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The Unicel DxH 800 Coulter Cellular Analysis System with Early Sepsis Indicator Application is the quantitative measurement of Monocyte Distribution Width (MDW). The Early Sepsis Indicator is intended for use with adult patients presenting to the emergency department, on whom a white cell differential test has been ordered.

MDW is measured from a (K2EDTA) whole-blood venous sample within 2 hours of collection. MDW values greater than 20.0 together with other laboratory findings and clinical information, aids in identifying patients with sepsis or at increased risk of developing sepsis within the first 12 hours of hospital admission.

MDW values greater than 20.0 should be interpreted in association with other clinical information and diagnostic testing, as a proportion of patients without sepsis may have an elevated MDW value at baseline.

MDW values less than or equal to 20.0 cannot rule out sepsis or the development of sepsis within 12 hours of hospital admission. The Early Sepsis Indicator should not be used as the sole basis to determine the absence of sepsis.

The predictive value of the Early Sepsis Indicator for identifying sepsis in patients with hematological abnormalities has not been established.

The Early Sepsis Indicator (ESI) requires the use of the UniCel DxH 800 Coulter Cellular Analysis System (DxH 800) and its reagents, controls and calibrators last cleared under 510(k) K140911.

The UniCel DxH 800 Coulter Cellular Analysis System contains a quantitative, automated hematology analyzer (DxH 800) designed for in vitro diagnostic use in screening patient populations by clinical laboratories. The system provides a Complete Blood Count (CBC), Leukocyte 5 Part Differential (Diff), Reticulocyte (Retic), Nucleated Red Blood Cell (NRBC) on whole blood, as well as, Total Nucleated Count (TNC), and Red Cell Count (RBC) on Body Fluids (cerebrospinal, serous and synovial). This submission adds a new parameter, Monocyte Distribution Width (MDW) to those mentioned above. This parameter has been shown to aid in the early detection of Sepsis in emergency room patients.

The system consists of two primary components, the workstation and the DxH 800 analyzer as shown in Figure 1. DxH 800 System Configuration. The primary function of the DxH 800 analyzer is to process samples and provide results to the workstation. The primary functions of the workstation are: user interface, system control, results processing and storage and external communications. The analyzer runs embedded code and the workstation runs Microsoft Windows 7 Operating System (OS).

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

Acceptance Criteria and Device Performance for UniCel DxH 800 Cellular Analysis System with Early Sepsis Indicator Application

The device is intended for the quantitative measurement of Monocyte Distribution Width (MDW) to aid in identifying adult patients with sepsis or at increased risk of developing sepsis within the first 12 hours of hospital admission. The key acceptance criterion for clinical accuracy revolves around sensitivity and specificity at a specified MDW cut-off.

1. Table of Acceptance Criteria and Reported Device Performance

Note: The document states that the study demonstrated that an MDW cut-off of 20.0 units provided an optimum diagnostic ability by balancing the ability to detect positive patients (sensitivity) and negative patients (specificity), and thus this cut-off was selected. Detailed numerical values for sensitivity and specificity at this cut-off are not explicitly provided in the table, but the text assures they met the acceptance criteria.

2. Sample Size and Data Provenance for Test Set

• Sample Size: Not explicitly stated for the "test set" in a distinct way, but the "Clinical Accuracy" study states it was a "multi-center prospective cohort study."
• Data Provenance:
  • Country of Origin: Not specified in the provided text.
  • Retrospective or Prospective: Primarily prospective. The clinical accuracy study was a "multi-center prospective cohort study."

3. Number of Experts and Qualifications for Ground Truth

• Number of Experts: Not specified.
• Qualifications of Experts: Not specified.

Note: The document mentions "clinical information and diagnostic testing" and "other laboratory findings" were used in conjunction with MDW values, implying expert judgment in establishing the ground truth for sepsis diagnosis.

4. Adjudication Method

• Adjudication Method: Not specified.

