(37 days)
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:
| Acceptance Criteria Category | Reported Device Performance (Summary) |
|---|---|
| Overall Performance | Substantially equivalent to the performance of the unmodified Peripheral Guiding Sheath. |
| Validation Method | Equivalence shown through bench and vessel model testing. |
| Sterilization | Validated in accordance with EN ISO 11135-1 to provide a Sterility Assurance Level of 10-6. |
| Biocompatibility | Blood contacting materials tested per FDA G95-1 (ISO 10993) for "Externally Communicating Device, Circulating Blood, Limited Contact (≤24hrs)" and found to be biocompatible. |
| Expiration Dating | Established at 30 months. |
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.
§ 870.1340 Catheter introducer.
(a)
Identification. A catheter introducer is a sheath used to facilitate placing a catheter through the skin into a vein or artery.(b)
Classification. Class II (performance standards).