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The STERIZONE® VP4 Test Pack is intended to be used for routine monitoring of the STERIZONE® VP4 Sterilizer cycle (Cycle 1) and for the performance validation of the STERIZONE® VP4 Sterilizer system.

The STERIZONE® VP4 Test Pack is a Process Challenge Device (PCD) designed to have greater resistance than the worst-case sterilization load of the STERIZONE® VP4 Sterilizer. The STERIZONE® VP4 Test Pack is intended to simulate products to be sterilized and to constitute a defined challenge to the sterilization process and used to assess the effective performance of the process.

The STERIZONE® VP4 Test Pack (subject device) is composed of a Self-contained Biological Indicator (the Terragene's Bionova® BT96), a 10 mL syringe and its plunger, and a diffusion restrictor. A STERIZONE® CI+ Chemical Indicator is also added, external to the syringe, to allow differentiating processed from unprocessed test packs. All components of the Test Pack are single-use, disposable items.

The provided text describes the performance testing of the STERIZONE® VP4 Test Pack (subject device) which uses the Terragene Bionova® BT96 biological indicator, compared to a predicate device that used a different biological indicator. The goal was to demonstrate substantial equivalence.

Here's the breakdown of the acceptance criteria and study information:

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 explicitly state the numerical sample size for the test set (e.g., number of test packs, number of sterilization cycles). It mentions "all the limit parameter loads tested" for half-cycle survivability and "partial cycles" for increased resistance, implying multiple runs, but no specific number.

The data provenance is from bench testing ("Performance Testing - Bench") conducted by TSO3 Inc. (now part of Stryker) for this 510(k) submission. The location of the testing is not specified, but the submitter is TSO3 Inc. in Québec, Canada and Stryker in Portage, Michigan, USA. The nature of the study is prospective, as it's performance testing for a new device qualification.

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

This information is not provided in the document. For biological indicators, the ground truth is typically established by the growth or non-growth of spores, which is a direct biological outcome, not subject to expert interpretation in the same way as, for example, a medical imaging diagnosis.

4. Adjudication method for the test set:

This information is not applicable and therefore not provided. The results of biological indicator testing (growth or no growth) are objective and do not require adjudication by multiple 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:

This information is not applicable as the device is a sterilization process indicator, not an AI-powered diagnostic tool for human readers.

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

This information is not applicable. The device is not an algorithm, but a physical biological indicator used in a sterilization process. Its performance is inherent to its design and biological response, not an algorithm's output.

7. The type of ground truth used:

The ground truth used is biological growth/non-growth of Geobacillus stearothermophilus spores. This is a direct measure of the effectiveness of the sterilization process in inactivating microorganisms.

8. The sample size for the training set:

This information is not applicable. The STERIZONE® VP4 Test Pack is a physical device, not a machine learning model, so there is no training set in the context of AI/ML. The device's resistance characteristics are determined through experimental validation, not by "training" an algorithm.

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

This information is not applicable as there is no training set. The performance is assessed against established standards for biological indicators.

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The STERIZONE® VP4 Sterilizer is intended for use in terminal sterilization of cleaned, rinsed, and dried metal and non-metal reusable medical devices in health care facilities.

The STERIZONE® VP4 Sterilization chamber has a capacity of 4.4 cu. ft. (125 liters). It requires oxygen (94% pure and greater), electricity and the 125-280 Solution™ containing 50% hydrogen peroxide by weight. Both hydrogen peroxide and ozone are used in a multiphase process.

The STERIZONE® VP4 Sterilizer is equipped with a factory-programmed control system offering a unique sterilization cycle.

Processed medical instruments are ready to use immediately after the cycle ends; no aeration is required.

Polypropylene non-woven wrapping material, non-woven polyethylene (Tyvek™) with polyester/LDPE transparent film pouches, and vaporized hydrogen peroxide compatible aluminium containers using disposable polypropylene filters, are used as packaging for medical devices to be sterilized. Plastic and metal trays are also suitable packaging means when combined with polypropylene wraps.

