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The ARCHITECT B R A H M S PCT assay is a chemiluminescent microparticle immunoassay (CMIA) for the quantitative determination of procalcitonin (PCT) in human serum and plasma (lithium heparin and K2EDTA) on the ARCHITECT iSystem.

Used in conjunction with other laboratory findings and clinical assessments, the ARCHITECT BR A-H-M-S PCT assay is intended for use as an:

· Aid in the risk assessment of critically ill patients on their first day of intensive care unit (ICU) admission for progression to severe sepsis and septic shock.

· Aid in assessing the cumulative 28-day risk of all-cause mortality for patients diagnosed with severe sepsis or septic shock in the ICU or when obtained in the emergency department or other medical wards prior to ICU admission, using a change in PCT level over time.

· Aid in decision making on antibiotic therapy for patients with suspected or confirmed lower respiratory tract infections (LRT) - defined as community-acquired pneumonia (CAP), acute bronchitis, and acute exacerbation of chronic obstructive pulmonary disease (AECOPD) - in an inpatient setting or an emergency department.

· Aid in decision making on antibiotic discontinuation for patients with suspected or confirmed sepsis.

The ARCHITECT B R A H M S PCT Calibrators are for the ARCHITECT iSystem when used for the quantitative determination of procalcitonin (PCT) in human serum and plasma (lithium heparin and K2EDTA). For in vitro diagnostic use only.

The ARCHITECT B-R-A-H-M-S PCT Controls are for the estimation of test precision and the detection of systematic analytical deviations of the ARCHITECT iSystem when used for the quantitative determination of procalcitonin (PCT) in human serum and plasma (lithium heparin and K2EDTA). For in vitro diagnostic use only.

The ARCHITECT B.R.A.H.M.S PCT assay reagents are available in 100 or 500 test kits. The kit components include PCT Microparticles coated with Rat monoclonal anti-PCT and PCT Conjugate with Mouse monoclonal anti-PCT acridinium-labeled conjugate. Both contain Bovine serum albumin and preservatives. The ARCHITECT B.R.A.H.M.S PCT Calibrators kit consists of 6 bottles, with Calibrator A containing normal human plasma and Calibrators B-F containing recombinant human PCT in phosphate buffer. The ARCHITECT B.R.A.H.M.S PCT Controls kit consists of 2 x 3 bottles at three target concentrations of recombinant PCT in phosphate buffer. The assay is a two-step immunoassay using chemiluminescent microparticle immunoassay (CMIA) technology.

The ARCHITECT B.R.A.H.M.S PCT assay is a chemiluminescent microparticle immunoassay (CMIA) for the quantitative determination of procalcitonin (PCT) in human serum and plasma (lithium heparin and K2EDTA) on the ARCHITECT iSystem. It is intended to aid in the risk assessment of critically ill patients for progression to severe sepsis and septic shock, aid in assessing the cumulative 28-day risk of all-cause mortality for patients diagnosed with severe sepsis or septic shock, and aid in decision-making on antibiotic therapy for patients with suspected or confirmed lower respiratory tract infections (LRTI) or sepsis.

Here's an analysis of the acceptance criteria and study proving the device meets these criteria:

1. Table of Acceptance Criteria and Reported Device Performance:

The document doesn't explicitly state "acceptance criteria" in a tabulated format for all performance characteristics. Instead, it describes validated performance characteristics. I will compile a table based on the provided performance summaries and their implied acceptance as suitable for the intended use.

