Search Results

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.

Ask a specific question about this device

The SPOTFIRE® RSP Pos & Neg Controls kit is intended for use (as an external positive and negative assayed quality control to monitor performance of in vitro laboratory nucleic acid testing procedures for the qualitative detection of Bordetella parapertussis, Bordetella pertussis, Chlamydia pneumoniae, Mycoplasma pneumoniae, Streptococcus dysgalactiae (Group C/G Strep), Streptococcus pyogenes (Group A Strep), Adenovirus SARS-CoV-2, Coronavirus (seasonal), Human Metapneumovirus, Human Rhinovirus/Enterovirus, Influenza A Subtype H1-2009, Influenza A Subtype H3, Influenza B, Parainfluenza Virus and Respiratory Syncytial Virus using the BIOFIRE® SPOTFIRE Respiratory (R) Panel, BIOFIRE SPOTFIRE Respiratory (R) Panel Mini, BIOFIRE SPOTFIRE Respiratory/Sore Throat (R/ST) Panel and BIOFIRE SPOTFIRE Respiratory/Sore Throat (R/ST) Panel Mini on the BIOFIRE System. SPOTFIRE RSP Pos & Neg Controls is designed for and intended to be used solely with the BIOFIRE SPOTFIRE R Panel, BIOFIRE SPOTFIRE R Panel Mimi, BIOFIRE SPOTFIRE R/ST Panel, and BIOFIRE SPOTFIRE R/ST Panel Mini assays. The SPOTFIRE RSP Positive Control contains synthetic RNA transcripts in stabilizing solution, and the SPOTFIRE RSP Negative Control contains buffers and preservatives. This product is not intended to replace manufacturer internal controls provided with these devices.

Quality control materials should be used in accordance with local, state, federal regulations, and accreditation requirements.

SPOTFIRE® RSP Negative Control is intended for use (as applicable) as an external negative assayed quality control to monitor performance of in vitro laboratory nucleic acid testing procedures for the qualitative detection of Bordetella parapertussis. Bordetella pertussis. Chlamydia pneumoniae. Streptococcus dysgalactiae (Group C/G Strep), Streptococcus pyogenes (Group A Strep), Adenovirus SARS-CoV-2, Coronavirus (seasonal), Human Metapneumovirus, Human Rhinovirus, Influenza A Subtype H1-2009, Influenza A Subtype H3, Influenza B, Parainfluenza Virus and Respiratory Syncytial Virus using the BIOFIRE® SPOTFIRE Respiratory (R) Panel, BIOFIRE SPOTFIRE Respiratory (R) Panel Mini, BIOFIRE SPOTFIRE Respiratory/Sore Throat (R/ST) Panel, and BIOFIRE SPOTFIRE Respiratory/Sore Throat (R/ST) Panel Mini on the BIOFIRE System. SPOTFIRE RSP Negative Control is designed for and intended to be used solely with the BIOFIRE SPOTFIRE R Panel, BIOFIRE SPOTFIRE R Panel Mini, BIOFIRE SPOTFIRE R/ST Panel, and BIOFIRE SPOTFIRE R/ST Panel Mini assays. SPOTFIRE RSP Negative Control is comprised of a solution of buffer and preservatives that does not contain target analytes. This product is not intended to replace manufacturer internal controls provided with these devices.

Quality control materials should be used in accordance with local, state, federal regulations, and accreditation requirements.

SPOTFIRE RSP Pos & Neg Controls, P/N M425, is a quality control panel consisting of 12 readyto-use, liquid controls, 6 of SPOTFIRE RSP Positive Control (Positive Control), P/N M42638, and 6 of SPOTFIRE RSP Negative Control (Negative Control), P/N M42738, in a single kit box, and a separate kit of 6 additional SPOTFIRE RSP Negative Controls (Negative Control), P/N M42738. The separate kit of SPOTFIRE RSP Negative Control allows and encourages the end user to check for environmental contamination by testing additional negative controls. The Positive Control contains non-infectious surrogate control material; a solution of synthetic RNA transcripts in buffer, stabilizers and preservatives. The RNA in the Positive Control carries RNA segments of all the respiratory and sore throat pathogens detected by the BIOFIRE SPOTFIRE Respiratory (R) Panel, BIOFIRE SPOTFIRE Respiratory (R) Panel Mini, BIOFIRE SPOTFIRE Respiratory/Sore Throat (R/ST) Panel, and BIOFIRE SPOTFIRE Respiratory/Sore Throat (R/ST) Panel Mini assays. performed on the BIOFIRE System. SPOTFIRE RSP Pos & Neg Controls are specifically designed for and intended to be used solely with the BIOFIRE SPOTFIRE R Panel, BIOFIRE SPOTFIRE R Panel Mini, BIOFIRE SPOTFIRE R/ST Panel, and BIOFIRE SPOTFIRE R/ST Panel Mini assays on the BIOFIRE SPOTFIRE System. The Negative Control contains buffer and preservatives with no RNA. Each liquid control of SPOTFIRE RSP Pos & Neg Controls is processed separately according to the SPOTFIRE Panel assay manufacturer's Instructions for Use for patient samples (nasopharyngeal swabs or throat swabs placed in transport media) obtained from individuals with signs and symptoms of respiratory tract infection or pharyngitis. Engineering drawings, schematics, etc. are not applicable to the device (device is a reagent).

The provided text is a 510(k) premarket notification for a medical device called "SPOTFIRE® RSP Pos & Neg Controls." This document focuses on the regulatory aspects of changing an existing, cleared device (K233611) rather than presenting a detailed study proving performance against specific acceptance criteria for a new device.

Therefore, I cannot extract the information required to populate a table of acceptance criteria and reported device performance from this document, nor can I describe a study that proves the device meets specific acceptance criteria in the context of an AI/ML-driven medical device, as the device in question is an assayed quality control material for clinical microbiology assays, not an AI/ML diagnostic tool.

The document states:

• "Performance data presented in the predicate 510(k) submission (K233611) has all the required data to support the labeling change to the existing device to include the SPOTFIRE R/ST Panel Mini in the intended use for SPOTFIRE RSP Pos & Neg Controls, and the packaging change to combine Positive and Negative controls in a single kit box. No additional performance data are required as the SPOTFIRE RSP Pos & Neg Controls have not been changed, the assay consumables are identical for the SPOTFIRE R/ST Panel used to collect original performance data and the SPOTFIRE R Panel Mini. In addition, the targets reported in the SPOTFIRE R/ST Panel Mini are a subset of the SPOTFIRE R/ST Panel."

This explicitly states that no new performance study was conducted for this specific submission (K241289) because the changes were considered minor (labeling and packaging, and the new panel is a subset of an already cleared panel). The previous 510(k) (K233611) would contain the original performance data, but that information is not provided in this document.

