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The Rusch TracheoFix Set (TFS) is a single patient disposable tracheostomy tube for airway management of tracheostomized patients.

TracheoFix Sets will be offered in two (2) versions - Cuffed and Uncuffed. Descriptions are as follows:

Rüsch TracheoFix Set, Cuffed:
The Rüsch TracheoFix Set, Cuffed consists of a polyvinylchloride (PVC) outer tube with low pressure cuff and pilot balloon, a PVC flexible flange with a PVC turn lock fastener. The flange on this device is not adjustable. In addition, the set will also include a polyethylene cannula with standard taper and a replacement cannula which will be offered separately as an accessory, a polyethylene introducer, a standard nylon connector, a Velcro head band also offered separately as an accessory, an ABS phonation valve, an ABS cough cap and an ABS sealing cap.
This set will be offered in a variety of sizes from 7.0mm, to 11.0mm in 0.5mm increments. The size determinations are the Inside Diameter (I.D.) of the outer tube.

Rüsch TracheoFix Set, Uncuffed:
The Rüsch TracheoFix Set, Uncuffed consists of a polyvinylchloride (PVC) outer tube, a PVC flexible flange with a PVC turn lock fastener. The flange on this device is not adjustable. In addition, the set will also include a polyethylene inner tube with standard taper and a replacement inner tube which will be offered separately as an accessory, a polyethylene introducer, a standard nylon connector, a Velcro head band which will also be offered as an accessory, an ABS phonation valve, an ABS cough cap and an ABS sealing cap.
This set will be offered in a variety of sizes from 7.0mm, to 11.0mm in 0.5mm increments. The size determinations are the Inside Diameter (I.D.) of the outer tube.

Each Rüsch TracheoFix Set, Cuffed and Uncuffed will be provided sterile, by either Gamma Irradiation or Ethylene Oxide, in a clear plastic thermoformed tray with a Tyvek barrier/label. Each pack will be individually labeled. The device will then be packaged in a labeled outer cardboard carton. The device will be marketed one unit per box. The Velcro headband and the inner cannula will be marketed separately as accessories under separate part numbers. Both accessories will be marketed sterile, individually packaqed and labeled, ten (10) units per box .

The provided text is a 510(k) Summary for a medical device (Rüsch TracheoFix Set, Cuffed and Uncuffed tracheostomy tube). It focuses on establishing substantial equivalence to existing legally marketed devices, rather than presenting a performance study with acceptance criteria.

Therefore, this document does not contain the information requested regarding acceptance criteria and a study proving the device meets those criteria, specifically:

• A table of acceptance criteria and reported device performance.
• Sample sizes, data provenance, number and qualifications of experts, or adjudication methods for a test set.
• Multi-reader multi-case (MRMC) comparative effectiveness study results.
• Standalone (algorithm only) performance.
• Details on the type of ground truth used.
• Sample size for the training set or how ground truth for the training set was established.

The 510(k) summary explains the device, its intended use, and claims substantial equivalence to predicate devices based on design and materials, effectively stating that its performance is implicitly acceptable because it is similar to already approved devices. It does not describe an independent performance study with defined acceptance criteria and results.

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