• Low control: 2.5% to 2.8%
• Medium control: 2.1% to 2.5%
• High control: 3.5% to 3.8%
• Panel 1: 2.5%
• Panel 3: 2.1%
• Panel 5: 2.2% to 2.3% |
  | | Meets CLSI EP15-A3 guidelines for multi-site precision. | Multi-Site Precision:
• Within-laboratory %CVs (individual sites): 1.5% to 4.0% for concentrations > 0.1 ng/mL; SD ≤ 0.005 ng/mL for concentrations ≤ 0.1 ng/mL.
• Total precision %CVs (pooled data): 2.3% to 4.0% for concentrations > 0.1 ng/mL; SD ≤ 0.005 ng/mL for concentrations ≤ 0.1 ng/mL. |
  | Linearity/Assay Reportable Range | Meets CLSI EP06-A for linearity across the intended range. Bias acceptance criteria met for auto-dilution. | Linearity: Linear in the range of 0.01 to 106.80 ng/mL.
  Dilution Tests: 1:10 auto-dilution protocol meets 10% bias acceptance criteria from 20.5 ng/mL to 1000 ng/mL.
  Analytical Measuring Range: 0.02 to 100.00 ng/mL.
  Extended Measuring Range (with auto-dilution): Up to 1000.00 ng/mL. |
  | Reagent Stability | Sufficient shelf-life for intended use. | Reagent Shelf Life: 9 months for intended storage (2-8°C).
  Transport Stability: Can be shipped at ambient or refrigerated conditions. |
  | Calibrator Stability | Sufficient shelf-life for intended use. | Calibrator Shelf Life: 9 months for frozen conditions (-10°C or colder), including 3 freeze/thaw cycles. |
  | Control Stability | Sufficient shelf-life for intended use. | Control Shelf Life: 9 months for frozen conditions (-10°C or colder).
  In Use Storage: 30 days post-thaw at 2-8°C. |
  | Detection Limit | Meets CLSI EP17-A2 for detection capabilities. | LoB: 0.0004 ng/mL
  LoD: 0.0018 ng/mL
  LoQ: 0.0077 ng/mL |
  | Analytical Specificity/Cross Reactivity | No significant interference from tested substances. | No interference seen with up to:
• 10 ng/mL Human Katacalcin
• 2 ng/mL Human Calcitonin
• 10 µg/mL Human α-CGRP
• 10 µg/mL Human β-CGRP |
  | Interfering Substances (Endogenous) | Less than 5% interference from tested endogenous substances. | Interferent levels not affecting test performance:
• Hemoglobin: ≤ 500 mg/dL (1.9% interference)
• Triglycerides: ≤ 3000 mg/dL (0.9% interference)
• Unconjugated Bilirubin: ≤ 20 mg/dL (2.8% interference)
• Conjugated Bilirubin: ≤ 30 mg/dL (3.9% interference)
• Total Protein: ≤ 12 g/dL (4.8% interference) |
  | Interfering Substances (Exogenous) | No significant interference from tested substances. | No interference seen with up to listed concentrations for: Imipenem, Cefotaxime, Vancomycin, Dopamine, Noradrenaline, Dobutamine, Heparin, Furosemide.
  HAMA Effect: No interference seen with up to 3600 ng/mL.
  RF Effect: No interference seen with up to 2000 IU/mL. |
  | High Dose Hook Effect | No hook effect within the tested range. | Free of hook effects up to 10,000 ng/mL PCT. |
  | Specimen Stability | Samples remain stable for specified storage conditions and times. | On Board Stability: Stable for up to 3 hours.
  Room Temperature (15-30°C): Stable for up to 24 hours (plasma/serum harvested); ≤ 8 hours (on cells/clot/separator gel); ≤ 24 hours (off cells/clot/separator gel).
  Refrigerated (2-8°C): Stable for up to 48 hours.
  Freeze-Thaw Cycles: Up to 3 cycles (EDTA plasma, no-additive serum, SST serum); 1 cycle (lithium heparin plasma).
  Frozen Short Term (-10°C or colder): Up to 15 days.
  Frozen Long Term (-70°C): 18 months. |
  | Matrix Comparison | Different matrix types are equivalent within defined bias. | Minimal bias between K2EDTA plasma (base tube) and other types:
• Lithium heparin plasma: +2% bias
• Serum: -4% bias
• SST: -6% bias
  All four tube types considered equivalent. |
  | Method Comparison | Strong correlation with the predicate device. | Correlation coefficient (r): 0.99 (between ARCHITECT B.R.A.H.M.S PCT and B.R.A.H.M.S PCT sensitive KRYPTOR®).
  Slope: 1.00; Intercept: -0.02. |
  | Clinical Performance (28-day mortality) | Significant association between ΔPCT and 28-day mortality. Prognostic accuracy demonstrated. Ability to differentiate risk groups. | MOSES Study:
• Binary test result (ΔPCT > 80% or ≤ 80%) significantly associated with 28-day cumulative mortality (p=0.001).
• Adjusted for ICU vs. non-ICU: p=0.017.
• Relative mortality ratios (ΔPCT positive vs. negative) ranged from 1.49 to 3.38 across subgroups.
• Kaplan-Meier curves showed lower survival probability for ΔPCT positive.
• Hazard ratio for ΔPCT ≤ 80% vs. > 80% was 1.99 (p=0.002) for Day 0 to Day 4 change, indicating a ~2-fold higher mortality risk.
• ΔPCT remains a prognostic parameter even when adjusted for other mortality predictors in Cox multi-regression models.
• Clinical Concordance: >96% total agreement with predicate at 0.5 µg/L and 2.0 µg/L decision points. |

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

• Analytical Performance Studies (Precision, Linearity, Detection Limit, Specificity, Interference, Hook Effect, Reagent/Calibrator/Control Stability):

  • Precision (Internal): 320 replicates (80 per sample-reagent-calibrator lot combination) for controls and plasma panels.
  • Precision (Multi-Site): 25 replicates per sample per site over 5 days.
  • Linearity: 3 unique EDTA plasma High pools, each diluted to 10 levels.
  • Dilution Tests: 5 specimens evaluated by three methods (neat, manual, auto-dilution) in replicates of five for concentrations between Cal E and Cal F; 5 specimens evaluated by manual and auto-dilution in replicates of five for concentrations between Cal F and 1000 ng/mL.
  • Detection Limit (LoB): 288 replicates (4 blank plasma lots, 6 replicates each, on 2 instruments with 2 reagent lots per instrument for 3 days).
  • Detection Limit (LoD): 400 replicates (1 blank plasma lot spiked to 4 levels, 5 replicates each, for 5 days on 2 instruments with 3 reagent lots and 2 calibrator lots).
  • Detection Limit (LoQ): 1000 replicates (2 blank plasma lots spiked to 5 levels, 5 replicates each, for 5 days on 2 instruments with 3 reagent lots and 2 calibrator lots).
  • Analytical Specificity/Cross Reactivity: Samples tested in replicates of seven in a single run.
  • Interfering Substances (Endogenous): 3 plasma-based panels, each tested in replicates of eight across three runs.
  • Interfering Substances (Exogenous): 8 potential drug interferents, spiked into 3 plasma panels, run in replicates of eight. HAMA stock solutions spiked into 3 plasma panels, run in replicates of eight. RF stock solution spiked into 3 plasma panels, run in replicates of eight.
  • High Dose Hook Effect: 7 spiked samples and Cal F tested in 18 replicates each.
  • Specimen Stability: Fresh samples from 53 patients for 4 tube types.
  • Matrix Comparison: Matched set specimens from patients (number not specified but assumed to be sufficient per CLSI EP09-A3).
  • Method Comparison: 142 human K2EDTA plasma specimens.
  • Reference Range Study: n=446 normal healthy donor K2EDTA plasma individuals.
  • Data Provenance: Primarily conducted at the Thermo Fisher internal laboratory. Multi-site precision involved two external CLIA certified laboratories and the Thermo Fisher internal laboratory. Clinical samples for linearity were from multiple donors; for specimen stability and matrix comparison, samples were prospectively collected from two hospital sites in Switzerland. The clinical study (MOSES) involved 13 investigational sites in the United States. The method comparison study used human K2EDTA plasma specimens. All samples appear to be retrospective clinical samples or laboratory-prepared panels.

