Search Results

This catheter is recommended for Percutaneous Transluminal Angioplasty (PTA) of the femoral, iliac, and renal arteries. This catheter is not indicated for use in the coronary arteries, stent placement or stent redilation.

The Mullins X™ catheter is an Ultra High Pressure Dilatation catheter recommended for Percutaneous Transluminal Angioplasty (PTA) of the femoral, iliac and renal arteries. The catheter is a coaxial over the wire catheter with a balloon near the distal tip. One lumen permits guidewire insertion to facilitate advancement of the catheter, while the other lumen is for balloon inflation and deflation.

The balloons of the MULLINS X™ PTA Catheter are made of a non-compliant polymeric material. The two laminate balloon system is designed to inflate to a specific diameter at a given pressure. The change in diameter is minimal over the range of inflation pressures. The balloons are heat bonded to the shaft.

The outer body is made of polymeric tubing, and the inner tubing is comprised of a multi layer extrusion of polyamide (Vestamid PA12) that surrounds a braid of 304 LV Stainless Steel. The area under the balloon is enhanced with four radiopaque platinum image bands. Two are 5mm on each side of the balloon center and two more under the balloon shoulders.

The catheter is white in color and the balloon material is clear. The catheter balloon diameter and name is stamped onto the Y sleeve and the balloon extension is labeled with balloon diameter x balloon length x introducer size x shaft size x usable length x guidewire size and the catheter lot number. The catheter is packaged in a polyethylene sheath and is double packed in two heat sealed Tyvek pouches.

This document is a 510(k) Pre-market Notification for a medical device, specifically a PTA catheter. It is a submission to the FDA to demonstrate substantial equivalence to a legally marketed predicate device. This type of submission relies on comparisons to existing devices and bench testing, rather than extensive clinical studies with human subjects or AI algorithms as would be required for the information requested.

Therefore, many of the requested categories related to clinical studies, AI algorithms, and ground truth establishment are not applicable to this particular document.

Here's a breakdown of what can be extracted and what cannot:

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

The document does not explicitly state formal "acceptance criteria" with numerical targets for clinical performance in the way an AI study would. Instead, it demonstrates performance through bench testing and comparison to a predicate device.

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

• Sample Size: Not applicable. This document refers to bench testing and comparison to a predicate device. It does not involve a "test set" of patient data for evaluating an AI algorithm.
• Data Provenance: Not applicable.

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

Not applicable. "Ground truth" in the context of expert consensus is not relevant for this type of device submission. The "ground truth" for a medical device in this context would be its physical and mechanical properties, and its safety and efficacy, demonstrated through bench testing and clinical equivalence to a known predicate.

4. Adjudication method for the test set

Not applicable. There is no "test set" of data requiring expert adjudication.

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 approval for a physical catheter, not an AI algorithm.

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

Not applicable. This is a medical device approval for a physical catheter, not an AI algorithm.

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

The closest concept to "ground truth" here would be:

• Bench Test Results: Objective measurements of the catheter's physical and mechanical properties (e.g., inflation diameter at a given pressure, material strength, radiopacity). These results, which are "on file at NuMED, Inc.", serve as the factual basis for its performance claims.
• Predicate Device Performance: The established safety and effectiveness of the legally marketed predicate device (NuMED Mullins-X PTA Catheter, K041093, and Z-MED Catheter, K931009) provides the "ground truth" for comparison to establish substantial equivalence.

8. The sample size for the training set

Not applicable. This is a medical device approval for a physical catheter, not an AI algorithm.

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

Not applicable. This is a medical device approval for a physical catheter, not an AI algorithm.

Summary of what the document focuses on:

This 510(k) summary focuses on demonstrating the substantial equivalence of the new Mullins-X PTA Catheter to previously cleared predicate devices by:

• Stating identical materials for biocompatibility.
• Indicating that bench testing was performed according to GMPs, with results on file (though specifics are not in this summary).
• Directly comparing the device's characteristics (indications, size, materials, construction) to a predicate device, showing minimal differences, with the primary difference being an additional balloon diameter.

The content is typical for a 510(k) submission for a non-AI medical device and does not contain the information requested about AI performance or clinical study details.

Ask a specific question about this device

This catheter is recommended for Percutaneous Transluminal Angioplasty (PTA) of the femoral, iliac, and renal arteries. These catheters are not designed to be used in the coronary arteries.

The Mini Ghost PTA Catheter is a coaxial catheter indicated for PTA of small vessels outside of the heart. This catheter is not intended for use in the coronary arteries. The catheter consists of a 3.5F polyamide outer shaft with a distally mounted balloon. The catheter terminates proximally in a bifurcated Y sleeve with separate extensions for the balloon and the guidewire. The inner tubing extends through the balloon and accommodates a 0.018" guidewire. The lumen has radiopaque platinum marker bands under the balloon shoulders for placement using fluoroscopy. The catheter balloon diameter is stamped onto the Y sleeve and the balloon extension is labeled with balloon diameter x balloon length x introducer size x shaft size x usable length x guidewire size and the catheter lot number. The catheter is packaged in a polyethylene sheath and is double packed in two heat sealed Tyvek pouches.

This document is a 510(k) summary for a medical device called the NuMED Mini Ghost PTA Catheter. It focuses on demonstrating substantial equivalence to a predicate device, rather than proving performance against specific acceptance criteria through a clinical study. Therefore, most of the requested information regarding acceptance criteria and study details cannot be extracted from this document.

