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The NAMSA Biological Indicator Spore Strip (single species Geobacillus stearothermophilus ATCC® 7953, product code STS-05R, or dual species Geobacillus stearothermophilus ATCC® 7953 and Bacillus atrophaeus ATCC® 9372. product code STNS-65R) is intended for use in testing the efficacy of chemiclave sterilization.

Performance characteristics are established for exposure at 132ºC for 20 minutes in a MDT Harvey Chemiclave model EC5500 chemiclave sterilizer. Vapo-Steril Solution is the sterilant utilized in the MDT Harvey Chemiclave sterilizer. The solution was cleared under 510(k) number K984270. The validation load used for evaluation of the device performance characteristics consisted of stainless steel dental instruments in a wrapped tray with a mass of 1 kg.

A reduced incubation time of 72 hours for chemiclave sterilization at 132°C has been validated when the Biological Indicator Spore Strips are used in conjunction with Tryptic Soy Broth (TSB) modified with Bromocresol Purple and incubated at 58° - 62°C.

The Biological Indicator Spore Strips are typically used in a dental office but may be used by other small healthcare offices which utilize chemiclave processes to sterilize instruments. The spore strips are utilized to verify the chemiclave exposures were effective at killing the Geobacillus stearothermophilus bacterial spores present on the strips in high volume.

Modification to K113221 are to include chemiclave sterilization at 132°C for 20 minutes in a Harvey model EC5500. The predicate device was not specific to sterilizer type or model number but rather is legally marketed for use in monitoring the chemiclave process. Specificity of the chemiclave model in no way affects the safety or effectiveness of the device.

NAMSA Biological Indicator Spore Strips are easy to use; simply place the spore strips in the most difficult area to sterilize and process the load as normal. After exposure, remove the spore strips and aseptically transfer to growth medium and incubated. After incubation if no signs of bacterial growth are present, the sterilization cycle was effect.

The spore strips may be aseptically transferred to standard media such as Tryptic Soy Broth (TSB) and incubated for a minimum of 7 days. Growth will be indicated by the presence of turbidity. Conversely, the strips may be cultured using TSB which has been modified with a pH indicator (Bromocresol Purple) for a reduced incubation time of 72 hours. Growth will be indicated by a change in color of the media from purple to yellow and/or presence of turbidity.

Biological Indicator Spore Strips consist of a 1.25" x 0.25" filter paper strip which has been inoculated with either single species (Geobacillus stearothermophilus ATCC® 7953 at a population level of 105 per strip), or dual species (Geobacillus stearothermophilus ATCC® 7953 at a population level of 105 and Bacillus atrophaeus ATCC® 9372 at a population level of 106 per strip). The spore strips are individually packaged in a 30# glassine pouch.

This document describes the NAMSA Biological Indicator Spore Strip, a device intended to test the efficacy of chemiclave sterilization. However, the provided text does not contain a typical acceptance criteria table with reported device performance metrics in the format usually associated with AI/ML device studies. Instead, it outlines the technological characteristics of the device and a list of testing performed to demonstrate substantial equivalence to a predicate device.

Given the nature of this submission (a 510(k) for a biological indicator, not an AI/ML device), the "acceptance criteria" discussed are primarily about meeting performance characteristics analogous to existing predicate devices, rather than predefined statistical thresholds for a new analytical algorithm.

Here's an attempt to extract the relevant information based on the provided text, reformatted to fit the request where possible, keeping in mind the device is a biological indicator, not an AI algorithm.

1. Table of Acceptance Criteria (Technological Characteristics) and Reported Device Performance

The acceptance criteria are implicitly defined by the properties of the predicate device and the new device's ability to demonstrate substantial equivalence in key performance characteristics. The document presents a comparison of the new device's technological characteristics against the predicate device.

