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Terragene® Bionova® SCBI (BT95, BT96) is a self-contained biological indicator inoculated with a minimum of 10º viable Geobacillus stearothermophilus bacterial spores and is intended for monitoring the efficacy of vaporized hydrogen peroxide sterilization processes in the following systems:

• · Sterrad® 100S Sterilization System.
• · Sterrad® 100NX Sterilization System (Standard and Express cycles).
• · V-Pro® maX Low Temperature Sterilization System (Non Lumen and Flexible cvcles).
• · Sterizone® VP4 Sterilizer ( cycle 1 ).
• · LowTem Crystal 120 Sterilizer (Standard cycle).

BT95 has rapid readout at 2 hours at 60 ℃ while BT96 has super rapid readout at 30 minutes at 60 ℃.

Terragene® Chemdye® (CD42) is a chemical process indicator intended for monitoring the efficacy of vaporized hydrogen peroxide sterilization processes in the following systems:

• · Sterrad® 100S Sterilization System.
• · Sterrad® 100NX Sterilization System (Standard and Express cycles).
• · V-Pro® maX Low Temperature Sterilization System (Non Lumen, Lumen and Flexible cycles).
• · Sterizone® VP4 Sterilizer ( cycle 1 ).
• · LowTem Crystal 120 Sterilizer (Standard cycle).

The chemical indicator changes from red to yellow to indicate that the conditions of the cycle have been met. Terragene® Cintape® CT40 is a chemical process indicator tape intended for monitoring the efficacy of vaporized hydrogen peroxide sterilization processes in the following systems:

• · Sterrad® 100S Sterilization System.
• · Sterrad® 100NX Sterilization System (Standard and Express cycles).
• · V-Pro® maX Low Temperature Sterilization System (Non Lumen and Flexible cycles).
• · Sterizone® VP4 Sterilizer ( cycle 1 ).
• · LowTem Crystal 120 Sterilizer (Standard cycle).

The indicating tape changes from purple to green when exposure to vaporized hydrogen peroxide.

Not Found

The provided text does not contain information about acceptance criteria for a medical device's performance (such as sensitivity, specificity, or accuracy) or details about a study designed to prove the device meets these criteria. The document is an FDA 510(k) clearance letter for sterilization process indicators, not a performance study report for a diagnostic or AI-powered device.

Therefore, I cannot provide the requested information, including:

1. A table of acceptance criteria and reported device performance.
2. Sample sizes for a test set, data provenance, or details about training sets.
3. Number and qualifications of experts for ground truth establishment.
4. Adjudication methods.
5. Details of a multi-reader, multi-case (MRMC) comparative effectiveness study or related effect sizes.
6. Standalone performance details.
7. Type of ground truth used.
8. How ground truth for the training set was established.

The document focuses on the regulatory clearance for biological and chemical indicators used to monitor sterilization processes, confirming their substantial equivalence to predicate devices, and outlining applicable regulations. It does not describe a clinical performance study as one would typically find for a diagnostic or AI device.

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Terragene® Bionova® Photon Biological Indicator (BT225) is a 7-second readout Self-Contained Biological Indicator (SCBI) inoculated with a minimum of 100 viable Geobacillus stearothermophilus bacterial spores and is intended for routine monitoring of the efficacy of steam sterilization processes. BT225 SCBI is not recommended and should not be used for qualification testing purposes. On each Terragene® Bionova® SCBI is a chemical process indicator that changes color from pink to brown when exposed to steam.

• Gravity-displacement Steam Sterilization Cycles 132 °C, 25 minutes 132 °C, 15 minutes 132 °C, 10 minutes 135 ℃, 10 minutes

• Dynamic-air-removal Steam Sterilization Cycles 132 °C. 4 minutes 135 °C, 3 minutes

Terragene® Bionova® Photon Auto-reader Incubator (BPH) incubates at 60 ℃ and reads the Terragene® Bionova® Photon SCBIs at the times prescribed in the User Manual.

