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The Sterilucent SCBI is intended to be used as a standard method for frequent monitoring of the Sterilucent HC 80TT Sterilizer Cycles, when incorporated into a test pack.

The Sterilucent Process Challenge Device (PCD) test pack is used for routine monitoring of the Sterilucent HC 80TT Sterilizer Lumen and Flexible Cycles. The Sterilucent PCD may also be used for performance qualification of the Sterilucent HC 80TT sterilizer Lumen and Flexible Cycles during initial installation, after relocation, major repairs or mal functions, or after sterilization process failures.

Both the Sterilucent Lumen Cycle PCD and the Sterilucent Flexible Cycle PCD are intended to have greater resistance than the stand alone SCBI. Both devices are designed to have increased resistance beyond the sterilization half-cycle, but complete inactivation upon exposure to the full cycle.

The Sterilucent Self-Contained Biological Indicator (SCBI) is a sterilization process indicator that conforms to ANSI/AAMI/ISO 11138-1, and is intended for use only with the Sterilucent HC 80TT Hydrogen Peroxide Sterilizer. The HC 80TT Hydrogen Peroxide Sterilizer has two pre-programmed sterilization cycles ("Lumen" and “Flexible") which both utilize vaporized hydrogen peroxide (VHP) to rapidly sterilize a variety of reusable medical devices.

The Sterilucent SCBI is to be used in a test pack configuration, with a different test pack (Process Challenge Device) used for each sterilization cycle. Each Process Challenge Device (PCD) is designed to have greater resistance than the worst-case sterilization load, allowing for survival beyond the sterilization half-cycle, but complete inactivation upon exposure to the full cycle.

The Sterilucent SCBI provides information on whether necessary conditions were met to kill a specified number of microorganisms upon exposure to either cycle of the Sterilucent HC 80TT Hydrogen Peroxide Sterilizer.

The document describes the acceptance criteria and study results for the Sterilucent Self-Contained Biological Indicator (SCBI) and Process Challenge Device (PCD).

1. Table of Acceptance Criteria and Reported Device Performance

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

The document does not specify the exact sample sizes used for each individual test. The provenance of the data is not explicitly stated in terms of country of origin, but the submission is for the U.S. Food and Drug Administration (FDA), implying the testing was conducted to meet U.S. regulatory standards. The testing appears to be prospective as it was conducted to demonstrate the functionality of the device.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

This information is not applicable. The device is a biological indicator and process challenge device for sterilization. Its performance is evaluated through biological and physical tests based on established standards, not through expert interpretation of data like in diagnostic imaging.

4. Adjudication method for the test set

This information is not applicable for this type of device and testing. The evaluation relies on quantitative measurements and adherence to predefined performance metrics rather than expert consensus on subjective outcomes.

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 information is not applicable. This device is a sterilization indicator, not an AI-powered diagnostic tool, so MRMC studies involving human readers and AI are irrelevant.

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

This information is not applicable. The device itself is non-algorithmic and does not involve AI or human-in-the-loop performance in the conventional sense of software-as-a-medical-device. Its performance is inherent to its design and material properties.

7. The type of ground truth used

The ground truth for the SCBI and PCD testing is established by recognized international standards and methodologies for sterilization indicators. This includes:

• Biological inactivation: The absence or presence of viable Geobacillus stearothermophilus spores after exposure to sterilization conditions.
• Physical/chemical parameters: Measurements of D-value, survival/kill windows, spore population counts, pH changes, and color changes in chemical indicators.
• Compliance with standards: Adherence to ANSI/AAMI/ISO 11138-1, ANSI/AAMI/ISO 11140-1, and FDA Guidance documents.

8. The sample size for the training set

This information is not applicable. The Sterilucent SCBI and PCD are not AI/ML-based devices; therefore, there is no "training set" in the context of machine learning.

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

This information is not applicable as the device does not utilize a training set in the AI/ML sense.

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A chemical indicator for monitoring all cycles within the Sterilucent™ HC 80TT Hydrogen Peroxide Sterilizer (Lumen & Flexible), STERRAD® 100S (Standard & Long), 200, 100NX (Standard, Flex & Express), NX (Standard & Advanced), STERIS® VPRO™ 1, V-PRO™ 1 Plus (Lumen & Non-Lumen), VPRO® maX (Flexible, Lumen & Non-Lumen) and Sterilucent PSD-85 (Lumen & Non-Lumen). The VH2O2 Indicators are intended to be used by health care providers with sterilization wraps, containers, cassettes, or pouches to distinguish between processed and unprocessed units. Colors other than blue such as yellow/green should be treated as a process failure.

