(130 days)
The TELEFLEX ISIS™ HVT™ Tracheal Tube, Cuffed with Subglottic Secretion Port is indicated for airway management by oral intubation during mechanical ventilation and anesthesia including the capability to aid in the removal of subglottic secretions.
The Teleflex ISIS™ HVT™ Tracheal Tube, Cuffed with Subglottic Secretion Suction Port is a single-use, sterile tracheal tube made of a polyvinyl chloride tube body, cuff inflation line and a compatible pilot balloon and one-way valve. A radiopaque line is incorporated into the full length of the tracheal tube. Each tracheal tube is supplied with an appropriately sized 15mm connector. The Teleflex ISIS™ HVTTM Tracheal Tube, Cuffed with Subglottic Secretion Suction Port is sold in Murphy eye style. Each tube has a dorsal lumen with an opening above the cuff and a male suction connector port attached to the tube, which is close to the machine end of the tube. Access to the suction lumen is accomplished via a connection of the suction accessory pack (P/N 5-23000) directly to the male suction connector.
The provided document is a 510(k) Pre-market Notification for the Teleflex ISIS™ HVT™ Tracheal Tube, Cuffed with Subglottic Secretion Suction Port. This document describes the device and its substantial equivalence to a predicate device, rather than an AI/ML powered device. Therefore, the information requested regarding acceptance criteria, study details, sample sizes, ground truth establishment, expert adjudication, and MRMC studies, which are typically relevant for AI/ML device evaluations, is not present in this document.
The document primarily focuses on demonstrating that the new device is substantially equivalent to a previously cleared predicate device (K091761) by comparing their characteristics and conducting non-clinical performance testing.
Here's an analysis of the information that is available in the document, framed as closely as possible to your request, but highlighting the difference in context:
1. A table of acceptance criteria and the reported device performance
The document does not provide a table of acceptance criteria with numerical performance targets and reported results in the way it would for an AI/ML algorithm's accuracy, sensitivity, or specificity. Instead, it describes "bench testing" to verify performance is "substantially equivalent" to the predicate. The "Principle of Test" column serves as the qualitative "acceptance criteria" for these non-clinical tests.
| Test | Principle of Test (Acceptance Criteria - qualitative) | Reported Device Performance (Qualitative) |
|---|---|---|
| Ink adherence | Ink adherence is tested by application and removal of tape to the inked surface according to the test parameters and inspected to a rating scale. (ISO 5361, Section 5.3.2) | "Bench testing has been performed to verify that the performance of the proposed Teleflex ISIS™ HVT™ Tracheal Tube... is substantially equivalent to the predicate device, and that the Teleflex ISIS™ HVT™ Tracheal Tube... will perform as intended." (Implicitly passed) |
| Cytotoxicity | Tests the potential biological reactivity of a mammalian cell culture in response to exposure to the extract of the test article. (ISO 10993-5) | "Bench testing has been performed to verify that the performance of the proposed Teleflex ISIS™ HVT™ Tracheal Tube... is substantially equivalent to the predicate device, and that the Teleflex ISIS™ HVT™ Tracheal Tube... will perform as intended." (Implicitly passed) |
| Irritation | Test the potential of the test article to produce primary skin irritation after topical application when extracted in sodium chloride for injections and cottonseed oil. (ISO 10993-10) | "Bench testing has been performed to verify that the performance of the proposed Teleflex ISIS™ HVT™ Tracheal Tube... is substantially equivalent to the predicate device, and that the Teleflex ISIS™ HVT™ Tracheal Tube... will perform as intended." (Implicitly passed) |
| Sensitization | Test the potential of the test article to produce allergenic reaction when extracted in sodium chloride and cottonseed oil. (ISO 10993-10) | "Bench testing has been performed to verify that the performance of the proposed Teleflex ISIS™ HVT™ Tracheal Tube... is substantially equivalent to the predicate device, and that the Teleflex ISIS™ HVT™ Tracheal Tube... will perform as intended." (Implicitly passed) |
| Extractables & Leachables | Assesses the ET tube relative to leachable/extractable profiles with GC/MS, LC/MS, LC/UV, ICP and FTIR under clinical use conditions. | "Bench testing has been performed to verify that the performance of the proposed Teleflex ISIS™ HVT™ Tracheal Tube... is substantially equivalent to the predicate device, and that the Teleflex ISIS™ HVT™ Tracheal Tube... will perform as intended." (Implicitly passed) |
2. Sample size used for the test set and the data provenance
The document refers to "bench testing" but does not specify sample sizes for these tests. For a physical device, this would typically involve a certain number of units manufactured for testing. The provenance of material or components isn't explicitly stated beyond the manufacturer, Teleflex Medical, Inc. The document does not describe the use of "data" in the context of an AI/ML algorithm.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable to this type of device submission. Ground truth, in the context of AI/ML, involves human expert annotations or definitive outcomes, which are not relevant for the bench testing described here. The tests rely on established ISO standards and methods.
4. Adjudication method for the test set
Not applicable. Adjudication methods are used to resolve discrepancies in expert interpretations, which is not relevant for the objective bench tests described.
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/ML device that assists human readers.
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
For the non-clinical tests, the "ground truth" is defined by the objective pass/fail criteria of the referenced ISO standards (e.g., ISO 10993-5 for cytotoxicity). This is not "expert consensus, pathology, or outcomes data" in the AI/ML sense, but rather adherence to validated scientific and engineering testing protocols.
8. The sample size for the training set
Not applicable. This is not an AI/ML device that requires training data.
9. How the ground truth for the training set was established
Not applicable. This is not an AI/ML device.
§ 868.5730 Tracheal tube.
(a)
Identification. A tracheal tube is a device inserted into a patient's trachea via the nose or mouth and used to maintain an open airway.(b)
Classification. Class II (performance standards).