Here's what can be extracted and inferred:

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

The document does not state explicit numerical acceptance criteria for device performance in the way one might see for a diagnostic AI device (e.g., sensitivity > X%, specificity > Y%). Instead, the acceptance criteria are largely implied by establishing "substantial equivalence" to a predicate device, meaning the new device should perform similarly and be as safe and effective.

The reported device performance is conveyed through a comparison with the predicate device, focusing on shared characteristics and intended use.

Regarding the "study that proves the device meets the acceptance criteria":

Based on the provided text, no clinical study proving the device meets numerical performance acceptance criteria was conducted for this 510(k) submission. Instead, the submission relies on:

• Bench Testing: Laboratory (Bench) Testing was performed according to GMPs, and results are on file. This testing would verify the physical and mechanical properties of the device against design specifications.
• Biocompatibility Testing: The materials used are identical to previously cleared devices which underwent biocompatibility testing in compliance with established guidance.
• Comparison to Predicate: The primary "proof" for 510(k) clearance is demonstrating substantial equivalence to an already legally marketed device (the predicate). This means showing the new device has the same intended use, similar technological characteristics, and is as safe and effective as the predicate.

Given this context, the following information cannot be extracted or is not applicable:

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

• Not applicable; no clinical test set described. Bench testing sample sizes would be internal to NuMED.

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

• Not applicable; no clinical test set or ground truth described.

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

• Not applicable; no clinical test set described.

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) 510(k), not an AI diagnostic algorithm.

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

• Not applicable; this is a medical device (catheter) 510(k), not an AI diagnostic algorithm.

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

• For biocompatibility, the ground truth was the established standards and testing methods.
• For bench testing, the ground truth was the engineering specifications and performance expectations for the device.
• No clinical ground truth as no clinical study was conducted for this 510(k).

8. The sample size for the training set

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

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

• Not applicable; this is not an AI/ML device.

Ask a specific question about this device

This catheter is recommended for Percutaneous Transluminal Angioplasty (PTA) of the femoral, iliac, and renal arteries. These catheters are not designed to be used in the coronary arteries.

The Mini Ghost PTA Catheter is a coaxial catheter indicated for PTA of small vessels outside of the heart. This catheter is not intended for use in the corronary arteries. The catheter consists of a 3.5F polyamide outer shaft with a distally mounted balloon. The catheter terminates proximally in a bifurcated Y sleeve with mounted bandem. For the balloon and the guidewire. The inner tubing extends through the balloon and accommodates a 0.018" guidewire. The lumen has radiopaque platinum marker bands under the balloon shoulders for placement using fluoroscopy. The catheter balloon diameter is stamped onto the Y sleeve and the balloon extension is labeled with balloon diameter x balloon length x introducer size x shaft size x usable length x guidewire size and the catheter lot number. The catheter is packaged in a polyethylene sheath and is double packed in two heat sealed Tyvek pouches.

The provided text describes a 510(k) summary for the NuMED Mini Ghost PTA Catheter. This type of submission is for demonstrating substantial equivalence to a predicate device, not typically a study proving performance against specific acceptance criteria.

Therefore, the document does not contain the following information regarding acceptance criteria and a study proving a device meets them in the way usually associated with novel device performance evaluation:

• A table of acceptance criteria and the reported device performance: No such table is presented. The comparison table focuses on device specifications (shaft size, guidewire size, materials, etc.) rather than performance metrics with acceptance limits.
• Sample size used for the test set and the data provenance: Not mentioned.
• Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable as there's no clinical performance study described.
• Adjudication method for the test set: Not applicable.
• 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-based diagnostic device.
• If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable, as this is not an AI-based diagnostic device.
• The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable.
• The sample size for the training set: Not applicable.
• How the ground truth for the training set was established: Not applicable.

However, the document does describe the performance evaluation conducted for device clearance, which is primarily focused on bench testing and biocompatibility testing to establish substantial equivalence.

Here's a breakdown of the relevant information from the provided text regarding device performance evaluation:

Biocompatibility Testing:

• Acceptance Criteria: Implicitly, the materials must demonstrate biocompatibility in compliance with the Tripartite Biocompatibility Guidance for Medical Devices.
• Reported Device Performance: "Test results indicate that all materials demonstrate the biocompatibility of the NuMED catheter and are on file at NuMED, Inc."
• Study Description: The materials used in the Mini Ghost PTA Catheter are the same as those used in the predicate device, NuMED Z-MED PTA Catheter (K931009), which were tested for biocompatibility.

Laboratory (Bench) Testing:

• Acceptance Criteria: Implicitly, the device must meet design specifications and functional requirements typical for PTA catheters. No specific numerical acceptance criteria are listed in the summary.
• Reported Device Performance: "All bench testing was performed in accordance with GMP's and the results are kept on file at NuMED, Inc."
• Study Description: Bench testing was performed. No further details on specific tests or results are provided in the 510(k) summary (they are stated to be on file).

Substantial Equivalence Comparison (Functional and Material Performance):

While not a "study" in the traditional sense of a clinical trial, the 510(k) submission relies on a comparison table to the predicate device to demonstrate that the new device performs similarly or is safe and effective for its intended use.