The Sterilucent VH2O2 Chemical Indicator is a Class 1/Type 1 process indicator that conforms to ANSI/AAMI/ISO 11140-1:2014, and is intended to be used with currently cleared hydrogen peroxide sterilizers (STERRAD® 100S, 200, 100NX, NX, STERIS® VPRO™ 1, V-PRO™ 1 Plus, VPRO® maX and the Sterilucent PSD-85) and the Sterilucent HC 80TT Hydrogen Peroxide Sterilizer. The HC 80TT Hydrogen Peroxide Sterilizer has two pre-programmed sterilization cycles ("Lumen" and "Flexible") which both utilize vaporized hydrogen peroxide (VHP) to rapidly sterilize a variety of reusable medical devices. The Sterilucent VH2O2 Chemical Indicator is provided in two different formats: Strip and Label. Both formats consist of a polymeric material on which indicator ink is deposited. A pressure-sensitive adhesive is provided on the back of the Label, which allows the process indicator to be adhered to various substrates including containers, pouches, tamper-proof arrows or locks, etc. The Sterilucent VH2O2 Chemical Indicator provides a visual indication that a sterilization load has been exposed to the VHP sterilization process. The indicator works by means of a chemical reaction, which results in a recognizable color change from red to blue.

The provided text is a 510(k) summary for a medical device (Sterilucent VH2O2 Chemical Indicator), but it does not describe a study involving an AI/ML-based medical device or comparative effectiveness with human readers. Therefore, many of the requested points, such as MRMC studies, training set details, or expert ground truth adjudication, are not applicable to this type of device (a chemical indicator).

However, I can extract the relevant information regarding the acceptance criteria and performance of this chemical indicator device.

Here's a breakdown of the information available in the provided document, addressing the closest applicable aspects of your request:

Device: Sterilucent VH2O2 Chemical Indicator (a non-AI, non-software device)

1. Table of Acceptance Criteria and Reported Device Performance

Color Change Specifics: The device is designed to change color from Red/Pink to Blue upon exposure to the VHP sterilization process. Colors other than blue (e.g., yellow/green) indicate a process failure.

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

The document does not specify exact sample sizes for each test listed (e.g., how many indicators were tested for ISO compliance, shelf-life, etc.). It only states that "Performance testing was conducted to demonstrate the functionality..." and that the tests "Passed."

• Sample Size: Not explicitly stated for each test.
• Data Provenance: The tests were conducted to demonstrate compliance with the ANSI/AAMI/ISO 11140-1:2014 standard for vaporized hydrogen peroxide sterilization indicators. The testing is non-clinical performance testing of the physical device. Country of origin for testing is not specified, but the applicant is Sterilucent, Inc. in Minneapolis, Minnesota, USA. It is retrospective in the sense that the testing was performed and then summarized for the 510(k) submission.

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

This concept is not applicable to this type of device. The ground truth for a chemical indicator's performance is established by whether it correctly changes color under specific chemical and physical sterilization conditions according to established international standards (ISO 11140-1). It's a binary chemical reaction/physical property, not an interpretation requiring human experts like in imaging.

4. Adjudication Method for the Test Set

This concept is not applicable. There is no "adjudication" in the sense of resolving disagreements among human readers or expert labelers for this type of device. The pass/fail criteria are based on objective physical/chemical changes and adherence to the ISO standard.

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

No, an MRMC study was not done. This type of study is relevant for AI/ML-based diagnostic devices where human readers' performance with and without AI assistance is being evaluated. This device is a chemical indicator, not an AI/ML diagnostic tool.

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

This concept is not applicable. This is a physical chemical indicator, not an algorithm. Its "standalone performance" refers to its ability to react correctly to sterilization conditions, which is what the non-clinical tests (ISO 11140-1 compliance, functionality, etc.) evaluated.

7. The Type of Ground Truth Used

The ground truth is based on:

• International Consensus Standards: Specifically, ANSI/AAMI/ISO 11140-1:2014, which defines the expected performance and pass/fail criteria for chemical indicators.
• Physical/Chemical Properties: The expected color change reaction when exposed to specific concentrations of hydrogen peroxide vapor and other parameters of the sterilization cycle.
• Absence of Toxicity: Biocompatibility testing to ensure the device does not release known toxic substances.

This is not a ground truth derived from expert consensus, pathology, or outcomes data in the medical imaging or diagnostic sense.

8. The Sample Size for the Training Set

This concept is not applicable. This device is a physical chemical indicator, not an AI/ML model that requires a training set. The device's "training" is its chemical formulation and manufacturing process, which are designed to react consistently.

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

This concept is not applicable for the reason stated in point 8.