As a result, I cannot provide details on:

1. A table of acceptance criteria and the reported device performance: Not present, as no new performance study was conducted.
2. Sample size used for the test set and data provenance: Not present.
3. Number of experts used to establish ground truth and qualifications: Not applicable/present.
4. Adjudication method for the test set: Not applicable/present.
5. Multi Reader Multi Case (MRMC) comparative effectiveness study: Not applicable, as this is a quality control material, not an AI diagnostic tool involving human readers.
6. Standalone (algorithm only) performance: Not applicable.
7. Type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable/present in this document.
8. Sample size for the training set: Not applicable (not an AI/ML device, and no new training/testing).
9. How the ground truth for the training set was established: Not applicable.

The document's purpose is to demonstrate substantial equivalence to an existing predicate device based on minor changes, not to present novel performance data for a new device.

Ask a specific question about this device

SPOTFIRE® RSP Positive Control is intended for use (as applicable) as an external positive assayed quality control to monitor performance of in vitro laboratory nucleic acid testing procedures for the qualitative detection of Bordetella parapertussis, Bordetella pertussis, Chlamydia pneumoniae, Mycoplasma pneumoniae, Streptococcus dysgalactiae (Group C/G Strep), Streptococcus pyogenes (Group A Strep), Adenovirus SARS-CoV-2, Coronavirus (seasonal), Human Metapneumovirus, Human Rhinovirus, Influenza A Subtype H1-2009, Influenza A Subtype H3, Influenza B, Parainfluenza Virus and Respiratory Syncytial Virus using the BIOFIRE® SPOTFIRE Respiratory (R) Panel, BIOFIRE SPOTFIRE Respiratory (R) Panel Mimi, and BIOFIRE SPOTFIRE Respiratory/Sore Throat (R/ST) Panel on the BIOFIRE SPOTFIRE System. SPOTFIRE RSP Positive Control is comprised of in vitro RNA transcripts and stabilizing solution and is designed for and intended to be used solely with the BIOFIRE SPOTFIRE R Panel, BIOFIRE SPOTFIRE R Panel Mini, and BIOFIRE SPOTFIRE R/ST Panel assays. This product is not intended to replace manufacturer internal controls provided with these devices.

Quality control materials should be used in accordance with local, state, federal regulations, and accreditation requirements.

SPOTFIRE® RSP Negative Control is intended for use (as applicable) as an external negative assayed quality control to monitor performance of in vitro laboratory nucleic acid testing procedures for the qualitative detection of Bordetella parapertussis, Bordetella pertussis, Chlamydia pneumoniae, Streptococcus dysgalactiae (Group C/G Strep), Streptococcus pyogenes (Group A Strep), Adenovirus SARS-CoV-2, Coronavirus (seasonal), Human Metapneumovirus, Human Rhinovirus, Influenza A Subtype H1-2009, Influenza A Subtype H3, Influenza B, Parainfluenza Virus and Respiratory Syncytial Virus using the BIOFIRE® SPOTFIRE Respiratory (R) Panel, BIOFIRE SPOTFIRE Respiratory (R) Panel Mini, and BIOFIRE SPOTFIRE Respiratory/Sore Throat (R/ST) Panel on the BIOFIRE System. SPOTFIRE RSP Negative Control is comprised of a solution that does not contain target and is designed for and intended to be used solely with the BIOFIRE SPOTFIRE R Panel, BIOFIRE SPOTFIRE R Panel Mini, and BIOFIRE SPOTFIRE R/ST Panel assays. This product is not intended to replace manufacturer internal controls provided with these devices.

SPOTFIRE RSP Pos & Neg Controls, P/N M425, is a quality control panel consisting of 2 readyto-use, liquid controls, SPOTFIRE RSP Positive Control (Positive Control), P/N M42638 and SPOTFIRE RSP Negative Control (Negative Control), P/N M42738. The Positive Control contains non-infectious surrogate control material; a solution of synthetic RNA transcripts in buffer, stabilizers and preservatives. The RNA in the Positive Control carries RNA segments of all the respiratory and sore throat pathogens detected by the BIOFIRE SPOTFIRE Respiratory (R) Panel, BIOFIRE SPOTFIRE Respiratory (R) Panel Mini, and BIOFIRE SPOTFIRE Respiratory/Sore Throat (R/ST) Panel assays, performed on the BIOFIRE System. The Negative Control contains buffer and preservatives with no RNA. Each liquid control of SPOTFIRE RSP Pos & Neg Controls is processed separately according to the SPOTFIRE Panel assay manufacturer's Instructions for Use for patient samples (nasopharyngeal swabs or throat swabs placed in transport media) obtained from individuals with signs and symptoms of respiratory tract infection or pharyngitis.

The provided text is a 510(k) Summary for a medical device called "SPOTFIRE RSP Pos & Neg Controls," which are quality control materials for molecular diagnostic assays. The submission is a change to an existing device (K230868) to include compatibility with a new panel, the "BIOFIRE SPOTFIRE Respiratory/Sore Throat (R/ST) Panel."

The document details the device's intended use, its description, and a summary of performance data collected to demonstrate that the modified device remains substantially equivalent to its predicate.

Here's the breakdown of the acceptance criteria and study information, as requested:

Acceptance Criteria and Reported Device Performance

• 3 control lots
• 27 pouch lots (across all sites, including one shared between internal and external)
• Multiple operators (specified as "multiple" for external sites, 4 for internal)
• Multiple instruments (specified as "multiple" for external sites, 1 for internal)
• 6 testing sites (5 external clinical sites + 1 internal MMQCI site)
• Testing over time (21 different days for internal testing) |

Study Information

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

   • Total Test Results: 361 initially, with 10 invalid results that were repeated, leading to 351 valid test results used for performance analysis.
   • Data Provenance:
     • External Study: 232 test results collected from 5 near-patient clinical sites. The document does not specify the country of origin of these sites, but given the FDA submission, it's presumed to be in the USA. This was a prospective study as the sites were asked to follow specific protocols for testing controls during normal operations (e.g., training new operators, new kit shipments, new/repaired instruments).
     • Internal Study: 129 test results collected from MMQCI's facility in Saco, Maine (USA). This was also a prospective study.

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

   • This study evaluates the performance of quality control materials for in vitro laboratory nucleic acid testing. The "ground truth" here is objective: either the control produced the expected positive result (detecting the specified analytes) or the expected negative result (no target analytes detected).
   • Therefore, no human experts (like radiologists) were establishing a subjective "ground truth" diagnosis. The performance is based on whether the automated instrument correctly identifies the presence or absence of the target analytes in the control material as designed.

3. Adjudication Method for the Test Set:

   • Not applicable in the conventional sense of human expert discrepancies. The performance is measured against the pre-defined composition of the positive and negative control materials.
   • Invalid results (instrument errors, failed internal pouch controls) were re-tested according to BioFire instructions and excluded from the "Percent Correct" analysis. This acts as a form of "adjudication" for technical failures rather than diagnostic disagreement.

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

   • No, an MRMC comparative effectiveness study was not done. This study is not evaluating a diagnostic AI algorithm that assists human readers. It's evaluating the performance of quality control materials for a molecular diagnostic assay. The "users" are laboratory professionals (or non-lab professionals in CLIA waived settings) operating the BIOFIRE SPOTFIRE System. The study assessed the reproducibility of the control materials, not the improvement of human readers with AI assistance.

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

   • This is not an AI algorithm. The performance evaluation is inherently "standalone" in the sense that the control materials are processed by the BIOFIRE SPOTFIRE System, and the system's output (positive or negative detection of specific analytes) is compared against the known composition of the control. The "human-in-the-loop" would be the technician performing the test, but their role is to follow instructions, not to interpret complex images or data subjectively.

6. The Type of Ground Truth Used:

   • The ground truth is the known, manufactured composition of the control materials.
     • Positive Control: Contains synthetic RNA transcripts for all target respiratory and sore throat pathogens. The ground truth is that these specific targets should be detected by the assay.
     • Negative Control: Contains buffer and preservatives with no RNA targets. The ground truth is that no target analytes should be detected.

7. The Sample Size for the Training Set:

   • Not applicable. This device is a quality control material, not a machine learning or AI model. Therefore, there is no "training set" in the context of algorithm development. The control materials are manufactured to a specific design.

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

   • Not applicable, as there is no training set for an AI/ML model. The ground truth for the control materials is inherent in their design and manufacturing process.

Ask a specific question about this device

SPOTFIRE® RSP Positive Control is intended for use (as applicable) as an external positive assayed quality control to monitor performance of in vitro laboratory nucleic acid testing procedures for the qualitative detection of Bordetella parapertussis, Bordetella pertussis, Chlamydia pneumoniae, Adenovirus, Adenovirus, seasonal Coronavirus, Coronavirus SARS-CoV-2, Human Metapneumovirus, Human Rhinovirus, Influenza A Subtype H1-2009, Influenza A Subtype H3, Influenza B, Parainfluenza Virus and Respiratory Syncytial Virus using the BIOFIRE® SPOTFIRE® Respiratory (R) Panel (SPOTFIRE® R Panel) and BIOFIRE® Respiratory (R) Panel Mini (SPOTFIRE® R Panel Mini) assays performed on the BIOFIRE® System. SPOTFIRE® RSP Positive Control is comprised of in vitro RNA transcripts and stabilizing solution and is designed for and intended to be used solely with the SPOTFIRE R Panel and the SPOTFIRE R Panel Mini assays. This product is not intended to replace manufacturer internal controls provided with the device.

Quality control materials should be used in accordance with local, state, federal regulations, and accreditation requirements.

SPOTFIRE® RSP Negative Control is intended for use (as applicable) as an external negative assayed quality control to monitor performance of in vitro laboratory nucleic acid testing procedures for the qualitative detection of Bordetella parapertussis, Bordetella pertussis, Chlamydia pneumoniae, Adenovirus, Adenovirus, seasonal Coronavirus, Coronavirus SARS-CoV-2, Human Metapneumovirus, Human Rhinovirus, Influenza A Subtype H1-2009, Influenza A Subtype H3, Influenza B, Parainfluenza Virus and Respiratory Syncytial Virus using the BIOFIRE® SPOTFIRE® Respiratory (R) Panel (SPOTFIRE® R Panel) and BIOFIRE® Respiratory (R) Panel Mini (SPOTFIRE® R Panel Mini) assays performed on the BIOFIRE® System. SPOTFIRE® RSP Negative Control is comprised of a solution that does not contain target analytes and is designed for and intended to be used solely with the SPOTFIRE R Panel and SPOTFIRE R Panel Mini assays. This product is not intended to replace manufacturer internal controls provided with the device.

Quality control materials should be used in accordance with local, state, federal regulations, and accreditation requirements.

SPOTFIRE RSP Pos & Neg Controls, P/N M425, is a quality control panel consisting of 2 separate kits of ready-to-use, liquid controls, SPOTFIRE RSP Positive Control (Positive Control), P/N M42638 and SPOTFIRE RSP Negative Control (Negative Control), P/N M42738. The Positive Control contains non-infectious surrogate control material; a solution of synthetic RNA transcripts in buffer, stabilizers and preservatives. The RNA in the Positive Control carries RNA segments of all the respiratory pathogens detected by the SPOTFIRE R Panel (Table 1) and SPOTFIRE R Panel Mini (Table 2) on the SPOTFIRE System and is specifically designed for and intended to be used solely with the SPOTFIRE R Panel and SPOTFIRE R Panel Mini assays on the SPOTFIRE System. The Negative Control contains buffer and preservatives with no RNA. Each liquid control of SPOTFIRE RSP Pos & Neg Controls, P/N M425, is processed separately according to the SPOTFIRE R Panel and SPOTFIRE R Panel Mini assay manufacturer's Instructions for Use for Quality Control testing.

This document describes a 510(k) premarket notification for a change to an existing device, the SPOTFIRE® RSP Pos & Neg Controls. The change specifically involves including the BIOFIRE® SPOTFIRE® Respiratory (R) Panel Mini (SPOTFIRE R Panel Mini) in the device's intended use. As such, the presented information focuses on demonstrating substantial equivalence rather than a detailed de novo device performance study.

Based on the provided text, the device in question is an "Assayed Quality Control Material For Clinical Microbiology Assays". The performance data presented in the 510(k) submission (K221253) for the original device is deemed sufficient to support the change, meaning no new performance data specific to this submission (K230868) was generated.

Here's a breakdown of the requested information based on the provided text:

1. A table of acceptance criteria and the reported device performance:

The document explicitly states: "No additional performance data are required as the SPOTFIRE RSP Pos & Neg Controls have not been changed, the assay consumables are identical for the SPOTFIRE R Panel used to collect original performance data and the SPOTFIRE R Panel Mini added to the intended use of the device. In addition, the targets reported in the SPOTFIRE R Panel Mini are a subset of the SPOTFIRE R Panel."

This indicates that the performance of the control material (SPOTFIRE® RSP Pos & Neg Controls) with the SPOTFIRE R Panel Mini is expected to be consistent with its performance on the broader SPOTFIRE R Panel, for which performance data was previously submitted and accepted under K221253.

Therefore, the table of acceptance criteria and reported device performance from the original K221253 submission would be relevant, but those details are not provided in this document.

2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective):

No new test set was used for this specific 510(k) submission (K230868). The submission relies on performance data from the previous submission (K221253). The document does not provide details of the sample size or data provenance from K221253.

