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The FLASH Mini Ostial System is indicated for balloon dilatation of the stenotic portion of a coronary artery or bypass graft for the purpose of improving myocardial perfusion. The FLASH Mini Ostial System is also indicated for the post delivery expansion of balloon expandable stents within the coronary vasculature.

The FLASH Mini Ostial System is a 0.014" guidewire-compatible, rapid exchange (RX) coronary angioplasty balloon catheter with a working length of 135cm. The FLASH Mini Ostial System uses a dual balloon design that features a complaint Proximal Balloon which prevents distal migration of the balloon during angioplasty. The second semi-compliant higher-pressure balloon allows for luminal dilatation of de novo lesions and post deployment stent expansion.

The FLASH Mini Ostial System is packaged with two accessory syringes. A standard 10cc syringe intended for use in deflation of the Proximal Balloon and a 1.0cc syringe with a pressure relief feature intended for use in inflation of the Proximal Balloon. The pressure relief feature is intended to improve patient safety by limiting the maximum achievable pressure in the Proximal Balloon if the user attempts to inflate the Proximal Balloon when incorrectly positioned.

I am unable to provide a description of the acceptance criteria and the study that proves the device meets them based on the provided text.

The text describes a 510(k) premarket notification for a modification to an existing medical device, the FLASH Mini Ostial System. Specifically, it details the addition of a pressure relief feature to a 1.0cc accessory syringe. While it mentions that performance data was collected for this modification, it does not explicitly list the acceptance criteria or elaborate on the results of the study that proves these criteria were met.

Here's what the document indicates regarding new performance data:

• Focus of new performance data: Functionality of the pressure relief feature and ensuring syringe compatibility with the balloon catheter.
• Tests performed for Pressure Relief Syringe: Minimum Expansion Pressure, Maximum Expansion Pressure, Freedom from Leakage.
• Tests performed for Balloon Catheter Compatibility: Proximal Balloon Inflation Time, Simulated Use and Proximal Balloon Inflation Port Compatibility.
• Conclusion: "All test results demonstrate that the pressure relief feature does not impact the use of the device under normal operating conditions. Additionally, the test result demonstrates that the Pressure Relief Syringe consistently limits the maximum pressure that can be achieved in the Proximal Balloon." And "All test results demonstrated that the accessory Pressure Relief Syringe component of the FLASH Mini Ostial System meets all predetermined design verification and validation acceptance criteria necessary to verify safe and consistent performance of the Pressure Relief Syringe."

However, it does not provide:

1. A table of acceptance criteria and reported device performance.
2. Sample sizes or data provenance for the test set.
3. Number or qualifications of experts, or adjudication methods for ground truth.
4. Information about MRMC or standalone studies.
5. Details on the type of ground truth used.
6. Sample size for the training set (as this appears to be a physical device modification, not an AI/ML-based device).
7. How ground truth for the training set was established.

The document refers to "predetermined design verification and validation acceptance criteria," but does not explicitly state what those criteria are or the specific performance values achieved against them.

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The FLASH Ostial System OTW is indicated for Percutaneous Transluminal Angioplasty in the peripheral vasculature at aorto-ostial locations, including iliac, renal and carotid arteries. This device is also indicated for post-dilatation of balloon expandable stents in the peripheral vasculature.

The Flash Ostial System OTW is designed for the dilatation of stenotic ostial lesions in the peripheral vasculature. The FLASH Ostial System OTW is a 0.035" guidewire-compatible, over the wire (OTW) angioplasty balloon catheter with proximal anchoring and a working length of either 80cm or 135cm. All device sizes in the Flash Ostial System OTW product family are designed to be compatible with 6F guiding sheaths. The FLASH Ostial System OTW uses a dual balloon design that features a compliant proximal balloon, which prevents distal migration of the balloon during angioplasty. The second semi-compliant higher-pressure distal balloon allows for luminal dilatation of de novo lesions and post deployment stent expansion.

Here's an analysis of the provided text regarding the acceptance criteria and supporting studies for the FLASH Ostial System OTW.

Acceptance Criteria and Reported Device Performance

The document states that the FLASH Ostial System OTW line extension device sizes were evaluated using a series of in-vitro and performance bench tests. The key acceptance criterion for all these tests was that the device sizes "meet the established product specifications." The conclusion explicitly states: "All test results demonstrate that the FLASH Ostial System OTW line extension device sizes meet the established product specifications."

Since the specific numerical "product specifications" (acceptance criteria) are not detailed in the provided text, and only the fact that they were met is stated, I will list the tests performed and indicate that the reported performance was "Met established product specifications" for each.

