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The MicroTract Access System is intended to allow the use of a .018" guidewire with a .035" or .038" guidewire compatible dilator up to 23cm in overall length.

The MicroTract Access System contains a 20 gauge Access Needle, a 0.018" Guidewire, and a Dilator Adapter. The Dilator Adapter is a sterile, single use device that is hollow and has a tapered increase in outer diameter on one end. This shape allows the Adapter to fill the excess space between .018" guidewires and dilators with larger inner diameters.

The provided text is a 510(k) summary for the MicroTract Access System, a medical device. It describes the device, its indications for use, and a summary of performance data used to demonstrate substantial equivalence to predicate devices.

However, the document does not contain the level of detail requested regarding specific acceptance criteria, study methodologies (like sample sizes for test/training sets, data provenance, expert qualifications, or adjudication methods), or outcomes of a multi-reader multi-case (MRMC) comparative effectiveness study or standalone algorithm performance.

The "Performance Data" section in the summary is very high-level and states: "The MicroTract Access System was subjected to tensile testing to demonstrate that it met ISO11070-1998 specifications for dilators. The System also underwent testing for dimensional specifications, design verification and validation including insertion forces and useability as assessed on a simulated clinical bench model."

This statement confirms that some performance testing was conducted, but it doesn't provide the detailed acceptance criteria or study results in the format requested.

Therefore, I cannot provide a table of acceptance criteria and reported device performance, nor can I answer the specific questions about sample sizes, ground truth establishment, expert involvement, or MRMC studies for this device based on the information provided. The document focuses on demonstrating substantial equivalence through general performance testing rather than a detailed AI-related study or clinical trial.

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The AXERA Access System is intended to provide access for the percutaneous introduction of devices into the peripheral vasculature and to promote hemostasis at the arteriotomy site as an adjunct to manual compression. AXERA is indicated for use in patients undergoing diagnostic femoral artery catheterization procedures using 5F or 6F introducer sheaths.

The AXERA 2 is a device that is comprised of a Latchwire, anchor mechanism, shaft and handle with control features.

Here's an analysis of the provided text regarding the AXERA 2 Access System, focusing on acceptance criteria and study details:

1. Table of Acceptance Criteria and Reported Device Performance

The provided text only states that the device "met all performance testing acceptance criteria" and lists the types of tests performed. It does not detail the specific numerical acceptance criteria (e.g., "tensile strength of X N") or the exact reported device performance values. Therefore, a complete table as requested cannot be constructed from the given information.

However, based on the text, we can infer the categories of tests and the general outcome:

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

• Test Set (Bench Testing): The document does not specify the exact sample sizes (number of units) used for each individual bench test. It only states that "test units" were used "following sterilization."
• Test Set (Simulated Use): "a cadaveric model" (singular) was used.
• Test Set (Clinical Evaluations):
  • Short-term safety and clinical performance: "multiple clinical evaluations were conducted." The exact number of patients is not provided.
  • Long-term safety and re-access: "retrospectively studied in a smaller cohort of patients." The exact number of patients for this cohort is not provided.
• Data Provenance: The document does not explicitly state the country of origin for the clinical or cadaveric data. It generally refers to "preliminary animal studies (non-GLP) and cadaver assessments, as well as clinical investigations." Given the FDA submission, it can be inferred that the data would be acceptable to the US regulatory body, but the origin itself is not specified as, for example, "US data." The clinical studies are described as both "preliminary" and "retrospective," indicating a blend of prospective and retrospective aspects for different evaluations.

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

The document does not specify that "experts" were used to establish ground truth in the context of device performance in bench, cadaver, or clinical studies, nor does it list their qualifications. The testing appears to be objective measurements (e.g., tensile strength, deployment forces) and observations of safety and performance. For the clinical evaluations, the "ground truth" would likely be based on clinical outcomes, investigator assessments, and patient data rather than a separate expert panel establishing a "ground truth" in the diagnostic sense.

4. Adjudication Method for the Test Set

Not applicable/not specified. The testing described primarily involves objective device performance measurements and clinical observations rather than subjective assessments requiring adjudication (like image interpretation).

