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The LIAISON® Anti-HAV assay is an in vitro chemiluminescent immunoassay intended for the qualitative detection of total antibodies to hepatitis A (anti-HAV) in human serum and sodium heparin plasma samples using the LIAISON® Analyzer family*. The assay is indicated as an aid in the laboratory diagnosis of current or previous HAV infections in conjunction with other serological and clinical information and to determine the presence of an antibody response to HAV in vaccine recipients.

This assay is not intended for screening blood or solid or soft tissue donors.

The DiaSorin LIAISON® XS Analyzer is a fully automated, closed, continuous loading of samples and reagents in vitro diagnostic immunoassay system utilizing chemiluminescent technology to provide rapid sample results. The analyzer uses DiaSorin proprietary reagents in which chemiluminescence of an analyte is measured in a sample by the reaction of a magnetic particle solid phase coated with antigen or antibody and a chemiluminescent tracer. The LIAISON® XS Analyzer is intended for use in professional clinical laboratories only.

The method for qualitative determination of anti-HAV is a competitive sandwich chemiluminescence immunoassay (CLIA) based on neutralization. The assay uses magnetic particles (solid phase) coated with IgG antibodies to HAV (mouse monoclonal), and a mouse monoclonal anti-HAV antibody conjugate linked to an isoluminol derivative (isoluminolantibody conjugate).

The provided text describes a 510(k) premarket notification for a modified medical device, the LIAISON® XS Analyzer, used with the LIAISON® Anti-HAV assay. However, the document does not contain specific details about acceptance criteria, reported device performance (in terms of sensitivity, specificity, etc.), sample sizes for test sets, data provenance, number of experts, adjudication methods, MRMC studies, standalone performance, or ground truth details for either test or training sets.

The submission is for a device modification (moving fluid canisters onboard) to an already cleared device (K210272). The focus of the provided text is on demonstrating that these modifications do not negatively impact the device's performance or safety/effectiveness, rather than a full de novo performance study of the Anti-HAV assay itself.

Therefore, most of the requested information cannot be extracted from this document. The "Summary of Performance Data" section states that "Non-clinical verification and validation activities conducted with the LIAISON® XS Analyzer demonstrate that the modified device met predetermined acceptance criteria," but it does not specify what those criteria were or quantitatively report the performance. It merely lists the types of studies conducted.

Here is what can be inferred or stated based on the provided text:

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

The document does not explicitly list the acceptance criteria or quantitative performance results (e.g., sensitivity, specificity, accuracy) for the LIAISON Anti-HAV assay after the modifications. It broadly states: "Non-clinical verification and validation activities conducted with the LIAISON® XS Analyzer demonstrate that the modified device met predetermined acceptance criteria, supporting equivalency of the modified device to the cleared device." And "Testing verified all acceptance criteria were met."

The primary goal of this 510(k) is to demonstrate that the modifications to the analyzer (moving fluid canisters onboard) do not alter the safety and effectiveness of the existing cleared device. The previous clearance (K210272) would have contained the detailed performance data for the LIAISON® Anti-HAV assay itself.

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

Not provided in this document. The document refers to "non-clinical verification and validation activities" which are typically internal testing, not necessarily clinical studies with patient test sets.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not applicable and not provided. This information would be relevant for a de novo clinical study with expert ground truth, which is not the focus of this modification submission.

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

Not applicable and not provided.

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. The LIAISON® XS Analyzer is an in vitro diagnostic immunoassay system, not an AI-assisted diagnostic tool that requires human reader interpretation.

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

The LIAISON® Anti-HAV assay on the LIAISON® XS Analyzer is a standalone diagnostic test. Its performance is evaluated based on its accuracy in detecting antibodies, as indicated by the chemiluminescence signal, and does not involve human interpretation of complex images or signals in the same way an AI algorithm might. The document does not provide the specific performance metrics (e.g., sensitivity, specificity, NPV, PPV) for this standalone device in the context of this specific 510(k) submission, as it refers to these having been established in the previous clearance (K210272).

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

Not explicitly stated in this specific document. For an immunoassay like this, the ground truth for clinical studies would typically be established through a combination of:

• Established reference methods: Usually another FDA-cleared or gold standard HAV antibody test.
• Clinical diagnosis: Based on patient symptoms, epidemiological information, and other laboratory markers.
• Seroconversion panels: Well-characterized samples from individuals demonstrating progression of infection or immune response.

Since this 510(k) is for a modification to an existing device, it relies on the ground truth established during the original clearance of the LIAISON® Anti-HAV assay.

8. The sample size for the training set

Not applicable and not provided. Immunoassays are not "trained" in the same way machine learning models are. Performance characteristics are established through various analytical and clinical studies.

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

Not applicable and not provided (see point 8).

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The LIAISON® Anti-HAV assay is an in vitro chemiluminescent immunoassay intended for the qualitative detection of total antibodies to hepatitis A (anti-HAV) in human serum and sodium heparin plasma samples using the LIAISON® Analyzer family. The assay is indicated as an aid in the laboratory diagnosis of current or previous HAV infections in conjunction with other serological and clinical information and to determine the presence of an antibody response to HAV in vaccine recipients.

This assay is not intended for screening blood or solid or soft tissue donors.

The DiaSorin LIAISON® XS Analyzer is a fully automated, closed, continuous loading of samples and reagents in vitro diagnostic immunoassay system utilizing chemiluminescent technology to provide rapid sample results. The analyzer uses DiaSorin proprietary reagents in which chemiluminescence of an analyte is measured in a sample by the reaction of a magnetic particle solid phase coated with antigen or antibody and a chemiluminescent tracer. The LIAISON® XS Analyzer is intended for use in professional clinical laboratories only.

The method for qualitative determination of anti-HAV is a competitive sandwich chemiluminescence immunoassay (CLIA) based on neutralization. The assay uses magnetic particles (solid phase) coated with IgG antibodies to HAV (mouse monoclonal), and a mouse monoclonal anti-HAV antibody conjugate linked to an isoluminol derivative (isoluminol-antibody conjugate).

The information provided pertains to the DiaSorin LIAISON® Anti-HAV assay running on the LIAISON® XS Analyzer. This premarket notification is a "Special 510(k)" for device modifications to the existing LIAISON® XS analyzer (K193532), primarily addressing improvements in reliability related to the reagent pipettor. The LIAISON® Anti-HAV assay component and procedures themselves remain unchanged.

Here's an analysis of the acceptance criteria and study information:

1. Table of Acceptance Criteria and Reported Device Performance

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

The document does not explicitly state the sample size used for the test set for the immunometrical performance assessment.

• Data Provenance: Not specified. It's unclear if the data is retrospective or prospective, or the country of origin.