Study Proving Acceptance Criteria is Met:

The document describes a series of studies designed to demonstrate that the NAMSA Biological Indicator Spore Strip is substantially equivalent to the predicate device and performs as intended. These include:

• Survival-Kill Window Verification: Demonstrated equivalence with the predicate device at the manufacturer's certified chemiclave resistance characteristics (5-minute survival, 15-minute kill). This was also verified at the end of the device's shelf life.
• Population Evaluation: Confirmed equivalent population levels to the predicate device.
• Readout Time Evaluation: Confirmed equivalent reduced incubation times to the predicate device.
• Resistance Characterization (D-value Determination and Verification): Determined D-values at 124°C, 132°C, and 140°C using the Fraction Negative Method. Verified D-values using expired Vapo-Steril solution to account for its full shelf life.
• Load/Chamber Evaluation Studies: Verified device performance in a full chamber with a standard load (stainless steel dental instruments in a wrapped tray with a mass of 1 kg) to confirm no negative influence on sterilization conditions.
• Quantitative Determination of Pre-Exposure Phase Lethality: Quantified spores killed prior to the exposure phase across various load conditions and temperature extremes.
• Carrier and Primary Packaging Material Evaluation: Assessed inhibitory properties and degradative changes of materials.
• Holding Time Assessment: Verified that the Biological Indicators (BIs) were not negatively impacted if left at room temperature for 96 hours post-exposure prior to incubation.
• Recovery Protocols - Reduced Incubation Time (RIT): Determined that the 72-hour RIT claim remains valid even with a 96-hour delay in incubation post-exposure.

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

The document does not explicitly state the specific sample sizes (number of biological indicators or test runs) for each individual test or for a single "test set" in the context of an algorithm. However, testing involved:

• Evaluation of "NAMSA's Biological Indicator Spore Strips" for population and readout time.
• "Three lots of the device" were evaluated for D-values with expired Vapo-Steril solution.
• "Standard chemiclave sterilizer" at "standard 132°C cycle for 20 minutes."
• "Validation load...consisted of stainless steel dental instruments in a wrapped tray with a mass of 1 kg."
• "BI's not processed...immediately following exposure are not negatively impacted" if left at room temperature for 96 hours.

The provenance of data is not explicitly stated in terms of country of origin, but all testing appears to be conducted by NAMSA (North American Science Assoc., Inc.) to support their 510(k) submission to the US FDA. The studies are prospective in nature, as they involve performing specific tests on the device under defined conditions.

3. Number of Experts and Qualifications for Ground Truth

This type of submission for a biological indicator does not typically involve human experts establishing "ground truth" for a test set in the way an AI/ML diagnostic device does. The ground truth for biological indicators is established through objective biological and physical measurements:

• Bacterial spore population counts: Measured via standard microbiological techniques.
• Survival/kill determination: Based on the presence or absence of bacterial growth after incubation, which is an objective observation (turbidity or color change).
• D-value calculations: Derived mathematically from experimental data on spore survival at different exposure times.
• Sterilization efficacy: Determined by the physical/chemical process itself and validated by the BI's response.

Therefore, the concept of "number of experts used to establish ground truth" and their "qualifications" is not directly applicable in the same way it would be for medical image interpretation or similar diagnostic tasks. The "experts" in this context would be the microbiologists and engineers who designed and executed the validated test methods.

4. Adjudication Method for the Test Set

Not applicable. As explained above, the "ground truth" for a biological indicator is based on objective biological and physical measurements rather than expert human interpretation requiring adjudication.

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

Not applicable. This is not an AI/ML diagnostic device that would be used by human readers. Its purpose is to indicate the success of a sterilization process.

6. Standalone (Algorithm Only) Performance Study

Not applicable. This is a physical biological indicator, not an algorithm. Its performance is inherent in its biological and physical properties.

7. Type of Ground Truth Used

The ground truth used is based on:

• Biological viability: Growth or no growth of Geobacillus stearothermophilus spores.
• Quantitative microbiology: Spore population counts and D-value calculations.
• Physical sterilization parameters: Exposure time, temperature, and sterilant concentration, which are controlled experimental variables against which the BI's performance is measured.

8. Sample Size for the Training Set

Not applicable. This is not an AI/ML device that uses training data. The device's performance is based on its inherent physical and biological characteristics, which are then validated through empirical testing, not learned from a dataset.

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

Not applicable, as there is no training set for this type of device.

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The NAMSA Biological Indicator Spore Strip (single species Geobacillus stearothermophilus ATCC® 7953, or dual species Geobacillus stearothermophilus ATCC® 7953 and Bacillus atrophaeus ATCC® 9372) · is intended for use in testing the efficacy of steam sterilization for single species and steam and ethylene oxide sterilization for dual species.

