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510(k) Data Aggregation
(29 days)
OVY
The VERIFY Spore Test Strip for S40 Sterilant Concentrate is intended to provide users with a means to assess spore kill by S40 Sterilant use dilution in the STERIS automated Liquid Chemical Sterilant Processing Systems (SYSTEM 1E and SYSTEM 1® endo Liquid Chemical Sterilant Processing Systems and enspire 3000 Series Cleaning and Liquid Chemical Sterilant Processing System). A "no growth" result from the VERIFY Spore Test Strip for S40 Sterilant Concentrate after 24 hours of incubation indicates that the liquid chemical sterilization process achieved the conditions necessary to kill at least 1 x 105 viable spores (5 logs) on the spore test strip (STS). It does not confirm the expected full performance of the liquid chemical sterilization cycle.
The Spore Test Strip for S40 Sterilant Concentrate (STS) consists of a 1 % in. x 14 in. filter paper-based strip inoculated with Geobacillus stearothermophilus spores and is enclosed in a glassine envelope. The STS are provided with media vials containing a modified tryptic soy broth with phenol red pH indicator, and a transfer clip. The transfer clip is used to remove the STS from the glassine envelope and serves to hold the strip in a fixed location in either the enspire 3000 Series Cleaning and Liquid Chemical Sterilant Processing System (enspire CLCSPS) or the SYSTEM 1E or SYSTEM 1 endo Liquid Chemical Sterilant Processing system. After the cycle concludes, the transfer clip is used to aseptically transfer the STS from the processor into the growth media for incubation at 55-60°C for a minimum of 24 hours but may be incubated for up to 7 days. If the media remains red and non-turbid, the user interprets the results as a pass. If the media color turns yellow or is turbid, the user interprets the result as a fail. The shelf life is 12 months when stored at 2-24°C and 30-80% relative humidity (RH) away from sterilizing agents and excessive heat.
There are no changes to the strip itself for this submission; only an expansion to the exposure time to the chemical sterilant.
The provided document, an FDA 510(k) Premarket Notification summary for the "VERIFY SPORE TEST STRIP for S40 STERILANT CONCENTRATE," details the acceptance criteria and the study proving the device meets these criteria.
Here's the breakdown:
1. Table of Acceptance Criteria and the Reported Device Performance:
The primary acceptance criteria for this device revolve around demonstrating its continued performance as a spore test strip, specifically that the expansion of contact time with the liquid chemical sterilant does not negatively impact its ability to accurately assess spore kill.
| Test | Acceptance Criteria | Result |
|---|---|---|
| Population Wash Off Testing | The modification does not affect the performance of the device. | Pass |
| Bacteriostasis Testing | The modification does not affect the performance of the device. | Pass |
| Implied Performance Criteria (from Intended Use & Predicate Comparison): | ||
| Ability to indicate ≥ 5 logs kill of Geobacillus stearothermophilus spores | A "no growth" result from the VERIFY Spore Test Strip for S40 Sterilant Concentrate after 24 hours of incubation indicates that the liquid chemical sterilization process achieved the conditions necessary to kill at least 1 x 105 viable spores (5 logs) on the spore test strip (STS). | Demonstrated as substantially equivalent to predicate, which has this capability. |
| Shelf Life | 12 months | Identical to predicate. |
| Resistance Characteristics (at 1635 ppm PAA) | D-value 12 – 26 seconds; Survival Time ≥ 38 seconds; Kill Time ≥ 239 seconds | Identical to predicate. |
2. Sample Size Used for the Test Set and the Data Provenance:
The document does not explicitly state the numerical sample size for the "Population Wash Off Testing" and "Bacteriostasis Testing." It only indicates that these tests were performed and passed.
The data provenance is implied to be prospective testing conducted by the manufacturer, STERIS Corporation, in support of this 510(k) submission. The country of origin of the data is not specified, but given that STERIS Corporation is based in Mentor, Ohio, USA, it is highly probable the testing was conducted in the USA.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts:
This information is not provided in the document. The nature of these tests (Population Wash Off and Bacteriostasis Testing for a biological indicator) suggests laboratory-based assessments rather than expert interpretation of complex medical images, therefore, detailed information on expert consensus is not typically required or provided for this type of device.