A self-contained biological indicator containing spores of G. stearothermophilus, incorporated into a test pack, is recommended to monitor cycle performance.

The STERIZONE® VP4 Sterilizer could be installed as a free standing unit or recessed behind the wall.

No exhaust gas ventilation duct is required as long as the room is adequately ventilated.

The document is a 510(k) premarket notification for the STERIZONE® VP4 Sterilizer, which is intended for terminal sterilization of reusable medical devices in healthcare facilities. It provides information regarding the device's indications for use, its sterilization process, safety and effectiveness testing, and a comparison to predicate devices to establish substantial equivalence.

Here's an analysis of the acceptance criteria and the study that proves the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance:

The document presents "Performance Requirements for Effectiveness" and "Performance Requirements for Safety" for the STERIZONE® VP4 Sterilizer, along with the results.

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

The "Effectiveness" validation was demonstrated using a "representative sample of one or more device types and packaging, in seven separate validation loads" (Table 1 and 2, pages 2-3 and 7-8). Each load contained various medical instruments representing different geometries and packaging types. The specific number of individual devices or biological indicators within each load is not explicitly stated as a "sample size" in the way it might be for a clinical trial. Instead, the "overkill" approach mentions inoculating medical devices with 10^6 microorganisms, implying a high concentration of test organisms rather than a large count of unique physical samples being tested. This type of testing is generally prospective, designed specifically for validation. The country of origin of the data is not explicitly stated, but the applicant's address is in Quebec, Canada, suggesting Canadian provenance for at least some of the underlying work.

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

This type of sterilization efficacy testing does not typically rely on human expert consensus for "ground truth" in the same way as, for example, image interpretation. The ground truth for sterilization is established through microbiological testing (e.g., demonstrating the eradication of 10^6 microorganisms, achieving a sterility assurance level (SAL) of 10^-6), and chemical analysis for residue. The document does not specify the number or qualifications of experts involved in analyzing these microbiological and chemical results, as these are standardized laboratory procedures.

4. Adjudication Method for the Test Set:

Not applicable in the context of sterilization device validation. Adjudication methods like "2+1" are used in studies involving subjective human interpretation, such as clinical image reading. Sterilization efficacy is determined by objective microbiological and chemical tests.

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

No, an MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic devices where human readers interpret outputs, often looking at how AI assistance changes their performance. For a sterilizer, the focus is on the device's inherent ability to achieve sterility, not on human interpretation of data.

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

Yes, the effectiveness testing describes the standalone performance of the STERIZONE® VP4 Sterilizer. The entire study focuses on the device's ability to sterilize medical devices on its own, independent of human intervention during the sterilization cycle once initiated. The "half-cycle validation testing," "simulated-use testing," and "in-use testing" all evaluate the device's performance directly.

7. The Type of Ground Truth Used:

The primary ground truth used for effectiveness testing is microbiological efficacy, specifically demonstrating a sterility assurance level (SAL) of 10^-6, which means a probability of one non-sterile item in a million. This is achieved through controlled inoculation of medical devices with a known quantity (10^6) of highly resistant microorganisms (e.g., Geobacillus stearothermophilus spores) and verifying their eradication after sterilization. Secondary ground truths include chemical analysis to ensure the absence of toxic residues and by-products.

8. The Sample Size for the Training Set:

This document does not describe a "training set" in the context of machine learning. The STERIZONE® VP4 Sterilizer is not an AI/ML device in the sense of requiring a training set of data for an algorithm to learn from. The "training" for a sterilization device would be the engineering design, development, and iterative testing that precedes the final validation studies.

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

Not applicable, as the device is not an AI/ML device that requires a training set and corresponding ground truth. The "ground truth" during the development and design phases would be based on established principles of microbiology, chemistry, and engineering for effective and safe sterilization.