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

• MRMC Study: No, an MRMC comparative effectiveness study was not done. This device measures a quantitative biomarker (MDW) from a blood sample, not something interpreted by human readers from images or complex data.

6. Standalone (Algorithm Only) Performance

• Standalone Performance: Yes, the fundamental performance assessed is the standalone diagnostic ability of the MDW parameter as an aid in identifying sepsis. The clinical accuracy study directly evaluated the MDW parameter's performance in detecting sepsis.

7. Type of Ground Truth Used

• Type of Ground Truth: The ground truth for sepsis diagnosis was established based on "other laboratory findings and clinical information" and "diagnostic testing." This suggests a comprehensive clinical diagnosis of sepsis, likely involving a combination of clinical assessment, laboratory parameters (beyond MDW), and potentially culture results or other confirmatory tests, as determined by clinicians.

8. Sample Size for Training Set

• Sample Size for Training Set: Not explicitly stated as a separate "training set" in the context of machine learning model development. The document focuses on the validation of the MDW parameter and its cut-off.

Note: The MDW parameter itself is a quantitative measurement derived from hematology analyzer data, not a machine learning model that would typically have a distinct training set in the conventional sense. The "training" or development of the algorithm to calculate MDW would have occurred prior to this validation study, but details are not provided here.

9. How Ground Truth for Training Set Was Established

• How Ground Truth for Training Set Was Established: Not specified, as a distinct training set for a machine learning model is not explicitly mentioned or implied for the MDW parameter's development in this document. The MDW value is a quantitative measurement from the analyzer, not a diagnosis itself.

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Tina-quant Transferrin ver.2 (urine application) assay is an in vitro test for the quantitative determination of transferrin in human urine on Roche/Hitachi cobas c systems.

A transferrin immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the transferrin (an iron-binding and transporting serum protein) in urine. Measurement of transferrin levels aids in the diagnosis of malnutrition, acute inflammation, infection, and red blood cell disorders, such as iron deficiency anemia.

The Tina-quant Transferrin ver.2 (urine application) assay is a two reagent assay for the in vitro quantitative determination of transferrin in human urine on automated clinical chemistry analyzers. It is an immunoturbidimetric assay in which human transferrin forms a precipitate with a specific antiserum which is determined turbidimetrically.

Engineering drawings, schematics, and figures are not pertinent to describe the device, as the device is a reagent.

The document provided is a 510(k) Premarket Notification for an in vitro diagnostic device, the "Tina-quant Transferrin ver.2 (urine application) assay." This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving clinical effectiveness through extensive human studies often seen with novel medical devices. Therefore, the information regarding acceptance criteria and study design will be primarily focused on analytical performance validation rather than multi-reader multi-case clinical studies involving human interpretation of images, as this is a laboratory reagent.

Here's an analysis of the provided text in the context of your request:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for this device are largely implicit in the fact that "All data passed the predetermined acceptance criteria" for each analytical study. The performance is reported as the results of these studies.

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

• Precision and Analytical Sensitivity (LoB, LoD, LoQ):
  • Precision (Repeatability and Intermediate Precision): 5 human urine sample pools and 2 control samples. Tested for 21 days, 1 run/day, with 2 aliquots per sample in singlicate per part. This setup generates a large number of individual measurements over time to assess variability.
  • LoB: One analyte-free sample, measured 10-fold per run across 6 runs (over 4 days) on 3 reagent lots, resulting in 60 measurements per lot.
  • LoD: Five human urine samples with low-analyte concentration, measured 2-fold per run across 6 runs (over 4 days) on 3 reagent lots, resulting in 60 measurements per lot.
  • LoQ: A low-level sample set prepared by diluting 5 human urine samples, tested in 5 replicates per sample on 4 days, 1 run per day.
• Linearity/Assay Reportable Range: Dilution series prepared using human urine sample pools (number of pools not specified, but likely at least one concentrated pool), with 13 concentrations measured on 3 lots in triplicate.
• Endogenous Interferences: Two human urine pools (at two transferrin concentrations) were used for each interferent. