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Dorado™ PTA Balloon Dilatation Catheter is recommended for Percutaneous Transluminal Angioplasty (PTA) of the renal, iliac, femoral, popliteal, tibial, peroneal, and subclavian arteries and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae. This device is also recommended for post-dilatation of balloon expandable and self expanding stents in the peripheral vasculature. This catheter is not for use in coronary arteries.

The Dorado™ PTA Balloon Dilatation Catheter is a high-performance balloon catheter consisting of an over the wire catheter with a balloon fixed at the distal tip. The proprietary non-compliant, low-profile balloon is designed to provide consistent balloon diameters and lengths even at high pressures. Two radiopaque markers delineate the working length of the balloon and aid in balloon placement. The catheter includes an atraumatic tip to facilitate advancement of the catheter to and through the stenosis. The novel catheter consists of a distal triple lumen and a proximal coaxial lumen and is designed to optimize the balance between pushabilty and trackability. The over the wire catheter is compatible with 0.035" guidewire and is available in 40, 80, 120, and 135 cm working lengths. The proximal portion of the catheter includes a female luer lock hub connected to the inflation lumen, and a female luer-lock hub connected to the guidewire lumen. Packaged with every product is a profile reducing sheath that is positioned over the balloon for protection before use. A re-wrapping tool is also provided on the catheter shaft. A stylet is placed into the tip of the catheter to aid in rewrap/refolding of the balloon. These products are not made with natural rubber latex.

This 510(k) clearance letter is for a medical device (Dorado™ PTA Balloon Dilatation Catheter), not an AI/Software as a Medical Device (SaMD).

Therefore, the information requested in your prompt (e.g., acceptance criteria for AI algorithm performance, sample sizes for test/training sets, expert adjudication, MRMC studies, ground truth establishment) is not applicable to this document.

The document discusses the performance evaluation of a physical medical device, focusing on in vitro pre-clinical testing to demonstrate substantial equivalence to a predicate device. This includes:

• Performance Data: Trackability, Balloon Burst Strength, Balloon Fatigue, Sheath Compatibility, Dimensional Verification, Simulated Use, etc.
• Biocompatibility Testing: Cytotoxicity, Sensitization, Irritation, Systemic Toxicity, Hemocompatibility.

The acceptance criteria for this device would be engineering specifications and safety standards for balloon catheters, not statistical metrics for AI algorithm performance.

In summary, based on the provided document, I cannot answer the questions related to AI/SaMD acceptance criteria and study design. The document describes the clearance of a traditional physical medical device.

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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.

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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.

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The Parafleet SC 014 / Parafleet SC 035 is intended to dilate stenoses in the iliac. femoral, iliofemoral, popliteal, infrapopliteal, and renal arteries, and for the treatment of obstructive or synthetic arteriovenous dialysis fistulae.

This device is also indicated for stent dilatation post-deployment in the peripheral vasculature.

The Parafleet balloon dilatation catheter family consists of Parafleet SC 014, Parafleet SC 018 and Parafleet SC 035 PTA balloon catheter. The PTA (OTW type) device is an over the wire (OTW) peripheral balloon catheter, specially designed for Percutaneous Transluminal Angioplasty (PTA). The Parafleet SC catheter is available in working lengths of 40cm, 90cm, 120cm, 150cm and 200cm, with balloon diameters ranging from 1.25mm to 12.0mm. The Parafleet features an outer tube and inner tube lumen shaft ending in a Y-hub manifold with luer lock fittings. One lumen is used for inflation of the balloon and accessed via the side leg port. The second lumen, starting at the straight entry port, allows access to the distal tip of the catheter for a standard 0.014 inch / 0.018 inch / 0.035 inch guide wire insertion. The catheter is sterilized with EO and for single use only. The design of this dilatation catheter does not incorporate a lumen for distal dye injections or distal pressure measurements.

The BrosMed Medical Co., Ltd.'s Parafleet SC 014, Parafleet SC 018, and Parafleet SC 035 PTA Balloon Dilatation Catheters underwent various performance tests to ensure substantial equivalence to predicate devices and suitability for their intended use.

