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The Poseidon Microcatheter is intended for use in peripheral and coronary vessels for diagnostic and interventional procedures including small or superselective anatomy.

The Poseidon Microcatheter is a single lumen catheter constructed using an internal lubricious layer encapsulated by a metallic braid and lubricious outer layer. The distal tip includes a radiopaque marker band, and the distal 60 - 90 cm of the microcatheter has a hydrophilic coating.

The provided document is a 510(k) Premarket Notification for the Heraeus Poseidon Microcatheter. It focuses on demonstrating substantial equivalence to a predicate device, rather than proving the device meets specific performance acceptance criteria via a clinical study that would involve expert readers, complex adjudication, or MRMC studies.

Therefore, many of the questions asked cannot be answered directly from this type of FDA submission. The document details bench testing against general regulatory standards and comparisons to a predicate device's characteristics.

Here's a breakdown of what can and cannot be answered based on the provided text:

What can be answered:

• Acceptance Criteria and Reported Device Performance (as listed in bench tests): The document provides a table of in vitro bench tests conducted and states that "Samples passed the acceptance criteria and the device was found to be [performance outcome]." The specific numerical acceptance criteria themselves are generally not detailed in this type of summary, but the qualitative outcome is stated as "passed."

  Test	Acceptance Criteria (Qualitative)	Reported Device Performance
  Cytotoxicity	Non-cytotoxic	Passed acceptance criteria; non-cytotoxic
  Sensitization	No sensitization response	Passed acceptance criteria; did not elicit sensitization
  Irritation	No irritation response	Passed acceptance criteria; did not elicit irritation
  Systemic Toxicity	Non-toxic	Passed acceptance criteria; non-toxic
  Pyrogenicity	Non-pyrogenic	Passed acceptance criteria; non-pyrogenic
  Hemolysis	Non-hemolytic	Passed acceptance criteria; non-hemolytic
  Hemocompatibility	Comparable to predicate comparison article	Passed acceptance criteria; comparable to predicate
  Thrombogenicity	Non-thrombogenic	Passed acceptance criteria; non-thrombogenic
  Corrosion Resistance	No corrosive response	Passed acceptance criteria; did not elicit corrosive response
  Dimensions	Comparable to predicate	Passed acceptance criteria; comparable to predicate
  Package Integrity Testing	Comparable to predicate	Passed acceptance criteria; comparable to predicate
  Tensile Strength	Comparable to predicate	Passed acceptance criteria; comparable to predicate
  Torque Strength	Comparable to predicate	Passed acceptance criteria; comparable to predicate
  Kink Resistance	Comparable to predicate	Passed acceptance criteria; comparable to predicate
  Radiopacity	Comparable to predicate	Passed acceptance criteria; comparable to predicate
  Flow Rate	Comparable to predicate	Passed acceptance criteria; comparable to predicate
  Burst Pressure/Freedom from Leakage	Comparable to predicate	Passed acceptance criteria; comparable to predicate

• Sample size used for the test set: Not explicitly stated as "sample size" in the context of cases/patients, but rather in terms of number of device units or samples tested for each bench test. These are standard in vitro tests, not human studies.

• Data provenance: For bench tests, this would be laboratory data.

• Training Set (for AI-related questions): This device is a microcatheter, not an AI/ML device. Therefore, there is no training set in the context of an algorithm.

What cannot be answered from this document:

• Number of experts used to establish ground truth: Not applicable for a physical medical device clearance based on substantial equivalence and bench testing.
• Qualifications of those experts: Not applicable.
• Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable.
• If a multi-reader multi-case (MRMC) comparative effectiveness study was done: No, this is not an AI/imaging device.
• Effect size of how much human readers improve with AI vs. without AI assistance: Not applicable.
• If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable.
• The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Ground truth in this context refers to the defined acceptance criteria for physical properties and biological responses established through international standards (ISO, ASTM) and FDA guidance for medical devices, not clinical outcomes or expert consensus on medical images.
• Sample size for the training set: Not applicable (no AI/ML algorithm).
• How the ground truth for the training set was established: Not applicable (no AI/ML algorithm).

In summary: The provided 510(k) summary demonstrates the safety and effectiveness of the Heraeus Poseidon Microcatheter through a comparison to a legally marketed predicate device and extensive in vitro bench testing against established international standards. It is not an AI/ML device, and thus the questions related to clinical study design, human readers, ground truth establishment by experts, and training/test sets for algorithms are not applicable to this submission.

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Intended to facilitate the placement of balloon dilation catheters during percutaneous transluminal angioplasty (PTA), in peripheral arteries including but not limited to femoral, popliteal arteries. This guide wire may also be used with compatible interventional devices during therapeutic procedures. The guide wire may also be used to reach and cross a target lesion, provide a pathway within the vessel structure, facilitate the substitution of one diagnostic or interventional device for another, and to distinguish the vasculature.

The Heraeus Peripheral Guidewire is a guidewire constructed using a steel core with an optional nitinol alloy tip encapsulated by polymer and lubricious outer layer. The distal polymer includes a radiopaque loading, and the distal polymer section has a hydrophilic coating.

