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STERRAD VELOCITY® Biological Indicator/Process Challenge Device, in conjunction with the STERRAD VELOCITY Reader, is intended to be used as a standard method for frequent monitoring and periodic testing of the following STERRAD Sterilization Systems:

• · STERRAD® 100NX (STANDARD, FLEX, EXPRESS, and DUO Cycles) with and without ALLClear® Technology
• STERRAD NX® (STANDARD and ADVANCED Cycles) with and without ALLClear® Technology
• · STERRAD® 100S

The STERRAD VELOCITY Biological Indicator (BI) /Process Challenge Device (PCD) is a selfcontained biological indicator, used in conjunction with the STERRAD VELOCITY Reader, that is intended for frequent monitoring and periodic testing of the STERRAD Sterilization Cycles, using rapid readout technology that provides a final fluorescence result in 15 minutes at the incubation temperature of 57 ± 2ºC.

The STERRAD VELOCITY BI/PCD can also be determined as growth-positive or growth-negative via an optional visual pH-based color change result (using bromocresol purple) if used for frequent monitoring purposes. When using this method, the biological indicator must be cultured in an incubator at 55-60°C for 5 to 7 days to get a final visual result.

The STERRAD VELOCITY BI/PCD consists of a glass fiber disc containing a minimum of 1 x 100 Geobacillus stearothermophilus (ATCC 7953) spores and a glass ampoule containing nutrient growth medium and non-fluorescent substrate, as well as a vial, cap, cap label, insert, and chemical indicator. The spore disc, growth media ampoule, and insert are contained in a clear plastic vial with a vented cap. The cap is designed with sterilant ingress openings which allow for penetration of hydrogen peroxide vapor into the vial during the sterilization process. The chemical indicator (CI), placed on the top of the cap, is a Type 1 process indicator that changes color from red/pink to yellow with some red/orange/brown dots when exposed to hydrogen peroxide.

The STERRAD VELOCITY BI/PCD has the same a-glucosidase enzyme system for the fundamental scientific technology as the predicate device cleared under K182404. The a-glucosidase enzyme, which is generated naturally during growth of G. stearothermophilus and released during spore germination, hydrolyzes the bond between the glucose and 4-methylumbelliferyl (4-MU) moieties of 4methylumbelliferyl a-D-glucopyranoside (α-MUG). In the combined state, α-MUG is not fluorescent. Once the bond between the glucose and 4-MU is hydrolyzed, the 4-MU component becomes fluorescent when excited with UV light. Therefore, the a-glucosidase enzyme in its active state can be detected by measuring the fluorescence produced by the enzymatic hydrolysis of a-MUG.

The resultant fluorescent by-product (4-MU), is detected by the Reader and the fluorescent signal is used to determine the positive or negative result of the biological indicator. The measured enzyme activity is reduced upon exposure to hydrogen peroxide. As the enzyme activity is directly correlated with the spore outgrowth, the reduction of the enzyme activity below a certain level indicates that all spores have been inactivated. The level of the fluorescence response is determined using the algorithm developed for the STERRAD VELOCITY BI/PCD and is used to distinguish between the positive and negative responses.

The STERRAD VELOCITY Reader is designed to automatically read the STERRAD VELOCITY BI/PCD to obtain the final fluorescence result in 15 minutes at the incubation temperature of 57 ± 2℃. The STERRAD VELOCITY Reader utilizes the fluorometric assay method to detect the enzyme activity from the BI and the fluorescence emitted from the BI is converted into a voltage. This voltage reading is then used by the fluorescence algorithm in the Reader to determine the final fluorescence result.

There are eight individual BI incubation wells in the STERRAD VELOCITY Reader. Its heater system is designed to maintain the biological indicators at 57 ± 2℃ to promote the outgrowth of the indicator organisms. Each well contains an ultraviolet light source that excites fluorescence in the growth medium, and a photodetector to detect that fluorescence.

The STERRAD VELOCITY Reader features a touch screen for an effective user interface. Directly under each well is a well number illuminated by a well status indicator light. Three colors (white, green, and red) and two states (off and solid line) are used for the indicator light on the touch screen to show the status of the BI processing. The Reader has a thermoplastic exterior which makes it easy to clean and maintain. A built-in barcode scanner coupled with network connectivity makes maintaining sterilization records easy.

