(178 days)
The Phoneris™ Inner Cannulae with Phoneris™ Aero-Flex™ Ventilator Circuit Connector is indicated for airway maintenance of tracheostomised patients. The single use, disposable device is an accessory to a tracheostomy tube, serving as an interlocking, detachable, coupling between the ventilator circuit and tracheostomy tube. The Phoneris™ Inner Cannulae component is designed to replace the disposable inner cannulae component of the Shiley Disposable Cannula Tracheostomy Tube.
The proposed Phoneris™ Inner Cannulae with Phoneris™ Aero-Flex™ Ventilator Circuit Connector device consists of two components, the sterile Phoneris™ Inner Cannulae (Inner Cannulae) and the non-sterile Aero-Flex™ Ventilator Circuit Connector (Aero-Flex™). The Inner Cannulae is designed to replace the disposable inner cannulae component of the Shiley Disposable Cannula Tracheostomy Tube that was cleared for market in K811447.
The Inner Cannulae consists of a snap-lock connector with an integral tube. The Inner Cannulae is inserted into the outer cannula of the Shiley Disposable Cannula Tracheostomy Tube and snap-locked into place at the proximal end of the snap-lock connector component of the Inner Cannulae. The distal end of the Inner Cannulae snaplock connector attaches to the proximal end of the Aero-Flex™ in an interlocking fashion. The free end of the Aero-Flex™ in turn attaches to the leading connector of the ventilator tube via a standard tapered connection that complies with ISO 5356-1:2004 "Anaesthetic and Respiratory Equipment - Conical connectors - Part 1: Cones and Sockets".
The proposed Phoneris™ Inner Cannulae with Phoneris™ Aero-Flex™ Ventilator Circuit Connector device provides a positive, detachable connection between the Shiley Disposable Cannula Tracheostomy Tube and ventilator circuit. This interlocking coupling design relieves patient discomfort associated with the frequent necessary disconnections and recomections of the outer cannula from the ventilator circuit for maintenance purposes, and reduces the opportunity for inadvertent detachment of the tracheostomy tube from the connected respiratory delivery system. This decreases patient discomfort by relieving the suffocation sensation a ventilator dependent patient may experience with disconnection. It also decreases valuable nursing and respiratory therapists' time needed to repeatedly reconnect the patient to the ventilator as well as decreasing the potentially catastrophic effects of ventilator disconnects.
The proposed Phoneris™ Inner Cannulae with Phoneris™ Aero-Flex™ Ventilator Circuit Connector device is not supplied with an outer cannula. Neither component of the proposed device is indicated for insertion into the patient's windpipe.
The provided text is a 510(k) summary for a medical device (Phoneris™ Inner Cannulae and Phoneris™ Aero-Flex™ Ventilator Circuit Connector). It describes the device, its intended use, and argues for its substantial equivalence to a predicate device.
However, this document does NOT contain information about acceptance criteria or a study that proves the device meets specific performance criteria in the way typically found in performance studies for diagnostic or AI-driven medical devices.
Instead, the document focuses on demonstrating substantial equivalence to a legally marketed predicate device (Shiley Disposable Cannula Tracheostomy Tube). The "testing" mentioned is to validate sterilization, confirm biocompatibility, and support shelf life, which are general safety and performance aspects, not a direct assessment of clinical performance against specific acceptance criteria the way an AI algorithm might be evaluated for sensitivity, specificity, or accuracy.
Therefore, I cannot populate the table or answer most of the questions as the required information is not present in the provided text.
Here is what can be inferred or stated based on the text:
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A table of acceptance criteria and the reported device performance:
- Acceptance Criteria: Not explicitly defined in terms of specific performance metrics (e.g., success rate for connection, specific force required for detachment). However, the implicit acceptance criteria are that the device performs similarly and safely as compared to the predicate device and meets general standards for medical devices (sterilization, biocompatibility).
- Reported Device Performance:
- "Testing was conducted to validate the sterilization of the Inner Cannulae component." - Result not specified but implied to be successful.
- "Biocompatibility testing confirmed the biological safety of the proposed Phoneris™ Inner Cannulae with Phoneris™ Aero-Flex™ Ventilator Circuit Connector for use as a tracheostomy tube accessory." - Result implied to be successful.
- "Additional testing was initiated to support the claimed shelf life." - Result not specified but implied to be successful.
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Sample sized used for the test set and the data provenance: Not applicable. This is not a study involving patient data or a "test set" in the context of diagnostic performance. The "testing" described is likely bench testing or laboratory-based, often following ISO or other standards for material compatibility, sterilization, and mechanical properties.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. No "ground truth" derived from expert consensus is mentioned.
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Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
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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 device is not an AI-driven diagnostic tool or a device that assists human readers.
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If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable. This device is a physical medical accessory, not an algorithm.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable. The "ground truth" here would be established standards (e.g., ISO for conical connectors, recognized biocompatibility tests, sterilization protocols) and performance compared to the predicate device's general function.
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The sample size for the training set: Not applicable. This is not a machine learning device.
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How the ground truth for the training set was established: Not applicable.
In summary, the provided document is a 510(k) summary demonstrating substantial equivalence for a physical medical device, not a performance study for an AI/diagnostic device. As such, most of the requested information regarding "acceptance criteria" and "study" in the context of diagnostic accuracy or expert-adjudicated performance is not present. The "study" mentioned refers to engineering and laboratory testing for safety and basic function (sterilization, biocompatibility, shelf life), which are common for physical medical devices seeking 510(k) clearance based on substantial equivalence.
§ 868.5800 Tracheostomy tube and tube cuff.
(a)
Identification. A tracheostomy tube and tube cuff is a device intended to be placed into a surgical opening of the trachea to facilitate ventilation to the lungs. The cuff may be a separate or integral part of the tracheostomy tube and is, when inflated, intended to establish a seal between the tracheal wall and the tracheostomy tube. The cuff is used to prevent the patient's aspiration of substances, such as blood or vomit, or to provide a means for positive-pressure ventilation of the patient. This device is made of either stainless steel or plastic.(b)
Classification. Class II.