(49 days)
The Abiomed 23 Fr Sheath is intended for introduction of pacing leads or catheters.
The Abiomed 23 Fr Sheath is packaged as a sterile kit, which includes an introducer sheath (consisting of sheath with sideport tubing, stopcock and hemostasis valve assembly), and dilators, and a guidewire. It is identical to the commercially available predicate device, the Oscor 23 Fr Adelante-S2 Introducers, K122084.
The provided text is related to an FDA 510(k) premarket notification for a medical device called the "Abiomed 23 Fr Sheath." It is a regulatory document affirming that the device is substantially equivalent to a legally marketed predicate device.
Crucially, this document does not describe the acceptance criteria or a study that proves the device meets specific performance criteria. Instead, it states that the device is identical to a previously cleared predicate device, and therefore, no additional qualification testing was required for substantial equivalence.
Therefore, I cannot provide the requested information from the given text as it explicitly states that no such studies or acceptance criteria comparisons were performed for this specific 510(k) submission.
Here's a breakdown based on the information provided, and why most of your questions cannot be answered from this document:
1. A table of acceptance criteria and the reported device performance
- Not Applicable. The document explicitly states: "Since the Abiomed 23 Fr Sheath is identical to its commercially available predicate device, no additional qualification testing was required for the substantial equivalence determination." Therefore, no new acceptance criteria or reported device performance data is presented.
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. No new testing was performed for this 510(k) submission. The substantial equivalence is based on the device being identical to the predicate.
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. No new ground truth establishment or expert review was part of this submission, as no new testing was conducted.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not Applicable. No test set was generated for this 510(k) submission.
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 sheath, not an AI or imaging device, so MRMC studies are not relevant. This document is a regulatory clearance for a physical medical device.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- Not Applicable. This is not an AI algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not Applicable. No new ground truth was established for this submission.
8. The sample size for the training set
- Not Applicable. This is not an AI algorithm.
9. How the ground truth for the training set was established
- Not Applicable. This is not an AI algorithm.
Summary from the provided text:
The Abiomed 23 Fr Sheath obtained 510(k) clearance (K201116) by demonstrating substantial equivalence to a predicate device, the Oscor Adelante-S Introducer Series (K122084).
The basis for this substantial equivalence is that the Abiomed 23 Fr Sheath is identical to its commercially available predicate device in terms of "design, packaging, manufacturing, sterilization, and labeling." Because of this asserted identity, no additional qualification testing was required for this specific 510(k) submission. Therefore, the document does not contain information about new acceptance criteria or studies performed to demonstrate performance.
§ 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).