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Use the ConFirm 20 Minute Incubator to incubate and automatically read ConFirm Rapid 20 Minute Biological Indicators for Steam and Vaporized Hydrogen Peroxide sterilization at 55°C-60°C for a fluorescent result.

The ConFirm 20 Minute Incubator incubates and reads fluorescent Vaporized Hydrogen Peroxide (VHP) and Steam Biological Indicators (BIs). The Bl is incubated at 59°C with an acceptable tolerance of -4°C/+1°C. During incubation, the BI is monitored for a potential fluorescence signal generated as a result of the production of a-glucosidase. When a growth response has been detected or when the required incubation time has elapsed, the incubator indicates the results to the user.

While the provided text describes the "ConFirm 20 Minute Incubator" and its 510(k) submission, it explicitly states under the "Summary of Non-Clinical Testing" section that "Testing was performed to evaluate performance and demonstrate substantial equivalence to the predicate as summarized in Table 2." Following this, Table 2 only contains "Regression Testing" with an acceptance criterion of "No unresolved anomalies" and a result of "PASS."

This document does NOT contain a study that proves the device meets specific performance acceptance criteria for its intended function (automatically reading biological indicators with a certain accuracy, sensitivity, or specificity). It primarily highlights that the "ConFirm 20 Minute Incubator" is substantially equivalent to a predicate device (Celerity Incubator K223715) based on technological characteristics and that regression testing passed.

Therefore, I cannot fulfill the request to describe a study proving the device meets performance acceptance criteria for reading biological indicators, as that information is not present in the provided text. The document focuses on regulatory equivalence rather than detailed performance study results.

However, based on the information provided, I can infer and state what is present and what is absent from the document regarding acceptance criteria and performance studies:

Analysis of Acceptance Criteria and Device Performance (Based only on provided text):

The provided 510(k) summary for the "ConFirm 20 Minute Incubator" (K233681) does not detail specific performance acceptance criteria related to its ability to accurately incubate and read biological indicators (e.g., sensitivity, specificity, accuracy rates). Instead, the evaluation focuses on demonstrating substantial equivalence to a predicate device (Celerity Incubator K223715) and passing regression testing.

The only explicit "acceptance criteria" and "result" provided in the "Summary of Non-Clinical Testing" (Table 2) are for Regression Testing.

1. Table of Acceptance Criteria and Reported Device Performance:

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

• Not specified. The document does not provide details on sample size for any performance testing related to the incubation and reading of biological indicators. The "Regression Testing" mentioned in Table 2 is a general software/system testing term and does not imply a specific sample size for a clinical or performance study of the device's primary function.

3. Number of Experts Used to Establish Ground Truth and Qualifications:

• Not applicable/Not specified. The document does not describe any study involving expert readers or establishment of ground truth in the context of device performance in reading biological indicators. The assessment relies on a comparison to a predicate device and internal regression testing.

4. Adjudication Method for the Test Set:

• Not applicable/Not specified. As no multi-reader or similar performance study is described, there is no mention of an adjudication method.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:

• No, a MRMC comparative effectiveness study was not done according to the provided text. The device is an incubator/reader for biological indicators, not an AI-assisted diagnostic tool that would typically involve a multi-reader study with human interpretation.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop) Performance Study was done:

• Not specified/Not applicable in the typical AI sense. While the device "automatically read[s]" results, the document does not present a standalone performance study with metrics like sensitivity, specificity, or accuracy for this automated reading function. The evaluation focuses on substantial equivalence to a predicate.

7. The Type of Ground Truth Used:

• Not specified. For the "Regression Testing," the ground truth would likely be defined by expected system behavior or documented requirements. For the primary function of reading biological indicators, the inherent ground truth would be the actual viability of the microorganisms within the biological indicator, often determined by traditional microbiological culture methods (which are not mentioned here as part of a performance study).

8. The Sample Size for the Training Set:

• Not applicable. The device is an incubator and reader for biological indicators, not an AI/ML device that requires a training set in the conventional sense.

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

• Not applicable. As the device is not an AI/ML device with a training set, this information is not relevant or provided.

In summary, the provided FDA 510(k) letter and summary focus on demonstrating substantial equivalence to a legally marketed predicate device (Celerity Incubator) and passing internal regression testing. It does not present detailed performance studies with specific statistical metrics (e.g., accuracy, sensitivity, specificity) for the device's core function of interpreting biological indicators, nor does it discuss clinical studies, human readers, or AI algorithms in the context of diagnostic performance.

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