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The Chocolate PTA Balloon Catheter is intended for balloon dilatation of lesions in the peripheral vasculature, including the iliac, femoral, ilio-femoral, popliteal, and infra-popliteal arteries.

The Chocolate PTA Balloon Catheter is an "over-the-wire" balloon dilatation catheter with a braided shaft and an atraumatic tapered tip. The product family consists of 0.014" and 0.018" systems that are compatible with 0.014" and 0.018" guidewires, respectively. Overall catheter lengths range from 120-150 cm.

The distal end of the catheter has a semi-compliant balloon that expands to known diameters at specific pressures. The balloon is constrained by a nitinol constraining structure (CS) which provides fast deflation and uniform re-wrap. Upon deflation, the CS is removed from the vessel along with the balloon catheter. The balloon is available in multiple sizes and contains two radiopaque markers to assist with positioning. The proximal end of the device is a common balloon catheter design of a braided shaft connected to a plastic hub and strain relief. The hub has two ports; the balloon port is used to inflate the balloon and the guidewire port connects to the guidewire lumen.

The Chocolate PTA balloon catheter is intended for single-use only and is provided sterile and non-pyrogenic.

The provided text describes a 510(k) premarket notification for the Medtronic Chocolate PTA Balloon Catheter. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving safety and effectiveness through a comprehensive de novo clinical trial with defined acceptance criteria and extensive performance studies.

Therefore, the document does not contain the information typically found in a study proving a device meets acceptance criteria, such as:

• A table of acceptance criteria and reported device performance: The submission focuses on comparing the new device's characteristics to a predicate, not on setting and meeting specific quantitative performance metrics like sensitivity, specificity, or accuracy.
• Sample sizes used for the test set and data provenance: No clinical test set involving patients or human data is described for performance evaluation.
• Number of experts used to establish ground truth or their qualifications: Ground truth establishment is not relevant in this type of submission, as it's about equivalence, not novel performance claims.
• Adjudication method for the test set: Not applicable.
• Multi-reader multi-case (MRMC) comparative effectiveness study: Not applicable as this is not an AI-assisted diagnostic device, nor is it a study comparing human performance with and without the device.
• Standalone (algorithm only) performance: Not applicable as this is a medical device (balloon catheter), not an algorithm or AI.
• Type of ground truth used: Not applicable.
• Sample size for the training set and how ground truth for training set was established: Not applicable, as this is a physical medical device, not an AI/ML algorithm.

What the document does describe in terms of "proving acceptance criteria":

The "acceptance criteria" in the context of this 510(k) submission are not performance metrics for clinical efficacy, but rather the demonstration of substantial equivalence to an existing predicate device. The "study that proves the device meets the acceptance criteria" refers to the various tests and analyses performed to support this equivalence.

Here's an interpretation based on the provided text:

Implicit Acceptance Criteria (for 510(k) Substantial Equivalence):

The implied acceptance criteria for this 510(k) submission are that the modified Chocolate PTA Balloon Catheter is as safe and effective as the predicate device (Chocolate PTA Balloon Catheter K130414) and does not raise new questions of safety or effectiveness. This is demonstrated by showing:

• Identical/Similar Intended Use: The intended use is largely the same, with a minor change in the exclusion of renal arteries.
• Equivalent Technological Characteristics: Key design principles, balloon specifications, and catheter technical specifications remain identical or acceptably similar.
• Biocompatibility: The device is biocompatible and safe for patient contact.
• Sterilization: The sterilization method is unchanged and validated.
• Packaging: Packaging changes do not compromise sterility or device integrity.

The "Study" (Evidence) Proving the Device Meets These Implicit Acceptance Criteria:

The "study" in this context is a compilation of various non-clinical testing and comparisons.