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The STERIZONE® BI+ Self-contained Biological Indicator (SCBI) is intended for routine monitoring of the STERIZONE® VP4 Sterilizer, which offers a single pre-set sterilization cycle ("Cycle 1"). The SCBI should only be used in a Test Pack configuration to monitor Cycle 1. The SCBI placed within the STERIZONE® VP4 Test Pack monitors exposure to both vaporized hydrogen peroxide (H2O2 or VHP) and ozone (O3) which are both used in the STERIZONE® VP4 Sterilizer. The STERIZONE® VP4 Test Pack is intended to have equivalent to greater resistance than worst case devices and loads in any load configuration.

The STERIZONE® BI+ Self-contained Biological Indicator (TSO3 product code 42602) consists of at least 106 Geobacillus stearothermophilus viable spores, known to be the reference microorganism for the STERIZONE® VP4 Sterilizer sterilization process, grouped on a stainless steel carrier and enclosed in a protective package. Subsequent growth or failure of the microorganisms to grow under suitable conditions indicates the adequacy of sterilization. The presence of G. stearothermophilus spores is detected by a visual color change (media turns yellow). The yellow color change indicates bacterial growth. No change of color indicates that the process achieved the conditions necessary to kill at least 1 × 106 viable spores of G. stearothermophilus (6 logs) on the SCBI inoculated stainless steel carrier. The final readout of a negative result (media remains purple) is made after 18 hours of incubation when using a dry-bath type incubator.

The STERIZONE® VP4 Test Pack is a device composed of the STERIZONE® BI+ Selfcontained Biological Indicator (TSO3 product code 42602, including crusher), a 10 mL syringe and its plunger, and a diffusion restrictor (sold in the form of a kit - TSO3 product code: 44020). A STERIZONE® CI+ Chemical Indicator (TSO3 product code 43810) is also added, external to the syringe, to allow differentiating processed test packs. All components of the Test Pack are single-use, disposable items.

The provided document describes the STERIZONE® BI+ Self-contained Biological Indicator and STERIZONE® VP4 Test Pack and includes a summary of nonclinical performance tests.

Here's a breakdown of the requested information:

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 used for each of the nonclinical tests. It only lists the tests performed and their results. The data provenance is not specified (e.g., country of origin, retrospective/prospective). These were likely laboratory-based studies conducted by the manufacturer, TSO3 Inc., in Québec, Canada.

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

This information is not provided in the document. The tests performed are objective, laboratory-based assays (e.g., population counts, growth inhibition) that do not typically rely on human expert consensus for ground truth establishment in the way clinical diagnostic devices might.

4. Adjudication Method for the Test Set

This information is not applicable and is not provided in the document. The tests are scientific measurements or observations with clear pass/fail criteria, not subjective interpretations 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 typically used for diagnostic devices where human readers interpret medical images or data. The STERIZONE® BI+ Biological Indicator is a sterilization process indicator evaluated through laboratory performance tests.

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

The device itself is a physical biological indicator, not a software algorithm. Therefore, the concept of "standalone (algorithm only)" is not applicable. The performance evaluation is based on the biological and chemical responses of the indicator to sterilization conditions.

7. The Type of Ground Truth Used

The ground truth for these nonclinical tests is based on established scientific principles and standards for biological indicators and sterilization efficacy.

• Viable population assay: Ground truth is the measured number of viable spores, compared against a specified range (e.g., $\ge1 \times 10^6$ viable spores).
• Growth inhibition: Ground truth is the observation of microbial growth/no growth in the presence/absence of carrier materials and pack materials.
• Reduced incubation time/stability of biological read/positive controls: Ground truth is the presence or absence of spore growth within specified timeframes or under specific conditions.
• BI validation in the STERIZONE® VP4 process & Test Pack performance evaluation: Ground truth is the kill of a specified log reduction of Geobacillus stearothermophilus spores (6 logs) under defined sterilization conditions (half-cycle vs. full cycle).

8. The Sample Size for the Training Set

The document does not describe a "training set" in the context of machine learning or AI. The tests described are validation tests for the physical device's performance characteristics. Development and optimization of the biological indicator would have involved internal testing, but this is not detailed as a "training set."

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

As there is no "training set" in the AI/ML sense, this question is not applicable. The device's performance is established through direct physical and biological testing against known sterilization challenges, rather than through a learning algorithm trained on data.