Study Details:

1. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
   The document mentions "in-vitro and performance bench testing." The sample sizes for these tests are not specified in the provided text for each individual test. The data provenance is from bench testing, meaning it's conducted in a laboratory setting, not with human or animal subjects in a clinical environment. Therefore, it is neither retrospective nor prospective in the clinical sense.

2. 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 section of the report describes bench testing and biocompatibility testing, not a clinical study involving diagnosis or expert review. Therefore, there were no experts used to establish ground truth in the context of clinical interpretation. The "ground truth" for these engineering and biological tests is derived from established scientific methods, standards (e.g., ISO, ASTM), and laboratory protocols, presumably by qualified engineers and scientists.

3. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
   As this is bench testing and biocompatibility evaluation, no adjudication method (like 2+1 or 3+1) was used. These methods are typically employed in clinical studies for establishing expert consensus on diagnoses.

4. 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, an MRMC comparative effectiveness study was not done. This document describes the clearance of a physical medical device (balloon catheter) and its mechanical/biological performance, not an AI-powered diagnostic tool. Therefore, there is no mention of human readers or AI assistance.

5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
   No, a standalone (algorithm only) performance study was not done. This is a physical medical device, not a software algorithm.

6. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
   For the performance bench testing, the "ground truth" is defined by established product specifications, engineering standards, and scientific principles. For biocompatibility, the ground truth is determined by well-defined ISO and ASTM biological evaluation standards and protocols, which provide objective criteria for toxicity, sensitization, etc.

7. The sample size for the training set:
   This device is a physical medical product, not an AI/machine learning model. Therefore, there is no concept of a "training set" in this context.

8. How the ground truth for the training set was established:
   As there is no training set for a physical device, this question is not applicable. The "ground truth" for the device's acceptable performance is defined by its compliance with design specifications and relevant regulatory standards.

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The FLASH Ostial System OTW is indicated for Percutaneous Transluminal Angioplasty in the peripheral vasculature at aorto-ostial locations, including iliac, renal and carotid arteries. This device is also indicated for post-dilatation of balloon expandable stents in the peripheral vasculature.

The Flash Ostial System OTW is a 0.035" guidewire-compatible, over the wire (OTW) angioplasty balloon catheter with proximal anchoring and a working length of either 80cm or 135cm. The FLASH Ostial System OTW uses a dual balloon design that features a compliant anchoring balloon, which prevents distal migration of the balloon during angioplasty. The second semi-compliant higher-pressure balloon allows for luminal dilatation of de novo lesions and post deployment stent expansion.

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

The document does not explicitly present a table of acceptance criteria alongside reported device performance values. Instead, it states that "All test results demonstrated that the FLASH Ostial System OTW meets all predetermined design verification and validation acceptance criteria necessary to verify safe and consistent performance of the device for its Indications for Use."

The performance characteristics for which testing was conducted are listed:

**Performance Characteristics Evaluated:**
*   Balloon Crossing Profile
*   Catheter Shaft Diameter
*   Catheter Working Length
*   Catheter Inner Diameter
*   Angioplasty Balloon Rated Burst Pressure
*   Anchoring Balloon Burst Volume
*   Angioplasty Balloon Compliance
*   Balloon Inflation Time
*   Balloon Deflation Time
*   Angioplasty Balloon Rated Burst Pressure (in Stent)
*   Anchoring Balloon Burst Volume (in Stent)
*   Angioplasty Balloon Fatigue
*   Anchoring Balloon Fatigue
*   Catheter Bond Strength
*   Catheter Tip Pull Strength
*   Catheter Torque Strength
*   Simulated Use
*   Flexibility and Kink Resistance
*   Radiopacity
*   Angioplasty Balloon Fatigue (in Stent)
*   Anchoring Balloon Fatigue (in Stent)

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 the sample sizes used for each of the in-vitro and performance bench tests. It also does not provide details on data provenance (e.g., country of origin, retrospective or prospective) as these were bench tests, not clinical studies involving patient data.

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

This information is not applicable. The study involved in-vitro and performance bench testing of a medical device, not a diagnostic or prognostic algorithm that requires expert ground truth establishment from medical images or clinical data.

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

This information is not applicable for in-vitro and performance bench testing. Adjudication methods are typically relevant for clinical studies involving human observers or panels.

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, an MRMC comparative effectiveness study was not done. This study is for a physical medical device (balloon catheter) and not an AI-assisted diagnostic or prognostic tool.

