(30 days)
The PathAssist Light Seeker is intended to locate, illuminate within, and transilluminate across nasal and sinus structures, including the frontal, ethmoid and maxillary sinuses, in patients aged 18 and over.
The PathAssist™ Light Seeker™ is a fiber optic based, manually operated, reusable sinus seeker that can be connected to a light source to emit light from its distal end. It is labeled non-sterile and must be cleaned and sterilized or cleaned and high level disinfected prior to each use. The Light Seeker comes with two standard light post adapters, which allow the device to be compatible with commonly used 2.5mm - 3.5mm light guides (cables).
Here's an analysis of the provided text regarding the acceptance criteria and study for the Entellus Medical PathAssist™ Light Seeker™:
This submission is for a 510(k) premarket notification, which demonstrates substantial equivalence to a legally marketed predicate device, rather than proving device effectiveness through extensive clinical trials. Therefore, the "acceptance criteria" discussed are primarily related to design specifications, safety, and equivalence to the predicate, not clinical performance metrics like sensitivity or specificity.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Criteria/Tests Performed | Reported Device Performance (as stated in submission) |
|---|---|---|
| Design Verification | Dimensional Testing | Meets design specifications |
| Thermal Safety Testing | Meets design specifications | |
| Biocompatibility | Performed per ISO 10993-1 | Device is safe |
| Packaging | Performed per ASTM D4169-09 | Performs as intended |
| Functional Equivalence | Same Indications for Use as Predicate | Confirmed |
| Same Fundamental Scientific Technology as Predicate | Confirmed | |
| Same Technological Characteristics (principle of operation, basic design, function, materials, reprocessing) as Predicate | Confirmed |
2. Sample Size Used for the Test Set and Data Provenance
The document does not describe a "test set" in the context of clinical performance data. The performance testing focused on design verification, biocompatibility, and packaging. These tests would have involved specific units of the device or its components for each test (e.g., a certain number of devices for dimensional checks, samples of materials for biocompatibility, packaged units for shipping tests), but the exact sample sizes are not specified in this summary.
Data Provenance: The data is generated internally by Entellus Medical, Inc. based on their design, manufacturing, and testing processes. No external data provenance (e.g., country of origin, retrospective/prospective) is applicable in the sense of clinical data.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
Not applicable. This submission does not involve a clinical "test set" requiring expert ground truth in the way a diagnostic AI device would. The "ground truth" for design verification tests would be established by engineering specifications and industry standards.
4. Adjudication Method for the Test Set
Not applicable. There was no clinical "test set" requiring adjudication.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size of How Much Human Readers Improve with AI vs Without AI Assistance
Not applicable. This device is a manual surgical instrument, not an AI-assisted diagnostic tool.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Not applicable. This is a physical, manual surgical instrument, not an algorithm.
7. The Type of Ground Truth Used
For the engineering and safety tests performed:
- Design Verification (Dimensional, Thermal Safety): Ground truth is established by the device's own engineering design specifications, industry standards, and test protocols.
- Biocompatibility: Ground truth is established by the criteria and methods outlined in ISO 10993-1.
- Packaging: Ground truth is established by the specified standards in ASTM D4169-09.
8. The Sample Size for the Training Set
Not applicable. This device does not use machine learning or AI, so there is no "training set."
9. How the Ground Truth for the Training Set Was Established
Not applicable. There is no training set for this type of device.
§ 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.