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The STERIZONE® CI+ Chemical Indicator is a single-use process indicator intended to distinguish between processed and unprocessed packaged medical devices to be sterilized using the STERIZONE® VP4 Sterilizer. The device is intended for use only with the STERIZONE® VP4 Sterilizer, which has a single sterilization cycle ("Cycle 1"). Critical process parameters for Cycle 1 are summarized in Table 1.

The red stripe chemical indicator is located above the peach-colored stripe labeled as the "REFERENCE". After exposure to the Cycle 1 of the STERIZONE® VP4 Sterilizer, the chemical indicator color changes from red to peach-Reference color (or lighter).

The STERIZONE® CI+ Chemical Indicator (CI+) is a Class 1 process indicator that conforms to ANSI/AAMI/ISO 11140-1: 2005(R)2010, and is intended to only be used with the STERIZONE® VP4 Sterilizer. The single pre-set cycle (Cycle 1) of the STERIZONE® VP4 Sterilizer utilizes vaporized hydrogen peroxide and ozone in a multiphase process, to rapidly sterilize a variety of reusable medical devices.

The CI+ chemical indicator consists of a polymeric material strip on which an indicator ink, a reference color and a varnish coating have been deposited. The CI+ provides a visual indication that a sterilization load has been exposed to the STERIZONE® VP4 Sterilizer Cycle 1. The indicator works by means of a chemical reaction, which results is a recognizable color change from red to peach (or lighter).

The provided text describes the STERIZONE® CI+ Chemical Indicator and its assessment for substantial equivalence to a predicate device. It explicitly states that "Performance testing was conducted to demonstrate the functionality of the STERIZONE® CI+ Chemical Indicator and general conformance with the requirements for Class 1 vaporized hydrogen peroxide sterilization indicators as detailed in ANSI/AAMI/ISO 11140-1:2005(R)2010."

However, the document does not describe a study involving an AI device or algorithm. The "device" in question is a chemical indicator that changes color. Therefore, most of the requested information regarding AI device-specific criteria (like sample sizes for test/training sets, data provenance, number/qualification of experts, adjudication methods, MRMC studies, or standalone algorithm performance) is not applicable or cannot be extracted from this text.

I will provide the acceptance criteria and performance as described for the chemical indicator, and note where the requested information is not relevant to this type of device.

1. Table of Acceptance Criteria and Reported Device Performance:

2. Sample Sizes and Data Provenance for Test Set:
The document does not specify specific sample sizes (e.g., number of indicators tested) for each non-clinical test.
Data provenance (country of origin, retrospective/prospective) is not mentioned for these tests, which are laboratory-based functionality tests for a chemical indicator, not typically tied to patient data.

3. Number and Qualifications of Experts for Ground Truth (Test Set):
Not applicable. This device is a chemical indicator with a physical color change. Its performance is assessed by physical and chemical tests against a standard, not by human expert interpretation in the same way an AI diagnostic tool would be.

4. Adjudication Method for Test Set:
Not applicable for the reasons stated above. The "ground truth" for a chemical indicator is its physical response to sterilization parameters as defined by industry standards.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
Not applicable. This is a chemical indicator, not an AI system. There are no "human readers" to improve with "AI assistance" in this context.

6. Standalone (Algorithm Only) Performance Study:
Not applicable. This device is a passive chemical indicator, not an algorithm.

7. Type of Ground Truth Used:
The ground truth used for evaluating the STERIZONE® CI+ Chemical Indicator is based on industry standards and physical/chemical properties. Specifically, performance is assessed against the requirements for Class 1 vaporized hydrogen peroxide sterilization indicators as detailed in ANSI/AAMI/ISO 11140-1:2005(R)2010. The color change (red to peach or lighter) triggered by exposure to the STERIZONE® VP4 Sterilizer's Cycle 1 is the intended functional ground truth.

8. Sample Size for Training Set:
Not applicable. This is a manufactured chemical indicator, not an AI model that requires a training set.