Terragene® Bionova® Photon Biological Indicator (BT225) is a Biological Indicator for monitoring gravity-displacement and dynamic-air-removal steam sterilization cycles at 132 °C -135 ℃. When BT225 is used in conjunction with the Terragene® Bionova® Photon Auto-reader Incubator (BPH), it provides a final fluorescent result at 7 seconds.

Terragene® Bionova® Photon Biological Indicators (BT225) are single-use Self-Contained Biological Indicators (SCBIs) that are formed by a carrier with Geobacillus stearothermophilus ATCC 7953 spores and an ampoule containing a bacteriological growth medium. Both, the media ampoule and the carrier, are contained in a polypropylene tube enclosed with a black cap with holes and a barrier permeable to steam.

Each SCBI has a label located on the outside of the tube. This label contains information regarding the expiration date and the lot of the SCBI, as well as a chemical process indicator that turns from pink to brown to indicate that the SCBI has been exposed to steam.

Terragene® Bionova® Photon Auto-reader Incubator (BPH) has been designed for the incubation at 60 ℃ and automatic readout of the Bionova® Photon line of Self-contained Biological Indicators (SCBIs) appropriate for monitoring steam sterilization cycles. It allows an instant readout (7-second) of the BT225 SCBI using fluorescence technology and 48-hour incubation for visual color change confirmation.

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

Acceptance Criteria and Device Performance

• Resistance characteristics study (D-value, Z-value, Survival Time, Kill Time): All samples met specifications of FDA guidance, ANSI/AAMI ISO 11138-1:2017, and ANSI/AAMI ISO 11138-3:2017.
• Recovery medium test: Culture medium from three lots supported spore recovery after steam sterilization, complying with ANSI/AAMI ISO 11138-1 (Subclause 7.2).
• Carrier and primary packaging materials evaluation: Tested according to FDA special controls guidance, demonstrating compliance with ANSI/AAMI ISO 11138-1:2017. |
  | - (iii) Comparison of detected signal with number of surviving spores (sensitivity and specificity): | - Reduced Incubation Time: For 7-second readout, 48-hours, and 7-days, tests showed appropriate sensitivity > 97% and specificity > 87.5% (The general benefit states >97% sensitivity, specificity did not achieve >95% threshold).
• Limit of detection testing: Fluorescence readouts compared with plating results; positive fluorescence readouts obtained for every BI with 1-100 viable count, demonstrating ability to detect low numbers of spores. |
  | - (iv) Limit of detection testing: | - Limit of detection testing: Demonstrated detection of 1-100 viable spores. |
  | - (v) End point color stability testing: | - Visual readout stability: Visual inspection of culture medium for 7 days confirmed color stability for lethal and non-lethal cycles; stable during 7 days of incubation.
• Chemical Process Indicator: Endpoint stability reaction: chemical indicator endpoint remained unchanged for a period of not less than 6 months. |
  | - (vi) Validation of accuracy over a specified readout time: | - Reduced Incubation Time: 7-second reduced incubation time validated for 7-second, 48-hour, and 7-day readouts.
• Holding time assessment: Validated claimed 7-day holding time (between sterilization and incubation); sensitivity > 97%, indicating no difference in results for 7-day holding time. Results for 7-second fluorescence, 48-hour visual, 7-day, and 14-day readouts were equivalent. |
  | (2) Performance data supports the shelf life by demonstrating continued device functionality over the labeled shelf life. | - Shelf Life/Sterility: 18 months for BT225, supported by validation testing.
• Shelflife stability study: Three lots evaluated via real-time aging for 18 months; all samples met acceptance criteria per ANSI/AAMI ISO 11138-1:2017 and ANSI/AAMI ISO 11138-3:2017 for spore population stability and D-value at all time points.
• Chemical Process Indicator: Endpoint stability for 6 months using SCBI; real-time aged for 18-24 months showed equivalent results to fresh samples for CI performance. Another test for 18-month shelf-life showed compliance. |
  | (3) Software verification, validation, and hazard analysis performed for any software components. | Software testing conducted per FDA guidance "Content of premarket submissions for Device Software Functions." V&V included description, LOC (Moderate), hazard analysis, requirements/design, architecture, development/maintenance, anomalies, revision, cybersecurity, traceability, and validation testing. Reports found adequate. |
  | (4) Performance data demonstrates electromagnetic compatibility (EMC) and electrical safety. | Demonstrated following IEC 61010-1 (electrical safety), IEC 61010-2-010 CB, ANSI C63.27 2017 (Wireless Coexistence), IEC 61326-1 (EMC). Test reports found adequate. |