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

Not applicable for this type of in vitro diagnostic device (immunoassay). Ground truth for these assays is typically established by reference methods or clinical diagnosis, not by experts reviewing images or other data.

4. Adjudication method for the test set

Not applicable for this type of in vitro diagnostic device. Result determination is quantitative or qualitative based on the assay's output measurements against a defined cutoff, not through expert adjudication of individual cases.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done

No, an MRMC comparative effectiveness study was not done. This type of study is typically associated with imaging devices or AI-assisted diagnostic tools where human readers interpret results. The LIAISON® Anti-HAV assay is an automated chemiluminescent immunoassay.

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

Yes, the performance presented in Table 6-3 represents the standalone performance of the LIAISON® Anti-HAV assay on the modified LIAISON® XS Analyzer. This device is an automated immunoassay system, and its output is directly interpreted as a qualitative detection of antibodies.

7. The type of ground truth used

The ground truth for the immunometrical performance assessment:

• Analytical Sensitivity: Established against a "WHO standard preparation."
• Positive/Negative Agreement: Implied to be established against a reference method or clinical diagnosis for Hepatitis A infection, as is standard for serological assays. The document does not explicitly name the specific reference method used for establishing positive and negative agreement.

8. The sample size for the training set

The document does not provide information regarding a separate "training set" or its sample size. For an immunoassay like this, the development likely involves optimization and validation steps, but not a distinct "training set" in the machine learning sense. The performance data presented is for the evaluation of the validated device.

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

As there is no explicit mention of a training set in the context of machine learning, there is no information on how its ground truth was established. The development of such an assay involves careful analytical and clinical validation, ensuring its performance aligns with established diagnostic standards.

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The JBAIDS Anthrax Detection System is a real-time polymerase chain reaction (PCR) test system intended for the qualitative in vitro diagnostic (IVD) detection of target DNA sequences on the pXO1 plasmid (Target 1) and the pXO2 plasmid (Target 2) from Bacillus anthracis. The system can be used to test human whole blood collected in sodium citrate from individuals suspected of having anthrax, positive blood cultures, and cultured organisms grown on blood agar plates. The JBAIDS Anthrax Target 2 assay is used as a supplementary test only after a positive result with the Target 1 Assay.

The JBAIDS Anthrax Target 1 and Target 2 Assays are run on the JBAIDS instrument using the Diagnostic Wizard.

Results are for the presumptive identification of B. anthracis, in conjunction with culture and other laboratory tests. The following considerations also apply:

• The diagnosis of anthrax infection must be made based on history, signs, symptoms, exposure likelihood, and other laboratory evidence, in addition to the identification of pXO1 and pXO2 targets either from cultures or from direct blood specimens.
• The assays have not been evaluated with blood from individuals without clinical signs or symptoms who were presumed exposed and who subsequently developed anthrax (inhalation or other forms of the disease), or from individuals with any form of anthrax (inhalational, cutaneous, or gastrointestinal).
• The level of plasmid targets that would be present in blood from individuals with early systemic infection is unknown.
• The definitive identification of B. anthracis from colony growth, liquid blood culture growth, or from blood specimens requires additional testing and confirmation procedures in consultation with public health or other authorities for whom reports are required.

The safety and effectiveness of other types of tests or sample types (not identified as "For in vitro diagnostic use") have not been established.

The Joint Biological Agent Identification and Diagnostic System (JBAIDS) Anthrax Detection System is a fully integrated in vitro diagnostic (IVD) system composed of the following:

• JBAIDS instrument with laptop computer
• Software
• Two different freeze-dried reagent assays (in one kit) for the qualitative detection of pathogenic Bacillus anthracis
• Four different sample preparation protocols, two for isolating target DNA from whole blood, one for processing blood culture, and another for processing colonies.

The JBAIDS instrument, using Polymerase Chain Reaction (PCR) technology, is a portable thermocycler and real-time fluorimeter. The JBAIDS Anthrax Detection Kit is specially designed for PCR in glass capillaries using the JBAIDS instrument and hydrolysis probes for sequence-specific detection of B. anthracis DNA found on the pX01 plasmid (Target 1) and the pX02 plasmid (Target 2).

The reagent kit contains four different types of freeze-dried reagent vials: Positive Controls, Negative Controls, Inhibition Controls, and Unknowns (used for testing the patient sample). Each JBAIDS assay requires a Positive and Negative Control, and each sample is tested using both an Inhibition Control vial and an Unknown reagent vial.

Before testing, whole-blood samples are purified using the Idaho Technology IT 1-2-3 FLOW or QFLOWdir Sample Purification Kit (or validated equivalent), while blood culture and direct culture specimens are prepared using the IT 1-2-3 SWIPE Sample Purification Kit (or validated equivalent). The resulting purified sample is added to an Unknown reagent vial and an Inhibition Control reagent vial, along with reconstitution buffer. A Positive Control and a Negative Control vial are prepared using reconstitution buffer and reagent grade water. Aliquots from each reagent vial are transferred to two reaction capillaries that are tested together in the JBAIDS instrument. The instrument is programmed to perform heating and cooling cycles that drive the PCR process. The heating and cooling cycles are generated using a heating coil and varying fan speeds. Fluorescence emission is monitored over one of three wavelengths, and the instrument software interprets the change in fluorescence to determine whether the target DNA is present.

When the organism is present, a fragment of B. anthracis DNA is amplified using specific primers. The amplicon is detected by fluorescence using a specific hydrolysis probe. The hydrolysis probe contains a short oligonucleotide that hybridizes to an internal sequence of the amplified fragment during the annealing phase of the PCR cycle. This probe has the 5' and 3' ends labeled with a reporter dye and a quenching dye, respectively. When the probe hybridizes to the specific DNA target, the Taq polymerase enzyme, replicating the target-specific DNA, hydrolyzes the probe, which separates the two fluorophores, thus allowing the reporter dye to fluoresce.

The level of fluorescence from each unknown sample and control is measured by the JBAIDS instrument. JBAIDS Software analyzes fluorescence amplification curves and reports results as "Positive," "Negative," "Inhibited," or "Uncertain." A failure of the Positive or Negative Control will result in the entire run being called "Invalid." Failure of the Inhibition Control yields an Inhibited result for the associated sample and requires retesting of that sample.

The JBAIDS Anthrax Detection System is a real-time PCR test system intended for the qualitative in vitro diagnostic (IVD) detection of target DNA sequences on the pXO1 plasmid (Target 1) and the pXO2 plasmid (Target 2) from Bacillus anthracis.

1. Acceptance Criteria and Reported Device Performance:

The provided document describes a method comparison and carry-over study rather than specific acceptance criteria thresholds with a pass/fail outcome. The studies aim to demonstrate equivalence between a new sample purification kit (IT 1-2-3 QFLOWdna) and an existing one (IT 1-2-3 FLOW).

