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The LIC Instrument Processor when used with the Manzi Detergent MD10, the Manzi Sterilant MS10 concentrate ( MEC 0.49% PAA, minimum contact temperature of 120° F for a contact time of 5 minutes), and filtered and ozonated final rinse water, is indicated for cleaning and high level disinfection of heat sensitive semi-critical endoscopes used in health care settings by health care workers. Manual cleaning of medical devices (endoscopes) is not required prior to placement in the LIC Instrument Processor.

The Manzi Detergent MD10 concentrate when used with the LIC Instrument Processor is indicated for the cleaning of heat sensitive semi-critical endoscopes used in health care settings by health care workers.

The Manzi Sterilant MS10 concentrate when used in the LIC Instrument Processor is indicated for high level disinfection of heat sensitive semi-critical endoscopes used in health care settings by health care workers.

The filtered ozonated final rinse water generated by the LIC Instrument Processor is indicated for the final rinsing in the LIC Instrument Processor of of heat sensitive semi-critical endoscopes used in health care settings by health care workers.

The LIC Instrument Processing System consists of a LIC Instrument Processor, a proprietary Manzi sterilant, MS10; a proprietary enzymatic Manzi Detergent, MD10; and internally generated filtered ozonated final rinse water. The LIC Instrument Processing System requires no connectors to be attached to the endoscope.

The LIC Instrument Processor is a self-contained stand-alone system designed to clean and provide high level disinfection of semi-critical endoscopes using the MD10 detergent, the MS10 sterilant, and a patented push-pull agitation system. The push-pull agitation system effectively scrubs the interior and exterior surfaces of the semi-critical endoscopes without the use of special connectors. The scope is placed in a processing chamber where it is exposed to a push-pull agitation cleaning cycle that provides cleaning to a protein residual level ≤ 6.4 ug / cm², followed by hot water rinses, a push-pull agitation disinfection cycle that provides high level disinfection of the instrument being processed and final rinses with filtered ozonated water.

The hardware for the LIC Instrument Processor consists of a stainless steel processing chamber, a push-pull agitation pump, an ozonator, a neutralization tank, and a variety of components that are mounted in a movable covered frame. The cleaner-processor system utilizes accessories such as disposable water filters, reusable semi-critical endoscopes trays, baffle inserts, and printer paper.

The LIC Instrument Processor is designed to: (1) be used in accordance with the reprocessing instructions provided in the operator's manual of the instruments being processed, and (2) facilitate the health care facility's compliance with reprocessing guidelines published by SGNA, APIC, AORN, ASGE, CDC, and other professional organizations.

MD10 is a low foaming enzyme chemical detergent packaged in single use containers for attachment to the LIC Instrument Processor. MD10 is intended to be used with the LIC Instrument Processor only.

MS10 is a peracetic acid based liquid chemical sterilant packaged in single use containers for attachment to the LIC Instrument Processor. MS10 is intended to be used with the LIC Instrument Processor.

1. Acceptance Criteria and Reported Device Performance:

2. Sample Size for Test Set and Data Provenance:

• Sample Size: Not explicitly stated for each test beyond "endoscopes" or "inoculated endoscope" in various simulated use and in-use tests.
• Data Provenance: The document does not specify the country of origin. The study includes both simulated use testing (laboratory-controlled conditions with specific microbial loading) and in-use testing (using endoscopes contaminated by clinical endoscopy with naturally occurring soils). This indicates a mix of prospective (potentially for the simulated use) and retrospective/observational (for in-use samples) approaches.

3. Number of Experts and Qualifications for Ground Truth:

Not applicable as the ground truth for this device (an instrument processing system) is based on quantitative laboratory measurements and microbiological assays, not expert interpretation of images or clinical assessments.

4. Adjudication Method for Test Set:

Not applicable, as ground truth is established through quantitative measurements and laboratory tests.

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

An MRMC study was not done. This device is an automated instrument processing system, not a diagnostic imaging AI tool that assists human readers. Therefore, the concept of human readers improving with AI vs. without AI assistance does not apply.

