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The Modified Concentric Microcatheter is indicated for use in the selective placement of fluids and/or other devices or agents into the peripheral, coronary and neuro vasculature during diagnostic and/or therapeutic procedures.

The Modified Concentric Microcatheter is a line extension to the existing Concentric Microcatheter, cleared under K113260. Like the predicate device, the Modified Concentric Microcather is a single-lumen, braided shaft, variable stiffness catheter designed for use in the selective placement of fluids and/or other devices or agents into the peripheral, coronary and neuro vasculature during diagnostic and/or therapeutic procedures. A luer hub on the proximal end of the shaft enables connection to the rotating hemostasis valve included in the package. The radiopaque shaft and distal marker facilitate fluoroscopic visualization. The catheter shaft is coated with a hydrophilic coating to reduce friction during use. The Modified Concentric Microcatheter differs from its predicate in that it has smaller shaft diameters and a longer effective shaft length. Device dimensions and configuration are shown on the product label. A rotating hemostasis valve with side-arm adapter is provided with each microcatheter.

The provided submission describes a medical device, the "Modified Concentric Microcatheter," which is a line extension to an existing product. The submission focuses on demonstrating substantial equivalence to the predicate device rather than presenting a de novo study with acceptance criteria for a new AI/software device. Therefore, many of the requested categories related to AI/software performance evaluation (e.g., effect size with human readers, standalone performance, ground truth establishment for training) are not applicable to this document.

Here's an analysis of the provided information concerning acceptance criteria and the supporting study, tailored to the context of a medical device submission demonstrating substantial equivalence:

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

The submission does not explicitly list quantitative acceptance criteria in a tabular format with corresponding performance metrics for the Modified Concentric Microcatheter. Instead, it describes various tests and states that the device successfully met the evaluation for each. The acceptance criteria generally seem to be "successful evaluation" or "meets its intended use" for each test. The performance is reported qualitatively as "successfully evaluated."

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

The document does not explicitly state the sample sizes (number of devices or tests performed) for each specific test. It simply mentions that tests were "performed" or "evaluated."

For the Design Validation Simulated Use Testing, it states "testing was performed in a porcine model." This indicates the use of an ex vivo or in vivo animal model. Data provenance is implied to be from internal testing by Concentric Medical, Inc. The timing of testing is prospective to the submission.

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 submission is for a medical device (microcatheter) and not an AI/software device requiring expert interpretation for ground truth. The "ground truth" for this device relates to its physical and functional performance, which is assessed through engineering and simulated-use testing.

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

This is not applicable as the testing described pertains to the physical and mechanical properties of a microcatheter, not to the interpretation of images or data that would necessitate an adjudication method among 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

This is not applicable. The device is an intravascular catheter, not an AI-powered diagnostic tool. Therefore, an MRMC study related to human reader performance with AI assistance is irrelevant to this submission.

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

This is not applicable as the device is a physical medical instrument and does not involve an algorithm.

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

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

• Engineering specifications and standards: For physical and mechanical properties (kink resistance, leak resistance, flexibility, tensile strength, torque, coating).
• Dimensional measurements: For shaft diameters and length.
• Fluoroscopic visibility standards: For radiopacity.
• Functional assessment in a simulated environment: In the porcine model to confirm intended use.

There is no "expert consensus" or "pathology" in the diagnostic sense, nor is there "outcomes data" presented in this 510(k) summary, as it's a pre-market submission focused on substantial equivalence.

8. The sample size for the training set

This is not applicable as the device is a physical medical instrument and does not involve AI or machine learning algorithms that require a training set.

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

This is not applicable for the same reason as point 8.

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The Modified Concentric Microcatheter is indicated for use in the selective placement of fluids and/or other devices or agents into the peripheral, coronary and neuro vasculature during diagnostic and/or therapeutic procedures.

The Modified Concentric Microcatheter is a single lumen, braided, variable stiffness catheter designed for use in the selective placement of fluids and/or other devices or agents into the peripheral, coronary and neuro vasculature during diagnostic and/or therapeutic procedures. A luer hub on the proximal end of the shaft enables connection to the rotating hemostasis valve included in the package. The radiopaque shaft and distal marker facilitate fluoroscopic visualization. The catheter shaft is coated with a hydrophilic coating to reduce friction during use.

Here's an analysis of the provided text regarding the Modified Concentric Microcatheter, focusing on acceptance criteria and the study proving it:

Summary of Device and Regulatory Status:

The Modified Concentric Microcatheter is a Class II diagnostic intravascular catheter (21 CFR 870.1200) seeking 510(k) clearance. Its intended use is for selective placement of fluids, devices, or agents in peripheral, coronary, and neuro vasculature during diagnostic/therapeutic procedures. The submitter claims substantial equivalence to the Concentric Microcatheter (K091961) based on identical technological characteristics (design, materials, function, physical properties, composition).

1. Table of Acceptance Criteria and Reported Device Performance

Note on Acceptance Criteria: The provided document does not explicitly state quantitative acceptance criteria (e.g., "kink resistance must exceed X Newtons" or "leakage must be less than Y mL/min"). Instead, it uses qualitative terms like "successfully evaluated" or "demonstrate that it performs as designed." This is common in 510(k) summaries where the focus is on demonstrating equivalence to a predicate device, implying that the acceptance criteria are met if the new device performs comparably to the predicate device, which has already established safety and efficacy.

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

• Sample Size: The document does not explicitly state the sample size used for any of the tests (e.g., how many catheters were tested for kink resistance).
• Data Provenance: The data provenance for the functional tests is implied to be from the manufacturer's internal testing ("results of verification and validation conducted on the Modified Concentric Microcatheter"). For biocompatibility, it states that tests were "leveraged" from the predicate device, meaning they relied on existing data for the same materials previously approved. The country of origin and whether the data is retrospective or prospective are not specified.

