(49 days)
These instruments have been designed to be used with a Suction Pump and EndoTherapy accessories and other ancillary equipment for airway management, which includes diagnosis, and observation endoscopic treatment. to access airway anatomy, endotracheal/endobronchial intubation and management.
The TRACHEAL INTUBATION FIBERVIDEOSCOPE LF-Y0004 and LF-Y0005 are all-in-one cordless endoscopes with great portability which include light source, video processor, and video monitor functions.
The new endoscopes are basically identical to each predicate device shown in Table 14-1 in intended use, and similar in specifications, performance and materials.
The provided 510(k) summary for the TRACHEAL INTUBATION FIBERVIDEOSCOPE LF-Y0004 and LF-Y0005 does not contain information about specific acceptance criteria or an associated study that proves the device meets those criteria in the context of clinical performance or diagnostic accuracy.
The document primarily focuses on demonstrating substantial equivalence to predicate devices (Olympus LF-DP Tracheal Intubation Fiberscope, OLYPUS BF TYPE XP160F, and Olympus Bronchoscope BF-XT40) based on intended use, technological characteristics, and safety/effectiveness.
Therefore, most of the requested information cannot be extracted from this summary.
Here's a breakdown of what can be inferred or what is explicitly missing:
1. Table of acceptance criteria and the reported device performance:
This information is not provided in the document. The document lists specifications of the subject devices and predicate devices (e.g., Field of View, Depth of Field, Outer Diameter, Angulation, Working Length), but these are technical specifications, not acceptance criteria for a clinical performance study. There are no reported device performance metrics in relation to any acceptance criteria.
2. Sample size used for the test set and the data provenance:
This information is not provided. The document does not describe any test set for a clinical performance study.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
This information is not provided. There is no mention of a test set, experts, or ground truth establishment.
4. Adjudication method for the test set:
This information is not provided.
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:
This information is not provided. The device is an endoscope, not an AI-assisted diagnostic tool, and no MRMC study is mentioned.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
This information is not applicable/not provided. The device is a medical instrument (fibervideoscope), not an algorithm.
7. The type of ground truth used:
This information is not provided. There is no mention of a ground truth in the context of clinical performance testing.
8. The sample size for the training set:
This information is not applicable/not provided. As no AI/algorithm is described, there would be no training set in this context.
9. How the ground truth for the training set was established:
This information is not applicable/not provided.
Summary of what is available from the document:
The 510(k) summary for the TRACHEAL INTUBATION FIBERVIDEOSCOPE LF-Y0004 and LF-Y0005 relies on substantial equivalence to predicate devices. The "study" proving the device meets criteria is primarily the comparison of technological characteristics and an assertion that "When compared to the predicate device, the TRACHEAL INTUBATION FIBERVIDEOSCOPE LF-Y0004 and LF-Y0005 do not incorporate any significant changes in intended use, method of operation, material, or design that could affect the safety or effectiveness of the device." This implies that the safety and effectiveness of the subject devices are comparable to those of the legally marketed predicate devices, which were presumably demonstrated as safe and effective through their own regulatory pathways. No new clinical performance data or studies are presented in this 510(k) summary.
§ 874.4680 Bronchoscope (flexible or rigid) and accessories.
(a)
Identification. A bronchoscope (flexible or rigid) and accessories is a tubular endoscopic device with any of a group of accessory devices which attach to the bronchoscope and is intended to examine or treat the larynx and tracheobronchial tree. It is typically used with a fiberoptic light source and carrier to provide illumination. The device is made of materials such as stainless steel or flexible plastic. This generic type of device includes the rigid ventilating bronchoscope, rigid nonventilating bronchoscope, nonrigid bronchoscope, laryngeal-bronchial telescope, flexible foreign body claw, bronchoscope tubing, flexible biopsy forceps, rigid biopsy curette, flexible biopsy brush, rigid biopsy forceps, flexible biopsy curette, and rigid bronchoscope aspirating tube, but excludes the fiberoptic light source and carrier.(b)
Classification. Class II.