The STERRAD VELOCITY Reader of the subject device has the same hardware and uses same fundamental scientific technology as the predicate device cleared under K182404. Only the algorithm for fluorescence reading has been modified in the subject device to reduce the fluorescence readout time from 30 minutes to 15 minutes.

Here's a breakdown of the acceptance criteria and study information for the STERRAD VELOCITY Biological Indicator/Process Challenge Device and Reader, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

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

The document does not explicitly state the specific sample sizes for the test sets in each study. It mentions that:

• For "Hydrogen Peroxide Dose Response and Sterilization Verification," "Design evaluation and Performance Qualification for Periodic Testing," "Verification of Reduced Incubation Time," and "Verification of BI Holding Time," the device's performance was evaluated by reanalyzing fluorescence results and data collected from previously submitted studies using the modified algorithm. No additional sterilization cycles were performed for these specific re-evaluations. This suggests the data provenance is retrospective, using previously gathered data.
• The original provenance of the data used for the reanalysis (e.g., country of origin) is not specified.

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

This information is not provided in the document. The studies primarily involve analytical testing against established biological and chemical indicators, rather than expert interpretation of medical images or other data requiring clinical expertise.

4. Adjudication Method for the Test Set:

This information is not applicable as the studies are based on analytical measurements (fluorescence readings, growth/no growth, chemical indicator changes) and adherence to set criteria. There is no mention of a human adjudication process for interpreting results.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and the effect size of how much human readers improve with AI vs without AI assistance:

No, an MRMC comparative effectiveness study was not done. This device is a biological indicator system used for monitoring sterilization, not a diagnostic AI system that assists human readers.

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

Yes, the studies described are essentially standalone performance evaluations of the STERRAD VELOCITY BI/PCD and Reader. The modified algorithm's ability to accurately read and interpret the biological indicator's fluorescence (without human intervention in the interpretation process) is the core of the verification. The reader automatically determines and displays the result ("Positive" or "Negative").

7. The type of Ground Truth Used:

The ground truth used in these studies is primarily biological/chemical reference standards and established scientific principles:

• Biological model: For periodic testing, the BI's resistance is compared to a "biological model," which represents the most difficult item routinely processed.
• Sterile BIs (growth and fluorescence): The "growth" outcome of the Geobacillus stearothermophilus spores (or lack thereof) after incubation, and the corresponding fluorescence, serve as the biological ground truth for assessing sterilization effectiveness.
• Chemical indicator changes: The color change of the chemical indicator (from red/pink to yellow/orange/brown dots) provides a chemical ground truth for exposure to hydrogen peroxide.
• 7-day incubation spore growth results: For verifying reduced incubation time, the rapid fluorescence results are compared against the longer, traditional 7-day visual assessment of spore growth, which is a well-established method for confirming biological indicator results.

8. The Sample Size for the Training Set:

This information is not provided. Given that the modification was an update to an existing algorithm based on reanalysis of previous data, and the device is a biological indicator reader rather than a deep learning AI, a distinct "training set" in the context of machine learning might not be applicable or explicitly documented in this way. The algorithm's development would have likely involved extensive testing and refinement, but the specific size or methodology for a formal "training set" is not detailed here.

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

As with the training set size, the specific methodology for establishing ground truth for any potential "training set" for algorithm development is not detailed. However, it can be inferred that the ground truth would have been established through controlled experiments involving the exposure of biological indicators to varying levels of hydrogen peroxide and subsequent traditional incubation and growth assessment (e.g., the 7-day incubation method mentioned). The previous K182404 submission would have contained details on the initial algorithm's development and associated ground truth.

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The ASP AEROFLEX™ Automatic Endoscope Reprocessor (AER) with AUTOSURE™ MRC Monitor is indicated for use with high-level disinfectant ASP AERO OPA™ ortho-Phthalaldehyde Solution to achieve high-level disinfection of flexible semi-critical endoscopes. Manual cleaning of endoscopes is required prior to placement in the AER.

The AEROFLEX Automatic Endoscope Reprocessor (AER) with AUTOSURE MRC Monitor is designed to provide high-level disinfection for flexible, submersible endoscopes that have been manually cleaned. The AEROFLEX system consists of the software-driven AER, the AUTOSURE MRC reagent, AERO-OPA™ disinfectant solution, and AEROZYME™ enzymatic detergent.

The AEROFLEX AER with AUTOSURE MRC Monitor is indicated for use with high-level disinfectant ASP AERO-OPA ortho-Phthalaldehyde Solution to achieve high-level disintection of semi-critical endoscopes; high-level disinfection requires that the AER be used with the AERO-OPA Solution per its Instructions for Use.