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

   • Acceptance Criteria (Implicit for 510(k)): Demonstration of substantial equivalence to the predicate device (K130414) for the Chocolate PTA Balloon Catheter. This is assessed by comparing intended use, technological characteristics, and performance data to ensure safety and effectiveness are maintained.
   • Reported Device Performance (as described in the document):
     • Intended Use: "The Chocolate PTA balloon catheter is intended for balloon dilatation of lesions in the peripheral vasculature, including the iliac, femoral, ilio-femoral, popliteal, and infra-popliteal arteries." (Note: this is a slight modification from the predicate, which also included renal arteries). The change does not introduce new safety concerns.
     • Technological Characteristics:
       • Identical: Intended Use (largely), Principle of Operation, Balloon technical specifications (diameters, lengths, materials, markers, burst pressure, nominal pressure, constraining structure material), Catheter technical specifications (lengths, guidewire/introducer compatibility, most materials), Packaging materials, Testing and Compliance to ISO 10993 and ISO 11135-1, Sterilization Method.
       • Similar (with justification for equivalence): Inner Member components (resin changes in outer and inner layers, tie-layer unchanged), IFU specifications (size, stitching), Compliance Card size/artwork, Pouch Label dimensions, Carton Label dimensions.
     • Biocompatibility: Passed required tests per ISO 10993-1:2018 (Cytotoxicity, Sensitization, Irritation/intracutaneous reactivity, Acute systemic toxicity, Material mediated pyrogenicity, Hemocompatibility). No new or increased biocompatibility concerns.
     • Packaging Validation: Passed packaging validation, packaging aging, and sterilization testing with a worst-case 72-page IFU and eIFU leaflet. No additional risks identified.
     • Sterilization: Successfully completed testing indicated no sterilization process changes required. Sterilization assurance level 10-6 maintained.
     • Performance Equivalence Conclusion: "The technological characteristics and performance criteria of the Chocolate PTA Balloon Catheter are equivalent to the predicate device, and the subject device performs in a manner equivalent to the predicate device currently on the market."

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

   • This document describes non-clinical testing (e.g., biocompatibility testing on material samples, packaging validation on multiple units). It does not specify "sample sizes" in terms of clinical patient populations.
   • Data Provenance: Not explicitly stated, but typical for medical device testing to be conducted at manufacturer facilities or contracted laboratories. No mention of country of origin for any human data (as none was used). The testing is retrospective in the sense that it supports the premarket notification.

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 diagnostic sense is not established for this device's performance given the 510(k) pathway. Expert knowledge would be involved in designing and interpreting the engineering and material safety tests, but not in diagnosing conditions.

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

   • Not applicable, as this is not a diagnostic imaging study requiring multi-reader 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:

   • No. This is a physical medical device (balloon catheter), not an AI diagnostic tool.

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

   • No. This is a physical medical device (balloon catheter), not an algorithm.

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

   • Not applicable in the clinical diagnostic sense. The "ground truth" for this submission is based on established engineering principles, material science, validated test methods (e.g., ISO standards), and a comparison to the known performance and safety profile of the legally marketed predicate device.

8. The sample size for the training set:

   • Not applicable. This is a physical device, not an AI/ML algorithm that requires training data.

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

   • Not applicable.

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The PTA Balloon Catheter is indicated for Percutaneous Transluminal Angioplasty (PTA) in the peripheral vasculature, including illac, femoral, ilio-femoral, popliteal, infra-popliteal and renal arteries, and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae.

The PTA Balloon Catheters (PVQ) is a sterile, single use, non-pyrogenic balloon catheter for peripheral indication. The device features an ultra-low profile, semi-compliant balloon combined with a low-profile tip.

The PTA Balloon Catheters (PVQ) has a coaxial shaft design. The outer lumen is used for inflation of the balloon, and the wire lumen permits the use of 0.014 in (0.36 mm), 0.018 in (0.46mm), guidewires to facilitate advancement of the catheter to and through the stenosis to be dilated. The PTA Balloon Catheters (PVQ) features a dual lumen shaft that provides rapid inflation/deflation times for the catheters compatible with 0.035 in (0.89mm) guidewires. The balloon is designed to provide an inflatable segment of known diameter and length at recommended pressures. The catheter includes a tapered tip to facilitate advancement of the catheter. The working lengths of the balloon catheter range between 10 mm and 280 mm. and are selected based on patient requirements for PTA. The radiopaque marker(s) (see RMD in Figure 1) are placed beneath the "usable balloon length" of the balloon and are visible when used in conjunction with fluoroscopy and aid in the placement of the balloon. The effective length could increase by 1 cm in a fully hydrated state.

Each balloon inflates to the stated diameter and length at a specific pressure. The maximum rated burst pressure is different for each size. It is important that the balloon not be inflated beyond the rated burst pressure.

The proximal portion of the catheter includes one female luer-lock port connected to the inflation lumen, and one female luer-lock port for the guidewire lumen. The devices can be supplied with and without hydrophilic coating. The hydrophilic coating when applied is applied proximally to the balloon for a length of 20 mm and 40 mm.

