/pathologists during the respective tests, based on established protocols and standards. No specific number or qualifications are provided as this is a traditional medical device submission.

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

Not applicable, as this is not an AI/ML device requiring human adjudication of results for a test set. The non-clinical and animal studies are assessed against predefined pass/fail criteria.

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

Not applicable, as this is not an AI/ML device and there is no mention of human readers or AI assistance.

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

Not applicable, as this is not an AI/ML device.

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

The "ground truth" for this device's performance is established through:

• Objective measurements and observations from bench testing against engineering specifications and regulatory standards (e.g., burst pressure, tensile strength, dimension checks).
• Biological responses observed in biocompatibility tests (e.g., cell viability, immune response, blood compatibility).
• In vivo observations in animal studies (e.g., absence of thrombus, dissection, perforations, successful deployment/retraction).
• Anatomical measurements from cadaver studies (for the reference device) to inform design parameters.

8. The sample size for the training set

Not applicable, as this is not an AI/ML device. There is no concept of a "training set" for physical device testing as described.

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

Not applicable, as this is not an AI/ML device.

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

The Serranator™ Alto PTA Serration Balloon Catheter is an over-the-wire (OTW) balloon dilatation catheter designed to perform percutaneous transluminal angioplasty (PTA) for peripheral vasculature as described in the Indications for Use statement. The Serranator™ has a nylon semi-compliant balloon with four embedded external metal strips, or scoring elements. The scoring elements are designed to create linear, interrupted scoring along the endoluminal surface that occurs during balloon angioplasty.

The given text is a 510(k) Summary for the Serranator™ Alto PTA Serration Balloon Catheter. It describes the device, its intended use, and provides non-clinical testing, biocompatibility, animal, and cadaver study results to support its substantial equivalence to a predicate device.

Here's an analysis of the provided information regarding acceptance criteria and studies:

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

The document doesn't explicitly provide a table of acceptance criteria alongside the reported device performance in a quantitative manner. Instead, it states that:

• "The non-clinical testing results demonstrated that the Serranator™ met all acceptance criteria." (Page 6)
• "All testing passed the required acceptance criteria and the product is biocompatible for human use." (Page 6)

The tests performed include: Shipping, environmental stresses, Flex/Kink, Peel Strength, Visual Inspection, Particulates, Delivery, Deployment, Retraction, Fatigue, Rated Burst/Compliance, Torsion, Corrosion, Tensile Test of Joints, Lubricious Coating Integrity, and Biocompatibility (following ISO-10993).

While the tests are listed, the specific quantitative acceptance criteria (e.g., "flex strength must be > X Newtons") and the quantitative results for each test are not detailed in this summary. The statement "met all acceptance criteria" is a blanket declaration.

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

• Non-clinical testing: The document mentions "sterile, unaged (Time Zero) and accelerated aged (Time Aged) test samples." No specific sample sizes for these tests are provided. Data provenance is implied to be from the manufacturer's testing facilities (Cagent Vascular).
• Biocompatibility testing: "sterile, finished devices." No specific sample size is provided. Data provenance is implied to be from the manufacturer's testing or contracted labs.
• Animal Studies: "Peripheral vessels in a porcine model were treated with a Serranator™ Alto PTA Serration Balloon Catheter or control, AngioSculpt® PTA Scoring Balloon Catheter." No specific number of animals or vessels is given. The model is porcine. (Prospective study, likely a controlled experiment).
• Cadaver Studies: "Cadaver testing was performed comparing the Serranator™ to the predicate device." No specific number of cadavers or tests is given. (Prospective 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)

This information is not provided in the document. The studies described are primarily technical device performance, biocompatibility, and comparative morphological studies in animal models and cadavers. There is no mention of human expert-established ground truth as would be relevant for an AI/diagnostic device.

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

This information is not provided as the studies are not clinical trials or diagnostic performance studies requiring adjudication of human expert opinions.

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

There is no mention of an MRMC comparative effectiveness study, nor any evaluation of human readers with or without AI assistance. This device is a physical medical device (balloon catheter), not an AI diagnostic tool.

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

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

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

For the animal studies, the "ground truth" or primary endpoints appear to be morphometric measurements (e.g., neointimal areas, thickness, percent stenosis) derived from analyzing treated vessels. These measurements would likely be obtained via histological analysis or imaging post-treatment.

For non-clinical and biocompatibility testing, the "ground truth" is adherence to pre-defined engineering specifications, material properties, and biological safety standards (e.g., ASTM, ISO standards).

8. The sample size for the training set

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

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

This is not applicable for the same reason as above.

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