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Steam Dot Blu ° Process Indicator is a chemical sterilization indicator intended to be used by a health care provider with sterilization wraps, containers, cassettes, pouches or other packaging materials to distinguish between processed and unprocessed units.

The indicator changes color from blue to pink when exposed to steam sterilization conditions at 121°C in gravity displacement and 132°C, 134°C and 135°C in pre-vacuum cycles.

The performance of the Steam Dot-Blu® Process Indicator meets the requirements of ANSI/AAMI/ISO 11140-1:2005 for process (Class 1) indicators.

No lead or heavy metals or their compounds are added in the production of the indicator.

Steam Dou Blu® Process Indicator is a single use chemical sterilization indicator for steam sterilizers. It complies with the requirements established in the FDA guidance document "Premarket Notification [510(k)] Submissions for Chemical Indicators," issued on December 19, 2003 and "ANSI/AAMVISO 11140-1:2005, Sterilization of health care products - Chemical indicators - Part 1: General requirements" standard for process indicators.

Steam Dot Blu® Process Indicator is designed to be used in 121°C gravity and in 132°C, 134°C and 135°C pre-vacuum steam sterilization cycles. During sterilization cycles the indicator change color from blue to pink. The color change after processing is stable. No lead or heavy metals or their compounds are added in the production of the indicator.

The provided text describes a chemical sterilization indicator, the "Steam Dot Blu® Process Indicator," and a study demonstrating its performance. However, there are aspects of the requested information that are not fully available in the provided document, particularly regarding specifics of a medical device study (e.g., sample sizes of test sets, number of experts, adjudication methods, MRMC studies, standalone performance, training sets). This is because the device is a chemical indicator, not an AI/software medical device.

Response based on the provided text:

The device described is a chemical sterilization indicator, not an AI or software-driven medical device. Therefore, many of the typical elements of a study for an AI medical device (like test set sample sizes, expert ground truth, adjudication methods, MRMC studies, or training sets) are not applicable or detailed in the provided 510(k) summary for this type of product. The study performed is a performance verification against an established standard for chemical indicators.

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size: The document does not specify a "sample size" in the context of individual units tested. Instead, it refers to the device being tested according to the requirements of the ANSI/AAMI/ISO 11140-1:2005 standard. This standard prescribes the methods and stringency for testing chemical indicators.
• Data Provenance: The testing was conducted according to the FDA recognized consensus standard ANSI/AAMI/ISO 11140-1:2005. The specific country of origin for the data is not mentioned, but the submission is for a US market authorization (510(k)). The testing described would be considered experimental validation against a standard, not retrospective or prospective data collection in the context of clinical studies.

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

• Not applicable in this context. For a chemical indicator, "ground truth" is established by the physical and chemical properties of the indicator and its performance against the specified physical conditions (temperature, steam, time) defined by the international standard. There are no human "experts" establishing a subjective ground truth for the color change. The standard itself specifies the acceptable performance.

4. Adjudication Method

• Not applicable in this context. Since there's no subjective interpretation or expert consensus needed for the chemical color change, no adjudication method (like 2+1, 3+1) is described or required. The performance is objectively measured against the standard.

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

• No. This is not an AI medical device or an imaging device requiring human interpretation; thus, an MRMC study is not relevant or described. The device's function is a direct chemical reaction.

6. Standalone (Algorithm Only) Performance Study

• Yes (in principle, but interpreted differently). The "standalone" performance for this device refers to the indicator itself, without human interpretation beyond observing the color change. The study involves assessing the indicator's intrinsic ability to change color accurately under specified sterilization conditions, as per the ANSI/AAMI/ISO 11140-1:2005 standard. The device is the "algorithm" in a sense – a chemical reaction that visually signals a process outcome. Its performance is evaluated as a standalone unit.

7. Type of Ground Truth Used:

• Objective Standard/Physical Conditions: The ground truth is the precise physical conditions of steam sterilization (specific temperatures and states of steam, e.g., 121°C gravity, 132°C, 134°C, 135°C pre-vacuum cycles) as defined and established by the ANSI/AAMI/ISO 11140-1:2005 standard. The indicator is expected to react predictably to these defined conditions.