Each PTA Balloon Catheters (PVQ) is packaged as follows:

• . The balloon is protected within a protective tube with an inner lumen protective stainless-steel wire.
• The entire catheter is provided in a Polyethylene or Poly propylene Protectivetubing ● spiral dispenser.
• The protected catheter is placed in a Tyvec pouch, which is sealed to form the sterile ● barrier.
• Then the pouch is placed into an outer box. .

The PTA Balloon Catheters (PVQ) is used with commercially available sheath introducers, guide catheter and guidewires. These are not included with the PTA Balloon Catheter (PVQ).

The provided text is a 510(k) summary for the QualiMed USA PTA Balloon Catheter (PVQ). It describes the device, its intended use, and the testing performed to demonstrate substantial equivalence to predicate devices. However, this document does not describe the acceptance criteria or a study proving the device meets said criteria in the format requested for AI/ML devices.

The document outlines performance testing for a medical device (a balloon catheter), which involves established engineering and biocompatibility tests to ensure the catheter's physical characteristics, safety, and functionality. These tests are not AI/ML-related performance studies.

Therefore, I cannot extract the requested AI/ML specific information from this document. The concepts of "test set," "training set," "ground truth," "experts," "adjudication," and "MRMC studies with AI assistance" are not applicable to the type of device and testing described in this 510(k) summary.

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The Cronus HP PTA Balloon Catheter is indicated for Percutaneous Transluminal Angioplasty in the following vessel areas:

• Femoral arteries
• Popliteal arteries
• Iliac arteries
• Renal arteries
• For the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae.
  These catheters are not intended for use in coronary arteries or the neurovasculature.

The Cronus™ HP PTA Balloon Catheter is intended for PTA (Percutaneous Transluminal Angioplasty) procedures. It is an over the wire (OTW) 0.035" dual lumen catheter with a distally mounted semi- compliant inflatable balloon and a flush cut tip. The catheter manifold includes two lumens. A y-connector adaptation is located at the proximal part of the catheter and provides access to the two different lumens. The lumen marked "GW" is the central lumen of the catheter which terminates at the distal tip. This lumen is used to pass the catheter over a guidewire with a maximum outer diameter of 0.035 inches. The lumen, marked "BALLOON" is used to inflate and deflate the dilatation balloon with a solution of contrast medium and saline. The balloon has two radiopaque markers for positioning the balloon relative to the stenosis. The balloon segment expands to a known diameter at a specific inflation pressure.
The Cronus™ HP PTA Balloon Catheter is sterilized using ethylene oxide gas and satisfies a minimum Sterility Assurance Level (S.A.L.) of 10 °. Shelf-life is determined to be 4 years.
The device is available in multiple configurations ranging in sizes of balloon diameter 4-10mm, balloon lengths 20-80mm, and catheter lengths of 45 and 80cm

This document is a 510(k) Premarket Notification from the FDA regarding the Cronus HP PTA Balloon Catheter. It focuses on demonstrating substantial equivalence to a predicate device, rather than proving a device meets specific acceptance criteria based on performance study results.

Therefore, the requested information regarding acceptance criteria and a study proving the device meets them cannot be extracted from the provided text. The document explicitly states:

• "This submission does not warrant any clinical testing, therefore no clinical testing was performed for or provided in this submission."

This indicates that clinical performance studies to establish specific acceptance criteria and prove the device meets them were not part of this 510(k) submission. The submission relies on non-clinical (bench) testing and comparison of technological characteristics to a legally marketed predicate device to demonstrate substantial equivalence.

Here's what can be inferred from the document regarding the device's evaluation (though it doesn't directly address the acceptance criteria and study proving performance as you've requested):

The 510(k) process for this device, as detailed, focuses on demonstrating substantial equivalence to an existing predicate device (Cronus HP (K151141)). This means the manufacturer is asserting their new device is as safe and effective as the predicate device, not necessarily that it meets a set of isolated performance criteria from a clinical trial.

The "tests" mentioned are primarily bench tests and biocompatibility tests, which establish the basic safety and physical characteristics of the device, and ensure it functions as intended in a laboratory setting. These are not clinical studies designed to show performance against specific clinical acceptance criteria.

