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Like the predicated devices, the Canada Endoscope is used to visualize the urinary tract for diagnostic and therapeutic procedures.

The Canada Endoscope is a rigid type endoscope with a compact objectives and a developed rod-lens system. The basic design of the Canada Endoscope is similar to those legally available for sale in the USA. It consists of an eyepiece and the body with light guide and rod-lens system. The body is designed of an outer and an inner tube of surgical steel. The fiber optics (light carrying fibers) are located between these tubes. The inner tube of the body contains the rod-lens system.

Here's a breakdown of the acceptance criteria and study information based on the provided document:

This document is a 510(k) summary for a rigid cystoscope. 510(k) submissions typically demonstrate substantial equivalence to a predicate device rather than conducting extensive clinical efficacy studies with predefined acceptance criteria. Therefore, the "acceptance criteria" here are aligned with demonstrating this equivalence, and the "study" is primarily a comparison to a legally marketed predicate device.

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Implicit: Substantial Equivalence to Predicate Device K031141)

2. Sample Size Used for the Test Set and Data Provenance

• Sample Size: Not applicable in the context of a clinical test set as described for AI/diagnostic devices. This submission relies on a comparison to a predicate device's existing characteristics and performance, not a new clinical study with a "test set" of patients.
• Data Provenance: The "data" used is the documented design specifications, materials, and intended use of both the new device and the predicate device (Asap Cystoscope, K031141).
  • The predicate device is described as "presently in commercial distribution globally, including the USA."
  • The Canada Endoscope Cystoscope "has been on the Canadian market since the year 2000 and is currently used at major hospitals such as Toronto General Hospital. Mount Sinai Hospital, Sunnybrook Hospital, St. Mikes Hospital, North York General Hospital, Sudbury Regional Hospital, Southlake Hospital, and Sick Kids Hospital Toronto." This indicates retrospective real-world usage data from Canadian hospitals, but not as part of a controlled "test set" for this 510(k) submission.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

Not applicable. This is not an AI/diagnostic device that generates an output requiring expert interpretation for ground truth. The submission relies on engineering specifications and comparison to an established predicate device.

4. Adjudication Method

Not applicable. No expert adjudication process is detailed as there is no diagnostic output from the device being evaluated using a test set against ground truth.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done

No, an MRMC comparative effectiveness study was not done. This device is a rigid endoscope, not an AI system. The submission focuses on demonstrating substantial equivalence in design and function to a predicate device.

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

Not applicable. This device is a physical medical instrument, not a standalone algorithm.

7. The Type of Ground Truth Used

Not applicable in the AI/diagnostic sense. The "ground truth" for this submission is the established performance, safety, and intended use of the predicate device, and the engineering specifications and material properties of the new device that demonstrate its equivalence.

8. The Sample Size for the Training Set

Not applicable. This is a physical medical device, not an AI model requiring a training set.

9. How the Ground Truth for the Training Set Was Established

Not applicable. This is a physical medical device, not an AI model.

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