8. Sample Size for the Training Set

• Not applicable. This device is a chemical indicator, not an AI model that requires a "training set." Its design and formulation are based on chemical principles and engineering, not machine learning.

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

• Not applicable. As a chemical indicator, there is no "training set" or corresponding ground truth establishment in the conventional sense for AI/machine learning. The device's operational characteristics are determined by its chemical composition and manufacturing process, which are designed to react to specific physical parameters (heat, steam) according to the established industry standards.

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The Emu-Chex™ Sterilization Indicator is an emulating indicator intended to be used by a health care provider to monitor steam sterilization processes. Ennu-Chex" Sterilization Indicator comes in three varieties; for use in a gravity steam sterilization process operating at 121°C for 20 minutes, for use in pro-vacuum steam sterilization processes operating at 132°C for 4 minutes and 135°C for 3 minutes.

The Emu-Chex™ Sterilization Indicators can be placed together with items to be steam sterifized. The indicator changes color from blue-green to brown when the sterilization cycle is complete. The performance of the Enni-Chex" Sterilization Indicator meets the requirements of ANSI/AAMI/ISO 11140-1:2005 for emulating indicators.

The Emu-Chex™ Sterilization Indicator is a chemical sterilization indicator for steam sterilizers that complies with ANSI/AAMI/ISO 11140-1:2005, Sterilization of health care products - Chemical indicators - Part 1 : General requirements, emulating indicators. The variety of Emu-Chex sterilization indicators includes those for use in a gravity steam sterilization process operating at 121°C for 20 minutes, for use in prevacuum steam sterilization process operating at 132° C for 4 minutes and 135° C for 3 minutes. No lead or heavy metals or their compounds are added in the production of the indicator.

Here's a breakdown of the acceptance criteria and study information for the Emu-Chex™ Sterilization Indicator based on the provided 510(k) summary:

1. Table of Acceptance Criteria and Reported Device Performance

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

The provided document does not explicitly state the sample size used for the test set. It also does not specify the data provenance (e.g., country of origin, retrospective or prospective).

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

The provided document does not mention the use of experts to establish ground truth for the test set. For a chemical indicator, the ground truth is typically established by physical parameters of the sterilization cycle (e.g., temperature, time, steam presence) rather than human interpretation.

4. Adjudication Method for the Test Set

The provided document does not describe any adjudication method. This is consistent with the nature of a chemical indicator, where the outcome (color change) is a direct physical response.

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

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study is typically relevant for interpretative devices (e.g., imaging AI) and not for simple color-changing chemical indicators.

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

Yes, the testing described is effectively a standalone performance evaluation of the chemical indicator. The device's performance is assessed based on its physical response (color change) to specific sterilization conditions, without human interpretation as part of the primary functional assessment.

7. The Type of Ground Truth Used

The ground truth used for this device is based on physical parameters of the sterilization process as defined by the ANSI/AAMI/ISO 11140-1:2005 standard. This standard sets specific conditions (e.g., 121°C for 20 minutes, 132°C for 4 minutes, 135°C for 3 minutes) at which an emulating indicator must demonstrate a color change, and conditions under which it must not change color (to indicate an incomplete cycle).

8. The Sample Size for the Training Set

The provided document does not mention a "training set" in the context of this device. Chemical indicators are typically developed through chemical formulation and empirical testing rather than machine learning or algorithmic training.

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

As there is no concept of a "training set" for this type of device, the question of how its ground truth was established is not applicable. The development process would involve chemical engineering and validation against established scientific principles and standards for sterilization efficacy.