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The Sterilucent HC 80TT Hydrogen Peroxide Sterilizer is a vaporized hydrogen peroxide sterilizer intended for use in the terminal sterilization of cleaned, rinsed and dried reusable metal medical devices used in healthcare facilities. The two pre-programmed sterilization cycles, the Lumen Cycle and the Flexible Cycle, operate at low temperature and are thus suitable for processing medical devices that are sensitive to heat and moisture.

The HC 80TT Lumen Cycle can sterilize:
o Lumen and non-lumen medical devices with diffusion-restricted spaces or mated surfaces such as the hinged portion of forceps and scissors;
O Single or dual channeled rigid and semi-rigid endoscopes, with stainless steel lumens that are:

• · ≥ 0.77 mm internal diameter (ID) and ≤ 410 mm long, or
• · ≥ 1.33 mm ID and ≤ 430 mm long; and,
  o Triple channeled rigid and semi-rigid endoscopes, with stainless steel lumens that are:
• ≥ 1.00 mm ID and ≤ 310 mm long.
  The validation testing for all lumen sizes was conducted using a maximum of fifteen (15) lumens per load. Hospital loads should not exceed the maximum number of lumens validated by this testing. The validation studies were performed using two (2) separate validation loads as described in the following table.

The HC 80TT Flexible Cycle can sterilize:

• · Rigid or semi-rigid non-lumen medical devices including non-lumen devices with metallic diffusion-restricted spaces such or mated surfaces such as the hinged portion of forceps or scissors;
• · Single channel flexible endoscopes with flexible lumens that are:
  • · ≥ 1.00 mm ID and ≤ 1280 mm long; and,
• · Dual channel flexible endoscopes with flexible lumens that are:
  • · ≥ 0.80 mm ID and ≤ 1000 mm long.

The Sterilucent HC 80TT Hydrogen Peroxide Sterilizer (HC 80TT) is a self-contained standalone device, using vaporized hydrogen peroxide as the sterilant. The HC 80TT is intended for use in the terminal sterilization of cleaned, rinsed, and dried, reusable metal and non-metal medical device used in healthcare facilities. The sterilization cycle operates at low pressure and temperatures and is therefore suitable for processing medical devices that are sensitive to heat and moisture. The hydrogen peroxide vapor is generated by heating aqueous hydrogen peroxide and injecting into a chamber.

This document is a 510(k) summary for the Sterilucent HC 80TT Hydrogen Peroxide Sterilizer. It details the device's technical characteristics, indications for use, and a comparison to a predicate device (Sterilucent PSD-85 Hydrogen Peroxide Sterilizer). It extensively describes the performance testing conducted to demonstrate the device's safety and efficacy.

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

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

The document does not explicitly present a discrete table of "acceptance criteria" with quantitative targets alongside the "reported device performance." Instead, it describes various performance tests and the positive outcomes, implying that successful completion of these tests serves as the acceptance criteria. The overarching acceptance criterion for a sterilizer is achieving a Sterility Assurance Level (SAL) of 10^-6.

Below is a table summarizing the performance claim and the evidence provided:

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

• Sample Size: The document provides some detail on sample sizes indirectly through load descriptions.
  • Lumen Cycle Validation Loads: Two separate validation loads were used. Load #1 contained 15 total lumens. Load #2 contained 10 lumens. The validation testing for all lumen sizes was conducted using a maximum of fifteen (15) lumens per load.
  • Flexible Cycle Validation Loads: Four separate validation loads were used. No specific lumen counts are given for these, but Load #1 included one single-channel flexible angioscope and one single-channel flexible ureteroscope. Load #3 included one dual-channel flexible ureteroscope and one single-channel flexible angioscope.
  • Surface Sterilization, Mated Surface Sterilization, Lumen Sterilization: Tests involved "a wide variety of material coupons" or "a variety of medical device materials" or placing "at least 10⁶ Geobacillus stearothermophilus spores in the center of the lumens." The exact number of samples (coupons, devices) used in each of these tests is not explicitly stated numerically, beyond the load descriptions for the overall cycle validation.
  • Simulated Use Testing: "Representative lumen and non-lumen devices" were inoculated. The exact number is not quantified.
  • In-Use Testing: "Devices representative of surface features and lumen claims for the HC 80TT were selected." The exact number is not quantified.
• Data Provenance: The document does not specify the country of origin of the data. Given it's an FDA submission for a US-based company (Minneapolis, Minnesota), it's highly probable the testing was conducted in the United States, likely in a laboratory setting. The studies described are prospective in nature, as they involve actively setting up and running sterilization cycles under controlled conditions to observe outcomes, rather than analyzing existing, previously collected data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

This information is not applicable in the context of this device. The "ground truth" for sterilization devices is established by objective microbiological methods, specifically the inactivation of highly resistant bacterial spores (Geobacillus stearothermophilus) to a statistically defined Sterility Assurance Level (SAL). It does not involve human expert interpretation of images or clinical data in the same way an AI diagnostic device would.