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. As this submission is for a quality control material and not an AI/ML diagnostic algorithm relying on expert interpretation of images, the concept of "experts establishing ground truth" in the same manner as for image-based diagnostics is not directly applicable. For a quality control material, the ground truth is typically established by the known composition of the control material itself (e.g., presence or absence of specific RNA transcripts).

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

Not applicable, as no new test set requiring adjudication of interpretations was presented in this submission.

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:

Not applicable. This device is a quality control material, not an AI/ML diagnostic tool, and therefore MRMC studies are not relevant.

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

Not applicable. This device operates as a control for an in vitro diagnostic test, not as a standalone algorithm.

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

For a quality control material like the SPOTFIRE® RSP Pos & Neg Controls, the ground truth is the defined composition of the control material itself.

• Positive Control: Contains "in vitro RNA transcripts" of the target pathogens. So, the ground truth for the positive control is the presence of these specific RNA transcripts.
• Negative Control: Comprised of a "solution that does not contain target analytes." So, the ground truth for the negative control is the absence of the target analytes.

8. The sample size for the training set:

Not applicable. This device is a quality control material, not an AI/ML algorithm that requires a training set.

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

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

Summary of Device Acceptance & Study Information (Based on the Provided Text):

The acceptance of K230868 is based on demonstrating substantial equivalence to the previously cleared predicate device (K221253). The core argument for acceptance is that:

• The SPOTFIRE® RSP Pos & Neg Controls have not been physically changed.
• The assay consumables for the original SPOTFIRE R Panel and the newly included SPOTFIRE R Panel Mini are identical.
• The targets detected by the SPOTFIRE R Panel Mini are a subset of those included in the SPOTFIRE R Panel, which was already covered by the previous clearance.

Therefore, the performance data previously submitted for K221253 is considered sufficient and no new performance studies specific to the addition of the SPOTFIRE R Panel Mini were required for this submission. The "study that proves the device meets the acceptance criteria" refers to the previously conducted and accepted studies for K221253, the details of which are not included in this document.

Ask a specific question about this device

SPOTFIRE® RSP Positive Control is intended for use as an external positive assayed quality control to monitor performance of in vitro laboratory nucleic acid testing procedures for the qualitative detection of Bordetella parapertussis, Bordetella pertussis, Chlamydia pneumoniae, Mycoplasma pneumoniae, Adenovirus, seasonal Coronavirus, Coronavirus SARS-CoV-2, Human Metapneumovirus, Human Rhinovirus, Influenza A Subtype H1-2009, Influenza A Subtype H3, Influenza B, Parainfluenza Virus and Respiratory Syncytial Virus using the BIOFIRE® SPOTFIRE® Respiratory (R) Panel performed on the BIOFIRE® SPOTFIRE® System. SPOTFIRE RSP Positive Control is comprised of in vitro RNA transcripts and stabilizing solution and is designed for and intended to be used solely with the BIOFIRE SPOTFIRE R Panel. This product is not intended to replace manufacturer internal controls provided with the device.

SPOTFIRE® RSP Negative Control is intended for use as an external negative assayed quality control to monitor performance of in vitro laboratory nucleic acid testing procedures for the qualitative detection of Bordetella parapertussis, Bordetella pertussis, Chlamydia pneumoniae, Mycoplasma pneumoniae, Adenovirus, seasonal Coronavirus, Coronavirus SARS-CoV-2, Human Metapneumovirus, Human Rhinovirus, Influenza A Subtype H1-2009, Influenza A Subtype H3, Influenza B, Parainfluenza Virus and Respiratory Syncytial Virus using the BIOFIRE® SPOTFIRE® Respiratory (R) Panel performed on the BIOFIRE® SPOTFIRE® System. SPOTFIRE RSP Negative Control is comprised of a solution that does not contain target analytes and is designed for and intended to be used solely with the BIOFIRE SPOTFIRE R Panel. This product is not intended to replace manufacturer internal controls provided with the device.

SPOTFIRE® RSP Pos & Neg Controls, P/N M425, is a quality control panel consisting of 2 separate kits of ready-to-use, liquid controls, SPOTFIRE® RSP Positive Control (Positive Control), P/N M42638 and SPOTFIRE® RSP Negative Control (Negative Control), P/N M42738. The Positive Control contains non-infectious surrogate control material; a solution of synthetic RNA transcripts in buffer, stabilizers and preservatives. The RNA in the Positive Control carries RNA segments of all the respiratory pathogens detected by the BIOFIRE® SPOTFIRE® Respiratory (R) Panel on the BIOFIRE® SPOTFIRE® System (see Table 1 below) and is specifically designed for and intended to be used solely with the SPOTFIRE R Panel assay on the SPOTFIRE System. The Negative Control contains buffer and preservatives with no RNA. Each liquid control of SPOTFIRE® RSP Pos & Neg Controls, P/N M425, is processed separately according to the SPOTFIRE R Panel assay manufacturer's Instructions for Use for Quality Control testing.

The provided text describes the acceptance criteria and the study that proves the device (SPOTFIRE® RSP Pos & Neg Controls) meets those criteria. The device being reviewed is a quality control material for clinical microbiology assays, not an AI/ML-enabled diagnostic device. Therefore, many of the requested categories pertaining to AI/ML device studies (e.g., number of experts for ground truth, adjudication methods, MRMC studies, effect size of human reader improvement with AI, standalone performance, training set details) are not applicable to this submission.

However, I can extract the relevant information regarding the acceptance criteria and the performance study for this quality control material.

Here's the information based on the provided text, focusing on what is applicable to the described device and study:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are not explicitly stated as numerical thresholds (e.g., "sensitivity must be > 90%"). Instead, the document refers to "predetermined criteria" for reproducibility that were met. The reported performance is an "overall correct result rate."

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

• Total Test Results: 361 initially, leading to 351 valid test results after repeating invalid ones.
• External Performance Study (Test Set): 232 initially, leading to 225 valid controls after repeating invalid ones.
  • Data Provenance: Prospective, collected from 5 near-patient clinical sites across the US (presumably, given the context of FDA submission, though not explicitly stated but implied by "near-patient clinical sites" in the context of an FDA filing for a US company).
• Internal Study (Test Set): 129 initially, leading to 126 valid results after repeating invalid ones.
  • Data Provenance: Prospective, conducted at MMQCI facility in Saco, Maine, USA.

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

• Not Applicable. This is a quality control material where the "ground truth" is inherent to the control material itself (i.e., whether it should be positive for specific analytes or negative for all analytes). The "correctness" of the result is determined by its agreement with the expected outcome for that control. The study evaluates the reproducibility and performance of the control and the assay system, not a diagnostic decision requiring expert consensus.

4. Adjudication Method for the Test Set

• Not Applicable. As this is a quality control material, the "ground truth" for each control (whether it should yield a positive or negative result) is predefined by its composition. There is no human adjudication process for categorizing results as "correct" or "incorrect" beyond comparing them to the expected outcome based on the control's design. Invalid results were repeated as per BioFire instructions.