2. Sample Sizes and Data Provenance:

• Method Comparison - Spiked Samples: 6 citrated whole blood samples spiked with B. anthracis at the Limit of Detection (LOD).
• Method Comparison - Negative Samples: 16 normal healthy donors (citrated whole blood samples).
• Carry-over Study:
  • Strongly positive samples (spiked at 5 x 10" CFU/mL) processed next to negative (unspiked) samples.
  • QFLOW™ protocol: 42 negative capillaries were assessed for carry-over.
  • IT 1-2-3 FLOW protocol: 12 negative capillaries were assessed for carry-over.
• Data Provenance: Not explicitly stated (e.g., country of origin). The studies appear to be prospective as they were specifically performed to evaluate the new sample purification kit.

3. Number of Experts and Qualifications for Ground Truth: No information provided. This is a molecular diagnostic test, and ground truth would typically be established based on the known spiked concentration of B. anthracis or confirmed negative status of healthy donor samples, rather than expert interpretation of images or clinical data.

4. Adjudication Method: Not applicable. For this type of molecular test, objective results (positive/negative/inhibited) are generated by the instrument based on fluorescence curves and software analysis, not human interpretation requiring adjudication.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study: No. This is not an imaging device or one that relies on human interpretation for diagnosis; therefore, an MRMC study comparing human readers with and without AI assistance is not applicable.

6. Standalone Performance: Yes, the device's performance results (detection of B. anthracis DNA, specificity in negative samples, carry-over rate) are reported for the algorithm (JBAIDS Anthrax Detection System) based on its analysis of samples. The system reports "Positive," "Negative," "Inhibited," or "Uncertain" results without human intervention in the interpretation of the raw data.

7. Type of Ground Truth Used:

• For the method comparison using spiked samples: The ground truth was based on the known presence of B. anthracis DNA at a defined concentration (LOD).
• For the method comparison using healthy donor samples: The ground truth was the known absence of B. anthracis DNA in these healthy individuals.
• For the carry-over study: The ground truth for positive samples was their known high concentration of B. anthracis, and for negative samples, it was the known absence of B. anthracis.

8. Sample Size for the Training Set: Not specified. This document describes performance validation for a specific modification (new sample purification kit) rather than the initial development and training of the PCR assay's core algorithms. PCR assays are typically developed based on laboratory experiments to define primer/probe specificity and amplification efficiency, rather than machine learning on a "training set" in the traditional sense.

9. How the Ground Truth for the Training Set Was Established: Not specified. As mentioned above, for a PCR assay, "training" involves optimizing molecular biology parameters, and ground truth is based on known biological characteristics of the target organism and non-target organisms.

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The ETI-MAX 3000™ is a fully automated microtiter plate analyzer designed to perform the complete sample processing of qualitative and semi-quantitative assays with respect to (sample dilutions, sample and reagent dispensing, incubations, wash processes, plate transports) as well as the photometric measurement and evaluation. The qualitative and semi-quantitative performance of the ETI-MAX 3000 ™ instrument were assessed using the DiaSorin ANAScreen ELISA kit, the DiaSorin Anti-SS-A (Ro) ELISA kit and the EuroDiagnostica AB ENA Single Well Screen Kit.

The ETI- MAX 3000™ is a fully automated, microtiter plate laboratory analyzer performing the complete sample processing (barcode scanner, predilution station, pipetting station, plate transport, wash station, incubators and photometric measurement). The instrument is controlled by the Windows PC software ETI- MAX 3000™. This software allows the user to process the pre-defined assays of DiaSorin.

Here's a breakdown of the acceptance criteria and study information for the DiaSorin ETI-MAX 3000™ Automated Laboratory Analyzer, based on the provided text:

Acceptance Criteria and Device Performance

The acceptance criteria for the DiaSorin ETI-MAX 3000™ are implicitly defined by the demonstration of equivalent performance to manual methods for various analytical parameters of previously cleared immunology assays. The performance metrics reported are specific to analytical sensitivity, linearity, reproducibility/precision, carry-over, and method comparison/correlation.

Study Details

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

   • Reproducibility/Precision: 8 frozen repository serum samples were tested with 4 replicates per run over 5 days, at 3 different sites, using 3 different instruments. This means for each site, per sample, there were 20 individual results (4 reps/day * 5 days). The total number of measurements for precision is (8 samples * 20 measurements/sample * 3 sites) = 480 measurements per assay. The text indicates "N" could be 20 per site per sample.
   • Method Comparison/Correlation: 159 retrospective samples per assay were used.
   • Data Provenance:
     • Precision: The coded panel was prepared at DiaSorin (Stillwater, MN, USA), and testing was conducted at two external US laboratories and at DiaSorin Inc in Stillwater, MN. This indicates US-based data.
     • Method Comparison: "Retrospective samples (w/clinical history)" were used. The country of origin is not specified, but given DiaSorin is based in Minnesota, it is likely US-based or at least North American.

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

   • The ground truth for all performance evaluations (linearity, reproducibility, carry-over, and method comparison) was established by the "manual method" of the three FDA previously cleared immunology assays. The study design does not involve human experts establishing ground truth for the samples themselves. Instead, the manual method serves as the reference standard against which the automated device's performance is compared.

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

   • Not applicable. This device is an automated laboratory analyzer, and its performance is compared to a manual laboratory method, not interpreted by human readers requiring adjudication.

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

   • No MRMC study was done, as this is an automated analyzer, not an AI-assisted diagnostic tool that relies on human interpretation improving with AI. The comparison is between an automated system and a manual laboratory process.

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

   • Yes, the performance study is primarily a standalone evaluation of the DiaSorin ETI-MAX 3000™ automated system compared to manual methods. There is no human-in-the-loop aspect described; the device performs the assay steps and provides quantitative/qualitative results directly.

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

   • The ground truth used for comparison was the results obtained from the manual method of the FDA-previously cleared immunology assays. This acts as the "reference standard" for evaluating the automated system. The samples themselves were "frozen repository serum samples" or "retrospective samples (w/clinical history)."

7. The sample size for the training set:

   • The document does not describe a "training set" in the context of machine learning or AI. This device is an automated instrument, not a learning algorithm. Its operation is based on pre-programmed protocols for known assays, not trained data.

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

   • Not applicable, as there is no training set in the context of machine learning/AI for this device. The device's functionality is based on its mechanical and software design to execute laboratory protocols.

