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Scope Buddy Plus Endoscope Flushing Aid is an electro-mechanical to pump fluids through channels of flexible, immersible endoscopes during the endoscope manual cleaning process.

The subject device is intended to provide fluid delivery to endoscope channels in the same manner as a manual syringe would be used during the manual cleaning phase of endoscope reprocessing as defined by the endoscope manufacturer's instructions. The subject device utilizes an external peristaltic pump and 24-hour multi-use connection tubing (tubing used for 24 hours with multiple endoscopes and then discarded) to deliver specific volumes of detergent solution and rinse water to the endoscope channels during the manual cleaning phase. These fluid volumes are defined by the endoscope manufacturer. Scope Buddy Plus is intended to be used only during the manual cleaning phase of endoscope reprocessing, in conjunction with the instructions and labeling provided by the endoscope manufacturer, to deliver an endoscope manufacturer specified volume of fluid to the endoscope channels. The subject device is not an endoscope washer-disinfector and does not bear labeling claims for direct cleaning efficacy or high-level disinfection efficacy for endoscope reprocessing.

The provided text is a 510(k) Summary for the "Scope Buddy Plus Endoscope Flushing Aid" and details its equivalence to a predicate device, not its acceptance criteria or a study proving it meets such criteria in the traditional sense of a clinical trial for diagnostic performance.

The document focuses on demonstrating substantial equivalence to a previously cleared predicate device (Fluid Pump CP-3, K914524) rather than establishing novel safety and effectiveness through a clinical performance study with acceptance criteria like sensitivity, specificity, or accuracy. Therefore, many of the requested points below are not directly applicable or available in this type of submission.

However, I can extract information related to the device's functional performance testing which serves as a form of "acceptance criteria" for its intended mechanical function.

Here's an attempt to answer your questions based on the provided document:

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

Since this is a mechanical flushing aid, the "acceptance criteria" from the document revolve around its ability to deliver fluids according to manufacturer specifications and meet safety standards.

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

• Sample Size for Test Set: The document does not specify sample sizes for any of the functional or safety tests. These types of tests typically involve a set number of devices or iterations to demonstrate performance and compliance, but the exact numbers are not provided in this summary.
• Data Provenance: The document does not explicitly state the country of origin or if the data was retrospective or prospective. Given that Medivators Inc. is a US-based company and the submission is to the US FDA, the testing was likely conducted in the US and prospectively as part of the device development and validation.

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 question is not applicable to this type of device. The "ground truth" for a mechanical flushing aid is its ability to perform its specified function (e.g., deliver a certain volume of fluid, meet safety standards). This is assessed through engineering and performance testing, not via expert interpretation of diagnostic images or patient outcomes.

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

• This question is not applicable. Adjudication methods like 2+1 or 3+1 are used in studies involving human interpretation (e.g., radiologists reviewing medical images). For engineering and functional tests, results are typically objective measurements against a predefined specification, not subjective interpretations requiring 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 question is not applicable. The Scope Buddy Plus Endoscope Flushing Aid is a mechanical device, not an AI-powered diagnostic tool involving human readers or interpretation of cases. No MRMC study was conducted.

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

• This question is not applicable. The device is not an algorithm, but a mechanical flushing aid. While it has software, its "standalone" performance refers to its ability to pump fluids, which is what the functional performance testing assessed.

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

• The "ground truth" for this device's performance is objective measurement against engineering specifications and regulatory standards. For example:
  • Detergent Dosing/Fluid Delivery: Measured volumes and flow rates compared to pre-defined manufacturer requirements.
  • Electrical Safety/EMC: Compliance with specified international standards (IEC 61010-1, IEC 61326-1) based on test measurements.
  • Software Validation: Adherence to software development lifecycle processes and functional requirements.
  • Human Factors/Usability: Observation and assessment of user interaction against usability goals and safety criteria.

8. The sample size for the training set

• This question is not applicable. The Scope Buddy Plus Endoscope Flushing Aid is a hardware device with software controls, not a machine learning or AI algorithm that requires a "training set" in the context of data-driven model training.