• Clinical Studies (MOSES Study):

  • Sample Size: 858 adult patients initially, analyzed population of 598 subjects.
  • Data Provenance: Prospective clinical trial conducted across 13 investigational sites in the United States.

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

This device is an in-vitro diagnostic (IVD) assay that measures a biomarker (PCT) quantitatively. The "ground truth" for analytical performance tests is typically established through reference methods, certified standards, and rigorous statistical analysis according to CLSI guidelines, rather than expert interpretation of images or clinical cases. For the clinical study, the ground truth for mortality was the outcome data (28-day all-cause mortality). No information is provided about experts establishing ground truth for the test set in the traditional sense of consensus reading for subjective data.

4. Adjudication Method for the Test Set:

Not applicable in the typical sense for quantitative biomarker assays. The clinical ground truth (28-day mortality) is an objective outcome, not requiring adjudication. Analytical studies rely on quantitative measurements against defined standards and statistical methods.

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 a standalone quantitative diagnostic assay for a biomarker (PCT), not a device that assists human readers in interpreting medical images or clinical cases.

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

Yes, the device is explicitly a standalone assay. It quantitatively determines PCT levels. Although the indications for use state "Used in conjunction with other laboratory findings and clinical assessments," the performance data presented is for the assay's output itself, not for human-in-the-loop interpretation of the assay's results. The hazard ratios and mortality predictions are based solely on the PCT values generated by the device.

7. The Type of Ground Truth Used:

• Analytical Performance: Various types of ground truth relevant to analytical testing were used:
  • Reference standards/gravimetric dilutions: For linearity, detection limits, and calibrator/control value assignment.
  • Known concentrations: For spike-recovery and interference studies.
  • Predicate device results: For method comparison (B.R.A.H.M.S PCT sensitive KRYPTOR®).
• Clinical Performance (MOSES Study):
  • Outcomes Data: 28-day all-cause mortality was the primary outcome for the clinical study. This is objective, hard outcome data.

8. The Sample Size for the Training Set:

The document describes performance studies, not a machine learning model that requires a distinct "training set." The analytical studies and clinical validation study (MOSES study) collectively serve as the evidence base demonstrating the device's performance and suitability for its intended use. The samples used in these studies, as detailed in point 2, were used for validation and verification, not for training a model in the AI/ML sense.

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

Not applicable, as there isn't a "training set" in the context of an AI/ML model for this device. The ground truth for the various performance evaluation samples was established through established laboratory methods, reference standards, and objective clinical outcomes as described in point 7.

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ARCHITECT STAT Troponin-I is a Chemiluminescent Microparticle Immunoassay (CMIA) for the quantitative determination of cardiac troponin-I in human serum or plasma on the ARCHITECT i 2000SR System. Troponin-I values are used to assist in the diagnosis of myocardial infarction (MI).

ARCHITECT STAT Myoglobin is a Chemiluminescent Microparticle Immunoassay (CMIA) for the quantitative determination of myoglobin in human serum or plasma on the ARCHITECT i System with STAT protocol capability. Myoglobin values are used to assist in the diagnosis of myocardial infarction (MI).

Not Found

This is an FDA Premarket Notification (510(k)) letter for the ARCHITECT STAT Troponin-I Immunoassay and ARCHITECT STAT Myoglobin Immunoassay. It confirms that the devices are substantially equivalent to legally marketed predicate devices.

However, the provided document does not contain any information about acceptance criteria, device performance studies, sample sizes, expert ground truth establishment, adjudication methods, or MRMC studies.

This type of FDA letter is an approval document, not a study report. To find the information you're looking for, you would typically need to consult:

• The original 510(k) submission document itself (which includes the detailed performance data).
• The device's Instructions for Use (IFU) or package insert, which often summarizes performance characteristics.
• Clinical studies or validation reports associated with the device, usually referenced or summarized in the 510(k) submission.

Since the provided text does not contain the requested information, I cannot complete the table or answer the specific questions about the study design, sample sizes, or ground truth.

