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The Rüsch Crystal Clear Tracheostomy Sets, Cuffed and Cuffless are intended for airway management of tracheostomized patients.

The Rüsch Crystal Clear Tracheostomy Sets will be offered in two (2) versions - Cuffed and Cuffless. Descriptions are:

Rüsch Crystal Clear Tracheostomy Set, Cuffed:
The Rüsch Crystal Clear Tracheostomy Set, Cuffed consists of a polyvinylchloride (PVC) tracheostomy tube with high volume/low pressure cuff, pilot balloon and tapered tip to facilitate insertion, a PVC flexible neck plate with a Nylon 15mm swivel connector and a polyethylene obturator with a tapered tip to facilitate insertion. The flange on this device is not adjustable. In addition, a PVC disposable inner cannula will be offered separately as an accessory.
This set will be offered in a range of sizes from 3.5mm - 10.5mm in 0.5mm increments. The size determinations are the Inside Diameter (I.D.) of the tracheostomy tube.

Rüsch Crystal Clear Tracheostomy Set, Cuffless:
The Rüsch Crystal Clear Tracheostomy Set, Cuffless consists of a polyvinylchloride (PVC) tracheostomy tube with a tapered tip to facilitate insertion, a PVC flexible flange with a PVC turn lock fastener neck plate with a Nylon 15mm swivel connector and a polyethylene obturator with a tapered tip to facilitate insertion. The flange on this device is not adjustable. In addition, a PVC disposable inner cannula will be offered separately as an accessory.
This set will be offered in a range of sizes from 3.5mm - 10.5mm in 0.5mm increments. The size determinations are the Inside Diameter (I.D.) of the tracheostomy tube.

Each Rüsch Crystal Clear Tracheostomy Set, Cuffed and Cuffless will be provided sterile, by either Gamma Irradiation or Ethylene Oxide, inside a protective inner pouch in a blister pack sheet with a Tyvek paper seal to provide a sterility barrier. Each pack will be individually labeled. The device will then be packaged, five units per carton, in a labeled outer cardboard carton. The inner cannulae will be marketed separately as accessories under separate part numbers.

The provided text describes a 510(k) Pre-market Notification for a medical device (Rüsch Crystal Clear Tracheostomy Sets, Cuffed and Cuffless) seeking substantial equivalence to a predicate device. This type of submission** does not typically include a detailed study proving performance against acceptance criteria in the way a clinical trial for a novel device would.**

Instead, the submission focuses on demonstrating that the new device has substantially equivalent technological characteristics and intended use to a previously cleared device. Therefore, many of the requested elements for a detailed acceptance criteria study are not present in this document.

Here's an analysis based on the provided text:

1. Table of acceptance criteria and reported device performance:

This document does not explicitly state quantitative acceptance criteria or provide performance data from a study designed to meet such criteria. The "performance" being demonstrated here is the substantial equivalence to an existing predicate device, not the achievement of specific, novel performance metrics.

2. Sample size used for the test set and the data provenance:

Not applicable in this document. The assessment is based on a comparison of device characteristics and intended use.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

Not applicable. The ground truth for a 510(k) submission is typically the established safety and effectiveness of the predicate device, not a new, expert-adjudicated dataset for the new device.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

Not applicable.

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:

Not applicable. This is not an AI-enabled device, and no MRMC study is mentioned.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

Not applicable. This is a physical medical device, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):

The "ground truth" implicitly used for this type of submission is the established safety and effectiveness of the existing predicate device (Rüsch Crystal Tracheostomy Set - K972546). The claim is that the new device shares similar technological characteristics and intended use, and therefore can be presumed to be as safe and effective as the predicate.

8. The sample size for the training set:

Not applicable. This device does not involve machine learning or a training set.

9. How the ground truth for the training set was established:

Not applicable.

Summary of the "study" that proves the device meets "acceptance criteria" (within the context of a 510(k) submission):

The "study" or justification for equivalence is described in section "6. Summary of Technological Characteristics."

• Acceptance Criteria (implicit for 510(k) Substantial Equivalence): The device must be deemed "substantially equivalent" to a legally marketed predicate device in terms of intended use and technological characteristics, such that it raises no new questions of safety or effectiveness.

• Device Performance / Proof of Equivalence:

  • Basis of claim: The Rüsch Crystal Clear Tracheostomy Sets are claimed to be substantially equivalent in design and materials to the predicate device, Rüsch Crystal Tracheostomy Set (K972546).
  • Technological Characteristics Comparison: "The Rüsch Crystal Clear Tracheostomy Sets are identical in materials and sizes to the 510(k) # K972546, Rüsch Crystal Tracheostomy Set, which was determined to be substantially equivalent on April 14, 1998." (Page 3, Section 6)
  • Materials: Both the new device and the predicate are described as being made of polyvinylchloride (PVC) for the tube, pilot balloon, and flexible neck plate; Nylon for the 15mm swivel connector; and polyethylene for the obturator.
  • Sizes: The new device is offered in a range of sizes from 3.5mm - 10.5mm in 0.5mm increments. The document notes that "The 3.0mm and 11.0mm sizes indicated in K972546 have been removed from the current product line" for the new device, implying a slight modification in available sizes but not a fundamental change in the technology or intended use.
  • Intended Use: Both the new device and the predicate device (by virtue of the claim of equivalence) are intended "for airway management of tracheostomized patients."

Conclusion:

This 510(k) summary demonstrates substantial equivalence by comparing the new device's materials, design, and intended use directly to a previously cleared predicate device. It does not involve a traditional clinical study with defined acceptance criteria and performance metrics for the new device itself, but rather leverages the established safety and effectiveness of the predicate. The FDA's letter (Page 3-4) confirms their review led to a finding of "substantial equivalence" based on this comparison.

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