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 catheter introducer, not an AI-powered diagnostic or treatment assistance system. Therefore, MRMC studies with AI assistance are not relevant to its evaluation.

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 a software algorithm.

7. The Type of Ground Truth Used

• Bench Testing: Engineering specifications, physical performance metrics, and established manufacturing standards (e.g., for tensile strength, component integrity, functionality).
• Simulated Use (Cadaveric Model): Observational outcomes related to device performance in tissue (e.g., successful access, shallow path creation).
• Clinical Evaluations: Clinical outcomes, safety data (adverse events), and efficacy observations (successful vascular access, hemostasis, ability to re-access) gathered from actual patient procedures. The document mentions "short term safety and clinical performance" and "long term safety, as well as the ability to access and re-access."

8. The Sample Size for the Training Set

Not applicable. This is a physical medical device, not a machine learning model that requires a training set in the AI sense. The development of the device would involve iterative design and testing, but not a "training set" in the context of AI.

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

Not applicable, as there is no "training set" in the AI sense for this device. The "ground truth" for its design and manufacturing would be based on engineering principles, material science, clinical needs, and regulatory requirements.

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The AXERA Access System is intended to provide access for the percutaneous introduction of devices into the peripheral vasculature and to promote hemostasis at the arteriotomy site as an adjunct to manual compression. AXERA is indicated for use in patients undergoing diagnostic femoral artery catheterization procedures using 5F or 6F introducer sheaths.

The AXERA RX is a device that is comprised of a flexible tip, anchor mechanism, shaft and handle with control features.

The provided text describes modifications to an existing device (AXERA 2 Access System to AXERA RX Access System) and various tests performed to demonstrate substantial equivalence to its predicate. However, it does not provide explicit acceptance criteria in a table format, nor does it detail a study that proves the device meets specific numerical acceptance criteria in the way an AI/ML device would be evaluated for metrics like sensitivity, specificity, or AUC.

Instead, the document focuses on engineering and performance testing for a medical device (catheter introducer). Therefore, much of the requested information regarding AI/ML device evaluation is not applicable or cannot be extracted from this text.

Here's an attempt to answer the questions based on the provided text, highlighting where information is absent or not applicable:

1. Table of acceptance criteria and reported device performance

The document states: "The AXERA RX Access Device met all performance testing acceptance criteria." However, it does not provide a table detailing those acceptance criteria or specific numerical performance results. It only lists the types of tests performed.

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

• Test Set Description: The document refers to "Bench testing," "Simulated use testing on a cadaveric model," and "Clinical investigations."
• Sample Size for Bench Testing: Not specified.
• Sample Size for Cadaveric Model: Not specified.
• Sample Size for Clinical Investigations: Not specified, but a "smaller cohort of patients" was used for the retrospective study.
• Data Provenance:
  • Bench testing: Likely in-house laboratory.
  • Simulated use testing: Cadaveric model (source/country not specified).
  • Clinical investigations: Patients, but country of origin and whether prospective or retrospective for the initial investigations are not specified. The long-term safety study was explicitly retrospective.

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

Not applicable. This device is a physical medical instrument, not an AI/ML imaging device requiring expert ground truth for interpretation. The "ground truth" (or "reference standard") for this device would be direct physical measurement, engineering standards, and direct observation of device performance in simulated and clinical settings.

4. Adjudication method for the test set

Not applicable. This device is a physical medical instrument. Adjudication methods like "2+1" are relevant for expert review of AI/ML outputs, not for device performance testing like tensile strength or functionality.

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/ML device that assists human readers.

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.)

For the various tests performed, the "ground truth" would be:

• Bench Testing: Engineering specifications, ISO standards, validated measurement techniques (e.g., force gauges, calipers, visual inspection for functionality).
• Simulated Use (cadaveric): Observable performance relative to intended function (e.g., successful access, no damage to surrounding tissue, hemostasis).
• Clinical Investigations: Clinical outcomes data, typically adverse event rates, success rates of access, and achievement of hemostasis.