Manual cleaning of endoscopes is required prior to placement in the AEROFLEX AER. After an endoscope is manually cleaned according to its manufacturer's recommended procedures, it is loaded into the AER. After starting the reprocessing cycle, the AER displays its progress during the cycle and signals that the cycle is complete on the control panel and with an audible tone.

The minimum recommended concentration (MRC) of ASP AERO-OPA ortho-Phthalaldehyde Solution is automatically checked and verified by the AER for every cycle using an integrated MRC monitor and reagent. The MRC monitor- tests the OPA concentration in every high-level disinfection cycle without the use of test strips; if the OPA concentration is below the MRC the system cancels the cycle and notifies the user.

To reduce user error and facilitate assurance of disinfection efficacy, the AEROFLEX System uses Radio Frequency Identification (RFID) technology to identify the ASP-branded consumables that are used with the system. Additionally, to enable electronic record-keeping by hospitals, the AEROFLEX system can be configured by users to transmit cycle printout information and/or print cycle records from the facility's network; the AEROFLEX System will also be compatible with ASP ACCESS™ Technology to allow automated record keeping.

This document describes the premarket notification (510(k)) for the AEROFLEX™ Automatic Endoscope Reprocessor (AER) with AUTOSURE™ MRC Monitor. It focuses on demonstrating substantial equivalence to predicate devices, primarily through non-clinical performance testing.

Here's an analysis of the acceptance criteria and the study proving the device meets them, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document doesn't present a formal table of acceptance criteria with corresponding performance metrics in the way one might expect for a diagnostic AI device. Instead, it describes various performance tests conducted and reports a "Pass" for each. The acceptance criteria are implicitly defined by the "Guidance for Industry and FDA Staff: Premarket Notification [510(k)] Submissions for Automated Endoscope Washers, Washer/Disinfectors, and Disinfectors Intended for Use in Health Care Facilities (August 1993)" and the relevant electrical safety and EMC standards.

Here's a summary of the performance testing and their reported results:

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

The document does not explicitly state specific sample sizes for most of the performance tests (e.g., number of cycles for simulated use, number of endoscopes for in-use testing). It refers to "worst-case conditions" and "various OPA solution and MRC reagent conditions," implying a robust testing methodology but lacking numerical specifics.

• Provenance: The data provenance is internal testing conducted by Advanced Sterilization Products (ASP). The geographic location of the testing facility is not explicitly stated, but the company address is Irvine, California, USA, implying the testing was likely conducted in the US.
• Retrospective or Prospective: The testing would be considered prospective as it involves controlled experiments and data collection designed specifically to evaluate the performance of the device prior to marketing.

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

This document describes a medical device (automatic endoscope reprocessor) rather than an AI/ML clinical diagnostic device. Therefore, the concept of "experts establishing ground truth for a test set" often seen in AI/ML performance studies is not directly applicable in the same way.

• Ground Truth Establishment: The "ground truth" for this device's performance is established by physical and chemical measurements (e.g., OPA concentration, temperature, flow rates, microbial reduction for disinfection efficacy) and engineering validation against predefined specifications and regulatory guidance documents.
• Experts: While not explicitly stated as "experts establishing ground truth," the development and testing would have involved qualified engineers, microbiologists, and other scientific personnel with expertise in sterilization, disinfection, and medical device design and validation. Summative Usability Testing involved "representative end-user technicians and nurses," who can be considered "experts" in the context of device usability in a clinical setting.

4. Adjudication Method for the Test Set

Again, given that this isn't an AI-powered diagnostic device, there's no "adjudication method" in the sense of reconciling disagreements between expert readers. Performance is determined by quantitative measurements and validation against predefined technical specifications and regulatory (FDA) guidance.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

No. This is not an AI/ML diagnostic device that provides interpretations that human readers would then review. The device discussed is an Automatic Endoscope Reprocessor, focused on disinfection efficacy and automated processes. MRMC studies are not applicable here.

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

The "standalone" performance here refers to the device operating independently to perform its intended function. The various "Performance Testing" categories listed in the tables (Process Parameter Physical Testing, Simulated Use Testing, In-Use Testing, Self-Disinfection Efficacy, System Verification Testing, MRC Monitor Testing, etc.) represent the standalone performance of the AEROFLEX system in achieving its disinfection and monitoring goals without direct human intervention during the cycle. Human interaction occurs before loading and after completion, but the process itself is automated and tested as such.

