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The V-Cath® PICC is indicated for the patient that requires repeated access for infusion or injection therapy. It can also be used for blood sampling although a 3.8FR or larger catheter is recommended.

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This is a medical device clearance letter for the V-Cath® PICC (Peripherally Inserted Central Catheter) from 1998. The document primarily serves to confirm that the device is substantially equivalent to legally marketed predicate devices.

Crucially, this document is a regulatory clearance letter and not a study report or clinical trial summary. Therefore, it does not contain the detailed information requested regarding acceptance criteria, device performance, sample sizes, ground truth establishment, or expert evaluations. It simply indicates that the device has been cleared for marketing based on a determination of substantial equivalence.

Here's why the requested information cannot be extracted from the provided text:

• Acceptance Criteria & Reported Performance: Regulatory clearance letters typically don't detail the performance metrics or acceptance criteria used in specific verification or validation studies. They generally conclude that the device meets safety and effectiveness requirements based on comparison to a predicate device.
• Sample Size & Data Provenance: There's no mention of specific studies, sample sizes, or data provenance.
• Experts & Adjudication: There's no information about experts, ground truth establishment, or adjudication methods.
• MRMC Study: No mention of a multi-reader multi-case comparative effectiveness study.
• Standalone Performance: No details on standalone algorithm performance, as this device is a physical catheter, not an AI or software algorithm.
• Type of Ground Truth: Not applicable in this context.
• Training Set Sample Size & Ground Truth: Not applicable for a physical medical device.

In summary, the provided document does not contain the information necessary to complete the requested table and study details. It is a regulatory notification of clearance, not a technical report detailing performance criteria and study outcomes.

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The V-Cath® PICC is indicated for the patient that requires repeated access for infusion or injection therapy. It can also be used for blood sampling although a 3.8FR or larger catheter is recommended.

Not Found

I am sorry, but based on the provided text, there is no information available about acceptance criteria, device performance metrics, or any studies conducted to prove the device meets specific criteria.

The text is a 510(k) clearance letter from the FDA for the V-Cath® PICC. This letter confirms that the device is substantially equivalent to a predicate device and can be marketed. It discusses regulatory matters, product classification, and general controls, but it does not contain any data, results, or details of studies regarding the device's performance against specific acceptance criteria.

Therefore, I cannot populate the table or answer the specific questions you've posed as the necessary information is not present in the provided document. The document only states the "Indications for Use" of the device.

Ask a specific question about this device