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ARCHITECT® Anti-TPO is a Chemiluminescent Microparticle Immunoassay (CMIA) for the quantitative determination of the IgG class of thyroid peroxidase autoantibodies (anti-TPO) in human serum and plasma (EDTA and Heparin) on the ARCHITECT® i System. The ARCHITECT® Anti-TPO assay is intended for use as an aid in the diagnosis of autoimmune thyroid disease.

The ARCHITECT® Anti-TPO Calibrators are for the calibration of the ARCHITECT® i System when used for the quantitative determination of the IgG class of thyroid peroxidase autoantibodies (anti-TPO) in human serion and plasma.

The ARCHITECT® Anti-TPO Controls are for the estimation of test precision and the detection of systematic analytical deviations of the ARCHITECT® i System (reagents, calibrators and instrument), when used for the quantitative determination of the IgG class of thyroid peroxidase autoantibodies (anti-TPO) in human ser im and plasma.

The ARCHITECT Anti-TPO assay is a two-step immunoassay for the quantitative determination of anti-TPO in human serum and plasma using CMIA technology with flexible assay protocols, referred to as Cherriflex® In the first step, sample, assay diluent and TPO coated paramagnetic microparticles are combined and incubated. Anti-TPO present in the sample binds to the TPO coated microparticles. After washing, anti-human IGG acridinium labeled conjugate is added in the second step. Following and wash, herearinger and trigger solutions are added to the reaction mixture. The resulting chemiluminessent reaction is measured as relative light units (RLU). A direct relationship exists between the amount of anti-TPO in the samble and the RLUs detected by the ARCHITECT i system optics.

The provided text describes a 510(k) submission for the ARCHITECT® Anti-TPO Immunoassay, which is a medical device for the quantitative determination of anti-TPO antibodies. The document focuses on demonstrating substantial equivalence to a predicate device, the Abbott AxSYM® anti-Thyroid peroxidase (Anti-TPO) Microparticle Enzyme Immunoassay (MEIA).

Here's an analysis of the acceptance criteria and study information based on the provided text:

Acceptance Criteria and Device Performance

The core acceptance criterion for substantial equivalence in this context is method concordance between the new device and the predicate device.

Study Information

1. Sample sizes used for the test set and the data provenance:
   The document states that a "method concordance using the NCCLS Standard (EP-12A) was also conducted". However, it does not provide the specific sample size used for this clinical performance study or the geographical origin of the data. It is implicitly a retrospective study comparing a new method to an existing one using collected samples.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
   This information is not provided in the document. For an immunoassay, the "ground truth" often refers to the results obtained from a reference method or a well-established predicate device. The document uses the Abbott AxSYM® anti-Thyroid peroxidase (Anti-TPO) Microparticle Enzyme Immunoassay (MEIA) as the predicate for comparison, implying this served as the reference for establishing concordance.

3. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
   This information is not applicable and not provided. Adjudication typically applies to studies where human reviewers independently assess data and their discrepancies are resolved. In this case, it's a comparison of automated immunoassay results.

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:
   This is not applicable as the device is an automated immunoassay system, not an AI-assisted diagnostic tool that involves human readers' interpretation of images or other data.

5. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
   Yes, the performance presented for the ARCHITECT® Anti-TPO assay is its standalone performance as an automated immunoassay. The comparison is made purely between the results generated by the ARCHITECT® system and the predicate AxSYM® system.

6. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
   The "ground truth" in this context is the results obtained from the legally marketed predicate device, the Abbott AxSYM® anti-Thyroid peroxidase (Anti-TPO) Microparticle Enzyme Immunoassay (MEIA). The new device's results are compared against this established method to demonstrate substantial equivalence.

7. The sample size for the training set:
   This information is not provided and is generally not applicable in the context of a traditional immunoassay device. Immunoassays are based on biochemical reactions and established protocols, not machine learning models that require training sets in the same way.

8. How the ground truth for the training set was established:
   As mentioned above, this is not applicable in the context of this immunoassay device.

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ARCHITECT® Anti-Tg is a Chemiluminescent Microparticle Immunoassay (CMIA) for the quantitative determination of the IgG class of thyroglobulin autoantibodies (anti-Tg) in human serum and plasma on the ARCHITECT i System. The ARCHITECT Anti-Tg assay is intended for use as an aid in the diagnosis of thyroid disease.

The ARCHITECT® Anti-Tg Calibration of the calibration of the ARCHITECT® i System when used for the quantitative determination of IgG class of thyroglobulin autoantibodies (anti-Tg) in human serum and plasma.

The ARCHITECT® Anti-Tg Controls are for the estimation of test precision and the detection of systematic analytical deviations of the ARCHITECT® i System (reagents, calibrators and instrument) when used for the quantitative determination of the IgG class of thyroglobulin autoantibodies (anti-Tg) in human serum and plasma.

The ARCHITECT Anti-Tg assay is a two-step immunoassay for the quantitative determination of the IgG class of thyroglobulin autoantibodies (anti-Tg) in human serum and plasma using CMIA technology with flexible assay protocols, referred to as Chemiflex®.

