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The MaxiFlex Semi Flex Scopes are intended to be used by trained medical professionals to examine the urinary tract, and using additional accessories, to perform various diagnostic and therapeutic procedures. Device may be re-used and re-sterilized by the EtO sterilization process up to 3 times

The Maxi-Flex Semi Flex Scopes™ is flexible endoscope that allows operator-controlled deflection of the distal end or tip of the scope. The devices will be made available in lengths (25 cm and 65 cm), each length with a working channel. With a Maxi-Flex accessory a 'Y Port' the working channel may be utilized as an irrigation channel.

The provided text describes a 510(k) premarket notification for the "Maxi-Flex Semi-Flex Scopes" device. The acceptance criteria and the study proving the device meets those criteria are primarily related to its reusability after sterilization.

Here's an analysis of the requested information:

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

*Note: There is a discrepancy between the "Testing" section which states "four (4) EtO sterilization cycles without any degradation" and the "Indications for Use Statement" which specifies "up to 3 times." The FDA's letter mentions "for the indications for use stated in the enclosure," which would imply the 3 times limit is the accepted one for marketing.

2. Sample sized used for the test set and the data provenance

• Sample Size for Test Set: The document mentions "four (4) EtO sterilization cycles" as the test to prove reusability. It does not explicitly state how many individual Maxi-Flex Semi-Flex Scopes were subjected to these cycles. It's implied that at least one device was tested.
• Data Provenance: Not explicitly stated (e.g., country of origin). The testing was conducted internally by Maxi-Flex, LLC as part of their submission. It's a prospective test specifically for this submission.

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 in the document. The testing described is a performance/durability test of the scope itself, not a diagnostic device requiring expert interpretation of results. It likely involved engineering and quality control personnel within Maxi-Flex, LLC, rather than medical experts to establish a "ground truth" in the clinical sense.

4. Adjudication method for the test set

This information is not applicable/provided. The testing was a direct measurement of the device's ability to withstand sterilization cycles without degradation, not a subjective clinical assessment requiring adjudication.

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 applicable/provided. This is a medical device (endoscope), not an AI-powered diagnostic tool, and therefore, an MRMC study comparing human readers with and without AI assistance would not be relevant.

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

This information is not applicable/provided. This is a physical medical device, not a software algorithm.

7. The type of ground truth used

The "ground truth" for this performance test was defined by the original design specifications of the device. The test aimed to show that the device, after multiple sterilization cycles, still met these predefined engineering and functional specifications.

8. The sample size for the training set

This information is not applicable/provided. This is a physical medical device, not a machine learning model, so there is no concept of a "training set" in this context.

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

This information is not applicable/provided for the same reason as point 8.

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The MaxiFlex Semi Flex Scopes™.are intended to be used by trained medical professionals to examine the urinary tract, and using additional accessories, to perform various diagnostic and therapeutic procedures

Not Found

I am sorry, but this document is a 510(k) premarket notification letter from the FDA to Technology Delivery Systems, Inc. regarding their MaxiFlex-Semi Flex Scope.

It does not contain any information about acceptance criteria, device performance studies, sample sizes, ground truth establishment, expert qualifications, or comparative effectiveness studies.

Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them based on the provided text.

Ask a specific question about this device