(27 days)
The Modified Acumen Lead Delivery Sheath is indicated for the introduction of various types of pacing or defibrillator leads and catheters.
The Acumen Lead Delivery Sheath (LDS) is a single-use perculaneous catheter intended (1) introduce various types of pacing or defibrillator leads and catheters. The Modified Acumen LDS has a guidewire lumen and a lumen for introduction of leads.
The provided text contains information about a 510(k) submission for a medical device (Modified Acumen Lead Delivery Sheath). However, it does not include information about acceptance criteria, device performance metrics, or study details (like sample size, ground truth establishment, expert qualifications, or MRMC studies) typically found in a clinical or performance study report.
The document primarily focuses on regulatory aspects, such as:
- Device Description: A single-use percutaneous catheter to introduce pacing/defibrillator leads.
- Intended Use: Introduction of various types of pacing or defibrillator leads and catheters.
- Predicate Device: Acumen Lead Delivery Sheath (K051515).
- Materials: Stated as suitable and used in previously cleared products.
- Testing: "Appropriate testing has been performed and all components, subassemblies, and/or full devices met the required specifications for the completed tests." This statement indicates that testing was done and met specifications, but it does not provide the acceptance criteria or the specific results of those tests.
- Substantial Equivalence: Claimed based on identical or substantially equivalent intended use, method of operation, construction, and materials to the predicate device.
Therefore, I cannot populate the requested table or answer most of the detailed questions about acceptance criteria and the study that proves the device meets them because that information is not present in the provided text.
Here's a breakdown of what can be extracted and what cannot:
1. Table of Acceptance Criteria and Reported Device Performance
- N/A: This information is not explicitly stated in the provided text. The document only mentions "all components, subassemblies, and/or full devices met the required specifications for the completed tests," without detailing what those specifications or results were.
2. Sample size used for the test set and the data provenance
- N/A: The document does not describe a clinical test set or details about data provenance. The testing mentioned is likely bench testing for design verification, not a clinical study with human subjects.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- N/A: No ground truth establishment is described, as there's no mention of a clinical test set requiring expert interpretation.
4. Adjudication method for the test set
- N/A: Not applicable, as no test set requiring adjudication is described.
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
- N/A: This device is a physical medical instrument (catheter sheath), not an AI-powered diagnostic or assistive technology. Therefore, an MRMC study related to AI assistance is irrelevant and not mentioned.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- N/A: Not applicable, as this is a physical device, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- N/A: Not applicable, as no ground truth for "testing" in the context of diagnostic performance is described. The "testing" referred to in the document is likely engineering/bench testing (e.g., tensile strength, flexibility, biocompatibility, etc.) that would have defined specifications, but these are not provided.
8. The sample size for the training set
- N/A: Not applicable, as this is a physical device, not an AI model or a device requiring a training set in that context.
9. How the ground truth for the training set was established
- N/A: Not applicable, for the same reason as above.
In summary, the provided K062145 document is a regulatory submission for premarket notification (510(k)) asserting substantial equivalence, not a detailed performance study report. It confirms that "appropriate testing has been performed and all components... met the required specifications," but does not disclose those specifications or the detailed results.
§ 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).