In the first step, sample, assay diluent and Tg coated paramagnetic microparticles are combined and incubated. Anti-Tg present in the sample binds to the Tg coated microparticles. After washing, anti-human IgG acridinium labeled conjugate is added in the second step. Following another incubation and wash, pre-trigger and trigger solutions are added to the reaction mixture. The resulting chemiluminescent reaction is measured as relative light units (RLU). A direct relationship exists between the amount of anti-Tg in the sample and the RLUs detected by the ARCHITECT i system optics.

The ARCHITECT® Anti-Tg assay is a device for the quantitative determination of IgG class thyroglobulin autoantibodies (anti-Tg) in human serum and plasma, intended as an aid in the diagnosis of thyroid disease.

1. Table of Acceptance Criteria and Reported Device Performance:

The provided document does not explicitly state numerical acceptance criteria in a table format. However, it indicates that the ARCHITECT® Anti-Tg assay demonstrated substantial equivalence to the predicate device, the Nichols Advantage Thyroglobulin Autoantibodies Assay, based on various performance characteristics.

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

The document mentions a "summary clinical performance" study and a "method concordance using the NCCLS Standard (EP-12A)". However, the sample size for the test set is not explicitly stated. The data provenance (e.g., country of origin of the data, retrospective or prospective) is also not specified.

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

This information is not provided in the document. The study focuses on comparing the new device against a predicate device, rather than establishing a de novo ground truth with expert consensus.

4. Adjudication method for the test set:

This information is not provided in the document.

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 device is an immunoassay system for laboratory analysis, not an AI-assisted diagnostic imaging or interpretation device that would involve human readers. Therefore, an MRMC comparative effectiveness study with human readers and AI assistance is not applicable and was not done.

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

The performance described is inherently a "standalone" or "algorithm-only" performance in the context of an automated immunoassay system. The document reports non-clinical performance (precision, linearity, interferences, stability) and clinical performance (method concordance, sample stability) where the device's output is compared to the predicate device. There is no human-in-the-loop interaction for interpretation in the same way as, for example, an AI-powered image analysis tool.

7. The type of ground truth used:

The "ground truth" for the comparison studies was implicitly established by the results of the legally marketed predicate device, the Nichols Advantage Thyroglobulin Autoantibodies Assay. The goal was to demonstrate substantial equivalence to this existing device.

8. The sample size for the training set:

This information is not applicable as this is an immunoassay system, not a machine learning or AI-based device that typically requires a separate training set. The device uses established biochemical principles for measurement.

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

This question is not applicable for the same reason as point 8.

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ARCHITECT STAT MYOGLOBIN is a Chemiluminescent Microparticle Immunoassay (CMIA) for the quantitative determination of Myoglobin in human serum and plasma on the ARCHITECT i System with STAT protocol capability. Myoglobin values are used to assist in the diagnosis of myocardial infarction (MI).
The ARCHITECT STAT MYOGLIBIN Calibrators are for the calibration of the ARCHITECT i System with STAT protocol capability when used for the quantitative determination of myoglobin in human serum or plasma.

The ARCHITECT® STAT Myoglobin assay is a two-step immunoassay for the quantitative determination of myoglobin in human serum and plasma using CMA technology with flexible assay protocols, referred to as Chemiflex®. In the first step, sample and anti-myoglobin coated paramagnetic microparticles are combined and incubated. Myoglobin present in the sample binds to the anti-myoglobin coated microparticles. After washing, antimyoglobin acridinium labeled conjugate is added in the second step. Following another incubation and wash, pre-trigger and trigger solutions are added to the reaction mixture. The resulting chemiluminescent reaction is measured as relative light units (RLUs). A direct relationship exists between the amount of myoglobin in the sample and the RLUs detected by the ARCHITECT® I* system optics.

Here's a summary of the acceptance criteria and study information for the ARCHITECT® STAT MYO immunoassay, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The provided text (K042924) is a 510(k) summary for a diagnostic device. In this type of submission, specific numerical acceptance criteria for performance metrics are often compared against the predicate device rather than against predefined, distinct "acceptance criteria" for the new device as would be seen in a clinical trial protocol. The primary goal is to demonstrate "substantial equivalence" to a legally marketed predicate device.

Therefore, the "acceptance criteria" are implied by the performance of the predicate device (Abbott AxSYM® MYO Assay, K983848), and the "reported device performance" demonstrates that the new device is substantially equivalent to that predicate. Explicit numerical acceptance criteria are not detailed in this summary, but rather the conclusion of substantial equivalence in key performance areas.

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

The provided text does not specify the exact sample size for the clinical method comparison study. It only states that a "method comparison using the CLSI EP-9A (EP-9A) was also conducted with the ARCHITECT® STAT MYO and AxSYM® MYO assays."

• Sample Size: Not explicitly stated. CLSI EP-9A provides guidance on method comparison studies, which typically involve a reasonable number of patient samples to demonstrate correlation.
• Data Provenance: Not explicitly stated (e.g., country of origin). The study appears to be a retrospective or prospective laboratory comparison of samples on two different devices. Given the context of a 510(k) in the US, it's likely the data was generated in a US-based laboratory, but this is not confirmed. It's an analytical and clinical comparison study, not a population-based study in terms of provenance.

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

The concept of "experts" to establish ground truth in the traditional sense (e.g., radiologists interpreting images) is not applicable here. This is an immunoassay for a biomarker (myoglobin). The "ground truth" for the test set is established by the results from the predicate device (Abbott AxSYM® MYO Assay), which is already legally marketed and established. The study's purpose is to show agreement between the new device and the predicate device's measurements. There are no "experts" involved in determining the "truth" of the myoglobin levels other than the performance of the predicate method itself.

