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510(k) Data Aggregation
(153 days)
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):
| Test | Acceptance Criteria | Reported Performance |
|---|---|---|
| Confirmation of flow rate | The average mean flow of the 100551-production sample must be no lower than 10% of the flow of the same tubeset without a filter | PASS |
| Prevention of backflow | The 100551 shall not allow water to backflow into the CO2EFFICIENT insufflator | PASS |
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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(36 days)
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
| Test | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Fluid Delivery Flow Rate Verification | Meet manufacturers minimum requirements for individual channel flushing volumes. | PASS |
| Tubing Durability Verification | The 24-hour tubing shall withstand at least 40 full automatic cycles without leaking. | PASS |
| Software Verification | Verification steps outlined in procedure must be met for acceptance of the protocol. | PASS |
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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(105 days)
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
| Performance Testing | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Simulated-Use Testing (Demonstrates high-level disinfection with Rapicide PA HLD and Intercept Plus detergent) | Achieve 6-log reduction of the test organism in each endoscope channel and endoscope exterior. | Pass |
| Clinical In-Use Testing (Demonstrates high-level disinfection after patient/clinical use) | Demonstrate no viable organisms remain after reprocessing. | Pass |
| Water-Line/Self-Disinfection Cycle Testing (Evaluation of bactericidal effectiveness of the self-disinfection cycle and biofilm analysis) | Survivors after the SDC must be ≤ 10 CFU of test organism per 100 mL. Absence of biofilm formation following self-disinfection cycle. | Pass |
| Rinse Residual Testing (Evaluation of residual levels of Rapicide PA and Intercept Plus) | Any chemistry residuals must be equal to or lower than the lowest reported LD50 exposure with a 10-fold safety margin. | Pass |
| Material Compatibility (Demonstrates system compatibility with Rapicide PA HLD and Intercept Plus Detergent) | Acceptance criteria included dimensional and weight changes <5%, visual observations and FTIR spectra. | Pass |
| Critical Parameter/Component Functionality Testing (Demonstrates consistent and reliable delivery of physical process parameters) | All critical process parameters must achieve and maintain required specifications. | Pass |
Since this is a submission for an endoscope reprocessing system rather than an AI/ML device, the following points are not applicable or not mentioned in the document:
2. Sample size used for the test set and the data provenance:
* Not applicable for AI/ML data sets. The "test set" here refers to the number of reprocessing cycles or endoscope samples tested in the described performance studies. The exact number of cycles/samples for each test type (Simulated-Use, Clinical In-Use, etc.) is not explicitly stated in this summary, nor is the country of origin or whether the data was retrospective/prospective in the context of an AI/ML clinical study. The studies are described as "Performance bench testing" and "Clinical In-Use Testing," implying a prospective experimental design for product validation.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
* Not applicable. Ground truth for an AI/ML system, especially relating to expert consensus, is not relevant to the validation of an endoscope reprocessing device. The "ground truth" in this context is based on quantifiable microbiological reduction (e.g., 6-log reduction of test organisms, absence of viable organisms) and chemical residual levels, measured by laboratory methods, not human expert interpretation.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
* Not applicable. Adjudication methods are typically used to resolve discrepancies in human expert labeling or diagnoses for AI/ML ground truth, which is not relevant here.
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 pertains to the evaluation of AI assistance for human readers, which is outside the scope of this device's function.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
* Not applicable. The "performance" of this device is its ability to disinfect endoscopes, and its "standalone" performance is what these non-clinical tests evaluate – the device working as intended without human intervention in the disinfection process itself, beyond loading/unloading and initiation.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
* The ground truth for this device's performance relies on microbiological testing results (e.g., colony-forming unit (CFU) counts of test organisms to determine log reduction, confirmation of no viable organisms, biofilm analysis) and chemical analyses (e.g., measurement of chemical residuals, verification of minimum recommended concentration, material properties). It is not based on expert consensus, pathology, or patient outcomes data in the sense of a diagnostic device.
8. The sample size for the training set:
* Not applicable. This device is an electro-mechanical system, not an AI/ML algorithm that requires a training set.
9. How the ground truth for the training set was established:
* Not applicable. As above, there is no AI/ML training set.
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(142 days)
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.
| Acceptance Criteria (Functional Performance) | Reported Device Performance |
|---|---|
| Detergent Dosing Capability: Ability to dose a set volume of detergent. | Demonstrated the ability of the subject device to dose a set volume of detergent. (Specific volumes/tolerances are not detailed in this summary, but the general capability was affirmed.) |
| Fluid Delivery Flow Rate Performance: Meet or exceed the endoscope manufacturer's requirements for fluid delivery through endoscope channels during manual cleaning. | Determined the flushing times required by the subject device to meet endoscope manufacturers' requirements for fluid volumes delivered to endoscope channels during manual cleaning. (Specific flow rates/tolerances are not detailed, but compliance with requirements was affirmed.) |
| Electrical Safety: Compliance with IEC 61010-1. | Compliance demonstrated. |
| Electromagnetic Compatibility (EMC): Compliance with IEC 61326-1. | Compliance demonstrated. |
| Software Validation: Compliance with FDA's guidance for software in medical devices. | Software Validation conducted as recommended per FDA's guidance. (Specific validation results are not detailed.) |
| Human Factors/Usability: Safe and effective use by users per IEC 62366-1 and FDA guidance. | Human Factors/Usability Evaluation conducted to validate that users can safely and effectively use the subject device. (Specific evaluation results are not detailed.) |
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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(200 days)
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:
| Study | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Dynamic Range | Negative response at concentrations at or below MRC, positive response at higher concentrations. | Met Acceptance Criteria: Negative response at concentrations at or below MRC, positive response at higher concentrations. |
| Comparative Sensitivity and Specificity | Comparative sensitivity and specificity of 1 (implicitly, indicating perfect agreement with a reference method or ideal performance). | Met Acceptance Criteria: Comparative sensitivity and specificity of 1. |
| Analytic Specificity – Contaminants | Negative response at MRC (for contaminants), positive response at higher concentration (for the active ingredient). (This implies the device should not give a false positive due to contaminants at MRC, and correctly identify the active ingredient above MRC). | Met Acceptance Criteria: Negative response at MRC, positive response at higher concentration. |
| Analytic Specificity - Other Germicides | Negative response to other germicides. (Ensuring the device is specific to peracetic acid and does not react with other common germicides). | Met Acceptance Criteria: Negative response to other germicides. |
| Shelf Life | Met specifications after storage for a labeled shelf life of 12 months (unopened). | Met Acceptance Criteria: Met specifications after storage for labeled shelf life of 12 months (unopened). |
| In-Use (Open Bottle) Stability | Met specifications after storage for a labeled open bottle shelf life of one month. | Met Acceptance Criteria: Met specifications after storage for labeled open bottle shelf life of one month. |
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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