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The JBAIDS Anthrax Detection System is a real-time polymerase chain reaction (PCR) test system intended for the qualitative in vitro diagnostic (IVD) detection of target DNA sequences on the pXO1 plasmid (Target 1) and the pXO2 plasmid (Target 2) from Bacillus anthracis. The system can be used to test human whole blood collected in sodium citrate from individuals suspected of having anthrax, positive blood cultures, and cultured organisms grown on blood agar plates. The JBAIDS Anthrax Target 2 assay is used as a supplementary test only after a positive result with the Target 1 Assay.
The JBAIDS Anthrax Target 1 and Target 2 Assays are run on the JBAIDS instrument using the Diagnostic Wizard.
Results are for the presumptive identification of B. anthracis, in conjunction with culture and other laboratory tests. The following considerations also apply:

• The diagnosis of anthrax infection must be made based on history, signs, symptoms, exposure likelihood, other laboratory evidence, in addition to the identification of pXO1 and pXO2 targets either from cultures or from direct blood specimens.
• The assays have not been evaluated with blood from individuals without clinical signs or symptoms who were presumed exposed and who subsequently developed anthrax (inhalation or other forms of the disease), or from individuals with any form of anthrax (inhalational, cutaneous, or gastrointestinal).
• The level of plasmid targets that would be present in blood from individuals with early systemic infection is unknown.
• The definitive identification of B. anthracis from colony growth, liquid blood culture growth, or from blood specimens requires additional testing and confirmation procedures in consultation with public health or other authorities for whom reports are required.
  The safety and effectiveness of other types of tests or sample types (not identified as "For in vitro diagnostic use") have not been established.

The Joint Biological Agent Identification and Diagnostic System (JBAIDS) Device Anthrax Detection System is a fully integrated in-vitro diagnostic (IVD) system composed of the JBAIDS instrument with laptop computer, software, 2 different freeze-dried reagent assays (in one kit) for the qualitative detection of pathogenic Bacillus anthracis, and 3 different sample preparation protocols for isolating target DNA from whole blood, blood culture, or direct culture.
The JBAIDS instrument, using Polymerase Chain Reaction (PCR) technology, is a portable thermocycler and real-time fluorimeter. The JBAIDS Anthrax Detection Kit is specially designed for PCR in glass capillaries using the JBAIDS instrument and hydrolysis probes for detection of the pXO1 plasmid (Target 1) and the pXO2 plasmid (Target 2) DNA sequences. A fragment of plasmid DNA is amplified using specific primers, creating amplicon. The amplicon is detected using a specific hydrolysis probe, which is a short oligonucleotide that hybridizes to an internal sequence of the amplified fragment during the annealing phase of the PCR cycle. This probe has the 5' and 3' ends labeled with a reporter dye and a quenching dye, respectively. When the probe hybridizes to the specific DNA target, the Taq polymerase enzyme replicating the target-specific DNA hydrolyzes the probe, separating the two fluorophores, thus allowing the reporter dye to fluoresce.
The reagent kit contains 4 different types of freeze-dried reagent vials: Positive Controls, Negative Controls, Inhibition Controls, and Unknowns (used for testing the patient sample). Each JBAIDS run requires a Positive and Negative Control, and each sample is tested using both an Inhibition Control vial and an Unknown reagent vial. The characteristics of the amplification curves from the positive control (PC), negative control (NC), inhibition controls (IC) and from each unknown sample are analyzed by the JBAIDS Software, and results are reported as Positive. Negative, Inhibited or Uncertain. When PCs or NCs are unacceptable, the test results for all samples in the JBAIDS run are considered invalid and must be repeated.
Prior to testing, whole-blood samples are purified using the Idaho Technology IT 1-2-37M FLOW Sample Purification Kit (or validated equivalent), while blood culture and direct culture specimens are prepared using the IT 1-2-31M SWIPE Sample Purification Kit (or validated equivalent). The resulting purified sample is added to an Unknown reagent vial and an Inhibition Control reagent vial, along with reconstitution buffer.

Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:

JBAIDS Anthrax Detection System Acceptance Criteria and Study Details

1. Table of Acceptance Criteria and Reported Device Performance

The provided document does not explicitly state formal "acceptance criteria" with numerical thresholds for sensitivity and specificity in a table format for the JBAIDS Anthrax Detection System. Instead, it describes performance characteristics that demonstrate substantial equivalence to a predicate device and good analytical and clinical performance. The closest interpretation of acceptance criteria would be that the device needs to achieve high sensitivity and specificity in detecting B. anthracis targets, similar to or exceeding the predicate method.

Here's a summary of the stated performance:

• Direct Culture Panel: 23/23 (100%) detected
• Blood Culture Panel: 11/11 (100%) detected
• Whole Blood Spiked Samples: 67/68 (98.5%) detected (at limit of detection levels) |
  | Analytical Specificity: | No cross-reactivity with non-B. anthracis organisms |
• Direct Culture Panel: 34/37 (91.9%) negative for non-B. anthracis strains
• Blood Culture Panel: 12/12 (100%) negative for non-B. anthracis strains
• Note: Cross-reacted with 3 virulent B. cereus strains known to cause anthrax-like illness. |
  | Clinical Specificity: | No false positives in samples from individuals suspected of anthrax (but without confirmed anthrax) | 150/150 (100%) negative in blood samples from hospitalized subjects (95% CI, 98%-100%) |
  | Equivalence to Predicate (CDC Gamma Phage Lysis Assay): | As effective as predicate, with additional benefits | "As effective as the predicate assay," "easier to use," "highly sensitive and specific." |

2. Sample Sizes and Data Provenance

The provided document indicates the following sample sizes and data provenance:

• Test Set (Analytical Studies):

  • Direct Culture Panel: 23 virulent B. anthracis strains (positive detection) + 37 non-B. anthracis strains (negative detection) = 60 samples.
  • Blood Culture Panel: 11 virulent B. anthracis strains (positive detection) + 12 non-B. anthracis strains (negative detection) = 23 samples.
  • Whole Blood Spiked Samples: 68 samples spiked with limit of detection levels of live B. anthracis.
  • Data Provenance: The document does not explicitly state the country of origin. It refers to "virulent strains of B. anthracis tested" and "non-B. anthracis strains." Given the context of CDC involvement and FDA submission, it's highly likely these were laboratory-controlled samples and reference strains, possibly from a national or international repository, and not necessarily patient data from a specific country. This appears to be retrospective testing of characterized samples.

• Test Set (Clinical Specificity Study):

  • Sample Size: 150 blood samples.
  • Data Provenance: "Blood samples from hospitalized subjects with clinical signs and symptoms consistent with inhalation or systemic anthrax and for whom a blood culture had been ordered." This indicates a prospective data collection from a clinical setting, presumably within the US. The document does not specify the exact location(s).

3. Number of Experts and Qualifications for Ground Truth

The document does not explicitly state the number of experts used or their specific qualifications (e.g., "radiologist with 10 years of experience") for establishing ground truth in a systematic way for the test set.

