(201 days)
The Portex Reinforced Tracheal Tubes (cuffed and uncuffed) are designed for oral or nasal intubation for airway management during anaesthesia. The product may be used where the patient's neck is likely to be moved or flexed or the patient is in the prone position so that a non-reinforced tracheal tube might become kinked.
Single use. A Tracheal tube with additional metal wire spiral reinforcement to provide kink-resistance. This type of product is typically used during operations where a high degree of flexibility is required from the tube, for instance prone position, head and neck surgery, oral surgery. The plastic material and the spring allow the tube to be easily bent in all directions. The steel reinforcement maintains the patency of the lumen. The Portex Ltd PVC, Single-use Reinforced tracheal tube is available in cuffed and uncuffed variants. The cuff is intended to provide a seal against the trachea, ensuring that inspiratory and expiratory gases are directed through the tube and not allowed to escape to the patients upper airway, thus preventing loss of ventilation / anaesthetic and nebulised drugs, and reducing the likelihood of any aspirated stomach contents from entering the lungs. Uncuffed tubes are used mainly for paediatric applications who require less protection from loss of ventilation / anaesthetic and nebulised drugs and or stomach aspiration. The reinforced tracheal tube (Cuffed Murphy eye) is available in sizes 5.0, 5.5, 6.0, 6.5, 7.0, 7.5, 8.0, 8.5, 9.0 and 9.5mm only. The reinforced tracheal tube (Uncuffed) is available in sizes 3.0, 3.5, 4.0, 4.5 and 5.0mm only.
This document is a 510(k) premarket notification for a medical device, which typically focuses on demonstrating substantial equivalence to a predicate device rather than providing detailed acceptance criteria and a study report as would be found in a clinical trial publication. Therefore, much of the requested information regarding a device meeting specific acceptance criteria through a dedicated study is not present in this submission.
However, I can extract the available information and explain why other details are missing based on the nature of a 510(k) submission.
Analysis of the Provided Text and Missing Information:
The document describes the Portex Ltd. PVC, Single Use Reinforced, Oral/Nasal Endotracheal Tube. It details the device, its intended use, and compares its technological characteristics to several predicate devices to establish substantial equivalence.
1. A table of acceptance criteria and the reported device performance
This information is not explicitly present in the provided 510(k) summary. A 510(k) submission primarily focuses on demonstrating that a new device is "substantially equivalent" to a legally marketed predicate device. This often involves comparing technological characteristics (materials, design, performance standards) rather than reporting against specific, pre-defined acceptance criteria from a new, comprehensive performance study that would generate detailed performance metrics like sensitivity, specificity, accuracy, etc.
The document states:
- "TECHNOLOGICAL CHARACTERISTICS OF PROPOSED VERSUS PREDICATE DEVICES:" section, which lists comparisons of materials, design (reinforced tube, cuff, print markings, inflation line, pilot balloon, connector) between the proposed device and various predicate devices. This implicitly suggests that the acceptance criteria are met if these characteristics are deemed equivalent to existing, safely marketed devices.
- "PERFORMANCE / CLINICAL DATA: Performance data for the proposed device is shown in Section 8.0 Performance." However, Section 8.0 is not included in the provided text. This section would likely contain the specifics of any performance testing conducted. Without it, we cannot create a table of acceptance criteria and reported device performance.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not available in the provided text. Since the document is a 510(k) summary focused on substantial equivalence, it does not typically detail the specifics of clinical trial design, sample sizes for test sets, or data provenance in the way a research paper would. If performance data were included in the unprovided Section 8.0, it might contain some of this information, but it's not guaranteed to be as detailed as requested.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This information is not applicable/available from the provided text for the following reasons:
- The device is an endotracheal tube, a mechanical device. Its performance is typically evaluated through engineering tests (e.g., tensile strength, kink resistance, material biocompatibility) and sometimes limited clinical observations, not through image interpretation or diagnostic tasks that would require "ground truth" established by experts in the context of diagnostic accuracy.
- The 510(k) process for such devices relies on demonstrating equivalence to predicate devices, often through non-clinical bench testing and material characterization, rather than extensive clinical studies requiring expert consensus on "ground truth."
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not applicable/available for the same reasons as point 3. Adjudication methods are relevant in studies where human interpretation of data is involved and a consensus or tie-breaking mechanism is needed to establish ground truth or evaluate diagnostic performance, which is not the primary mechanism for evaluating an endotracheal tube in a 510(k) submission.
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
This information is not applicable/available.
- The device is a physical medical device (endotracheal tube), not an AI-powered diagnostic tool or imaging software.
- Therefore, an MRMC study and the concept of "human readers" improving with AI assistance are irrelevant to this device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is not applicable/available for the same reasons as point 5. This device is not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
This information is not applicable/available for the same reasons as point 3. The evaluation of this device would involve engineering specifications, biocompatibility testing, and potentially some clinical observation of device function (e.g., ease of insertion, kink resistance in use), rather than ground truth in the diagnostic sense.
8. The sample size for the training set
This information is not applicable/available. The device is not a machine learning model, so there is no "training set."
9. How the ground truth for the training set was established
This information is not applicable/available for the same reasons as point 8.
§ 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).