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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 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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