8. The sample size for the training set

Not applicable. This is a physical medical device, not an AI/ML model that requires a training set. The "unmodified AXERA RX design features" mentioned undergoing preliminary animal studies, cadaver assessments, and clinical investigations could be considered analogous to prior data that informed the design, but this is distinct from AI/ML training data.

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

Not applicable (as it's not an AI/ML device). For the foundational understanding of the device's design and performance (which could be loosely considered 'training' in an engineering context), the ground truth was established through:

• Engineering principles and design specifications.
• Pre-clinical studies (animal and cadaveric models) where physiological responses and anatomical interactions serve as the "truth."
• Prior clinical evaluations of the unmodified device, where actual patient outcomes and medical assessments provided the "truth."

Ask a specific question about this device

The AXERA Access System is intended to provide access for the percutaneous introduction of devices into the peripheral vasculature and to promote hemostasis at the arteriotomy site as an adjunct to manual compression. AXERA is indicated for use in patients undergoing diagnostic femoral artery catheterization procedures using 5F or 6F introducer sheaths.

The AXERA 2 is a device that is comprised of a Latchwire, anchor mechanism, shaft and handle with control features.

The provided text describes the AXERA 2 Access System, a catheter introducer device, and its substantial equivalence to a predicate device. The document focuses on bench testing and prior studies rather than a detailed clinical study with acceptance criteria and a "device performance" section in the traditional sense of a diagnostic or AI device.

However, I can extract the information based on the provided text's focus for a medical device regulatory submission.

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

For the AXERA 2 Access System, the acceptance criteria are related to specific bench tests and its ability to meet performance requirements for its intended use, based on the predicate device. The document explicitly states that the device met all acceptance criteria.

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

• Bench Testing (current submission): The sample sizes for each specific bench test (Latchwire attachment, tensile strength, procedural sheath insertion) are not provided. The data provenance is "following sterilization of test units," implying lab-based, controlled testing. No country of origin is specified.
• Bench Testing (predicate device): Sample sizes are not provided for the various bench tests listed. Data provenance is implied to be lab-based.
• Preliminary Animal Studies and Cadaver Assessments: The text mentions "preliminary animal studies (non-GLP)" and "cadaver assessments," stating they were "conducted using prototypes of a similar design and configuration." Sample sizes are not specified.
• Clinical Investigations: "Multiple clinical evaluations were conducted" for short-term safety and performance. Sample size is not specified.
• Retrospective Study: "The long term safety, as well as the ability to access and re-access, was retrospectively studied in a smaller cohort of patients." The exact sample size of this "smaller cohort" is not specified. Data provenance is retrospective.

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 section is not applicable as the studies described are for a medical device (catheter introducer) focusing on mechanical performance, safety, and functionality, not a diagnostic or AI device requiring expert-established ground truth on images or patient outcomes in that specific manner. The "ground truth" for bench tests would be the physical properties and performance metrics. For animal/cadaver/clinical studies, it would be direct observation of device function, safety, and patient outcomes by medical professionals.

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

Not applicable for the types of studies described (bench testing, animal/cadaver assessments, clinical evaluations of a mechanical device). Adjudication methods like 2+1 or 3+1 are typically used in studies involving subjective interpretation of data (e.g., medical images) by multiple readers.

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 catheter introducer, not an AI or imaging-related diagnostic tool that would involve human readers or AI assistance in interpretation.

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

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

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

• Bench Testing: The ground truth for bench tests is the objective physical measurements and functional performance against predefined engineering specifications.
• Preliminary Animal Studies & Cadaver Assessments: The ground truth would be direct observation of the device's interaction with tissue, its ability to create an access path, and any observed complications or successes, likely assessed by researchers/medical professionals conducting the studies.
• Clinical Investigations: The ground truth would include direct observation of device functionality, success of arterial access, hemostasis, and patient outcomes (e.g., complications, adverse events) as documented by clinicians.
• Retrospective Study: The ground truth would be patient outcomes data (e.g., long-term safety, re-access capability) extracted from medical records.

