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The Spirus Medical, Inc. Endo-Ease Endoscopic Overtube is indicated to aid endoscopic insertion and advancement to the mid-ileum using during diagnostic and therapeutic upper GI endoscopy and enteroscopy. The Endo-Ease is used with an endoscope of appropriate diameter and length (such as an enteroscope or pediatric colonoscope).

The device described in this 510(k) consists of a modified sterile, single use, flexible overtube designed for use with currently marketed flexible endoscopes in the lower GI tract.

The provided 510(k) summary document focuses on establishing substantial equivalence for the Spirus Medical, Inc. Endo-Ease Endoscopic Overtube based on a clinical study and physical comparison to a predicate device.

Here's an analysis of the requested information, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state pre-defined "acceptance criteria" in terms of specific performance thresholds for device approval. Instead, it relies on a clinical study to "demonstrate the device's effectiveness." The primary effectiveness metric reported is the ability to reach the ileum.

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

• Sample Size: 101 patients
• Data Provenance: The document does not specify the country of origin of the data. It also does not explicitly state whether the study was retrospective or prospective, although the phrasing "In a study involving the treatment of 101 patients" suggests a prospective clinical trial.

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

The document does not provide information on the number of experts, their qualifications, or how ground truth was established for the clinical study. The "user" successfully reaching the ileum implies a determination made by the endoscopist performing the procedure.

4. Adjudication Method for the Test Set

The document does not describe any adjudication method for the test set. The outcome simply reports what the "user" (presumably the treating physician) achieved.

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

No information about a multi-reader multi-case (MRMC) comparative effectiveness study is present in the document. The study described is a single-arm study focused on the performance of the device itself, not a comparison of human readers with and without AI assistance.

6. Standalone (Algorithm Only) Performance

This device is an endoscopic overtube, a mechanical medical device, not an AI algorithm. Therefore, the concept of "standalone (algorithm only)" performance is not applicable.

7. Type of Ground Truth Used

The ground truth used appears to be clinical observation/outcome as determined by the endoscopist during the procedure (i.e., whether the ileum or mid-ileum was successfully reached).

8. Sample Size for the Training Set

This device is a physical medical device, not a machine learning model. Therefore, the concept of a "training set" is not applicable in this context. The 101 patients mentioned are part of the clinical study to demonstrate effectiveness for regulatory submission, not for training an algorithm.

9. How Ground Truth for the Training Set Was Established

As this is not an AI/ML device, there is no training set and thus no ground truth establishment for a training set.

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