Study Details

The provided text describes several performance studies, but it is primarily focused on bench testing and in-use performance testing for the biological indicator and its auto-reader. It does not describe a typical "test set" in the context of machine learning or AI algorithm validation with expert ground truth review. Instead, the validations are against established scientific and regulatory standards for biological indicators.

1. Sample Size used for the test set and the data provenance:

   • In-Use Performance Testing: "All results including positive controls met the acceptance criteria" suggests a complete set was tested, but a specific number of samples or facilities is not provided. Data provenance is implied to be "health-care facilities steam sterilizers."
   • Viable spore population assay: "Three lots were evaluated."
   • Resistance characteristics study: Not explicitly stated, but "all the samples" suggests a defined set.
   • Recovery medium test: "Culture medium was evaluated from three different lots."
   • Carrier and primary packaging materials evaluation: Not explicitly stated, but "the subject device was tested."
   • Reduced Incubation Time: Not explicitly stated, but "tests carried out" implies numerous tests.
   • Visual readout stability: "different lots of BIs" evaluated.
   • Holding time assessment: Not explicitly stated, but "The tests carried out" implies numerous tests.
   • Limit of detection: Not explicitly stated, but "every BI which showed 1 to 100 viable count result" implies a comprehensive test.
   • Shelflife stability study: "Three different lots of SCBIs were evaluated."
   • Chemical Indicator Performance: "all samples" tested, and "samples aged throughout the 18-month claimed shelf-life."
   • Data Provenance: The studies appear to be primarily prospective bench studies conducted by the sponsor (Terragene SA, Argentina) to validate the device against various international standards and FDA guidance documents. There is no mention of data from different countries of origin beyond the sponsor's location.

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

   • There is no mention of human experts being used to establish "ground truth" in the way it's typically described for AI/ML validation (e.g., radiologists reviewing images).
   • The "ground truth" for these studies is established by objective biological and chemical measurements against recognized international standards (e.g., ANSI/AAMI ISO 11138-1, ANSI/AAMI ISO 11138-3, ANSI/AAMI ISO 11140-1) and FDA guidance documents. These standards inherently define what constitutes a "positive" (growth/failure) or "negative" (no growth/success) result for a biological or chemical indicator.

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

   • Not applicable. As described above, the "ground truth" is determined by objective physical and biological measurements against predefined standards, not by human expert consensus or adjudication.

4. 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 MRMC study was performed as this device is not an AI-assisted diagnostic tool that involves human readers interpreting results. The device (biological indicator and auto-reader) automatically performs the read-out (fluorescence detection).

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

   • Yes, in essence, the "device" (Terragene Bionova Photon Biological Indicator and Auto-Reader Incubator) operates as a standalone system for detecting sterilization efficacy. The Auto-Reader automatically reads the fluorescence, and the indication of the success or failure of sterilization is based on this automated readout. There is no human-in-the-loop performance requirement for the readout process itself for the primary 7-second result. While a 48-hour visual confirmation is mentioned, the core claim is the automated 7-second fluorescence readout.