However, for the predicate device and confirmation methods:

• Predicate Method: The predicate for the JBAIDS Anthrax Detection Kit is "traditional microbiological identification of the organism (preamendment methods) with confirmation by the Centers for Disease Control Laboratory Response Network Gamma Phage Lysis assay." This implies that the ground truth for B. anthracis identification was established by microbiologists and experts within the CDC's Laboratory Response Network, following standard microbiological identification criteria and the gamma phage lysis assay procedure.
• Confirmation for Analytical Studies: For the direct culture and blood culture panels, "all of the samples were confirmed as B. anthracis using standard biochemical identification and tested positive using the CDC Reference Laboratory Procedure for Identification of B. anthracis Using Lysis by Gamma Phage." This again points to verification by microbiology experts using established CDC protocols.

4. Adjudication Method for the Test Set

The document does not describe an explicit adjudication method (e.g., 2+1, 3+1). The ground truth for the analytical studies was established by standard biochemical identification and the CDC Reference Laboratory Procedure for Identification of B. anthracis Using Lysis by Gamma Phage, which are definitive laboratory methods rather than subjective expert consensus requiring adjudication.

For the clinical specificity study, the ground truth for ruling out anthrax was "not identified in any of the blood cultures." This implies a definitive laboratory result rather than a consensus decision requiring adjudication.

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

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. The JBAIDS Anthrax Detection System is an in-vitro diagnostic (IVD) PCR system that provides an automated result (Positive, Negative, Inhibited, Uncertain). It's an algorithm-only device without a human-in-the-loop component in its primary function, thus improvements in human reader performance with or without AI assistance are not applicable.

6. Standalone (Algorithm Only) Performance

Yes, a standalone (algorithm only) performance study was done for the JBAIDS Anthrax Detection System. The device itself is an automated system that uses PCR technology to detect specific DNA sequences and its software then analyzes the amplification curves and reports results as Positive, Negative, Inhibited, or Uncertain (as described in the "Description" section).

The performance metrics reported (sensitivity, specificity, detection rates for various samples) are directly from the JBAIDS system's automated output.

7. Type of Ground Truth Used

The ground truth used was:

• Microbiological Identification/Pathology: For the analytical studies, ground truth for B. anthracis presence was established by "standard biochemical identification and ... the CDC Reference Laboratory Procedure for Identification of B. anthracis Using Lysis by Gamma Phage." For non-B. anthracis strains, their identification as non-anthrax was also based on standard microbiological characterization.
• Outcomes Data (Indirect/Surrogate): For the clinical specificity study, the ground truth for the absence of anthrax was based on "blood cultures" being negative for B. anthracis. This serves as a clinical outcome surrogate to confirm the absence of the infection in symptomatic patients.

8. Sample Size for the Training Set

The document does not specify the sample size for a training set. This is common for PCR-based IVD systems, where the "training" (development and optimization) often relies on well-characterized laboratory strains and known genetic sequences rather than a distinct "training set" in the machine learning sense. The device is designed to detect known specific DNA sequences rather than learn patterns from a broad dataset.

9. How Ground Truth for the Training Set Was Established

As no specific "training set" is mentioned, the method for establishing ground truth for training data is not provided. However, the development of the assays (e.g., designing primers and probes for pXO1 and pXO2) would rely on the established genomic sequences of B. anthracis, confirmed by techniques such as genomic sequencing, traditional microbiological identification, and confirmed virulence studies from expert laboratories like the CDC. The document highlights that the targets (pXO1 and pXO2 plasmids) are "essential for the organism's pathogenicity," implicitly referencing well-established biological facts about B. anthracis.

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The LightCycler Instrument is a fully automated amplification and detection system for nucleic acids using fluorescence detection. The LightCycler is intended to be used by laboratory professionals trained in laboratory techniques and on the use of the analyzer.

The LightCycler Instrument consists of a microvolume fluorimeter integrated with a thermal cycler. It combines rapid-cycler PCR in glass capillaries heated with hot-air with real-time fluorescence monitoring. The system is designed to reduce the time needed to achieve results from PCR and to enable the user to monitor the amplification of the PCR product simultaneously, in real-time and on-line.

The provided text is a 510(k) summary for the LightCycler Instrument Version 1.2, which is an automated analyzer for nucleic acid amplification and detection. The core purpose of this document is to demonstrate "substantial equivalence" to a predicate device, the COBAS TaqMan Analyzer (K012966), rather than to present a study proving the device meets specific acceptance criteria through performance metrics.

Therefore, many of the requested categories (acceptance criteria, reported device performance, sample size for test set, data provenance, number of experts, adjudication method, MRMC study, standalone study, type of ground truth, sample size for training set, and how ground truth was established for the training set) are not applicable or not explicitly detailed in this 510(k) summary.

The document primarily focuses on comparing the features and intended use of the LightCycler Instrument to its predicate device to argue for substantial equivalence. It does not contain information about a prospective study with specific acceptance criteria and performance data for the LightCycler Instrument Version 1.2.

However, based on the provided text, here's what can be extracted:

1. A table of acceptance criteria and the reported device performance:
   • Acceptance Criteria: Not explicitly stated as pass/fail criteria for a new study. The acceptance is based on demonstrating "substantial equivalence" to the predicate device.
   • Reported Device Performance: While not acceptance criteria in the traditional sense of a performance study, the document reports technical specifications for the LightCycler Instrument that are compared to the predicate.

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

   • Not applicable/Not provided. The document describes the device and compares its technical specifications to a predicate, but does not detail a specific performance study with a test set of samples.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):

   • Not applicable/Not provided. No human-expert-based ground truth establishment is mentioned as this is a device for nucleic acid analysis, not an imaging or diagnostic interpretation device.

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

   • Not applicable/Not provided.

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 fully automated instrument for nucleic acid amplification and detection. It is not an AI-assisted diagnostic tool that aids human readers, and therefore, an MRMC study is not relevant here.

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

   • The document describes the LightCycler Instrument as a "fully automated amplification and detection system," implying it operates in a standalone manner. However, no specific standalone performance study with detailed methodology and results is presented in this 510(k) summary; rather, its operational specifications are presented for comparison.

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

   • Not applicable/Not provided. For a device like this, the "ground truth" would typically refer to the known presence or absence of specific nucleic acid targets based on validated reference methods. This 510(k) summary does not contain details of such a validation study.

8. The sample size for the training set:

   • Not applicable/Not provided. This document describes a physical instrument, not a machine learning algorithm that requires a training set.

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

   • Not applicable/Not provided.