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

No, this question is not applicable. The device is a physical balloon catheter, not an algorithm. The performance testing was of the physical device.

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

For the in-vitro and performance bench tests, the "ground truth" implicitly refers to "established product specifications" or "predetermined design verification and validation acceptance criteria" for the mechanical and physical properties of the device. These specifications would be based on engineering standards, regulatory requirements, and internal design parameters.

8. The sample size for the training set

This information is not applicable. This is not a study involving machine learning or AI where a training set would be used. The testing described is for a physical medical device.

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

This information is not applicable. As stated above, there is no "training set" in the context of this device's performance testing.

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The FLASH Mini Ostial System is indicated for balloon dilatation of the stenotic portion of a coronary artery or bypass graft for the purpose of improving myocardial perfusion. The FLASH Mini Ostial System is also indicated for the post delivery expansion of balloon expandable stents within the coronary vasculature.

The FLASH Mini Ostial System is a .014" guidewire-compatible, rapid exchange (RX) angioplasty balloon catheter with proximal anchoring and a working length of 135cm. The FLASH Mini Ostial System uses a dual balloon design that features a compliant anchoring balloon, which prevents distal migration of the balloon during angioplasty. The second semicompliant higher-pressure balloon allows for luminal dilatation of de novo lesions and post deployment stent expansion.

The provided text describes a 510(k) premarket notification for the FLASH Mini Ostial System, a PTCA Catheter. The document focuses on demonstrating substantial equivalence to a predicate device through performance data and biocompatibility testing. It does not include details about a study evaluating a device's performance against acceptance criteria using a test set, expert ground truth, or human readers, as would be common for AI/ML-based medical devices.

Therefore, many of the requested categories are not applicable to the information provided in this document.

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

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

The document states: "All test results demonstrate that the FLASH Mini Ostial System meets the established product specifications." and "All test results demonstrated that the FLASH Mini Ostial System meets all predetermined design verification and validation acceptance criteria necessary to verify safe and consistent performance of the device for its Indications for Use."

However, the specific quantitative acceptance criteria (e.g., "Balloon Crossing Profile must be

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The Flash-C PTCA Balloon Dilatation Catheter is indicated for balloon dilatation of the stenotic portion of a coronary artery or bypass graft for the purpose of improving myocardial perfusion. The Flash-C PTCA Balloon Dilatation Catheter is also indicated for the post delivery expansion of balloon expandable stents within the coronary vasculature.

The Flash-C PTCA Balloon Dilatation Catheter is a .014" guidewire-compatible, rapid exchange (RX) angioplasty balloon catheter with proximal anchoring and a working length of 135cm. The Flash-C PTCA Balloon Dilatation Catheter uses a dual balloon design that features a compliant anchoring balloon, which prevents distal migration of the balloon during angioplasty. The second semi-compliant higherpressure balloon allows for luminal dilatation of de novo lesions and post deployment stent expansion.

The provided text describes a 510(k) premarket notification for the "Flash-C PTCA Balloon Dilatation Catheter" and does not contain information about a study proving the device meets acceptance criteria.

The document details the device's intended use, its substantial equivalence to predicate devices, and the performance data refers to a list of in-vitro bench testing and biocompatibility testing. These tests are used to confirm the performance characteristics as compared to the predicate device and meet established specifications, rather than proving achievement of specific clinical acceptance criteria in a study.

Therefore, many of the requested categories for a study proving acceptance criteria cannot be extracted from the provided text, as this type of clinical study was not described.

Here's a breakdown of what can be extracted or inferred based on the context of a 510(k) submission for this type of device:

1. Table of acceptance criteria and the reported device performance:

The document broadly states: "All test results demonstrate that the device materials, the manufacturing process, and the design for the Flash-C PTCA Balloon Dilatation Catheter met the established specifications necessary for consistent performance according to its intended use." And "The Flash-C PTCA Balloon Dilatation Catheter met all predetermined acceptance criteria of design verification and validation as specified by applicable standards, test protocols, and/or customer inputs."

However, specific quantitative acceptance criteria and their corresponding reported device performance values are NOT provided in the text. The document only lists the types of tests performed.

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

• Sample Size: Not specified for any of the in-vitro or biocompatibility tests.
• Data Provenance: Not specified. These are laboratory bench tests and in-vitro biocompatibility tests, not clinical data from patients.

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

• This information is not applicable as the "test set" described consists of in-vitro and biocompatibility testing, not human-read clinical data requiring expert ground truth establishment.