4. Adjudication Method for the Test Set:
This information is not provided in the document. For the type of testing described (objective laboratory assays), an adjudication method like 2+1 or 3+1 for human readers is not applicable. The results are likely determined by predefined laboratory protocols and measurements.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done:
No, an MRMC comparative effectiveness study was not done. This type of study is relevant for AI-assisted diagnostic tools where human readers interpret medical images. The device in question is a biological indicator for sterilization monitoring, not a diagnostic imaging device.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:
Yes, in essence. The "Population Wash Off Testing" and "Bacteriostasis Testing" are standalone tests of the device's physical and biological integrity and performance characteristics, independent of human interpretation beyond reading the final culture results (growth/no growth). The device itself functions as a standalone indicator of sterilization efficacy.
7. The Type of Ground Truth Used:
The ground truth for the performance of this device is established by:
- Laboratory Testing: Directly measuring the
Population Wash Off(the number of viable spores remaining on the strip after specified processing) andBacteriostasis(the absence of inhibitory substances affecting subsequent bacterial growth). - Biological Efficacy: The ultimate ground truth for a spore test strip is its ability to accurately reflect the killing of the specified 5 logs of Geobacillus stearothermophilus spores, as confirmed by standard microbiological culture methods (absence of growth after incubation).
8. The Sample Size for the Training Set:
This information is not applicable and therefore not provided. This device is a biological indicator, not a machine learning or AI model that requires training data.
9. How the Ground Truth for the Training Set Was Established:
This information is not applicable. As stated above, this device does not involve a training set as it is not an AI/ML model.
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(88 days)
OVY
The VERIFY Spore Test Strip for S40 Sterilant Concentrate is intended to provide users with a means to assess spore kill by S40 Sterilant use dilution in the STERIS automated Liquid Chemical Sterilant Processing Systems (SYSTEM 1E and SYSTEM 1® endo Liquid Chemical Sterilant Processing Systems and enspire 3000 Series Cleaning and Liquid Chemical Sterilant Processing System). A "no growth" result from the VERIFY Spore Test Strip for S40 Sterilant Concentrate after 24 hours of incubation indicates that the liquid chemical sterilization process achieved the conditions necessary to kill at least 1 x 105 viable spores (5 logs) on the spore test strip (STS). It does not confirm the expected full performance of the liquid chemical sterilization cycle.
The Spore Test Strip for S40 Sterilant Concentrate (STS) consists of a 1 % in. x 14 in. filter paper-based strip inoculated with Geobacillus stearothermophilus spores and is enclosed in a glassine envelope. The STS are provided with media vials containing a modified tryptic soy broth with phenol red pH indicator, and a transfer clip. The transfer clip is used to remove the STS from the glassine envelope and serves to hold the strip in a fixed location in either the enspire 3000 Series Cleaning and Liquid Chemical Sterilant Processing System (enspire CLCSPS) or the SYSTEM 1E or SYSTEM 1 endo Liquid Chemical Sterilant Processing system. After the cycle concludes, the transfer clip is used to aseptically transfer the STS from the processor into the growth media for incubation at 55-60℃ for a minimum of 24 hours but may be incubated for up to 7 days. If the media remains red and non-turbid, the user interprets the results as a pass. If the media color turns yellow or is turbid, the user interprets the result as a fail. The shelf life is 12 months when stored at 2-24°C and 30-80% relative humidity (RH) away from sterilizing agents and excessive heat.
The provided text describes a 510(k) premarket notification for a medical device called "VERIFY Spore Test Strip for S40 Sterilant Concentrate." This submission is for a device that already has a predicate (K180553) and the main change is an expansion of its indications for use to include a new processing system, the "enspire 3000 Series Cleaning and Liquid Chemical Sterilant Processing System (CLCSPS)."
The "acceptance criteria" and "study that proves the device meets the acceptance criteria" in this context refer to the performance testing conducted to demonstrate that the expanded use of the spore test strip in the new system is safe and effective, performing as well as the previous approved uses.