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

• This question is not applicable, as there is no "training set" for this type of device.

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To be attached to the distal end of the endoscope to facilitate endoscopic therapy, to be used for the following:

• Keeping the suitable depth of endoscope's view field
• Helping the endoscope with being inserted into the gastrointestinal tract

The subject device is a sterile, single use, disposable medical device. It is designed to be placed on the distal end of an endoscope during endoscopic procedures to improve the physician's ability to visualize and examine the mucosa. AmplifEYE is made of injection molded polymer and consists of a main body tube with flexible wings arranged in a single row around one end of the main body tube. In a standard colonoscopy procedure, the endoscope is intubated through the rectum and advanced forward through the length of the colon. The endoscope is then retracted while the physician visually examines the colon mucosa for polyps or other abnormalities. The AmplifEYE wings fold down during intubation and movements that advance the endoscope forward so that forward movement is not hindered. During endoscope withdrawal, the wings open and fold outward to keep the depth of the endoscope's view field by manipulating the colonic folds and stabilizing the position of the endoscope within the intestinal lumen, thus aiding in the physician's ability to visualize and examine the mucosa.

The Medivators AmplifEYE device, an endoscope accessory, does not present Acceptance Criteria in the provided text. Instead, the document focuses on demonstrating substantial equivalence to predicate devices (Arc EndoCuff and Arc Endocuff Vision) rather than defining specific performance thresholds as acceptance criteria for a new clinical indication or outcome.

The study presented is a non-clinical performance evaluation comparing the AmplifEYE with its predicate devices.

Here's an analysis based on the provided text, addressing your points where possible:

1. Table of Acceptance Criteria and Reported Device Performance:

As no explicit acceptance criteria are provided in the document for the AmplifEYE's primary function of "keeping the suitable depth of endoscope's view field" or "helping the endoscope with being inserted into the gastrointestinal tract," a table of acceptance criteria and reported device performance cannot be created as requested. The document primarily focuses on demonstrating equivalence through design and non-clinical testing.

The document highlights:

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

• Sample Size for Test Set: Not explicitly stated for specific tests.
  • Bench Testing: Indicated for "open wing diameter difference" and "Design Verification (Force to Remove Testing, Force to Deflect Testing)". The exact number of units or repetitions used for these tests is not provided.
  • Animal Testing: Performed. The number and type of animals used are not specified.
• Data Provenance: Not specified, but likely internal company testing (Medivators Inc.). The document does not indicate external or multi-center trial data. The data is non-clinical, related to device characteristics and animal studies, not human patient data.

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

• Not Applicable. This study is a non-clinical evaluation for substantial equivalence, primarily focusing on engineering and material performance, and animal testing. It does not involve human subjects or the establishment of a medical 'ground truth' by experts in a diagnostic or clinical efficacy context.

4. Adjudication Method for the Test Set:

• Not Applicable. As no 'ground truth' from human data or expert consensus is established for a diagnostic or efficacy claim, no adjudication method would be relevant or discussed in this context.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done:

• No. An MRMC comparative effectiveness study was not done. This type of study is relevant for evaluating the impact of AI or other tools on human reader performance with medical images, which is not the scope of this device or its evaluation. The AmplifEYE is a physical accessory to an endoscope, not a diagnostic AI tool.

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

• Yes, in spirit, as a non-clinical standalone device evaluation. The testing performed (Design Verification, Shelf-life, Sterilization Validation, Animal Testing) evaluates the device's inherent characteristics and performance without human interaction in a diagnostic or interpretive loop. However, it's important to note this is not an "algorithm-only" performance as the device is mechanical/physical, not software. The performance demonstrated in these tests is for the device itself.

7. The Type of Ground Truth Used:

• Engineering specifications, industry standards, and biological response.
  • For Design Verification (Force to Remove, Force to Deflect): Ground truth would be defined by engineering design requirements and acceptable ranges for mechanical properties.
  • For Sterilization Validation: Ground truth involves demonstrating a Sterility Assurance Level (SAL), often 10^-6, through established microbiological testing methods.
  • For Biocompatibility: Ground truth is adherence to standards like ISO 10993-1.
  • For Animal Testing: Ground truth would be observed physiological responses, safety, and functionality in a living system.