4. Adjudication Method for the Test Set

Not applicable. As described above, the "ground truth" is primarily based on the predicate device's measurements. There is no independent panel or expert adjudication process described for the myoglobin values themselves. The adjudication, if any, would be in the statistical analysis and clinical interpretation of the comparison results by regulatory reviewers.

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 an in vitro diagnostic immunoassay for a biomarker. It is not an imaging AI device that involves human readers or their improvement with AI assistance.

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

This device is a standalone algorithm (an immunoassay performed by an automated instrument). Its performance is evaluated analytically and in comparison to a predicate device, without a human "in-the-loop" influencing the immediate result generation for a single test. The "human-in-the-loop" aspect comes in the clinician's interpretation of the measured myoglobin level in conjunction with other clinical data. The summary describes the standalone analytical performance of the ARCHITECT® STAT MYO immunoassay.

7. The Type of Ground Truth Used (Expert Consensus, Pathology, Outcomes Data, etc.)

The primary "ground truth" for this comparative study is the measurements obtained from the legally marketed predicate device (Abbott AxSYM® MYO Assay). The new device's performance is compared against these established measurements to demonstrate substantial equivalence, rather than against an independent physiological "ground truth" like pathology or clinical outcomes. The clinical utility is framed in terms of its ability to measure myoglobin, which is then used by clinicians for diagnosis, but the study itself focuses on equivalence to an existing method.

8. The Sample Size for the Training Set

Not applicable. This is not an AI/ML device that requires a "training set." It is an immunoassay based on chemical and biological reactions. The development of such assays involves optimization and validation, but not in the sense of an "AI training set."

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

Not applicable, as there is no "training set" in the AI/ML sense for this type of device. The development and calibration of the assay would involve various analytical methods to ensure accuracy and precision, but this is distinct from establishing "ground truth" for an AI model.

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ARCHITECT STAT Troponin-I is a Chemiluminescent Microparticle Immunoassay (CMIA) for the quantitative determination of cardiac troponin-l (cTnl) in human serum and plasma on the ARCHITECT i System with STAT capability. Troponin-I values are used to assist in the diagnosis of myocardial infarction (MI).

The ARCHITECT STAT Troponin-I Calibrators are for calibration of the ARCHITECT i 2000SR System when used for the quantitative determination of cardiac Troponin-I in human serum or plasma.

The ARCHITECT STAT Troponin-I assay is a two-step assay to determine the presence of cardiac troponin-I in human serum and plasma using CMIA technology with flexible assay protocols, referred to as Chemiflex®.

In the first step, sample, assay diluent and anti-troponin-l antibody-coated paramagnetic microparticles are combined. After incubation and washing, anti-troponin-l acridinium labeled conjugate is added in the second step. Following another incubation and wash, pre-trigger and trigger solutions are added to the reaction mixture. The resulting chemilyminescent reaction is measured as relative light units (RLUs). A direct relationship exists between the amount of troponin-I in the sample and the RLUs detected by the ARCHITECT i system optics. The concentration of troponin-I is read relative to a standard curve established with calibrators of known troponin-l concentration.

Here's a breakdown of the acceptance criteria and study information for the ARCHITECT® STAT Troponin-I Assay, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document doesn't explicitly state quantitative acceptance criteria in terms of specific performance thresholds for sensitivity, specificity, or other metrics. Instead, it frames the acceptance criteria implicitly as demonstrating "substantial equivalence" to a predicate device.

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

The document does not explicitly state the sample size used for the clinical test set. It mentions "clinical data in this 510(k) submission" and a "sample stability study." However, specific numbers for patients or samples are not provided.

The data provenance is not explicitly stated regarding country of origin or whether it was retrospective or prospective. It refers to "clinical data" which typically implies human samples.

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

The document does not provide information on the number of experts used or their qualifications to establish ground truth for the test set.

4. Adjudication Method for the Test Set

The document does not describe any adjudication method for the test set. The comparison is made against a predicate device.

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

No multi-reader multi-case (MRMC) comparative effectiveness study is mentioned. This device is an in-vitro diagnostic assay, not an imaging or interpretation system that would typically involve multiple human readers.

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

This is an in-vitro diagnostic (IVD) assay, which by nature operates as a standalone algorithm (the ARCHITECT i System) to determine troponin-I concentration. The performance described (precision, linearity, sensitivity, specificity) is inherent to the assay and the instrument, without a human-in-the-loop performance component in the traditional sense of AI system evaluation. The output is a quantitative value used by clinicians for diagnosis.

7. Type of Ground Truth Used

The ground truth for evaluating the ARCHITECT® STAT Troponin-I assay's performance (specifically sensitivity and specificity for MI diagnosis) is implicitly established by comparison to the ACCESS® AccuTnl Assay as a predicate device, using an "optimal AMI 'cut-off' of 0.30 ng/mL." This suggests that the ground truth for MI diagnosis with respect to troponin-I levels was derived from established clinical criteria and comparison to a legally marketed equivalent device, rather than pathology or long-term outcomes data explicitly.