To answer your specific questions in the context of this document's limitations:

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

   • Not applicable / Not provided. The document lists various non-clinical tests (e.g., packaging burst, balloon compliance, balloon rated burst pressure) and states they were "conducted successfully." However, it does not provide specific quantitative acceptance criteria or reported performance values for these tests in a table, nor does it present the results of a clinical study proving performance against acceptance criteria.

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

   • Not applicable / Not provided for clinical data. Since no clinical testing was performed, there's no test set for clinical data. For the bench tests, sample sizes are not explicitly stated in this summary. Data provenance would be laboratory testing in an ISO-certified facility likely, but specifics are missing.

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

   • Not applicable. No clinical test set where "ground truth" would be established by experts is mentioned.

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

   • Not applicable. No clinical test set requiring adjudication is mentioned.

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

   • Not applicable. This device is a PTA Balloon 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, not an algorithm.

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

   • Not applicable. For the bench tests, physical measurements and engineering standards serve as the "truth," but this isn't analogous to clinical ground truth.

8. The sample size for the training set:

   • Not applicable. This device does not involve machine learning or a "training set."

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

   • Not applicable.

In summary, this FDA document is a 510(k) summary for a physical medical device that achieved clearance through demonstrating substantial equivalence to a predicate device, primarily via non-clinical testing. It did not involve or report on a clinical study designed to prove the device met specific acceptance criteria.

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The Angioslide PROTEUS™ Percutaneous Transluminal Angioplasty (PTA) Balloon Catheter with Embolic Capture Feature is indicated for peripheral transluminal angioplasty and for capture and removal of embolic material (e.g. debris, thrombus) during angioplasty, for the femoral, iliac, ilio-femoral, popliteal, tibial, peroneal, and profunda arteries.

The Angioslide PROTEUS™ PTA Balloon Catheter with Embolic Capture is not intended for use in the renal, cerebral, coronary or carotid vasculature.

The Angioslide PROTEUSTM Percutaneous Transluminal Angioplasty (PTA) Balloon Catheter with Embolic Capture Feature is an over the wire dual lumen catheter with a foldable balloon (5) located near the distal atraumatic soft tip (9).

One lumen is used for inflation of the balloon and is accessed via the inflation port (2). The other lumen, starting at the guidewire port (10), allows access to the distal tip for guidewire insertion (max. 0.035"). The balloon has two radiopaque markers (8) for positioning the balloon relative to stenosis. The radiopaque markers indicate the dilating section of the balloon and help in balloon placement. The balloon is designed to provide an inflatable segment of known diameter and length at specified pressure.

The shaft (4) comprises the outer shaft (6) and the inner shaft (7). The distal end of the balloon (A) is connected to the inner shaft and the proximal end of the balloon (B) is connected to the outer shaft. The inner shaft is connected to the proximal hub (10) which is connected to the pulling knob (1) and the outer shaft is connected to the handle grip (3). The pulling knob lock (11) locks the handle grip and the pulling knob together. The distal end of the balloon is folded inwards towards the proximal end of the balloon, by pressing on pulling knob lock (11) and pulling the pulling knob away from the handle (1). The inward-folding of the balloon forms a cavity and allows for collection and removal of embolic material.

The provided document describes the Angioslide PROTEUS™ PTA Balloon Catheter with Embolic Capture Feature. It is a medical device designed for peripheral transluminal angioplasty and for capturing embolic material during angioplasty in various peripheral arteries. The document is a 510(k) summary, demonstrating substantial equivalence to a predicate device (K133043).

Here's an analysis of the acceptance criteria and study information:

1. Table of Acceptance Criteria and Reported Device Performance

The document presents a comprehensive table of non-clinical bench tests. All tests passed, indicating the device met its acceptance criteria. Below is a summarized version of the table provided in the document:

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The Chameleon PTA Balloon Catheter is indicated for use in Percutaneous Transluminal Angioplasty of the femoral, iliac, and renal arteries and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae. The Chameleon enables the infusion of diagnostic or therapeutic fluids. This catheter is not for use in coronary arteries or cerebral vasculature.

The Chameleon Percutaneous Transluminal Angioplasty (PTA) Balloon Catheter is an over-the-wire, multi-lumen balloon catheter. The Chameleon enables the injection of diagnostic fluids, such as contrast medium or therapeutics fluids through a dedicated opening proximal to the balloon. The multi-lumen shaft incorporates a balloon inflation/deflation lumen and a Guide Wire (GW) lumen which also serves as the infusion lumen.