4. Adjudication method for the test set:

• Not applicable for the described in-vitro and biocompatibility testing.

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

• No MRMC study was done. This device is a PTCA Balloon Dilatation Catheter (a physical medical device, not an AI or imaging diagnostic tool). The provided text does not mention any AI component or human reader interpretation studies.

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:

• Not applicable in the sense of expert consensus, pathology, or outcomes data for clinical performance. The 'ground truth' for the in-vitro and biocompatibility tests would be the established engineering specifications and biological safety standards, respectively.

8. The sample size for the training set:

• Not applicable. This is a physical medical device, not an AI model requiring a training set.

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

• Not applicable.

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The Flash PTA Balloon Catheter is indicated for Percutaneous Transluminal Angioplasty in the peripheral vasculature at aorto-ostial locations, including iliac, renal and carotid arteries. This device is also indicated for post-dilatation of balloon expandable stents in the peripheral vasculature.

The Flash PTA Balloon Dilatation Catheter is designed for the dilation of stenotic ostial lesions in the peripheral vasculature. The Flash PTA Balloon Dilatation Catheter is a 0.014" guidewire-compatible, rapid exchange (RX) angioplasty balloon catheter with proximal anchoring. The Flash PTA Balloon Dilatation Catheter uses a dual balloon design, which prevents distal migration of the balloon during angioplasty. The distal semi-compliant higher-pressure balloon allows for luminal dilatation of de novo lesions and post deployment stent expansion.

The Flash PTA Balloon Dilatation Catheter underwent in vitro performance bench testing to confirm its characteristics compared to a predicate device.

1. Acceptance Criteria and Reported Device Performance:

2. Sample Size and Data Provenance for Test Set:

The document does not specify the exact sample size for each performance test. It broadly states that "The Flash PTA Balloon Dilatation Catheter was evaluated using the following in-vitro performance bench testing." The data provenance is in-vitro bench testing, implying laboratory-controlled conditions. No information on country of origin or retrospective/prospective nature is provided for this specific testing, as it's not clinical data.

3. Number of Experts and Qualifications for Ground Truth (Test Set):

Not applicable. The study involved in-vitro bench testing and biocompatibility assessments, not a diagnostic task requiring expert interpretation for ground truth establishment.

4. Adjudication Method for Test Set:

Not applicable. This was bench testing against established engineering specifications, not a subjective assessment requiring adjudication.

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

No MRMC comparative effectiveness study was mentioned. The testing focused on device performance against a predicate and established specifications, not human reader performance with or without AI assistance.

6. Standalone (Algorithm Only) Performance:

Not applicable. The Flash PTA Balloon Dilatation Catheter is a physical medical device, not an AI algorithm.

7. Type of Ground Truth Used:

The ground truth for the in-vitro performance bench testing was based on established specifications and comparison to the predicate device. For biocompatibility testing, the ground truth was based on the requirements of ISO 10993 and other relevant biological evaluation standards.

8. Sample Size for Training Set:

Not applicable, as this refers to a physical medical device and its manufacturing/performance characteristics, not an AI model that requires a training set.

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

Not applicable for the same reason as above.

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The Flash-C PTCA Balloon Dilatation Catheter is indicated for balloon dilatation of the stenotic portion of a coronary artery or bypass graft for the purpose of improving myocardial perfusion.

The Flash-C PTCA Balloon Dilatation Catheter is a 0.014" guidewire-compatible, rapid exchange (RX) angioplasty balloon catheter with proximal anchoring. The device uses a dual balloon design featuring a compliant anchoring balloon, which enables the operator to precisely position the catheter at aorto-ostial anatomies and prevent distal migration of the balloon during angioplasty. The second semi-compliant high pressure balloon allows for luminal dilatation.

The provided text describes a medical device, the Flash-C PTCA Balloon Dilatation Catheter, and its performance evaluation for a 510(k) submission. However, it does not include information about AI/ML device performance, acceptance criteria, or a study comparing its performance against predefined criteria using metrics like accuracy, sensitivity, or specificity. The document focuses on regulatory approval based on substantial equivalence to existing devices and standard medical device performance testing, such as biocompatibility and bench testing.

Therefore, many of the requested sections about AI/ML performance, sample sizes for test/training sets, expert adjudication, or MRMC studies cannot be answered from the provided text.

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 lists various performance bench tests and in-vivo testing, but it does not explicitly state acceptance criteria (e.g., "Balloon Burst Pressure must be > X psi"). It only states that the device "meet the established specifications necessary for consistent performance" and "meets all predetermined design verification and validation acceptance criteria." Without the specific criteria, a comparative table cannot be created.