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

• Not Applicable. This is not an AI/ML-enabled diagnostic device. No human readers, AI assistance, or comparative effectiveness studies of this nature were performed.

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

• Not Applicable. This is a physical quality control material used with an in-vitro diagnostic system (BIOFIRE® SPOTFIRE® System). Its performance is evaluated within that system, not as a standalone algorithm.

7. The Type of Ground Truth Used

• Defined Composition: The ground truth for the SPOTFIRE® RSP Positive Control is the presence of synthetic RNA transcripts corresponding to specific respiratory pathogens, manufactured to be detected by the BIOFIRE® SPOTFIRE® Respiratory (R) Panel.
• Defined Absence: The ground truth for the SPOTFIRE® RSP Negative Control is the absence of target analytes, designed to yield a negative result.
• The "correct" result for each control is based on its predetermined design and expected performance with the intended assay.

8. The Sample Size for the Training Set

• Not Applicable. As this is a quality control material and not an AI/ML model, there is no "training set." The study described evaluates the performance and reproducibility of the manufactured control materials within their intended use.

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

• Not Applicable. See point 8.

Ask a specific question about this device

BioFire JI Control Panel M420 is intended for use as an external positive assayed quality control to monitor the performance of in vitro laboratory nucleic acid testing procedures for the qualitative detection of gram-positive and gram-negative bacteria: Anaerococcus prevotii/vaginalis, Clostridium perfringens, Cutibacterium avidum/granulosum, Enterococcus faecalis, Enterococcus faecium, Finezoldia magna, Parvimonas micra, Peptoniphilus, Peptostreptococcus anaerobius, Staphylococcus aureus, Staphylococcus lugdunensis, Streptococcus spp., Streptococcus agalactiae, Streptococus pneumoniae, Streptococcus pyogenes, Bacteroides fragilis, Citrobacter cloacae complex, Escherichia coli, Haemophilus influenzae, Kingella kingae, Klebsiella aerogenes, Klebsiella pneumoniae group, Morganella morganii, Neisseria gonorrhoeae, Proteus spp., Pseudomonas aeruginosa, Salmonella spp., and Serratia marcescens, antimicrobial resistance genes: CTX-M, IMP, KPC, mecA/C and MREJ (MRSA), NDM, OXA-48-like, vanA/B, VIM, and yeast pathogens: Candida albicans on the BioFire JI Panel assay on the BioFire systems. BioFire II Control Panel M420 is composed of synthetic DNA specifically designed for and intended to be used solely with the BioFire II Panel assay. This product is not intended to replace manufacturer controls provided with the device.

BioFire JI Control Panel M420, P/N M420, is a quality control panel consisting of 2 controls, BioFire JI Positive Control, P/N M42118, and JI Negative Control, P/N M42218. The Positive Control contains non-infectious surrogate control material; a solution of synthetic DNA in buffers, stabilizers and preservatives. The DNA in the Positive Control carries nucleic acid corresponding to the genome segments of all the pathogens and antimicrobial resistance genes detected and identified by the BioFire® Joint Infection (JI) Panel assay (see Table 1. below) on the BioFire® systems. The Negative Control contains buffers, stabilizers and preservatives. Each liquid control of BioFire JI Control Panel M420 is processed separately according to the BioFire JI Panel assay manufacturer's Instructions for Use for patient samples (synovial fluid) obtained from individuals suspected of infection. Each tube of control contains sufficient liquid for a single use.

The provided text describes a 510(k) premarket notification for the BioFire JI Control Panel M420, a quality control material. The study demonstrates the reproducibility of this control panel.

Here's the breakdown of the acceptance criteria and study information:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size and Data Provenance

• Test Set Sample Size:
  • Combined Reproducibility Study: 301 tests (1 Invalid result was repeated and not included in correct analysis, leading to 300 correct results analyzed).
  • External Site Testing: 181 tests (1 Invalid result was not included in percent correct analysis, leading to 180 valid results analyzed).
  • Internal Site Testing (MMQCI): 120 tests.
• Data Provenance: The study involved both internal (MMQCI, Saco, Maine, USA) and external sites (3 CLIA-certified clinical sites, likely within the US given the FDA submission context). The data is prospective, generated specifically for this performance evaluation.

3. Number of Experts and Qualifications for Ground Truth

The document does not mention the use of experts to establish a ground truth for the test set. Instead, the performance of the control panel is evaluated against its expected positive or negative detection for each target, as designed by the manufacturer (Maine Molecular Quality Controls, Inc.). The BioFire JI Control Panel M420 itself is intended to be an external control for an in vitro laboratory nucleic acid testing procedure (BioFire JI Panel assay).

4. Adjudication Method for the Test Set

No adjudication method is described for the test set. The results are straightforward positive or negative detections as determined by the BioFire JI Panel assay. "Correct" results are based on whether the assay detected what was designed to be in the positive control or did not detect anything in the negative control.

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

There is no mention of a Multi-Reader Multi-Case (MRMC) comparative effectiveness study being performed, nor any effect size of human readers improving with or without AI assistance. This study focuses on the performance of a quality control material and not on human interpretation or AI assistance.

6. Standalone (Algorithm Only) Performance

This study is inherently a standalone performance evaluation of the BioFire JI Control Panel M420 in combination with the BioFire JI Panel assay. The control panel itself is a diagnostic device (quality control material), not an algorithm. The performance described is the control material's ability to consistently elicit the expected results from the BioFire JI Panel assay.

7. Type of Ground Truth Used

The ground truth used is the expected composition of the BioFire JI Control Panel M420. The Positive Control is "composed of synthetic DNA specifically designed for" and contains "nucleic acid corresponding to the genome segments of all the pathogens and antimicrobial resistance genes detected and identified by the BioFire® Joint Infection (JI) Panel assay." The Negative Control is designed to contain "buffers, stabilizers and preservatives" but no target nucleic acid. The "correct" result for each test is predefined based on this engineered composition.

8. Sample Size for the Training Set

This document describes the performance evaluation of a quality control material and does not mention a "training set" in the context of an algorithm or machine learning model.

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

As noted above, there is no "training set" in this context. The control panel is a manufactured product with a defined composition that serves as its inherent ground truth for validation.

