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510(k) Data Aggregation
(264 days)
The Ultraphon Chemical Indicator is used exclusively for monitoring the High Level Disinfection process when placed within the Nanosonics trophon® 2 chambers. The color of the Ultraphon Chemical Indicator changes from red to yellow when exposed to hydrogen peroxide, the active ingredient used in trophon® 2 disinfectant. This occurs above the minimum effective concentration (MEC) established for this solution.
The Ultraphon Chemical Indicator is used exclusively for monitoring the High Level Disinfection process when placed within the Nanosonics trophon® EPR and trophon® 2 chambers. The color of the Ultraphon Chemical Indicator changes from red to yellow when exposed to hydrogen peroxide, the active ingredient used in trophon® EPR and trophon® 2 disinfectant. This occurs above the minimum effective concentration (MEC) established for this solution.
The device is a qualitative, single use, disc (26 mm in diameter) that has a hydrogen peroxide sensitive chemical indicating ink applied to a Tyvek® substrate (Product Code: TRO-T) or polypropylene substrate (Product Code: TRO-B). The hydrogen peroxide sensitive chemical indicating ink has been designed to transition from an initial red color to a signal yellow color when subjected to sources of hydrogen peroxide.
The provided text describes the acceptance criteria and a summary of non-clinical testing for the Ultraphon Chemical Indicator (TRO-T and TRO-B). Here's a breakdown of the requested information:
1. A table of acceptance criteria and the reported device performance
| Name of Test | Acceptance Criteria | Subject Device Result |
|---|---|---|
| Performance Testing | Pass result when hydrogen peroxide solution is above the MEC (signal color achieved for all product codes) and fail color when hydrogen peroxide solution is at MEC achieved when exposed to the HLD cycle in combination of a worst-case load: trophon® EPR and trophon® 2 HLD Systems | PASS |
| End Point Stability | 1 month | PASS |
| Offset/Transference | The chemical indicators 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 |
| Chemical Indicator Performance Testing in the Presence of Contaminated Ultrasound Probes | Hydrogen Peroxide 31.5% (1.8g): More yellow than MEC Hydrogen Peroxide 31.5% (1.0g): Equal to MEC or more red | PASS |
| Color Analysis (X-Rite Spectrophotometer) | More yellow than the MEC using 31.5%, 1.8 grams Equal to or more red than MEC using 31.5%, 1.0 gram More red than MEC using 31.5%, 0.8 grams More Yellow than MEC using 31.5%, 1.2 grams | PASS |
| Sensitivity, Specificity, Accuracy, and Precision of Performance Data | Comparative Sensitivity: > 0.95 Analytic Sensitivity (31.5% H2O2): 1.8 g H2O2 solution: 0.56 - 0.58 g H2O2 1.2 g H2O2 solution: 0.37 - 0.39 g H2O2 1.0 g H2O2 solution: 0.31 – 0.33 g H2O2 0.8 g H2O2 solution: 0.25 - 0.27 g H2O2 Comparative Specificity: > 0.95 Accuracy: > 0.95 Precision: < 1 ΔΕ using X-Rite spectrophotometer Analytic Specificity Exposure to Bleach Wipe - Yellow Exposure to Lysol - Yellow Exposure to IPA (70%) - Yellow Dry Heat Exposure 100°C, 15 min - Red UV Exposure - 2 hours - Light Red Ethylene Oxide Exposure 20 min. 54° C 600 ppm, 60%RH - Red | PASS |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document mentions "multiple lots of the subject devices (TRO-T and TRO-B chemical indicators)" were used for testing, but does not specify the exact sample size for the test set. The data provenance (country of origin, retrospective/prospective) is also not explicitly stated.
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 product is a chemical indicator, not an AI or imaging device requiring human interpretation for ground truth. Therefore, no
experts were used in this context. The "ground truth" is determined by the chemical reaction and concentration of hydrogen peroxide.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Since this is a chemical indicator, the ground truth is based on the chemical reaction and color change, not human interpretation. Therefore, no adjudication method was used for a test set in the traditional sense of expert consensus.