6. Standalone Performance:

Yes, a standalone performance evaluation was done. The entire study describes the performance of the LIC Instrument Processing System (the algorithm/device itself) in cleaning and high-level disinfection. All efficacy tests (cleaning, disinfection, rinse water) and residue evaluations directly assess the device's capabilities without human intervention during the processing cycle.

7. Type of Ground Truth Used:

The ground truth used is primarily quantitative laboratory measurements and microbiological assays, including:

• Protein residual levels (µg/cm²)
• Total Organic Carbon (TOC) levels (µg/cm²)
• Microbial loading reduction (log reduction, absence of CFUs)
• Detection of viable organisms
• Chemical residue levels

8. Sample Size for the Training Set:

Not applicable. This document describes the validation of an automated instrument processing system, not a machine learning or AI model that requires a training set. The system operates based on established physical and chemical principles, not learned patterns from data.

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

Not applicable, as there is no training set for this type of device.

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The Manzi Mach 1 Instrument Cleaner Processor System is indicated for use with the High Level Disinfectant MS10 concentrate (MEC 0.49% PAA, minimum contact temperature of 120°F for a contact time of 15 minutes) for cleaning and high level disinfecting flexible bronchoscopes used in health care settings by health care workers.

The Manzi Mach 1 Instrument Cleaner-Processor System consists of a Manzi Mach 1 Instrument Cleaner-Processor, a proprietary Manzi germicide, MS10; and a proprietary Manzi Detergent, MD10.

The Manzi Mach 1 Instrument Cleaner-Processor is a self-contained stand-alone system of hardware and software designed to clean and provide high level disinfection of bronchoscopes using the MD10 detergent, the MS10 germicide, and a patented push-pull agitation system. The push-pull agitation system effectively scrubs the interior and exterior surfaces of the bronchoscope without the use of special connectors. The scope is placed in a processing chamber where it is exposed to a push-pull agitation cleaning cycle followed by two hot water rinses, a push-pull agitation disinfection cycle that provides high level disinfection (spore log reduction of > 10 ° microorganisms with no CFUs) of the device, and a final rinse with an ozonated sanitized water rinse.

The hardware for the Manzi Mach 1 Instrument Cleaner-Processor consists of a stainless steel processing chamber, a push-pull agitation pump, an ozonator, and a variety of components that are mounted in a movable covered frame. The cleaner-processor system utilizes accessories such as disposable water filters, reusable bronchoscope trays, and printer paper.

The Manzi Mach 1 Instrument Cleaner-Processor is designed to: ( ) be used in accordance with the reprocessing instructions provided in the operator's manual of the instruments being processed, and (2) facilitate the health care facility's compliance with reprocessing guidelines published by SGNA, APIC, AORN, ASGE, CDC, and other professional organizations.

MD10 is a low foaming enzyme chemical detergent packaged in single use containers for attachment to the Manzi Cleaner. MD10 is intended to be used with the Manzi Instrument Cleaner-Processor.

MS10 is a peracetic acid based liquid chemical germicide. MS10 is intended to be used with the Manzi Instrument Cleaner-Processor.

Here's a breakdown of the acceptance criteria and study information for the Manzi Mach 1 Instrument Cleaner-Processor, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

The document outlines three main sets of qualification testing: FDA Guidance, EU Guidance, and Langford IC Systems (LIC) Requirements.

FDA Guidance (August 1993: "Guidance on Premarket Notification [510(k)] Submissions for Automated Endoscope Washer / Disinfectors, and Disinfectors Intended for Use in Health Care Facilities")

EU Guidance (Draft prEN ISO 15883-1: 2003 and Draft prEN ISO 15883-4: 2001)

Langford IC Systems (LIC) Requirements

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

The document does not explicitly state the numerical sample size for the test set (number of scopes, surrogates, or runs). Instead, it refers to broad categories of tests such as "Simulated Use Tests," "In-Use Tests," and testing on "Olympus Bronchoscopes" and "Surrogates".

