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510(k) Data Aggregation
(86 days)
This instrument has been designed to be used with an OLYMPUS video system center, light source, documentation equipment, video monitor, endo-therapy accessories(such as a biopsy forceps) and other ancillary equipment for endoscopy and endoscopic surgery within the thoracic and abdominal cavities.
This subject device "XENF-DP Rhino-Laryngofiberscope" is the endoscope for observation within nasal and nasopharyngeal lumen. This endoscope enables two ways of light source, detachable and single use battery powered and light cable source.
The provided 510(k) summary does not include specific acceptance criteria or an explicit study detailing how the device meets such criteria. Instead, it focuses on demonstrating substantial equivalence to predicate devices, particularly regarding safety and technological characteristics.
Here's a breakdown of the requested information based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| No new patient-contacting materials | All patient-contacting materials are cleared by previous 510(k) submissions. |
| Compliance with voluntary safety standards | Designed, manufactured, and tested in compliance with IEC 60601-1 and IEC 60601-2-18. |
| Equivalence in safety and efficacy for electrosurgical applications (compared to predicate devices) | Expected to present no differences in safety or efficacy for electrosurgical applications compared to predicate devices, despite being a flexible endoscope where rigid endoscopes were historically used. |
| Intended Use as a pleuravideoscope | Designed for endoscopic diagnosis and surgery within the thoracic and abdominal cavities, with an Olympus video system, light source, documentation equipment, video monitor, endo-therapy accessories, and other ancillary equipment. |
2. Sample Size Used for the Test Set and Data Provenance
Not applicable. The submission does not describe a test set or clinical study with a sample size for performance evaluation. The device gained clearance based on substantial equivalence to predicate devices and compliance with safety standards, not through a direct performance study with a test set.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Experts
Not applicable. No ground truth establishment by experts for a test set is mentioned.
4. Adjudication Method for the Test Set
Not applicable. No adjudication method is mentioned as there was no test set or clinical study.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
Not applicable. No MRMC study was conducted or mentioned in the summary. The clearance was based on substantial equivalence to existing devices, not on demonstrating an improvement in human reader performance with AI assistance (as this is not an AI device).
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
Not applicable. This device is not an algorithm or AI system, so a standalone performance study in that context is irrelevant. The LTF-240 Pleuravideoscope is a medical instrument.
7. Type of Ground Truth Used
Not applicable. The clearance was based on demonstrating substantial equivalence to predicate devices and compliance with recognized safety standards, not on a ground truth established through expert consensus, pathology, or outcomes data from a performance study.
8. Sample Size for the Training Set
Not applicable. This device is a medical instrument and not an AI/ML algorithm that requires a training set.
9. How the Ground Truth for the Training Set Was Established
Not applicable. As this device is a medical instrument and not an AI/ML algorithm, it does not have a training set or associated ground truth.
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