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 MRMC comparative effectiveness study was done. This device is a chemical indicator, not intended to assist human readers in interpreting medical images or data.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
This product is a standalone chemical indicator. Its performance is evaluated based on its color change in response to hydrogen peroxide without human interpretation being part of its core function or acceptance criteria.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The ground truth for this device is based on chemical reactions and concentrations of hydrogen peroxide. Specifically, the "minimum effective concentration (MEC)" of hydrogen peroxide (1.0 gram of 31.5% hydrogen peroxide) is the key reference point for expected color change.
8. The sample size for the training set
The document does not specify a training set sample size. As a chemical indicator, it likely does not involve machine learning or traditional "training sets" in the same way an AI algorithm would. Its performance is based on the inherent chemical properties and manufacturing consistency.
9. How the ground truth for the training set was established
Since there is no mention of a training set for machine learning, the establishment of ground truth in that context is not applicable. The underlying "ground truth" for the device's function is the known chemical reaction between the indicator ink and hydrogen peroxide at specific concentrations.
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(260 days)
The Chemical Indicator for Steam is intended for use with individual materials (i.e. pouches, packs, trays) to demonstrate the material has been exposed to a steam sterilization process to distinguish between processed goods.
The Chemical Indicator for Steam can transition from an initial color of yellow and turn to a dark brown/black color for Product Code: CSYN-US, pink to a dark brown/black color for Product Code: CSPN-US, and blue to a dark brown/black color for Product Code: CSBN-US when exposed to high temperature steam at the following time and temperature intervals as process indicators:
Gravity: 121°C/250 F - 30 minutes (wrapped/porous)
Pre-vacuum: 132℃/270 F - 3 minutes (unwrapped/nonporous)
Pre-vacuum: 132°C/270 F - 4 minutes (wrapped/porous)
Pre-vacuum: 134℃/273 F - 4 minutes (wrapped/porous)
Pre-vacuum: 135°C/275 F - 3 minutes (wrapped/porous and unwrapped/nonporous, mixed load)
The True Indicating Lead-Free Chemical Indicator for Steam product codes CSYN-US (yellow to dark), CSPN-US (pink to dark), and CSBN-US (blue to dark), all turn a permanent dark brown/black color when exposed to high temperature steam.
Paper Strip printed with Bismuth based chemical indicator ink with polyester overlaminate applied over the entire indicating ink strip
The provided text describes the acceptance criteria and the results of nonclinical tests for a chemical indicator for steam sterilization, not an AI/ML-based device. Therefore, many of the requested points, such as MRMC studies, number of expert readers, adjudication methods, and training set information, are not applicable.
Here's an analysis of the provided information concerning the acceptance criteria and performance of the Chemical Indicator for Steam (K220778):
Device: Chemical Indicator for Steam (K220778)
Type: Chemical Indicator
Purpose: To demonstrate that individual materials (pouches, packs, trays) have been exposed to a steam sterilization process, distinguishing between processed and unprocessed goods.