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

This information is not applicable. The "ground truth" (i.e., whether sterilization was achieved) is determined by the absence or presence of viable spores after exposure to the sterilization process, which is an objective laboratory measure (incubation of biological indicators) and does not require adjudication by multiple human experts.

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

There was no MRMC comparative effectiveness study done. This type of study is relevant for AI-powered diagnostic devices where human readers interpret medical images. The Sterilucent HC 80TT is a sterilizer, not an AI diagnostic device, and its performance is evaluated through its ability to inactivate microorganisms, not through human interpretation of results.

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

This refers to the device's performance as a sterilizer without human intervention in the sterilization process itself. The entire battery of tests described (Dose-Response, Surface, Mated Surface, Lumen, Simulated Use, In-Use, Sporicidal Activity) are essentially "standalone" performance evaluations of the device's ability to sterilize. The human role is in setting up the device, loading items, initiating cycles, and performing post-sterilization analysis (e.g., biological indicator incubation), not in assisting the sterilization process itself in real-time. The device operates automatically once a cycle is initiated.

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

The ground truth used is microbiological proof of sterility, specifically the inactivation of a highly resistant biological indicator organism, Geobacillus stearothermophilus, to a demonstrated Sterility Assurance Level (SAL) of 10^-6. This is an objective and quantitative measure, not subjective like expert consensus or pathology in a diagnostic context. This is also supported by the AOAC Official Method 966.04 for Sporicidal Activity.

8. The sample size for the training set

The concept of a "training set" is not applicable here. This device is a traditional medical device (a sterilizer), not an AI/ML-based device that learns from data. Therefore, there is no training set in the machine learning sense. The testing described is verification and validation.

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

As there is no training set for this traditional sterilizer, this question is not applicable.

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The Sterilucent Sterilization Container System is a device intended to enclose another medical device that is to be sterilized by a healthcare provider. It is intended to allow sterilization of the enclosed medical device and also to maintain sterility of the enclosed device until used. This container system is intended to be used in the Sterilucent PSD-85 Hydrogen Peroxide Sterilizer Lumen Cycles. The sterility maintenance period has been validated for a period of up to 180 days.

Reusable baskets and accessory items (clips, posts, pins, dividers, bars and mats) are intended to organize and secure enclosed medical devices during sterilization, transport, and storage of the container.

Consumable accessory items (filter media, data card and tamper evident arrows) provide a range of functions and are indicated as single-use devices. Filter media allows ingress of sterilant while providing a microbial barrier. Data cards are used to record information regarding a specific sterilization process load. Tamper evident arrows provide a visual indication that the container system has not been inadvertently opened prior to use. Each arrow contains an external process indicator that serves as a visual indication that the system has been exposed to the Sterilization process.

The Sterilucent Sterilization Container System is an assortment of rigid, reusable, stackable containers that are used to sterilize other medical devices and maintain sterility of those devices until used. The container system is comprised of a lid, bottom, filter, tamper evident arrows, and data cards.

The container system houses reusable baskets of varying depths and organizing accessory items that are used to organize and secure surgical instrumentation and/or other medical devices.

The provided text describes the acceptance criteria and performance of the Sterilucent Sterilization Container System (K142109) through non-clinical studies.

Here's the breakdown of the information you requested:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria for Sterilization Performance (Sterilization Container System):

• Demonstrate a 12 log reduction in microbial load.
• Achieve a Sterility Assurance Level (SAL) of 10^-6.
• Demonstrate sterility maintenance for a period of up to 180 days.
• Maintain appropriate microbial barrier properties following exposure to hydrogen peroxide sterilization processes under worst-case conditions.

Reported Device Performance:

• Sterilization efficacy testing demonstrated a 12 log reduction and a sterility assurance level (SAL) of 10^-6.
• Real-time event-related shelf-life studies demonstrated sterility maintenance for a 180-day time period.
• Whole package microbial challenge testing demonstrated appropriate microbial barrier properties following exposure to the Sterilucent hydrogen peroxide sterilization processes under worst-case conditions.

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

The document does not explicitly state the specific "sample size" in terms of number of devices or iterations for the efficacy and sterility maintenance tests. It refers to "studies" and "testing" without quantifying the number of units tested.