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The Precision Systems™ ANALETTE™ Chemistry Analyzer is intended for the quantitative determination of Calcium, Creatinine, Phosphorus, Albumin, Total Protein, Glucose, Urea Nitrogen, Magnesium, Creatine Kinase, Alkaline Phosphatase, Cholesterol(includes HDL), Triglycerides, Total Bilirubin, Direct Bilirubin, Uric Acid, Lactate Dehydrogenase L, Alanine Aminotransferase, Aspartate Aminotransferase, Gamma Glutamyl Transferase, Chloride, and etc. analytes in solution such as serum, plasma, or urine. It is an "open" System, which can use a variety of commercially manufactured reagents such as but not limited to Synermeds® Reagents, Medical Analysis Systems Reagents and STANBIO Laboratory Reagents. It is used to monitor various physiological diseases or conditions. Precision Systems Inc will distribute, recommend and sales STANBIO Reagents without any modification of STANBIO packaging using PSI Applications sheets.

The ANALETTE™ Chemistry Analyzer is an in vitro diagnostic automated clinical chemistry analyzer for the analysis of analytes in solution. It is an "open" System, which can use a variety of commercially manufactured reagents.

The document describes the acceptance criteria and the study conducted to demonstrate the substantial equivalence of the Precision Systems™ ANALETTE™ Chemistry Analyzer using STANBIO Laboratory Reagents to its predicate devices (ANALETTE™ using Synermed® Reagents and ANALETTE™ using Medical Analysis Systems Inc® Reagents).

Here's an analysis based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

The document explicitly states: "Performance specifications: None established under Section 514." Instead, it refers to "Acceptance Criteria" (Exhibit E and F) but does not detail the specific numerical acceptance criteria within the provided text.

However, the "Results" section (G.) provides the reported performance relative to "acceptable/equivalent results" or "Manufacturers' claim."

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

• Imprecision: Two control serums were used for both within-run and total precision.
  • Within-run: Up to 20 repeats.
  • Total precision: Duplicates for up to 20 days.
• Correlation: "about 100 serums" were used.
• Linearity: "Commercially available linearity material" was assayed.
• Recovery: "Commercial available Controls with assigned values" were used.

Data Provenance: The document does not specify the country of origin for the data or explicitly state if it was retrospective or prospective. However, the nature of the tests (using control serums, commercial linearity material, and patient serums for correlation by assaying them) suggests it was a prospective study conducted for the purpose of this 510(k) submission.

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. The "ground truth" for the test set appears to be established by comparing the performance of the STANBIO Laboratory Reagents on the ANALETTE™ to the performance of predicate reagents (Synermed® and Medical Analysis Systems Inc® Reagents) on the same ANALETTE™ or to manufacturer's claims for linearity and recovery. This is a comparison study, not a ground truthing exercise with independent experts reviewing clinical cases.

4. Adjudication Method for the Test Set:

This information is not applicable as the study described is a laboratory performance study comparing reagent efficacy, not a human reader or image-based diagnostic study requiring adjudication. The performance is assessed against established laboratory methods or manufacturer claims for the predicate reagents.

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 as the device is a chemistry analyzer and reagents, not an AI-assisted diagnostic tool for human readers. No MRMC study was conducted.

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

This is an algorithm-only (standalone) performance study in the sense that it evaluates the analytical performance of the ANALETTE™ Chemistry Analyzer with STANBIO reagents. The purpose is to demonstrate that the device produces accurate measurement results independently. Human intervention is limited to operating the analyzer and interpreting the numerical output.

7. The Type of Ground Truth Used:

The "ground truth" in this context is established by:

• Comparison to Predicate Devices/Reagents: For imprecision and correlation, the performance of the STANBIO reagents is compared to the performance of legally marketed Synermed® and Medical Analysis Systems Inc® reagents on the ANALETTE™ device (which effectively act as the reference standard).
• Manufacturer's Claims/Expected Values: For linearity and recovery, the results are compared against the manufacturer's claims for the reagents or assigned values for commercial controls.

This is therefore a form of comparative analytical performance against established and accepted methods/claims, rather than clinical outcomes or pathology reports.

8. The Sample Size for the Training Set:

This information is not applicable as the ANALETTE™ is a chemistry analyzer, not a machine learning or AI-based device that requires a "training set" in the conventional sense. The "training" for such a system would involve instrument calibration and quality control procedures, which are standard for laboratory devices.

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

This information is not applicable for the reasons stated above (not an AI/ML device requiring a training set with established ground truth).

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The COBAS TaqMan Analyzer is a fully automated amplification and detection system for nucleic acids using 5' nuclease technology. The COBAS TaqMan Analyzer is intended to be used by laboratory professionals trained in laboratory techniques and on the use of the analyzer.

The COBAS TaqMan Analyzer is a flexible, automated batch analyzer that automates the real-time kinetic amplification and detection steps of the Polymerase Chain Reaction (PCR) process. The COBAS TaqMan Analyzer combines the operations of automated handling of reaction tubes (K-Tubes), thermal cycling, controlled temperature incubation, real-time photometric detection at each cycle and result reporting into a single automated analyzer. The instrument consists of four major sub-components: (1) a thermal cycler module; (2) a robotic transfer unit; (3) a photometer module and (4) a workstation, which together with an on-board real-time processor controls and monitors the major components including system and run control, results calculation, and system diagnostic tests and provides the user interface.

Here's an analysis of the COBAS TaqMan™ Analyzer based on the provided 510(k) summary, aiming to address your specific questions about acceptance criteria and study details.

Important Note: The provided document is a 510(k) summary for a device (the analyzer itself), not a specific assay that runs on the analyzer. Therefore, the acceptance criteria and performance data presented are for the instrument's capabilities as a whole, often in comparison to a predicate instrument, rather than clinical performance metrics (like diagnostic sensitivity/specificity for a disease). Clinical performance metrics would typically be found in the 510(k) for the specific assays validated for use on the analyzer.

Acceptance Criteria and Reported Device Performance

1. Table of Acceptance Criteria and Reported Device Performance:

Explanation of 'Implied' Performance: For a 510(k) for an instrument, the "acceptance criteria" are generally that the new device performs as well as or better than the legally marketed predicate device for the functions it performs. The document states that the COBAS TaqMan Analyzer was "substantially equivalent to the COBAS AMPLICOR Analyzer in all non-clinical performance studies." Where specific improvements are noted (e.g., dynamic range, sensitivity, specificity), these indicate that the new device exceeded the predicate's performance, which is also an acceptable outcome for equivalence.

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

• Sample Size for Test Set:
  • For specificity, 96 EIA sero-negative specimens were initially tested, with 3 subsequently retested, resulting in a final count of 94 for the recalculated specificity.
  • No other specific sample sizes are provided for linearity, dynamic range, precision, carryover, or correlation studies. These are described in a general comparative sense.
• Data Provenance: Not explicitly stated (e.g., country of origin). The studies are described as "non-clinical performance studies." It's not specified if they were retrospective or prospective, but given they are performance evaluations of an instrument, they would typically involve prospective testing of prepared samples.