The provided text is a 510(k) Premarket Notification from the FDA for a medical device called the "Heraeus Peripheral Guidewire." This document focuses on demonstrating substantial equivalence to an already legally marketed predicate device, rather than proving the safety and effectiveness of a novel device through clinical trials against pre-defined acceptance criteria for diagnostic performance (such as those associated with AI/ML-based devices).

Therefore, many of the specific questions about acceptance criteria for diagnostic performance, and detailed study methodologies (like sample sizes for test sets, expert adjudication, MRMC studies, standalone performance of an algorithm, and ground truth establishment for training sets) do not directly apply to this type of regulatory submission and the device described.

This document describes a guidewire, which is a physical medical instrument, not a diagnostic algorithm or AI system. The "performance testing" mentioned is bench testing to ensure physical and material properties meet established standards for similar devices.

However, I can extract and present the information that is relevant to the document's content:

Acceptance Criteria and Device Performance (Bench Testing for Physical Properties)

The document states that the Heraeus Peripheral Guidewire met all predetermined acceptance criteria through in vitro bench tests. While the specific numerical acceptance criteria values are not explicitly detailed in this summary, the types of performance characteristics evaluated are listed. The "reported device performance" is summarized by the statement: "The Heraeus Peripheral Guidewire met all predetermined acceptance criteria and compared favorably with the predicate."

Table of Acceptance Criteria and Reported Device Performance (as inferred from the document):

Study Details (as applicable to a 510(k) for a physical device):

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

   • The document mentions "in vitro bench tests" and "test data," but does not specify the sample sizes (e.g., number of guidewires tested for each parameter).
   • Data Provenance: The tests were conducted to demonstrate equivalence with reference to "FDA Guidance - Coronary and Cerebrovascular Guidewire Guidance - January 1995." The data would originate from Heraeus Medical Components, LLC's internal testing facilities. The provenance is implied to be laboratory-based (in-vitro bench tests). The document does not specify country of origin for the direct test data, but the company is in Plymouth, Minnesota, USA. It's retrospective in the sense that the tests were performed and compiled for the submission.

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

   • This question is not applicable as the "ground truth" here refers to pre-defined engineering and material specifications, not clinical diagnostic interpretations. The "experts" would be the engineers and quality assurance professionals performing and evaluating the bench tests.

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

   • Not applicable. This concept pertains to resolving discrepancies in expert interpretations of clinical data, which is not what was done for this device. The evaluation of bench tests typically relies on meeting pre-defined quantitative or qualitative engineering specifications.

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:

   • Not applicable. This is a physical guidewire, not a diagnostic imaging/AI device. Therefore, no MRMC study looking at human reader improvement with AI assistance was conducted or would be relevant.

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

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

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

   • For this device, the "ground truth" for proving performance equivalence is based on established engineering specifications, material standards (e.g., ISO 10993-1), and comparative testing against the predicate device's known characteristics. It is not clinical "ground truth" like pathology or outcomes data.

7. The sample size for the training set:

   • Not applicable. This concept relates to machine learning models. This device underwent bench testing, not a machine learning training process.

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

   • Not applicable. As above, there was no machine learning training set for this device.

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The Odyssey Micro Catheter is intended to provide support to facilitate the placement of guidewires in the coronary and peripheral vasculatures and can be used to exchange one guide wire for another. The Odyssey Micro Catheter is also intended to assist in the infusion of contrast media. The micro catheter is not intended to be used in the neurovasculature.

The Odyssey Micro Catheter is a single lumen catheter constructed using a PTFE liner inside of metallic coil and a polymer outer layer. The distal tip is a radiopaque polymer material and the distal 30 cm to 60 cm of the micro catheter has a hydrophilic coating. The key components of the catheter are the core, coil(s), tip, and coatings.

The provided text describes a 510(k) premarket notification for a medical device called the Odyssey Micro Catheter. The document focuses on demonstrating substantial equivalence to a predicate device, rather than proving a device meets specific acceptance criteria through a clinical study in the typical sense of a novel AI/software medical device.

Therefore, the information requested for AI/software-centric studies (like sample sizes for test/training sets, data provenance, number/qualification of experts for ground truth, adjudication methods, MRMC studies, standalone performance, etc.) is not applicable to this submission, as it concerns a physical medical device and its performance in in vitro bench tests.

However, I can extract the acceptance criteria (inferred from the tests performed) and summarize the study's findings:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly list numerical acceptance criteria values for each test but states that the Odyssey Micro Catheter "met all predetermined acceptance criteria." The "reported device performance" is essentially that the device performed comparably or favorably to the predicate and met established standards.

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

• Sample Size: Not explicitly stated as a "test set" in the context of clinical data. The testing involved in vitro bench tests on the device itself. The number of units tested for each specific bench test is not detailed.
• Data Provenance: Not applicable in the context of human data. The "study" here refers to "Performance in vitro bench tests" conducted by the manufacturer, Heraeus Medical Components, LLC.