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

This information is not applicable (N/A) to this specific submission. This document describes a 510(k) submission for a medical device (catheter), not an AI/Software as a Medical Device (SaMD). The tests are physical and material-based, not diagnostic accuracy assessments relying on expert interpretations or ground truth.

4. Adjudication Method for the Test Set

This information is not applicable (N/A) for the same reasons as above. Adjudication methods like 2+1 or 3+1 are typically used in clinical studies involving interpretation of data (e.g., images) by human readers where there might be disagreement, which is not the case for device performance testing.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance

This information is not applicable (N/A). This is a medical device (catheter) submission, not an AI/SaMD submission. No MRMC study was conducted, and there is no AI component or human reader assistance involved.

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

This information is not applicable (N/A). This is a medical device (catheter) submission. There is no algorithm or software being tested in a standalone capacity.

7. The Type of Ground Truth Used

The "ground truth" for the functional tests is the objective physical performance of the catheter according to engineering standards and specifications. For biocompatibility, the ground truth is established by validated biological test methods and accepted safety standards, leveraging previous test results for identical materials. This is not "expert consensus," "pathology," or "outcomes data" in the typical sense applied to diagnostic or prognostic devices.

8. The Sample Size for the Training Set

This information is not applicable (N/A). This is a medical device (catheter) submission, not an AI/machine learning product. Therefore, there is no "training set" in the context of data used to train an algorithm.

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

This information is not applicable (N/A) for the same reasons as above. There is no training set or associated ground truth for an algorithm in this device submission.

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The Modified Concentric Microcatheter is indicated for use in the selective placement of fluids and/or other devices or agents into the peripheral, coronary and neuro vasculature during diagnostic and/or therapeutic procedures.

The Modified Concentric Microcatheter consists of a single lumen, braided, variable stiffness shaft with a radiopaque marker on the distal end and a luer hub on the proximal end. The catheter shaft has a hydrophilic coating to reduce friction during use.

The provided text, K091961, is a 510(k) summary for a medical device called the "Modified Concentric Microcatheter." This document is a premarket notification to the FDA for a modified version of an already cleared device.

Crucially, this type of 510(k) submission (specifically a "Special 510(k): Device Modification") and the information provided within it are primarily focused on demonstrating substantial equivalence to a predicate device, rather than detailed performance studies with acceptance criteria, ground truth, or human reader studies typically associated with AI/ML device evaluations.

Therefore, most of the requested information regarding acceptance criteria, study details, sample sizes for test/training sets, expert involvement, and ground truth types is not applicable or present in this document. The document specifically states: "The results of verification and validation conducted on the Modified Concentric Microcatheter demonstrate that it performs as designed, is suitable for its intended use and is substantially equivalent to the predicate device." This indicates that the "study" conducted was a series of engineering verification and validation tests, not a clinical performance study with human subjects or experts establishing ground truth in the way described in your request.

Here's a breakdown of what can be extracted from the provided text, and where information is missing or not applicable:

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

• Not explicitly stated in the provided text. The document states that "The results of verification and validation conducted on the Modified Concentric Microcatheter demonstrate that it performs as designed, is suitable for its intended use and is substantially equivalent to the predicate device."
• For a medical device like a microcatheter, acceptance criteria would typically relate to physical and mechanical properties (e.g., burst pressure, tensile strength, lubricity, steerability, trackability, radiopacity, dimensions) and biocompatibility. The document implies these tests were performed and met success criteria but does not detail them.

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

• Not applicable/Not provided. This device is a physical medical instrument, not an AI/ML algorithm that processes data. The "test set" would refer to the number of microcatheters or components tested in engineering verification and validation, which is not specified.
• "Data provenance" in the context of clinical data for AI is not relevant here.

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

• Not applicable/Not provided. As this is a physical device, ground truth for its performance would be established through engineering measurements and established medical device testing standards, not by human experts adjudicating clinical cases.

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

• Not applicable/Not provided. Adjudication methods are relevant for subjective interpretations (like medical images) where expert consensus establishes ground truth. For objective physical device performance, this is not applicable.

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/No evidence. This is a physical medical device, not an AI/ML diagnostic or assistive tool for human readers. Therefore, an MRMC study is not relevant to this submission.

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

• Not applicable/No evidence. This is a physical medical device. There is no algorithm involved in its direct function.

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

• Not explicitly stated, but implied to be engineering and performance specifications. Given the nature of a microcatheter, ground truth would be based on:
  • Engineering specifications: Conformance to dimensional tolerances, material properties.
  • Pre-defined performance criteria: E.g., ability to navigate a tortuous path, resistance to kinking, lubricity, burst pressure, tensile strength.
  • Biocompatibility testing results: Adherence to ISO standards for material safety.

8. The sample size for the training set

• Not applicable/Not provided. This is a physical medical device, not an AI/ML algorithm. There is no concept of a "training set" for its development in the context of this 510(k).

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

• Not applicable/Not provided. As there is no training set for an AI/ML model, this question is not relevant.

In summary, the K091961 document details a 510(k) submission for a modification to a physical medical device (microcatheter). The "study" mentioned refers to engineering verification and validation tests to ensure the modified device meets its design specifications and remains substantially equivalent to a predicate device. It does not involve AI/ML performance evaluation, expert ground truth establishment for clinical data, or human reader studies. Therefore, most of the specific questions asked, which are highly relevant to AI/ML device submissions, are not applicable to this particular document.

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