(156 days)
The VenSure™ LightGuide is used to locate, illuminate within, and transilluminate across, nasal and sinus structures in adults.
VenSure™ LightGuide is a sterile, single-use device designed to emit light from the distal end. The device is an accessory to the VenSure™ Balloon device and used to locate, illuminate within and transilluminate across nasal and sinus structures. The device consists of a flexible light fiber, a protective sheath and an integrated battery-powered LED light source. When activated, the light fiber will emit red light from the distal tip for two (2) hours. It has a fiber nominal working length of 20mm (0.79 inch) with an outer diameter of 0.5mm (0.02 inch). The VenSure™ LightGuide is packaged separately.
The provided text describes the VenSure™ LightGuide, a manual surgical instrument for ear, nose, and throat procedures. However, the document does not contain any information about an AI/algorithm component or a study involving human readers or expert ground truth for diagnostic purposes. The device described is a physical medical tool (a light guide), not an AI-powered diagnostic or assistive tool.
Therefore, I cannot provide details on:
- Acceptance criteria for an AI algorithm's performance (e.g., sensitivity, specificity, AUC).
- Any study data related to AI performance, human reader improvement with AI assistance, or standalone algorithm performance.
- Sample sizes for test or training sets related to AI.
- Number/qualifications of experts, adjudication methods, or types of ground truth for an AI study.
The document focuses on the substantial equivalence of the VenSure™ LightGuide to a predicate device (PathAssist LED Light Fiber) based on:
- Intended use
- Technological characteristics
- Bench testing (mechanical integrity, light output, electrical safety, etc.)
- Biocompatibility
- Sterilization & Stability
- Electromagnetic compatibility and Electrical Safety
It states that "All tests met the predefined acceptance criteria" for these engineering and safety-related characteristics, but it does not specify what those numerical acceptance criteria were for each test.
Summary of what CAN be extracted (related to the physical device, not AI):
1. Table of Acceptance Criteria and Reported Device Performance:
The document broadly states that "All tests met the predefined acceptance criteria" for various bench tests, biocompatibility, sterilization, and electrical safety. However, specific numeric acceptance criteria (e.g., minimum light output in lumens, specific force in Newtons, etc.) and the exact measured performance values are not provided in this regulatory summary.
| Test Category | Acceptance Criteria (General Statement) | Reported Device Performance (General Statement) |
|---|---|---|
| Dimensional and Slider Characterization | Predefined criteria (not specified) | Met |
| Light Output and Run Time Test | Predefined criteria (not specified) | Met |
| Slider Separation Force | Predefined criteria (not specified) | Met |
| Advancement and Retraction Force | Predefined criteria (not specified) | Met |
| Light Fiber Tensile | Predefined criteria (not specified) | Met |
| Comparative Light Output Testing against predicate device | Predefined criteria (not specified) | Met |
| Biocompatibility (Cytotoxicity, Irritation, Sensitization, Acute Systemic Toxicity) | Required acceptance criteria per ISO 10993-1 (not specified) | Successfully met |
| Sterilization | Compliance with ISO 11135-1 (not specified) | Successfully completed |
| Shelf Life and Packaging | Predefined criteria (not specified) | Successfully completed |
| Electromagnetic Compatibility (EMC) and Electrical Safety | Compliance with IEC 60601-1 and IEC 60601-1-2 (not specified) | Complied with |
2. Sample size and Data Provenance: Not applicable to an AI study, and specific sample sizes for the engineering tests mentioned (e.g., how many devices were tested for light output) are not disclosed in this summary. The data provenance is a regulatory submission to the FDA for a medical device cleared in the US.
3. Number of experts and Qualifications: Not applicable, as this is not an AI diagnostic study.
4. Adjudication Method: Not applicable.
5. MRMC Comparative Effectiveness Study: Not applicable.
6. Standalone Algorithm Performance: Not applicable.
7. Type of Ground Truth Used: Not applicable. The "ground truth" for this device would be defined by engineering specifications, material standards, and safety standards, not clinical diagnostic accuracy based on expert consensus or pathology.
8. Sample size for training set: Not applicable.
9. How the ground truth for training set was established: 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.