This document is a 510(k) premarket notification for a medical device (Chameleon PTA Balloon Catheter), not a study for an AI/ML medical device. Therefore, it does not contain the specific information requested in your prompt regarding acceptance criteria and performance data for an AI/ML-driven diagnostic or assistive technology.

The document primarily focuses on establishing "substantial equivalence" of a new version of the existing Chameleon PTA Balloon Catheter (with new balloon sizes) to a legally marketed predicate device. This type of submission relies heavily on bench testing and simulated use to demonstrate that the physical and functional characteristics of the device remain safe and effective for its intended purpose.

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

• No AI/ML Component: The device is a physical medical instrument (a balloon catheter used in angioplasty), not a software or AI/ML algorithm that interprets medical images or data.
• No Diagnostic Performance: The "performance data" mentioned (Section 13) refers to mechanical and physical properties of the catheter (e.g., balloon compliance, burst pressure, fatigue, leakage), not diagnostic accuracy (e.g., sensitivity, specificity) of an AI system.
• No Human Readers/Experts for Interpretation: The context of "human readers" assisting with AI or "expert consensus" for ground truth isn't relevant to a physical catheter's mechanical performance.

However, I can extract what is relevant to the document about its "acceptance criteria" and "study" (bench testing):

Acceptance Criteria and Reported Device Performance (as pertains to this physical device)

The document states: "All test results demonstrate that the Chameleon PTA Balloon Catheter met the established specifications necessary for consistent performance during its intended use." And "The Chameleon PTA Balloon Catheter met all predetermined acceptance criteria of design verification and validation as specified by applicable standards, and test protocols."

While specific numerical targets or thresholds for each bench test are not provided in this summary document, the general categories of acceptance criteria and the finding that they were met are clear.

Regarding the specific questions in your prompt, here's why they are largely unanswerable from this document:

1. A table of acceptance criteria and the reported device performance: Partially addressed above for mechanical properties, but no diagnostic performance like an AI would have.
2. Sample sizes used for the test set and the data provenance: Sample sizes for bench tests (e.g., N=X catheters tested for burst pressure) are not detailed. Data provenance is "bench testing and simulated use," implying lab conditions. No patient data is involved for this type of device submission.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for a physical catheter's mechanical properties is derived from engineering specifications and testing methods, not expert human interpretation of medical images.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable. This is for AI/ML diagnostic studies, not device mechanical 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: Not applicable. This is for AI/ML diagnostic studies.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. There is no algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): For this mechanical device, the "ground truth" for its performance is adherence to engineering specifications and performance benchmarks (e.g., it must not burst below X pressure, it must meet Y compliance).
8. The sample size for the training set: Not applicable. There is no AI/ML model to train.
9. How the ground truth for the training set was established: Not applicable.

In summary, the provided document is for a traditional medical device (catheter) and illustrates a "substantial equivalence" pathway, not a submission for an AI/ML-driven medical device requiring clinical performance evaluation of diagnostic accuracy.

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The Chameleon PTA Balloon Catheter is indicated for use in Percutaneous Transluminal Angioplasty of the femoral, iliac, and renal arteries and for the treatment of obstructive or synthetic arteriovenous dialysis fistulae. The Chameleon enables the infusion of diagnostic or therapeutic fluids. This catheter is not for use in coronary arteries or cerebral vasculature.

The Chameleon Percutaneous Transluminal Angioplasty (PTA) Balloon Catheter is an over-the-wire, multi-lumen balloon catheter. The catheter enables the injection of fluids such as contrast media through a dedicated opening proximal to the balloon. The multi-lumen shaft incorporates a balloon inflation/deflation lumen and a Guide Wire (GW) lumen which also serves as the infusion lumen.

This document is a 510(k) premarket notification for the Chameleon PTA Balloon Catheter, and as such, it does not contain the detailed information about acceptance criteria and specific study results that would be found in a clinical study report or a more comprehensive technical document. The FDA 510(k) pathway focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than proving de novo safety and effectiveness through extensive clinical trials.

However, based on the provided text, here's what can be extracted and what cannot:

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

The document states: "All test results demonstrate that the Chameleon PTA Balloon Catheter met the established specifications necessary for consistent performance during its intended use." and "The Chameleon PTA Balloon Catheter met all predetermined acceptance criteria of design verification and validation as specified by applicable standards, and test protocols."