• Sample size for test set: Not explicitly stated (e.g., "three containers were tested" or "n=X runs"). The document refers to "studies" and "testing."
• Data provenance: Prospective non-clinical studies. The country of origin of the data is not specified, but the device is submitted for FDA clearance in the USA.

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. Non-clinical studies for sterilization effectiveness typically rely on laboratory assays and established microbiological standards, rather than expert human interpretation of results in the way, for example, a radiology AI model would.

4. Adjudication Method for the Test Set

This information is not applicable as the studies are non-clinical (laboratory-based microbiological and physical testing), not involving human readers or interpretation requiring adjudication.

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

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This type of study is relevant for diagnostic devices that involve human interpretation of images or other data, not for sterilization container systems.

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

This question is not applicable as the device is a physical sterilization container system, not an algorithm or AI model. The performance described is that of the physical device itself.

7. The Type of Ground Truth Used

The ground truth for the non-clinical studies was established using microbiological assays, specifically:

• Biological indicator (BI) overkill method: For sterilization efficacy (demonstrating a 12 log reduction and SAL of 10^-6).
• Microbial challenge testing: For evaluating microbial barrier properties, using a specified quantity of Bacillus atrophaeus colony forming units (CFU).
• Real-time event-related shelf-life studies: To determine sterility maintenance over time.

8. The Sample Size for the Training Set

This information is not applicable. The device is a physical product (a sterilization container system), not a software or AI model that requires a training set. The studies described are validation and performance tests, not training data for an algorithm.

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

This information is not applicable for the reasons stated in point 8.

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The Sterilucent Self-Contained Biological Indicator is for monitoring the efficacy of the hydrogen peroxide sterilization process in the Sterilizer Lumen and Non-Lumen cycles. It is intended for use solely in a test pack.

The Sterilucent Biological Indicator Monitoring System is intended for incubating and monitoring of the Sterilucent Self-Contained Biological Indicator.

The Sterilucent Self-Contained Biological Indicator is a self-contained biological indicator (SCBI) designed for use in monitoring the efficacy of the Sterilucent PSD-85 Sterilizer Lumen and Non-Lumen cycles. The SCBI consists of Geobacillus stearothermophilus bacterial spores, inoculated on a stainless steel carrier, and placed into a thermoplastic vial that serves as a culture tube. A small glass ampoule containing sterile culture medium (soybean casein digest formulation) and pH color indicator (Bromocresol Purple) is also contained in the vial.

The user places the Sterilucent SCBI into the Sterilucent PSD-85 sterilizer load and initiates a sterilization cycle appropriate for the particular type of load. After cycle completion, the SCBI is retrieved and activated by breaking the glass ampoule which contains a growth media. The activated SCBI is then incubated at 60°C ± 2°C for 18 hours and monitored for any color change. The appearance of a yellow color in the media indicates bacterial growth (a failing result); no color change indicates conditions for sterilization were achieved (a passing result).

The Sterilucent Biological Indicator Monitoring System is a biological indicator incubator which monitors for the presence and condition (growth [as indicated by a yellow color in the growth media] or no-growth [as indicated by purple growth media]) of Sterilucent SCBI. When an activated Sterilucent SCBI is placed into one of the incubation cavities, the LED in front of the cavity will illuminate amber. The incubator maintains the operating temperature specifications under all potential loading conditions over the recommended incubation time. It can incubate and monitor up to ten (10) Sterilucent SCBI plus one control unit.

The provided text describes the 510(k) summary for the Sterilucent Self-Contained Biological Indicator (K141238) and the Sterilucent Biological Indicator Monitoring System. While it outlines the non-clinical performance data and states that the results met established acceptance criteria, it does not provide explicit acceptance criteria in a table format with corresponding reported device performance, nor does it describe a study involving an "AI device" or human readers.

The document discusses a biological indicator for sterilizers, which functions very differently from a typical AI/ML-based medical device. Therefore, several of the requested points, such as "number of experts used to establish ground truth," "adjudication method," "multi-reader multi-case (MRMC) comparative effectiveness study," and "standalone (i.e., algorithm only without human-in-the-loop performance)," "training set sample size," or "how ground truth for training set was established" are not applicable to this type of device.

However, I can extract the relevant information from the document to address the applicable parts of your request.

Acceptance Criteria and Study for Sterilucent Self-Contained Biological Indicator (K141238)

This submission pertains to a biological indicator and its monitoring system, not an AI/ML-based device. Therefore, many of the typical acceptance criteria and study designs associated with AI/ML devices (e.g., MRMC studies, expert adjudication of AI output) are not relevant here. The studies described are performance tests for a biological indicator in a sterilization context.

