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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.

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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.

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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.

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