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The Once-A-Day® Vertos™ Test Pack is an air removal indicator that is intended to be used by a health care provider as a standardized test pack, e.g., Bowie Dick Test Pack, to assess the ability of a pre-vacuum sterilizer to remove air and allow steam to penetrate into wrapped goods and porous loads operating at 134° C using a 3.5 minutes exposure time. The Once-A-Day® Vertos™ Test Pack is directed to be positioned on the lowest shelf over the chamber drain in an otherwise empty chamber. An unexposed test pattern is uniformly blue and a uniform pink test pattern represents an acceptable cycle. The Once-A-Day® Vertos™ Test Pack is not an indication that the sterilizer has reached the parameters for sterilization.

The Once-A-Day® Vertos™ Test Pack is a Bowie & Dick type test for prevacuum steam sterilizers that complies with requirements of AAMI/ANSI/ISO 11140-1:2005 as class 2 indicator, which includes conformance with the labeling requirements and general requirements on the performance. The pack also complies with requirements of AAMI/ANSI/ISO 11140-5:2007, which includes the test format parameters, performance at 134° C for 3.5 min in Pass and Fail cycles, dry heat test parameters, ink transfer limitations, labeling requirements, and all normative described in annexes.

The provided text is a 510(k) summary for the Once-A-Day® Vertos™ Test Pack, a chemical sterilization process indicator. It describes the device, its intended use, and its substantial equivalence to a predicate device. However, it does not contain detailed information about a specific study with acceptance criteria, test set sample size, expert qualifications, or adjudication methods in the way a clinical trial or AI performance study would. It focuses on the device's conformance to ISO standards.

Based on the provided text, here's what can be extracted and what information is missing:

1. Table of Acceptance Criteria and Reported Device Performance:

The document states that the device complies with specific ISO standards, which inherently include performance criteria. The performance is described in terms of color change.

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

• Sample Size for Test Set: This information is not provided in the document. The document states compliance with ISO standards, which would imply testing, but not the specific sample size used for those tests.
• Data Provenance: This information is not provided. The testing would have been conducted by the manufacturer, but specific details on where or how are not mentioned.

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. The device's performance is based on chemical reactions and color interpretation, likely validated against physical/chemical references as defined by the ISO standards, rather than expert human interpretation of complex medical images.

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

• This information is not provided. Given the nature of a chemical indicator, adjudication methods typical for subjective human interpretation (like in imaging studies) are not applicable. The assessment would be objective, based on color change.

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, an MRMC comparative effectiveness study was not conducted or described. This type of study is relevant for AI-assisted diagnostic tools, not for a chemical sterilization indicator. The device is not an AI product.

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 or AI system. Its performance is inherent to its physical and chemical properties. Operators simply observe the color change.

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

• The ground truth for this device is based on physical and chemical parameters defined by international standards (AAMI/ANSI/ISO 11140-1:2005 and 11140-5:2007) for steam sterilization. This includes precisely defined "Pass" and "Fail" cycle conditions at specific temperatures and exposure times (e.g., 134°C for 3.5 minutes). The color change observed in the indicator is then correlated to these established physical parameters representing effective air removal and steam penetration.

8. The sample size for the training set:

• This concept is not applicable as the device is not an AI or machine learning system that requires a training set.

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

• This question is not applicable for the same reason as point 8.

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The Propper Vapor Line PCD is indicated for use in routine challenge testing steam sterilizers in pre-vacuum cycles operating at 273.2°F/134°C.

The PROPPER VAPOR LINE PCD is indicated for use as a routine process challenge test for steam sterilizers in pre-vacuum cycles at 273.2°F/134°C.

Propper Vapor Line PCD is a process challenge test device for use in pre-vacuum steam sterilization processes at 273.2°F/134°C. It consists of a capsule with a removable cap and sample holder to permit the positioning and removal of the Propper Vapor Line Integrator. One end of the capsule is connected to a lumen. During the sterilization cycle, the open end of the lumen permits residual air to exit and steam to enter the capsule The integrator display will indicate whether or not sterilization conditions were attained inside the metal capsule.