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

   • Objective Biophysical and Biochemical Measurements against Regulatory and Industry Standards: The ground truth is primarily established by:
     • Direct biological assay (e.g., viable spore count).
     • Measurement of physical resistance characteristics (D-value, Z-value, survival/kill times) in controlled sterilization conditions.
     • Chemical color change reactions.
     • Fluorescence detection.
     • All these measurements are assessed against specified acceptance criteria defined by ANSI/AAMI ISO standards and FDA guidance for biological and chemical indicators.

7. The sample size for the training set:

   • There is no mention of a "training set" in the context of machine learning, as this is not an AI/ML-based device in the traditional sense that requires training data. The development of the device itself (e.g., setting alarm thresholds for fluorescence) would be based on internal engineering and testing, but not described as an AI training set here.

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

   • Not applicable, as there is no "training set" described for an AI/ML algorithm. The calibration and performance specifications of the auto-reader and biological indicator are established through rigorous engineering design, material science, and conformance to the aforementioned international standards.

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Terragene® Chemdye® Multivariable Chemical Indicator (CD40) is a multivariable chemical indicator intended for monitoring the efficacy of vaporized hydrogen peroxide sterilization processes in the following systems:

• · Sterrad® 100S Sterilization System.
• · Sterrad® NX Sterilization System (Standard and Advanced cycles).
• · Sterrad® NX with ALLClear® Technology Sterilization System (Standard and Advanced cycles).
• · Sterrad® 100NX Sterilization System (Standard, Flex, Express and Duo cycles).
• · Sterrad® 100NX with ALLClear® Technology Sterilization System (Standard, Flex, Express and Duo cycles).
• · V-Pro® maX Low Temperature Sterilization System (Non Lumen and Flexible cycles).
• · V-Pro® maX 2 Low Temperature Sterilization System (Fast Non Lumen, Lumen and Flexible cycles).
  The chemical indicator changes from purple to green to indicate that the conditions of the cycle have been met.

Terragene® Chemical Process Indicator (CD42) is a chemical process indicator intended for monitoring the efficacy of vaporized hydrogen peroxide sterilization processes in the following systems:

• · Sterrad® 100S Sterilization System.
• · Sterrad® NX Sterilization System (Standard and Advanced cycles).
• · Sterrad® NX with ALLClear® Technology Sterilization System (Standard and Advanced cycles).
• · Sterrad® 100NX Sterilization System (Standard, Flex, Express and Duo cycles).
• · Sterrad® 100NX with ALLClear® Technology Sterilization System (Standard, Flex, Express and Duo cycles).
• · V-Pro® maX Low Temperature Sterilization System (Non Lumen and Flexible cycles).
• · V-Pro® maX 2 Low Temperature Sterilization System (Fast Non Lumen, Lumen and Flexible cycles).
• · Sterizone® VP4 Sterilizer (Cycle 1).
  The chemical indicator changes from red to yellow to indicate that the conditions of the cycle have been met.

Terragene® Cintape® Chemical Process Indicator Tape (CT40) is a chemical process indicator tape intended for monitoring the efficacy of vaporized hydrogen peroxide sterilization processes in the following systems:

• · Sterrad® 100S Sterilization System.
• · Sterrad® NX Sterilization System (Standard and Advance cycles).
• · Sterrad® NX with ALLClear® Technology Sterilization System (Standard and Advanced cycles).
• · Sterrad® 100NX Sterilization System (Standard, Flex, Express and Duo cycles).
• · Sterrad® 100NX with ALLCrear® Technology Sterilization System (Standard, Flex, Express and Duo cycles).
• · V-Pro® maX Low Temperature Sterilization System (Non Lumen and Flexible cycles).
• · V-Pro® maX 2 Low Temperature Sterilization System (Fast Non Lumen, Lumen and Flexible cycles).
• · Sterizone® VP4 Sterilizer (Cycle 1).
  The indicating tape changes from purple to green when exposure to vaporized hydrogen peroxide.

