Search Results

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.

Ask a specific question about this device

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.

Ask a specific question about this device

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.

Ask a specific question about this device