Here's a breakdown of the requested information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are implicitly defined by the successful outcomes ("PASS") of the performance tests, demonstrating that the device functions appropriately under the new use conditions. The "performance" is the conclusion that the device passed these tests.
| Acceptance Criteria (Implicit) | Reported Device Performance |
|---|---|
| Population Wash Off Stability: Evaluate the population of the spores remaining on the STS after processing without sterilant. | PASS (Demonstrated that the population of spores remaining on the STS after processing without sterilant was acceptable.) |
| Simulated Use: Demonstrate the STS functions appropriately in the enspire CLCSPS. | PASS (Demonstrated that the STS functions appropriately in the enspire CLCSPS.) |
| Bacteriostasis: Ensure no inhibitory effects on the outgrowth of a low number of spores. | PASS (Demonstrated no inhibitory effects on the outgrowth of a low number of spores.) |
2. Sample size used for the test set and the data provenance
The document does not explicitly state the sample sizes (e.g., number of strips, number of runs) used for each of the performance tests (Population Wash Off Stability, Simulated Use, Bacteriostasis).
- Data Provenance: The study was conducted by STERIS Corporation, an American company (Mentor, Ohio). Given the context of a 510(k) submission to the FDA, the data would have been generated in a controlled environment to meet regulatory standards. The document does not specify whether the data was retrospective or prospective, but performance testing for a 510(k) generally involves prospective testing of the device.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This type of device (spore test strip for sterilant efficacy) does not typically involve human expert interpretation of images or clinical outcomes in the same way an AI diagnostic device would. Ground truth is established through laboratory methods (e.g., microbial growth/no growth, quantitative spore counts). Therefore, the concept of "experts" for ground truth establishment in the human-in-the-loop sense, or their qualifications, is not applicable directly to this device. Competent laboratory personnel would conduct and interpret the tests according to established protocols.
4. Adjudication method for the test set
Adjudication methods (like 2+1, 3+1) are common in clinical studies involving human interpretation or subjective assessments. For a biological indicator like a spore test strip, the results (growth/no growth, quantitative counts) are objective, and adjudication is not typically applied in the same manner. The outcome is determined by the presence or absence of growth and quantitative measurements.
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
An MRMC study is not applicable to this device. This is not an AI diagnostic device that assists human readers. It is a biological indicator for sterilization processes.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
The device itself is a standalone biological indicator. It provides a result (growth/no growth) based on a biological process (spore killing by sterilant and subsequent incubation). There is no "algorithm" in the sense of artificial intelligence. The device's performance is its ability to accurately reflect the 5-log kill of spores under specified conditions. The performance tests ("Population Wash Off Stability," "Simulated Use," "Bacteriostasis") directly evaluate this standalone performance.
7. The type of ground truth used
The ground truth for this device is based on biological and chemical efficacy.
- Biological Efficacy: The primary ground truth is the presence or absence of Geobacillus stearothermophilus growth after exposure to the sterilant and incubation, indicating whether a 5-log reduction of spores has occurred. This is a direct measure of microbial inactivation.
- Chemical/Physical Parameters: The ground truth also relates to the specific conditions of the sterilization process (e.g., PAA concentration, temperature, time) as defined for the sterilant and the processing systems.
8. The sample size for the training set
This device does not involve machine learning or AI, and therefore, there is no "training set" in the typical sense for algorithms. The "training" of the product's design would be based on historical data, prior knowledge of sterilant efficacy, and established microbiological methods for biological indicators, rather than a data set used to train a predictive model.
9. How the ground truth for the training set was established
As there is no training set for an AI algorithm, this question is not applicable. The underlying scientific principles for spore test strips and sterilization efficacy are well-established through decades of microbiological and chemical research. The "ground truth" for the development of such a device is rooted in these scientific principles and standard test methods (e.g., those from AAMI, ISO).