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

• Test Set Sample Size:
  • In-vitro Bench Testing: Not specified. Standard tests would involve multiple units, but the exact number isn't mentioned.
  • In-vivo Testing: "A swine model" was used. The number of animals in the test and control groups is not specified.
• Data Provenance: Not specified, but a swine model implies animal testing, likely in a controlled laboratory environment. The location of the testing is not mentioned.
• Retrospective/Prospective: The in-vivo study would be prospective in nature, as it involved performing a procedure and observing animals post-procedure.

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 and not provided. The ground truth for the device's performance is established through direct physical/biological measurements and observations in the bench and in-vivo tests, not by expert interpretation as would be the case for an AI/ML diagnostic device.

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

This is not applicable and not provided, as the tests performed are not based on subjective interpretation requiring 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 device is a physical medical device (catheter), not an AI/ML-driven diagnostic tool that assists human readers.

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

Not applicable. This device is a physical medical device.

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

• For Biocompatibility: Laboratory test results based on established ISO and ASTM standards (e.g., MEM Elution Assay results, Hemolysis Assay results).
• For In-vitro Bench Testing: Direct physical measurements against established engineering specifications (e.g., precise measurements of balloon crossing profile, rated burst pressure tests until failure).
• For In-vivo Testing: Physiological and clinical observations in the swine model post-procedure (e.g., assessment for downstream and cognitive effects).

8. The sample size for the training set:

Not applicable. This is not an AI/ML device, so there is no training set in the context of machine learning.

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

Not applicable, as there is no training set.

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The ArchStent Biliary system is intended for use in the palliation of malignant neoplasms in the biliary tree

The ArchStent Biliary System is a 0.014" guidewire-compatible, rapid exchange (RX) balloonexpandable stent system. It consists of a stainless steel stent that can flare in the proximal segment and a dual balloon delivery catheter. Accessories include a 1.0 cc Syringe and a 10 cc Deflation Syringe.

The provided document is a 510(k) summary for the ArchStent Biliary System. It details the device description, intended use, and performance data from bench testing. However, it does not contain information related to software AI/ML performance, such as acceptance criteria for AI algorithms, clinical study design, sample sizes for test or training sets in an AI context, expert ground truth establishment, or multi-reader multi-case studies.

Therefore, I cannot extract the requested information regarding AI device performance.

The document describes material and mechanical bench testing for a physical medical device (biliary stent system), which falls under a different regulatory pathway and testing paradigm than AI/ML-driven software.

Here's a summary of the information that is present in relation to the device's performance data, but it's not related to AI:

F. Performance Data:

• Type of Testing: In-vitro performance bench tests.
• Tests Performed:
  • Deployment Testing
  • Compression Force Testing
  • Dimensional Testing
  • Corrosion Testing
  • Balloon Performance Testing
  • Stent Deformation Testing
  • Tensile Strength Testing
• Testing Conditions: All testing was performed on sterile, finished devices per FDA guidance document "Guidance for the Content of Premarket Notifications for Metal Expandable Biliary Stents," February 1998.
• Biocompatibility: Performed as suggested by ISO 10993 Guidelines, FDA General Program Memorandum No. G95-1, ODE Bluebook Memorandum, No. G95-1, and FDA guidance document "Guidance for the Content of Premarket Notifications for Metal Expandable Biliary Stents," February 1998.
• Conclusions: All test results demonstrate that the materials, manufacturing process, and design of the ArchStent Biliary System meet the established specifications necessary for consistent performance according to its intended use and is biocompatible.

The following information fields from your request cannot be fulfilled from the provided text as they pertain to AI/ML device studies:

1. A table of acceptance criteria and the reported device performance (for AI)
2. Sample sized used for the test set and the data provenance (for AI)
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (for AI)
4. Adjudication method (for AI)
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
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
7. The type of ground truth used (for AI)
8. The sample size for the training set (for AI)
9. How the ground truth for the training set was established (for AI)

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The Flash PTA Balloon Catheter is indicated for Percutaneous Transluminal Angioplasty in the peripheral vasculature at aorto-ostial locations, including iliac, renal and carotid arteries. This device is also indicated for post-dilatation of balloon expandable stents in the peripheral vasculature.