Acceptance Criteria and Device Performance for Propper Vapor Line PCD Steam Sterilization Process Challenge Test

1. Table of Acceptance Criteria and Reported Device Performance

The provided document does not explicitly state formal, quantitative acceptance criteria for the Propper Vapor Line PCD Steam Sterilization Process Challenge Test (PCD), beyond the general statement that it "will not indicate acceptable 'PASS' results until after complete spore death has occurred." However, based on the comparative testing against the predicate device (Propper Bio-Challenge Test-Pak, referred to here as Predicate) and the subsequent multiple device equivalency study, we can infer the performance expectations.

The primary inferred acceptance criterion is that the PCD should demonstrate equivalent or better performance in challenging steam sterilization conditions compared to the Predicate, specifically by failing (indicating non-sterilization) when spore death has not occurred and passing (indicating sterilization) when spore death has occurred, under controlled exposure times.

2. Sample Size and Data Provenance

The study utilized two main test sets:

• Comparative Testing (PCD vs. Predicate):

  • Exposure Time 0.25 min: 5 tests for PCD, 5 for Duo-Spore, 5 for BI-O.K..
  • Exposure Time 0.60 min: 20 tests for PCD, 20 for Duo-Spore, 20 for BI-O.K..
  • Exposure Time 1.00 min: 20 tests for PCD, 20 for Duo-Spore, 20 for BI-O.K..
  • Exposure Time 1.50 min: 5 tests for PCD, 5 for Duo-Spore, 5 for BI-O.K..
  • Exposure Time 1.75 min: 20 tests for PCD, 20 for Duo-Spore, 20 for BI-O.K..
  • Exposure Time 2.00 min: 20 tests for PCD, 20 for Duo-Spore, 20 for BI-O.K..
  • Total number of PCD tests: 90
  • Data Provenance: The document does not explicitly state the country of origin. Given the submitter information (Propper Manufacturing Co., Inc., Long Island City, NY) and the FDA 510(k) submission, it is highly probable the data was generated in the United States. The study involved experimental cycles run in a steam sterilizer, indicating a prospective experimental design.

• Multiple Device Equivalency Study:

  • Exposure Time 1.50 min: 5 tests (1 from each of 5 PCD devices).
  • Exposure Time 1.75 min: 30 tests (6 from each of 5 PCD devices).
  • Exposure Time 2.00 min: 30 tests (6 from each of 5 PCD devices).
  • Total number of PCD tests: 65
  • Data Provenance: Similar to the comparative testing, likely United States and prospective experimental data.

3. Number of Experts and Qualifications for Ground Truth

The concept of "experts" in the traditional sense (e.g., radiologists interpreting images) is not directly applicable here. The ground truth for sterilization efficacy is established by biological indicators (BIs), which are scientifically recognized methods for verifying sterilization.

For the comparative testing:

• Duo-Spore indicator: A spore strip that is aseptically removed and incubated in trypticase soy broth for seven days. Viable spores (survival) indicate a failure of sterilization.
• BI-OK indicator: A vial activated and incubated for 48 hours. Growth indicates a failure of sterilization.

The interpretation of these biological indicators (e.g., checking for growth) would be conducted by trained laboratory personnel following established protocols, rather than "experts" in a diagnostic medical imaging context. The document does not specify the number or qualifications of individuals performing these readings, as it's a standard laboratory procedure.

4. Adjudication Method for the Test Set

Adjudication methods like "2+1" or "3+1" are typically used for subjective assessments (e.g., expert interpretation disagreements). This study involves objective readings:

• PCD: "PASS" or "FAIL" reading based on the integrator display.
• Duo-Spore: Growth or no growth after incubation.
• BI-OK: Growth or no growth after incubation.

Since these are objective outcomes, an explicit adjudication method for reconciling disagreements between human readers is not mentioned, as it would be unnecessary. Discrepancies would likely point to experimental error or issues with the indicator itself, not subjective interpretation.

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

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not conducted in the context of human readers improving with AI vs. without AI assistance. This device is a process challenge test for steam sterilizers, not an AI-powered diagnostic tool. The "readers" are the devices themselves (PCD, Duo-Spore, BI-OK) or the trained personnel observing their objective outputs.