1. Acceptance Criteria and Reported Device Performance:

The document lists several performance tests conducted, implying that the acceptance criteria for these tests were met to demonstrate substantial equivalence. The reported device performance is that "The test results met all acceptance criteria, were same or similar to the predicate devices, and ensure that the Parafleet SC 014 / Parafleet SC 018 / Parafleet SC 035 PTA Balloon Dilatation Catheter design and construction are suitable for its intended use."

While specific numerical acceptance criteria and precise performance values are not provided in the summary, the general categories of tests and their "met" status serve as the reported performance against inferred acceptance criteria derived from FDA guidance and predicate device characteristics.

Here’s a table summarizing the types of tests (representing categories of acceptance criteria) and the reported performance:

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

The document does not specify the exact sample sizes used for each of the performance tests. The data provenance (e.g., country of origin, retrospective/prospective) for these tests is also not explicitly stated in the provided text. However, it's typical for such bench and biocompatibility tests to be conducted in a laboratory setting by the manufacturer (BrosMed Medical Co., Ltd. in China) or a contract research organization.

3. Number of Experts and Qualifications for Ground Truth:

This section is not applicable to the provided document. The submission pertains to a medical device's performance characteristics (e.g., mechanical, material, biocompatibility) rather than an AI/ML-driven diagnostic or prognostic device that would require expert-established ground truth for interpretation of images or patient data. The tests performed are objective, physical, and chemical evaluations.

4. Adjudication Method for the Test Set:

This section is not applicable for the same reasons as point 3. No subjective interpretation requiring adjudication is mentioned for the performance testing of these physical medical devices.

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

This section is not applicable as the device is a PTA Balloon Dilatation Catheter, not an AI-assisted diagnostic tool. Therefore, there is no human-in-the-loop performance or comparison with AI assistance.

6. Standalone Performance (Algorithm Only):

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

7. Type of Ground Truth Used:

The "ground truth" for the performance tests in this context is established by objective engineering specifications, material standards, and regulatory guidance documents (e.g., FDA guidance 'Peripheral Percutaneous Transluminal Angioplasty (PTA) and Specialty Catheters - Premarket Notification (510(k)) Submissions, Guidance for Industry and FDA Staff' and ISO 10993-1 for biocompatibility).

For example:

• Dimensional verification checks against the device's design specifications.
• Balloon Rated Burst Pressure tests against the manufacturer's specified burst pressure and regulatory safety limits.
• Biocompatibility testing assesses against established biological safety endpoints defined by ISO standards.

8. Sample Size for the Training Set:

This section is not applicable as the device is a physical medical device and does not involve machine learning or a "training set."

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

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

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This device is indicated for use in adult and adolescent populations to endoscopically dilate strictures of the gastrointestinal tract. It is also indicated in adults for endoscopic dilatation of Sphincter of Oddi with or without prior sphincterotomy.

According to the structure of the device, it can be divided into three types, RX type, OTW type and OTW with Stainless Wire-guided type. The Rx proposed device mainly consists of tip, balloon, marker band, shaft, sleeve, stress diffusion tube and hub. The OTW proposed device mainly consists of tip, balloon, marker band, shaft, stress diffusion tube and hub. The structure of the OTW with Stainless Wire-guided model same with the structure of OTW model. The difference between OTW with Stainless Wire-guided type catheter and OTW type catheter is that OTW with Stainless Wire-guided type catheter is preloaded with a guide wire and a guide wire locking component. The difference between the RX type catheter and the OTW series catheter is that the guidewire exit position is different. The guide wire of OTW series catheter passed through the guide wire lumen of the catheter. The guidewire of the Rx type catheter will pass through the guidewire exchange port on the shaft.

Single-use Balloon Dilatation Catheter is divided into different specifications. Shafts are available in two different diameters. The effective length of the catheter is 180cm and 240cm. Balloon diameters are available in six different diameters 6-7-8mm, 8-9-10 mm, 12-13.5-15 mm, 15-16.5-18 mm, 18-19-20 mm, and the balloon lengths are available in 30 mm,55 mm and 80 mm three different length.