9. How Ground Truth for Training Set Was Established:
Not applicable. As above, no training set or AI model is involved.

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TSO3 125L Ozone Sterilizer is intended for use in the sterilization processing of reusable medical devices in health care facilities. TSO 125L Ozone Sterilizer is designed for sterilization of both metal and non-metal medical devices at low temperatures.

TSO3 125L Ozone Sterilizer has the ability to sterilize successfully packaged rigid and flexible lumen medical devices, including single and multi channel flexible endoscopes such as fiberoptic and video endoscopes.

TSO3 Ozone Sterilizer, model 125L is intended to sterilize medical devices that has been previously cleaned.

The sterilization chamber has a capacity of 125 liters (4.3 cu. ft.).

It requires USP grade oxygen, water and electricity. TSO3 Sterilizer could be installed as a free standing unit or recessed behind the wall. No exhaust gas ventilation duct is required as long as the room is adequately ventilated. By-products are oxygen and low humidity water vapor.

Model 125L is equipped with a unique factory-programmed control system.

Non-woven wrapping material or pouches and anodized aluminum containers are used as packaging for medical devices to be sterilized.

OZO-TEST® self-contained Biological Indicators (B. stearothermophilus) are recommended for use in evaluating cycle performance.

TSO3 Chemical Indicators are available for this process.

No aeration is needed following the sterilization cycle. The sterilized items are cool to the touch and can be removed immediately and used, or stored for future use.

The provided text describes the TSO3 Ozone Sterilizer, Model 125L, and its validation for sterilizing flexible endoscopes. However, it does not contain a typical "acceptance criteria" table with specific quantitative metrics (like sensitivity, specificity, accuracy) and corresponding performance outcomes for an AI/device, as it's a sterilizer, not a diagnostic or AI-powered medical device.

Based on the information provided, here's a breakdown of the requested elements adapted for this type of device:

Acceptance Criteria and Study for TSO3 Ozone Sterilizer, Model 125L

The primary acceptance criterion for a sterilizer is to achieve a sufficient Sterility Assurance Level (SAL), typically 10^-6, meaning a one-in-a-million probability of a non-sterile item. The study demonstrates effectiveness through an "overkill" approach and validated test cycles.

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size: Not explicitly stated as a number of distinct "cases" in the way a diagnostic device would have patient samples. Instead, the study involved:
  • Testing with flexible endoscopes: "single and multi channel flexible endoscopes such as fiberoptic and video endoscopes." Specific types evaluated include: Colonoscope, Gastroscope, Broncho videoscope, Choledofiberscope, and Ureteroscope.
  • A specific test load configuration was used for qualification testing: 2 multi-channel and 1 single-channel flexible endoscope, plus 14 medical devices packaged in TSO3 Sterilization Pouches, and a Process Challenge Device.
  • Biological Indicators (B. stearothermophilus) were used to evaluate cycle performance, though the number of indicators per test is not specified.
• Data Provenance: The study was conducted as a validation of a medical device sterilizer, implying laboratory and simulated-use testing. The document is a 510(k) submission to the FDA for a device manufactured by TSO3 Inc. in Québec, Canada. The document itself does not specify a country of origin for the "data" in terms of patient population or retrospective/prospective clinical data, as this is a device effectiveness study, not a clinical trial. It is a prospective validation study.

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

This information is not provided in the document. For a sterilizer, "ground truth" is typically established by microbiological testing (e.g., negative growth of biological indicators after processing), not by expert consensus on visual or diagnostic interpretation.

4. Adjudication Method for the Test Set

This information is not provided in the document. Adjudication methods like 2+1 or 3+1 are typically used in clinical studies where multiple human readers assess a case and their disagreements need resolution. This is not applicable to a sterilizer performance study.

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

• No, an MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic devices where human readers interpret images or data, and an AI system might assist them. The TSO3 Ozone Sterilizer is a medical device sterilizer, not an AI-powered diagnostic tool.