In summary, the provided text describes a 510(k) submission that demonstrates substantial equivalence primarily by:

1. Stating identical biocompatible materials to a previously cleared predicate device.
2. Confirming bench testing was performed according to GMPs, with results on file (but not detailed in the summary).
3. Providing a comparison table highlighting that the new device shares the same intended use, materials, and fundamental construction as the predicate, with modifications (smaller sizes) that are consistent with its "Mini Ghost" designation for small vessel PTA. The changes are presented as variations within the same device category, not as requiring new performance studies to prove efficacy or safety in a new domain.

Ask a specific question about this device

This device is labeled for Percutaneous Transluminal Angioplasty (PTA) if the femoral, iliac and renal arteries. These catheters are not designed to be used in the coronary arteries.

The BIB PTA Catheter has a tri-axial shaft design which allows for inflation of two balloons, one contained inside the other, and a guidewire lumen for placement inside the vasculature. Both balloons are identical to those currently marketed by NuMed on the Tyshak PTA and Z-Med PTA catheters. The balloons are non-compliant and include radiopaque platinum marker bands on the catheter shaft to facilitate placement of the device under fluoroscopy. The BIB catheter will be available in standard diameters from 8 mm to 24 mm for the outer balloon and 4 mm to 12 mm for the inner balloon. Balloon lengths of 1.5 cm to 5.5 cm will available. The device has an overall shaft length of 110 cm.

The provided text describes a 510(k) summary for the BIB PTA Balloon Catheter. This document is a regulatory submission for a medical device and, as such, focuses on demonstrating substantial equivalence to a predicate device rather than presenting a performance study with detailed acceptance criteria and results as typically found in clinical trials for novel devices or AI algorithms.

Therefore, the requested information regarding acceptance criteria, study details, sample sizes, expert involvement, and ground truth establishment, as they relate to proving a device meets specific acceptance criteria through a study, is not present in the provided text.

The document states: "The BIB PTA Balloon Catheter have been tested and compared to the Summary of predicate devices listed herein. All data gathered demonstrate the BIB PTA Safety and Effectiveness Catheter is substantially equivalent. No new issues of safety or efficacy have been raised." This indicates that verification and validation activities were performed to support substantial equivalence, but the specifics of those tests and their acceptance criteria are not detailed.

Here's an assessment based on the provided text, indicating where information is not available:

1. Table of Acceptance Criteria and Reported Device Performance

Not available. The document does not provide a table of acceptance criteria or specific performance metrics. It generally states that the device has been "tested and compared" to predicate devices and deemed "substantially equivalent" with "no new issues of safety or efficacy."

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

Not available. The document does not specify a test set sample size or data provenance (e.g., country of origin, retrospective/prospective). It refers to "all data gathered" for demonstrating substantial equivalence.

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

Not applicable/Not available. This device is a PTA Balloon Catheter, not an AI diagnostic device. The concept of "ground truth" and "experts to establish ground truth" as typically applied to image analysis or diagnostic AI algorithms does not directly apply here. For a physical medical device, "ground truth" would be related to its physical properties, biocompatibility, and functional performance, which are evaluated through engineering tests, material analysis, and potentially animal or human clinical data (though no specific clinical study details are provided here beyond reference to predicate devices).

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

Not applicable/Not available. As explained above, an adjudication method for a test set, pertaining to expert consensus on diagnostic outcomes, is not relevant to this type of device and its regulatory submission.

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 specific type of study (MRMC for AI assistance) is not relevant for a physical medical device like a balloon catheter.

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

Not applicable. This concept pertains to AI algorithms, not a physical medical device.

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

Not available. While the document states "biocompatibility tests" were passed and the device was "tested and compared" to predicate devices, it does not specify the type of ground truth used for these tests. For a physical device, ground truth would typically refer to validated measurement techniques for physical properties (e.g., burst pressure, inflation/deflation times), material science standards, and potentially in vivo or in vitro models for biocompatibility and performance.

8. The sample size for the training set

Not applicable/Not available. The concept of a "training set" applies to machine learning algorithms, which is not the subject of this 510(k) submission.

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

Not applicable/Not available. As above, this concept pertains to machine learning algorithms.

Ask a specific question about this device

Multi-Track Angiographic Catheter (K952984, K003902) - Recommended for use in Multi-Track Anglography of cardiovascular vessels and/or chambers. It can be used for catheterization for anglogiap. In and pressure measurement in any chamber or vessel.

Ghost II PTA (K003972, K011557) - This catheter is recommended for Percutaneous Gransbuminal Angioplasty (PTA) of the femoral, iliac, and renal arteries. These catheters are not designed to be used in the coronary arteries.

Z-MED Catheter (K991977, K003114, K003643, K011557) - This catheter is recommended for Percutaneous Transluminal Valvuloplasty (PTV) of the pulmonary valve.

• A patient with isolated pulmonary stenosis .
• A patient with valvular pulmonary stenosis with other minor congenital heart disease that 사 does not require surgical intervention. And;

(K931009, K011557) This catheter is recommended for Percutaneous Transluminal Angioplasty (ISSIN67) Internoral, ilias, and renal arteries. These catheters are not designed to be used in the coronary arteries.

Tyshak Mini Pediatric PTV Catheter (K003276, K011557, K032591) - This catheter is I your recuration for Percutaneous Transluminal Valvuloplasty (PTV) of the pulmonary valve in Pediatric applications.

• A patient with isolated pulmonary stenosis. u
• A patient with valvular pulmonary stenosis with other minor congenital heart disease that l does not require surgical intervention.

