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Medivators Advantage Plus Endoscope Reprocessing System tests, cleans, disinfects and rinses endoscopes, such as fiberoptic and video endoscopes between patient uses. The Advantage Plus system is indicated to provide high level disinfection of heat sensitive semi-critical endoscopes and related accessories. Manual cleaning of endoscopes is not required prior to placement in the Advantage Plus system. The scopes must be precleaned immediatelv after use.

The Advantage Plus Endoscope Reprocessing System uses Rapicide PA High Level Disinfectant to provide high level disinfection of endoscopes when used according to the directions for use. The system uses Intercept Detergent in its cleaning cycle at a concentration of 0.5%.

Rapicide PA Test Strips are used after the disinfection cycle to ensure that the used disinfectant is above the minimum recommended concentration (MRC) of 850ppm peracetic acid; this ensures that the disinfectant was above MRC during the entire disinfection cycle. Rapicide PA should be used in the Advantage Plus System under the following contact conditions:

Contact Time: 5 minutes
Temperature: 30℃
MRC: 850ppm

The Advantage AER is an electro-mechanical system intended to test, clean, and high level disinfect fiberoptic and video endoscopes and their related accessories between uses.

The Advantage system uses the peracetic acid based Rapicide PA High Level Disinfectant.

The AER machine has the capability of cleaning endoscopes as part of the overall cleaning/disinfection cycle of the machine. The users may use the cleaning cycle to replace manual cleaning of the endoscope, however, the users are instructed that they need to preclean the endoscope immediately after use to the SGNA and facility guidelines.

Here's an analysis of the provided text regarding the Medivators Advantage Plus Endoscope Reprocessing System, structured to address your specific questions.

Device Name: Medivators Advantage Plus Endoscope Reprocessing System
510(k) Number: K102996

1. Table of Acceptance Criteria and Reported Device Performance

• Contact Time: 5 minutes
• Temperature: 30°C
• Minimum Recommended Concentration (MRC) of Peracetic Acid: 850ppm |
  | Disinfectant Concentration Maintenance | Rapicide PA Test Strips are used after the disinfection cycle to ensure the used disinfectant is above the MRC of 850ppm peracetic acid, guaranteeing it was above MRC throughout the entire cycle. |

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

The document mentions "simulated use testing with the major brands of endoscopes and testing of used clinical scopes." However, specific sample sizes for either the simulated use testing or the used clinical scopes are NOT provided.

The data provenance is not explicitly stated (e.g., country of origin). Since this is a U.S. FDA 510(k) submission, it is highly likely the testing was conducted to meet U.S. regulatory standards, but the physical location of the testing is not described. The document does not specify if the data was retrospective or prospective.

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

The document does not provide information on the number of experts used or their qualifications for establishing ground truth. The evaluation seems to rely on the results of the cleaning and disinfection tests themselves, rather than expert interpretation of images or other data.

4. Adjudication Method for the Test Set

The document does not describe any adjudication method as it relates to expert review of test results. The testing appears to follow standardized protocols for evaluating cleaning and disinfection efficacy.

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

A Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not conducted for this device. This type of study is typically relevant for interpretative devices (e.g., imaging AI) where human readers are involved in diagnosis. This device is an endoscope reprocessor.

6. Standalone Performance (Algorithm Only Without Human-in-the-Loop Performance)

This question is not directly applicable in the context of an endoscope reprocessor. The device itself is an automated system for cleaning and disinfection, so its "performance" is inherently "standalone" in executing its programmed cycles. There isn't a human-in-the-loop component in the reprocessing itself that would then have its performance compared to an algorithm-only scenario. The machine's performance is its standalone function.