Ask a specific question about this device

BioFire RP2.1/RP2.1plus Control Panel M441 is intended for use as an external positive and negative assayed quality control to monitor the performance of in vitro laboratory nucleic acid testing procedures for the qualitative detection of Adenovirus, Coronavirus, Human Metapneumovirus, Human Rhinovirus, Influenza A, Influenza A subtype H1, Influenza A subtype H1-2009, Influenza A subtype H3, Influenza B, Middle East Respiratory Syndrome Coronavirus, Parainfluenza Virus, Respiratory Syncytial Virus, Severe Acute Respiratory Syndrome Coronavirus 2, Bordetella parapertussis, Bordetella pertussis, Chlamydia pneumoniae, and Mycoplasma pneumoniae on the BioFire Respiratory Panel 2.1 (RP2.1), BioFire Respiratory Panel 2.1 plus) and BioFire Respiratory Panel 2.1-EZ (RP2.1-EZ) assay performed on the BioFire FilmArray systems. BioFire RP2.1/RP2.1plus Positive control is composed of synthetic RNA transcripts specifically designed for and intended to be used solely with the BioFire RP2.1phus and BioFire RP2.1-EZ assay. This product is not intended to replace manufacturer controls provided with the device.

BioFire RP2.1/RP2.1plus Control Panel M441, P/N M441, is a quality control panel consisting of 2 ready-to-use, liquid controls, BioFire RP2.1/RP2.1plus Positive (Positive Control) and BioFire RP2.1/RP2.1plus Negative Control). The Positive Control contains noninfectious surrogate control material; a solution of synthetic RNA transcripts in buffer, stabilizers and preservatives. The RNA carries segments of all respiratory pathogens detected by the BioFire® Respiratory Panel 2.1 (RP2.1), BioFire® Respiratory Panel 2.1plus (RP2.1plus), and BioFire® Respiratory Panel 2.1-EZ (RP2.1-EZ) assays (Table 1. below) on the BioFire® FilmArray systems, including Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2). BioFire RP2.1/RP2.1plus Negative contains buffer and preservatives with no RNA. Each liquid control of BioFire RP2.1/RP2.1plus Control Panel M441 is processed separately according to BioFire RP2.1, RP2.1plus, and RP2.1-EZ assays manufacturer's Instructions for Use for patient samples (nasopharyngeal swabs) obtained from individuals suspected of respiratory tract infection and placed in Viral Transport Media (VTM)).

Here's an analysis of the acceptance criteria and study detailed in the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Total Test Set Sample Size: 172 tests (Internal and External studies combined).
  • Internal Study: 120 tests (Precision testing).
  • External Study: 52 tests.
• Data Provenance:
  • Internal Study: Performed at MMQCI's facility in Saco, Maine, USA.
  • External Study: Performed at an independent U.S. facility.
• Retrospective/Prospective: The studies appear to be prospective as they involved testing newly manufactured lots of the control panel on BioFire FilmArray systems under specified conditions.

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. For quality control materials like the BioFire RP2.1/RP2.1plus Control Panel M441, the "ground truth" is inherent to the composition of the control. The positive control is designed to contain synthetic RNA transcripts for specific pathogens, and the negative control is designed to not contain them. The "correctness" of results is determined by whether the BioFire FilmArray system detects the expected pathogens in the positive control and no pathogens in the negative control. It doesn't rely on human expert interpretation of results, but rather on the objective measurement by the instrument.

4. Adjudication Method for the Test Set

This information is not applicable as the "ground truth" for quality control materials is defined by their manufacturing composition and expected reaction, not by expert interpretation requiring adjudication. Results are either "correct" (matching the known composition) or "incorrect," or "invalid" by the instrument.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and the effect size of how much human readers improve with AI vs without AI assistance

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not conducted. This device is an assayed quality control material for clinical microbiology assays, not an AI-powered diagnostic device that would assist human readers in interpreting clinical cases. Therefore, the concept of human readers improving with AI assistance is not applicable here.

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

This question is not applicable as the device is a physical quality control material, not a software algorithm. The "performance" being evaluated is how reliably the BioFire FilmArray system detects the components of the control panel. The control panel itself does not operate as a standalone algorithm.

7. The Type of Ground Truth Used

The ground truth used is the known composition of the control material.

• Positive Control: Contains synthetic RNA transcripts for all respiratory pathogens detected by the BioFire® Respiratory Panel 2.1 (RP2.1), BioFire® Respiratory Panel 2.1plus (RP2.1plus), and BioFire® Respiratory Panel 2.1-EZ (RP2.1-EZ) assays, including SARS-CoV-2.
• Negative Control: Contains buffer and preservatives with no RNA.

8. The Sample Size for the Training Set

This information is not applicable/not provided in the context of this device. This device is a quality control material, not a machine learning model that requires a training set. The manufacturing process and formulation are based on established molecular biology principles, not on training data.

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

This information is not applicable as there is no "training set" for this quality control material.

Ask a specific question about this device

FilmArray BCID2 Control Panel M416 is intended for use as an external positive and negative assayed quality control to monitor the performance of in vitro laboratory nucleic acid testing procedures for the qualitative detection of antimicrobial resistance genes: CTX-M, IMP, KPC, mcr-1, mecA/C and MREJ (MRSA), NDM, OXA-48-like, vanA/B, VIM; Gram positive and Gram negative bacteria: Enterococcus faccalis, Enterococcus faccium, Listeria monocytogenes, Staphylococcus spp., Staphylococcus aureus, Staphylococcus epidermidis, Staphylococcus lugdunensis, Streptococus spp., Streptococcus agalactiae (Group B), Streptococcus pneumoniae, Streptococcus pyogenes (Group A), Acinetobacter calcoaceticus-baumannii complex, Bacteroides fragilis, Enterobacter cloacae complex, Escherichia coli, Klebsiella aerogenes, Klebsiella pneumoniae group, Proteus spp., Salmonella spp., Serratia marcescens, Haemophilus influenzae, Neisseria meningitidis, Pseudomonas aeruginosa and Stenotrophomonas maltophilia; and yeast pathogens: Candida albicans, Candida glabrata, Candida krusei, Candida parapsilosis, Candida tropicalis, and Cryptococcus neoformans/gattii on the BioFire® Blood Culture Identification 2 (BCID2) Panel on the FilmArray® systems. FilmArray BCID2 Control Panel M416 is composed of synthetic DNA specifically designed for and intended to be used solely with the BioFire BCID2 Panel assay. This product is not intended to replace manufacturer controls provided with the device.

FilmArray BCID2 Control Panel M416, P/N M416, is a quality control panel consisting of 2 controls, FilmArray BCID2 Positive Control, P/N M41718, and FilmArray BCID2 Negative Control. P/N M41818. The Positive Contains non-infectious surrogate control material; a solution of synthetic DNA in buffers, stabilizers and preservatives. The DNA in the Positive Control carries nucleic acid corresponding to the genome segments of all the pathogens and antimicrobial resistance genes detected and identified by the BioFire® Blood Culture Identification 2 (BCID2) Panel assay (see Table 1. below) on the FilmArray systems. The Negative Control contains only buffers, stabilizers and preservatives. Each liquid control of FilmArray BCID2 Control Panel M416 is processed separately according to BioFire BCID2 Panel assay manufacturer's Instructions for Use for patient samples (positive blood cultures) obtained from individuals suspected of sepsis. Each tube of contains sufficient liquid for a single use.