Performance characteristics are established in accordance with ANSI/AAMI/ISO 11138 and USP for 121°C steam gravity displacement for 30 minutes and ethylene oxide at 600 mg/L, 60% RH and 55°C for 2 hours, 10 minutes.

A reduced incubation time of 24 hours for steam sterilization has been validated when the Biological Indicator Spore Strips are used in conjunction with Tryptic Soy Broth (TSB) modified with Bromocresol Purple.

The NAMSA Biological Indicator Spore Strip consists of a 1.25" x 0.25" filter paper strip inoculated with either a single species (Geobacillus stearothermophilus ATCC® 7953, 105) or dual species (Geobacillus stearothermophilus ATCC® 7953, 106 and Bacillus atrophaeus ATCC® 9372, 106) bacterial spores. The strip is packaged in a 30# glassine pouch.

Operational Principles: The NAMSA Biological Indicator Spore Strip (single species Geobacillus stearothermophilus ATCC® 7953, or dual species Geobacillus stearothermophilus ATCC® 7953 and Bacillus atrophaeus ATCC® 9372) is intended for use in testing the efficacy of steam sterilization for single species and steam and ethylene oxide sterilization for dual species.

Performance characteristics are established in accordance with ANSI/AAMI/ISO 11138 and USP for 121°C steam gravity displacement for 30 minutes and ethylene oxide at 600 mg/L, 60% RH and 55°C for 2 hours, 10 minutes.

The media containing the spore strip should be incubated at the organism's growth temperature. Media should be monitored daily for visible signs of growth and results recorded.

When standard media is utilized, incubate strips for a minimum of 7 days. Growth will be indicated by the presence of turbidity. A reduced incubation time of 24 hours for steam sterilization has been validated when the Biological Indicator Spore Strips are used in conjunction with Tryptic Soy Broth (TSB) modified with Bromocresol Purple.

The provided document describes the NAMSA Biological Indicator Spore Strips and their performance, focusing on their substantial equivalence to predicate devices for assessing sterilization efficacy.

Here's an analysis of the acceptance criteria and the study that proves the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance:

The document doesn't explicitly state a table of acceptance criteria with numerical targets. Instead, it refers to compliance with recognized standards. The performance characteristics are established according to:

• ANSI/AAMI/ISO 11138: This is a series of international standards for biological indicators.
• USP (United States Pharmacopeia): This outlines pharmaceutical and medical device standards.

The performance is reported in the context of these standards for specific sterilization parameters:

• Efficacy for 121°C steam gravity displacement for 30 minutes.
• Required resistance characteristics (e.g., D-value, Z-value, Survival/Kill Windows) must meet standard specifications.
• Required Total Viable Spore Count.
• Medium suitability for organism growth.
• Holding time assessment must confirm stability.
• Recovery protocols must be effective.
• Reduced incubation time (24 hours with specific media) validation (if applicable). | Demonstrates efficacy in testing steam sterilization for Geobacillus stearothermophilus ATCC® 7953.
• Testing performed for Total Viable Spore Count.
• Testing performed for Resistance Characteristics Studies including D-value, Z-value and Survival/Kill Windows.
• Compliance with ANSI/AAMI/ISO 11138 and USP for 121°C steam gravity displacement for 30 minutes.
• Holding Time Assessment performed.
• Recovery Protocols evaluated.
• Medium Suitability evaluated.
• Reduced incubation time of 24 hours for steam sterilization has been validated when used with Tryptic Soy Broth (TSB) modified with Bromocresol Purple. |
  | For Steam and Ethylene Oxide (EO) Sterilization (Dual Species: Geobacillus stearothermophilus ATCC® 7953 and Bacillus atrophaeus ATCC® 9372):
• Efficacy for 121°C steam gravity displacement for 30 minutes.
• Efficacy for ethylene oxide at 600 mg/L, 60% RH and 55°C for 2 hours, 10 minutes.
• Required resistance characteristics (e.g., D-value, Z-value, Survival/Kill Windows) must meet standard specifications.
• Required Total Viable Spore Count.
• Medium suitability for organism growth.
• Holding time assessment must confirm stability.
• Recovery protocols must be effective.
• Reduced incubation time (24 hours with specific media) validation (if applicable). | Demonstrates efficacy in testing steam and ethylene oxide sterilization for Geobacillus stearothermophilus ATCC® 7953 and Bacillus atrophaeus ATCC® 9372.
• Testing performed for Total Viable Spore Count.
• Testing performed for Resistance Characteristics Studies including D-value, Z-value and Survival/Kill Windows.
• Compliance with ANSI/AAMI/ISO 11138 and USP for 121°C steam gravity displacement for 30 minutes and ethylene oxide at 600 mg/L, 60% RH and 55°C for 2 hours, 10 minutes.
• Holding Time Assessment performed.
• Recovery Protocols evaluated.
• Medium Suitability evaluated.
• Reduced incubation time of 24 hours for steam sterilization has been validated when used with Tryptic Soy Broth (TSB) modified with Bromocresol Purple. |
  | General Acceptance Criteria:
• Total viable spore count within specified limits.
• Carrier and Primary Packaging Materials Evaluation to ensure integrity and compatibility. | - Total Viable Spore Count testing was performed.
• Carrier and Primary Packaging Materials Evaluation was performed. |

