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The FilmArray GI Control Panel M238 is intended for use as an external positive and negative assayed quality control to monitor performance of the BIOFIRE FILMARRAY Gastrointestinal (GI) Panel and the BIOFIRE FILMARRAY Gastrointestinal (GI) Panel Mid assays on the BIOFIRE FILMARRAY systems. BIOFIRE FILMARRAY Gastrointestinal (GI) Panel and the BIOFIRE FILMARRAY Gastrointestinal (GI) Panel Mid assays qualitatively detect the following targets: Campylobacter (C. jejuni/C. coli/C. upsaliensis), Clostridium (Clostridioides) difficile toxin A/B, Plesiomonas shigelloides, Salmonella, Vibrio (V. parahaemolyticus/V. vulnificus/V. cholerae), Yersinia enterocolitica, Enteroaggregative E. coli (EAEC), Enteropathogenic E. coli (EPEC), Enterotoxigenic E. coli (ETEC) lt/st, Shiga-like toxin-producing E. coli (STEC) stx1/stx2, E. coli O157, Shigella/Enteroinvasive E. coli (EIEC), Cryptosporidium, Cyclospora cayetanensis, Entamoeba histolytica, Giardia lamblia, Adenovirus F 40/41, Astrovirus, Norovirus GI/GII, Rotavirus A, and Sapovirus. The FilmArray GI Control Panel M238 contains synthetic RNA transcripts in stabilizing solution, buffers, and preservatives. The FilmArray GI Control Panel M238 is designed for and intended to be used solely with the BIOFIRE FILMARRAY GI Panel and the BIOFIRE FILMARRAY GI Panel Mid assays. This product is not intended to replace manufacturer internal controls provided with these devices.

FilmArray GI Control Panel M238, P/N M238, is a quality control panel consisting of 2 single use, ready-to-use, liquid controls, FilmArray GI Control M239, P/N M239, and FilmArray GI Control M240, P/N M240. Each kit of FilmArray GI Control Panel M238 is comprised of 6 tubes of M239 and 6 tubes of M240. Together the 2 controls contain synthetic RNA corresponding to genome segments of all the pathogens detected by the BIOFIRE FILMARRAY Gastrointestinal (GI) Panel and BIOFIRE FILMARRAY GI Panel Mid assays, suspended in a non-infectious solution of buffers, preservatives and stabilizers.

Each liquid control of FilmArray GI Control Panel M238 is processed separately according to the BIOFIRE GI Panel and BIOFIRE GI Panel Mid manufacturer's Instructions for Use for patient samples, stool samples in Cary Blair transport media obtained from individuals with signs and/or symptoms of gastrointestinal infection.

The provided FDA 510(k) clearance letter and summary discuss the validation of the FilmArray GI Control Panel M238. This device is an assayed quality control material, not an AI/ML-driven diagnostic device. Therefore, many of the requested elements the prompt is asking for (e.g., number of experts, adjudication methods, MRMC study, training sets, human-in-the-loop performance) are not applicable to this type of device.

However, I can extract and present the relevant information regarding its acceptance criteria and the study that proves it meets those criteria, focusing on the concepts applicable to quality control materials:

Device: FilmArray® GI Control Panel M238 (M238)

This device is an external positive and negative assayed quality control used to monitor the performance of the BIOFIRE FILMARRAY Gastrointestinal (GI) Panel and the BIOFIRE FILMARRAY Gastrointestinal (GI) Panel Mid assays. It contains synthetic RNA transcripts as targets.

Acceptance Criteria and Reported Device Performance

The core acceptance criterion for a quality control material like this is its ability to consistently produce the correct expected results (either positive or negative depending on the specific control) when tested with the target assay. The study demonstrated 100% correctness across all valid tests.

Table 1: Acceptance Criteria and Reported Device Performance

Study Details Proving Acceptance Criteria are Met

1. Sample Size Used for the Test Set and Data Provenance:
* Sample Size: A total of 165 samples were tested.
* 79 samples of FilmArray GI Control M239 (positive control)
* 86 samples of FilmArray GI Control M240 (negative control)
* Data Provenance: The device was manufactured at MMQCI's facility in Saco, Maine, and tested at 2 unspecified sites. The study was prospective in nature, as it involved the creation and testing of new control lots specifically for this submission. The country of origin of the data is implicitly the USA, given the FDA filing and US company address.

2. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:
* Not applicable in the conventional sense for a quality control material. The "ground truth" for a quality control material is its pre-defined composition, meaning it is designed to contain specific targets (for the positive control) or no targets (for the negative control). The BIOFIRE FILMARRAY GI Panel itself serves as the reference against which the control material's behavior is assessed.
* The study involved 9 operators, who presumably were trained laboratory personnel using the BIOFIRE FILMARRAY system according to its Instructions for Use. Their role was in executing the tests, not in establishing a medical "ground truth" through expert review as would be the case for image-based diagnostic AI.

3. Adjudication Method for the Test Set:
* Not applicable. The results are qualitative (Positive/Negative for specific targets, or Valid/Invalid run) and are determined by the automated output of the BIOFIRE FILMARRAY system. There is no subjective interpretation requiring adjudication among experts. The "adjudication" is purely objective: did the control material yield the expected automated result on the instrument?

4. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:
* No. MRMC studies are typically performed for diagnostic imaging devices where human readers interpret patient cases. This device is a quality control material for an in vitro diagnostic (IVD) assay, not a diagnostic imaging device, nor does it involve human interpretation of complex medical cases. The study demonstrated the device's ability to monitor the performance of the BIOFIRE FILMARRAY system itself.

5. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done:
* This question is more relevant to AI/ML software. In the context of this quality control material, its "standalone" performance refers to its ability to elicit the expected results from the BIOFIRE FILMARRAY system independently. The study demonstrates this functional performance, showing 100% correct results triggered by the control material when used with the instrument, which is the equivalent of "standalone" functionality for this type of product.

6. The Type of Ground Truth Used:
* Defined Composition: For quality control materials, the ground truth is the known, pre-defined composition of the control panel itself. The M239 control is designed to be positive for certain targets, and the M240 control is designed to be negative or non-reactive. The "correctness" is therefore a measure of whether the BIOFIRE FILMARRAY system, when challenged with these known controls, reports the expected results.

7. The Sample Size for the Training Set:
* Not applicable. This is a quality control material, not an AI/ML algorithm that requires a training set. The "training" for such a product implicitly involves its manufacturing and formulation process to achieve the desired composition and stability.

8. How the Ground Truth for the Training Set was Established:
* Not applicable, as there is no training set in the context of an AI/ML algorithm. For the manufacturing of the quality control material, the "ground truth" is established by the precise formulation and characterization of the synthetic RNA transcripts and other components to ensure the desired positive or negative reactivity.

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