The Flash PTA Balloon Dilatation Catheter is designed for dilation of stenotic ostial lesions in the peripheral vasculature. The Flash PTA Balloon Dilatation Catheter is a .014" guidewire-compatible, rapid exchange (RX) angioplasty balloon catheter with proximal anchoring and a working length of 135cm. The Flash PTA Balloon Dilatation Catheter uses a dual balloon design that features a compliant anchoring balloon, which prevents distal migration of the balloon during angioplasty. The second semicompliant higher-pressure balloon allows for luminal dilatation of de novo lesions and post deployment stent expansion.

This document describes the acceptance criteria and the study conducted for the Flash PTA Balloon Dilatation Catheter.

1. Table of Acceptance Criteria and Reported Device Performance

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

The provided document does not specify a separate "test set" in the context of clinical data or patient samples. The study described is a series of in-vitro performance bench tests and biocompatibility tests. Therefore, the concept of data provenance (e.g., country of origin, retrospective/prospective) and sample size in terms of clinical cases is not applicable here. The samples for these tests would be physical devices or materials, not patient data.

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

Not applicable. The "ground truth" for the in-vitro and biocompatibility tests would be established through predefined scientific and engineering specifications, and validated laboratory methodologies, rather than human expert consensus on clinical findings.

4. Adjudication Method for the Test Set

Not applicable. As described above, the acceptance criteria are based on pre-defined specifications and validated laboratory testing, not human-reviewed clinical cases that would require adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. The document describes laboratory (in-vitro) and biocompatibility testing, not clinical studies involving human readers or patient cases.

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

Not applicable. This device is a physical medical device (balloon catheter), not an algorithm or AI system. Therefore, the concept of "standalone performance" for an algorithm is not relevant.

7. The Type of Ground Truth Used

The "ground truth" for this device's evaluation is based on:

• Established Scientific and Engineering Specifications: For the in-vitro performance bench testing, the device's performance characteristics (e.g., burst pressure, inflation/deflation time, fatigue) must meet predetermined quantitative and qualitative standards.
• Regulatory Standards and Guidelines: For biocompatibility, the ground truth is defined by compliance with international standards such as ISO-10993 and FDA guidelines (e.g., Blue Book Memorandum May 1, 1995) which specify acceptable biological responses to the device materials.

8. The Sample Size for the Training Set

Not applicable. This is a physical medical device, not an AI/algorithm that requires a "training set."

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

Not applicable, as no training set was used.

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The Flash PTA Balloon Dilatation Catheter is indicated for use in Percutaneous Transluminal Angioplasty in the peripheral vasculature at aorto-ostial locations, including iliac, renal and carotid arteries. This catheter is not intended for use in coronary arteries.

The Flash PTA Balloon Dilatation Catheter is a 0.014" guidewire-compatible, rapid exchange (RX) angioplasty balloon catheter with proximal anchoring. The device uses a dual balloon design featuring a compliant anchoring balloon, which enables the operator to precisely position the catheter at aorto-ostial anatomies and prevent distal migration of the balloon during angioplasty. The second semi-compliant high pressure balloon allows for luminal dilatation.

The provided text describes a 510(k) premarket notification for the Flash PTA Balloon Dilatation Catheter. It focuses on demonstrating substantial equivalence to a previously cleared device (K102482) and reports on bench testing for product line extensions.

The document does not contain information on acceptance criteria or a study proving the device meets those criteria in a clinical setting. The performance data section exclusively mentions "Bench testing."

Therefore, most of the requested information cannot be extracted from the provided text.

Here's a breakdown of what can be inferred or directly stated based on the given document:

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

Explanation: The document states, "All test results demonstrate that the materials, manufacturing process, and design of the Flash PTA Balloon Dilatation Catheter meet the established specifications necessary for consistent performance according to its intended use." This indicates that for each bench test listed, there were pre-defined acceptance criteria (specifications) that the device successfully met. However, the exact numerical or qualitative specifications themselves are not provided in this summary.

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: Not specified. The document only mentions "Bench testing performed."
• Data provenance: Not specified. This was bench testing, not human or animal study data.

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

• Not applicable. This document describes bench testing of a physical medical device, not a diagnostic algorithm that requires expert-established ground truth.

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

• Not applicable. This document describes bench testing of a physical medical device.

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 document is for a physical balloon catheter, not an AI or diagnostic imaging device.

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

• No. This document is for a physical balloon catheter.

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

• Not applicable. For physical device bench testing, "ground truth" refers to the established engineering specifications and physical measurements.

8. The sample size for the training set:

• Not applicable. There is no mention of a training set as this is not an algorithm being developed.

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

• Not applicable. There is no mention of a training set.

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