(84 days)
To locate, illuminate within, and transilluminate across nasal and sinus structures in adults aged 18 and over.
The PathAssist Light Fiber is a flexible instrument that can be connected to a light source to emit light from its distal end. The Light Fiber is provided sterile and is for single use only. It comes with a male tuohy borst adapter, which allows the device to be secured within compatible working lumen instruments. The Light Fiber is also compatible with standard light post adapters and light cables.
The provided document describes the PathAssist Light Fiber, an ENT manual surgical instrument, and its substantial equivalence to a predicate device. It does not detail specific acceptance criteria with numerical targets for device performance or a formal study specifically designed to prove all acceptance criteria.
However, based on the information provided, we can infer some aspects of the "acceptance criteria" and the "study" that supports the device meeting its intended purpose and regulatory requirements.
Here's an interpretation based on the provided text:
Acceptance Criteria and Reported Device Performance
The core "acceptance criteria" for this 510(k) submission are primarily based on demonstrating substantial equivalence to the predicate device and meeting general device safety and performance standards through design verification.
| Acceptance Criteria Category | Reported Device Performance (Implied) |
|---|---|
| Intended Use & Indications for Use | "The intended use and indications for use of the subject device are the same as the predicate device [Relieva Luma Sinus Illumination System, K071845]." This implies the device meets the functional requirement of "To locate, illuminate within, and transilluminate across nasal and sinus structures in adults aged 18 and over." |
| Technological Characteristics (Design, Function, Principle of Operation, Materials) | "The technological characteristics of the subject device are very similar to the predicate device [K071845], including: design, function, principle of operation, materials..." "Both the subject device and predicate device [K071845] are flexible devices that transmit light from the proximal to distal tip of the device via Light Fibers that can be seen via transillumination. Both devices can be connected to a standard light source via a light cable and an adapter." This implies the device successfully transmits light and is compatible with standard equipment. |
| Biocompatibility | "Both devices... are biocompatible per ISO 10993-1." This means the device meets established biocompatibility standards. |
| Sterilization | "Both the subject and predicate device [K071845] are sterilized using Ethylene Oxide (EtO), validated per ISO 11135-1, and have a Sterility Assurance Level (SAL) of 10-6. Both devices are provided sterile, are for single use only..." This implies the device achieves and maintains sterility. |
| Packaging & Shelf Life | Performance testing included "packaging, sterilization, shelf life..." This implies the device maintains its integrity and sterility over its intended shelf life. |
| Functional & Mechanical Performance | "Design verification testing included functional and mechanical testing, and compatibility testing." "Performance testing showed that the device meets design specifications and performed as intended." This implies the device performs its light transmission function reliably and withstands expected mechanical stresses. |
| Compatibility | "Compatibility testing" was performed. "The Light Fiber is also compatible with standard light post adapters and light cables." This implies the device successfully connects and functions with relevant accessories. |
| Simulated Use Performance | "Simulated use in a cadaver model." This implies the device can be used successfully in a simulated clinical environment for its intended purpose. |
Details about the "Study" (Performance Data)
The document refers to "Performance Data" rather than a single, comprehensive "study" with a defined test set and ground truth in the traditional sense of a diagnostic or AI device study. The provided information describes a series of tests:
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Sample size used for the test set and the data provenance:
- The document does not specify a distinct "test set" sample size in terms of patient data or a specific number of devices tested for each performance criterion.
- The "simulated use in a cadaver model" implies in vitro or ex vivo testing, not human subjects. The number of cadavers or specific trials is not stated.
- The provenance is not applicable in the sense of country of origin for patient data, as no clinical human data was submitted. The tests were likely conducted in a controlled lab setting by the manufacturer.
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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 as there was no "ground truth" to be established by experts for a diagnostic or AI performance study. The tests are focused on engineering performance criteria (e.g., light output, material integrity, sterility).
- For the cadaver model, "performance as intended" would likely be assessed by technical staff or medical professionals involved in the simulated use, but these are not explicitly termed "experts establishing ground truth."
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Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable. Adjudication methods are typically for clinical endpoints or diagnostic accuracy, which are not part of this device's performance data.
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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:
- No. This is not an AI device or a diagnostic device. It's a manual surgical instrument.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is not an algorithm or AI device. The device itself is a "standalone" physical instrument and its performance was evaluated.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- For engineering tests (biocompatibility, sterilization, mechanical), the "ground truth" is adherence to established standards (e.g., ISO 10993-1, ISO 11135-1) and internal design specifications.
- For simulated use, the "ground truth" is that the device successfully performs its function (locating, illuminating, transilluminating) in the cadaver model as expected for its indications for use.
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The sample size for the training set:
- Not applicable. This is not an AI/machine learning device that requires a training set.
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How the ground truth for the training set was established:
- Not applicable for the same reason as above.
§ 874.4420 Ear, nose, and throat manual surgical instrument.
(a)
Identification. An ear, nose, and throat manual surgical instrument is one of a variety of devices intended for use in surgical procedures to examine or treat the bronchus, esophagus, trachea, larynx, pharynx, nasal and paranasal sinus, or ear. This generic type of device includes the esophageal dilator; tracheal bistour (a long, narrow surgical knife); tracheal dilator; tracheal hook; laryngeal injection set; laryngeal knife; laryngeal saw; laryngeal trocar; laryngectomy tube; adenoid curette; adenotome; metal tongue depressor; mouth gag; oral screw; salpingeal curette; tonsillectome; tonsil guillotine; tonsil screw; tonsil snare; tonsil suction tube; tonsil suturing hook; antom reforator; ethmoid curette; frontal sinus-rasp; nasal curette; nasal rasp; nasal rongeur; nasal saw; nasal scissors; nasal snare; sinus irrigator; sinus trephine; ear curette; ear excavator; ear rasp; ear scissor, ear snare; ear spoon; ear suction tube; malleous ripper; mastoid gauge; microsurgical ear chisel; myringotomy tube inserter; ossici holding clamp; sacculotomy tack inserter; vein press; wire ear loop; microrule; mirror; mobilizer; ear, nose, and throat punch; ear, nose and throat knife; and ear, nose, and throat trocar.(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 § 874.9.