This document describes the FilmArray BCID2 Control Panel M416, an assayed quality control device. Here's a breakdown of the requested information based on the provided text:

1. Table of Acceptance Criteria and the Reported Device Performance

2. Sample size used for the test set and the data provenance

• Test Set Sample Size: 307 total tests were performed for the reproducibility study. After excluding 2 invalid results, 305 valid tests were used for the percentage calculation.
  • Internal Testing (MMQCI): 122 tests (20 samples * 3 lots, with 2 repeats)
  • External Testing (3 Clinical Laboratories): 186 tests (10 samples * 3 lots * 3 sites, with 6 repeats)
• Data Provenance: The study involved both internal testing at MMQCI (Saco, Maine, USA) and external testing at 3 CLIA-certified clinical laboratories. The study was prospective in nature, as new lots of the control panel were manufactured and then tested according to a predefined protocol.

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 device is a quality control material for nucleic acid testing, which typically has an objective ground truth based on the known composition of the synthetic DNA targets. The performance is assessed against the expected positive or negative result for each control.

4. Adjudication method for the test set

This information is not explicitly provided. Given the nature of a quality control material, the results are expected to be either positive or negative for predefined analytes. "Incorrect" results (positive controls) were retested, and those retested correctly are not included in the main performance summary (e.g., "The incorrect Positive controls were all correct upon retesting."). This suggests a form of retesting for discrepant results, rather than an expert adjudication panel.

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

Not Applicable. This document describes a quality control material for in vitro diagnostic assays, not an AI-powered diagnostic device that would involve human readers or AI assistance.

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

Not Applicable. This device is a quality control material, not an algorithm. Its performance is evaluated by its ability to elicit the correct positive or negative response from the BioFire BCID2 Panel assay.

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

The ground truth for this quality control material is known composition.

• Positive Control: Contains synthetic DNA corresponding to the genome segments of all the pathogens and antimicrobial resistance genes detected by the BioFire BCID2 Panel assay. Therefore, the expected ground truth for the positive control is the detection of all these targets.
• Negative Control: Contains only buffers, stabilizers, and preservatives. The expected ground truth for the negative control is the absence of any detected targets.

8. The sample size for the training set

Not Applicable. This device is a quality control material, not a machine learning algorithm that requires a training set. Its manufacturing and testing involve standard analytical performance studies.

9. How the ground truth for the training set was established

Not Applicable. As explained above, there is no training set for this type of device.

Ask a specific question about this device

FilmArray PneumonialPneumoniaplus Control is intended for use as an external positive and negative assayed quality control to monitor performance of in vitro laboratory nucleic acid testing procedures for the qualitative detection of bacteria: Acinetobacter calcoaceticus-baumannii complex, Enterobacter cloacae complex, Escherichia coli, Haemophilus influenzae, Klebsiella aerogenes, Klebsiella pneumoniae group, Moraxella catarrhalis, Proteus spp., Pseudomonas aeruginosa, Serratia marcescens, Staphylococcus agalactiae, Streptococcus agalactiae, Streptococcus pneumoniae, Streptococcus pyogenes, Chlamydia pneumonila, Mycoplasma pneumoniae; antimicrobial resistance genes: CTX-M, IMP, KPC, mecA/C and MREJ, NDM, OXA-48 like, VIM; and viruses: Adenovirus, Coronavirus, Human Metapneumovirus, Human Rhinovirus/Enterovirus, Influenza B, Middle East Respiratory Syndrome Coronavirus (MERS-CoV), Parainfluenza Virus and Respiratory Syncytial Virus on the FilmArray Pneumonia Panel or Pneumonia Panel plus assays performed on FilmArray Pneumonia/ Pneumoniaplus Control is composed of synthetic DNA and RNA designed for and intended to be used solely with the FilmArray Pneumonia Panel and FilmArray Pneumonia Panel plus assays. This product is not intended to replace manufacturer internal controls provided with the test system.

FilmArray Pneumonia/Pneumoniaplus Control, P/N M340, is a quality control panel consisting of 2 controls, FilmArray Pneumoniaplus Positive (Positive Control), P/N M34235, and FilmArray Pneumonia/Pneumoniaplus Negative Control), P/N M34135. The Positive Control contains non-infectious surrogate control material; a solution of synthetic DNA and RNA in buffers, stabilizers and preservatives. The DNA and RNA in the Positive Control carries nucleic acid corresponding to the genome segments of all the respiratory pathogens and antimicrobial resistance genes detected and identified by the FilmArray® Pneumonia Panel and Pneumonia Panel plus assays (see Table 1. below) on the FilmArray® systems. The Negative Control contains only buffers, stabilizers and preservatives. Each liquid control of FilmArray Pneumonia/Pneumoniaplus Control is processed separately according to FilmArray® Pneumonia Panel or Pneumonia Panel plus assays manufacturer's Instructions for Use for patient samples (Sputum) obtained from individuals suspected of lower respiratory tract infection. Each tube of control contains sufficient liquid for a single use.

The document describes the FilmArray Pneumonia/Pneumoniaplus Control, a quality control material intended to monitor the performance of in-vitro laboratory nucleic acid testing procedures conducted with the FilmArray Pneumonia Panel or Pneumonia Panel plus assays.

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

While explicit "acceptance criteria" against which individual performance metrics (e.g., minimum percentage correct results) are not provided in the document, the studies demonstrate consistent high performance. The "Total Percent Correct" for both external and internal testing can be considered the device performance. The objective is for the controls to consistently produce the correct positive or negative results.

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

• Test Set (Overall): 308 tests of FilmArray Pneumonia/Pneumoniaplus Control.
  • External Study: 185 samples.
  • Internal Study: 123 samples.
• Data Provenance: The studies were conducted by Maine Molecular Quality Controls, Inc. (MMQCI) for the internal portion, and at 3 CLIA-certified clinical sites for the external portion. This indicates a mix of controlled laboratory (internal) and real-world clinical (external) settings within the United States. The data is prospective, as it explicitly states the studies were performed over defined periods (e.g., 60 days for internal, 10 days for external).

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

This information is not applicable in this context. The "ground truth" for a quality control material like this is inherent in its design: a positive control should produce a positive result for specific targets, and a negative control should produce a negative result. There are no "experts" involved in determining the ground truth for the control itself, as it is a manufactured reference material with known components.

4. Adjudication Method for the Test Set

The document mentions that for initial false positive or false negative results, a single retest was performed, and all retests produced the correct results. This indicates an informal adjudication through retesting, rather than a formal expert-based adjudication process.

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 is not applicable. The device is a quality control material for in-vitro diagnostic assays, not an AI-powered diagnostic device for human interpretation or a device that assists human readers.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

This is not applicable. The device is a quality control material, not an algorithm or an AI device. Its performance is evaluated by how accurately an assay (FilmArray Pneumonia Panel) detects its known synthetic components.