1. A table of acceptance criteria and the reported device performance:
| Name of Test | Purpose | Acceptance Criteria | Reported Device Performance (Subject Device Result) |
|---|---|---|---|
| Steam Resistometer Testing | To test the pass/fail criteria for each critical cycle parameter and provide the pass/fail results to show how the chemical indicator reacts to the critical parameters in the sterilization cycle for which it is intended. | Pass result (signal color achieved for all product codes) at the value for each temperature claimed:- 121°C for 10 minutes- 134°C for 2 minutes- 135°C for 2 minutesFail result (signal color not achieved for all product codes) at the value for each temperature claimed:- 121°C for 2 minutes- 134°C for 0.3 minutes- 135°C for 0.3 minutes | PASS |
| Hospital Steam Sterilizer Testing | Determine if the chemical indicators reach specified endpoint color of dark brown/black when combined with a sterilization load and exposed to the sterilization cycle for which it is intended. | Pass result (signal color achieved for all product codes) at the value for each temperature claimed in combination of a sterilization load:- Gravity: 121°C/250 F - 30 minutes (wrapped/porous)- Vacuum assisted (prevacuum): 132°C/270 F - 3 minutes (unwrapped/nonporous)- Vacuum assisted (prevacuum): 132°C/270 F - 4 minutes (wrapped/porous)- Vacuum assisted (prevacuum): 134°C/273 F - 4 minutes (wrapped/porous)- Vacuum assisted (prevacuum): 135°C/275 F - 3 minutes (wrapped/porous and unwrapped/nonporous, mixed load) | PASS |
| Dry Heat Testing | Demonstrate that the Chemical Indicator for Steam does not change color following a dry heat cycle. | Fail result when exposed to dry heat alone for 30 minutes (±1 minute) at 140°C (±2°C) | PASS |
| End Point Stability | Determine the length of time that an exposed Chemical Indicator for Steam retains its post-exposure signal color. | 1 Month | PASS |
| Offset/Transference | Demonstrate the chemical indicators do not bleed or offset to the substrate to which it's applied. | The chemical indicators 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 document states that testing was performed using "multiple lots of True Indicating Chemical Indicator for Steam over the range of the shelf life."
- Specific numerical sample sizes for each test (e.g., number of indicators per lot, number of cycles) are not provided in the given text.
- The data provenance is from nonclinical laboratory testing following FDA guidance and relevant ISO standards (ISO 11140-1:2014) for the performance of chemical indicators. It is not patient data; rather, it is performance data of the physical device under controlled laboratory conditions simulating sterilization processes. The location of the testing is not explicitly stated as a country but is likely within the US given the FDA submission. The nature of the testing is experimental/prospective, as it involves putting the indicators through specific sterilization cycles and observing their color change.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This question is not applicable as the device is a chemical indicator that undergoes a physical color change (yellow/pink/blue to dark brown/black) in response to steam exposure. The ground truth (whether the indicator changed color correctly) is determined by direct observation of the physical chemical reaction, not by expert interpretation of complex medical images or data. No human experts are involved in establishing the ground truth for the performance of the chemical indicator itself. The "experts" would be the laboratory technicians or scientists conducting the tests according to the defined protocols and visually confirming the color change.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- This question is not applicable. Adjudication methods are relevant for human interpretation tasks, especially in medical imaging where inter-reader variability exists. For a chemical indicator, the color change is a physical phenomenon intended to be unambiguous. The "ground truth" is the presence or absence of the expected color change based on exposure to the specified steam conditions.
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 question is not applicable. An MRMC study is relevant for AI/ML-based devices assisting human readers in diagnostic tasks. This device is a passive chemical indicator, not an AI system.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- This question is not applicable. This device is a chemical indicator, not an algorithm. Its performance is inherent to its chemical composition and design, observed directly as a color change.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- The ground truth is established by the physical and chemical properties of the indicator and the controlled steam sterilization conditions to which it is exposed.
- For "pass" criteria, the ground truth is that the indicator was exposed to the required steam conditions (temperature, time) and should show the signal color change.
- For "fail" criteria (e.g., inadequate exposure, dry heat), the ground truth is that the indicator was not exposed to the required conditions to trigger a full color change (or was exposed to conditions it should not react to) and should not show the signal color.
- The "ground truth" for End Point Stability and Offset/Transference is the observable physical property of the indicator maintaining its color and not bleeding.
8. The sample size for the training set:
- This question is not applicable. This is a physical chemical indicator, not a machine learning model; therefore, it does not have "training data" in the sense of an AI algorithm. Its performance is based on its intrinsic chemical formulation and manufacturing quality.