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

The document states that "The results of all studies met the established acceptance criteria when applicable," but it does not explicitly list these criteria in a table format with precise performance numbers for each. Instead, it describes general compliance with "Guidance for Industry and FDA Staff - Biological Indicator (BI) Premarket Notification [510(k)] Submissions (October 4, 2007)."

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

The document does not specify exact sample sizes for each test (e.g., "multiple lots" for population and D-value, "a series of sub-lethal exposures" for holding time).

• Sample Size: Not explicitly stated as numerical counts (e.g., N=X units). Described qualitatively (e.g., "multiple lots," "a series of sub-lethal exposures").
• Data Provenance: The studies were conducted by the manufacturer, Sterilucent, Inc., and the data refers to the performance of their device. The country of origin for the data is implicitly the USA, where the company is located. The studies are prospective performance characterization tests of the manufactured biological indicators.

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 a biological indicator is based on microbiological growth/no-growth, which is an objective biological outcome, not a subjective interpretation by experts like radiologists for image-based AI. The 'ground truth' is the objective determination of sterilization efficacy.

4. Adjudication method for the test set

Not applicable. The outcome of a biological indicator (color change indicating growth or no growth) is an objective, binary result that does not require expert adjudication in the way medical image interpretations might.

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 is not an AI-assisted diagnostic device, and human reader performance is not a factor.

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

Not applicable. This is a physical biological indicator, not an algorithm. Its 'standalone' performance is its inherent microbiological and chemical response to sterilization.

7. The type of ground truth used

The ground truth used is the objective biological outcome of bacterial spore growth or inactivation after exposure to a sterilization process. This is determined by:

• The presence or absence of color change in the growth media within the biological indicator (yellow for growth/failure, purple for no-growth/pass).
• Microbiological assays (e.g., population counts, D-value determinations) to quantify resistance and viability.
• The efficacy of the sterilization process itself, which the BI is designed to monitor.

8. The sample size for the training set

Not applicable. This is not an AI/ML device that requires a training set.

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

Not applicable. This is not an AI/ML device.

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The Sterilucent Process Challenge Device PCD-L for Lumen Cycle is used for performance qualification of the Sterilucent PSD-85 sterilizer during initial installation, after relocation, major repairs or after sterilization process failures. The Sterilucent PCD-L may also be used for routine monitoring of the PSD-85 Sterilizer Lumen Cycle.

The Sterilucent Process Challenge Device PCD-NL for Non-Lumen Cycle is used for performance qualification of the Sterilucent PSD-85 Sterilizer during initial installation, after relocation, major repairs or after sterilization process failures. The Sterilucent PCD-NL may also be used for routine monitoring of the PSD-85 Sterlizer Non-Lumen Cycle.

The Sterilucent PCD-L and PCD-NL are pre-assembled devices that consist of a Sterilucent Self-Contained Biological Indicator (SCBI), a vial, a vial cap containing a challenge tube, and a Chemical Indicator (CI) Label. The design of the PCD is such that it creates a challenge at least as challenging as the most difficult to sterilize item routinely processed in the PSD-85 sterilizer.

The PCDs are used by healthcare providers for qualification testing of the Sterilucent PSD-85 sterilizer and for routine monitoring of the PSD-85 sterilizer Lumen and Non-Lumen Cycles.

The user places the Sterilucent PCD into the Sterilucent PSD-85 along with a load and initiates a sterilization cycle. After cycle completion, the PCD is retrieved. The Cl is immediately accessed for a passing color change from pink to blue. If the CI is blue, the SCBI is removed from the PCD vial and activated by breaking the glass ampoule which contains a growth media. The SCBI is then incubated at 60°C ± 2°C for 18 hours and monitored for any color change. The appearance of a yellow color in the media indicates bacterial growth (a failing result); no color change indicates adequate sterilization (a passing result).

Here's a breakdown of the acceptance criteria and study information for the Sterilucent Process Challenge Device (PCD-L and PCD-NL), based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Test Set Sample Size: "PCDs from three separate manufacturing lots" were used for testing. The exact number of PCDs per lot is not specified.
• Data Provenance: The data is retrospective, generated from testing conducted by Sterilucent, Inc. The country of origin is not explicitly stated but can be inferred to be USA, where Sterilucent, Inc. is located.

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

The document does not mention the use of experts to establish a "ground truth" in the traditional sense. The ground truth for sterilization effectiveness is based on the biological indicator (absence or presence of bacterial growth) and the response of the chemical indicator, which are inherent properties of the device and the sterilization process being tested. This is a technical evaluation rather than an expert consensus interpretation.

