(28 days)
To locate, illuminate within, and transilluminate across nasal and sinus structures in patients 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. It has a fiber nominal working length of 27.6cm with an outer diameter of 0.5mm (0.020"). The device consists of a flexible illumination fiber, a protective sheath and a light post, with an overall device length of 117cm. The Light Fiber is provided sterile and is for single use only. The Light Fiber is packaged with a commercially available male tuohy borst adapter and a sinus cannula.
This is a submission for a 510(k) premarket notification for a medical device called the "PathAssist™ Light Fiber™." As such, the documentation provided does not contain information about a study designed to prove the device meets acceptance criteria in the manner you've outlined for an AI/algorithm-based device.
The PathAssist™ Light Fiber™ is a manual surgical instrument, specifically a sinus guidewire. Its regulatory pathway relies on demonstrating substantial equivalence to a predicate device rather than undergoing extensive clinical trials with performance metrics like sensitivity, specificity, etc., typically associated with AI/ML diagnostic tools.
However, I can extract the relevant information available within the provided text to answer your questions where possible, and explicitly state when the requested information is not applicable or not provided.
Here's a breakdown based on the provided document:
Acceptance Criteria and Device Performance (Not applicable in the AI/ML sense)
For this device, "acceptance criteria" are related to demonstrating that the device meets its design specifications and performs its intended function safely and effectively, primarily through engineering and functional testing, and by establishing substantial equivalence to a predicate device.
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Functional Compatibility: Compatibility with LED light sources | "Design verification testing included functional testing to support compatibility of the Light Fiber with LED light sources." |
| Design Specifications: Meeting intended design parameters | "Performance testing demonstrated that the subject device meets design specifications and performs as intended." |
| Safety and Effectiveness: Performance as intended | "Performance testing has demonstrated that the device is safe and effective and that its performance is substantially equivalent to the predicate device." |
| Substantial Equivalence: To predicate device [K111763] | "The Light Fiber has the same indications for use and fundamental scientific technology as the predicate device. The Light Fiber is substantially equivalent to the predicate device." |
| Sterility: Provided sterile and for single use | "The Light Fiber is provided sterile and is for single use only." |
2. Sample size used for the test set and the data provenance
- Sample size: Not specified. The testing described is "design verification testing" and "functional testing," which typically involves engineering samples rather than patient data sets characteristic of AI/ML studies.
- Data provenance: Not applicable in the context of patient data. The provenance would be the internal testing facilities of Entellus Medical, Inc.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not applicable. This device is a physical instrument, not an AI/ML algorithm requiring expert opinion for ground truth. "Ground truth" for this device would be established by engineering specifications and physical measurements.
4. Adjudication method for the test set
- Not applicable. There is no mention of expert adjudication as this is not an AI/ML diagnostic device study.
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
- No. This is not an AI-assisted device. The document states that "animal and clinical data were not submitted."
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This device is a manual surgical instrument; it is not an algorithm and does not operate standalone.
7. The type of ground truth used
- Type of Ground Truth: Design specifications, functional requirements, and physical characteristics. For example, testing light emission, flexibility, and dimensions against pre-defined specifications.
8. The sample size for the training set
- Not applicable. This device does not use an AI/ML algorithm that requires a training set.
9. How the ground truth for the training set was established
- Not applicable. Does not apply to this type of device.
Summary of the Study (as described in the document):
The "study" or "performance data" provided for the PathAssist™ Light Fiber™ consisted solely of design verification testing. This testing included:
- Functional testing: Specifically to support the compatibility of the Light Fiber with LED light sources.
- Confirmation that the device meets its design specifications.
- Verification that the device performs as intended.
The document explicitly states that sterilization, shelf life, packaging testing, biocompatibility, animal, and clinical data were NOT submitted. The conclusion drawn from this performance data was that the device is safe and effective and is substantially equivalent to its predicate device [K111763]. This aligns with the regulatory requirements for Class I devices and the 510(k) pathway, which primarily focuses on demonstrating substantial equivalence.
§ 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.