6. Standalone Performance (Algorithm Only)

Yes, the study primarily assessed the standalone performance of the Propper Vapor Line PCD. The device's "PASS" or "FAIL" reading is an intrinsic characteristic of the device itself, determined by its design and the chemical integrator within it. It acts independently to indicate whether sterilization conditions were met. Its performance was then compared to established biological indicators.

7. Type of Ground Truth Used

The primary ground truth used for establishing the effectiveness of the Propper Vapor Line PCD was biological indicators (BIs), specifically:

• Duo-Spore indicator: Represents the "gold standard" for sterility assurance, as it directly assesses the death of highly resistant bacterial spores.
• BI-OK indicator: Another type of biological indicator used to confirm sterilization conditions.

These BIs provide an objective measure of whether sterilization was achieved (spore death) or not (spore survival).

8. Sample Size for the Training Set

The document does not describe a "training set" in the context of machine learning or AI. This device is a physical/chemical indicator, not an algorithm that requires training data. Its design and performance are based on physical and chemical principles, not learned from a dataset.

9. How Ground Truth for the Training Set Was Established

As there is no "training set" for this device, the question of how ground truth was established for it is not applicable. The device's function is dictated by its manufacturing and the chemical reaction of its integrator, not by a learning process from data.

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The Propper BI-O.K. steam biological indicator is indicated for use in testing both gravity displacement steam sterilizers at 121°C and prevacuum steam sterilizers at 134°C.

The Propper BI-O.K. self contained steam biological indicator consists of a plastic vial and cap which contain a paper strip impregnated with a known number of B. stearothermophilus spores and a sterile sealed glass ampule containing a modified Soybean Casein Digest Medium with pH indicator. Following exposure in a steam sterilizer, the glass ampule is crushed by squeezing the sides of the plastic vial , thus bringing the medium into contact with the spores. The vial is incubated at 56± 2℃ for at least 24 hours. If any of the spores survived the sterilization process, they will grow and produce acid. This will cause a drop in pH of the medium and change the indicator from red to yellow.

The provided text does not contain information about acceptance criteria or a study proving the device meets acceptance criteria in the format requested. The document is a 510(k) submission summary for a biological indicator and an FDA clearance letter. It describes the device, its intended use, and its substantial equivalence to previously marketed devices. However, it does not include a detailed study with specific performance metrics against acceptance criteria.

Therefore, I cannot fulfill the request for a table of acceptance criteria and reported device performance, sample sizes, ground truth establishment, or details about MRMC or standalone studies.

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The Propper PASS/FAIL Challenge Pack is indicated for use in testing gravity displacement steam sterilizers at 121°C and prevacuum steam sterilizers at 134°C.

The PASS/FAIL Challenge Pack consists of a Propper Vapor Line steam sterilization integrator placed inside a test pack similar in construction to the Propper BT- O.K. M steam sterilization test pack.

The provided document is a 510(k) summary for the Propper PASS/FAIL Challenge Pack, a biological/chemical indicator for steam sterilizers. It serves as a premarket notification for a Class II medical device, indicating that its approval is based on substantial equivalence to existing legally marketed devices, rather than comprehensive clinical trial data.

Therefore, the document does not contain the detailed acceptance criteria and a study proving the device meets those criteria in the way a clinical trial report would. Instead, it focuses on demonstrating substantial equivalence.

Here's an analysis of the provided text in relation to your questions, highlighting what is present and what is missing:

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

The document does not explicitly state a table of "acceptance criteria" with numerical targets and then list "reported device performance" against those targets in the manner of a clinical study report.

Instead, the closest equivalent is the statement under "Substantial Equivalence":
"Composite results from comparative testing of these products are given in the two figures which accompany this summary."

• Acceptance Criteria (Implied): The implied acceptance criterion is that the performance of the Propper PASS/FAIL Challenge Pack should be "substantially equivalent" to predicate devices. This means it should demonstrate similar performance characteristics as established, legally marketed biological test packs for steam sterilization.
• Reported Device Performance: The document states that "Composite results from comparative testing of these products are given in the two figures which accompany this summary." These figures (which are not included in the provided text) would presumably show the comparative performance data, allowing for an assessment of substantial equivalence.