7. Type of Ground Truth Used

The ground truth for the efficacy claims (cleaning and disinfection) is based on measurable outcomes of biological and chemical testing. This would typically involve:

• Microbiological assays: To confirm the reduction/elimination of microorganisms (for disinfection and cleaning).
• Chemical residue detection: To confirm the removal of organic and inorganic soils (for cleaning).
• Visual inspection (under magnification): To assess the cleanliness of lumina and exterior surfaces.
• Disinfectant concentration measurements: To confirm the maintenance of the active disinfectant's concentration.

8. Sample Size for the Training Set

The document does not mention a "training set" in the context of an AI/machine learning algorithm. This device is a physical electro-mechanical system, not an AI or diagnostic software.

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

Since there is no mention of a training set for an AI/ML algorithm, this question is not applicable.

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Medivators Advantage Plus Endoscope Reprocessing System tests, washes, disinfects and rinses flexible endoscopes, such as fiberoptic and video endoscopes between patient uses. The Advantage Plus system is indicated to provide high level disinfection of heat sensitive semi-critical endoscopes. Manual cleaning of endoscopes is required prior to placement in the Advantage Plus system.

Rapicide PA High Level Disinfectant is intended for use with the Advantage Plus Endoscope Reprocessing System to provide high level disinfection of endoscopes when used according to the directions for use. Rapicide PA Test Strips are used after the disinfection cycle to ensure that the used disinfectant is above the minimum recommended concentration (850ppm peracetic acid); this ensures that the disinfectant was above MRC during the entire disinfection cycle. Rapicide PA should be used under the following contact conditions:

Claim: High Level Disinfection
Time: 5 minutes
Temperature: 30(°C)
Minimum Recommended Concentration of Peracetic Acid (MRC): 850ppm

The Advantage Plus AER is an electro-mechanical system intended to test, wash, and high level disinfect flexible fiberoptic and video endoscopes between uses. It is not intended for reprocessing rigid endoscopes. The Advantage is capable of asynchronously reprocessing two scopes at a time.

The Advantage Plus system uses the peracetic acid based Rapicide PA High Level Disinfectant. The Advantage Plus is a single use system in that it mixes the Part A and Part B of the Rapicide PA with water immediately prior to reprocessing and the disinfectant is not reused.

Endoscopes must be pre-cleaned and manually cleaned to SGNA and facility guidelines prior to placing in the system for reprocessing.

After the scopes are connected to the AER, the system tests the endoscopes for blockages in the channels and leaks in the outer skin, and then proceeds to the washing step. The system also includes an optional channel connectivity test to verify proper connection of the fluid channels for reprocessing. If the endoscopes pass the blockage and leak tests and the washing cycle has been completed, the system proceeds to rinse the instruments and begins the disinfection cycle.

For the disinfection cycle, the incoming water is mixed with the two part germicide in the basin. The temperature of the incoming water is monitored to ensure that water temperature is within the operating constraints (30℃) required for disinfection after the water and germicide are mixed together. Following the 5 minute disinfectant contact time, the user takes a sample to test for MRC and then the disinfectant is emptied from the basin into the drain from the machine. Following disinfection, the endoscopes are rinsed and dried by the machine, either by filtered air or an optional alcohol rinse, and are then removed from the machine for the next use.

The machine has many built in safety features which stop the cycle and alarm when certain conditions exist which could indicate that disinfection might be compromised. These alarms and causes are defined in the directions for use for the product.

The machine also prints records by endoscope serial number indicating the results of testing, disinfection, number of disinfections, etc. which are required for permanent records.

Rapicide PA High Level Disinfectant is a peracetic acid based, two part disinfectant. Part A contains the active ingredients and Part B contains anticorrosive agents and surfactants. Part A and Part B are mixed in the machine and diluted with water. The Minimum Recommended Concentration (MRC) of Rapicide PA is 850 ppm of peracetic acid. A test strip is used to ensure that the use solution is above the MRC.

The provided document describes a 510(k) premarket notification for the Medivators Advantage Plus Endoscope Reprocessing System and Rapicide PA High Level Disinfectant. It focuses on demonstrating the device's substantial equivalence to existing devices and its safety and effectiveness.

