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The Endo SmartCap™ 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.

The Endo SmartCap™ supplies sterile water and either air or CO2 to an endoscope during endoscopic procedures when connected to a sterile water source and an air or CO2 source. Two tubes are arranged coaxially; air or CO2 supplied through the outer tube pressurizes the sterile water container, forcing water up through the inner tube and to the endoscope. The proximal end of the tube set includes a bottle cap for attachment to a user-provided sterile water container; the Endo SmartCap™ is compatible with all major brands of sterile water containers. The proximal end of the tube set terminates in a tube weight which keeps the tip of the tubing submerged. A pinch clip prevents water from dripping from the tube's distal end when the device is detached from the endoscope. The distal end of the tube set terminates in a connector which mates with the corresponding brand of endoscope; Endo SmartCap™ models are available for all major brands of endoscopes. The device is provided sterile (EtO). The device is fabricated from metals, plastics, and elastomers. The Endo SmartCap™ is intended for 24 hour multi-patient use and should be discarded daily. No portion of the device comes in direct contact with patients.

The provided text is a 510(k) Premarket Notification for the "Endo SmartCap™" device. This document focuses on demonstrating substantial equivalence to a predicate device, rather than proving that an AI/ML device meets specific performance criteria. The document describes a medical device accessory, not an AI/ML system.

Therefore, many of the requested details about acceptance criteria for AI/ML performance, study design, sample sizes for test/training sets, expert involvement, and ground truth establishment cannot be found in this document because the device is a physical accessory (Endoscope and Accessories), not an AI/ML software.

However, I can extract the information related to the device's functional performance testing.

Here's what can be extracted from the document:

1. Table of Acceptance Criteria and Reported Device Performance (for functional testing):

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

• Sample Size: Not explicitly stated as a number of devices/tests, but implies multiple production samples for the flow rate test ("average mean flow of the 100551-production sample").
• Data Provenance: The document does not specify the country of origin of the data. The tests conducted are functional performance tests of the device itself, not data-driven performance. The tests are retrospective in the sense that they were conducted for 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 is not applicable as the device is a physical accessory undergoing functional engineering tests (flow rate, backflow prevention), not an AI/ML algorithm requiring expert interpretation of medical images or data for ground truth. The "ground truth" here is the objective measurement of physical properties.

4. Adjudication method for the test set:

• Not applicable for functional engineering tests. The results are objective measurements against predefined engineering specifications.

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:

• Not applicable. This device is a physical medical accessory, not an AI/ML system for diagnostic assistance. No human reader studies with or without AI were conducted or are relevant.

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

• Not applicable. This is not an algorithm. The reported tests are for the standalone physical device's functional performance.

7. The type of ground truth used:

• For flow rate and backflow prevention tests, the "ground truth" is established by engineering specifications and direct physical measurement. For example, for flow rate, it would involve direct measurement of water/gas volume over time. For backflow, it's the observation of whether water backflows into the insufflator.

8. The sample size for the training set:

• Not applicable. This is not an AI/ML device, so there is no training set.

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

• Not applicable. As there is no training set for an AI/ML algorithm, there is no ground truth for a training set.

In summary, this document is for a traditional medical device accessory (Endo SmartCap™) seeking 510(k) clearance based on substantial equivalence. The "study that proves the device meets the acceptance criteria" in this context refers to engineering performance testing rather than the clinical validation or AI algorithm performance studies typically associated with the detailed questions provided.

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SCOPE BUDDY PLUS Endoscope Flushing Aid is an electro-mechanical device intended to pump fluids through the channels of flexible, immersible endoscopes during the manual cleaning process of endoscope reprocessing.

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. The minimum fluid volumes are defined by the endoscope manufacturer. SCOPE BUDDY PLUS Endoscope Flushing Aid 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 a volume of fluid to the endoscope channels which exceeds the minimum fluid volumes specified by the endoscope manufacturer. 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 describes the acceptance criteria and a summary of performance data for the SCOPE BUDDY PLUS Endoscope Flushing Aid.

Here's an analysis of the requested information:

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

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

The document does not specify the sample size used for the test set or the data provenance (e.g., country of origin, retrospective/prospective). It only states that "Performance testing to demonstrate substantial equivalence to the predicate has been completed."