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(89 days)
OVY
The VERIFY® Spore Test Strip for S40 Sterilant is intended to provide users with a means to assess spore kill by S40 sterilant use dilution in the STERIS automated Liquid Chemical Sterilant Processing Systems (SYSTEM 1E Liquid Chemical Sterilant Processing System and SYSTEM 1 endo Liquid Chemical Sterilant Processing System). A "no growth" result from the VERIFY Spore Test Strip for S40 Sterilant after 24 hours of incubation indicates that the liquid chemical sterilization process achieved the conditions necessary to kill at least 1 x 10E5 viable spores (5 logs) on the test strip. It does not confirm the expected full performance of the liquid chemical sterilization cycle.
The VERIFY® Spore Test Strip for S40 Sterilant consists of a 1 36 in. x 14 in. filter paper-based strip inoculated with Geobacillus stearothermophilus spores and is enclosed in a glassine envelope. The Spore Test Strips are provided with media vials containing a modified tryptic soy broth with phenol red pH indicator, and a transfer clip. Using the clip, the Spore Test Strip is secured on the available post located in the tray of the liquid chemical sterilant processor. The transfer clip thus holds the Spore Test Strip in a fixed location during a processing cycle in the STERIS Liquid Chemical Sterilant Processing System and enables aseptic transfer of the strip from the processor into the growth media vial after the cycle ends.
For use, the Spore Test Strip is removed from the glassine envelope and secured using the transfer clip in the SYSTEM 1E Liquid Chemical Sterilant Processing System or SYSTEM 1 endo Liquid Chemical Sterilant Processing System along with the items to be liquid chemically sterilized. The liquid chemical sterilization cycle is initiated. At the end of the full cycle, the Spore Test Strip is removed and placed into the vial of growth medium for incubation under the specified conditions that will promote spore growth for at least 24 hours. If the media remains red and non-turbid, the user interprets the results as a pass. If the media color turns yellow or is turbid, the user interprets the result as a fail.
The Spore Test Strip is incubated at 55-60°C for a minimum of 24 hours, but may be incubated for up to 7 days. The shelf life is 12 months when stored at 2-24℃ and 30-80% relative humidity (RH) away from sterilizing agents and excessive heat.
The current submission makes no changes to the strip itself; only the indications for use are changing to encompass the VERIFY Spore Test Strip's broader use in more than one STERIS automated liquid chemical sterilant processing system (SYSTEM 1E Liquid Chemical Sterilant Processing System and SYSTEM 1 endo Liquid Chemical Sterilant Processing System) that uses S40 Sterilant Concentrate under identical exposure conditions.
The provided text describes the 510(k) premarket notification for the VERIFY® Spore Test Strip for S40® Sterilant. This device is a biological indicator designed to assess the effectiveness of liquid chemical sterilization processes. It is important to note that this is not an AI/ML device, and therefore, several requested categories are not applicable.
Here's the breakdown based on the provided document:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria | Reported Device Performance (Table 1 & 2) |
|---|---|
| Population | |
| • At manufacture | $\geq$ 1.5 x 105 cfu/strip |
| • After wash-off (end of cycle) | $\geq$ 1.0 x 105 cfu/strip |
| Resistance (at 1635 ppm PAA) | |
| • D-value | 12-26 sec |
| • Survival Time | $\geq$ 38 seconds |
| • Kill Time | $\leq$ 239 seconds |
| Reduced Incubation Time | 24 hours |
| Simulated Use | PASS |
| Stability of Media Color | PASS |
| Shelf Life | PASS (for 12 months) |
2. Sample size used for the test set and the data provenance
The document indicates that non-clinical testing was performed for "Simulated Use", "Stability of Media Color", "Reduced Incubation Time", and "Shelf Life for 12 months." However, the specific sample sizes used for these tests are not provided in the document.
Regarding data provenance:
- Country of Origin: Not explicitly stated, but the submission is to the U.S. FDA by STERIS Corporation located in Mentor, Ohio, USA. It can be inferred that the testing likely occurred in the USA.
- Retrospective or Prospective: The testing described (simulated use, stability, reduced incubation time, shelf life) appears to be prospective laboratory-based testing designed to validate the device's performance characteristics.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This device is a biological indicator, not an AI/ML diagnostic device that requires expert interpretation of images or other complex data. The "ground truth" for its performance is established through microbiological methods and chemical analysis of the sterilant's effect on spores, rather than expert consensus on complex medical data.