This indicates that acceptance criteria were established and met, but the specific numerical criteria and the reported device performance values are not detailed in this summary. The summary mentions categories of bench tests performed but does not provide the quantitative acceptance criteria for each or the device's results against those criteria.

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

• Sample Size: The document does not specify the sample size for any of the bench tests.
• Data Provenance: The tests described are "bench testing and simulated use test data." This implies the data is prospective in nature (generated specifically for this submission). The country of origin for the testing or data is not explicitly stated, but the manufacturer (AV Medical Technologies Ltd.) is located in Tel Aviv, Israel, suggesting the testing likely occurred there or under their supervision.

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 studies described are bench tests and simulated use, not clinical studies requiring expert ground truth for interpretation.

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

This information is not applicable as the studies described are bench tests, not clinical studies involving human interpretation that would require 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:

This is not applicable. The device is a physical medical device (balloon catheter), not an AI-powered diagnostic tool. Therefore, an MRMC study and AI assistance effect size are irrelevant to this submission.

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

This is not applicable. The device is a physical medical device, not an algorithm.

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

For the bench testing, the "ground truth" would be established engineering specifications and applicable standards (e.g., ISO standards for medical devices). It is not expert consensus, pathology, or outcomes data.

8. The sample size for the training set:

This is not applicable as the device is not an AI/machine learning algorithm that requires a training set. The "Chameleon PTA Balloon Catheter" is an over-the-wire, multi-lumen balloon catheter.

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

This is not applicable for the same reason as above.

Summary of available and unavailable information:

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The Micro Medical Solutions PTA Balloon Catheter is intended for percutaneous transluminal angioplasty (PTA) of lesions in peripheral arteries including anterior tibial, posterior tibial, and pedal. Not for use in coronary arteries.

The Micro Medical Solutions PTA Balloon Catheter is a single lumen catheter with a balloon located at the distal tip. As the MMS PTA Balloon Catheter is not an Over-The-Wire device. The catheter consists of a single lumen for balloon inflation and deflation.. Inscribed on the proximal strain relief of the catheter is the balloon diameter (mm) and balloon length (mm). Platinum/Iridium marker bands are positioned on the shaft within the balloon to enable visualization of the catheter/balloon under fluoroscopy.

The provided text describes a 510(k) summary for the MMS PTA Balloon Catheter, focusing on its substantial equivalence to a predicate device. This document primarily details non-clinical performance testing for a medical device and does not include information about AI/ML algorithm performance studies or clinical studies with human readers. Therefore, I cannot provide details on questions related to AI-specific criteria, human reader performance, or multi-reader multi-case studies.

Here's an analysis of the available information:

1. Table of Acceptance Criteria and Reported Device Performance

The document states, "Product testing was completed and met all of the acceptance criteria." However, it does not explicitly list the acceptance criteria for each test or detail the specific results. It only lists the tests performed.

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

• Non-Clinical Testing: The document does not specify the sample size for the mechanical, physical, or chemical non-clinical tests (e.g., how many catheters were tested for burst pressure). It mentions testing was done on "sterile final product" and "baseline (non-aged) and aged products," but no specific numbers are given.
• Animal Testing: The document mentions "Animal testing was conducted to assess the simulated clinical performance" but does not specify the number of animals or the type of animal used.
• Cadaver Experience: "Cadaver testing was conducted using the vasculature below the knee" but does not specify the number of cadavers.
• Data Provenance: The studies are non-clinical (bench testing, animal, cadaver). The country of origin for this data is not specified but is presumed to be internal testing by Micro Medical Solutions, Inc., a US-based company. These are retrospective tests performed to support premarket notification.

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

This information is not applicable. The device is a physical medical device (balloon catheter), and the "ground truth" for its performance is established through objective, non-clinical tests (mechanical, physical, chemical, biocompatibility, animal studies, cadaver studies), not through expert interpretation of data like images or clinical outcomes that would require human experts to establish ground truth.

4. Adjudication Method for the Test Set

This is not applicable as the studies described are non-clinical performance evaluations of a physical device, not an AI/ML diagnostic algorithm that requires expert adjudication of results.

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 such study was conducted or reported in this 510(k) summary. This document pertains to a physical medical device (balloon catheter), not an AI/ML diagnostic or assistive device.