7. The Type of Ground Truth Used

The ground truth used is primarily based on:

• Physical and Chemical Measurements: Direct measurements of parameters like OPA concentration, temperature, flow, volume, and contact time.
• Microbiological Efficacy: Likely involves challenging the system with known levels of microorganisms (bioburden) and demonstrating a specified log reduction (e.g., "greater than 6-log10 reduction" mentioned in Flow Characteristic Evaluation). This would involve laboratory-based testing using culturing methods to determine viable microbial counts before and after reprocessing.
• Engineering Specifications and Design Requirements: The device's performance is validated against its pre-established technical specifications and the requirements outlined in relevant FDA guidance documents and international standards (e.g., for electrical safety, EMC).
• Usability Feedback: For summative usability testing, the "ground truth" would be direct observations and feedback from the intended users regarding the device's ease of use and safety in a simulated environment.

8. The Sample Size for the Training Set

This product is an automatic endoscope reprocessor, not a machine learning model developed with training data. Therefore, the concept of a "training set" for an algorithm's development is not applicable. The device's internal algorithms and control systems are likely developed through traditional software engineering principles and validated through the extensive non-clinical testing described.

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

As explained above, there is no "training set" for an AI/ML algorithm in this context. The "ground truth" against which the device's performance is validated is established through established scientific methods, engineering principles, and adherence to regulatory standards for disinfection and medical device functionality.

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The STERRAD VELOCITY™ Biological Indicator, in conjunction with the STERRAD VELOCITY Reader, is intended to be used as a standard method for frequent monitoring and periodic testing of the following STERRAD Sterilization Systems:

• · STERRAD® 100NX (STANDARD, FLEX, EXPRESS, and DUO Cycles) with and without ALLClear™ Technology
• STERRAD NX® (STANDARD and ADVANCED Cycles) with and without ALLClear™ Technology
  · STERRAD® 100S

The STERRAD VELOCITY Biological Indicator is a self-contained biological indicator, used in conjunction with the STERRAD VELOCITY Reader, that is intended for frequent monitoring and periodic testing of the STERRD Sterilization Cycles, using rapid readout technology that provides a final fluorescence result in 30 minutes at the incubation temperature of 57 ± 2ºC.
The STERRAD VELOCITY BI can also be determined as growth-positive or growth-negative via an optional visual pH-based color change result (using bromocresol purple) if used for frequent monitoring purposes. When using this method, the biological indicator must be cultured in an incubator at 55-60℃ for 5 to 7 days to get a final visual result.
The STERRAD VELOCITY BI consists of a glass fiber disc containing a minimum of 1 x 100 Geobacillus stearothermophilus (ATCC 7953) spores and a glass ampoule containing nutrient growth medium and non-fluorescent substrate, as well as a vial, cap, cap label, insert, and chemical indicator. The spore disc, growth media ampoule, and insert are contained in a clear plastic vial with a vented cap. The cap is designed with sterilant ingress openings which allow for penetration of hydrogen peroxide vapor into the vial during the sterilization process. The chemical indicator (CI), placed on the top of the cap, is a Type 1 process indicator that changes color from red/pink to yellow or yellow with some red/orange/brown dots when exposed to hydrogen peroxide.
The STERRAD VELOCITY BI has the same α-glucosidase enzyme system for the fundamental scientific technology as the predicate device cleared under K170039. The a-glucosidase enzyme, which is generated naturally during growth of G. stearothermophilus and released during spore germination, hydrolyzes the bond between the glucose and 4-methylumbelliferyl (4-MU) moieties of 4-methylumbelliferyl a-D-glucopyranoside (α-MUG). In the combined state, α-MUG is not fluorescent. Once the bond between the glucose and 4-MU is hydrolyzed, the 4-MU component becomes fluorescent when excited with UV light. Therefore, the a-glucosidase enzyme in its active state can be detected by measuring the fluorescence produced by the enzymatic hydrolysis of a-MUG.
The resultant fluorescent by-product (4-MU), is detected by the Reader and the fluorescent signal is used to determine the positive or negative result of the biological indicator. The measured enzyme activity is reduced upon exposure to hydrogen peroxide. As the enzyme activity is directly correlated with the spore outgrowth. the reduction of the enzyme activity below a certain level indicates that all spores have been inactivated. The level of the fluorescence response is determined using the algorithm developed for the STERRAD VELOCITY BI and is used to distinguish between the positive and negative responses.

