(94 days)
The Rusch Optosafe, sterile, for oral insertion to provide an airway though the patient's mouth and allow fiberoptic tracheal intubation is substantially equivlent in design, use and materials to the Williams Airway Intubator K830767 currently being marketed and sold in inter-state commerce.
The device is designed as a single use, sterile, oropharyngeal airway to maintain a patent airway through the mouth to the pharynx and allow fiberoptic tracheal intubation.
The device consists of a clear, implant tested, PVC tube formed into the conventional hooked shape of an oral airway. The tube is bonded with a polyurethane adhesive to a clear implant tested PVC bite block and flange molding. The flange is printed with the manufacturer's name, date code and size (nominal inner diameter of tube).
Here's a breakdown of the requested information based on the provided text, which appears to be a 510(k) summary for a medical device.
Crucial Caveat: The provided document is a 510(k) Pre-market Notification Summary, specifically for the "Rusch Optosafe." This type of document aims to establish substantial equivalence to a predicate device, not necessarily to present a detailed study with acceptance criteria and performance metrics in the way a clinical trial or AI device validation study would. Therefore, much of the requested information is not present in this type of regulatory submission. The document explicitly states: "Based upon the equivalence in materials, design and intended use between this tube and others presently being marketed and sold, no difference in safety and effectiveness is forecasted." This means the assessment relies on the predicate device's existing performance, not a new, independent performance study of the Optosafe itself.
Acceptance Criteria and Study to Prove Device Meets Criteria
Given the nature of the document, a traditional "acceptance criteria" table and a "study"proving the device meets those criteria, as one would expect for an AI/diagnostic device, are not detailed. The acceptance criterion for a 510(k) is typically substantial equivalence to a legally marketed predicate device.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Stated/Implied for 510(k)) | Reported Device Performance (Implied from Substantial Equivalence Claim) |
|---|---|
| Safety: Device presents no new safety risks. | "no difference in safety... is forecasted" compared to predicate. |
| Effectiveness: Device performs as intended. | "no difference in ... effectiveness is forecasted" compared to predicate. |
| Intended Use: Matches predicate device. | "substantially equivalent in design, use and materials" to predicate. |
| Design: Similar to predicate device. | "substantially equivalent in design..." to predicate. |
| Materials: Similar to predicate device. | "substantially equivalent in ... materials" to predicate. |
Note: The document does not provide quantitative performance metrics (e.g., sensitivity, specificity, accuracy, throughput) for the Rusch Optosafe itself. It relies on the predicate device (Williams Airway Intubator K830767) having already met such standards.
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: Not applicable. This document does not describe a performance study with a test set of patients/samples for the Rusch Optosafe.
- Data Provenance: Not applicable. The "proof" is based on the substantial equivalence to the predicate device, not new data generation for the Optosafe.
3. Number of Experts Used to Establish Ground Truth and Qualifications
- Number of Experts: Not applicable. No ground truth was established by experts for a novel performance study of the Rusch Optosafe. The assessment is regulatory (FDA), not a clinical expert consensus on new data.
- Qualifications of Experts: Not applicable.
4. Adjudication Method for the Test Set
- Adjudication Method: Not applicable. There was no test set requiring adjudication in the context of this 510(k) summary.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- MRMC Study: No, an MRMC comparative effectiveness study was not done, nor would it typically be expected for this type of device (an airway, not a diagnostic imaging AI).
- Effect Size of Human Readers Improve with AI vs. Without AI Assistance: Not applicable, as this is not an AI-assisted diagnostic device.
6. Standalone (Algorithm Only) Performance Study
- Standalone Study: No, a standalone performance study was not done. This device is a physical medical instrument, not an algorithm.
7. Type of Ground Truth Used
- Type of Ground Truth: The "ground truth" in this context is the established safety and effectiveness of the predicate device (Williams Airway Intubator K830767) as determined by its prior regulatory clearance and market history. No new, independent ground truth was established for the Rusch Optosafe beyond its comparative characteristics.
8. Sample Size for the Training Set
- Sample Size: Not applicable. There is no training set for an AI/algorithm mentioned in this document.
9. How the Ground Truth for the Training Set Was Established
- How Ground Truth Was Established: Not applicable, as there is no training set for an AI/algorithm mentioned.
§ 868.5110 Oropharyngeal airway.
(a)
Identification. An oropharyngeal airway is a device inserted into a patient's pharynx through the mouth to provide a patent airway.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 868.9.