Without those figures, specific performance metrics cannot be reported.

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

• Sample Size: Not explicitly stated in the provided text. The phrase "comparative testing of these products" suggests tests were conducted, but the number of units tested (sample size) is not given.
• Data Provenance: Not specified. It's unclear if the testing was prospective or retrospective, or the country of origin of the data.

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 type of information is not relevant or applicable to this device. As a biological/chemical indicator, its "ground truth" is determined by its physical and chemical response to specific sterilization conditions (temperature, time, steam penetration) rather than expert interpretation of images or patient outcomes. The performance is assessed by observing a color change or growth/no-growth of microorganisms.

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

This concept is not applicable to the evaluation of a biological/chemical indicator. Adjudication methods (like 2+1, 3+1) are typically used for establishing ground truth from multiple expert interpretations, often in diagnostic imaging, which is not relevant here.

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

• MRMC Study: No, an MRMC comparative effectiveness study was not done, and is not applicable to this device. MRMC studies are used for evaluating diagnostic devices that involve human interpretation (like AI-assisted imaging). The Propper PASS/FAIL Challenge Pack is a physical indicator, not a diagnostic aid requiring human interpretation in that sense. Its function is to provide a direct readout of sterilization conditions.

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

• Standalone Performance: This concept also does not apply to the Propper PASS/FAIL Challenge Pack. It's not an algorithm or software. It is a physical device that responds to environmental conditions. Its "standalone performance" would be its inherent response to steam sterilization conditions, which would have been tested, but it's not described in terms of an algorithm's performance.

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

The "ground truth" for a biological/chemical indicator like this is the known, controlled conditions of the steam sterilizer.

• For example, if testing at 121°C gravity displacement, the ground truth is that the sterilizer did reach and maintain 121°C for the specified time. The indicator is then observed to see if it correctly registers this (e.g., color change or no growth).
• Similarly for prevacuum sterilizers at 134°C.

Essentially, the "ground truth" is established by the physical parameters of the sterilization cycle itself, as measured by calibrated equipment, and verifying if the indicator responds as expected.

8. The sample size for the training set

• Training Set Sample Size: Not applicable. The Propper PASS/FAIL Challenge Pack is not an AI/ML device, so it doesn't have a "training set" in the computational sense. Its design and manufacturing are based on chemical and biological principles, not machine learning.

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

• Ground Truth for Training Set: Not applicable, as there is no training set for this type of device.

In summary:

The provided 510(k) summary is for a physical biological/chemical indicator. Many of the questions (experts, adjudication, MRMC, AI, training sets) are designed for evaluating AI/ML-driven diagnostic devices or those requiring complex human interpretation, and therefore do not apply to this submission. The core of this submission is demonstrating substantial equivalence to existing, legally marketed predicate devices through comparative performance testing. The specifics of that comparative testing, including exact acceptance criteria and the detailed data, are referenced as being in accompanying figures, which are not included in the text provided.

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Propper EO LINE™ is indicated to be an ethylene oxide sterilization integrator for use in EO sterilizers with 10% ethylene oxide : 90% HCFC gas mixtures. Its function is to monitor the exposure conditions for EO sterilization and to ensure that the four critical parameters: EO gas concentration, temperature, humidity and exposure time have been met.

Propper EO LINE™ Ethylene Oxide Sterilization Integrator

This document is a 510(k) clearance letter from the FDA for a medical device called "Propper EO LINE™ Ethylene Oxide Sterilization Integrator". It doesn't contain a detailed study report with specific acceptance criteria and performance data. Instead, it indicates that a study was done and found the device to be "comparable" to a predicate device.

Therefore, I cannot provide a detailed answer to your request regarding acceptance criteria and study particulars.