Tyshak Catheter (K991977, K003114, K011557) - This catheter is recommended for Percutaneous Transluminal Valvuloplasty (PTV) of the pulmonary valve.

• A patient with isolated pulmonary stenosis u
• A patient with valvular pulmonary stenosis with other minor congenital heart disease that ■ does not require surgical intervention. And;

(K931009, K011557) This catheter is recommended for Percutaneous Transluminal Angioplasty (RSS1007, Norths of I'ms cancenal arteries. These catheters are not designed to be used in the coronary arteries.

Tyshak II Catheter (K003052, K011557, K030589) - This catheter is recommended for I Yshak II Catherer in Catherer (PTV) of the pulmonary valve.

• A patient with isolated pulmonary stenosis i
• A patient with isolated pulmonary stenosis
  A patient with valvular pulmonary stenosis with other minor congenital heart disease that I does not require surgical intervention. And;

Z-MED II Catheter (K003052, K011557, K030589) - This catheter is recommended for Percutaneous Transluminal Valvuloplasty (PTV) of the pulmonary valve.

• A patient with isolated pulmonary stenosis .
• A patient with isolated pulmonary stenosis with other minor congenital heart disease that l does not require surgical intervention. And;

High Pressure PTA (Marauder) (K010880, K011557) - This catheter is recommended for right Fressure I 17x (maraduct) (PTA) of the femoral, iliac, and renal arteries. These catheters are not designed to be used in the coronary arteries.

Z-5 Atrioseptostomy (K960070, K011557) - Used for the palliation of several congenital heart 2-5 All loseptosition of the great arteries, total anomalous pulmonary venous drainage without delects. transposition of the Ereal arcess, mitral stenosis, mitral atresia, and pulmonary atresia with intact ventricular septum.

Z-5 Braided Atrioseptostomy (K001804, K011557) - Used for the palliation of several 2-3 Draided Attrioseptostom. (2001 of the great arteries, total anomalous pulmonary venous congential licar delected transportion, tricuspid atresia, mitral stenosis, mitral atressa, and pulmonary atresia with intact ventricular septum.

Tyshak X Catheter (K022722) - This catheter is recommended for Percutaneous Transluminal Valvuloplasty (PTV) of the pulmonary valve.

• A patient with isolated pulmonary stenosis .
• A patient with valvular pulmonary stenosis with other minor congenital heart disease that I does not require surgical intervention.

Tyshak II X Catheter (K022722) - This catheter is recommended for Percutaneous Transluminal Valvuloplasty (PTV) of the pulmonary valve.

• A patient with isolated pulmonary stenosis .
• A patient with valvular pulmonary stenosis with other minor congenital heart disease that 1 does not require surgical intervention.

Z-MED X Catheter (K022722) - This catheter is recommended for Percutaneous Transluminal Valvuloplasty (PTV) of the pulmonary valve.

• A patient with isolated pulmonary stenosis a
• A patient with valvular pulmonary stenosis with other minor congenital heart disease that . does not require surgical intervention.

Z ·MED II X Catheter (K022722) - This catheter is recommended for Percutaneous Transluminal Valvuloplasty (PTV) of the pulmonary valve.

• A patient with isolated pulmonary stenosis .
• A patient with valvular pulmonary stenosis with other minor congenital heart disease that . does not require surgical intervention.

COEfficient Catheter (K014124) - This catheter is recommended for Percutaneous Transluminal Valvuloplasty (PTV) of the pulmonary valve.

• A patient with isolated pulmonary stenosis ﺎ
• A patient with isolated pulmonary stenosis with other minor congenital heart disease that I does not require surgical intervention.

Ghost PTA (K931009, K011557) - This catheter is recommended for Percutaneous Gross ITTA (KSJ1007) RW115872 - The femoral, iliac, and renal arteries. These catheters are not designed to be used in the coronary arteries.

Mullins PTA (K013601) - This catheter is recommended for Percutaneous Transluminal Millins ITA (INVL001) - This Satileter and renal arteries. These catheters are not designed to be used in the coronary arteries.

Mullins X PTA (K022722)_- This catheter is recommended for Percutaneous Transluminal Mullins A F FA (XN22122) - Frid Sains and renal arteries. These catheters are not designed to be used in the coronary arteries.

PTS (K003320, K011557) - For use in those patients with cardiovascular defects wherein accurate measurement of the defect is important to select the appropriately sized occluder device.

Not Found

The provided document is a 510(k) summary for NuMED Catheters, primarily focusing on extending the shelf life of their existing devices from 3 to 5 years, and outlining their various intended uses. It does not contain information about acceptance criteria or a study proving device performance in the context of diagnostic or therapeutic efficacy.

The document details:

• K040830 - All NuMED Catheters: A submission for various catheters (angiographic, PTA, PTV, atrioseptostomy, etc.).
• Purpose of Submission: To extend the shelf life validation from 3 to 5 years, indicating a focus on stability rather than primary diagnostic or therapeutic performance.
• Predicate Devices: Numerous existing NuMED catheters.
• Regulatory Information: Class II devices, product codes, and relevant CFR sections.
• Indications for Use: Detailed indications for each specific catheter type (e.g., Multi-Track Angiographic Catheter for angiography, Ghost II PTA for Percutaneous Transluminal Angioplasty of femoral, iliac, and renal arteries, Z-MED Catheter for Percutaneous Transluminal Valvuloplasty of the pulmonary valve).