The provided text describes the acceptance criteria and a study proving the device meets the acceptance criteria for the STERRAD VELOCITY™ Biological Indicator.

Here's a breakdown of the requested information:

Acceptance Criteria and Device Performance Study

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criterion for the device, as outlined by the "Guidance for Industry and FDA Staff: Biological Indicator (BI) Premarket Notification [510(k)] Submissions, Section 10, Test Pack, issued on October 4, 2007," appears to be that the resistance of the subject device must be greater than or equal to the biological models for all claimed STERRAD Cycles. Additionally, all fluorescence-negative results during testing must be obtained in triplicate runs.

• Performance Study in STERRAD 100NX (STANDARD and FLEX Cycles, with/without ALLClear Technology): Pass
• Performance Study in STERRAD 100NX (EXPRESS Cycle, with/without ALLClear Technology): Pass
• Performance Study in STERRAD 100NX (DUO Cycle): Pass
• Performance Study in STERRAD NX (STANDARD and ADVANCED Cycles, with/without ALLClear Technology): Pass
• Performance Study in STERRAD 100S Cycle: Pass |

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

• Sample Size: The document states that "all fluorescence-negative results were obtained in triplicate runs." This implies that for each performance study listed, testing was conducted in triplicate. The exact number of biological indicators (BIs) or runs per condition is not explicitly stated beyond "triplicate runs."
• Data Provenance: The data is from non-clinical performance testing conducted by Advanced Sterilization Products (ASP). There is no explicit mention of the country of origin of the data, but given ASP is based in Irvine, California, it's highly likely the testing was conducted in the United States. The study is inherently prospective as it involves new performance testing of the device for expanded indications.

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

This information is not provided in the document. For a biological indicator, the ground truth is typically established by the growth or non-growth of the microbial spores after exposure to a sterilization process, which is an objective measurement. It does not typically involve expert interpretation in the same way as, for example, reading medical images.

4. Adjudication Method for the Test Set

This information is not applicable in the context of biological indicator testing as described. The results (fluorescence-negative or positive, and spore growth/non-growth) are objective measurements based on the device's functionality and the viability of the spores. It does not involve human interpretation that would require an adjudication method.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Its Effect Size

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study is typically performed for AI-powered diagnostic devices where human readers interpret medical images or data, and their performance with and without AI assistance is compared. The STERRAD VELOCITY™ Biological Indicator is a standalone device for monitoring sterilization processes and its performance is assessed directly, not in conjunction with human interpretation in an MRMC setting.

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

Yes, the performance study described is essentially a standalone (algorithm only) performance evaluation of the STERRAD VELOCITY™ Biological Indicator. The device, in conjunction with the STERRAD VELOCITY Reader, determines a "positive or negative result" based on the detected fluorescent signal, which is determined using an "algorithm developed for the STERRAD VELOCITY BI." The results presented ("Pass" or "Fail" for the performance studies and the resistance being "greater than" the biological model, and "fluorescence-negative results were obtained in triplicate runs") are indicative of the algorithm's direct performance in identifying effective sterilization.

7. The Type of Ground Truth Used

The ground truth for the biological indicator testing is based on the viability (growth or non-growth) of the Geobacillus stearothermophilus (ATCC 7953) spores after exposure to sterilization cycles, as well as the expected D-value (decimal reduction time) and and absence of growth in fully processed units. This is a biological/microbiological ground truth, directly tied to the primary function of a biological indicator. The "fluorescence-negative" result detected by the reader is directly correlated to the inactivation of spores. The document also mentions the optional visual pH-based color change result after 5-7 days of culture, which further confirms spore viability (or lack thereof).

8. The Sample Size for the Training Set

The document does not specify a training set sample size. This device is a biochemical indicator with an enzymatic detection system, rather than a machine learning or AI model that typically requires a large training dataset for learning patterns from data. The "algorithm developed for the STERRAD VELOCITY BI" likely refers to a pre-defined threshold or logic based on the biochemical reaction, rather than a machine-learned algorithm.

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

As no specific "training set" in the context of machine learning is indicated, the method of establishing ground truth for a training set is not applicable as described in the document. The foundational principles for the device's operation (α-glucosidase enzyme system, spore viability detection) are based on established microbiological and biochemical science. The development of the algorithm would have relied on understanding the relationship between enzyme activity, fluorescence, and spore inactivation, established through scientific studies and threshold determination rather than a traditional machine learning training process with a distinct training set.

