(85 days)
To locate, illuminate within, and transilluminate across nasal and sinus structures.
The PathAssist LED Light Fiber is a flexible instrument that emits light from the distal end. The LED Light Fiber is provided sterile and is for single use only. The device consists of a flexible illumination fiber, a protective sheath and an integrated battery powered LED light source. When the LED Light Fiber is activated the fiber will emit red light from the distal tip for over 60 minutes. It has a fiber nominal working length of 27.6cm with an outer diameter of 0.375mm (0.015").
The PathAssist LED Light Fiber is packaged alone or may be packaged with XprESS (LoProfile or Ultra).
Here's a breakdown of the acceptance criteria and study information for the PathAssist LED Light Fiber, based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Primary Outcome: Procedural Technical Success Rate (locating, illuminating within, and transilluminating across nasal and sinus structures) | 98.4% (127 successfully completed attempts out of 129 attempted sinus illuminations/transilluminations) This meets a high technical success rate, indicating the device effectively performs its intended function. |
| Secondary Outcome: Complication Rate | 0% (No complications reported during the study) This indicates a high level of safety for the device. |
| Reported Adverse Events related to the device procedure | 0 (No adverse events reported) This further supports the safety profile. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size (Test Set): 50 subjects, resulting in 129 sinus illuminations/transilluminations attempted.
- Data Provenance: Prospective, multicenter, single-arm study conducted in the United States.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
The document does not explicitly state the number of experts used to establish ground truth or their specific qualifications (e.g., "radiologist with 10 years of experience"). However, given the nature of a clinical study, it would implicitly involve clinical investigators/physicians proficient in ENT procedures to assess the procedural technical success and identify complications.
4. Adjudication Method for the Test Set
The document does not explicitly mention an adjudication method (such as 2+1 or 3+1) for the test set. It describes a single-arm study where outcomes were assessed, likely by the treating physicians or study coordinators participating in the multicenter trial.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not explicitly described. The study was a single-arm study focused on the device's performance, not a comparative study against other methods or human readers with and without AI assistance.
6. If a Standalone (i.e., Algorithm Only Without Human-in-the-loop Performance) Was Done
This question is not applicable as the device described, the PathAssist LED Light Fiber, is a manual surgical instrument (a light fiber) used directly by a clinician, not an AI algorithm. Therefore, there is no "algorithm only" performance to evaluate.
7. The Type of Ground Truth Used
The ground truth was established through clinical assessment during the prospective study.
- Technical Success: Assessed by the clinical investigators performing the procedure, based on their ability to "locate, illuminate within, and transilluminate across nasal and sinus structures" using the device.
- Complications/Adverse Events: Clinical observation and reporting by the investigators.
8. The Sample Size for the Training Set
The document does not provide information about a separate "training set" or "training data." This is consistent with the nature of the device; it's a physical medical instrument, not a machine learning algorithm that requires a training set. The clinical study described served as the primary performance evaluation for regulatory submission.
9. How the Ground Truth for the Training Set Was Established
As there is no mention of a "training set" for an AI algorithm, this information is not applicable to the PathAssist LED Light Fiber.
§ 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.