Not Found

I am sorry, but the provided text does not contain information about acceptance criteria, device performance, sample sizes for test or training sets, data provenance, the number or qualifications of experts, adjudication methods, MRMC studies, standalone algorithm performance, or the ground truth used for any of the Terragene products (Terragene® Chemdye® Multivariable Chemical Indicator (CD40), Terragene® Chemical Process Indicator (CD42), Terragene® Cintape® Chemical Process Indicator Tape (CT40)).

The document is an FDA 510(k) clearance letter, which confirms that the FDA has determined the devices are substantially equivalent to legally marketed predicate devices for their stated indications. It outlines regulatory requirements and general information about FDA processes but does not detail the specific studies, testing methodologies, or results that demonstrate the devices meet performance criteria.

Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them based on the provided input.

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Terragene® Bionova® Hyper Biological Indicator (BT98) is a self-contained biological indicator (SCBI) inoculated with a minimum of 106 viable Geobacillus stearothermophilus bacterial spores and is intended for monitoring the efficacy of Plasma or Vaporized Hydrogen Peroxide sterilization processes in the following systems:
-Sterrad® 100S Sterilization System.
-Sterrad® NX Sterilization System (Standard and Advanced Cycles).
-Sterrad® NX with ALLClear® Technology Sterilization System (Standard and Advanced Cycles).
-Sterrad® 100NX Sterilization System (Standard, Flex, Express and Duo Cycles).
-Sterrad® 100NX with ALLClear® Technology Sterilization System (Standard, Flex, Express and Duo Cycles).
-V-Pro@ S2 Low Temperature Sterilization System (Fast, Non Lumen and Flexible Cycles).
-V-Pro® maX 2 Low Temperature Sterilization System (Fast Non Lumen. Lumen and Flexible Cycles).
Terragene® Bionova® BT98 has Hyper Rapid readout at 5 minutes at 60 ℃.
Terragene® Bionova® Hyper Auto-reader Incubator (BHY) incubates at 60 °C and reads the Terragene® Bionova® Hyper SCBIs at the times prescribed in the User Manual.
Terragene® Bionova® NanoBio Auto-reader Incubator (BNB) incubates at 60 °C and reads the Bionova® SCBIs at the times prescribed in the User Manual.

Not Found

The provided text is related to a 510(k) premarket notification for sterilization process indicators and auto-reader incubators. It does not contain information about the acceptance criteria or a study proving that a device meets those criteria. The document is an FDA clearance letter and an "Indications for Use" statement, not a scientific study report.

Therefore, I cannot extract the requested information (acceptance criteria table, sample sizes, expert qualifications, adjudication methods, MRMC study details, standalone performance, ground truth type, or training set details) from the provided text.

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Terragene Chemdye® Bowie-Dick Test Pack (BD125X/1), Bowie-Dick Test Card (BD8948X/1) and Bowie-Dick Test Sheet (BDA4/1) are designed for testing air removal efficiency for cycles of 132ºC for 3.5 minutes in dynamicair-removal steam sterilizers.

Not Found

This document is a marketing authorization letter for a device and therefore does not contain the detailed information necessary to answer some of the questions. Specifically, it does not include information about acceptance criteria, device performance, sample sizes, data provenance, expert qualifications, adjudication methods, MRMC studies, standalone performance, or ground truth details.

However, based on the provided text, here's what can be extracted:

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

This information is not available in the provided document. The document is an FDA clearance letter, which confirms substantial equivalence but does not detail the specific performance metrics or acceptance criteria used in the underlying studies.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):

This information is not available in the provided document.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):

This information is not available in the provided document.

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

This information is not available in the provided document.

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 available in the provided document. The device, Terragene Chemdye® Bowie-Dick Test Pack, Bowie-Dick Test Card, and Bowie-Dick Test Sheet, are chemical indicators for sterilization processes, not an AI-powered diagnostic tool that would typically involve human readers.