The provided FDA 510(k) summary for the "Single-use Balloon Dilatation Catheter" (K241888) details a non-clinical study to demonstrate substantial equivalence to predicate devices, rather than an AI/ML software performance study. Therefore, most of the requested information regarding AI/ML device acceptance criteria, human reader studies, and ground truth establishment for AI/ML models is not applicable to this document.

The document describes performance testing for a physical medical device. Here's a breakdown of the applicable information:

1. Table of Acceptance Criteria and Reported Device Performance:

The document states: "All the test results demonstrate proposed device meet the requirements of its pre-defined acceptance criteria and intended uses." However, it does not provide a specific table detailing the exact quantitative acceptance criteria for each test and the corresponding measured performance values. It lists the types of tests performed.

2. Sample sizes used for the test set and data provenance:
The document states "The performance testing conducted on subject device and predicate device are listed below." and mentions "ASTM F3172 Standard Guide for Design Verification Device Size and Sample Size Selection for Endovascular Devices". This suggests that standard device testing sample sizes were used in accordance with this guideline, but the specific sample sizes for each test are not explicitly stated in this summary.
Data provenance: This is a physical device, so "data provenance" would refer to the testing conditions and results. The tests were performed in a lab setting to verify design specifications and compliance with international standards (e.g., ISO, ASTM, USP). The country of origin for the testing is not specified, but the applicant company is Leo Medical Co., Ltd. in China. The data is prospective as it's generated through device testing.

3. Number of experts used to establish the ground truth for the test set and qualifications of those experts:
This question is not applicable as this is a physical device performance study, not a study involving human reader interpretation of images or AI/ML model output requiring "ground truth" established by experts in a clinical context. The "ground truth" for these tests are the physical measurements and compliance with engineering and material standards.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
This is not applicable as it's a physical device performance study. Adjudication methods are typically for clinical consensus on ground truth in image interpretation or diagnosis, not for engineering performance tests.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
This is not applicable. No MRMC study was performed as this is not an AI/ML-assisted diagnostic device. The document explicitly states: "No clinical study is included in this submission."

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
This is not applicable. This is not an algorithm, but a physical medical device.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
For this physical device, the "ground truth" for the non-clinical tests is based on established engineering and material science standards, measurements, and pre-defined acceptance criteria. For example, burst pressure is measured against a standard, biocompatibility is assessed against ISO 10993, and sterility against ISO 11135.

8. The sample size for the training set:
This is not applicable. No training set was used as this is a physical device, not an AI/ML model being "trained."

9. How the ground truth for the training set was established:
This is not applicable. No training set was used.

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The Advance Serenity 18 Hydrophilic PTA Balloon Dilatation Catheter is indicated for Percutaneous Transluminal Angioplasty (PTA) of the peripheral vasculature in the iliac, femoral, popliteal, infrapopliteal, and renal arteries, and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae.

The Advance Serenity™ 18 Hydrophilic PTA Balloon Dilatation Catheter is a coaxial catheter with a semi compliant balloon near the distal tip. It is an Over-the-Wire (OTW) Percutaneous Transluminal Anqioplasty (PTA) device with various shaft lengths. The balloon has two radiopaque markers that aid in the placement of the balloon within the stenosis. The clearance between the inner and outer shafts acts as the passage for the inflation medium for balloon expansion. The proximal end of the catheter has a bifurcated manifold & strain relief that allows for the 0.018" guidewire and the attachment of a balloon inflation device via a standard luer connector. The inflation device is used to inflate and deflate the balloon with a contrast medium. The device is used by positioning the balloon catheter over a guidewire. The balloon is aligned under fluoroscopy in the diseased vessel at the area to be treated. The balloon is then inflation media to pressures ranging between the nominal and the rated burst pressure to dilate the occluded area. On completion the balloon is then deflated under vacuum and removed from the patient. The Advance Serenity™ 18 Hydrophilic PTA Balloon Dilatation Catheter is to be provided sterile (via ethylene oxide, EtQ) and is intended for single use only.

The provided text is an FDA 510(k) clearance letter and its associated summary for a medical device: the "Advance Serenity™ 18 Hydrophilic PTA Balloon Dilatation Catheter." This document focuses on demonstrating substantial equivalence to a predicate device, rather than proving the safety and effectiveness of a novel device through clinical trials and rigorous statistical validation against predefined acceptance criteria.