8. The sample size for the training set

Not applicable. This device is not an AI algorithm requiring a training set.

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

Not applicable. This device is not an AI algorithm.

Ask a specific question about this device

The AXERA Access System is intended to provide access for the percutaneous introduction of devices into the peripheral vasculature and to promote hemostasis at the arteriotomy site as an adjunct to manual compression. AXERA is indicated for use in patients undergoing diagnostic femoral artery catheterization procedures using 5F or 6F introducer sheaths.

The AXERA 2 is a device that is comprised of a Latchwire, anchor mechanism, shaft and handle with control features.

Here's a breakdown of the acceptance criteria and study information based on the provided text, focusing on the changes made to the AXERA 2 Access System.

It's important to note that the provided documents are a 510(k) summary and acceptance letter, which typically focus on demonstrating substantial equivalence to a predicate device rather than providing a detailed clinical study report with acceptance criteria usually seen for novel devices or significant changes. The information available is based on the description of testing performed for the modifications.

Acceptance Criteria and Reported Device Performance

The provided text states: "The AXERA 2 Access Device met all performance testing acceptance criteria." However, specific numerical acceptance criteria and their corresponding reported device performance values are not explicitly detailed in the text. The summary lists the types of tests performed.

Note: The document states that "all performance testing acceptance criteria" were met, but it does not specify what those criteria were (e.g., minimum tensile strength, maximum deployment force range).

Study Details

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

   • Bench Testing: The document mentions "test units" were used for the various bench tests (device functionality, tensile strength, corrosion, etc.). The specific number of units used for each test is not provided.
   • Preliminary Animal Studies & Cadaver Assessments: Not specified, but referred to as "prototypes of a similar design and configuration."
   • Clinical Investigations: The document mentions "multiple clinical evaluations were conducted" for short-term safety and performance. For long-term safety and re-access ability, it was "retrospectively studied in a smaller cohort of patients." The specific number of patients or cases in these clinical evaluations and the retrospective study is not provided.
   • Data Provenance: Not explicitly stated for all studies. Clinical investigations imply human data, likely from medical centers. The animal studies and cadaver assessments are explicitly mentioned. The country of origin for the clinical data is not mentioned.

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

   • This information is not provided in the document. For device performance testing, "ground truth" is typically established by engineering specifications and objective measurements rather than expert consensus on individual cases. For clinical studies, the "ground truth" would be clinical outcomes, and the experts involved (e.g., physicians conducting the procedures, interpreting results) are implied but not explicitly detailed in terms of number or specific qualifications (like "radiologist with 10 years of experience").

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

   • This information is not applicable to the descriptions of bench testing provided. For clinical studies, no adjudication method is mentioned.

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:

   • An MRMC comparative effectiveness study is not relevant here as the AXERA 2 Access System is a medical device (catheter introducer), not an AI-powered diagnostic imaging tool. Therefore, terms like "human readers" and "AI assistance" do not apply.

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

   • This question is not applicable. The AXERA 2 Access System is a mechanical medical device, not an algorithm or software. It requires human-in-the-loop for its intended use.

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

   • Bench Testing: The ground truth for bench tests would be the established engineering specifications and physical measurements, designed to ensure the device performs as intended (e.g., materials withstand certain forces, dimensions are correct, no corrosion).
   • Clinical/Animal/Cadaver Studies: The ground truth would be clinical outcomes related to safety and performance (e.g., ability to access the vessel, hemostasis, absence of complications, confirmed by medical observation and records).

7. The sample size for the training set:

   • This question is not applicable to a mechanical medical device. The device is not "trained" in the machine learning sense. Design and development are based on engineering principles and iterative testing.

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

   • This question is not applicable for the reasons stated above (not an AI/ML device).

Ask a specific question about this device

The AXERA Access System is intended to provide access for the percutaneous introduction of devices into the peripheral vasculature and to promote hemostasis at the arteriotomy site as an adjunct to manual compression. AXERA is indicated for use in patients undergoing diagnostic femoral artery catheterization procedures using 5F or 6F introducer sheaths.