Therefore, this question is not applicable in the context of this device.
4. Adjudication method for the test set
As the "ground truth" for this device is based on objective microbiological and chemical measurements (e.g., spore kill, population counts, D-values, color change indicating growth), an adjudication method involving multiple human experts is not applicable or described. The results (PASS/FAIL, numerical values) are determined by laboratory assays.
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 pertains to AI/ML devices involving human readers. The VERIFY® Spore Test Strip is a biological indicator, not an AI/ML device.
Therefore, this question is not applicable.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
This question pertains to AI/ML devices. The VERIFY® Spore Test Strip is a biological indicator, not an AI/ML device. While its performance is "standalone" in the sense of being an automated indicator, it does not involve an algorithm generating a diagnostic output without human input in the way a medical AI would. Users visually interpret the media color.
Therefore, this question is not applicable in the context of an AI algorithm.
7. The type of ground truth used
The ground truth used for this device is based on microbiological viability testing and chemical resistance characteristics.
- Spore Kill: Demonstrated by the absence of growth (no color change) in the culture medium, indicating that the targeted 5-log reduction of Geobacillus stearothermophilus spores was achieved.
- Population Counts: Directly measured in colony-forming units (CFU/strip).
- Resistance Characteristics (D-value, Survival Time, Kill Time): These are experimentally determined values that quantify how resistant the spores on the strip are to the sterilant under specific conditions.
- Stability of Media Color: Objective observation of the indicator color over time.
8. The sample size for the training set
This device is not an AI/ML device that requires a training set. Its performance characteristics are inherent to its biological and chemical design, validated through laboratory experiments.
Therefore, this question is not applicable.
9. How the ground truth for the training set was established
This device is not an AI/ML device that requires a training set.
Therefore, this question is not applicable.
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(242 days)
OVY
The Steris Verify Spore Test Strip for S40 is intended to provide users with a means to assess spore kill by the S40 sterilant at its use dilution in the System 1E Liquid Chemical Sterilant Processing System. A "no growth" result from the Steris Verify Spore Test Strip for S40 after 24 hours of incubation indicates that the liquid chemical sterilization process achieved the conditions necessary to kill at least 1 x 10 viable spores (5 logs) on the test strip. The Steris Verify Spore Test Strip for S40 does not confirm the expected full performance of the SYSTEM 1E Liquid Chemical Sterilization Cycle.
The Steris Verify Spore Test Strip for S40 consists of a 1 3/8 in x ¼ in filter paper-based strip inoculated with Geobacillus stearothermophilus spores and is enclosed in a glassine envelope. The Spore Test Strips are provided with media vials containing a modified tryptic soy broth with phenol red pH indicator, and a transfer clip. The transfer clip holds the Spore Test Strip in a single location during a processing cycle in the System 1E Liquid Chemical Sterilant Processing System (System 1E processor; cleared under K090036) and enables aseptic transfer of the Strip from the processor into the growth media vial. Using the clip, the Spore Test Strip is secured on the available post located in the tray of the System 1E processor.