The data provenance is not specified in terms of country of origin. The study appears to be retrospective in the sense that the test results are reported after the completion of the tests rather than being part of an ongoing prospective clinical trial.

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

The document does not provide information on the number of experts used or their qualifications for establishing ground truth. The ground truth for effectiveness (cleaning, disinfection, organism reduction) is established by laboratory-based microbiological and chemical testing, not expert consensus in the diagnostic sense.

4. Adjudication Method for the Test Set:

This is not applicable to this type of device evaluation. Adjudication methods like 2+1 or 3+1 are typically used for interpreting diagnostic outputs where human readers might disagree. For device performance in cleaning and disinfection, the results are quantitative (e.g., protein levels, log reduction of microorganisms) and therefore do not require such 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 is not applicable. The Manzi Mach 1 is an automated instrument cleaner-processor, not an AI-powered diagnostic or assistive tool for human readers. Therefore, an MRMC study and the concept of human reader improvement with AI are not relevant.

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

Yes, the studies describe the standalone performance of the Manzi Mach 1 Instrument Cleaner-Processor combined with its proprietary chemicals (MS10 germicide and MD10 detergent). The device operates automatically to clean and disinfect the instruments, without human intervention in the core cleaning/disinfection process itself. The "Results" section in the tables reflects the performance of the automated system.

7. The Type of Ground Truth Used:

The ground truth used in these studies is primarily laboratory-based microbiological and chemical testing against established standards and validated methods. Examples include:

• Microbiological assays: To determine log reduction of specific test organisms (e.g., Bacillus subtilis, Mycobacterium terrae, Candida albicans) to assess disinfection efficacy.
• Chemical assays: To measure remaining protein levels (e.g., Ninhydrin test) to assess cleaning efficacy.
• Biological indicator assessment: Counting Colony Forming Units (CFUs) to confirm complete elimination or reduction of microorganisms.
• Adherence to recognized standards: FDA Guidance, EU ISO standards (prEN ISO 15883-1 and 15883-4), and AAMI TIR30: 2003.

8. The Sample Size for the Training Set:

The document does not mention a "training set" in the context of machine learning or AI. This is a traditional medical device pre-market notification (510(k)) for a physical cleaning and disinfection system. Therefore, the concept of a training set as used in AI development is not applicable here. The device itself is "trained" during its engineering and design phase, and validated through the qualification testing described.

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

As there is no "training set" in the AI sense, this question is not applicable. The device's performance parameters were likely established through iterative design, engineering, and testing phases to meet the specified performance metrics, but this is not analogous to establishing ground truth for an AI training dataset.

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The Manzi Cleaner, when used in accordance with its labeling and the Manzi Detergent MD10, is for the cleaning of bronchoscopes in a health care setting by health care workers.

The Manzi Cleaner System consists of a Manzi Cleaner and a proprietary Manzi Detergent, MD10. The Manzi Cleaner is a self-contained stand-alone system of hardware and software designed to clean bronchoscopes using the MD10 detergent and a patented push-pull agitation system. The push-pull agitation system effectively scrubs the interior and exterior surfaces of the bronchoscope without the use of special connectors. The scope is placed in a processing chamber where it is exposed to a push-pull agitation cleaning cycle followed by two hot water rinses. The hardware for the Manzi Cleaner consists of a stainless steel processing chamber, a push-pull agitation pump, and a variety of components that are mounted in a movable covered frame. The cleaner system utilizes accessories such as disposable water filters. reusable bronchoscope trays, and printer paper. MD10 is a low foaming anionic chemical detergent packaged in custom containers for attachment to the Manzi Cleaner. The detergent is automatically diluted to a use dilution of 2.0% detergent concentration. MD10 is intended to be used exclusively with the Manzi Cleaner.

The provided text describes the Manzi Cleaner System, a device for cleaning bronchoscopes, and details the nonclinical tests conducted to demonstrate its performance and substantial equivalence to a predicate device.

Here's an analysis of the acceptance criteria and the study information based on the provided text:

Acceptance Criteria and Reported Device Performance

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