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The "TissueBags" are intended for safe collection and removal of specimen, such as appendix, gallbladder, myoma, cysts, ovaries, fibroid tumours and other tissues, and calculi during surgical procedures.

The TissueBags are intended as receptacles for safe collection and removal of specimen during surgical procedures. Removal is accomplished by positioning the bag that serves as a receptacle for the specimen, close to the specimen that is intended to be removed. The bag opens, and the feeding-mouth is kept open automatically. Closure of the filled bag is done either by pulling back the complete device, or by pulling back an integrated purse string only.

The TissueBags comprise various types of retrieval bags, which share similarities of the basic functional principle, materials, Sterile-Barrier-Packaging, delivery status and sterilisation method. The TissueBags differ in the size of their bag (loading capacity), the availability of an integrated handle, respectively the need for being connected to an A.M.I.-dock Applicator pre-operatively and the possibility to disconnect the filled bag from the instrument.

Each TissueBag consists of a bag, a suspension mechanism, a protection sleeve and a handle, that is either an integrated part of the device or attached in terms of an A.M.I.dock Applicator. One type of the TissueBags is additionally equipped with a purse string.

All TissueBags are designed to be applicable with 10 mm ports for minimally invasive surgery. They are disposable, delivered sterile as single use devices. Their Sterile-Barrier-Packaging consists of two independently sealed pouches made from Tyvek and PET-foil. Sterilisation by means of Radiation guarantees a Sterility Assurance Level of 10° Biocompatibility evaluation has shown the TissueBags to meet the requirements of ISO 10993-1.

This document does not contain the information required to populate the table and answer the questions related to acceptance criteria and device performance studies. The provided text is a 510(k) summary for a medical device called the "A.M.I. TissueBag System," and it primarily focuses on:

• Device description: How the TissueBag functions and its components.
• Comparison to a predicate device: Stating substantial equivalence in design, principle, and clinical effectiveness to a previously marketed device.
• Regulatory information: Classification, regulation number, and FDA's determination of substantial equivalence.
• Indications for Use: The intended surgical procedures and types of specimens the device is designed for.

There is no mention of specific acceptance criteria, performance metrics, a study to demonstrate these criteria are met, sample sizes, expert involvement, or any form of clinical or standalone algorithm performance evaluation. The document states that "The TissueBags provoke no new safety or effectiveness issues when used as intended," implying reliance on the predicate device's established safety and effectiveness rather than new performance studies for this specific 510(k).

Therefore, I cannot provide the requested information from the given text.

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