The AXERA 2 is a device that is comprised of a latchwire, anchor mechanism, shaft and handle with control features.

Here's a breakdown of the acceptance criteria and study information for the AXERA 2 Access System based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

The document broadly states that the device "met all performance testing acceptance criteria." However, it does not explicitly list the specific quantitative acceptance criteria alongside the reported performance for each individual test. It's implied that for each test listed, the device's performance was deemed acceptable.

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

• Bench Testing: No specific sample sizes are provided for the bench tests.
• Simulated Use Testing: Performed on a "cadaveric model." The exact number of cadavers is not specified.
• Preliminary Animal Studies: No specific sample size is provided. The studies were conducted using "prototypes of a similar design and configuration."
• Cadaver Assessments: No specific sample size is provided. The assessments were conducted using "prototypes of a similar design and configuration."
• Clinical Investigations: The document mentions "Multiple clinical evaluations were conducted" and "The long term safety, as well as the ability to access and re-access, was retrospectively studied in a smaller cohort of patients." No specific sample sizes for these cohorts are provided.
• Data Provenance: The document does not explicitly state the country of origin for any of the studies or if they were retrospective or prospective, beyond the "smaller cohort" for long-term safety being studied retrospectively.

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

The document does not provide details on the number or qualifications of experts used to establish ground truth for any of the testing. For cadaveric and clinical studies, it can be inferred that healthcare professionals (e.g., surgeons, interventionalists) would have evaluated the device, but their specific roles, number, or qualifications are not mentioned.

4. Adjudication Method for the Test Set:

The document does not describe any specific adjudication method (e.g., 2+1, 3+1) for establishing ground truth from experts.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size:

No, an MRMC comparative effectiveness study comparing human readers with and without AI assistance was not done, as this device is a medical access system, not an AI-assisted diagnostic tool.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done:

Not applicable. This device is a physical medical instrument, not an algorithm. Its performance is inherent to its design and how it's used by a human operator, not a standalone AI algorithm.

7. The Type of Ground Truth Used:

• Bench Testing: The ground truth for bench testing would be objective measurements and defined engineering specifications.
• Simulated Use Testing (Cadaveric Model): The ground truth would be the observed physical outcomes and successful performance of the device in a cadaver, likely assessed by medical professionals.
• Preliminary Animal Studies: The ground truth would be physiological and anatomical observations in live animals regarding safety and performance.
• Clinical Investigations: The ground truth would be clinical outcomes, safety endpoints, and successful procedural completion, as determined by medical professionals treating patients.

8. The Sample Size for the Training Set:

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

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

Not applicable. This device is a physical medical device and does not have a training set.

Ask a specific question about this device

The AXERA Access System is intended to provide access for the percutaneous introduction of devices into the peripheral vasculature and to promote hemostasis at the arteriotomy site as an adjunct to manual compression. AXERA is indicated for use in patients undergoing diagnostic femoral artery catheterization procedures using 5F or 6F introducer sheaths.

The AXERA 2 is a device that is comprised of a latchwire, anchor mechanism, shaft and handle with control features.

The provided text describes the AXERA 2 Access System, a catheter introducer. However, it states that the device is unchanged from its predicate device (AXERA Access System, K121521) and relies on the predicate's performance data. Therefore, the details below pertain to the predicate device's testing.

There is no detailed information provided regarding specific acceptance criteria or a dedicated study documenting the predicate's performance against those criteria in a format suitable for the requested table. The document only generally states that the predicate "met all performance testing acceptance criteria."

Therefore, for aspects related to specific acceptance criteria, reported performance, sample sizes, expert involvement, and ground truth establishment, the information is synthesized from the general descriptions provided. Many fields will state "Not specified" due to the lack of granular detail in the submission for the AXERA 2 that references the predicate's testing.