6. Standalone Performance Study

• Yes, a standalone study was done. The "Effectiveness" section states that "Ozone Sterilizer validation testing... was performed using the 'overkill' approach to demonstrate the effectiveness of the process." This demonstrates the performance of the algorithm/device (the sterilizer itself) without human intervention in the sterilization process (beyond loading/unloading).
  • The study included:
    • Full cycle validation testing in simulated use conditions.
    • Half-cycle validation testing.
    • In-use testing.

7. Type of Ground Truth Used

The ground truth used was microbiological evidence and validated laboratory sterility testing. This is inferred from:

• The use of the "overkill" approach to demonstrate effectiveness.
• The goal of achieving a Sterility Assurance Level (SAL) of 10^-6.
• The recommendation for using OZO-TEST® self-contained Biological Indicators (B. stearothermophilus) to evaluate cycle performance. This implies the absence of viable microorganisms is the ground truth.

8. Sample Size for the Training Set

This information is not applicable / not provided. Sterilizers are not "trained" in the way AI algorithms are. Their design and validation are based on engineering principles and microbiological test standards.

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

This information is not applicable / not provided for the same reason as point 8. The device's operational parameters are factory-programmed based on scientific validation and engineering design, not through a "training set" with established ground truth.

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The TSO3 Ozone Sterilization Wrap is a single-use, non-sterile device. It is intended to be used 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 wrap is intended for use with TSO3 Ozone Sterilization process.

The TSO3 Ozone Sterilization Wrap is a single-use, non-sterile device. It is intended to be used 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 wrap is intended for use in the TSO3 Ozone Sterilization process.

The TSO3 Ozone Sterilization Wrap is a 2 layer laminate consisting of an ePTFE membrane and a 100% Polyethylene/Polyester (PE/PET) bi-component nonwoven backer.

The TSO3 Ozone Sterilization Wrap is a single-use, non-sterile device intended to enclose a medical device for sterilization and maintain its sterility until use, specifically with the TSO3 Ozone Sterilization process.

Here's a breakdown of the acceptance criteria and study information:

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 sample size used for the test set for the sterilization performance and shelf-life sterility studies. It only mentions that "sterilization performance studies and shelf-life sterility tests were conducted."

For biocompatibility testing, it states that "A skin irritation test was performed by an independent laboratory to demonstrate that the final product does not induce any biocompatibility hazard." The specific sample size for this test is not provided in the summary.

The provenance of the data (country of origin, retrospective/prospective) is not specified in the provided text.

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

This information is not provided in the given text.

4. Adjudication Method for the Test Set

This information is not provided in the given text.

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

A multi-reader multi-case (MRMC) comparative effectiveness study was not done as this device is a sterilization wrap, not an AI-assisted diagnostic tool where human readers would be involved in interpreting results. Therefore, there is no effect size of human readers improving with AI assistance.

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

This is not applicable as the device is a physical sterilization wrap, not an algorithm.

7. Type of Ground Truth Used

• For Effectiveness (Sterilization Performance and Shelf-life Sterility): The ground truth would likely be established by microbiological testing, confirming the absence of viable microorganisms after sterilization and during the shelf-life. The document states "all acceptance criteria were met," implying these tests confirmed the desired outcome.
• For Biocompatibility (Skin Irritation, Cytotoxicity, Sensitization): The ground truth was established by laboratory testing according to ISO 10993 standard, part 1. This involves observing biological responses (e.g., cell viability, skin reactions) to the device materials.

8. Sample Size for the Training Set

This information is not applicable as the device is a physical product, not an AI model that requires a training set.

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

This information is not applicable for the same reason as above.

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The TSO3 Model 125L is an Ozone Sterilizer intended for use in the sterilization processing of reusable medical devices in health care facilities. The TSO3 Ozone Sterilizer, Movol 1252. is designed for sterilization of both metal and non-metal medical devices at low temperatires. The sterilization cycle operates at very low pressure and low temperature, consequently it is suitable for processing medical devices sensitive to heat and moisture.

The TSO3 Ozone Sterilizer, Model 125L, is designed to sterilize instruments and devices with diffusion-restricted spaces, such as the hinged portion of forceps and sciators.

