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The Reliance Endoscope Processing System is intended for washing and high level disinfection of up to two manually pre-cleaned, immersible, reusable, heat-sensitive, semi-critical devices such as GI flexible endoscopes and their accessories. High level disinfection is achieved within the 50 - 57°C HLD Phase of the endoscope processing cycle (4 minute generation sequence followed by a 6-minute exposure sequence).

The Reliance Endoscope Processing System is a high level disinfection system that can wash and high level disinfect up to two manually precleaned, immersible, reusable, heatsensitive, semi-critical devices such as GI flexible endoscopes and related accessories. The system utilizes Reliance™ DG Dry Germicide, a proprietary, safe, and dry peracetic acid generating oxidative chemistry. The Reliance Endoscope Processing System was designed to be versatile in meeting the growing demands of the modern flexible endoscope processing department, while offering the highest level of patient and staff safety. The Reliance Endoscope Processing System is a combination of products that are used to wash and high level disinfect flexible endoscopes and their accessories.

The provided text describes a 510(k) premarket notification for a medical device called the "Reliance Endoscope Processing System." The submission is to demonstrate substantial equivalence to a legally marketed predicate device (K102244) and specifically addresses a change to the ink used on the label of the Reliance DG Dry Germicide.

Therefore, the study described is not for the primary performance of an AI/ML medical device, but rather a biocompatibility study related to a minor modification in a non-AI medical device's labeling. As such, many of the requested elements for an AI/ML device (e.g., sample size for test/training sets, data provenance, expert adjudication, MRMC studies, standalone performance, ground truth establishment) are not applicable (N/A) to this specific submission.

However, I can extract the relevant information regarding the acceptance criteria and the biocompatibility study performed.

Acceptance Criteria and Device Performance (Biocompatibility Study)

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample size used for the test set and the data provenance:

• Test Set Sample Size: Not explicitly stated in terms of number of samples, but refers to "Extracts from devices processed in the Reliance EPS with Reliance DG with the alternate ink on the label." This is a laboratory-based biomechanical/biocompatibility test, not a clinical study with patients.
• Data Provenance: The study is a non-clinical, laboratory test (biocompatibility). Country of origin is not specified, but it's a verification activity performed by the manufacturer, STERIS Corporation. It is prospective testing for this specific change.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

• N/A. This is a non-clinical biocompatibility test with a defined chemical/biological assay (ISO 10993-5:2009, Annex A Neutral Red Assay). The "ground truth" is measured objectively by the assay, not by expert consensus.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

• N/A. Not applicable for a laboratory biocompatibility test. The result is a direct measurement against a predefined standard.

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:

• N/A. This is not an AI/ML device.

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

• N/A. This is not an AI/ML device.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):

• For this biocompatibility study: The "ground truth" is the objective measurement of cytotoxicity as defined by the ISO 10993-5:2009, Annex A Neutral Red Assay.

8. The sample size for the training set:

• N/A. This is not an AI/ML device, and no training set is described or relevant for this type of non-clinical testing.

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

• N/A. As no training set is relevant, this question is not applicable.

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