8. Sample Size for the Training Set

The document does not provide information on the sample size for any training set. This is typical for an IVD assay where development often involves calibration and validation with characterized samples rather than a "training set" in the machine learning sense.

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

Since no "training set" is explicitly mentioned in the context of machine learning, the establishment of its ground truth is not applicable or described in this document. The assay's "ground truth" implicitly refers to the accuracy and reliability of its quantitative measurements of cTnl compared to established methods and its ability to assist in MI diagnosis per clinical standards.

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ARCHITECT STAT CK-MB is a Chemiluminescent Microparticle Immunoassay (CMIA) for the quantitative determination of CK-MB in human serum and plasma on the ARCHITECT i System with STAT capability. CK-MB values are used to assist in the diagnosis of myocardial infarction (MI).

The ARCHITECT STAT CK-MB assay is a two-step assay to determine the presence of the MB isoenzyme of creatine kinase (CK-MB) in human serum and plasma using CMA technology with flexible assay protocols, referred to as Chemiflex®. In the first step, sample and anti-CK-MB coated paramagnetic microparticles are combined. After incubation and washing, anti-CK-MB acridinium conjugate is added in the second step. Following another incubation and wash, pre-trigger and trigger solutions are added to the reaction mixture. The resulting chemiluminescent reaction is measured as relative light units (RLUs). A direct relationship exists between the amount of CK-MB in the sample and the RLUs detected by the ARCHITECT i* optical system.

Here's a breakdown of the acceptance criteria and study information for the ARCHITECT® STAT CK-MB immunoassay, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size: The document does not explicitly state the exact sample size for the test set used in the clinical performance study. It mentions a "sample stability study" and a "method comparison using the NCCLS Bias Estimation Standard (EP-9A)" which imply a test set was used, but the number of samples is not provided.
• Data Provenance: The document does not specify the country of origin of the data. It also does not explicitly state whether the data was retrospective or prospective.

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 study involved a comparison against a predicate device (AxSYM® CK-MB assay), and the "ground truth" for the test samples would have been the results obtained from the predicate device or a clinical outcome implicitly associated with CK-MB levels. There's no mention of a ground truth established by external experts.

4. Adjudication Method for the Test Set

• This information is not provided in the document. Since the "ground truth" was based on comparison to a predicate device, an explicit expert adjudication method for the test set is unlikely to have been employed in the traditional sense (e.g., multiple experts reviewing and reaching consensus).

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance

• No, an MRMC comparative effectiveness study was not done. This device is an immunoassay (a lab test), not an AI-assisted diagnostic imaging device or an AI system designed to aid human readers. Therefore, the concept of "human readers improve with AI vs. without AI assistance" does not apply here.

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

• This is a standalone diagnostic test. The ARCHITECT® STAT CK-MB immunoassay is a device that itself performs the quantitative determination of CK-MB from a sample. It generates a numerical result, which is then interpreted by clinicians. It does not involve a human-in-the-loop performance analysis in the context of an algorithm. Its performance is evaluated compared to a predicate device.

7. The Type of Ground Truth Used (Expert Consensus, Pathology, Outcomes Data, etc.)

• The primary "ground truth" used for evaluating the ARCHITECT® STAT CK-MB assay was the results obtained from the predicate device, the Abbott AxSYM® CK-MB Assay. The study aimed to demonstrate substantial equivalence, meaning the new device's measurements correlated well with the established predicate. The clinical utility of CK-MB values (used to assist in the diagnosis of MI) represents the broader clinical "ground truth" for both devices.

8. The Sample Size for the Training Set

• This information is not applicable/provided in the context of this device's development. Immunoassays are not "trained" in the same way machine learning models are. Their performance is established through rigorous analytical and clinical validation studies using samples, not through a "training set" for an algorithm.

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

• This information is not applicable as there is no "training set" in the context of an immunoassay. The development and validation of an immunoassay rely on established chemical reactions, antibodies, and measurement principles, with performance characterized through analytical studies and comparison to established methods.

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The Fisher Diagnostics ThromboScreen® 1000 is a photo-optical instrument used for the performance of in-vitro diagnostic coagulation testing of citrated plasma specimens in the clinical laboratory. Coagulation testing capabilities of the device include routine clotting tests such as Prothrombin Time (PT), Activated Partial Thromboplastin Time (APTT), and Fibrinogen.

The Pacific Hemostasis® Fibrinogen Reagent plus Kaolin is intended to be used on the Fisher Diagnostics ThromboScreen® 1000 Coagulation Instrument for the quantitative determination of fibrinogen in plasma.

The ThromboScreen® 1000 (TS1000) is a photo-optical instrument used for the performance of in-vitro diagnostic clotting procedures in the clinical laboratory. The instrument utilizes photo-optical principles to measure and record the time required for subject plasma specimens to clot. The TS1000 light source is provided by a 660 nm LED. The incubator block is temperature regulated to 36.5 - 37.5°C and contains six measuring positions and six reagent positions.

The Pacific Hemostasis® Fibrinogen Reagent plus Kaolin is identical to the Pacific Hemostasis® Thrombin for Fibrinogen Kit, except that the thrombin is reconstituted with water containing kaolin rather than water. Kaolin is added to increase the visibility of the clot in the stirred reaction cell.

