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The Pinnacle® Destination® Peripheral Guiding Sheath is designed to be used for the introduction of interventional and diagnostic devices into the human vasculature, including but not limited to lower extremity access via a contralateral approach.

The Pinnacle® Destination® Peripheral Guiding Sheath is designed to perform as a guiding catheter and an introducer sheath. The Peripheral Guiding Sheath is packaged with the following components: a Sheath, a Dilator, a Hemostatic Valve, and a Dilator Retaining Clip (Devices with TBV Valve only).

The provided document is a 510(k) summary for the Pinnacle® Destination® Peripheral Guiding Sheath. This type of regulatory submission focuses on demonstrating substantial equivalence to a predicate device, rather than providing detailed clinical study data with acceptance criteria for device performance as would be expected for a novel device.

Therefore, many of the requested details regarding acceptance criteria, study design parameters (sample size, data provenance, expert adjudication, MRMC study, standalone performance), and ground truth establishment are not applicable or not provided in this document because it's a submission for a substantially equivalent medical device, not a new clinical trial of a diagnostic or AI-driven aid.

Here's a breakdown of the available information:

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

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 mentions "bench and vessel model testing" but does not specify sample sizes for these tests.
• Data provenance is not specified. These would typically be laboratory-based tests.

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. The testing described (bench and vessel models, biocompatibility, sterilization) does not involve expert interpretation or ground truth establishment in the way a diagnostic imaging study would.

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

• Not applicable / not provided. Adjudication is relevant for interpreting subjective assessments, which is not the primary mode of testing for this type of device (an introducer sheath).

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 manual catheter introducer, not an AI-assisted diagnostic or interventional tool. Therefore, an MRMC study with AI assistance is entirely irrelevant.

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 operated manually, not an algorithm.

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

• For performance testing (bench and vessel models), the "ground truth" would be established engineering and biomechanical specifications and measurements compared to the predicate device's performance.
• For biocompatibility, the ground truth is established by the results of standardized biological tests (e.g., cytotoxicity, sensitization, irritation) according to ISO 10993.
• For sterilization, the ground truth is established by microbiological challenge testing validating the sterilization cycle to achieve the specified SAL.

8. The sample size for the training set

• Not applicable / not provided. No "training set" is relevant for a device like this, which is compared to a predicate based on physical and material properties and performance in bench/vessel models.

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

• Not applicable / not provided. As there is no training set for this type of device, ground truth establishment for it is not relevant.

In summary: The document is a 510(k) submission for a substantially equivalent medical device. The "study" described is a series of bench and vessel model tests, along with biocompatibility and sterilization validations, to demonstrate equivalence to a previously cleared predicate device. It does not involve human readers, AI algorithms, or extensive clinical trials with detailed statistical endpoints that would require the typical "acceptance criteria" breakdown seen for diagnostic devices or AI-driven systems.

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The Pinnacle® Destination® Peripheral Guiding Sheath is designed to be used for the introduction of interventional and diagnostic devices into the human vasculature, including but not limited to lower extremity access via a contralateral approach.

The Pinnacle® Destination® Peripheral Guiding Sheath is designed to perform as a guiding catheter and an introducer sheath. The Peripheral Guiding Sheath is packaged with the following components: a Sheath, a Dilator, a Hemostatic Valve, and a Dilator Retaining Clip.

The provided text describes a Special 510(k) submission for the Pinnacle® Destination® Peripheral Guiding Sheath. The submission asserts substantial equivalence to a predicate device, which allows for a streamlined review process based on demonstrating that the new device is as safe and effective as a legally marketed device. This type of submission does not typically involve the rigorous performance studies with human subjects or complex AI evaluation that would require detailed acceptance criteria, test set characteristics, or MRMC studies.

Here's an analysis of the provided information in the context of your request:

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

The document does not explicitly state quantitative acceptance criteria or detailed reported device performance in the way a clinical study for a novel device or AI algorithm would. Instead, it relies on demonstrating substantial equivalence to a predicate device. The "performance" section states:

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

For this type of 510(k) submission, there isn't a "test set" in the context of clinical data for an AI algorithm. The performance evaluation was based on bench and vessel model testing. No human clinical data from a specific test set is mentioned. Therefore, there is no information on sample size, country of origin, or whether it was retrospective or prospective.