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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(298 days)
The True Indicating Instant 20s Indicator, a multiple, interactive, bacterial enzyme indicator, is used for monitoring saturated steam sterilization processes operating at: 121°C, 30 minutes (Gravity), 132°C, 4 minutes (Pre- Vacuum), 135°C, 3 minutes (Pre-Vacuum).
The True Indicating Instant 20s Indicator consists of a polycarbonate vial, polypropylene cap, a silicone vented cap which serves as a base, a vinyl sealant, and a biological tablet produced using cellulose, and enzymes from Geobacillus stearothermophilus ATCC® 7953.
The provided text describes the nonclinical tests conducted for the "Instant 20s Indicator" device (K210481), a sterilization process indicator. The information pertains to the device's performance in laboratory settings to ensure it meets the required safety and effectiveness standards for its intended use.
Here's an analysis of the acceptance criteria and study that proves the device meets them, based on the provided text:
1. A table of acceptance criteria and the reported device performance
| Name of Test | Purpose and Guidance Document/Standard | Acceptance Criteria | Subject Device Result |
|---|---|---|---|
| D value Based on Enzymatic Activity | Determine the resistance of the Instant 20s Indicator following ISO 11138-1 and 11138-3 | D121 ≥ 1.5 minD132 ≥ 10 sD135 ≥ 8 s | PASSD121 ≥ 1.7 minD132 ≥ 12 sD135 ≥ 12 s |
| z value Based on Enzymatic Activity | Determine the z-value of the Instant 20s Indicator per ISO 11138-1 and 11138-3 | ≥10 | PASS≥13.6 |
| Survival Time Based on Enzymatic Activity | Determine the exposure time for all Instant 20s Indicator to retain viable spores (Survival Time) per ISO 11138-1, 11138-3 and Guidance for Industry and Staff - Biological Indicator (BI) Premarket Notification [510(k)] Submission | Meets the longer of FDA and ISO 11138-3 requirements | PASS121°C ≥ 5.1 min132°C ≥ 1.0 min135°C ≥ 40 sec |
| Kill Time Based on Enzymatic Activity | Determine the exposure time for all Instant 20s Indicator to inactivate all spores (Kill Time) per ISO 11138-1, 11138-3 and Guidance for Industry and Staff - Biological Indicator (BI) Premarket Notification [510(k)] Submission | Meets the shorter of FDA and ISO 11138-3 requirements | PASS121°C ≤ 15.3 min132°C ≤ 1.8 min135°C ≤ 1.8 min |
| Hold Time | Determine the length of time that an exposed Instant 20s Indicator can be held before incubation (Hold Time) per Guidance for Industry and Staff – Biological Indicator (BI) Premarket Notification [510(k)] Submission | Performance not affected if used within 72 hours of exposure to steam sterilization | PASS |
| Growth Inhibition | Determine if positive result is achieved when primary packaging is subject to worst case steam exposure per Guidance for Industry and Staff – Biological Indicator (BI) Premarket Notification [510(k)] Submission | 100% Positive Results | Pass |
| Shelf Life | Resistance and Survival/Kill must meet above criteria at each stability time point per ISO 11138-1, 11138-3 and Guidance for Industry and Staff - Biological Indicator (BI) Premarket Notification [510(k)] Submission | D value = see aboveSurvival = see aboveKill = see above | PASS |
| Chemical Indicator Performance | Determine the pass/fail criteria for each critical cycle parameter and provide the pass/fail results to show how the chemical indicator reacts to all the critical parameters in the sterilization cycle for which it is intended according to ANSI/AAMI/ISO 11140-1:2014 Sterilization of health care products - Chemical indicators - Part 1: General requirements and Guidance for Industry and FDA Staff - Premarket Notification [510(k)] Submissions for Chemical Indicators | Pass result at Stated Value for each temperature claimed:121°C, 30 minutes (Gravity)132°C, 3 minutes (Pre-Vac)135°C, 3 minutes (Pre-Vac)Fail Result at 15% less time and -1°C of Stated Value | PASS |
| Endpoint Stability of Positive Result Color | Determine the endpoint stability of developed color due to a positive result (failure) per Guidance for Industry and FDA Staff - Premarket Notification [510(k)] Submissions for Chemical Indicators | 7 Days | PASS |
| Endpoint Stability of Negative Result Color | Determine the endpoint stability of color due to a negative result (pass) per Guidance for Industry and FDA Staff - Premarket Notification [510(k)] Submissions for Chemical Indicators | 30 Minutes | PASS |