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

No standalone algorithm performance study was done. This document is for a physical medical device.

7. The Type of Ground Truth Used

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

• Objective Material and Mechanical Standards: Such as those defined by ISO 10993 for biocompatibility, and internal specifications for physical properties like burst pressure, dimensions, flexibility, etc.
• Animal Models: For simulated clinical performance.
• Cadaver Models: For simulated clinical use in specific anatomical contexts (below the knee vasculature).

8. The Sample Size for the Training Set

This is not applicable to a physical medical device. There is no AI/ML algorithm involved that requires a training set.

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

This is not applicable to a physical medical device. There is no AI/ML algorithm involved that requires a training set.

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The Chameleon PTA Balloon Catheter is indicated for use in Percutaneous Transluminal Angioplasty of the femoral, iliac, and renal arteries and for the treatment of obstructive or synthetic arteriovenous dialysis fistulae. This catheter is not for use in coronary arteries.

The Chameleon Percutaneous Transluminal Angioplasty (PTA) Balloon Catheter is an over-the-wire, multi-lumen balloon catheter. The catheter enables the injection of fluids such as contrast media through a dedicated opening proximal to the balloon. The multi-lumen shaft incorporates a balloon inflation/deflation lumen and a Guide Wire (GW) lumen which also serves as the infusion lumen.

This document describes the premarket notification (510(k)) for the Chameleon PTA Balloon Catheter. It outlines the device's characteristics and the nonclinical performance data submitted to demonstrate substantial equivalence to a predicate device.

Here's an analysis of the provided text in relation to your request:

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

The document provides a general statement regarding acceptance criteria and performance rather than a specific table.

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

The document does not specify the sample sizes used for the test sets in the bench tests, biocompatibility tests, or simulated use tests. It also does not mention the country of origin of the data or whether the tests were retrospective or prospective.

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

This document describes technical device performance testing (biocompatibility, bench, and simulated use tests), not clinical studies involving human patients where expert-established ground truth would typically be needed for diagnostic or prognostic accuracy. Therefore, this information is not applicable and not provided in the document.

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

Not applicable, as this document focuses on technical device performance testing, not human-read clinical data.

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 not an AI-assisted device, and the document describes the substantial equivalence of a medical device (PTA balloon catheter), not a diagnostic or AI-driven system.

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

Not applicable. This is not an algorithmic or AI device. The document details the physical and functional performance of a medical device.

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

For the nonclinical performance data (biocompatibility, bench, and simulated use tests), the "ground truth" would be established by:

• Biocompatibility: Adherence to ISO standards and guidelines for biological evaluation of medical devices.
• Bench testing: Engineering specifications, design requirements, and relevant industry standards for balloon catheters (e.g., burst pressure, tensile strength, inflation time, etc.).
• Simulated use testing: Performance against predefined functional criteria in a simulated environment, often mimicking physiological conditions.

8. The sample size for the training set

Not applicable. This is not a machine learning or AI device, so there is no "training set."

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

Not applicable, as there is no training set for this type of device.

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The Advance® Enforcer™ 35 Focal Force PTA Balloon Catheter is intended for percutaneous transluminal angioplasty (PTA) of lesions in peripheral arteries, including iliac, renal, popliteal, infrapopliteal, femoral and iliofemoral, as well as obstructive lesions of native or synthetic arteriovenous dialysis fistulae. Not for use in the cerebral or coronary vasculature.

The Advance® Enforcer™ 35 Focal Force PTA Balloon Catheters are over-the-wire catheters that will be available with inflated balloon diameters of 6, 8, 10, 12 millimeters and a balloon length of 4 centimeters. The balloon includes four polymer elements, which provide focal force upon inflation. These elements will aid in opening lesions. The catheters are 5.2 French, dependent upon device specification, and will be available in lengths of 50, 80, or 135 centimeters. The catheters are compatible with a 0.035 inch (0.89 millimeter) diameter wire guide. The catheters will be supplied sterile and are intended for one-time use.

The provided document describes the mechanical and performance testing of the Advance® Enforcer™ 35 Focal Force PTA Balloon Catheter to demonstrate its substantial equivalence to a predicate device. This is a medical device, and the evaluation is based on engineering and material science tests, not artificial intelligence. Therefore, many of the requested fields related to AI/expert ground truth/etc. are not applicable.