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

1. A table of acceptance criteria and the reported device performance:

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):

The document does not explicitly state the sample sizes for most of the efficacy tests (e.g., number of replicates for sporicidal, virucidal, etc., or number of endoscopes/tests for simulated-use and in-use).

• In-Use Study: "Clinically Used Scopes" were used. The number is not specified.
• Country of Origin: Not specified, but the manufacturer is "Medivators Reprocessing Systems, a Division of Minntech Corporation" with an address in Minneapolis, MN, USA. This suggests the testing was likely conducted in the USA or under US regulations.
• Retrospective or Prospective: The nature of the efficacy and performance testing implies prospective studies designed to meet regulatory requirements, as they are "provided to the FDA to show" these aspects.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):

This information is not provided in the document. The efficacy tests are primarily microbiological and engineering in nature, relying on laboratory methods and established quantitative measures (e.g., cell/spore counts, log reduction, temperature, concentration). "Experts" in this context would likely be microbiologists, chemists, and engineers, but their number and specific qualifications are not detailed.

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

This concept of "adjudication method" (typically used for expert consensus on image interpretation) is not applicable to the type of testing described (microbiological efficacy, material compatibility, machine performance). The results are based on objective measurements and established laboratory protocols.

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. An MRMC study is relevant for diagnostic imaging interpretation with AI assistance. The Medivators device is an endoscope reprocessor and high-level disinfectant, not an AI-powered diagnostic tool for human readers.

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

This is not applicable in the context of an AI algorithm. However, if interpreted as "device function without human intervention during the critical phases," the document describes the Advantage Plus AER as an automated system that performs cycles (washing, disinfection, rinsing, drying) with built-in safety features and alarms. The disinfection cycle itself is automated after manual pre-cleaning and loading. A human user takes a sample for MRC testing after the disinfection cycle, indicating a human "check" but not necessarily "in-the-loop" performance during the automated disinfection process itself. The efficacy tests for Rapicide PA are a standalone assessment of the disinfectant's capability.

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

The ground truth for most of the efficacy claims is established by:

• Microbiological assays: Quantitative laboratory methods to determine the reduction or "kill" of specific microorganisms (bacteria, spores, viruses, fungi) under controlled conditions. This involves standard protocols for culture, inoculation, exposure, and enumeration.
• Chemical analysis: To confirm concentration (e.g., ppm peracetic acid).
• Physical measurements: Temperature, time.
• Engineering validation: Testing of machine functions (leak check, blockage check, washing, rinsing, drying, error messages) against design specifications and operational requirements.

8. The sample size for the training set:

This is not applicable. This device is not an AI/machine learning model that requires a training set. The term "training set" is relevant for AI systems, not for a physical reprocessing system and disinfectant.

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

This is not applicable as there is no "training set" for this device.

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Medivators Reprocessing Systems Modular Disinfection System (MDS) for Endoscope Reprocessing tests, disinfects and rinses flexible endoscopes. such as fiberoptic and video endoscopes between patient uses. The MDS is indicated to provide high level disinfection of heat sensitive semi-critical endoscopes. It is indicated for use with FDA cleared, liquid high level disinfectants.

The MDS does not replace manual cleaning of endoscopes, they must be precleaned and cleaned according to the endoscope manufacturer's instructions and professional guidelines prior to reprocessing them in the MDS.

The Modular Disinfection System (MDS) is an electro-mechanical system intended to test and high level disinfect heat sensitive semi-critical endoscopes. It is not intended for reprocessing rigid endoscopes. The machine can use any FDA cleared, reusable liquid germicide which is on the market that is labeled for high level endoscope disinfection. The testing provided to the FDA used both Medivators Rapicide® High Level Disinfectant and Cidex® OPA High Level Disinfectant.