Here's an analysis of the acceptance criteria and study details for the Steris Verify Spore Test Strip for S40, based on the provided text:
Evaluation of Automatic Class III Designation (De Novo) for the STERIS VERIFY SPORE TEST STRIP FOR S40
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Spore Test Strip Specifications (Table 1) | ||
| Population (At manufacture) | ≥1.5 x 10^5 cfu/strip | All initial spore populations were ≥1.5 x 10^5 cfu/strip (e.g., Lot 1: 1.8 x 10^5, Lot 2: 2.6 x 10^5, Lot 3: 2.3 x 10^5). |
| Population (After wash-off - end of cycle) | ≥1.0 x 10^5 cfu/strip | All recovered populations after processing in Builders-Only were ≥1.0 x 10^5 cfu/strip. |
| D-value | 12-26 sec at 1635 ppm PAA | D-values for 3 lots were 23 sec, 24 sec, and 18 sec respectively, all within 12-26 sec. Mean D-value of 19 sec with SD of 2.4 sec. |
| Survival Time | ≥38 seconds | All strips in Survival/Kill study survived at 41 seconds (50/50 for all 3 lots). |
| Kill Time | ≤239 seconds | All strips in Survival/Kill study were killed at 225 seconds (0/50 for all 3 lots). |
| Reduced Incubation Time | ≥97.0% growth correspondence with 7 day growth (for growth between 30-80%) | All lots and time points (0-12 months for 18/24hr RIT) showed ≥97.8% growth correspondence with 7-day growth. Many were 100%. |
| Viable Spore Population (Pre/Post Builders-Only - Table 3 & 8) | ||
| Averaged recovered post-processing population | >1.0 x 10^5 cfu/Spore Test Strip | All lots (except 6-month Lot 1 explained by petitioner) showed >1.0 x 10^5 cfu/strip post-processing (e.g., Lot 1 initial: 1.4 x 10^5). |
| Calculated initial population of each sample (average cfu) | ±50% of calculated mean sample population | Not explicitly detailed for individual samples, but Table 3 shows % Difference from Manufacturer Stated Population within this range. |
| Recovered average population of unprocessed Spore Test Strips | -50% to +300% of manufacturer's stated population | Table 3 shows initial recovered populations are within this range relative to manufacturer's stated (e.g., Lot 2: -18.2%). |
| Strips must not show any signs of damage | Not explicitly quantified, qualitative observation | "No visible signs of damage to the strip material" after two 6-minute cycles with S40 Sterilant. |
| Growth Inhibition | ||
| Strip material does not inhibit growth | Growth of G. stearothermophilus within 24 hrs. | All vials with autoclaved/processed strips inoculated with G. stearothermophilus showed growth within 24 hrs. |
| Transfer clip does not inhibit growth | Growth of G. stearothermophilus within 24 hrs. | All samples with processed transfer clip showed growth within 24 hrs. |
| Media Validation | Media support growth of low number of test organisms | Both solid and liquid media supported growth of low numbers of organisms under various conditions. |
| Effectiveness of Neutralization Method | Equivalent growth in all inoculated tubes | All inoculated tubes showed equivalent growth, validating the method. |
| Stability of Color | Inoculated samples demonstrate growth by color change, maintained for 7 days | All inoculated vials showed growth and color change within 24 hrs, maintained for 7 days. |
| Negative controls maintain same color for 7 days | All uninoculated vials showed no growth and no color change for 7 days. | |
| D-value Determination (Shelf-Life - Table 9) | D-value: 12-26 sec | All D-values across all lots and time intervals (0-12/15 months) were within 12-26 sec. |
| ±20% of initial calculated D-value for Spore Test Strip lot | All D-values (except for 12mo Lot 2 at -33.6%, explained by the petitioner) were within ±20% of initial (e.g., Lot 1: -23.6%, Lot 2: -19.6% at 3mo, Lot 3: 15.6%). | |
| Survival/Kill Times (Shelf-Life) | All survive: 38 sec | All samples exposed for 41 seconds showed growth. |
| All kill: 239 sec | All samples exposed for 225 seconds showed no growth. | |
| Processor Performance (Simulated Use & Shelf-Life) | All strips processed with S40 Sterilant Concentrate must not show growth for 7 days | 0/80 strips showed growth after Pass cycle. All strips processed with Sterilant were killed at each stability time point. |
| All strips exposed to S40 Builders only should show growth within 7 days | 80/80 strips showed growth after Builders Only cycle. All strips processed with Builders Only showed growth within 1 day. | |
| All in situ tests must complete a full cycle | Not explicitly reported as a pass/fail metric in results, but implied by successful cycle runs. |
2. Sample Sizes and Data Provenance
-
Test Set (Reduced Incubation Time - RIT):
- Use Dilution Vessel (0 and 3 month time points): 100 Spore Test Strips per lot per time point (3 lots = 600 strips).
- System 1E processor (6, 9, and 12 month time points): 100 Spore Test Strips from each of 3 lots (300 strips per time point, total 900 strips).
- Provenance: Retrospective, derived from laboratory testing conducted by STERIS Corporation (implied by manufacturer's submission). Country of origin is not specified but is a US-based company.