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

This information is not applicable/not available for this type of device. The devices are chemical indicators that change color to show air removal efficiency, and their performance is inherently standalone in their function (i.e., they indicate a condition without human interpretation of an algorithm's output).

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

This information is not available in the provided document. For Bowie-Dick tests, the "ground truth" would typically be established based on standardized test procedures and expected color changes under validated sterilization conditions.

8. The sample size for the training set:

This information is not applicable/not available in the provided document. The devices are chemical indicators, not machine learning algorithms that require a "training set."

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

This information is not applicable/not available for this type of device.

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Terragene Bionova® SCBI (BT224) is a self-contained biological indicator inoculated with viable 10 Geobacillus stearothermophilus bacterial spores and is intended for monitoring the efficacy of steam sterilization processes. On each Terragene Bionova® SCBI is a chemical process indicator that changes color from pink to brown when exposed to steam.

Terragene Bionova® PCD (PCD224-C, PCD224-2) and Integron® PCD (PCD26-C, PCD26-2) provides a defined challenge resistance against the claimed cycles shown below and demonstrated resistance equivalence to the AAMI/ANSI 16 towel pack. The device provides routine monitoring and sterilizer qualification processes.

Terragene Bionova® Reader Incubators (10/20FRLCD, Mini-Bio) incubate at 60° C and 37° C and read the Terragene Bionova® SCBI for fluorescent results at the times prescribed in the User Manuals.

Terragene Bionova® SCBI (BT110) is a self-contained biological indicator inoculated with viable 106 Bacillus atrophaeus bacterial spores and is intended for monitoring the efficacy of ethylene oxide sterilization processes.

The integrator Terragene Integron® IT12 is designed to chemically react over time with the critical parameters of ethylene oxide sterilization cycle within a specified tolerance. The integrating indicator strip is intended to be placed in each pack, pouch, container, tray or other containment device to function as an independent monitor of critical parameters for the following sterilization cycles: 55°C for 240 minutes, 600 mg/l, RH 60 %, SV37°C/75 min., SV54°C/30 min, SV55°C/28 min.

Terragene Chemdye® CD16 is a chemical process indicator intended for monitoring the efficacy of ethylene oxide sterilization processes. The chemical indicator changes from purple/brown to green to indicate that the conditions of the cycle have been met.

Terragene Bionova® SCBI (BT95, BT96) is a self-contained biological indicator inoculated with viable 10° Geobacillus stearothermophilus bacterial spores and is intended for monitoring the efficacy of vaporized hydrogen peroxide sterilization processes. BT95 is Rapid Readout while BT96 is Super Rapid Readout. BT95 has Ranid readout at 2 hours at 60° C while BT96 has Super Rapid readout at 30 minutes at 60° C.

Terragene Chemdye® (CD40, CD42) is a chemical process indicator intended for monitoring the efficacy of vaporized hydrogen peroxide sterilization processes. The chemical indicator changes from purple to green for CD40 and red to vellow for CD42 to indicate that the conditions of the cycle have been met.

The integrator Terragene Integron® TT26-1YS is designed to chemically react over time with the critical parameters of steam sterilization cycle within a specified tolerance. The integrating indicator strip is intended to be placed in each pack, pouch, container, tray or other containment device to function as an independent monitor of critical parameters for the following sterilization cycles: Gravity Displacement: 121° C for 30 minutes, 132° C for 25 minutes, 135° C for 10 minutes; Dynamic Air Removal (Vacuum Assist): 132° C for 3 minutes. SV121° C/16.5 min., SV132° C/2.0 min, SV135° C/1.2 min.

The integrator Terragene Integron® IT26-C is designed to chemically react over time with the critical parameters of steam sterilization cycle within a specified tolerance. The integrating indicator strip is intended to be placed in each pack, pouch, container, tray or other containment device to function as an independent monitor of critical parameters for the following sterilization cycles: Gravity Displacement: 121°C for 30 minutes, 132°C for 15 minutes, 135°C for 25 minutes, 135°C for 10 minutes; Dynamic Air Removal (Vacuum Assist): 132° C for 4 minutes, 135° C for 3 minutes. SV121° C/16.5 min., SV132° C/2.0 min, SV135° C/1.2 min..