TSO3 Ozone Sterilizer, model 125L is intended to sterilize medical devices that has been previously cleaned.

The sterilization chamber has a capacity of 125 liters (4.3 cu. ft.).

It requires USP grade oxygen, water and electricity. Model 125L could be installed as a free standing unit or recessed behind the wall. No exhaust gas ventilation duct is required as long as the room is adequately ventilated. By-products are oxygen and low humidity water vapor.

Model 125L is equipped with a unique factory-programmed control system.

Non-woven wrapping material or pouches and anodized aluminum containers are used as packaging for medical devices to be sterilized.

OZO-TEST® self-contained Biological Indicators (B. stearothermophilus) are recommended for use in evaluating cycle performance.

TSO3 Chemical Indicators are available for this process.

No aeration is needed following the sterilization cycle. The sterilized items are cool to the touch and can be removed immediately and used, or stored for future use.

Here's an analysis of the provided text regarding the TSO3 Ozone Sterilizer, Model 125L, focusing on acceptance criteria and the supporting study:

Device Performance and Acceptance Criteria

The TSO3 Ozone Sterilizer, Model 125L, was tested for its ability to sterilize medical devices with extended lumens. The acceptance criterion for sterilization is the achievement of a Sterility Assurance Level (SAL) of 10^-6, which means the probability of a single viable microorganism remaining on an item after sterilization is 1 in a million.

The study demonstrated the device's ability to sterilize a range of stainless steel lumens.

Table of Acceptance Criteria and Reported Device Performance

Note: The document states, "Testing on lumens were conducted employing half cycle to demonstrate achievement of a sterility assurance level (SAL) of 10^-6." This "half cycle" method is a common and stringent approach to demonstrate an SAL, as it proves that even under reduced sterilization conditions (half of a full cycle), the target SAL can still be met, implying that a full cycle would provide an even greater margin of safety.

Study Details

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

• Sample Size: The document does not explicitly state the numerical sample size (number of lumens) used for the test set. It lists five distinct lumen configurations (combinations of internal diameter and length) that were tested. For each configuration, multiple tests would have been performed using biological indicators to establish the SAL.
• Data Provenance: The study was conducted by TSO3 Inc. in Quebec, Canada. The data is likely prospective as it describes specific validation testing performed to support the extended lumen claims.

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

• The document does not mention the use of human experts or an expert panel to establish ground truth for the test set in the context of sterilization efficacy. Sterilization efficacy studies typically rely on quantitative laboratory methods (e.g., biological indicators) rather than subjective expert assessment.

4. Adjudication method for the test set:

• Not applicable. Adjudication methods (like 2+1, 3+1) are typically used for subjective diagnostic assessments where discrepancies among human readers need resolution. For sterilization efficacy, the "ground truth" is determined by the inactivation of biological indicators, which is an objective measure.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

• Not applicable. This device is a sterilizer, not an AI-powered diagnostic or assistive tool for human readers. Therefore, an MRMC study comparing human reader performance with or without AI assistance is irrelevant to this device.

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

• The device itself is a "standalone" sterilizer. Its performance is evaluated intrinsically through its ability to inactivate microorganisms, not as an algorithm assisting a human. The "effectiveness" section explicitly describes validation testing of the process (sterilizer) using an "overkill" approach and biological indicators, which is a standalone assessment of the device's function.

7. The type of ground truth used:

• The ground truth for sterilization efficacy was established using biological indicators (B. stearothermophilus). These indicators contain a known population of highly resistant bacterial spores. The complete inactivation of these spores after sterilization, especially in a "half cycle" challenge, directly demonstrates the achievement of the required Sterility Assurance Level (SAL). This is an objective, laboratory-based method.

8. The sample size for the training set:

• Not applicable. This device is a sterilizer, not an AI model that requires a training set. The "validation testing" described refers to the testing of the physical device's performance, not the training of an algorithm.

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

• Not applicable, as there is no training set for an AI/algorithm in this context.

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