8. The Sample Size for the Training Set:

• Not Applicable. As described, this is not an AI/machine learning device; therefore, there is no "training set." The device is a physical medical accessory.

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

• Not Applicable. See point 8.

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The Rapicide PA High-Level Disinfectant Test Strips are used as a chemical indicator after the disinfection cycle to ensure that the Rapicide PA High-Level Disinfectant Solution is above minimum recommended concentration (850ppm peracetic acid); this ensures the disinfectant was above MRC during the entire disinfection cycle.

Rapicide PA High-Level Disinfectant Test Strips have the ability to measure the disinfectant use solution concentration above 850ppm PAA. This is the minimum recommended concentration (MRC) of PAA for Rapicide PA high level disinfectant. If the solution is at or below MRC, the test strip pad will indicate a failure by turning dark grey, violet grey, light grey, or white (no change in color). A passing result will be indicated by the test strip pad turning solid black color.

The Medivators Rapicide PA High-Level Disinfectant Test Strips are designed to ensure that the Rapicide PA High-Level Disinfectant Solution is above its minimum recommended concentration (MRC) of 850ppm peracetic acid. A "pass" is indicated by the test strip pad turning a solid black color when the solution is above 850ppm PAA, while a "fail" is indicated by the pad turning dark grey, violet grey, light grey, or white (no color change) if the solution is at or below the MRC.

Here's an analysis of the acceptance criteria and study data provided:

1. Table of Acceptance Criteria and Reported Device Performance:

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

The document does not explicitly state the sample sizes used for each of the tests (Dynamic Range, Comparative Sensitivity and Specificity, Analytic Specificity – Contaminants, Analytic Specificity - Other Germicides, Shelf Life, In-Use Stability). It only indicates that "non-clinical tests" were performed.

The data provenance is from Medivators Inc., a company based in Minneapolis, MN, USA. The data is retrospective as it was generated prior to the 510(k) submission.

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 chemical indicator, the ground truth would likely be established by a laboratory assay (e.g., titration or spectrophotometry) to precisely determine the peracetic acid concentration, rather than by human experts interpreting the results.

4. Adjudication method for the test set:

This information is not applicable as the test strips are chemical indicators with a direct visual output (color change). The outcome is determined by the specific chemical reaction embedded in the strip, not by expert 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 device is a chemical test strip, not an AI-powered diagnostic tool requiring human interpretation with or without AI assistance.

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

This information is not applicable as the device is a chemical test strip, not an algorithm. The "standalone" performance is the inherent chemical reaction on the strip.

7. The type of ground truth used:

The ground truth used for these chemical test strips would be the actual concentration of peracetic acid in the disinfectant solution, determined by a precise analytical method (e.g., chemical titration, spectrophotometry, or a validated reference standard). The document implies this by referring to "concentrations at or below MRC" and "higher concentrations."

8. The sample size for the training set:

This information is not provided as chemical test strips do not typically involve a "training set" in the context of machine learning or AI. The performance of the test strip is a result of its chemical formulation and manufacturing process, optimized through R&D and verified through testing.

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

This is not applicable as there isn't a "training set" in the traditional sense for these chemical test strips. The chemical composition is designed to react at specific concentrations, and the ground truth for validating this design (during R&D and manufacturing quality control) would be established using precise analytical methods to determine peracetic acid concentrations in control solutions.

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The DEFENDO Disposable Suction Valve is intended to be used to control the suction function of a compatible bronchoscope during a pulmonary procedure.

The subject device is a sterile, single use, disposable medical device. It is designed to be attached to the suction port of a bronchoscope during a pulmonary procedure to help the user engage in the suction function of the bronchoscope by depressing/activating the valve. The activation of the suction valve allows the user to control the suction flow of fluids from the patient to a suction pump/waste canister.