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. The tests described (Fluid Delivery Flow Rate, Tubing Durability, Software Verification) appear to be engineering/performance tests rather than tests requiring expert human interpretation or ground truth establishment based on clinical observations.

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

This information is not applicable/not provided as the tests described are technical performance verifications and do not involve human adjudication for ground truth.

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

An MRMC comparative effectiveness study was not done. The device is an electro-mechanical flushing aid for endoscopes, not an AI or diagnostic tool that assists human readers.

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

This concept is not applicable to this device. It is an electro-mechanical device with software control, not an algorithm performing a standalone diagnostic or interpretative function. The software verification confirms the software's functionality within the device.

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

The "ground truth" for the tests appears to be engineering specifications and defined performance metrics.

• For Fluid Delivery Flow Rate, the ground truth is the "manufacturers minimum requirements for individual channel flushing volumes."
• For Tubing Durability, the ground truth is the specified requirement to "withstand at least 40 full automatic cycles without leaking."
• For Software Verification, the ground truth is the "verification steps outlined in procedure."

These are objective, measurable criteria rather than clinical ground truth established by experts.

8. The sample size for the training set

The document does not mention a "training set" as this device is not a machine learning or AI model.

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

This question is not applicable as there is no mention of a training set.

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

The Advantage Plus Pass-Thru 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 Plus Detergent in its washing 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 850 ppm 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 -Contact Time: 5 minutes Temperature: 30°C MRC: 850ppm

The Advantage Plus Pass-Thru is an electro-mechanical Automatic Endoscope Reprocessor (AER) intended to high-level disinfect pre-cleaned endoscopes and their related accessories by exposing them to a peracetic acid based disinfectant – Rapicide PA disinfectant solution (cleared under 510k – K082988).

The subject device is closely related to its predicate the Advantage Plus Endoscope Reprocessing System cleared in 510k – K082988 and K102996 but differs in that it is designed in a "pass-thru" configuration. The subject device is intended to be built into a wall which separates 'clean' and 'dirty' sides. It provides the ability to load an endoscope from the dirty side and unload the disinfected endoscope from the clean side, thus preventing potential mix-up between high level disinfected and contaminated endoscopes.

Contaminated endoscopes are placed in the subject device from the 'dirty' side and appropriate connections to the endoscope channels are made. The system is designed to test for proper channel connectivity, channel blockages and leaks in the outer endoscope sheath. After the endoscope passes these tests, the system proceeds to the washing cycle with Intercept Plus detergent, and the highlevel disinfection cycle. In the high-level disinfection cycle, Rapicide PA HLD is diluted by the incoming water to a minimum concentration of 850 ppm of peracetic acid. The system measures and maintains the temperature of this disinfectant solution to ensure that it is above the minimum recommended temperature of 30℃ for Rapicide PA for effective High Level Disinfection to occur. Following the 5 minute disinfectant contact time, the user takes a sample to test for MRC (850 ppm of peracetic acid). Once the MRC test passes, the disinfectant is emptied from basin and drained out of the AER. The endoscope is then rinsed, dried and removed from the 'clean side' of the AER.

The provided text describes the regulatory submission for the "Advantage Plus Pass-Thru Automated Endoscope Reprocessing System" (K172677). The document focuses on demonstrating substantial equivalence to a predicate device, rather than proving that the device meets specific acceptance criteria through a clinical study involving human readers or expert consensus for AI performance.

Therefore, much of the requested information regarding AI-specific criteria, human expert involvement, ground truth establishment for training and test sets, and MRMC studies, is not applicable or not present in this document. This submission pertains to a medical device for high-level disinfection of endoscopes, not an AI/ML-driven diagnostic or image-analysis device.

However, I can extract the acceptance criteria and performance for the non-clinical performance tests that were conducted to demonstrate substantial equivalence of this device.

Here's the information based on the provided text:

Acceptance Criteria and Reported Device Performance

The device is an Automated Endoscope Reprocessor (AER) intended for high-level disinfection. The performance testing conducted was to demonstrate its physical and microbiological effectiveness in this context.

1. Table of Acceptance Criteria and Reported Device Performance

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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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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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