(24 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).
PathAssist™ Light Seeker™ Acceptance Criteria and Study Details
1. Table of Acceptance Criteria and Reported Device Performance
The provided document describes a Class I medical device (ENT Manual Surgical Instrument), and as such, the focus of the performance data is on demonstrating its functional equivalence to a predicate device and meeting design specifications, rather than clinical performance metrics typically seen for diagnostic or therapeutic AI devices.
| Acceptance Criteria Category | Specific Criteria | Reported Device Performance |
|---|---|---|
| Design Specifications & Functional Equivalence | Compatibility with LED light sources (2.5mm - 3.5mm light guides) | Performance testing demonstrated compatibility with LED light sources. |
| Device performs as intended (locating, illuminating, and transilluminating nasal and sinus structures) | Performance testing demonstrated the subject device meets design specifications and performs as intended. | |
| Same indications for use as predicate device | Indications for use are the same as the predicate device. | |
| Same fundamental scientific technology as predicate device | Fundamental scientific technology is the same as the predicate device. | |
| Same technological characteristics (principle of operation, design, function, materials, biocompatibility, reprocessing) as predicate device | Technological characteristics are the same as the predicate device. | |
| Safety | No adverse events or safety concerns identified through performance testing relevant to this Class I device. | Performance testing demonstrated the device is safe. |
| Effectiveness | Achieves its stated purpose (locating, illuminating, and transilluminating nasal and sinus structures). | Performance testing demonstrated the device is effective. |
2. Sample Size Used for the Test Set and Data Provenance
The document does not detail a "test set" in the context of clinical data for algorithmic performance. Instead, it refers to "design verification testing" and "functional testing." This type of testing typically involves a set number of devices or components to confirm manufacturing and functional parameters.
- Sample Size for Test Set: Not explicitly stated, as this is not a clinical study involving patient data. The testing would have involved a sufficient number of manufactured devices or components to demonstrate consistent functionality.
- Data Provenance: Not applicable in the context of clinical data. The testing was conducted by Entellus Medical, Inc. as part of its design verification process.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
Not applicable. This device is a manual surgical instrument, and its performance evaluation does not involve establishing ground truth through expert consensus on medical images or diagnoses. The "ground truth" here is adherence to design specifications and functional requirements.
4. Adjudication Method for the Test Set
Not applicable. Adjudication methods are typically used in studies involving subjective expert review (e.g., radiology reads) to resolve discrepancies and establish a consensus ground truth. The performance testing for this device focused on objective functional parameters.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was Done
No. An MRMC comparative effectiveness study was not conducted for the PathAssist™ Light Seeker™. This type of study is relevant for evaluating the impact of AI on human reader performance, which is not applicable to a manual surgical instrument.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was Done
No. This device is a manual surgical instrument and does not incorporate any AI algorithms. Its performance is entirely human-in-the-loop.
7. The Type of Ground Truth Used
The "ground truth" for this device's performance evaluation was its design specifications and functional requirements. This includes ensuring compatibility with standard light guides, proper light emission, and adherence to physical design characteristics.
8. The Sample Size for the Training Set
Not applicable. As this device does not utilize AI or machine learning, there is no "training set."
9. How the Ground Truth for the Training Set was Established
Not applicable. As this device does not utilize AI or machine learning, there is no "training set" and thus no ground truth to be established for it.
§ 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.