The provided text describes a 510(k) premarket notification for the DEFENDO Disposable Suction Valve. This document focuses on demonstrating substantial equivalence to predicate devices rather than proving a device meets specific acceptance criteria through a comparative effectiveness study with AI.

Therefore, many of the requested details, such as those related to AI performance, sample sizes for test/training sets for an algorithm, ground truth establishment, or human reader performance with/without AI assistance, are not applicable or not present in this type of regulatory submission.

However, I can extract the relevant information from the document regarding the non-clinical performance data used to support substantial equivalence.

Here's a breakdown of the available information:

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

The document doesn't provide a table of precise numerical acceptance criteria and reported performance values in the way you might expect for an AI algorithm. Instead, it lists the types of non-clinical tests performed to demonstrate substantial equivalence to a predicate device. The implied "acceptance criterion" for these tests is that the new device performs similarly or equivalently to the predicate devices.

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

This information is not provided in the document. The 510(k) summary only generically states that "Medivators has conducted the following testing." It does not detail specific sample sizes for these non-clinical mechanical and functional tests. Data provenance (country of origin, retrospective/prospective) is not relevant for this type of non-clinical device testing.

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 applicable as this is not a study involving human interpretation of data where ground truth needs to be established by experts. The tests are focused on the mechanical and functional properties of the device.

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

This information is not applicable for the same reasons as above.

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, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This device is a disposable suction valve for bronchoscopes, not an AI-powered diagnostic tool. Therefore, there's no "human readers improve with AI vs without AI assistance" to report.

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

No, a standalone algorithm performance study was not done. This device is not an algorithm or AI system.

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

The "ground truth" for the non-clinical tests would be defined by the engineering specifications and performance characteristics necessary for a functional and safe suction valve. This is typically established through established engineering standards, predicate device performance, and internal design requirements. It's not "expert consensus, pathology, or outcomes data" in the medical sense, but rather adherence to functional and safety benchmarks.

8. The sample size for the training set:

This information is not applicable as this device does not involve a training set for an algorithm.

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

This information is not applicable for the same reasons as above.

Summary of the study conducted (Non-Clinical Performance Data):

The study conducted was a series of non-clinical design verification tests and validation tests to demonstrate that the DEFENDO Disposable Suction Valve is substantially equivalent to its predicate devices (Olympus Disposable Suction Valve (K920025) and Defendo Disposable Suction Valve (K102581)).

The specific tests performed include:

• Design Verification Comparison Tests to Predicate Device:
  • Valve Connection Test
  • Valve Depression Force Test
  • Suction Flow Test
• Shelf-life validation:
  • Functional Testing
  • Dye Penetration Testing
  • Peel Strength Testing
  • Visual Seal Inspection
• Sterilization validation

The purpose of these tests was to show that the new device performs safely and effectively in a manner comparable to the legally marketed predicate devices, thereby supporting the claim of substantial equivalence for regulatory clearance. The document concludes that "The information and performance data provided indicates that the subject device is as safe and as effective as its predicate devices for its intended use when used in accordance with the device labeling."

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Minncare HD is intended for the disinfection of water purification systems for hemodialysis. It should be diluted to a 1% concentration (1 part Minncare HD to 99 parts water) and used for a minimum contact time of 36 minutes at 20°C.

Minncare HD is a clear liquid disinfectant solution that consists of a stabilized mixture of hydrogen peroxide, peracetic acid and acetic acid. Minncare HD is intended to be used for hemodialysis water purification system disinfection when diluted to a 1% concentration (1 part Minncare HD to 99 parts water) and applied for a minimum contact time of 36 minutes at 20℃. The active microbicidal ingredient is peracetic acid (PAA), and the recommended use concentration of 1%. The concentration of the use solution should be confirmed with 1% Minncare HD indicator test strips to have reached the furthest point of the distribution loop during the system disinfection contact time. Upon completion of disinfection the system must be rinsed to remove residual levels of the disinfectant. Residual levels should be checked using Minncare HD residual test strips to ensure residual levels of 1 ppm PAA or less. Minncare HD is supplied in cases containing high density polyethylene plastic bottles. Individual bottles are labeled with all information necessary to use the device safely.

