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The Zutron Medical ZUTR-1003 Endoscope Leak Tester is designed to detect interior and exterior leaks in endoscopes.

The Zutron Medical Endoscope Leak Tester is a leak testing device that detects damage to the interior or exterior of an endoscope.

The provided text is a 510(k) premarket notification letter from the FDA regarding the Zutron Medical ZUTR-10003 Endoscope Leak Tester. It does not contain information about specific acceptance criteria or a study proving the device meets those criteria, as typically found in clinical trial reports or detailed performance studies.

The document states that "The device has passed internal testing and electrical safety testing requirements," and concludes that it is "substantially equivalent to the predicate device." However, no specific details about the methodology, sample sizes, or results of these tests are provided.

Therefore, the following information cannot be extracted from the provided text:

1. A table of acceptance criteria and the reported device performance: Not provided. The document only generally states that the device passed "internal testing."
2. Sample size used for the test set and the data provenance: Not provided.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not provided.
4. Adjudication method for the test set: Not provided.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and its effect size: Not applicable/provided. This device is an endoscope leak tester, not an AI-assisted diagnostic tool that would typically involve human readers.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable/provided in the context of an endoscope leak tester. Its function is to autonomously detect leaks.
7. The type of ground truth used: Not provided.
8. The sample size for the training set: Not applicable/provided. This device is not an AI/ML product where "training set" would apply in the usual sense.
9. How the ground truth for the training set was established: Not applicable/provided.

In summary, the provided FDA letter confirms the regulatory clearance for the Zutron Medical ZUTR-10003 Endoscope Leak Tester based on substantial equivalence, but it does not detail the specific performance studies, acceptance criteria, or experimental methodologies that would answer the requested questions. Its primary purpose is to inform of the FDA's decision regarding market clearance, not to be a scientific report of the device's performance characteristics.

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The intended use of the device is to allow the physician to increase the stiffness of the colonoscope when extra rigidity is required.

The Zutron Colonoscope Stiffening Device performs the same functions as several other devices on the market. Additionally, the subject device is composed of the same materials and has similar dimensions to some of the predicate devices.

The provided 510(k) summary for the Zutron Colonoscope Stiffening Device (Ko51068) does not contain information about a study that establishes acceptance criteria or proves the device meets specific performance metrics. This submission relies on substantial equivalence to predicate devices based on similar intended use, technological characteristics (materials, dimensions), and function.

Therefore, most of the requested information cannot be extracted from this document.

Here's a breakdown of what can be inferred or directly stated from the provided text, and what is missing:

1. Table of Acceptance Criteria and Reported Device Performance:

Explanation: The document states, "We believe the differences are minor and conclude that the subject device is as safe and effective as the predicate devices." This is a general statement of equivalence, not a report on specific performance metrics against defined acceptance criteria. There are no quantitative or qualitative performance results presented.

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

• Sample Size for Test Set: Not mentioned.
• Data Provenance: Not mentioned (no test set data presented). The submission implies a comparison of device characteristics rather than a study with a test set.

3. Number of Experts Used and Qualifications:

• Number of Experts: Not mentioned.
• Qualifications of Experts: Not mentioned.

Explanation: There is no indication of a study involving expert assessment or ground truth establishment.

4. Adjudication Method for the Test Set:

• Adjudication Method: Not mentioned.

Explanation: As no test set study is detailed, no adjudication method is described.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

• MRMC Study Done? No.
• Effect Size: Not applicable, as no MRMC study was conducted or reported.

6. Standalone Performance Study (Algorithm Only):

• Standalone Study Done? Not applicable. This is a mechanical device, not an AI or algorithm-based device.

7. Type of Ground Truth Used:

• Type of Ground Truth: Not applicable. There is no mention of a study requiring ground truth. The submission relies on a comparison of physical characteristics and intended use to predicate devices.

8. Sample Size for the Training Set:

• Sample Size for Training Set: Not applicable. There is no mention of a "training set" as this is a physical medical device, not an algorithm that requires training data.

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

• Ground Truth Establishment for Training Set: Not applicable.

Summary of Device-Specific Information from the Text:

• Device Name: Zutron Colonoscope Stiffening Device
• Intended Use: To allow the physician to increase the stiffness of the colonoscope when extra rigidity is required.
• Predicate Devices:
  • Steel Wire PreAmendment Device
  • Guide Wires and Cables (e.g., Sullivan Variable Stiffness Cable, GIP/Medi-Globe Guide Wires, Endo-Glide Guidewire)
  • Colonoscopes with Stiffness Controls (e.g., Olympus PCF-160AL/I)
• Basis of Equivalence: Performs the same functions, composed of same materials, and has similar dimensions to some predicate devices. The conclusion is that differences are minor and the device is as safe and effective as predicates.
• Regulatory Class: Class II
• Product Code: KOG
• Regulation Number: 21 CFR §876.1500 (Endoscope and accessories)

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