The MDS does not replace manual cleaning of endoscopes, they must be precleaned and cleaned according to the endoscope manufacturer's instructions and professional guidelines prior to reprocessing them in the MDS.

During its software based reprocessing cycle, the machine tests the endoscopes for leaks and blockages. Before and during the machine eveles, connectivity with the machine through the connector blocks is evaluated. If the scopes pass these tests, they are flushed with water and detergent, disinfected and rinsed. The disinfection cycle takes approximately 30 minutes. The MDS is capable of asynchronously reprocessing two scopes at a time.

The machine has many built in safety features which stop the cycle and alarm when certain conditions exist which could indicate that disinfection might be compromised. These alarms and causes are defined in the directions for use for the product.

The machine also prints records by endoscope serial number indicating the results of testing, disinfection, number of disinfections, etc. which are required for permanent records.

The provided text describes the Medivators Reprocessing Systems Modular Disinfection System (MDS) for Endoscope Reprocessing. The acceptance criteria and supporting studies are detailed, particularly focusing on its ability to achieve high-level disinfection.

Here's an organized breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance

The document describes the studies undertaken to demonstrate the substantial equivalence of the Medivators Reprocessing Systems Modular Disinfection System (MDS) for Endoscope Reprocessing. Here's a breakdown of the additional requested information:

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

• Sample Size: The document does not explicitly state the numerical sample size for the "simulated use" or "in use" efficacy testing in terms of the number of endoscopes or cycles performed. It only reports the outcome.
• Data Provenance: The document does not specify the country of origin for the data or whether the studies were retrospective or prospective. Given the context of a 510(k) submission to the FDA, it is highly likely that the testing was conducted prospectively in a controlled environment to demonstrate device performance for regulatory approval in the USA.

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

• This information is not provided in the document. For a disinfection device, "ground truth" would typically be established by microbiological laboratory results (e.g., colony counts) rather than expert consensus on interpretation of images or clinical outcomes. The document refers to "standard methods defined by the FDA guidance document," implying standardized microbiological assays.

4. Adjudication Method for the Test Set

• This information is not provided in the document. Adjudication methods (e.g., 2+1, 3+1) are usually relevant for human-interpreted diagnostic tasks, not for the objective microbiological or performance testing described for this device.

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

• No, an MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic devices that involve human interpretation of images or data, often comparing human performance with and without AI assistance. The Medivators MDS is an automated endoscope reprocessor, not a diagnostic imaging device with an AI component for human interpretation.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

• Yes, a standalone performance assessment was conducted for the device's critical functions. The entire testing regimen described for the MDS (efficacy, material compatibility, biocompatibility, and performance data) evaluates the device's automated capabilities and its output (disinfected endoscopes, residue levels, functional checks) without requiring human intervention in the core disinfection process. The device itself is an "algorithm only" type of system in the sense that its operational cycles are software-based and automated.

7. The Type of Ground Truth Used

• The ground truth for the efficacy testing was established through microbiological culture results. Specifically, for simulated use, it was the quantitative reduction of Mycobacterium terrae, and for in-use testing, it was the absence of viable organisms.
• For other tests (material compatibility, biocompatibility, performance data), the ground truth was based on objective measurements against defined thresholds or operational parameters (e.g., deterioration levels, residual chemical levels deemed safe, correct functioning of mechanical aspects like leak checks, temperature maintenance, proper alarm activation).

8. The Sample Size for the Training Set

• The Medivators MDS is a physical medical device (an automated endoscope reprocessor), not an AI/machine learning algorithm requiring a "training set" in the conventional sense. Therefore, the concept of a "training set" in this context is not applicable, and no information is provided. Its internal "rules" are programmed, not learned from a dataset.

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

• As explained above, there is no "training set" or "ground truth for a training set" applicable to this type of device in the context of machine learning. The device's operational parameters and safety features are based on engineering design, scientific principles of disinfection, and compliance with regulatory guidelines (e.g., FDA guidance).

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