This document is a 510(k) premarket notification for a disinfectant, not an AI/ML medical device. Therefore, the questions about acceptance criteria, study design, ground truth, and human reader performance with AI assistance are not applicable. The document describes a chemical disinfectant, Minncare HD, and its intended use for disinfecting water purification systems for hemodialysis.

However, I can extract and present the information available about the disinfectant's performance and the comparison to an equivalent predicate device.

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

Since this is a disinfectant and not an AI/ML device, the "acceptance criteria" here refers to the performance requirements for a chemical disinfectant. The document references "FDA Guidance for Content and Format of Premarket Notification [510(k)] Submission for Liquid Chemical Sterilants/High Level Disinfectants (Jan 2000)" as the basis for performance testing. However, it explicitly states that Minncare HD is not intended for high-level disinfection and is not claiming to be a sterilant.

The performance data listed as being submitted in support of substantial equivalence are:

• Sporicidal, tuberculocidal, fungicidal, virucidal and bactericidal efficacy
• Simulated-use disinfection efficacy
• Material compatibility
• Test strip performance
• Stability

The document does not explicitly state the quantitative acceptance criteria (e.g., specific log reduction values for microorganisms) for each of these categories in this summary. It only indicates that "Performance testing has been conducted to show that Minncare HD is safe and effective for its intended use." and "The performance testing data indicates that the subject device, Minncare HD, is substantially equivalent to the predicate device Hemoclean Disinfectant (K023064)."

Table: Acceptance Criteria and Reported Device Performance (as inferred for a disinfectant)

The document states that a "detailed description of physical and chemical properties" and "proposed labeling" were also provided, which are standard requirements for such submissions.

The following questions are not applicable to this document as it pertains to a chemical disinfectant and not an AI/ML medical device.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
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)
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
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
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
8. The sample size for the training set
9. How the ground truth for the training set was established

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The EndoSmart Bottle is intended to be used with an air or CO2 source and/or a pump along with a sterile water source to supply air or CO2 and sterile water to an endoscope during endoscopic procedures.

Endo Smart Bottle is designed to be attached to an endoscope, to help supply water, air/CO2. The device consists of a connector cap, a water bottle, a threaded cap, a small tube, and a male luer. The main function of the subject device is -

• . To provide water for rinsing the lens.
• To provide air or CO2 to insufflate the anatomical lumen, to help the end user to see . the inner wall more clearly.

Similar to its predicate device, the subject device is provided sterile to the end user, fabricated from plastics, and elastomers, intended for daily (24 hour) multi-patient use and must be discarded daily. Both the subject device and its predicate device do not come in direct contact with patients.

This document is a 510(k) summary for the Medivators Endo Smart Bottle, an endoscopic irrigation/suction system. It primarily focuses on demonstrating substantial equivalence to a predicate device, the Endo Smart Cap. The document describes the device, its intended use, and non-clinical performance data to support its safety and effectiveness.

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 "acceptance criteria" in a quantitative manner (e.g., minimum accuracy, sensitivity, or specificity thresholds). Instead, it lists types of performance tests designed to demonstrate equivalence to the predicate device. The "reported device performance" is described qualitatively as having passed these tests, indicating equivalence.

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

The document does not provide details on the specific sample sizes used for each non-clinical performance test (e.g., how many bottles were tested for lens rinsing function). It also does not mention data provenance (country of origin or retrospective/prospective nature) as these are non-clinical engineering and bench tests, not clinical studies involving patient data.

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

This information is not applicable. The evaluations described are "Design Verification," "Biocompatibility," "Shelf-life validation," and "Sterilization validation," which are engineering and laboratory tests based on established standards and protocols, not expert consensus on medical interpretation.

4. Adjudication Method for the Test Set

This is not applicable as the tests are non-clinical engineering and laboratory tests, not clinical performance studies requiring adjudication of results.