Therefore, the information regarding acceptance criteria, study design for proving device performance, sample sizes for test sets, establishment of ground truth, expert adjudication, MRMC studies, standalone performance, training set details, and ground truth for training data is not present in the provided text.

The document primarily outlines:

• Acceptance Criteria (Implicit via Substantial Equivalence): The implicit acceptance criterion for this 510(k) submission is that the device must be shown to be "substantially equivalent" to a legally marketed predicate device. This means it has the same intended use, similar technological characteristics, and any differences do not raise new questions of safety or effectiveness.
• Reported Device Performance: Instead of a detailed table of acceptance criteria and performance against them, the document lists bench tests performed to demonstrate that the small changes (expanded matrix of balloon sizes) compared to the predicate device do not compromise safety or effectiveness.

Here's a breakdown of what is available and what is missing from your request based on the provided text:

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

• Acceptance Criteria: Not explicitly stated as pass/fail thresholds for specific performance metrics in a table. The overall acceptance criterion is "substantial equivalence" to the predicate.

• Reported Device Performance: The document lists bench tests performed, indicating that the results "demonstrate that the technological differences identified do not raise new questions of safety or effectiveness." Specific quantitative results or acceptance criteria for these bench tests are not provided.

  Performed Bench Tests (as listed):

  • Rated burst pressure (RBP)
  • Inflation & deflation time
  • Balloon diameters at nominal pressure to RBP
  • Simulated use - Pushability & Trackability & Sheath Compatibility
  • Coating integrity (b)
  • Multiple inflation/fatigue & leak test
  • Tensile strength Balloon to Shaft (proximal bond)
  • Particulate
  • Balloon Length & Marker Band Position (Leveraged from predicate)
  • Radiopacity (Leveraged from predicate)
  • Ancillary Tool Compatibility (Guidewire) (Leveraged from predicate)
  • Catheter Effective Length (Leveraged from predicate)
  • Tensile Strength Manifold to Shaft (Manifold Bond) (Leveraged from predicate)
  • Tensile Strength (Distal / Tip Bond) (Leveraged from predicate)
  • Tip Profile (Geometry of the catheter most distal tip) (Leveraged from predicate)
  • Simulated Use, Push & Track (Leveraged from predicate)
  • Flexibility & Kink (Leveraged from predicate)
  • Coating Lubricity (Leveraged from predicate)
  • Coating Integrity (a) (Leveraged from predicate)
  • Torque Strength (Leveraged from predicate)

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

• Sample Sizes: Not specified. This document refers to bench testing of a medical device, which typically involves a number of units tested to engineering specifications, but these numbers are not disclosed.
• Data Provenance: The tests are bench tests, not clinical data, so country of origin/retrospective/prospective doesn't apply in the same way. The manufacturer is based in Ireland (Creagh Medical Ltd. dba Surmodics, Inc.).

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

• This is not part of a bench test evaluation for a substantial equivalence determination. Experts are not typically used to establish "ground truth" for physical device performance metrics like burst pressure.

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

• Not applicable to bench 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

• No MRMC study was done. This device is a physical catheter, not an AI/software device that assists human readers.
• The document explicitly states: "No clinical studies were required for the Advance Serenity 18 Hydrophilic PTA Balloon Dilatation Catheter."

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

• Not applicable as it's not an AI/software device.

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

• Not applicable. Performance is measured against engineering specifications and industry standards for physical device properties, not against "ground truth" derived from clinical data or expert consensus.

8. The sample size for the training set

• Not applicable; there is no training set for a physical medical device. (This is relevant for AI models).

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

• Not applicable; there is no training set.

In summary, the provided FDA document is a 510(k) clearance letter for a physical medical device, based on demonstrated "substantial equivalence" through bench testing, not clinical studies or AI model validation. Therefore, most of the detailed information requested regarding clinical study design, data characteristics, expert involvement, and AI model evaluation (points 2-9) is not found in this type of submission.

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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.

