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The Getinge Assured MI Steam Migrating Integrator strip is an internal pack integrating indicator designed to react to critical process parameters of a steam sterilization cycle within a stated tolerance. The integrating indicator is intended to be placed in each pack, pouch, tray or container to function as an independent monitor of critical parameters for the following sterilization cycles:

Steam Sterilization Cycles: 250°F/121°C, 30 minutes Gravity 270°F/132°C, 4 minutes Dynamic Air Removal 270°F/132°C, 15 minutes Gravity 275°F/135°C, 3 minutes Dynamic Air Removal 275°F/135°C, 10 minutes Gravity

Steam Sterilization Cycles (IUSS): 270°F/132°C, 4 minutes Dynamic Air Removal 270°F/132°C, 3 minutes Gravity 270°F/132°C, 10 minutes Gravity 275°F/135°C, 3 minutes Dynamic Air Removal 275°F/135°C, 3 minutes Gravity 275°F/135°C, 10 minutes Gravity

Stated values (as determined in a steam resistometer): 30 minutes at 121°C 9.1 minutes at 128°C 3.3 minutes at 132°C 1.5 minutes at 135°C

The Getinge Assured MI Steam Migrating Integrator is a single use device to monitor steam sterilization cycles. The integrating indicator is designed to react to critical process parameters of a steam sterilization cycle within a stated tolerance. The integrating indicator is intended to be placed in each pack, pouch, tray or container to function as an independent monitor of critical parameters for sterilization cycles. During steam sterilization, the integrating indicator pellet will migrate into the PASS zone when sterilization conditions have been met.

A paper wick and a steam sensitive chemical pellet containing blue colored dye. A pellet is held within a pocket located at one end of an aluminum foil base. The foil base is adhered to label material that has been bonded with a film. During steam sterilization, the integrating indicator pellet will migrate into the PASS zone when the specified critical parameters of steam sterilization have been met.

The provided text describes the Getinge Assured MI Steam Migrating Integrator, a chemical indicator used to monitor steam sterilization cycles. Here's a breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance

• 30 Minutes at 121°C
• 3.3 minutes at 132°C
• 1.5 minutes at 135°C | PASS |
  | Steam Resistometer (BIER vessel) Testing (Pass/Fail at Reduced Time) | Failing Result at 15% less time of SV for each temperature claimed | PASS |
  | Steam Resistometer (BIER vessel) Testing (Pass/Fail at Reduced Temperature) | Failing Result at 1°C less for each temperature claimed | PASS |
  | Hospital Steam Sterilizer Testing | 100% samples passing under passing conditions for each cycle
  100% samples failing under failing conditions for each cycle | PASS |
  | Dry Heat Testing | Failing result when exposed to dry heat alone for 30 minutes (±1 minute) at 140°C (±2°C) | PASS |
  | Side-by-side testing of biological indicator and integrator in steam resistometer | The integrator does not reach its endpoint before the biological indicator is inactivated | PASS |
  | Offset/Transference | The indicator agent shall not offset or bleed, penetrate the substrate to which it is applied, or materials in which it is in contact before, during or after the sterilization cycles for which it is designed | PASS |

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

The provided document does not specify the exact sample size for the test set (number of integrators used in each test). It also does not explicitly state the country of origin of the data or whether the studies were retrospective or prospective.

However, for "Hospital Steam Sterilizer Testing," it mentions "an actual sterilization cycle used in a health care facility," which implies real-world, prospective testing. The resistometer testing would typically be conducted in a laboratory setting.

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

This information is not provided in the document. The ground truth for chemical indicators like this is typically established by the physical and chemical parameters of the sterilization cycle itself (achieving specific temperature, time, and steam conditions), and comparing the indicator's response to these measured parameters or to a biological indicator. There is no mention of human experts establishing ground truth in the context of interpreting the indicator's performance.

4. Adjudication Method for the Test Set

This information is not applicable or provided for this type of device. The determination of "PASS" or "FAIL" for the chemical integrator is based on the physical migration of the pellet into a "PASS" zone, which is a direct, observable, and objective outcome. There is no mention of human adjudication in interpreting the results of the performance tests.

