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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 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.

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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 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.

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