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The Sterling Monorail PTA Balloon Dilatation Catheter is indicated for Percutaneous Transluminal Angioplasty in the peripheral vasculature, including iliac, femoral, popliteal, renal, and carotid arteries, and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae. This device is also indicated for post-dilatation of balloon expandable and selfexpanding stents in the peripheral vasculature.

The Sterling Balloon Dilatation Catheter is a Monorail brand rapid exchange catheter with a semicompliant balloon fixed at the distal tip. The balloon catheter has a coaxial shaft design. The outer lumen is used for inflation of the balloon, and the wire lumen permits the use of guidewires 0.014 in / 0.018 in to facilitate advancement of the catheter to and through the stenosis to be dilated. The product's catheter includes a tapered tip to facilitate advancement of the catheter to and through the stenosis. Two radiopaque marker bands (one proximal and one distal), in conjunction with fluoroscopy, enable accurate positioning of the balloon. The effective length of the balloon catheter is 200 cm; catheter markers indicate the exit of the dilatation catheter tip out of the guiding catheter (one at 90 cm and two at 100 cm).

This document is a 510(k) summary for a medical device called the Sterling™ MONORAIL™ PTA Balloon Dilatation Catheter. It seeks to demonstrate substantial equivalence to a predicate device.

The provided text does not contain information related to an AI/ML device or its performance criteria. Therefore, I cannot furnish the requested details regarding acceptance criteria, study methodologies for AI performance, sample sizes for test/training sets, expert ground truth establishment, MRMC studies, or standalone algorithm performance.

The document focuses on the bench testing performed to demonstrate substantial equivalence for this physical medical device (a balloon catheter), not a software or AI/ML product. The performance data section explicitly lists:

• Sterilization Testing
• Bench Testing (Dimensional Verification, Simulated Use, Balloon Inflation & Deflation Time, Catheter Bond Strength, Flexibility & Kink test, Torque Strength, Shaft & Bond Burst, Catheter Extension & Deflation, Packaging Testing, Design Validation Testing)

These are typical tests for a physical medical device to ensure its mechanical properties, function, and safety, not for evaluating an AI algorithm's diagnostic or predictive capabilities.

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The JADE PLUS PTA Balloon Dilatation Catheter is indicated for Percutaneous Transluminal Angioplasty in the peripheral vasculature, including iliac, femoral, popliteal, infra-popliteal, and renal arteries, and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae. This device is also indicated for postdilation of balloon expandable and self-expanding stents in the peripheral vasculature.

The JADE PLUS Percutaneous Transluminal Angioplasty (PTA) Balloon Dilatation Catheters are designed for peripheral indications with Over-The-Wire (OTW) structure. The overthe-wire design permits the use of standard 0.014 inch, 0.018 inch and 0.035 inch guidewires respectively.

This document is a 510(k) summary for the JADE PLUS PTA Balloon Dilatation Catheter. It does not describe an AI/ML powered device, therefore the requested information for acceptance criteria and studies are not applicable in the context of an AI/ML device.

The document discusses the substantial equivalence of the JADE PLUS PTA Balloon Dilatation Catheter to a predicate device, based on in vitro performance tests. The acceptance criteria and reported device performance mentioned relate to physical properties and functionality of the catheter, not to an AI algorithm's performance or accuracy.

The relevant information from the document is related to the device's physical performance testing:

Acceptance Criteria and Reported Device Performance:

The document states that "The test results met all acceptance criteria, which are the same or similar to the predicate device and ensure that the JADE PLUS PTA Balloon Dilatation Catheter design and construction are suitable for their intended use."

The specific performance tests conducted and the general nature of their acceptance criteria are listed:

The study that proves the device meets acceptance criteria is an in vitro performance test study conducted on the subject device in accordance with FDA guidance "Peripheral Percutaneous Transluminal Angioplasty (PTA) and Specialty Catheters" issued on April 14, 2023.

Given that this is a 510(k) summary for a physical medical device (balloon dilatation catheter) and not an AI/ML powered device, the following points are not applicable and therefore cannot be extracted from the provided text:

2. Sample size used for the test set and the data provenance.
3. Number of experts used to establish the ground truth for the test set and their qualifications.
4. Adjudication method.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done.
7. The type of ground truth used.
8. The sample size for the training set.
9. How the ground truth for the training set was established.

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