Therefore, I cannot provide the requested information regarding acceptance criteria and a study proving the device meets those criteria for diagnostic or therapeutic performance because this information is not present in the provided text. The document is a regulatory submission for shelf-life extension and outlines intended uses, not a clinical performance study.

Ask a specific question about this device

For use in those patients with cardiovascular defects wherein accurate measurement . I of the defect is important to select the appropriately sized occluder device.

The NuMED, Inc. PTS X™ Sizing Balloon catheter is a coaxial catheter for use in those patients with cardiovascular defects wherein accurate measurement of the defect is important to select the appropriately sized occluder device. The outer body is made of polymeric tubing, and the inner tubing is comprised of a multi layer extrusion of polyamide (Vestamid PA12) that surrounds a braid of 304 LV Stainless Steel. The catheter features a proximal end bifurcate with two distinct luminal passages. The inflation lumen terminates into a distally mounted balloon. This balloon is of the non-compliant variety and will have a typical single wall thickness of 0.0004". This balloon is designed to insert through the smallest possible introduction sleeve. The through lumen terminates at the tip of the catheter and will accept the passage of the appropriate guidewire. This lumen has radiopaque platinum marker bands under the balloon shoulders for placement using fluoroscopy. Additionally, there are two radiopaque platinum marker bands spaced at 10mm (as measured from leading edge to leading edge). These bands are located at the balloon center and are used as a distance reference. The catheter is white in color and the balloon material is clear. The catheter balloon diameter is stamped onto the Y sleeve and the balloon extension is labeled with balloon diameter x balloon length x introducer size x shaft size x usable length x guidewire size and the catheter lot number. The catheter is packaged in a polyethylene loop and is double packed in two heat sealed Tyvek pouches.

The provided text is a clearance letter from the FDA for the NuMED PTS X Sizing Balloon Catheter, not a study report. Therefore, it does not contain information about acceptance criteria, device performance, sample sizes, ground truth establishment, or multi-reader multi-case studies.

The document primarily states that the device is substantially equivalent to a legally marketed predicate device (NuMED PTS Catheter) based on its intended use and material similarity. It outlines the regulatory classification and general requirements for the device.

Here's a breakdown of why the requested information cannot be extracted from the provided text:

• No clinical study or performance data: The letter focuses on the regulatory clearance process and substantial equivalence, not on a detailed study proving performance against specific acceptance criteria.
• No mention of acceptance criteria: Specific metrics for device performance (e.g., accuracy of measurement, safety rates) that would constitute "acceptance criteria" are not listed.
• No device performance metrics: The document describes the device and its intended use but does not provide quantitative or qualitative data on how well it performs its function.
• No sample size for test set: No clinical or laboratory test results are detailed with sample sizes.
• No data provenance: Information on the origin of data (if any), such as geographical location or retrospective/prospective nature, is absent.
• No expert involvement: There is no mention of experts establishing ground truth or their qualifications.
• No adjudication method: This would be relevant to evaluating expert consensus, which isn't discussed.
• No MRMC study: The document does not describe any study involving human readers or AI assistance.
• No standalone algorithm performance: This device is a physical catheter, not an algorithm, so standalone algorithm performance is not applicable.
• No type of ground truth used: Since no performance study is described, there's no mention of ground truth.
• No sample size for training set/ground truth for training set: These concepts are typically relevant to AI/machine learning models, which this device is not. The "training" for this device would be its design and manufacturing processes, not data training.

In summary, the provided document is a regulatory clearance letter, not a study report. It does not contain the information required to populate the table or answer the specific questions about acceptance criteria, study details, and device performance.

Ask a specific question about this device

This catheter is recommended for Percutaneous Transluminal Angioplasty (PTA) of the femoral, iliac, and renal arteries. These catheters are not designed to be used in the coronary arteries.

The Mullins X™ catheter is recommended for Percutaneous Transluminal Angioplasty (PTA) of the femoral, iliac and renal arteries. The catheter is a coaxial over the wire catheter with a balloon near the distal tip. One lumen permits guidewire insertion to facilitate advancement of the catheter, while the other lumen is for balloon inflation and deflation.

The balloons of the MULLINS X™ PTA Catheter are made of a non-compliant polymeric material. The two laminate balloon system is designed to inflate to a specific diameter at a given pressure. The change in diameter is minimal over the range of inflation pressures. The balloons are heat bonded to the shaft.

The outer body is made of polymeric tubing, and the inner tubing is comprised of a multi layer extrusion of polyamide (Vestamid PA12) that surrounds a braid of 304 LV Stainless Steel. The area under the balloon is enhanced with five radiopaque platinum image bands. Two that are 5mm on each side of the balloon center and two more under the balloon shoulders. An additional image band is imbedded into the tip of the catheter as an additional safety measure.

The catheter is white in color and the balloon material is clear. The catheter balloon diameter and name is stamped onto the Y sleeve and the balloon extension is labeled with balloon diameter x balloon length x introducer size x shaft size x usable length x guidewire size and the catheter lot number. The catheter is packaged in a polyethylene sheath and is double packed in two heat sealed Tyvek pouches.

