Search Results

The Anchor Tissue retrieval system is a sterile disposable pouch used with a dedicated introducer for the encapture and removal of an organ or tissue from the body cavity during laparoscopic surgery.

The Anchor Tissue retrieval system is a sterile disposable pouch used with a dedicated introducer for the encapture and removal of an organ or tissue from the body cavity during laparoscopic surgery.

This document does not contain the detailed information necessary to complete the requested table and study description regarding acceptance criteria, device performance, and the specifics of a validation study (such as sample sizes, ground truth establishment, or expert qualifications).

The document is an FDA 510(k) clearance letter for the "Anchor Tissue Retrieval System." It confirms that the device is substantially equivalent to a legally marketed predicate device. However, it does not include:

• Acceptance Criteria Table: There is no specific table outlining performance metrics and their acceptance thresholds.
• Reported Device Performance: While the letter implies the device met the necessary criteria for substantial equivalence, it does not provide quantitative performance data.
• Details of a specific study: The letter refers to the "review of your Section 510(k) premarket notification" but does not detail the studies submitted within that notification, nor does it specify sample sizes, data provenance, ground truth methods, expert qualifications, or comparative effectiveness study results.
• Training set details: No information about a training set is provided.

In summary, the provided text confirms FDA clearance but lacks the technical details of the underlying validation studies to answer your specific questions.

Ask a specific question about this device

The Anchor Tissue retrieval system is a sterile disposable pouch used with a dedicated introducer for the encapture and removal of an organ or tissue from the body cavity during laparoscopic surgery.

Not Found

This document is a 510(k) clearance letter from the FDA for the Anchor Tissue Retrieval System. It confirms that the device is substantially equivalent to legally marketed predicate devices.

The document does not contain information about acceptance criteria, device performance studies, sample sizes, ground truth establishment, or expert qualifications as typically found in a study report for an AI/ML device.

Therefore, I cannot provide the requested information based on the text provided. This FDA letter is primarily a regulatory approval document based on substantial equivalence, not a detailed technical report of a study proving performance against defined acceptance criteria.

Ask a specific question about this device

The Anchor Espiner Tissue Retrieval system is a sterile disposable pouch that can be used with a dedicated introducer system for the encapture and removal of an organ, Introducer bystem for the body cavity during laparoscopic surgery.

The Anchor Espiner Tissue Retrieval system is a sterile disposable pouch that can be used with a dedicated introducer system for the encapture and removal of an organ, Introducer bystem for the body cavity during laparoscopic surgery.

This document is an FDA 510(k) clearance letter for a medical device. It does not contain information regarding acceptance criteria for device performance or the study that proves the device meets such criteria.

The letter explicitly states: "We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976... You may, therefore, market the device, subject to the general controls provisions of the Act."

This indicates that the device was cleared based on its substantial equivalence to a predicate device, not on meeting specific, pre-defined acceptance criteria from a performance study conducted by the manufacturer for this specific 510(k) submission.

Therefore, I cannot provide the requested information as it is not present in the provided text.

Ask a specific question about this device