4. Adjudication Method for the Test Set

Not applicable. The evaluation relies on objective measurements (biological indicator growth, chemical indicator color change) rather than subjective expert interpretations requiring adjudication.

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 typically used for diagnostic devices where human readers interpret output (e.g., images), and the goal is to assess reader performance with and without AI assistance. This device is a process challenge device for sterilizers, not a diagnostic tool requiring human interpretation comparison.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

Yes, the study described is a standalone performance evaluation of the device itself. The device is designed to provide an objective indication of sterilization effectiveness without human-in-the-loop interpretation of complex data. The performance evaluation focuses on the device's inherent characteristics (resistance, indicator response) against established biological models and half-cycle exposures.

7. Type of Ground Truth Used

The ground truth used is based on:

• Biological Indicator Results: The presence or absence of Geobacillus stearothermophilus growth after incubation of the Self-Contained Biological Indicator (SCBI). A lack of growth indicates effective sterilization (passing result), while growth indicates a failure.
• Chemical Indicator Response: The color change of the Chemical Indicator (from pink to blue). This provides an immediate visual indication of sterilant exposure.
• Fraction-Negative Data: This method involves exposing biological indicators to varying sub-lethal sterilization doses and observing the proportion of indicators that fail to show growth. This helps establish the resistance characteristics.
• Biological Model for Sterilizer Validation: The PCD's resistance is compared against a pre-established biological model for the PSD-85 sterilizer, which represents the worst-case challenge.

8. Sample Size for the Training Set

The document does not describe a "training set" in the context of an AI/machine learning model. The device itself is not an AI algorithm. The performance evaluation is based on direct testing with three manufacturing lots, as mentioned in point 2.

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

Not applicable, as there is no training set in the context of an AI model. The ground truth used for evaluating the device's performance (resistance, indicator response) is established through standardized microbiological and chemical indicator testing protocols.

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The Sterilucent PSD-85 Hydrogen Peroxide Sterilizer (PSD-85) is a vaporized hydrogen peroxide sterilizer intended for use in the terminal sterilization of cleaned, rinsed and dried reusable metal and nonmetal medical devices used in healthcare facilities. The two pre-programmed sterilization cycles, the Lumen Cycles, operate at low pressure and low temperature and are thus suitable for processing medical devices sensitive to heat and moisture.

The PSD-85 Lumen Cycle can sterilize*:

• · Instruments with diffusion-restricted spaces such as the hinged portion of forceps and scissors
• · Medical devices with a single stainless steel lumen with:
• o An inside diameter of 1 mm or larger and a length of 60 mm or shorter
• o An inside diameter of 2 mm or larger and a length of 250 mm or shorter

o An inside diameter of 3 mm or larger and a length of 350 mm or shorter

*The validation testing for all lumen sizes was conducted using a maximum of ten (10) lumens per load. Hospital loads should not exceed the maximum number of lumens validated by this testing. The validation studies were performed using a validation load consisting of one instrument tray with a total weight of 10.4 lbs.

The PSD-85 Non-Lumen Cycle can sterilize**:

· Non-lumen instruments including non-luments with stainless steel diffusion-restricted areas such as the hinged portion of forceps or scissors.

** The validation studies were conducted using a validation load consisting of one instrument tray with a total weight of 25.3 lbs.

The Sterilucent PSD-85 Hydrogen Peroxide Sterilizer (PSD-85) is a self contained stand alone device, using vaporized hydrogen peroxide as the sterilant. The PSD-85 is intended for use in the terminal sterilization of cleaned, rinsed, and dried, reusable metal and non-metal medical device used in healthcare facilities. The sterilization cycle operates at low pressure and temperatures, and is therefore suitable for processing medical devices that are sensitive to heat and moisture. The hydrogen peroxide vapor is generated by heating aqueous hydrogen peroxide and injecting into a chamber.

Acceptance Criteria and Study to Prove Device Meets Criteria

The Sterilucent PSD-85 Hydrogen Peroxide Sterilizer is a device intended for the terminal sterilization of cleaned, rinsed, and dried reusable metal and non-metal medical devices used in healthcare facilities. The device's performance was evaluated through various non-clinical studies to demonstrate its safety and effectiveness.

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for a sterilizer are generally tied to achieving a certain Sterility Assurance Level (SAL), typically a 10⁻⁶ probability of a viable microorganism remaining after sterilization. This is demonstrated through log reductions of highly resistant bacterial spores. While specific numerical acceptance criteria (e.g., minimum log reduction values for each test) are not explicitly enumerated in a single table, they are implied and demonstrated throughout the Non-clinical Performance Data section. The table below summarizes the critical performance aspects and the reported results which, by implication, demonstrate meeting the underlying acceptance criteria for sterilization efficacy.

