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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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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 organs, tissues, and subsystem: Nasal Passage, Pharynx, Larynx, 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 patient populations.

The EB-1970UK, Ultrasound Video Bronchoscope, must be used with a Pentax Video Processor (a software controlled device) and must be used with an Ultrasound Scanner (a software controlled device). The endoscope has a flexible insertion tube, a control body, PVE umbilical connector, and ultrasound scanner umbilical connector. The PVE connector will be attached to the Video Processor and has connections for illumination and video signals. The ultrasound umbilical connector will be attached to the ultrasound scanner unit.

The control body includes controls for up/down anqulation, suction control, video processor remote control buttons, and ports for manual balloon insufflation/ evacuation and accessory inlet. A sterile, single use disposable latex balloon is fitted over the convex array ultrasound transducer prior to the procedure. It is designed to be inflated with a specific volume of water during the procedure so that the effective transport of ultrasonic pulses from the ultrasound transducer to the target anatomical site and back to the ultrasound transducer can take place.

The endoscope contains light carrying bundles to illuminate the body cavity, a charge couple device (CCD) to collect endoscopic image data, and a convex array ultrasound transducer to collect ultrasonic image data. The instrument contains a working channel through which biopsy devices, or other devices, may be introduced. The video processor contains a lamp that provides white light focused at the endoscope PVE connector light guide prong. The endoscope light carrying bundles present the light to the body cavity and the CCD collects endoscopic image data. Image data and other screen display information are formatted and presented to the video outputs of the video processor for display.

The ultrasound transducer delivers ultrasonic pulses, reflections of the pulses are received and the signals are passed to the ultrasound scanner for processing and display. The instrument is immersible (with the use of supplied cleaning accessories).

The provided text describes the PENTAX Ultrasound Video Bronchoscope EB-1970UK and its regulatory submission. However, it does not contain information about a study proving the device meets specific acceptance criteria based on performance metrics like accuracy, sensitivity, or specificity with a test set, expert readers, or ground truth data.

Instead, the document focuses on demonstrating substantial equivalence to a predicate device and adherence to recognized non-clinical standards.

Here's an analysis based on the information provided and what is missing:

Acceptance Criteria and Study Details

The document details the device's conformance to various non-clinical standards and protocols, which serve as the "acceptance criteria" for safety and fundamental performance. However, there is no mention of a clinical or performance study with a test set of data, human readers, or a specific ground truth for diagnostic accuracy metrics.

1. Table of Acceptance Criteria and Reported Device Performance:

2. Sample size used for the test set and the data provenance:

• Not applicable for a clinical performance test. The testing focused on compliance with engineering, safety, and sterilization standards through in-house and external lab protocols. There isn't a defined "test set" of patient data in the context of diagnostic accuracy.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

• Not applicable. No clinical performance study involving expert assessment of diagnostic accuracy is described.

4. Adjudication method for the test set:

• Not applicable. No clinical performance study involving expert adjudication 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:

• No. This device is an Ultrasound Video Bronchoscope, not an AI-powered diagnostic system. No MRMC study or AI assistance is mentioned.

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

• No. This device is an instrument used by a clinician, not a standalone algorithm.

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

• Not applicable. For the non-clinical tests conducted, the "ground truth" was typically defined by the specified requirements and methodologies of the referenced standards (e.g., specific chemical levels for biocompatibility, sterility for reprocessing, electrical thresholds for safety).

8. The sample size for the training set:

• Not applicable. No training set for a diagnostic algorithm is mentioned.

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

• Not applicable. No training set for a diagnostic algorithm is mentioned.

Summary of what the document does provide regarding acceptance criteria and performance:

The document primarily focuses on demonstrating that the PENTAX Ultrasound Video Bronchoscope EB-1970UK meets the acceptance criteria for safety and basic functional performance by complying with a comprehensive list of FDA-recognized consensus standards and in-house test protocols for:

• Electrical safety
• Electromagnetic compatibility
• Biocompatibility of materials
• Reprocessing and sterilization effectiveness
• Usability
• Software life cycle processes
• Risk management
• Quality management systems
• Specific optical and mechanical characteristics relevant to endoscopes.

The "study" in this context refers to the comprehensive series of non-clinical design verification and validation tests performed according to these standards, with the reported device performance being that "All the study results satisfy the acceptance criteria specified by the above applicable standards." The ultimate conclusion is that the device is "as safe and effective and substantially equivalent" to its predicate device based on these non-clinical evaluations.

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