Terragene Chemdye® CD29 is a chemical process indicator intended for monitoring the effication processes. The chemical indicator changes from yellow to dark brown/black to indicate that the conditions of the cycle have been met.

Terragene Cintape® CT22 is a chemical process indicator tape intended for monitoring the efficacy of steam sterilization processes. The indicating tape changes from yellow to dark brown/black when exposure to steam.

Terragene Cintape® CT40 is a chemical process indicator tape intended for monitoring the efficacy of Vaporized Hydrogen Peroxide sterilization processes. The indicating tape changes from purple to green when exposure to vaporized hydrogen peroxide.

Not Found

This document describes the FDA's acceptance of a premarket notification for sterilization process indicators, not an AI-powered medical device. Therefore, the provided text does not contain the information required to answer your request about acceptance criteria and a study proving an AI device meets those criteria.

The document discusses:

• Medical devices: Terragene Bionova® SCBI, Terragene Bionova® PCD, Terragene Bionova® Reader Incubators, Terragene Integron®, Terragene Chemdye®, Terragene Cintape®.
• Purpose: Monitoring the efficacy of various sterilization processes (steam, ethylene oxide, vaporized hydrogen peroxide).
• Regulatory status: Class II medical devices, subject to general controls.
• Indications for Use: Detailed descriptions of what each device monitors and how it indicates sterilization efficacy (e.g., color changes, fluorescence read times).

There is no mention of AI, algorithms, human readers, or expert consensus on AI performance, which are all key elements of your request.

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Terragene Bionova® SCBI (BT220, BT221, BT222, BT223) is a self-contained biological indicator inoculated with viable 10f Geobacillus stearothermophilus bacterial spores and is intended for monitoring the effication processes. Oneach Terragene Bionova® SCB is a chemical process indicator that changes color from pink to brown when exposed to steam.

Terragene Bionova® PCD (PCD220-C. PCD222-C. PCD222-C. PCD222-2) provides a defined challenge resistance against the claimed cycles shown below and also demonstrated resistance equivalence to the AAMI/ANSI 16 towel pack. The device provides routine monitoring and sterilizer qualification testing steam sterilization processes.

Terragene Bionova® IC10/20FR Reader Incubates at 60 ℃ and reads the Terragene Bionova® SCBI (BT220, BT221, BT222, and BT223) for fluorescent results at 30 minutes (BT221, BT222), and 3 hours (BT220)

Not Found

This document is a 510(k) premarket notification decision letter from the FDA, along with an "Indications for Use" statement. It primarily concerns the regulatory approval of sterilization process indicators and an associated incubator. It does not contain information about a study that proves the device meets acceptance criteria in the context of an AI/human performance study as typically understood.

Therefore, I cannot provide the requested information for acceptance criteria and a study that proves device performance for an AI-based medical device. The document is about a different type of medical device (sterilization indicators) and does not describe performance metrics in the way you've requested (e.g., sensitivity, specificity, F1-score, effect size for human readers with AI assistance, etc.).

There is no mention of:

• A test set with a specific sample size or data provenance.
• Experts used to establish ground truth.
• Adjudication methods.
• MRMC comparative effectiveness studies.
• Standalone algorithm performance.
• Training set details.
• Ground truth used for training.

The "Indications for Use" section does provide performance characteristics related to the sterilization process indicators, such as incubation temperatures and read times for fluorescent results, and pH color change times. However, these are device specifications and not acceptance criteria in the context of an AI performance study with ground truth and expert reviews.

If you are looking for an example of a 510(k) summary (which usually includes performance data for medical devices), this document does not contain that level of detail for performance metrics.

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