(59 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 light guides (cables).
The provided 510(k) summary for the PathAssist™ Light Seeker™ (K113522) focuses on demonstrating substantial equivalence to a predicate device (K110158), rather than a detailed clinical study proving specific performance metrics against pre-defined acceptance criteria for a novel device. As such, many of the requested elements (e.g., sample sizes for test/training sets, number/qualifications of experts, adjudication methods, MRMC studies, standalone performance with explicit metrics, and ground truth establishment for novel algorithms) are not applicable or not reported in this type of submission.
The "acceptance criteria" in this context are primarily related to maintaining functionality and safety after reprocessing, aligning with the predicate device's performance, and meeting design specifications.
Here's a breakdown based on the provided document:
Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Criteria (Inferred/Reported) | Reported Device Performance |
|---|---|---|
| Functional Performance | Device performs as intended (locate, illuminate, transilluminate nasal/sinus structures). | Performance testing showed that the subject device meets design specifications and performs as intended. Functional testing supported the useful life of the device after repetitive reprocessing cycles. |
| Reprocessing Effectiveness | Device maintains functionality and safety after manual cleaning and manual high-level disinfection/sterilization. | Reprocessing validation (cleaning, HLD, sterilization) was performed, with validation results referenced from predicate devices ([K102366] for cleaning/HLD, [K110158] for sterilization). |
| Biocompatibility | Device materials are biocompatible (per ISO 10993-1). | Biocompatibility was established as having the same technological characteristics as the predicate device (same materials). No new biocompatibility data were submitted. |
| Substantial Equivalence | Device has the same indications for use and fundamental scientific technology as the predicate, with equivalent technological characteristics (principle of operation, design, function, materials). | The Light Seeker has the same indications for use and fundamental scientific technology as the predicate device. It is substantially equivalent to the predicate device. |
| Safety | Device is safe for its intended use. | Performance testing demonstrated that the device is safe and effective. |
Study Information
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Sample sizes used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not applicable/Not reported. This submission describes design verification testing and reprocessing validation, not a clinical study on patient data with a "test set" in the sense of an algorithm. The testing involved repetitive reprocessing cycling of the device itself.
- The document implies laboratory/engineering testing rather than patient-based data.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Not applicable. No ground truth in the context of clinical expert review of diagnostic output is established or mentioned, as this is a surgical instrument, not an interpretive diagnostic device.
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Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable. No clinical test set requiring adjudication is described.
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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. This is a Class I manual surgical instrument. No MRMC comparative effectiveness study was performed or is relevant to this device type. There is no AI component.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- No. This is a manual surgical instrument. There is no standalone algorithm.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- The "ground truth" for the performance testing of this surgical instrument would be its adherence to engineering specifications and demonstrated functionality (e.g., light output, structural integrity, cleanability, sterilizability) after simulated use and reprocessing cycles. This is based on design specifications and engineering validation.
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The sample size for the training set
- Not applicable. No training set for an algorithm is described.
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How the ground truth for the training set was established
- Not applicable. No training set for an algorithm is described.
§ 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.