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

• This information is not provided in the summary. For an instrument 510(k), experts typically wouldn't establish "ground truth" in the same way they would for a diagnostic assay's clinical performance study. The ground truth for instrument performance (e.g., linearity, precision) would be based on known concentrations of analytes in controls or characterized samples. For the specificity evaluation, the "EIA sero-negative specimens" served as a reference, and the "manual HCV AMPLICOR Test" was used for retesting and confirmation.

4. Adjudication Method:

• Not applicable/Not described in the context of this instrument performance study. Adjudication methods (like 2+1 or 3+1) are typically used in clinical studies where multiple human readers interpret results, and disagreement needs a resolution mechanism. Here, the instrument's performance is being evaluated against known standards or a predicate device. The retesting of three samples for specificity could be considered a form of "adjudication" or re-evaluation to refine the ground truth for those specific cases.

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

• No, an MRMC study was not done. This type of study focuses on human reader performance, often with or without AI assistance, which is not relevant for the evaluation of this automated instrument.

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

• Yes, a standalone performance study was done. The entire "Non-Clinical Performance" section (Section 7.1) describes the standalone performance of the COBAS TaqMan Analyzer. The analyzer is described as "fully automated" and provides "interpretative qualitative or quantitative result" without direct human intervention once samples are loaded. The entire evaluation compares "the analyzer comparing it to the predicate device (COBAS AMPLICOR Analyzer)."

7. Type of Ground Truth Used:

• The ground truth varied depending on the performance metric:
  • Linearity, Dynamic Range, Precision: Likely based on known concentrations of control materials or highly characterized samples.
  • Sensitivity (Lower Limit of Quantitation): Determined by testing serially diluted samples with known analyte concentrations.
  • Specificity: Initially referenced against EIA serology results ("EIA sero-negative specimens"). For discrepant results (TaqMan positive/EIA negative), a manual HCV AMPLICOR Test was used as a confirmatory "ground truth."
  • Correlation: Comparison against the COBAS AMPLICOR Analyzer's results on the same samples.

8. Sample Size for the Training Set:

• Not applicable/Not provided. This device is a molecular diagnostic instrument, not an AI/machine learning algorithm that requires a separate "training set" in the conventional sense. Its "training" is in its engineering and calibration. If it contained internal algorithms, those would be part of the instrument's design and fixed, not adjusted via a training set.

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

• Not applicable. As stated above, there is no "training set" in the context of this device.

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The CARESIDE Analyzer is an in vitro diagnostic instrument intended for the measurement of various clinical chemistry analytes in human whole blood, plasma, or serum. For in vitro diagnostic use. For point of care use.

The CARESIDE Analyzer is a compact chemistry instrument that performs multiple discrete analyses on human whole blood, plasma, or serum samples. The CARESDIDE Analyzer is semi-automated: the only operator steps are the addition of the sample to the test cartridge and the insertion of the dosed cartridge into the instrument. The CARESIDE Analyzer automatically warms, separates, meters, dispenses, and incubates the sample before reading the signal and calculating results. The CARESIDE Analyzer is intended only for use with CARESIDE test cartridges. The instrument is controlled through a touch-screen interface. Results are displayed on the interface screen. Results can also be downloaded on to a 3-1/2 inch diskette or to a computer via a RS-232 port. The CARESIDE Analyzer accepts up to 6 test cartridges from a single patient at the same time.

The provided text describes the CARESIDE™ Analyzer, an in vitro diagnostic instrument for measuring clinical chemistry analytes. The document focuses on establishing substantial equivalence to predicate devices for regulatory clearance (510(k)), rather than presenting a detailed study proving performance against explicit acceptance criteria.

However, based on the information provided, we can infer the approach taken for performance evaluation and how "acceptance criteria" are implied through comparison with a predicate device.

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly list quantitative acceptance criteria in the format requested (e.g., "Accuracy must be within X% of reference method"). Instead, it relies on demonstrating substantial equivalence to an existing legally marketed predicate device (the Vitros DT 60/DTSC/DTE II Module and their own previously cleared CARESIDE Analyzer for lab use).

For each analyte the CARESIDE Analyzer measures, its performance would have been compared to the predicate device. The general "acceptance criteria" for regulatory clearance in this context are that the new device's performance is equivalent or better than the predicate device for its intended use, without raising new questions of safety or effectiveness.

While specific percentage differences or statistical thresholds are not given in this summary, the "Comparative Performance Characteristics" section states: "The clinical data provided demonstrate that the CARESIDE Analyzer... performs equivalently or better than the other legally marketed predicate device." This implies that for each analyte, the observed agreement, correlation, bias, and precision met the FDA's criteria for substantial equivalence when compared to existing devices.

To illustrate how such a table would be structured if explicit criteria were available, and how the performance statement translates, let's use a hypothetical example for a single analyte (e.g., Glucose) and infer the comparison:

The document points out that details for each individual test's 510(k) submission would contain the specific performance data ("see individual test 510k submissions").

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

The provided 510(k) summary does not specify the sample size for the test set or the data provenance (e.g., country of origin, retrospective/prospective). It generally refers to "clinical data provided" without further detail. This information would typically be found in the specific validation studies submitted with each individual test cartridge's 510(k).

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

Given that this is a clinical chemistry analyzer, the "ground truth" for the test set would typically be established by comparison to a recognized reference method or a predicate device, as opposed to expert consensus on images or clinical assessments. Therefore, the concept of "number of experts" and "qualifications of those experts" for establishing ground truth is not directly applicable in the same way it would be for, say, an AI-powered diagnostic imaging device.

For a clinical chemistry analyzer, consistency and agreement with a predicate device or a gold standard laboratory method are the primary measures of ground truth. The "experts" involved would be clinical chemists, laboratory scientists, or medical technologists who perform the reference measurements and analyze the results. Their qualifications would include relevant certifications and experience in clinical laboratory testing.

4. Adjudication Method for the Test Set

As the ground truth is established by quantitative comparison to reference methods or a predicate device, an "adjudication method" in the sense of a committee resolving disagreements (e.g., 2+1, 3+1) is not typically used for clinical chemistry results. The differences between the new device and the reference/predicate would be analyzed statistically to determine agreement, bias, and correlation.

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

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not conducted. MRMC studies are typically used to evaluate the impact of a diagnostic aid (e.g., an AI algorithm) on human reader performance, particularly in fields like radiology or pathology where human interpretation is central. The CARESIDE Analyzer is a standalone instrument that provides quantitative measurements, not an aid designed to improve human reader performance in interpreting complex data.