The study described indicates that "testing was performed for steam for single specie spore strips and steam and Ethylene Oxide (EO) sterilization processes for dual species," validating the performance characteristics against these standards. The conclusion is that the device is "substantially equivalent to the predicate device."

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

• Sample Size: The document states that "Multiple lots of NAMSA Biological Indicator Spore Strips were utilized" for testing. However, it does not provide a specific numerical sample size for the test set (e.g., how many strips per lot, how many lots).
• Data Provenance: The document does not specify the country of origin of the data. It is a submission to the FDA in the US for a US-based company (NAMSA). The data is undoubtedly retrospective as it describes testing already performed to demonstrate device performance for regulatory submission.

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

• This information is not provided in the document. Biological indicator testing focuses on measurable biological and physical parameters (spore count, D-value, survival/kill) rather than human interpretation. Therefore, "experts" in the context of ground truth establishment as it applies to image interpretation or diagnostic test reading would not typically be relevant here. The ground truth is intrinsically tied to the viability of the spores after exposure to sterilization processes, assessed by laboratory culture methods.

4. Adjudication Method for the Test Set:

• This information is not applicable/provided. Adjudication methods are typically employed in studies where human readers or multiple assessments are involved (e.g., radiology studies). For biological indicators, the outcome (growth/no growth, quantitative spore count) is a direct, objective measurement.

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 study was not done. This type of study is relevant for diagnostic devices that involve human interpretation (e.g., medical imaging AI). Biological indicators are laboratory-based tools with objective outcomes.

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

• Not applicable in the context of an "algorithm." This device is a biological indicator, not a software algorithm. The "standalone performance" is the inherent performance of the spore strip itself as it responds to sterilization processes, which is what the testing describes.

7. The Type of Ground Truth Used:

• The ground truth in this context is based on direct biological measurement and adherence to established physical/chemical parameters of sterilization. Specifically:
  • Culture-based viability: Growth or no growth of spores after exposure to sterilization, assessed by incubating the strips in suitable media. This determines survival.
  • Quantitative Spore Count: Measurable number of viable spores.
  • Resistance Characteristics (D-value, Z-value, Survival/Kill Windows): These are quantitative measures directly derived from the resistance of the spores to specific sterilization conditions, which are established scientific benchmarks for biological indicators.
  • Adherence to ANSI/AAMI/ISO 11138 and USP standards: These standards define the accepted performance criteria for effective sterilization monitors.

8. The Sample Size for the Training Set:

• This information is not provided and is not applicable in the context of this device. Biological indicators do not involve machine learning algorithms that require training sets. Their performance is inherent to their biological and physical composition and is validated through experimental testing.

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

• Not applicable. As stated above, there is no "training set" for a biological indicator. The ground truth for validating their performance is established through rigorous laboratory testing against defined sterilization cycles and using culture methods to confirm spore viability, all under the guidelines of recognized standards like ANSI/AAMI/ISO 11138 and USP.

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