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

Not applicable. As noted above, there was no clinical "test set" with human data requiring expert ground truth establishment.

4. Adjudication method for the test set

Not applicable. There was no clinical "test set" requiring adjudication.

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

Not applicable. This device is a guiding sheath, a manual medical instrument, not an AI-powered diagnostic or assistive tool. Therefore, an MRMC study comparing human readers with and without AI assistance is not relevant and was not performed.

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

Not applicable. The device is a physical guiding sheath, not an AI algorithm.

7. The type of ground truth used

For the aspects evaluated:

• Performance (equivalence): The ground truth for "equivalence" was likely established by comparing engineering specifications and performance metrics from the bench and vessel model tests of the new device against the established performance characteristics of the predicate device.
• Sterilization: The ground truth is a Sterility Assurance Level of 10-6, achieved through validation according to EN ISO 11135-1.
• Biocompatibility: The ground truth is compliance with ISO 10993 standards and a finding of biocompatibility, based on laboratory tests.

8. The sample size for the training set

Not applicable. The device is a physical medical instrument, not an AI algorithm 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 an AI algorithm, this question is not relevant.

In summary: The provided document is a 510(k) summary for a peripheral guiding sheath, demonstrating substantial equivalence to a predicate device. The "study" proving it meets acceptance criteria is primarily bench and vessel model testing, along with standard biocompatibility and sterilization validations. It does not involve human clinical trials or the evaluation methodologies typically associated with AI-powered devices or complex diagnostic tools.

Ask a specific question about this device

The Pinnacle® Destination® Peripheral Guiding Sheath is designed to be used for the introduction of interventional and diagnostic devices into the human vasculature, including but not limited to lower extremity access via a contralateral approach.

The Pinnacle® Destination® Peripheral Guiding Sheath is designed to perform as a guiding catheter and an introducer sheath. The Peripheral Guiding Sheath is packaged with the following components: a Sheath, a Dilator, a Hemostatic Valve, and a Dilator Retaining Clip.

The provided text describes a 510(k) premarket notification for a medical device, specifically the Pinnacle® Destination® Peripheral Guiding Sheath. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving novel effectiveness through extensive clinical trials.

Therefore, the document does not contain the information requested regarding acceptance criteria and a study that proves the device meets those criteria in the context of an AI/algorithm-driven device. The details requested are typically associated with performance evaluations of AI algorithms, particularly those seeking de novo clearance or 510(k) clearance for AI-based functions.

Here's why the requested information is absent and what the document does provide:

1. Acceptance criteria and reported device performance (Table 1): The document outlines specifications for the device (Sheath Size, Nominal ID/OD, Length, Hydrophilic Coating, Distal Shape), which are analogous to acceptance criteria in terms of physical attributes. However, it does not present a table of performance acceptance criteria (e.g., sensitivity, specificity, or specific functional benchmarks in a clinical context) with corresponding reported performance for a new AI function. It states, "The performance of the Pinnacle® Destination® Peripheral Guiding Sheath is substantially equivalent to the performance of the unmodified Peripheral Guiding Sheath. The equivalence was shown through bench and vessel model testing." This indicates the performance was compared to the predicate, not measured against novel, AI-specific acceptance criteria.

2. Sample size for the test set and data provenance: Not applicable. This device is a manual medical instrument, not an AI/algorithm. Performance was assessed through bench and vessel model testing, not clinical data sets with "test sets" in the AI sense.

3. Number of experts used to establish ground truth for the test set and their qualifications: Not applicable. Ground truth as typically defined for AI models (e.g., expert consensus on image labels) is not relevant for this physical device's evaluation.

4. Adjudication method for the test set: Not applicable.

5. Multi-reader multi-case (MRMC) comparative effectiveness study: Not applicable. This study design is used for evaluating human reader performance with and without AI assistance. This device is a physical guiding sheath; it doesn't "assist" human readers with interpretation.

