Search Results

This instrument is intended to be used with a PENTAX video processor (including light source), documentation equipment, monitor, Endotherapy Device such as a Biopsy Forceps, and other ancillary equipment for endoscopy and endoscopic surgery within the lower digestive tract including the anus, rectum, sigmoid colon, colon, and ileocecal valve.

The PENTAX Medical Video Colonoscope EC34-i10T Series is compatible with the PENTAX Medical EPK-i7010 Video Processor (K150618) and PENTAX Medical EPK-i5010 Video Processor (K143727). They scopes are composed of three main components: an Insertion Portion, Control Body and PVE Connector. The Insertion Portion is inserted into the body cavity of patient. The Insertion Portion includes the Distal End and Bending Section. The Objective Lens, Light Guide, and Instrument Channel are located on the Distal End of the Insertion Portion. The Distal End also contains an Air/Water Nozzle and Water Jet Nozzle. The Bending Section of the Insertion Body is used to operate the endoscope angulation and is bent by the Angulation Control Knob on the Control Body. The Control Body is held by the user's hand. The Control Body includes the Angulation Control Knob, Angulation Lock Knob/Lever, Air/Water Cylinder, Suction Cylinder, Remote Button, and Instrument Channel Inlet. Endotherapy Device such as Biopsy Forceps may be inserted from the Instrument Channel Inlet into the body cavity through the instrument channel. The PVE Connector is connected to the Video Processor via an Electrical Contacts. The Light Guide of the Distal End is used to illuminate the body cavity by light that is carried through the Light Carrying Bundle. The Light Carrying Bundle guides the light from Light Guide Plug that is connected to the Light Source inside the video processor. The CCD built into the Distal End receives reflected light (image data) from the body cavity, and sends the image data to the Video Processor through the video cable. The image data is converted into the image signal by the Video Processor, and the image inside the body cavity is displayed on the Monitor. The EC34-i10T series includes three models: EC34-i10TF, and EC34-i10TF, and EC34-i10TM. These models are identical in all parameters and only differ in length of the insertion of the scopes.

The provided text describes a 510(k) premarket notification for a new medical device, the PENTAX Medical Video Colonoscope EC34-i10T Series. The document focuses on demonstrating that this new device is substantially equivalent to a previously cleared predicate device (PENTAX Medical EC34-i10L Video Colonoscope).

The nature of this submission (demonstrating substantial equivalence to a predicate device) means that the testing performed largely confirms that the new device maintains the safety and effectiveness characteristics of the predicate, despite minor dimensional and material changes. It does not involve a study to "prove the device meets the acceptance criteria" in the way one might for a novel diagnostic algorithm or a therapy with specific performance metrics against a defined standard. Instead, the acceptance criteria are largely met by demonstrating performance comparable to the predicate and compliance with relevant safety and reprocessing standards.

Therefore, the requested information, particularly regarding "device performance," "sample sizes," "ground truth," "experts," and "MRMC comparative effectiveness study," is not directly applicable in the context of this 510(k) submission, as it relates to a colonoscope, not an AI/ML-based diagnostic tool. The document primarily focuses on validation of reprocessing, biocompatibility, electrical safety, EMC, software, and optical/usability performance against established standards or the predicate device.

However, I can extract the relevant information that is present in the document related to acceptance criteria and the studies performed:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Reprocessing Validation: The document states that "The following testing has been performed for the PENTAX Medical Video Colonoscope EC34-i10T Series." This implies specific units of the device were tested. Sample sizes are not explicitly provided (e.g., how many colonoscopes were subjected to cleaning or HLD efficacy testing), but it would typically involve a statistically relevant number of units as per reprocessing validation standards. Data provenance is not mentioned, but these types of studies are typically conducted by the manufacturer or accredited testing labs.
• Biocompatibility: Involves testing of patient-contacting materials. Sample sizes are not specified but would be dictated by ISO 10993-1.
• Electrical Safety and EMC: Involves testing of device units. Sample sizes are not specified but are typically one or a few units for compliance testing.
• Optical Testing: The document states "PENTAX Medical completed optical testing of the PENTAX Medical Video Colonoscope EC34-i10T compared to the predicate, PENTAX Medical Video Colonoscope EC34-i10L." This indicates at least one unit of each (subject and predicate) was used for comparison.
• Usability Testing: The document states "A comparison of the usability of the PENTAX Medical Video Colonoscope EC34-i10T to PENTAX Medical i10 and k10 series of scopes was conducted." Sample sizes for the tested scopes are not mentioned, nor are the number of users involved in the usability assessment.

All these studies appear to be prospective (conducted specifically for this submission) in nature, performed by the manufacturer or their designated testing facilities. No country of origin for the data is specified, but given the manufacturer's location (Montvale, New Jersey, USA) and the submission to the FDA, it's reasonable to infer a U.S. or international standard-compliant testing environment.

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

This is not applicable to this type of device and submission. Colonoscopes are physical instruments, and their performance is evaluated through engineering and biological testing, not by establishing "ground truth" through expert clinical interpretation in the context of a diagnostic AI.

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

This is not applicable as there is no "ground truth" adjudication process involving experts for a physical device like a colonoscope.

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 is not applicable. The device is a video colonoscope, not an AI-assisted diagnostic tool. No human reader studies with or without AI assistance were conducted or reported.

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

This is not applicable. The device is a video colonoscope, not an algorithm.

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

This is not applicable for the reasons outlined above. The "ground truth" for colonoscope performance is adherence to engineering specifications, safety standards, and functional equivalence to a predicate device, demonstrated through direct physical and electrical testing.

8. The sample size for the training set:

This is not applicable. This is a hardware device, not a machine learning algorithm requiring a training set. The device does utilize software, but it is explicitly stated that "The subject devices utilize the same software as the predicate device," implying the software was previously
validated and no new training was performed for this submission.

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

This is not applicable. See points 7 and 8.

Ask a specific question about this device