Acceptance Criteria and Study for AXERA 2 Access System (Based on Predicate Device AXERA Access System K121521)

Since the AXERA 2 Access System is stated to be "unchanged for the predicate device" and its performance data relies entirely on the predicate, the acceptance criteria and study information below refer to the predicate device's testing. The submission for AXERA 2 does not provide specific numerical acceptance criteria or detailed study results for the predicate.

1. Table of Acceptance Criteria and Reported Device Performance

Note: Specific numerical acceptance criteria and reported performance values are not detailed in the provided document. The document broadly states that the predicate device met "all performance testing acceptance criteria" and "performance requirements for its intended use."

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

• Bench Testing: Not specified.
• Preliminary Animal Studies (non-GLP): Not specified. Prototypes of a similar design and configuration were used.
• Cadaver Assessments: Not specified. Prototypes of a similar design and configuration were used.
• Clinical Investigations: Two types of clinical evaluations were conducted:
  • Short-term safety and clinical performance: "Multiple clinical evaluations" were conducted. Sample size not specified. Data provenance (country of origin) not specified. Stated as clinical investigations, implying prospective in nature.
  • Long-term safety, access, and re-access: "Retrospectively studied in a smaller cohort of patients." Sample size not specified. Data provenance (country of origin) not specified.

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

• Not specified. The document does not mention the number or qualifications of experts for establishing ground truth in any of the testing types.

4. Adjudication Method for the Test Set

• Not specified. The document does not describe any adjudication methods used for the test sets.

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

• No, an MRMC comparative effectiveness study was not done. The device is a physical catheter introducer, not an AI or imaging device where human readers would typically be involved in interpreting data with or without AI assistance. The clinical studies focused on device performance metrics in patients.

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

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

7. The Type of Ground Truth Used

• Bench Testing: Engineering specifications and established test methodologies.
• Preliminary Animal Studies & Cadaver Assessments: Direct observation of device interaction with biological tissue.
• Clinical Investigations (Short-term & Efficacy): Clinical outcomes (e.g., time to hemostasis, ambulation), direct observation of device performance in patients, and patient safety data.
• Clinical Investigations (Long-term): Retrospective analysis of patient outcomes and device function over time.

8. The Sample Size for the Training Set

• Not applicable. The device is a physical medical device; there is no "training set" in the context of machine learning or algorithms. The preliminary animal studies and cadaver assessments used prototypes, which could be considered an early stage of development and refinement, but not a "training set" in the computational sense.

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

• Not applicable. As above, no "training set" in the computational sense. The "ground truth" for the device's design and engineering would have been based on clinical needs, engineering principles, and performance requirements for catheter introducers.

Ask a specific question about this device

The AXERA Access System is intended to provide access for the percutaneous introduction of devices into the peripheral vasculature and to promote hemostasis at the arteriotomy site as an adjunct to manual compression. AXERA is indicated for use in patients undergoing diagnostic femoral artery catheterization procedures using 5F or 6F introducer sheaths.

The AXERA is a device that is comprised of a latchwire, anchor mechanism, shaft and handle with control features.

Here's a breakdown of the acceptance criteria and the study information for the AXERA Access System, based on the provided text:

Important Note: The provided document is a 510(k) summary for a modification to an existing device (AXERA Access System, K113110). Therefore, the data presented focuses on demonstrating that the modified device still meets the safety and effectiveness criteria, often using bench testing. Clinical data for the original device serves as a foundation for substantial equivalence.

1. Table of Acceptance Criteria and Reported Device Performance

Study Details Proving Device Meets Acceptance Criteria

The provided document describes a "Special 510(k): Device Modification", meaning the primary focus is on demonstrating that changes to an already cleared device do not introduce new safety or effectiveness concerns. The "study" for this modification primarily consisted of bench testing.

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

• Sample Size: Not explicitly stated for each individual bench test. The text mentions "test units" without specifying the number per test.
• Data Provenance: The bench tests were performed by Arstasis, Inc. (the manufacturer) as part of their device modification review process. The studies were conducted after sterilization of test units. No information on country of origin for the data is provided, but it would presumably be from the manufacturer's testing facilities. The studies for the modification are prospective in nature (tests performed on modified devices).