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

No, a Multi Reader Multi Case (MRMC) comparative effectiveness study was not done. This type of study is relevant for AI-powered diagnostic devices or imaging analysis where human readers interpret output. The Getinge Assured MI Steam Migrating Integrator is a chemical indicator that provides a direct visual result (pellet migration to "PASS" zone), not an output that requires human interpretation in the same way as an imaging study. There is no AI component involved.

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 chemical indicator, not an algorithm. Its performance is inherent in its physical and chemical properties and its interaction with the sterilization parameters, not through an algorithm.

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

The ground truth used for testing the Getinge Assured MI Steam Migrating Integrator is based on:

• Physical and chemical parameters of the sterilization cycle: Measured temperature, time, and steam conditions in a controlled setting (steam resistometer).
• Comparison to a biological indicator (BI): For the side-by-side testing, the performance of the chemical integrator is compared against a biological indicator, which is considered the gold standard for verifying sterilization efficacy. The ground truth is that sterilization conditions must be sufficient to inactivate the biological indicator.

8. The sample size for the training set

This information is not applicable as there is no "training set" for a chemical indicator. Chemical indicators are designed and manufactured based on established chemical and physical principles, not through machine learning or algorithm training.

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

This information is not applicable as there is no training set.

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SteriTec Biological Test Pack with Instant Readout Integrator is a single-use device designed specifically for testing of 3 or 4 minutes at 132°C (270°F) and 3 minutes at 135°C (275°F) in pre-vacuum steam sterilizers. The test pack consists of a selfcontained biological indicator containing Geobacillus stearothermophilus inside a small package of porous and nonporous materials, simulating the biological indicator 16 towel test packs defined by AAMI ST79. When used as directed, the Chemical Indicator Record Card gives visible indication that sterilizing conditions were met.

The test pack consists of a selfcontained biological indicator containing Geobacillus stearothermophilus inside a small package of porous and nonporous materials, simulating the biological indicator 16 towel test packs defined by AAMI ST79. When used as directed, the Chemical Indicator Record Card gives visible indication that sterilizing conditions were met.

The provided text describes a 510(k) premarket notification for a medical device called the "SteriTec Biological Test Pack with Instant Readout Integrator, Model No.: B1 111." This device is a biological indicator designed for testing pre-vacuum steam sterilizers.

However, the document is a regulatory clearance letter, not a scientific study report. It states that the device is "substantially equivalent" to legally marketed predicate devices.

Therefore, the detailed information requested regarding acceptance criteria, device performance, study design, sample sizes, ground truth establishment, expert involvement, and comparative effectiveness studies (MRMC) is not available within this document. This letter does not provide the results of any clinical or performance studies.

To answer your questions comprehensively, information from the actual device validation study would be needed, which is not included in this FDA 510(k) clearance letter.

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SteriTec Smart Read Biological Test Pack with Instant Readout Integrator is a single-use device designed specifically for testing of 3 or 4 minutes at 132°C (270°F) and 3 minutes at 135°C (275°F) in pre-vacuum steam sterilizers. The test pack consists of a selfcontained biological indicator containing Geobacillus stearothermophilus inside a small package of porous and nonporous materials, simulating the biological indicator 16 towel test packs defined by AAMI ST79. When used as directed, the Chemical Indicator Record Card gives visible indication that sterilizing conditions were met.

The test pack consists of a selfcontained biological indicator containing Geobacillus stearothermophilus inside a small package of porous and nonporous materials, simulating the biological indicator 16 towel test packs defined by AAMI ST79. When used as directed, the Chemical Indicator Record Card gives visible indication that sterilizing conditions were met.

The provided text is a 510(k) clearance letter from the FDA for the SteriTec Smart-Read Biological Test Pack. It does not contain information about the acceptance criteria, device performance, or details of a study that proves the device meets acceptance criteria in the context of an AI/ML medical device.

The document discusses:

• The device name and model number.
• The regulation number and name.
• The regulatory class.
• The product code.
• The date of the submission and receipt.
• The determination of substantial equivalence to a legally marketed predicate device.
• General controls provisions of the Act that apply to the device.
• Contact information for various FDA divisions.
• The intended indications for use of the device, which is a biological test pack for steam sterilizers.

This biological test pack is a physical device used to verify sterilization conditions, not an AI/ML algorithm or software. Therefore, the requested information regarding AI/ML device performance metrics, sample sizes for test/training sets, expert adjudication, MRMC studies, or ground truth establishment relevant to AI/ML devices is not present in this document.