| Simulated Use | Determine the simulated use of the Instant 20s Indicator in a sterilizer per Guidance for Industry and FDA Staff - Biological Indicator (BI) Premarket Notification [510(k)] Submission | Demonstrates a survival (positive) result when exposed to abbreviated cycle, and all kill (negative) in full and half cycles | PASSAbbreviated cycles - positiveHalf cycles - negativeFull cycles - negative |
| Biocompatibility (In Vitro Cytotoxicity) | To determine if the device is cytotoxic to mammalian cells in vitro | Under conditions of the study, did not show potential toxicity to L-929 cells. | PASS |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document is a 510(k) submission for a non-clinical device (sterilization indicator). The testing described is not related to patient data or clinical studies in the traditional sense of medical imaging or diagnostic devices. Instead, it involves laboratory verification of the physical and biological characteristics of the "Instant 20s Indicator."
- Sample Size: The document does not specify exact numerical sample sizes (e.g., number of indicators tested for each criterion). It mentions "multiple lots of True Indicating Instant 20s Indicator over the range of the shelf life" were used for testing on page 5.
- Data Provenance: The data is generated from nonclinical laboratory tests of the device itself.
- Country of Origin: Not explicitly stated, but the company (True Indicating LLC) is based in Toledo, Ohio, USA, which implies the testing was likely conducted in the US or by US-affiliated labs.
- Retrospective or Prospective: Not applicable in the context of clinical studies. These are prospective laboratory tests conducted specifically for the 510(k) submission to demonstrate compliance with standards and guidance documents.
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 question is not applicable to this type of device and study. The "Instant 20s Indicator" is a physical product designed to provide a direct, observable biological or chemical reaction (color change) based on exposure to a sterilization process. Ground truth is established by:
- Objective physical measurements: Temperature, time, and steam conditions in the sterilization chambers used for testing.
- Biological viability (spores): Growth or inhibition of "Geobacillus stearothermophilus ATCC® 7953" enzymes. This "ground truth" is determined by established microbiological methods and is not subject to expert consensus in the way a medical image diagnosis would be.
- Chemical reaction: The color change observed.
There are no human "experts" establishing a subjective ground truth, as would be the case in image interpretation studies. The process is objective and measurable against established physical and biological standards.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. This is not a study involving human interpretation or subjective assessments that would require an adjudication process. The results are based on objective laboratory measurements and observations (e.g., color change, growth/no growth, D-value calculation).
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not applicable. This device is a sterilization indicator, not an AI-powered diagnostic tool. There are no human "readers" or AI assistance involved in its function or the testing described. Its output is a direct, observable color change or a measurable biological/chemical response, not an interpretation of complex data.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. There is no algorithm for this device. The device itself performs its function (indicating sterilization efficacy) in a "standalone" manner in that it is placed in the sterilizer and then removed and activated to provide a result. There is no human required during the sterilization process for the device to function.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The ground truth for this device is based on:
- Physical Parameters: Precisely controlled and measured temperature, time, and steam conditions in the sterilization test chambers. These parameters are rigorously defined by international standards (e.g., ISO 11138 series).
- Microbiological Viability: The known resistance characteristics of the Geobacillus stearothermophilus spores/enzymes used in the indicator. The "kill" or "survival" of these biological entities under defined conditions constitutes the ground truth.
