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The Universal Endoscope Tip Guard is intended to protect tip of the endoscope during transport and storage. It is not intended for use during sterilization.

The Andorate® Universal Endoscope Tip Guard is intended for single use. The universal endoscope tip guard is used to cover distal end of an endoscope prior to transportation and storage. The universal endoscope tip quard is individually packed in sealed package, and it is available both non-sterile and sterile.

The provided document describes the Andorate Universal Endoscope Tip Guard (K202838), which is intended to protect the tip of an endoscope during transport and storage. It is explicitly stated that it is not intended for use during sterilization.

Here's an analysis of the acceptance criteria and the study that proves the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance

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

The document states that "bench testing was performed to support substantial equivalence on both the subject device and the predicate device." However, specific sample sizes for these tests (e.g., number of tip guards tested for compression or compatibility) are not provided.

The data provenance is from bench testing conducted by GA Health Company Limited. The country of origin for the data is not explicitly stated, but the company is based in Hong Kong, China. The studies appear to be prospective in nature, designed specifically to test the new device against its predicate.

3. Number of Experts Used to Establish Ground Truth and Their Qualifications

Since the study involved bench testing of physical device performance (compression, compatibility, biocompatibility), the concept of "ground truth established by experts" in the clinical sense (e.g., radiologists interpreting images) is not applicable. The "ground truth" here is objective physical measurements and adherence to established technical standards (like ISO 10993 for biocompatibility). The experts would be the engineers and scientists conducting and analyzing these bench tests, ensuring they meet predefined technical specifications. Their qualifications are not explicitly detailed.

4. Adjudication Method for the Test Set

As this was a bench testing study, an adjudication method (like 2+1, 3+1 for clinical interpretations) is not applicable. The results are based on objective physical measurements and adherence to technical standards.

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 physical endoscope accessory, not a diagnostic AI algorithm that assists human readers.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

N/A. This is a physical medical device, not an AI algorithm.

7. The Type of Ground Truth Used

The "ground truth" for the performance tests was based on technical specifications and established industry standards. For example:

• Compression test: The standard for acceptable resistance to compression or ability to protect the endoscope tip from damage upon impact.
• Endoscope compatibility: The physical dimensions that reliably fit specific endoscope diameters (2.5mm - 14mm).
• Biocompatibility: Adherence to the requirements of ISO 10993-1, which involves tests for cytotoxicity, sensitization, and irritation.

8. The Sample Size for the Training Set

N/A. The device is a physical product, not an AI algorithm requiring a training set.

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

N/A. The device is a physical product and does not have a "training set."

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