(139 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 adults 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 prior to each use. The PathAssist Light Seeker comes with two standard light post adapters, which allow the device to be compatible with commonly used 2.5mm light guides (cables).
The Entellus Medical PathAssist Light Seeker is a manual surgical instrument intended to locate, illuminate within, and transilluminate across nasal and sinus structures in adults. The device demonstrated substantial equivalence to predicate devices through various performance tests.
Here's an analysis of the provided information:
1. Table of Acceptance Criteria and Reported Device Performance
The submission primarily focuses on establishing "substantial equivalence" to predicate devices, rather than defining specific numerical acceptance criteria for performance metrics that would be applicable to a diagnostic or AI-driven device. The "performance data" section details the types of testing performed to confirm the device's design specifications and intended function.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Technological Equivalence (Principle of Operation, Design, Function, Materials, Biocompatibility, Reusability, Reprocessing) to predicate devices [Sinus Seekers, 510(k) exempt] and/or [Relieva Luma Sinus Illumination System, K071845]. | Met: The subject device and predicate device [Sinus Seekers, 510(k) exempt] are both shaped like a sinus seeker, advanced under endoscopic visualization, made of stainless steel, non-sterile, reusable, and require cleaning/sterilization. Both are biocompatible per ISO 10993-1. The subject device and predicate device [Relieva Luma Sinus Illumination System, K071845] both transmit light from proximal to distal tip via light fibers, can be connected to a standard light source via a light cable and adapter, and are biocompatible per ISO 10993-1. Performance testing validated that the device meets design specifications and performs as intended. |
| Biocompatibility | Met: Biocompatibility testing was performed, and the device is biocompatible per ISO 10993-1. |
| Design Verification (Dimensional and Functional Testing) | Met: Design verification testing, including dimensional and functional testing, was performed to support the useful life of the device. |
| Simulated Use Design Validation | Met: Simulated use design validation testing was performed in a cadaver model. |
| Sterilization Efficacy | Met: Steam sterilization testing was conducted. The device is labeled non-sterile and must be cleaned and sterilized prior to each use. Cleaning validation testing performed on device [K102366] was referenced. |
| Compatibility with Light Guides | Met: Compatibility testing confirmed the device's ability to connect to commonly used 2.5mm light guides (cables) via two standard light post adapters. |
| Storage and Transportation Stability | Met: Storage and transportation testing was performed. |
2. Sample size used for the test set and the data provenance
The submission refers to "simulated use design validation testing in a cadaver model." However, it does not specify the sample size (number of cadavers) used for this test set.
The data provenance is from simulated use testing in a cadaver model, which would be considered prospective in the context of device validation. The country of origin of the data is not specified, but given the submitter's location (Maple Grove, MN, USA), it's likely from the US.
It's important to note that no animal or clinical data were submitted. This is typical for Class I devices seeking substantial equivalence where non-clinical testing is deemed sufficient.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
The document does not provide details on the number of experts used or their specific qualifications for evaluating the cadaver model testing. Given the nature of this type of testing (design validation for a manual surgical instrument), it would typically involve experienced surgical professionals or engineers assessing the device's function and performance within the cadaveric anatomy. However, this information is not explicitly stated.
4. Adjudication method for the test set
The document does not specify an adjudication method (e.g., 2+1, 3+1, none) for the cadaver model testing. For this type of design validation, observations and assessments are usually made by the testing personnel, and consensus would be implied if multiple individuals were involved, but a formal adjudication process is not described.
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, a multi-reader multi-case (MRMC) comparative effectiveness study was not performed. This device is a manual surgical instrument for illumination and transillumination, not an AI-driven or diagnostic imaging tool. Therefore, the concept of human readers improving with or without AI assistance is not applicable to this submission.
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. The PathAssist Light Seeker is a physical, manually operated device, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For the "simulated use design validation testing in a cadaver model," the "ground truth" would implicitly be the anatomical structures within the cadaver and the observed functionality of the device (its ability to locate, illuminate, and transilluminate as intended) as assessed by the testing personnel. This is a form of direct observation and functional assessment rather than a diagnostic 'ground truth' like pathology or expert consensus on image interpretation.
8. The sample size for the training set
Not applicable. This device is a manual surgical instrument and does not involve machine learning or an algorithm that requires a training set.
9. How the ground truth for the training set was established
Not applicable. As a manual surgical instrument, there is no training set or machine learning algorithm for which ground truth would be established.
§ 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.