The provided document is a 510(k) premarket notification for a medical device (NuMED Mullins X PTA Catheter), which primarily focuses on demonstrating substantial equivalence to a predicate device based on manufacturing specifications, materials, and intended use. It does not contain information about clinical studies, device performance in terms of efficacy or diagnostic accuracy, or specific acceptance criteria and their achievement through studies in the way a diagnostic AI device submission would.

Therefore, I cannot extract the requested information regarding acceptance criteria, study details, sample sizes, expert ground truth adjudication, MRMC studies, standalone performance, or training set details. This document describes a medical device for a physical intervention (PTA catheter), not a diagnostic algorithm or AI system.

I reiterate that the provided text does not contain any information about acceptance criteria or studies proving device performance related to diagnostic accuracy, AI, or human reader improvement.

The document does mention:

• Biocompatibility Testing: Materials used are the same as previously approved devices (K931009, K991977) which were tested for biocompatibility in compliance with the Tripartite Biocompatibility Guidance for Medical Devices. Test results are on file at NuMED, Inc.
• Laboratory (Bench) Testing: All bench testing was performed in accordance with GMP's and results are kept on file at NuMED, Inc.

However, these are general statements about compliance and are not the type of detailed performance studies asked for in the user's prompt (which implies a diagnostic or AI-driven device context).

Ask a specific question about this device

This catheter is recommended for Percutaneous Transluminal Valvuloplasty (PTV) of the pulmonary valve.

• A patient with isolated pulmonary stenosis
• A patient with valvular pulmonary stenosis with other minor congenital heart disease that does not require surgical intervention.

The NuMED, Inc. Tyshak II PTV catheter is a coaxial catheter for use in PTV applications where a small introduction site is necessary. The catheter inner and outer shafts are constructed of polymeric tubing. The catheter features a molded proximal end bifurcate with two distinct luminal passages. The inflation lumen terminates into a distally mounted balloon made of polymeric material. This balloon is of the non-compliant variety and will have a typical single wall thickness of 0.0004". This balloon is designed to insert through the smallest possible introduction sleeve. Both the shaft size and the guidewire size varies according to balloon diameter with the Tyshak II catheter. The distal lumen terminates at the tip of the catheter and will accept the passage of the appropriate guidewire. This lumen has radiopaque platinum marker bands under the balloon shoulders for placement using fluoroscopy. The catheter is white in color and the balloon material is clear. The catheter balloon diameter is stamped onto the Y connector and the inflation extension is labeled with balloon diameter x balloon length x introducer size x shaft size x usable length x guidewire size and the catheter lot number. The catheter is packaged in a polyethylene loop and is double packed in two heat sealed Tyvek pouches. This catheter is very similar in construction to the Tyshak PTV catheters except for the thinner balloon and lower profile. The Tyshak II catheter is available in standard diameters from 4mm to 30mm in standard lengths of 2cm, 3cm, 4cm, 5cm, 6cm, 8cm and 10cm. Guidewire sizes will vary from 0.021" to 0.035" and shaft sizes from 4F to 9F.

The NuMED, Inc. Z-MED II PTV catheter is a coaxial catheter for use in PTV applications. The catheter inner and outer shafts are constructed of polymeric tubing. The catheter features a molded proximal end bifurcate with two distinct luminal passages. The inflation lumen terminates into a distally mounted balloon made of polymeric material. This balloon is of the non-compliant variety. This balloon is designed to insert through the smallest possible introduction sleeve. Both the shaft size and the guidewire size varies according to balloon diameter with the Z-MED II catheter. The distal lumen terminates at the tip of the catheter and will accept the passage of the appropriate guidewire. This lumen has radiopaque platinum marker bands under the balloon shoulders for placement using fluoroscopy. The catheter is white in color and the balloon material is clear. The catheter balloon diameter is stamped onto the Y connector and the inflation extension is labeled with balloon diameter x balloon length x introducer size x shaft size x usable length x guidewire size and the catheter lot number. The catheter is packaged in a polyethylene loop and is double packed in two heat sealed Tyvek pouches. This catheter is very similar in construction to the Z-MED PTV catheter except for the thicker balloon material. The Z-MED II catheter is available in standard diameters from 4 mm to 30 mm in standard lengths of 2 cm to 10 cm. Guidewire sizes will vary from 0.025" to 0.035" and shaft sizes will vary from 5F to 9F.

The provided document describes a 510(k) premarket notification for the NuMED Tyshak II and Z-Med II PTV Catheters, which modifies previously approved devices by introducing new lengths. Since this is a 510(k) submission, the primary goal is to demonstrate substantial equivalence to a predicate device, rather than proving performance against specific acceptance criteria through a clinical trial or extensive standalone algorithm testing.

Therefore, many of the typical sections you'd expect for AI/algorithm performance studies (like sample size for test sets, number of experts, adjudication methods, MRMC studies, standalone performance with metrics like sensitivity/specificity, or training set details) are not applicable or explicitly mentioned in this type of submission. The focus is on demonstrating that the new device (with extended lengths) is as safe and effective as the predicate device already on the market.

Here's an analysis based on the provided text, addressing your points where possible:

1. Table of Acceptance Criteria and Reported Device Performance

For a 510(k) submission focused on modifications to an existing device, "acceptance criteria" are typically related to maintaining the same performance characteristics as the predicate device. The document states that the new models are "very similar in construction" to the predicate devices, with specific differences (thinner balloon for Tyshak II, thicker balloon material for Z-MED II) and new lengths.