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SteriTec Green Card Pack Bowie-Dick Test is a single designed to detect the presence of residusl air in pro-veauum steam sterilizers operating at 132°C for 3.5 minutes. The indicator card within the Green Card Pack will demonstrate a uniform color change from purple to green when proper sterlization conditions are met and no air is present to create a 2° C (+19-0° C) temperature difference between the center of the towel pack, as identified in ANSVAAMI/ISO 11140-5, and the drain temperature at the beginning of the final one minute of a three and half minute cycle the indicator card within the Green Card Pack will demonstrate a non-uniform color change.

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This document is a marketing authorization letter for a medical device (SteriTec Green Card Pack Bowie-Dick Test) and does not contain the detailed study information required to answer the prompt. The request asks for acceptance criteria and study details, including sample sizes, data provenance, expert qualifications for ground truth, adjudication methods, MRMC study results, standalone performance, and how ground truth for training data was established. This marketing authorization letter, specifically pages 1-3, focuses on regulatory approval, substantial equivalence, and indications for use. It does not provide the technical details of a performance study demonstrating acceptance criteria.

Therefore, I cannot fulfill the request using only the provided text.

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SteriTec Green Card Pack Bowie-Dick Test is designed to detect the presence of residual air in pre-vacuum steam sterilizers operating at 132°C for 3.5 minutes. The indicator card within the Green Card Pack will demonstrate a uniform color change from purple to green when proper sterilization conditions are met and no air is present. If enough air is present to create a 2° C (+1°-0° C) temperature difference between the center of the towel pack, as identified in ANSI/AAMI/ISO 11140-5, and the drain temperature at the beginning of the final one minute of a three and half minute cycle the indicator card within the Green Card Pack will demonstrate a non-uniform color change.

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The provided document is a 510(k) clearance letter for the SteriTec Green Card Pack Bowie-Dick Test, Model BD 126. It describes the device's intended use and FDA's determination of substantial equivalence. However, this document does not contain the detailed acceptance criteria for a study or the results of such a study.

The letter mentions that the device is "substantially equivalent" to legally marketed predicate devices, which implies that the device likely underwent testing to demonstrate this equivalence. However, the specific design of that testing, including the acceptance criteria, sample sizes, ground truth establishment, or any comparative effectiveness studies, is not included in this regulatory clearance letter.

Therefore, I cannot provide the requested information from the given text. To answer your questions, one would need access to the actual 510(k) submission data, which would include the performance testing report.

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SteriTec Green Tape can be used in 121°C gravity sterilizers for 30 minutes or pre-vacuum sterilizers operating at 132°C for 4 minutes and 135°C for 3 minutes. Stripes turn black after exposure to steam sterlization conditions, thus providing identification of processed items.

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The provided document {0-2} describes the FDA 510(k) clearance for the SteriTec Green Tape, Model No: CI 159/1, CI 159/.5, CI 159/.75. This document focuses on the regulatory approval process and includes an "Indications for Use" section.

However, the document does not contain the detailed information necessary to answer the specific questions about acceptance criteria, device performance studies, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, or ground truth establishment for a diagnostic AI/medical imaging device.

The SteriTec Green Tape is a sterilization process indicator, which is a chemical indicator designed to demonstrate that an item has been exposed to a sterilization process. It's not a diagnostic device involving complex algorithms, image analysis, or human reader interpretation in the way your questions are framed (e.g., radiologists, AI assistance).

Therefore, I cannot provide a table of acceptance criteria and reported device performance from this document for the type of device you envision. The information you are requesting is typically found in pre-market submission summaries for more complex diagnostic devices, not for a chemical sterilization indicator.

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SteriTec Smart Read Biological Test Pack with Instant Readout Integrator is designed specifically for testing of 3 or 4 minutes at 132°C (270°F) and 3 minutes at 135°C (275°F) in pre-vacuum steam sterilizers. When used as directed, the Chemical Indicator Record Card gives visible indication that sterilizing conditions were met.

The test pack consists of a self-contained biological indicator containing Geobacillus stearothermophilus inside a small package of porous and nonporous materials, simulating the biological indicator 16 towel test packs defined by AAMI ST79.

This document is a 510(k) clearance letter from the FDA for a medical device. It does not contain information about specific acceptance criteria or the study used to prove the device met those criteria. The letter acknowledges the submission and declares the device substantially equivalent to a predicate device based on the information provided by the applicant.