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The STERRAD VELOCITY™ Biological Indicator, in conjunction with the STERRAD VELOCITY™ Reader, is intended to be used as a standard method for frequent monitoring STERRAD Sterilization Systems: · STERRAD® 100NX (STANDARD, FLEX, EXPRESS, and DUO Cycles) with and without ALLClear™ Technology
• STERRAD NX® (STANDARD and ADVANCED Cycles) with and without ALLClear™ Technology
· STERRAD® 100S

The STERRAD VELOCITY Biological Indicator is a self-contained biological indicator (BI), used in conjunction with the STERRAD VELOCITY Reader, that is intended for frequent monitoring of the STERRD Sterilization Cycles, using rapid readout technology that provides a final fluorescence result in 30 minutes at the incubation temperature of 57 ± 2℃.
The STERRAD VELOCITY BI can also be determined as growth-positive or growth-negative via an optional visual pH-based color change result (using bromocresol purple). When using this method, the biological indicator must be cultured in an incubator at 55-60°C for 5 to 7 days to get a final visual result.
The STERRAD VELOCITY BI consists of a glass fiber disc containing a minimum of 1 x 10° Geobacillus stearothermophilus (ATCC 7953) spores and a glass ampoule containing nutrient growth medium and non-fluorescent substrate, as well as a vial, cap, cap label, insert, and chemical indicator. The spore disc, growth media ampoule, and insert are contained in a clear plastic vial with a vented cap. The cap is designed with sterilant ingress openings which allow for penetration of hydrogen peroxide vapor into the vial during the sterilization process. The chemical indicator (CI), placed on the top of the cap, is a Type 1 process indicator that changes color from red/pink to yellow with some red/orange/brown dots when exposed to hydrogen peroxide.
The STERRAD VELOCITY Reader is designed to automatically read the STERRAD VELOCITY BI to obtain the final fluorescence result in 30 minutes at the incubation temperature of 57 ± 2℃. The STERRAD VELOCITY Reader utilizes the fluorometric enzymatic assay method to detect the enzyme activity from the BI and the fluorescence emitted from the BI is converted into a voltage. This voltage reading is then used by the fluorescence algorithm in the Reader to determine the final fluorescence result.
There are eight individual BI incubation wells in the STERRAD VELOCITY Reader. Its heater system is designed to maintain the biological indicators at 57 ± 2℃ to promote the outgrowth of the indicator organisms. Each well contains an ultraviolet light source that excites fluorescence in the growth medium, and a photodetector to detect that fluorescence.
The STERRAD VELOCITY Reader features a touch screen for an effective user interface. Directly under each well is a well number illuminated by a well status indicator light. Three colors (white, green, and red) and two states (off and solid line) are used for the indicator light on the touch screen to show the status of the BI processing. The Reader has a thermoplastic exterior which makes it easy to clean and maintain. A built-in barcode scanner coupled with network connectivity makes maintaining sterilization records easy.
The STERRAD VELOCITY BI and Reader have intended capability for "ecosystem" connectivity and integration. This system is intended to allow communication among STERRAD Sterilizers with ALLClear™ Technology.

Here's a breakdown of the acceptance criteria and study information for the STERRAD VELOCITY™ Biological Indicator and Reader based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

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

The document does not explicitly state the specific sample sizes (number of biological indicators or test runs) used for each individual performance test (e.g., D-value determination, RIT study, performance in various sterilizers). However, it implies that the testing was rigorous enough to satisfy the requirements of ISO 11138-1:2006 and FDA guidance.

The data provenance is retrospective, as these are non-clinical lab performance tests conducted by the manufacturer for regulatory submission. The country of origin of the data is not specified, but the manufacturer is Advanced Sterilization Products (ASP), located in Irvine, California, USA, suggesting the studies were likely conducted in the US or in facilities compliant with US standards.

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

This information is not provided in the document. The "ground truth" for the biological indicator's performance is established by scientific methods for spore viability, resistance characteristics (D-value), enzyme activity, and growth inhibition, rather than expert interpretation of results. For electrical safety and EMC, the ground truth is established by adherence to recognized national and international standards by accredited testing bodies.