Here's the information extracted from the document:

1. Table of Acceptance Criteria and Reported Device Performance

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

The document does not specify exact sample sizes for each test beyond indicating "each balloon" or "balloons" and "catheters". The data provenance is not explicitly stated in terms of country of origin or retrospective/prospective. These are engineering performance tests, typically performed in a controlled laboratory environment.

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. This is a medical device based on physical and mechanical properties, not an AI or diagnostic device requiring expert interpretation for ground truth.

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

Not applicable, as described above.

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 not an AI-assisted diagnostic device.

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

Not applicable. This is not an AI algorithm.

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

For the engineering tests, the "ground truth" is defined by the physical specifications, industry standards (e.g., ISO 10555-1, ISO 10555-4), and internal design requirements of the device. For animal testing, it involves direct observation of performance and arterial impact.

8. The sample size for the training set

Not applicable. This device does not use an AI training set.

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

Not applicable. This device does not use an AI training set.

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The Fortrex 0.035" OTW PTA Balloon Catheter is intended to dilate stenoses in the iliac, femoral, popliteal, infra-popliteal, and renal arteries, and for the treatment of obstructive or synthetic arteriovenous dialysis fistulae. This device is also indicated for stent post-dilatation in the peripheral vasculature.

The Fortrex™ 0.035" PTA Balloon Catheter (Fortrex Catheter) is an over the wire (OTW) 0.035"dual lumen catheter with a distally mounted semi-compliant inflatable balloon and an atraumatic tapered tip. The manifold includes a lumen marked "THRU". This is the central lumen of the catheter, which terminates at the distal tip. This lumen is used to pass the catheter over a guidewire with a maximum diameter of 0.035". The lumen marked "BALLOON" is the balloon inflation lumen, which is used to inflate and deflate the balloon with a mixture of contrast medium and saline solution. The balloon has two radiopague markers for positioning the balloon relative to the stenosis. The radiopaque marker bands indicate the dilating or working section of the balloon.

The Fortrex Catheter is available with balloon diameters 4.0 mm to 12.00 mm, balloon lengths 20 mm, 40 mm, 80 mm, and 100 mm and with shaft lengths of 40 cm, 80 cm, and 135 cm.

This document is a 510(k) summary for the Fortrex™ 0.035" OTW PTA Balloon Catheter, which is a medical device intended to dilate stenoses in various arteries and for stent post-dilatation in the peripheral vasculature. The summary outlines the device's characteristics, its similarities to predicate devices, and the performance testing conducted to demonstrate substantial equivalence.

Here's an analysis of the provided text in response to your questions:

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

The document states: "The Fortrex catheter met all acceptance criteria for the performance testing. The results from these tests demonstrate that the technological characteristics and performance criteria of the Fortrex Catheter are comparable to the predicate EverCross Catheter and that the Fortrex Catheter performs in a manner equivalent to the predicate EverCross device currently on the market."

However, specific quantitative acceptance criteria values are not provided, nor are the numerical results for each test. The table below lists the performance tests conducted, but without the specific criteria or reported performance data.

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

The document lists performance tests but does not specify the sample sizes used for each test. It also does not provide information on the data provenance in terms of country of origin or whether the study was retrospective or prospective. The study appears to be an internal bench testing and biocompatibility testing conducted by the manufacturer, Covidien llc.

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 document describes performance testing of a medical device (PTA balloon catheter), not a diagnostic algorithm that requires expert-established ground truth from medical images or clinical data. Therefore, this question is not applicable to the type of study presented here. The "ground truth" for these tests would be established by validated test methods and reference standards.

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

Not applicable, as this is bench and biocompatibility testing of a physical device, not an assessment requiring human adjudication of results.

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 document pertains to the 510(k) clearance of a physical medical device (balloon catheter), not an AI/software device that would involve human readers or AI assistance.

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

Not applicable. This document is about a physical medical device, not an algorithm.

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

For the performance tests:

• Bench Testing: The "ground truth" is established by the specifications and validated test methods for a medical device (e.g., burst pressure measured by a pressure gauge, dimensions measured by calibrated instruments).
• Biocompatibility Testing: The "ground truth" is established by the accepted standards and protocols defined in ISO 10993-1, using biological assays and analytical methods.

8. The sample size for the training set

Not applicable. This is not an AI/machine learning study, so there is no training set.

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

Not applicable. There is no training set for this type of device study.

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