Therefore, I cannot extract the requested information from the provided text.

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SteriTec Smart-Read® Biological Test Pack with Instant Readout Integrator is designed specifically for testing of 3 minutes or longer at 132°C (270°F) in pre-vacuum steam sterilizers. The test pack consists of a self-contained biological indicator containing Geobacillus stearothermophilus inside a small package of porous and nonporous materials, simulating the biological indicator 16 towel test packs defined by ANSI/AAMI ST79. When used as directed, the Chemical Integrator Record Card gives visible indication that sterilizing conditions were met.

The test pack consists of a self-contained biological indicator containing Geobacillus stearothermophilus inside a small package of porous and nonporous materials, simulating the biological indicator 16 towel test packs defined by ANSI/AAMI ST79. When used as directed, the Chemical Integrator Record Card gives visible indication that sterilizing conditions were met.

The provided text is a 510(k) premarket notification FDA letter for a sterilization process indicator. It is not an AI/ML device and therefore does not contain the information required to answer the prompt.

The document discusses the regulatory approval of the "SteriTec Biological Test Pack with Instant Readout Integrator, Model No.: BI 108" and confirms its substantial equivalence to predicate devices. It outlines the general controls provisions of the Act that apply to the device and provides contact information for further inquiries. The "Indications for Use" section specifies that the device is designed for testing pre-vacuum steam sterilizers at particular temperatures and durations and visually indicates if sterilizing conditions were met.

Since this is a traditional medical device (a biological test pack for sterilization) and not an AI/ML powered device, the concepts of acceptance criteria in the context of AI/ML model performance (e.g., sensitivity, specificity, AUC), sample size for test sets/training sets, experts for ground truth, adjudication methods, MRMC studies, or standalone algorithm performance are not applicable here.

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SteriTec Emu-Graph is a steam sterilization emulator for use in a pre-vacuum steam sterilizer at 132°C (270° F) or 135° C (275° F). When exposed to a steam sterilization process, the 2 MIN and 4 MIN indicator bars will turn from purple to green giving an integrated response and visible indication that sterilization conditions were met. If only the 2 MIN indicator bar turns green and the 4 MIN indicator bar displays an incomplete color change, insufficient sterilization conditions occurred.

Critical Parameters in a standard hospital pre-vacuum steam sterilizer

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This document is a 510(k) clearance letter for a medical device called the Emu-Graph Emulator, Model No. CI 131, which is a steam sterilization emulator. The letter states that the device is substantially equivalent to legally marketed predicate devices.

The document does not contain the detailed acceptance criteria and the study that proves the device meets those criteria in the format requested. It primarily focuses on the FDA's clearance of the device based on substantial equivalence.

Therefore, I cannot provide a table of acceptance criteria and reported device performance or information about sample sizes, ground truth establishment, expert qualifications, adjudication methods, MRMC studies, or standalone performance from the provided text. The document only describes the intended use and the critical parameters for its function.

What is present in the document is a description of the device's function and expected visual indication related to sterilization conditions:

• Indications for Use: SteRiTec Emu-Graph is a steam sterilization emulator for use in a pre-vacuum steam sterilizer at 132°C (270°F) or 135°C (275°F).
• Expected Performance:
  • When exposed to sufficient sterilization process, the 2 MIN and 4 MIN indicator bars will turn from purple to green, giving an integrated response and visible indication that sterilization conditions were met.
  • If only the 2 MIN indicator bar turns green and the 4 MIN indicator bar displays an incomplete color change, insufficient sterilization conditions occurred.
• Critical Parameters:
  • Temperature: 132°C (270°F) - 4 MIN Indicator: 4 minutes
  • Temperature: 135°C (275°F) - 4 MIN Indicator: 3 minutes

This information describes what the device is designed to do and how it should visually respond, but it is not presented as formal acceptance criteria with corresponding study results in the structured way requested. The 510(k) clearance process often relies on demonstrating substantial equivalence to a predicate device, rather than requiring extensive de novo clinical studies with detailed acceptance criteria as would be seen for a novel, high-risk device. The details you are asking for would typically be found in the 510(k) submission summary or associated testing reports, which are not included in this FDA clearance letter.

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Ask a specific question about this device