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

Yes, the information provided describes the performance of the CARESIDE Analyzer as a standalone device. The instrument performs the measurement and calculation of results directly from the sample without human interpretation of raw signals. The comparison in the submission (as inferred) is between the measurements obtained by the CARESIDE Analyzer and those obtained by predicate devices or reference methods.

7. The Type of Ground Truth Used

The ground truth used for validating the CARESIDE Analyzer's performance would primarily be:

• Reference Methods: Measurements obtained from established, accurate laboratory methods (e.g., spectrophotometry, chromatography, highly accurate ion-selective electrodes) in a qualified clinical laboratory.
• Predicate Device Data: Performance data obtained from the legally marketed predicate device (Vitros DT 60/DTSC/DTE II Module and the CARESIDE Analyzer for lab use) on the same samples.

The document states that the individual test (analyte) cartridges were subject to separate 510(k) submissions, and those submissions would contain the detailed ground truth information for each specific analyte.

8. The Sample Size for the Training Set

The document does not specify the sample size for the training set. The CARESIDE Analyzer is factory-calibrated, and lot-specific calibration coefficients are provided via barcodes on the cartridges. This implies that extensive calibration and characterization data (which could be considered a form of "training data" for the internal algorithms/calibration curves) were collected by the manufacturer during development and manufacturing. However, the exact sample sizes for this internal development and calibration are not disclosed in this regulatory summary.

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

The ground truth for establishing the factory calibration (which is analogous to the "training set" for the device's inherent algorithms) would typically involve:

• Certified Reference Materials (CRMs) or Standard Solutions: Samples with known, highly accurate concentrations of analytes.
• Split Sample Analysis: Running samples on both the CARESIDE system and established reference methods (or predicate devices) in a robust laboratory setting to generate the dose-response curves and calibration coefficients.
• Statistical Modeling: Using the data from CRMs and split samples to derive the polynomial equations that convert raw reflectance/potentiometry signals into analyte concentrations.

The document mentions that "The observed reflectance (ODr) is adjusted by inputting it into the equation. The patient result is calculated from the adjusted ODr using the polynomial describing the master dose - response curve." This "master dose-response curve" and its associated polynomial are derived from this extensive calibration process using samples with established ground truth. This process ensures the instrument correctly interprets its raw signals into clinically meaningful concentrations across its analytical measuring range.

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CARESIDE LYTESTM For in vitro diagnostic use with the CARESIDE Analyzer™ to measure sodium, potassium and chloride ion concentrations using anti-coagulated whole blood, plasma or serum specimens to aid in the diagnosis and treatment of patients with electrolyte imbalance.

CARESIDE Analyzer™ For in vitro diagnostic use by laboratory professionals. Used in conjunction with reagent cartridges to duplicate manual analytical procedures in order to measure a variety of analytes.

The CARESIDE LYTES™, a single-use disposable in vitro diagnostic test cartridge, is used with the CARESIDE Analyzer™ to perform a simultaneous quantitative measurement of sodium, potassium and chloride ion concentrations from a single sample of anti-coagulated whole blood, plasma or serum. Each cartridge has a test element containing sodium-, potassium-, and chloride-selective electrodes. The CARESIDE LYTESTM test cartridge aids in specimen separation and delivers a measured volume of plasma or serum to the electrochemistry to initiate the measurement of sodium, potassium and chloride ion concentrations. The cartridge (patent pending) contains all reagents necessary to measure the concentration of sodium, potassium and chloride ions.

Here's a summary of the acceptance criteria and study findings for the CARESIDE LYTES™ device, based on the provided document:

CARESIDE LYTES™ Device Performance and Acceptance Criteria

The CARESIDE LYTES™ device, used with the CARESIDE Analyzer™, measures sodium, potassium, and chloride ion concentrations. The acceptance criteria are largely implied by the comparative performance characteristics against a legally marketed predicate device (Vitros Na+, K+, Cl- DT Slides and Vitros DT 60 II / DTE II). The study demonstrates that the CARESIDE LYTES™ performs "as well as or better than" the predicate device, indicating that performance comparable to or exceeding the predicate device's established levels constitutes acceptance.

1. Table of Acceptance Criteria and Reported Device Performance

Note: Acceptance criteria are inferred based on the predicate device's performance where direct criteria are not explicitly stated for the CARESIDE LYTES™ device. The submission aims to prove substantial equivalence, meaning performance should be comparable or better.

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

The document does not explicitly state the sample size used for the test set in terms of number of patient samples. It provides performance metrics like "Mean recovery", "Total CV" at specific concentrations, and "Method comparison" data (slope, intercept, and correlation coefficient r). This suggests a series of experiments were conducted.

The data provenance is not explicitly stated. However, given it's a 510(k) submission to the FDA, the data would typically originate from studies conducted under controlled laboratory conditions, likely in the US, and may involve both prospective lab-controlled samples and potentially retrospective clinical samples. The type of study presented here (method comparison, linearity, interference) is generally prospective laboratory testing.

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

This question is not applicable in the context of this device. The ground truth for chemical analytes like sodium, potassium, and chloride is established using recognized reference methods (e.g., Flame Photometry for Na/K, Coulometry for Cl) performed by qualified laboratory personnel, not by medical experts making diagnostic assessments. The document explicitly lists these reference methods.

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

This question is not applicable to this type of chemical analyzer validation. Adjudication methods are typically used in studies where subjective interpretation (e.g., image reading) requires consensus among experts. Here, the "ground truth" is determined by objective analytical measurements from established reference instruments.

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 question is not applicable. The CARESIDE LYTES™ is an in vitro diagnostic device for quantitative chemical analysis, not an AI or imaging device involving human readers or interpretation.

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

Yes, a standalone performance assessment was done. The reported performance characteristics (Detection limit, Reportable range, Accuracy, Precision, Method comparison, Linearity, Interference) all reflect the intrinsic analytical performance of the CARESIDE LYTES™ cartridge and CARESIDE Analyzer™ system without human interpretative intervention in the measurement result. The device automates the measurement process.

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

The ground truth for the performance studies was established using recognized reference methods:

• Sodium: Flame Photometry
• Potassium: Flame Photometry
• Chloride: Coulometry

8. The sample size for the training set

The document does not provide information on a "training set" in the context of machine learning or AI. This device is an analytical instrument based on established electrochemical principles, not a machine learning model that requires training data in the conventional sense. The development likely involved calibration and verification studies, but these are not typically referred to as "training sets" for this type of device.

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

This question is not applicable as there is no mention or indication of a "training set" for an AI or machine learning model in this submission. The device's functionality is based on established electrochemical principles and analytical validation.

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