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

The document does not explicitly state a single "sample size" for a unified test set in the traditional sense of a clinical trial. Instead, it details various non-clinical and microbiological tests, each with its own "test samples."

• Dose-Response Relationship: "various materials (representative of materials used in medical devices) as spore carriers"
• Surface Sterilization: "a wide variety of material coupons that were representative of materials used in re-usable medical devices."
• Mated Surface Sterilization: "a variety of medical device materials."
• Lumen Sterilization: Specific rigid stainless steel lumens of defined sizes. The validation testing for all lumen sizes was conducted using a maximum of ten (10) lumens per load.
• Simulated Use Testing: "Representative lumen and non-lumen devices" inoculated with spores. This process was repeated in triplicate for devices that were not clean for both the Lumen and Non-Lumen Cycles.
• In-Use Testing: "Devices representative of surface-features and lumen claims for the PSD-85 were selected for sterility testing... used in routine surgeries at a hospital." The number of devices is not specified.
• Bacteriostasis Testing: "coupons of representative materials."
• Sporicidal Activity of a Disinfectant: "carriers." (number not specified)

Data Provenance: The studies are non-clinical, laboratory-based tests primarily. The "In-Use Testing" involved devices "used in routine surgeries at a hospital," suggesting some real-world application data, likely performed within the United States. The document does not specify the country of origin for the other laboratory tests, but standard practice suggests they would be conducted in the country of manufacture or a certified testing facility. All studies are inherently prospective as they were designed experiments to test the sterilizer's performance.

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

For sterilization studies using biological indicators, the "ground truth" is intrinsically established by the viability or non-viability of the Geobacillus stearothermophilus spores after exposure to the sterilization process. This is a well-established microbiological assay. There is no mention of "experts" in the sense of physicians or radiologists reviewing output. Instead, qualified microbiologists or laboratory personnel would conduct and interpret these standard biological indicator tests. The document doesn't specify the number or specific qualifications (e.g., "microbiologist with X years of experience") of the individuals conducting or interpreting these lab tests.

4. Adjudication Method for the Test Set

Adjudication methods like "2+1" or "3+1" are typically relevant for human interpretation of data, such as imaging studies where multiple readers' opinions need to be reconciled. In these non-clinical, laboratory-based sterilization studies, the results (e.g., spore growth or no growth) are generally objective and interpreted according to established microbiological protocols. Therefore, a multi-reader adjudication method as described is not applicable and not mentioned in the document.

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 assesses the impact of a device (like AI assistance) on human reader performance. The Sterilucent PSD-85 is an automated sterilizer, not a diagnostic device that requires human interpretation. Therefore, a study of this nature is not relevant to its evaluation.

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

Yes, the entire evaluation presented in the "Summary of Non-clinical Performance Data" constitutes a standalone performance assessment of the Sterilucent PSD-85 sterilizer. The device operates autonomously without human intervention during the sterilization cycle (once loaded and initiated). The tests described (Dose-Response, Surface Sterilization, Mated Surface, Lumen, Simulated Use, In-Use, Bacteriostasis, Sporicidal Activity) all evaluate the device's inherent capability to achieve sterility.

7. The Type of Ground Truth Used

The primary ground truth used throughout the validation studies is microbiological proof of sterility, specifically the inactivation of Geobacillus stearothermophilus spores. This is achieved by:

• Biological Indicator (BI) Inoculation: Placing a known quantity of highly resistant bacterial spores (Geobacillus stearothermophilus) on various materials and within lumens.
• Viability Assessment: After exposure to the sterilization cycle, these inoculated samples are cultured (e.g., placed in growth media). The absence of growth confirms spore inactivation and thus sterility. The goal is often to achieve a Sterility Assurance Level (SAL) of 10⁻⁶, meaning a 1 in a million chance of a single viable microorganism remaining.
• Pathology/Outcomes Data: While "In-Use Testing" involves instruments from routine surgeries, the ground truth for sterility is still microbiological (i.e., checking for microbial growth after processing), not a clinical pathology diagnosis or patient outcome data directly.

8. The Sample Size for the Training Set

The concept of a "training set" is relevant for machine learning algorithms. The Sterilucent PSD-85 is a physical medical device (sterilizer) and not an AI/ML algorithm. Therefore, there is no "training set" in the context of machine learning. The device's operational parameters and design are based on engineering principles and established sterilization science, not iterative training on data.

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

As there is no "training set" for an AI/ML algorithm in this context, information on how its ground truth was established is not applicable.

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