- Chemical Reaction: The expected color change of the indicator solution when it reacts with viable or inviable enzymes, as per the device's design.
Essentially, the "ground truth" is the known effect of specific sterilization conditions on the indicator's biological and chemical components, established through adherence to recognized consensus standards and guidance documents.
8. The sample size for the training set
Not applicable. As a physical sterilization indicator, this device does not use machine learning or require a "training set" in the computational sense. Its function is based on inherent biological and chemical properties, not learned patterns from data.
9. How the ground truth for the training set was established
Not applicable, as there is no training set for this device.
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(259 days)
The True Indicating Self-Contained Biological Indicator is intended for monitoring the efficacy of saturated steam sterilization processes. The True Indicating Self-Contained Biological Indicator has a validated reduced incubation time of 10 hours and may be used in the following steam sterilization cycles: 121°C, 30 minutes (Gravity), 132°C, 4 minutes (Pre-Vacuum), and 135°C, 3 minutes (Pre-Vacuum).
The True Indicating Self-Contained Biological Indicator (SCBI) consists of a 6 - mm filter paper disc inoculated with Geobacillus stearothermophilus ATCC® 7953, at a minimum of 105 bacterial spores encased within a polypropylene cap, and a polypropylene vial which includes a glass ampule hermetically sealed containing a nutrient broth culture medium modified with a pH indicator, Bromocresol Purple.
The provided document is a 510(k) premarket notification for a medical device: the True Indicating Self-Contained Biological Indicator. This device is a biological indicator used to monitor the efficacy of steam sterilization processes. The document outlines the device's characteristics, intended use, and the non-clinical testing performed to demonstrate its substantial equivalence to a predicate device.
It's crucial to understand that this document describes the validation of a physical, in-vitro biological indicator, not an AI-powered diagnostic device or software. Therefore, many of the requested fields related to AI/MRMC studies, number of experts for ground truth establishment, data provenance for test/training sets, and adjudication methods are not applicable to this type of device and its validation.
Here's an analysis of the acceptance criteria and study proving the device meets them, based on the provided text, with explicit notes where information is not applicable:
Acceptance Criteria and Device Performance for True Indicating Self-Contained Biological Indicator
1. Table of Acceptance Criteria and Reported Device Performance
| Name of Test | Purpose | Acceptance Criteria | Subject Device Result |
|---|---|---|---|
| Viable Spore Population | Determine the spore population per the manufacturer's procedure following ISO 11138-1 | ≥10^5 or greater | PASS: 1.0 - 4.8 x 10^5 Spore/SCB |
| D value | Determine the resistance of the BI following ISO 11138-1 and 11138-3 | D121 ≥ 1.5 minD132 ≥ 10 sD135 ≥ 8 s | PASS: D121 ≥ 1.7 minD132 ≥ 18 sD135 ≥ 12 s |
| z value | Determine the z-value of the BI per ISO 11138-1 and 11138-3 | ≥10 | PASS: ≥11.6 |
| Survival Time | Determine the exposure time for all BI's to retain viable spores (Survival Time) per ISO 11138-1, 11138-3 and Guidance for Industry and Staff - Biological Indicator (BI) Premarket Notification [510(k)] Submission | Meets the longer of FDA and ISO 11138-3 requirements | PASS: 121°C ≥ 5.9 min132°C ≥ 1.1 min135°C ≥ 42 sec |
| Kill Time | Determine the exposure time for all BI's to inactivate all spores (Kill Time) per ISO 11138-1, 11138-3 and Guidance for Industry and Staff - Biological Indicator (BI) Premarket Notification [510(k)] Submission | Meets the shorter of FDA and ISO 11138-3 requirements | PASS: 121°C ≤ 28.0 min132°C ≤ 2.8 min135°C ≤ 1.8 min |
| Reduced Incubation Time (RIT) | Determine the Reduced Incubation Time outlined in Guidance for Industry and Staff - Biological Indicator (BI) Premarket Notification [510(k)] Submission | Meets FDA's requirement of > 97% alignment of the 10 hour results with the conventional incubation time of 7 days | PASS: Minimum of 10 Hours |
| Carrier growth inhibition / media growth promotion | Determine the carrier growth inhibition/media growth promotion per ISO 11138-1 and 11138-3 | Positive growth of less than 100 spores after primary packaging and media are subject to worst case steam exposure | PASS |