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 such study was conducted or is mentioned. This product is a physical medical device (endoscopic irrigation/suction system) and does not involve AI or human "readers" in the context of diagnostic interpretation.

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

This is not applicable. This device is a manual accessory for an endoscope and does not involve algorithms or AI.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)

The "ground truth" for the non-clinical performance tests would be defined by established engineering and biological standards, specifications, and test methodologies relevant to medical device performance (e.g., maintaining specific flow rates, successfully clearing a lens, demonstrating no cytotoxic effects, maintaining sterile barrier integrity). It is not based on expert consensus, pathology, or outcomes data in a clinical sense.

8. The Sample Size for the Training Set

This is not applicable. This device does not use machine learning or AI, and therefore does not have a "training set."

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 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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Rapicide™ High Level Disinfectant and Sterilant is intended to be used for the automated sterilization of clean, heat sensitive, critical medical equipment for which alternative methods of sterilization are not suitable. Critical medical devices are those that contact normally sterile areas of the body. Critical medical devices must be sterilized.

Rapicide™ High Level Disinfectant and Sterilant is a sterilant when used or reused, in a legally marketed Automated Endoscope Reprocessor according to Directions for Use, at a minimum recommended Concentration (MRC) of 1.5% glutaraldehyde at 35℃ (95°F), not to exceed 28 days, with a minimum contact or immersion time of at least 7 hours and 40 minutes.

Rapicide™ High Level Disinfectant and Sterilant is intended to be used for the automated high level disinfection of clean, heat sensitive, semi-critical medical devices for which sterlization is not practical. Semi-critical medical devices may be sterilized or high-level disinfected. Semi-critical medical devices are those that contact mucous membranes or other body surfaces not normally considered sterile.

Rapicide™ High Level Disinfectant and Sterilant is a high-level disinfectant when used or reused, in a legally marketed Automated Endoscope Reprocessor according to Directions for Use, at a minimum recommended concentration (MRC) of 1.5% glutaraldehyde at 35°C (95°F), not to exceed 28 days, with a minimum contact or immersion time of at least 5 minutes.

Rapicide™ High Level Disinfectant and Sterilant is a ready-to-use solution with an active ingredient of 2.5 ± 0.1% w/v qlutaraidehyde, with a slightly acidic pH value of 6.3 to 6.7. The patented formulation (U.S. Pat. Reg. No. 4,748,279) includes a non-ionic detergent for improved wetting of surfaces. The glutaraldehyde concentration is stabilized by means of a buffer to pH 6.3 to 6.7. Other formula ingredients include a corrosion inhibitor, silicone antifoam chemical, and dyes. The formula is about 90% purified water. The ingredients of Rapicide™ High Level Disinfectant and Sterilant are similar to those in the predicate, Wavicide-01 Solution.

Here's an analysis of the provided text regarding the acceptance criteria and study for Rapicide™ High Level Disinfectant and Sterilant:

This document is a 510(k) summary for a sterilant/disinfectant, not a diagnostic device using AI. Therefore, many of the requested categories like "Number of experts used to establish the ground truth," "Adjudication method," "MRMC study," "Standalone performance," "Training set sample size," and "How the ground truth for the training set was established" are not applicable to this type of product and study. The studies focus on microbiological efficacy rather than diagnostic accuracy.

Acceptance Criteria and Reported Device Performance

The acceptance criteria for Rapicide™ High Level Disinfectant and Sterilant are based on achieving specific antimicrobial efficacy under defined conditions. The reported device performance demonstrates successful fulfillment of these criteria.

