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The PENTAX Medical Video Bronchoscopes (EB Family) have been designed to be used with a PENTAX Medical Video Processor (including Light source), documentation equipment, video monitor, endo-therapy accessories (such as biopsy forceps) and other ancillary equipment for endoscopy and endoscopic surgery within the airways and tracheobronchial tree.

The PENTAX Medical Video Naso-Pharyngo-Laryngoscope (VNL-1570STK) is designed to be used with a PENTAX Medical video processor, light source, documentation equipment, display monitor, endoscopic accessories, and other ancillary equipment and intended to provide optical visualization (via a video monitor) of, and therapeutic access to, nasal, pharyngeal, laryngeal and the upper airway anatomy.

The EB-1970UK, Ultrasound Video Bronchoscope, is intended to provide optical visualization of, ultrasonic visualization of, and therapeutic access to, the Pulmonary Track including but not restricted to the organs, tissues, and subsystems: Nasal Passage, Pharynx, Trachea, Bronchial Tree (including access beyond the stem), and underlying areas. The instrument is introduced per orally when indications consistent with the requirement for procedure are observed in adult and pediatric populations.

The PENTAX Medical Video Bronchoscopes, Video Naso-Pharyngo-Laryngoscope and Ultrasound Video Bronchoscope are identical to their respective predicate devices with the sole exception being that epoxy has been added to the suction nipple of the subject devices to prevent loosening of the suction nipple. There are no other changes to the design, specifications, or technological characteristics of the predicate devices as described in K131028 (EB family), K162151 (VNL-1570STK) and K081518 (EB-1970UK).

Both the Bronchoscopes and Naso-Pharyngo-Laryngoscope are composed of an Insertion Portion, Control Body, PVE Connector and Light Guide Plug. In addition to the parts above, the Ultrasound Video Bronchoscope has an Ultrasound Umbilical Connector.

All the Bronchoscopes, Naso-Pharyngo-Laryngoscope and Ultrasound Video Bronchoscope are reusable devices initially supplied non-sterile to the user and require the user to reprocess prior to initial use and between each use. All the Bronchoscopes, Naso-Pharyngo-Laryngoscope and Ultrasound Video Bronchoscope are used with compatible PENTAX Medical Video Processors.

This document describes a 510(k) premarket notification for PENTAX Medical Video Bronchoscopes, PENTAX Medical Video Naso-Pharyngo-Laryngoscope, and PENTAX Medical Ultrasound Video Bronchoscope. The purpose of the 510(k) is to obtain clearance for the addition of epoxy to the suction nipple of these devices to prevent loosening.

Here's a breakdown of the information requested:

1. A table of acceptance criteria and the reported device performance

The document does not explicitly state numerical acceptance criteria in the typical "pass/fail" format often seen for performance metrics like sensitivity or specificity. Instead, the acceptance criterion for the modification is implied: the epoxy must sufficiently prevent the loosening of the suction nipple under specified stress conditions.

2. Sample sized used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)

The document does not specify the sample size (e.g., number of devices tested) for the performance testing. It also does not provide information about the country of origin or whether the study was retrospective or prospective.

3. 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)

This device is not an AI/ML device that requires expert-established ground truth. The performance testing described is engineering-based, focusing on the mechanical integrity of a component (suction nipple with epoxy).

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable for this type of engineering performance testing. No adjudication method concerning expert consensus or disagreements is 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

Not applicable. This is not an AI-assisted device, and no MRMC study was performed.

6. If a standalone (i.e. algorithm only, without human-in-the-loop performance) was done

Not applicable. This is not an AI/ML device. The "standalone" performance here refers to the device's mechanical integrity, which was tested.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

The "ground truth" in this context is the actual physical state of the suction nipple (i.e., whether it remains securely attached or loosens). This was determined by controlled mechanical stress testing.

8. The sample size for the training set

Not applicable. This is not an AI/ML device, so there is no training set.

9. How the ground truth for the training set was established

Not applicable. There is no training set for this device.

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