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

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

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

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

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

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

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

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

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

Acceptance Criteria and Device Performance

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

Study Details

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

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

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

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

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

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

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

4. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

   • No MRMC study was performed as this device is not an AI-assisted diagnostic tool that involves human readers interpreting results. The device (biological indicator and auto-reader) automatically performs the read-out (fluorescence detection).

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

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

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

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

7. The sample size for the training set:

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

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

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

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