Study Details

Below are the details of the studies, where applicable:

1. Sample sizes used for the test set and the data provenance:

   • Exposure time-sterilization response curve: 60 unglazed porcelain cylinders or silk suture loops per test, labeled with C. sporogenes or B. subtilis spores. The data provenance is non-clinical laboratory testing.
   • Full AOAC Sporicidal Activity of Disinfectants Test 966.04: Specific sample sizes are not explicitly stated beyond "three lots" in the summary, but the AOAC method implies a certain number of carriers per lot (typically 60 carriers). Data provenance is non-clinical laboratory testing.
   • Confirmative AOAC Sporicidal Activity of Disinfectants Test 966.04: 30 spore-labeled carriers per spore and carrier combination. Data provenance is non-clinical laboratory testing conducted at ViroMed Biosafety Laboratories and MicroBioTest Inc.
   • Quantitative Tuberculocidal Activity: Not directly stated, but implicit for a quantitative rate of kill test (multiple samples across three test dates). Data provenance is non-clinical laboratory testing.
   • AOAC Use Dilution Tests (Function of Exposure Time & Glutaraldehyde Concentration): 60 stainless steel penicylinders per test (labeled with S. aureus or P. aeruginosa) at each exposure time and concentration. Data provenance is non-clinical laboratory testing.
   • AOAC Use Dilution Tests: 60 stainless steel cylinders per bacterial species (S. aureus, P. aeruginosa, S. choleraesuis) per lot. Data provenance is non-clinical laboratory testing.
   • Fungicidal Activity: Not explicitly stated, but tests were performed on T. mentagrophytes, C. albicans, or A. niger. Data provenance is non-clinical laboratory testing.
   • Virucidal Activity: Not explicitly stated, but viruses tested included Pollovirus type 1, Adenovirus type 2, Influenza virus type A2, Herpes simplex virus type 1 and type 2, and HIV type 1. Data provenance is non-clinical laboratory testing.
   • Simulated Use - Sterilization Mode: Three Olympus brand flexible endoscopes (gastroscope, colonoscope, sigmoidoscope). Each endoscope was repeated several times. Data provenance is non-clinical simulated use testing.
   • Simulated Use - High-Level Disinfection Mode: Three different types of Olympus-brand flexible endoscopes (gastroscope, colonoscope, sigmoidoscope). Each endoscope was tested twice. Data provenance is non-clinical simulated use testing.
   • Clinical In-Use Tests: Three Pentax-brand gastroscopes and three Pentax-brand colonoscopes. Data provenance is prospective clinical testing at an endoscopy clinic in Fort Worth, TX.
   • Glutaraldehyde Reduction Tests: Three Olympus-brand flexible endoscopes (gastroscope, colonoscope, sigmoidoscope). Data provenance is non-clinical laboratory testing.
   • Glutaraldehyde Monitor Studies: Not explicitly stated but mentions testing a "stressed lot" of Rapicide™ against the monitor at various concentrations. Data provenance is non-clinical laboratory testing.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. The ground truth for this device's performance (antimicrobial efficacy) is established through standardized microbiological and chemical testing methods, not by expert consensus in the same way a diagnostic image would be. Live/dead microbes are objectively detected.

3. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable. As the studies are microbiological tests, the results (e.g., presence or absence of growth, log reduction) are objectively measured, not adjudicated by human interpretation in this manner.

4. 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: Not applicable. This is not a diagnostic device involving human readers or AI.

5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is a chemical disinfectant, not an algorithm. Its performance is inherently "standalone" in terms of its chemical action.

6. The type of ground truth used (expert consensus, pathology, outcomes data, etc): The ground truth for these studies is based on quantifiable microbiological end-points (e.g., absence of microbial growth, log reduction in CFU/spores, time to kill) as defined by established regulatory and industry-standard test methods (e.g., EPA Re-Use Test Protocol, AOAC Sporicidal Activity Test 966.04, Quantitative Tuberculocidal Activity tests, AOAC Use Dilution Tests, AOAC Fungicidal Activity Test 955.17, virucidal efficacy tests). For simulated and clinical use tests, the ground truth is the presence or absence of viable microorganisms after exposure to the disinfectant. Chemical concentration measurements also serve as ground truth for stability and monitoring.

7. The sample size for the training set: Not applicable. This is a chemical disinfectant, and its efficacy is tested, not "trained" like a machine learning model.

8. How the ground truth for the training set was established: Not applicable.

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