The primary "performance" demonstrated here is the meeting of biocompatibility and bench testing standards, implying that the modified devices perform equivalently to the predicate devices in these aspects. There are no explicit performance metrics (e.g., success rates in procedures) measured against numerical acceptance criteria presented in this specific document.

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

Not applicable for this type of submission. There is no mention of a "test set" in the context of clinical data for AI/algorithm performance. The biocompatibility and bench testing are presumably performed on a sample of the manufactured devices, but specific sample sizes for these tests are not provided and are internal to NuMED, Inc. The document states "Test results indicate that all materials demonstrate the biocompatibility... and are on file at NuMED, Inc." and "All bench testing was performed in accordance with GMP's and the results are kept on file at NuMED, Inc." This indicates the provenance is internal data from NuMED's labs from their testing.

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

Not applicable. This device is a catheter, not an AI or diagnostic algorithm requiring expert-established ground truth from medical images or clinical outcomes in a test set.

4. Adjudication Method for the Test Set

Not applicable, as there is no "test set" in the context of clinical data requiring expert adjudication.

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 catheter, not an AI-assisted diagnostic tool.

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

Not applicable. This is a physical medical device.

7. The Type of Ground Truth Used

For biocompatibility, the "ground truth" is compliance with established biological safety standards for medical device materials. For bench testing, the "ground truth" is adherence to engineering specifications and performance parameters demonstrated as safe and effective for the predicate device. These are established through standardized testing protocols (e.g., ISO, ASTM).

8. The Sample Size for the Training Set

Not applicable. There is no AI algorithm involved, thus no "training set."

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

Not applicable.

Ask a specific question about this device

This catheter is recommended for Percutaneous Transluminal Valvuloplasty (PTV) of the pulmonary valve.

• A patient with isolated pulmonary stenosis
• A patient with valvular pulmonary stenosis with other minor congenital heart disease that does not require surgical intervention.

The COEfficient PTV Catheter is a coaxial over-the-wire catheter with a balloon near the distal tip. One lumen permits guidewire insertion to facilitate advancement of the catheter into the pulmonary valve while the other lumen is for balloon inflation and deflation. The balloon of the COEfficient model is made of a non-compliant polyethylene. The balloons are designed to inflate to a specific diameter at a given pressure. The change in diameter is minimal over the range of inflation pressures. The catheter body ends proximally in a bifurcated 'Y' connector with a guidewire port and a balloon extension. The balloon extension is marked with the product lot number and the balloon size. The outer body and inner body tubing is made of pebax. The area under the balloon is enhanced with either one or two radiopaque platinum image bands depending on the model. If marked with one image band, it is centered under the midpoint of the balloon. If it is marked with two image bands, they are located under the shoulders of the balloon. This catheter is of the same design and construction as the NuMED PTV catheters for which the 510(K) has been approved. The differences are lower profile, smaller shaft, and higher rated burst pressure.

Here's an analysis of the provided text regarding the NuMED COEfficient PTV Catheter, focusing on acceptance criteria and study information:

Based on the provided Summary of Safety and Effectiveness Data for the NuMED COEfficient PTV Catheter (K014124), the device's acceptance criteria and studies primarily revolve around demonstrating substantial equivalence to a predicate device and meeting biocompatibility and bench testing standards.

It's important to note that this document is a 510(k) summary, which typically focuses on demonstrating equivalence rather than an independent clinical study proving efficacy against specific quantitative clinical outcomes.

1. Table of Acceptance Criteria and Reported Device Performance

Given that this is a 510(k) submission based on substantial equivalence, the "acceptance criteria" are implicitly defined by the characteristics of the predicate device, the NuMED Z-MED PTV Catheter. The device performance is reported as meeting or being comparable to these characteristics, with specific improvements highlighted.

• Introducer: 4 Fr - 7 Fr (Lower Profile)
• Shaft Size: 3.5 Fr (Smaller Shaft)
• Guidewire Size: 0.018"
• Usable Length: 75 cm
• Balloon Diameter: 4 mm - 12 mm
• Balloon Length: 2 cm - 4 cm |
  | Rated Burst Pressure | Implicitly, a safe and effective burst pressure for intended use. | Improved: Higher rated burst pressure (stated qualitatively compared to predicate). |

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

The document does not describe a clinical "test set" in the traditional sense of a patient cohort. The support for the device largely comes from:

• Materials Biocompatibility Testing: The "test set" here would refer to the materials themselves. The document states the materials were tested, but does not specify the sample size of material samples or the specific tests performed (though it references the Tripartite Biocompatibility Guidance).
• Laboratory (Bench) Testing: The "test set" here refers to the device units subjected to various bench tests (e.g., burst pressure, dimensional accuracy). The document states "All bench testing was performed," but does not specify the sample size of devices tested for each parameter.
• Comparison to Predicate: The "test set" is effectively the design and performance specifications of the NuMED COEfficient PTV Catheter compared to the NuMED Z-MED PTV Catheter.

Data Provenance: The data provenance is internal to NuMED, Inc. (Hopkinton, NY, USA), with testing described as being performed in accordance with GMPs (Good Manufacturing Practices). This constitutes retrospective evaluation against established standards and comparison to a previously approved device. There is no indication of prospective patient data collection for this 510(k) submission.

