(104 days)
To locate, illuminate within, and transilluminate across nasal and sinus structures in patients aged 18 and over.
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 0.5mm (0.020").
The provided text describes the Entellus Medical PathAssist LED Light Fiber, a flexible instrument emitting light from its distal end for locating, illuminating, and transilluminating nasal and sinus structures.
Based on the information provided, the acceptance criteria and the study proving the device meets them are as follows:
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria Category | Specific Criteria/Tests Performed | Reported Device Performance |
|---|---|---|
| Safety & Effectiveness | Electromagnetic Compatibility (EMC) | Passed, device meets specifications |
| Electrical Safety | Passed, device meets specifications | |
| Biocompatibility (ISO 10993-1) | Validated (referenced) | |
| Sterilization Validation (ISO 11135-1) | Validated, SAL of 10⁻⁶ | |
| Shelf Life | Met (testing performed) | |
| Functional/Performance | Functional Testing | Met design specifications |
| Mechanical Testing | Met design specifications | |
| Compatibility Testing | Met design specifications | |
| Simulated Use in Cadaver Model | Performed as intended | |
| Light Emission Duration (> 60 min) | Met (device specification outlines this) | |
| Distal Tip Red Light Emission | Met (device description) | |
| Nominal Working Length (27.6cm) | Met (device description) | |
| Outer Diameter (0.5mm / 0.020") | Met (device description) | |
| Other | Packaging | Met design specifications |
2. Sample size used for the test set and the data provenance:
The provided document does not specify a numerical sample size for the test set used in the performance testing.
The testing appears to be primarily laboratory-based and simulated use (cadaver model). Data provenance would be from internal testing conducted by Entellus Medical, Inc.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
The document does not mention the involvement of experts for establishing ground truth, as the testing described is primarily focused on engineering and performance validation rather than clinical ground truth (e.g., diagnosis of a condition). The simulated use in a cadaver model would likely be evaluated by internal engineers or potentially medical professionals involved in the simulated use, but specific numbers or qualifications are not provided.
4. Adjudication method for the test set:
The document does not describe any adjudication method like 2+1 or 3+1. Given the nature of the described performance tests (e.g., EMC, electrical safety, mechanical, functional, cadaver simulation), it's highly probable that pass/fail criteria based on predefined specifications were used, rather than an adjudication process involving multiple reviewers.
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, an MRMC comparative effectiveness study was not done. This device is a manual surgical instrument (light fiber), not an AI-assisted diagnostic tool. Therefore, there is no discussion of human readers or AI assistance.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
No, a standalone (algorithm-only) performance study was not done. This device is a physical medical instrument, not an algorithm or AI.
7. The type of ground truth used:
The "ground truth" for this device's performance is based on engineering design specifications, industry standards (e.g., ISO for biocompatibility and sterilization, IEC for electrical safety), and the intended functional performance (e.g., light emission, physical dimensions, ability to transilluminate in a cadaver). There is no mention of pathology or clinical outcomes data being used for ground truth in this submission.
8. The sample size for the training set:
The document does not mention a training set. This device is a physical instrument and does not involve AI or machine learning algorithms that would typically require a training set.
9. How the ground truth for the training set was established:
As there is no training set, this question is not applicable.
§ 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.