-
Test Set (Viable Spore Population - Builders Only):
- Initial Characterization: 10 Spore Test Strips/Lot (for maceration), 3 Spore Test Strips/Lot (for growth media) - total 39 strips (13 per lot).
- Shelf-Life: 10 Spore Test Strips per lot per time point (3 lots * 5 time points = 150 strips).
- Provenance: Retrospective, laboratory testing.
-
Test Set (D-value characterization):
- 100 Spore Test Strips evaluated per lot (for 3 lots = 300 strips).
- Shelf-Life: Not explicitly stated but "10 Spore Test Strips per lot per 5 exposure times" for D-value study in shelf-life section implies significant numbers.
- Provenance: Retrospective, laboratory testing.
-
Test Set (Survival/Kill Window):
- 100 Spore Test Strips evaluated per lot (for 3 lots = 300 strips).
- Shelf-Life: "50 Spore Test Strips per lot per survival time or kill time" implies 300 strips total.
- Provenance: Retrospective, laboratory testing.
-
Test Set (Simulated Use Testing in System 1E - Pass/Fail):
- 80 Spore Test Strips per lot (for 3 lots = 240 strips).
- Provenance: Retrospective, laboratory testing.
-
Other tests (Growth Inhibition, Media Validation, Neutralization, Color Stability): Sample sizes varied, typically small numbers of strips or media vials (e.g., 6 strips for growth inhibition, 10 vials for color stability).
3. Number of Experts and Qualifications for Ground Truth
- The ground truth in this submission is not established by human experts in the medical field (like radiologists). Instead, it is based on objective biological and chemical measurements and observations using established laboratory protocols.
- The "experts" are the laboratory personnel who conducted these tests, but their specific qualifications are not detailed beyond being able to perform the described scientific studies (e.g., microbiology techniques, chemical analysis).
4. Adjudication Method for the Test Set
- There appears to be no adjudication method in the traditional sense of multiple human readers independently assessing results.
- The ground truth is determined by direct scientific measurement and observation of biological phenomena (spore growth/kill, color change, spore count) and chemical properties (PAA concentration, pH). Results are quantitative or clearly qualitative (growth/no growth) and are not subject to expert interpretation requiring adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
- No, an MRMC comparative effectiveness study was not done. This device is a biological indicator (spore test strip) for a sterilization process, not an imaging or diagnostic device that involves human interpretation of complex data. Therefore, the concept of "human readers improve with AI vs without AI assistance" is not applicable here. The device itself provides a direct biological outcome.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
- Yes, the studies are essentially standalone performance evaluations of the device itself. The device provides a direct, objective result (growth or no growth, spore count, D-value) that is then interpreted according to established acceptance criteria. There isn't an "algorithm" in the sense of artificial intelligence, but rather a set of physical and biological processes designed to yield a clear outcome. Human involvement is primarily in executing the protocol and observing/recording the predetermined biological response (e.g., color change indicating growth).
7. The Type of Ground Truth Used
The ground truth used is primarily based on:
- Biological Activity and Quantitative Microbiology: Direct measurement of viable spore populations (colony forming units, cfu), observation of bacterial growth (colony formation, turbidity, color change), and calculation of resistance parameters like D-value and survival/kill times.
- Chemical Analysis: Measurement of peracetic acid (PAA) concentration and pH to define test conditions.
- Physical Observation: Assessment of strip material integrity.
- Reference Standards: Comparison against manufacturer's stated population and pre-defined acceptable ranges for specifications.
8. The Sample Size for the Training Set
- This submission describes a de novo classification for a medical device (spore test strip), not an AI/ML algorithm. Therefore, there is no "training set" in the context of machine learning. The studies described are validation and performance testing of the physical and biological properties of the device.
9. How the Ground Truth for the Training Set was Established
- As there is no "training set" for an AI/ML algorithm, this question is not applicable. The device's performance is intrinsically linked to the physical and biological characteristics of the Geobacillus stearothermophilus spores, the filter paper strip, and the chemical sterilant system, all validated through direct laboratory experimentation.
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