7. The Type of Ground Truth Used

The ground truth used is the known composition of the control material.

• The Positive Control contains synthetic DNA and RNA corresponding to the genome segments of targeted respiratory pathogens and antimicrobial resistance genes. Therefore, the "ground truth" is that these targets should be detected.
• The Negative Control contains only buffers, stabilizers, and preservatives, with no target nucleic acids. Therefore, the "ground truth" is that no targets should be detected.

8. The Sample Size for the Training Set

This is not applicable. The FilmArray Pneumonia/Pneumoniaplus Control is a quality control material, not an algorithm developed through machine learning. Therefore, there is no "training set" in the context of AI or algorithm development.

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

This is not applicable for the reasons stated in point 8. The "ground truth" (known composition) for the control material itself is established during its manufacturing and characterization by Maine Molecular Quality Controls, Inc., where the synthetic DNA/RNA components are precisely designed and incorporated into the positive control, and the negative control is formulated to be free of these target analytes.

Ask a specific question about this device

FilmArray RP2/RP2plus Control Panel is intended for use as an external positive and negative assayed quality control to monitor performance of in vitro laboratory nucleic acid testing procedures for the qualitative detection of Adenovirus, Coronavirus, Human Metapneumovirus, Human Rhinovirus/ Enterovirus, Influenza A subtype H1, Influenza A subtype H1-2009, Influenza A subtype H3, Influenza B, Middle East Respiratory Syndrome Coronavirus, Parainfluenza Virus, Respiratory Syncytial Virus, Bordetella parapertussis, Chlamydia pneumonia, and Mycoplasma pneumoniae by BioFire's FilmArray® RP2 and RP2plus assays on the FilmArray® Torch Systems. FilmArray RP2/RP2plus Control Panel is composed of synthetic RNA designed for and intended to be used solely with the FilmArray® RP2 and RP2plus assays. This product is not intended to replace manufacturer controls provided with the test system.

FilmArray RP2/RP2plus Control Panel, P/N M315, is a quality control panel consisting of controls, FilmArray RP2/RP2plus Positive (Positive Control), P/N M31721, and FilmArray RP2/RP2plus Negative, (Negative Control), P/N M31621. The Positive Control contains noninfectious surrogate control material; a solution of synthetic RNA transcripts in buffers, stabilizers and preservatives. The RNA carries segments of all respiratory pathogens detected by the FilmArray® RP2 and RP2plus assays (Table 1. below) on the FilmArray® 2.0 or FilmArray® Torch systems. The RNA in the Negative Control is non-specific RNA in buffers, stabilizers and preservatives. Each liquid control of FilmArray RP2/RP2plus Control Panel M265 is processed separately according to FilmArray® RP2 and RP2plus assays manufacturer's Instructions for Use for patient samples (nasopharyngeal swabs) obtained from individuals suspected of respiratory tract infection and placed in Viral Transport Media (VTM)).

The document describes the FilmArray RP2/RP2plus Control Panel, an assayed quality control material for clinical microbiology assays. The acceptance criteria and the study proving the device meets these criteria are detailed, focusing on its performance in monitoring BioFire's FilmArray® RP2 and RP2plus assays.

1. Acceptance Criteria and Reported Device Performance

The acceptance criteria for the FilmArray RP2/RP2plus Control Panel are implied by the performance metrics reported in the summary tables. The primary acceptance criteria appear to be:

• Correct Positive Control Result: All respiratory pathogen analytes in the Positive Control should be correctly detected.
• Correct Negative Control Result: No respiratory pathogens should be detected.
• Low Invalid Rate: A low or zero percentage of invalid results.

2. Sample Size and Data Provenance

The study involved both an internal and an external study.

• Internal Study (MMQCI):
  • Sample Size: 121 tests (60 Positive Controls, 61 Negative Controls)
  • Provenance: Retrospective data from MMQCI (Saco, Maine, USA) over 20 days, involving 4 pouch lots and 4 operators.
• External Study (Clinical Sites):
  • Sample Size: 180 tests (90 Positive Controls, 90 Negative Controls)
  • Provenance: Retrospective data from 3 CLIA-certified clinical sites (country not specified, but likely USA given FDA submission) between July and August 2017, over a period of 10 days, using 3 FilmArray RP2 pouch lots and multiple operators.

Combined Test Set Sample Size: 301 total tests (150 Positive Control, 151 Negative Control)

3. Number of Experts and Qualifications for Ground Truth

This device is an assayed quality control material for an in vitro diagnostic (IVD) test, not an AI or imaging device requiring expert interpretation of medical images. Therefore, the concept of "experts used to establish the ground truth" in the traditional sense of medical image interpretation (e.g., radiologists) does not apply here.

The "ground truth" for this device is the known composition of the control panel:

• Positive Control: Contains synthetic RNA transcripts for specific respiratory pathogens. The ground truth is that these pathogens should be detected.
• Negative Control: Contains non-specific RNA. The ground truth is that no specific respiratory pathogens should be detected.

The performance of the device is evaluated against this pre-defined, engineered ground truth. There are no "experts" establishing clinical diagnoses for the test set.

4. Adjudication Method for the Test Set

Not applicable. As described above, the ground truth is pre-defined by the engineered composition of the control material, not through human interpretation or adjudication processes like 2+1 or 3+1 that are common in AI or diagnostic studies where human agreement is required to establish a consensus diagnosis for real patient data.

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

Not applicable. The device is a quality control material, not a diagnostic device that assists human readers. Therefore, an MRMC study comparing human readers with and without AI assistance is not relevant to its evaluation.

6. Standalone Performance

Yes, the performance data presented is for the standalone performance of the FilmArray RP2/RP2plus Control Panel when run on the BioFire FilmArray® RP2 and RP2plus assays. The results indicate how well the control panel itself triggers the expected (positive or negative) outcome on the assay. The study assesses the characteristics of the control material, not how the control material assists humans in interpreting an assay result. The control material validates the assay's performance, ensuring its reliability.

7. Type of Ground Truth Used

The ground truth used is the engineered composition or known content of the control materials.

• For the Positive Control, the ground truth is the presence of specific synthetic RNA sequences designed to be detected by the FilmArray® RP2/RP2plus assays.
• For the Negative Control, the ground truth is the absence of these specific RNA sequences.

This is a form of analytical gold standard based on the intentional design and manufacturing of the control reagents.

8. Sample Size for the Training Set

Not applicable. The FilmArray RP2/RP2plus Control Panel is a manufactured reagent product, not an AI algorithm that requires a training set. The performance studies described are for validation and verification of the manufactured product's consistency and effectiveness as a quality control.

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

Not applicable, as there is no training set for this type of device. The "ground truth" for the control materials is inherent in their design and manufacturing specifications.

Ask a specific question about this device