However, I can extract the following limited information based on the provided text:

1. A table of acceptance criteria and the reported device performance
Not available in this document. The document states:

• "The performance of Propper EO LINE™ Integrator was comparable to SteriGage® EO Integrator when tested in a Joslyn BIER vessel."
  This implies that the acceptance criterion was likely "comparable performance" to the predicate device (SteriGage® EO Integrator), but the specific metrics for comparability are not detailed.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
Not available in this 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)
Not applicable/available. This device is an integrator for sterilization, not a diagnostic device requiring expert interpretation. The ground truth would be based on physical/chemical sterilization parameters.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable/available.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not applicable. This is not an AI-based diagnostic device.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an algorithm-based device. It is a physical sterilization integrator.

7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
The type of ground truth for a sterilization integrator would typically be the successful or unsuccessful sterilization based on established physical (temperature, humidity, time) and chemical (EO gas concentration) parameters, often confirmed by biological indicators. The document mentions: "ensure that the four critical parameters: EO gas concentration, temperature, humidity and exposure time have been met."

8. The sample size for the training set
Not applicable/available. Sterilization integrators are typically tested and validated, not "trained" in the machine learning sense.

9. How the ground truth for the training set was established
Not applicable/available.

In summary, the provided document is an FDA clearance letter, not the detailed study report itself. It indicates that a "comparable" study was performed against a predicate device (SteriGage® EO Integrator) using a Joslyn BIER vessel, but it does not contain the specifics of that study.

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The Prior BI O.K." EO Gas Biological Test-Pak is intended for use as a disposable device for the biological monitoring of ethylene oxide sterilizers in health care facilities. Its construction closely duplicates that described for such testing by AAMI/ANSI ST41-1992.

The Propper BI-O.K. Gas Biological Test Pack is indicated for use as an aid or adjunct for use in biological monitoring of ethylene oxide sterilizers only. Its performance was verified versus the standard AAMI pack under the conditions of 600 mg/L ethylene oxide, 60% RH, 54.4 C in a Joslyn BIER vessel using a 10% ethylene oxide, 90% HCFC gas mixture.

The BI-O.K. EO Gas Biological Test-Pak consists of a BI-O.K. EO Gas Biological Indicator placed inside a plastic syringe. The syringe along with a Record Card and absorbent towel are enclosed in a paper/plastic peel pouch suitable for use in ethylene oxide sterilizers.

Here's an analysis of the provided text, extracting the requested information about the device's acceptance criteria and studies:

Acceptance Criteria and Study for Propper BI-O.K. EO Gas Biological Test-Pak

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. It mentions "Performance studies" were done "in-house." This indicates the data was retrospective and likely originated from the manufacturer's own testing facility. Specific country of origin is not explicitly stated beyond "in-house," but given the manufacturer's address in Long Island City, New York, the data likely originates from the United States.

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

The document does not provide information on the number of experts used or their qualifications for establishing ground truth. The "Performance studies" section describes in-house testing in a BIER vessel as the basis for performance evaluation.

4. Adjudication Method for the Test Set

The document does not specify an adjudication method. Performance was evaluated through direct testing in a controlled environment.

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

A multi-reader multi-case (MRMC) comparative effectiveness study was not done. This device is a biological indicator for a sterilization process, not an imaging device or diagnostic tool that typically involves human readers.

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

Yes, a standalone study was performed. The "Performance studies" describe the device being tested "in-house in a Joslyn BIER vessel to determine the performance characteristics of the system under controlled, reproducible conditions." This indicates algorithm-only performance testing as the device functions independently of human interpretation in its initial role.

7. Type of Ground Truth Used

The ground truth used was direct experimental outcome (sterilization efficacy in a controlled environment). The device's performance was compared to "similar devices" and "the standard AAMI pack," implying a benchmark based on established scientific principles and industry standards for biological indicators.

8. Sample Size for the Training Set

The document does not mention a training set or any machine learning/AI component. The device is a biological indicator, which operates on a deterministic biological reaction, not a learned algorithm.

9. How Ground Truth for the Training Set Was Established

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

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