6. Standalone (algorithm-only) performance: Not applicable. There is no algorithm.

7. Type of ground truth used: For the physical characteristics, the ground truth would be engineering specifications and measurements. For the "performance" described as "substantially equivalent," the ground truth is the established performance of the predicate device.

8. Sample size for the training set: Not applicable. This is not an AI/ML device that requires training data.

9. How the ground truth for the training set was established: Not applicable.

In summary, the provided 510(k) summary focuses on demonstrating substantial equivalence of a physical medical device (a guiding sheath) to an existing predicate device, primarily through bench and vessel model testing. It does not involve any artificial intelligence or machine learning component, and thus, the specific questions related to AI algorithm performance evaluation are not addressed in this document.

Ask a specific question about this device

The Pinnacle® Destination® Peripheral Guiding Sheath is designed to be used for the introduction of interventional and diagnostic devices into the human vasculature, including but not limited to lower extremity access via a contralateral approach.

The Pinnacle® Destination® Peripheral Guiding Sheath is designed to perform as a guiding catheter and an introducer sheath. The Peripheral Guiding Sheath is packaged with the following components: a Sheath, a Dilator, a Hemostatic Valve, and a Dilator Retaining Clip.

This document is a 510(k) summary for the Pinnacle® Destination® Peripheral Guiding Sheath, not a study report, so it does not contain detailed acceptance criteria or a specific study that proves the device meets those criteria in the way a clinical trial or performance study report would.

However, based on the provided text, we can infer the basis of acceptance and the type of "study" conducted for this medical device, which is primarily a demonstration of "substantial equivalence" to a predicate device.

Here's an attempt to answer your questions based on the available information:

Acceptance Criteria and Device Performance (Inferred from Substantial Equivalence)

The primary "acceptance criterion" for this 510(k) submission is Substantial Equivalence to the predicate device, the Carotid Guiding Sheath (K012812) manufactured by Terumo Medical Corporation. This means the new device must perform comparably to the predicate device in terms of safety and effectiveness for its intended use.

Study Information (as inferrable from the 510(k) Summary)

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

   • Sample Size: Not explicitly stated. The document mentions "bench and cadaver testing" but does not provide details on the number of samples or subjects involved in these tests.
   • Data Provenance: The testing was likely conducted in a laboratory or clinical setting (cadaver testing) by the manufacturer (Terumo Medical Corporation). The document does not specify the country of origin of the data beyond the manufacturer's location in Elkton, MD, USA. It is prospective testing designed to support the 510(k) submission.

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

   • Not applicable/Not provided. For a device like a guiding sheath, "ground truth" typically relates to objective physical and mechanical properties, as well as biological responses (biocompatibility), rather than expert interpretation of medical images or diagnostic outcomes. Testing would involve engineers, materials scientists, and possibly medical professionals for cadaver use, but not in the sense of establishing a "ground truth" for diagnostic accuracy.

3. Adjudication method for the test set:

   • Not applicable. Adjudication methods like 2+1 or 3+1 are used for studies involving subjective human assessment (e.g., image interpretation). This device's evaluation is based on objective measurements and performance in bench and cadaver testing.

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

   • No. This is not an AI-assisted diagnostic device.

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

   • No. This is a manual guiding sheath, not an algorithm. Performance was evaluated through "bench and cadaver testing."

6. The type of ground truth used:

   • For bench testing: Engineering specifications, material properties, and physical performance characteristics (e.g., lubricity, flexibility, burst pressure, tensile strength, flow rates).
   • For cadaver testing: Practical usability, navigation capabilities, and potentially observable tissue interaction in a simulated anatomical environment.
   • For biocompatibility: Laboratory test results demonstrating compliance with ISO 10993.
   • For sterility: Validation results to achieve the specified Sterility Assurance Level (SAL).

7. The sample size for the training set:

   • Not applicable/Not provided. This device is not an AI/ML algorithm that requires a "training set." The materials and design are based on established engineering principles and comparison to a known predicate device.

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

   • Not applicable. There is no "training set" for this type of device.

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