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

• Not Applicable. Ground truth, in this context, would refer to the validated methods and standards used for in vitro testing (e.g., ISO standards, internal validation of test equipment). This isn't about expert consensus on clinical data.

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

• Not Applicable. Adjudication methods are relevant for human interpretation of data, typically in clinical studies or when establishing ground truth from expert readings. This was in vitro bench testing.

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

• Not Applicable. This is a physical micro catheter, not an AI/software device that would assist 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. "Standalone performance" in this context refers to the device's functional performance against engineering and safety specifications in vitro.

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

• The "ground truth" for the performance "study" was established by validated international standards (ISO 10555-1:2013, ISO10993-1:2009) and FDA guidance (G95-1) for in vitro functional performance and biocompatibility. The specific outcomes were measurements of physical and biological properties.

8. The sample size for the training set

• Not Applicable. There is no "training set" as this is not an AI/machine learning device.

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

• Not Applicable. There is no "training set."

Summary of the Study:

The "study" described in the 510(k) summary involves a series of in vitro bench tests designed to demonstrate the safety and effectiveness of the Odyssey Micro Catheter by proving its substantial equivalence to a legally marketed predicate device (ASAHI Corsair Microcatheter, K151103).

The key aspects of the study include:

• Tests Conducted: Biocompatibility testing (cytotoxicity, sensitization, acute systemic toxicity, pyrogenicity, hemolysis, complement activation, in-vivo thrombogenicity, chemical characterization), particulate testing, corrosion resistance, dimensional inspection, sterile package integrity, tensile strength, torque strength, kink resistance, radiopacity, flow rate, and burst pressure/freedom from leakage.
• Standards Followed: ISO 10555-1:2013 (Intravascular catheters - sterile and single-use catheters - Part 1: General requirements) for functional testing, and ISO10993-1:2009 and G95-1 (FDA guidance) for biocompatibility testing.
• Outcome: The Odyssey Micro Catheter "met all predetermined acceptance criteria and compared favorably with the predicate device." The study supported claims of substantial equivalence based on indications for use, physical and technological characteristics, and comparative device testing, without raising new questions of safety and effectiveness.

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The Heraeus TMW Guidewire is intended to facilitate the introduction and placement of catheters and interventional devices during Percutaneous Transluminal Angioplasty (PTA) and/or Percutaneous Transluminal Coronary Angioplasty (PTCA).

Heraeus TMW Guidewire is a steerable guidewire constructed of a bi-metal core wire. The distal core is made of Triton™ Nitinol alloy and has a coiled wire feature at the distal end. The proximal core is comprised of PTFE coated Stainless Steel material. The wire is available in .014" diameter and lengths ranging from 180 to 300 cm. The distal segment is coated with hydrophilic coating and is shapeable with a 3 cm radiopaque distal tip.

The provided document is a 510(k) Premarket Notification for the Heraeus TMW Guidewire, demonstrating its substantial equivalence to a predicate device. This document focuses on the physical and technological characteristics and performance testing of a medical device (guidewire), not an AI/ML-based medical device. Therefore, many of the requested criteria for an AI/ML device, such as "effect size of how much human readers improve with AI vs without AI assistance," "standalone (algorithm only without human-in-the-loop performance)," "training set sample size," or "ground truth establishment for training set," are not applicable or do not exist in this context.

However, I can extract information related to acceptance criteria, testing, and ground truth as it pertains to this physical medical device.

1. Table of Acceptance Criteria and Reported Device Performance

The document states that: "The Heraeus TMW Guidewire System met all predetermined acceptance criteria and compared favorably with the predicate device." However, a specific table detailing the exact numerical acceptance criteria and the corresponding reported performance values is not provided in this summary. It lists the types of tests conducted and implies that the results met the criteria and compared favorably to the predicate.

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

• Sample Size: The document does not specify the exact sample sizes (number of units tested) for each in vitro bench test. It generically states "bench tests were utilized."
• Data Provenance: The tests were "in vitro bench tests," meaning they were conducted in a laboratory setting, not on patient data. There is no information on country of origin of data, or whether it was retrospective or prospective, as these are concepts typically relevant to human subject studies.

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. The "ground truth" for a physical medical device like a guidewire is established through objective engineering and materials science principles and standards (e.g., ISO, ASTM). It does not involve human expert interpretation of images or clinical data in the same way an AI/ML diagnostic device would.

4. Adjudication method for the test set:

• This is not applicable. The performance of a physical device against engineering specifications does not typically involve an adjudication method by multiple human experts.

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 device is a guidewire, not an AI/ML diagnostic or assistive tool for human readers.

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

• No, this is not an AI/ML algorithm. Its performance is inherent in its physical and mechanical properties.

7. The type of ground truth used:

• The "ground truth" for this device is based on established engineering specifications, material properties, and biocompatibility standards (e.g., ISO 10993-1, ISO 10993-7, "Coronary and Cerebrovascular Guidewire Guidance, Jan 1995"). The device's performance is measured against these objective standards and compared to the predicate device's known characteristics.

8. The sample size for the training set:

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

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

• Not applicable, as there is no training set for a physical device.

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