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

• This question is not applicable for the bench testing described in this document. Bench tests rely on engineering specifications and measurement devices, not human expert interpretation for ground truth.
• For the clinical investigations mentioned (likely for the original device), details about experts are not provided in this summary.

4. Adjudication Method (e.g., 2+1, 3+1, none) for the Test Set:

• This question is not applicable for the bench testing described. Adjudication methods are typically used in clinical studies or image-based evaluations involving human readers.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done, 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. The AXERA Access System is a medical device (catheter introducer), not an AI-assisted diagnostic tool, so this type of study is not relevant.

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

• Not applicable. The AXERA Access System is a physical medical device, not an algorithm. Bench testing evaluates the physical device's performance against predefined engineering criteria, which is a standalone evaluation of the device itself.

7. The Type of Ground Truth Used:

• For the bench testing of the modified device: Engineering specifications and predefined acceptance criteria based on the device's intended function and safety requirements.
• For the prior clinical investigations (mentioned for the original device): The text refers to "short term safety and clinical performance" and "long term safety, as well as the ability to access and re-access." Without further detail, this would likely involve clinical outcomes data (e.g., successful access, hemostasis, complication rates) assessed by clinical professionals.

8. The Sample Size for the Training Set:

• This question is not applicable. The AXERA Access System is a physical medical device, not a machine learning model, so there is no "training set."

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

• This question is not applicable. (See point 8.)

Ask a specific question about this device

The AXERA Access System is intended to provide access for the percutaneous introduction of devices into the peripheral vasculature and to promote hemostasis at the arteriotomy site as an adjunct to manual compression. The System is indicated for use in patients undergoing diagnostic femoral artery catheterization procedures using 5F or 6F introducer sheaths.

The AXERA is a device that is comprised of a latchwire, anchor mechanism, shaft and handle with control features.

The provided text describes a Special 510(k) for a device modification of the AXERA Access System. It focuses on engineering and performance testing to demonstrate substantial equivalence, rather than a clinical study evaluating diagnostic performance with AI. Therefore, most of the requested information regarding acceptance criteria, sample size, ground truth, and expert evaluation for an AI-based study is not available in the provided document.

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

1. Table of Acceptance Criteria and Reported Device Performance

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

• Test Set Size: Not specified for each individual test. The document states "test units" were used but does not provide a specific number for each test or overall.
• Data Provenance: The testing was "bench testing," meaning it was conducted in a laboratory setting. There is no information regarding country of origin or whether it was retrospective or prospective in the context of human data, as no human data was primary to this specific modification submission.

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 this device modification was based on engineering specifications and physical performance measurements, not expert human interpretation for an AI system.

4. Adjudication method for the test set

• Not applicable. The testing described is physical performance testing against predetermined engineering specifications, not a subjective evaluation 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

• No. This was not an AI-based study. It was a device modification submission based on bench testing.

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

• Not applicable. This device is a manual catheter introducer system, not an AI algorithm.

7. The type of ground truth used

• The "ground truth" was derived from engineering specifications and objective physical measurements (e.g., forces, strengths, flexibility) established for the device's intended function.

8. The sample size for the training set

• Not applicable. No training set for an AI algorithm was involved.

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

• Not applicable. No training set for an AI algorithm was involved.

Summary of the Study Proving Device Meets Acceptance Criteria:

The study described is primarily a bench testing evaluation for a device modification to the AXERA Access System. The modifications included changing the needle material from nitinol to stainless steel, a minor change in the Needle Lumen Anchor (NLA) geometry and manufacturing process, and the addition of marking holes.

The study aimed to confirm that these modifications did not adversely affect the device's performance characteristics. A series of engineering tests were conducted on the modified AXERA device, including:

• Device functionality
• Deployment forces (heel, needle, plunger)
• Release forces (heel)
• Flex conditioning (latchwire)
• Tensile strength of multiple joints (latchwire, anchor, heel, plunger, needle)
• Compressive strength (handle/anchor)
• Torque loading (handle/anchor)

Additionally, prior testing results for corrosion resistance, flex conditioning, tensile testing, compressive strength, and biocompatibility were referenced as also having met acceptance criteria. Preliminary animal studies (non-GLP) and cadaver assessments, along with clinical investigations, were also mentioned as part of the broader evaluation history of the AXERA system, though not specifically for this modification.