Here's a breakdown of the acceptance criteria and the study details for the Fisher Diagnostics ThromboScreen® 1000 and Pacific Hemostasis® Fibrinogen Reagent plus Kaolin, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

The document doesn't explicitly state "acceptance criteria" in a quantitative manner (e.g., "The correlation coefficient must be >0.95"). Instead, it presents comparative performance data against predicate devices to demonstrate substantial equivalence. The implication is that the performance must be comparable to the legally marketed predicate devices.

Important Note: The acceptance criteria are implicitly met by demonstrating "substantial equivalence" to the predicate devices. The correlation coefficients are all very high (close to 1.0), and the precision data (CV%) also appears comparable between the ThromboScreen 1000 and the predicate MLA instruments.

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

• Test Set Sample Sizes:

  • Method Comparison (Correlation Studies):
    • Prothrombin Time (General Clinical Samples): 60 samples per site (across 3 sites = 180 total)
    • Prothrombin Time (Coumadin Samples): 100 samples per site (Site 1 & 2), 92 samples (Site 3) = 292 total
    • Activated Partial Thromboplastin Time (General Clinical Samples): 58 (Site 1), 60 (Site 2), 60 (Site 3) = 178 total
    • Activated Partial Thromboplastin Time (Heparin Samples): 60 samples per site (across 3 sites = 180 total)
    • Fibrinogen Concentration (General Clinical Samples): 28 (Site 1), 30 (Site 2), 30 (Site 3) = 88 total
  • Precision Studies: The specific number of samples for precision studies is not explicitly stated, but it involves "Coag 1, Coag 2, Coag 3" which likely represent different control levels or concentrations, and were performed "within-run," "run-to-run," and "day-to-day" at three sites.

• Data Provenance: The studies were conducted "in-house and at two external testing laboratories." While specific countries are not mentioned, the context of the FDA submission (U.S. Department of Health & Human Services) strongly suggests the data was generated within the United States or from sites compliant with U.S. regulatory standards. The data is prospective as it involves comparison testing and precision measurements on collected specimens. The document indicates specimens were collected from "apparently healthy individuals and from subjects with different pathological conditions which are expected to affect the results for a particular assay."

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

The description does not mention the use of "experts" in the sense of human readers adjudicating results or establishing ground truth for the test results. This is an in-vitro diagnostic device (IVD) where the "ground truth" is typically established by comparing the device's quantitative measurements against a legally marketed predicate device (MLA 900C/1600C) using the same patient samples and/or established reference methods for precision. The performance is assessed by correlation coefficients and precision metrics against these established methods, not by expert consensus on interpretations.

4. Adjudication Method for the Test Set:

Not applicable. As described above, this is an IVD device measuring quantitative coagulation parameters. The "ground truth" is based on the results from predicate devices and internal validation, not human adjudication of subjective interpretations.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size:

No, an MRMC comparative effectiveness study was not performed. This type of study is relevant for imaging or diagnostic interpretation devices where multiple human readers interpret cases. The ThromboScreen® 1000 is an automated instrument for quantitative laboratory tests (Prothrombin Time, APTT, Fibrinogen), not an interpretation aid for human readers.

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

Yes, a standalone performance evaluation was done. The entire study focuses on the performance of the ThromboScreen® 1000 instrument and the Pacific Hemostasis® Fibrinogen Reagent plus Kaolin. Its measurements are compared directly to those of established predicate instruments (MLA 900C/1600C). There is no "human-in-the-loop" aspect to its measurement process; it's an automated photo-optical instrument.

7. The Type of Ground Truth Used:

The ground truth for the device's performance was established by:

• Predicate Device Comparison: The results obtained from the ThromboScreen® 1000 were compared against results from legally marketed predicate devices, the MLA 900C and MLA 1600C, using the same "citrated plasma specimens."
• Internal Validation/Reference Methods: For precision studies, it implies that control materials or repeated measurements on samples were used to establish the variability (CV%) of the device itself and in comparison to the predicate devices.

Therefore, the ground truth is based on comparative measurements to predicate devices and established laboratory standards for precision and accuracy, rather than pathology, expert consensus, or outcomes data in the typical sense for imaging or pathology devices.

8. The Sample Size for the Training Set:

The document does not contain information about a "training set" or "training data." This type of terminology is usually associated with machine learning or artificial intelligence models. The ThromboScreen® 1000 is a photo-optical instrument. Its design and operational parameters would be developed through engineering and calibration processes, not a "training set" in the AI sense.

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

Not applicable, as there is no mention of a "training set" in the context of this device's development or evaluation.

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Pacific Hemostasis Reference Emulsion is intended to be used on Instrumentation Laboratories ACL system.

Not Found

The provided document is a 510(k) premarket notification letter from the FDA regarding the "Pacific Hemostasis Reference Emulsion" device. This document primarily focuses on regulatory approval and does not contain any information about acceptance criteria, device performance studies, sample sizes, expert qualifications, ground truth establishment, or any of the other specific details requested in the prompt regarding a study proving device meets acceptance criteria.

The letter states that the FDA has reviewed the 510(k) and determined the device is "substantially equivalent" to legally marketed predicate devices. This indicates that the device has met regulatory requirements for market approval based on comparison to existing devices, but it does not detail the specific performance metrics or studies used to demonstrate that equivalence.

Therefore, I cannot provide the requested information based on the content of the document.

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