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

This type of information is not applicable to this submission. The ground truth for biocompatibility is established by standardized testing protocols (e.g., ISO standards referenced by the Tripartite Guidance). The ground truth for bench testing (e.g., burst pressure, dimensions) is established by engineering specifications and direct measurement, not expert consensus. For substantial equivalence, the "ground truth" is the established safety and effectiveness of the predicate device, which would have been determined at its time of approval.

4. Adjudication Method for the Test Set

Not applicable. There is no clinical test set requiring expert adjudication for this 510(k) submission.

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

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This device is a physical medical device (catheter), not an AI/imaging diagnostic tool, and the submission is for substantial equivalence rather than a comparative clinical effectiveness trial. Therefore, an effect size of human readers improving with/without AI assistance is not relevant or provided.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

No, a standalone algorithm study was not done. This is a physical medical device, not a software algorithm.

7. The Type of Ground Truth Used

The "ground truth" for this 510(k) submission is established by:

• Predicate Device Equivalence: The primary ground truth is the established safety and effectiveness of the NuMED Z-MED PTV Catheter, to which the COEfficient PTV Catheter is demonstrated to be substantially equivalent.
• Standardized Bench Test Results: Objective measurements against engineering specifications (e.g., burst pressure, dimensions, inflation characteristics).
• Biocompatibility Standards: Compliance with recognized international and national guidelines for biocompatibility (Tripartite Biocompatibility Guidance).

There is no mention of expert consensus, pathology, or outcomes data from a clinical trial for establishing the ground truth for this specific submission, as it relies on equivalence to a predicate.

8. The Sample Size for the Training Set

Not applicable. This 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

Not applicable. As above, there is no training set for this device.

Ask a specific question about this device

This catheter is recommended for Percutaneous Transluminal Angioplasty (PTA) of the femoral, iliac, and renal arteries. These catheters are not designed to be used in the coronary arteries.

The NuMED, Inc. MULLINS™ PTA Catheter is a co-axial over-the-wire catheter with a balloon near the distal tip. It is available in sizes of 12-20mm diameter and 3-4cm in length. One lumen permits guidewire insertion to facilitate advancement of the catheter, while the other lumen is for balloon inflation and deflation. The balloons of the NuMED, Inc. MULLINS™ PTA Catheter is made of a noncompliant polymeric material and are the same balloons that are used on the approved Z-MED Catheter (K931009, K991977, and K011557). The two laminate balloon system is designed to inflate to a specific diameter at a given pressure. The change in diameter is minimal over the range of inflation pressures. The balloons are heat bonded to the shaft. The outer body and inner body tubing are made of polymeric tubing. The area under the balloon is enhanced with five radiopaque platinum image bands. Two that are 5mm on each side of the balloon center and two more under the balloon shoulders. An additional image band is imbedded into the tip of the catheter as an additional safety measure.

This document is a 510(k) premarket notification for the NuMED Mullins PTA Catheter. It claims substantial equivalence to the NuMED Z-MED PTA Catheter. The information provided is primarily focused on the device description, biocompatibility, and bench testing, rather than explicit acceptance criteria and a detailed study report with performance metrics.

Here's an analysis based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Based on the document, direct, quantifiable acceptance criteria with corresponding performance results are not explicitly stated in a table format. The submission relies on demonstrating substantial equivalence to a predicate device by comparing design, materials, and intended use. The "acceptance criteria" can be inferred as meeting the standards and performance of the predicate device and relevant biocompatibility/bench testing.

Missing specific quantifiable acceptance criteria and performance data. The document states that test results are "on file at NuMED, Inc.", indicating that the detailed data was submitted to the FDA but is not included in this summary.

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

• Sample Size: Not specified. The document only mentions "Biocompatibility Testing" and "Laboratory (Bench) Testing" without indicating the number of devices or components tested.
• Data Provenance: The tests were conducted internally by NuMED, Inc. ("on file at NuMED, Inc."). The document does not specify the country of origin of the data beyond "NuMED, Inc.", which is based in Hopkinton, NY, USA. The testing appears to be retrospective in the sense that the results were submitted for a premarket notification for a device that has undergone testing.

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

This type of information is not applicable to this submission. The device is a medical catheter, and its evaluation relies on physical and material properties, mechanical testing, and biocompatibility, not on expert interpretation of medical images or clinical data to establish a ground truth for a diagnostic output.

4. Adjudication Method for the Test Set

This is not applicable for the reasons stated above. There's no "ground truth" established by experts or adjudication involved in the type of testing described (biocompatibility, bench testing).

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

This is not applicable. The device is a medical catheter, not an AI-powered diagnostic tool requiring human readability or interpretation. Therefore, there's no comparison of human readers with and without AI assistance.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

This is not applicable. The device is a physical medical instrument, not an algorithm or AI system.

7. Type of Ground Truth Used

The "ground truth" for this device's safety and effectiveness relies on:

• Biocompatibility Standards: Compliance with the "Tripartite Biocompatibility Guidance for Medical Devices."
• Engineering Standards: Meeting the device's design specifications for dimensions, material integrity, and functionality (e.g., balloon inflation properties).
• Good Manufacturing Practices (GMPs): Adherence to quality system requirements during testing.

There is no "ground truth" derived from expert consensus, pathology, or outcomes data in the context of diagnostic interpretation, as this is an interventional device.

8. Sample Size for the Training Set

This is not applicable. The device is a physical medical instrument, not an AI algorithm 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 point 8.

Ask a specific question about this device