The conclusion was that "All acceptance criteria were met and test results demonstrated that the modified AXERA met performance requirements for its intended use. No new issues of safety or effectiveness were raised." This indicates that the device's performance after modification remained consistent with its original design and intended use, and therefore demonstrated substantial equivalence to the predicate device.

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The Adapter is intended to allow the use of a .018" guidewire with a .035" or .038" guidewire compatible dilator up to 23cm in overall length.

The Adapter is intended to allow the use of a .018" guidewire with a 0.035" or 0.038" guidewire compatible dilator up to 23 cm in overall length and to provide access and facilitate the percutaneous introduction of various devices into veins and/or arteries while maintaining hemostasis for a variety of diagnostic and therapeutic procedures.

The Adapter is a sterile, single use device that is hollow and has a tapered increase in outer diameter on one end. This shape allows the Adapter to fill the excess space between .018" guidewires and dilators with larger inner diameters.

The Dilator Adapter is a polyethylene bump extrusion that fits into a .035"-.038" compatible vessel dilator with an internal diameter-sized-- to an .018" guidewire.

Here's a breakdown of the acceptance criteria and study information for the Arstasis Dilator Adapter based on the provided text, formatted to address your specific questions.

Important Note: The provided text is a 510(k) summary document for a medical device. These types of documents are generally focused on demonstrating substantial equivalence to a predicate device rather than presenting extensive clinical trial data with detailed statistical analyses often associated with AI/software performance studies. As such, information regarding AI-specific criteria (like MRMC studies, training set details, or complex ground truth establishment) is not present. The document focuses on performance testing of the physical properties and usability of the dilator adapter.

Acceptance Criteria and Reported Device Performance

Study Details

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

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 explicitly stated in the provided text for individual tests. The document refers to "the Dilator Adapter" and its "performance testing," implying sufficient samples were used for the various physical and bench tests.
   • Data Provenance: Not specified. The testing was likely conducted in a controlled lab environment. The document is for a US FDA submission, so the tests were likely performed or overseen in the USA.
   • Retrospective/Prospective: Not applicable in the traditional sense for this type of device. The testing described is a prospective evaluation of the manufactured device's physical properties and function on a bench model.

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

   • This device is a physical medical tool, not an AI or diagnostic software. Therefore, the concept of "ground truth" established by human experts for diagnostic purposes (e.g., radiologists interpreting images) is not applicable.
   • The "ground truth" here is determined by engineering specifications, material standards (ISO11070-1998), and direct physical measurement/testing. For usability, it would involve qualified personnel performing the simulated procedures. The number and qualifications of individuals performing these tests are not detailed.

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

   • Not applicable. Adjudication methods like 2+1 or 3+1 refer to expert consensus processes for diagnostic interpretations, which is not relevant for this physical device testing. The results of the physical and mechanical tests are objective measurements against defined standards.

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

   • A MRMC study was not done. This is a physical dilator adapter, not an AI or imaging diagnostic device where human reader performance would be a primary metric.

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

   • This is not an algorithm or AI device. "Standalone" performance as an algorithm is not applicable. The device itself is a standalone physical component designed to facilitate a medical procedure.

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

   • The "ground truth" for this device's performance testing is based on:
     • Objective Engineering Standards: Adherence to "ISO11070-1998 specifications for dilators" for tensile testing.
     • Defined Dimensional Specifications: Meeting pre-defined measurements.
     • Functional Performance Criteria: Acceptable insertion forces and overall usability as determined by bench model testing against performance expectations.

8. The sample size for the training set:

   • Not applicable. There is no "training set" in the context of machine learning for this physical medical device. The device's design is based on engineering principles and material science, not learned from data.

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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