4. Adjudication Method for the Test Set

This information is not applicable/provided for these types of non-clinical laboratory performance studies. Adjudication methods (like 2+1, 3+1) are typically used in clinical studies or studies involving human interpretation of medical images/data, where discrepancies between readers need to be resolved. The "results" of these tests (e.g., Pass/Fail, numerical measurements) are objectively determined by the methodology described.

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

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This type of study is relevant for diagnostic devices where human readers interpret output (e.g., medical images) and the AI's assistance to human readers is evaluated. The STERRAD VELOCITY™ Biological Indicator and Reader is a system for objectively monitoring sterilization processes, not a diagnostic tool requiring human interpretation for its primary function.

6. Standalone Performance

Yes, a standalone (algorithm only) performance was done. The entire suite of "Non-Clinical Data" presented details the performance of the STERRAD VELOCITY™ Biological Indicator and Reader system independently. The Reader's algorithm determines the final fluorescence result without human-in-the-loop interpretation for its primary function of determining BI positivity/negativity within 30 minutes. The BI's performance (spore population, D-value, RIT, etc.) is also evaluated systematically.

7. Type of Ground Truth Used

The ground truth used for the scientific performance testing of the Biological Indicator is based on objective scientific measurements and established microbiological and sterilization standards. This includes:

• Microbiological assays: For spore population determination, growth inhibition, and characterization of Geobacillus stearothermophilus.
• Sterilization kinetics: For D-value determination (using Holcomb-Spearman-Karber Procedure (HSKP) and Survivor Curve method as per ISO 11138-1).
• Enzymatic activity measurements: Fluorescence detection and its correlation to spore outgrowth.
• Physical and Chemical Testing: For chemical indicator functionality and real-time shelf life studies.
• Compliance with recognized standards: For electrical safety (e.g., IEC/EN 61010-1) and EMC (e.g., FCC Part 15, Subpart B).

8. Sample Size for the Training Set

The document does not contain information about a "training set" in the context of machine learning. The STERRAD VELOCITY™ Biological Indicator and Reader is not described as an AI/machine learning device that requires a training set in the conventional sense. Its "algorithm" is for fluorescence detection and conversion of voltage readings to positive/negative results, based on established biological and enzymatic principles, not necessarily learned from a large dataset. If there was any internal calibration or parameter setting, the details are not provided.

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

As there is no explicit mention of a "training set" for an AI/machine learning model as understood in typical AI device submissions, this information is not applicable and not provided in the document. The device's operational parameters and decision thresholds would have been established through a combination of scientific principles, engineering design, and empirical testing against known positive and negative controls.

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The EVOTECH® ECR Endoscope Cleaner and Reprocessor, a washer/disinfector, is indicated for use with high-level disinfectant CIDEX® OPA Concentrate Solution and an enzymatic detergent (CIDEZYME XTRA) to achieve cleaning and high level disinfection of heat sensitive (>60°C) semi-critical endoscopes. Manual cleaning of medical devices (endoscopes) is not required prior to placement in the EVOTECH® ECR Endoscope Cleaner and Reprocessor System when selecting those cycles that contain a wash stage. (Manual cleaning of medical devices (endoscopes) is required when selecting the Disinfect only or Disinfect/Alcohol Flush Cycle.)

The EVOTECH® ECR Endoscope Cleaner and Reprocessor is a two-basin The washer/disinfector utilizing an enzymatic detergent and a concentrated high level disinfectant, CIDEX® OPA Concentrate Solution. Both the detergent and high level disinfectant are diluted in the system to in-use concentrations. The EVOTECH® ECR Endoscope Cleaner and Reprocessor is capable of cleaning endoscopes that have not been manually cleaned prior to placing in the system.

Here's a breakdown of the acceptance criteria and study information for the EVOTECH® ECR Endoscope Cleaner and Reprocessor, based on the provided text:

Important Note: This document is a 510(k) summary, which focuses on demonstrating substantial equivalence to a predicate device. Therefore, the "acceptance criteria" discussed are largely in reference to meeting established standards and demonstrating performance comparable to previously cleared devices, rather than a novel, bespoke set of criteria for this specific submission's unique functionality. The "study" largely refers to a compilation of previous testing and new verification for the minor modification.

1. Table of Acceptance Criteria and Reported Device Performance

Given that this is a 510(k) submission for a device with minor modifications (specifically, DCHP network capability), much of the performance data refers to studies conducted for previous iterations of the device (K040883, K061889, K140977). The "acceptance criteria" are derived from relevant FDA guidance and established standards for endoscope reprocessors.

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