| Hold Time | Determine the length of time that an exposed BI can be held before incubation (Hold Time) per Guidance for Industry and Staff - Biological Indicator (BI) Premarket Notification [510(k)] Submission | Performance not affected if incubated within 72 hours of exposure to steam sterilization | PASS |
| Simulated Use | Determine the simulated use of the BI in a sterilizer per Guidance for Industry and Staff - Biological Indicator (BI) Premarket Notification [510(k)] Submission | Demonstrate growth when exposed to abbreviated cycle, all kill in a full cycle and a half cycle. All cycles utilized full loads using porous, non-porous, and mixed load material | PASS: Abbreviated cycle - growthHalf cycle - no growthFull cycle - no growth |
2. Sample size used for the test set and the data provenance
- Sample Size: The document does not specify exact numerical sample sizes (e.g., number of BIs tested) for each test. Instead, it refers to conducting tests "using multiple lots of True Indicating SCBI for Steam over the range of the shelf life." This implies a sufficient number of units were tested to meet the requirements of the referenced ISO standards (ISO 11138-1:2017, ISO 11138-3:2017) and FDA guidance for BI submissions.
- Data Provenance: The data is generated from non-clinical laboratory testing of the physical medical device. The document does not specify country of origin for the testing itself, but the submission is to the U.S. FDA, and tested against international (ISO) and U.S. (FDA) standards. This is not retrospective or prospective in the sense of clinical study data; it's product performance testing.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not Applicable. This is a non-clinical device that relies on a physical, chemical, and biological reaction (spore inactivation and subsequent growth/no-growth). The ground truth is objective and established by the physical and biological properties of the system (e.g., spore count, thermal resistance characteristics, visual color change indicating growth) under controlled experimental conditions according to recognized international and national standards. There are no human "experts" establishing a "ground truth" through interpretation in the way there would be for an AI diagnostic device.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not Applicable. As this involves objective, quantifiable laboratory measurements of a physical device's performance, judicial adjudication methods are not relevant. The results are determined by the specified test protocols and acceptance criteria.
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-powered device or a diagnostic device that involves human readers interpreting images or data. Therefore, MRMC studies are irrelevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not Applicable. This is a physical biological indicator, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- The ground truth is established through objective laboratory measurements and biological principles as defined by recognized standards (ISO 11138 series) and FDA guidance documents for biological indicators. For example:
- Viable Spore Population: Determined quantitatively by plating and counting colony-forming units.
- D-value and Z-value: Calculated from survival curves generated under controlled sterilization conditions.
- Survival/Kill Time: Demonstrated by whether spores survive or are inactivated after specific exposure times, verified by incubation and visible growth/no growth.
- Reduced Incubation Time: Verified by statistical alignment (greater than 97%) of 10-hour results with conventional 7-day incubation results, where growth (yellow media) indicates sterilization failure and no growth (purple media) indicates success.
- Simulated Use: Demonstrated by objective growth/no-growth results after exposure to specific sterilization cycles (abbreviated cycle = growth, half cycle = no growth, full cycle = no growth), ensuring the indicator performs as expected under varied challenge levels.
8. The sample size for the training set
- Not Applicable for this type of device. Training sets are relevant for machine learning algorithms. This device is a physical biological indicator validated through non-clinical performance testing.
9. How the ground truth for the training set was established
- Not Applicable for this type of device. See point 8.
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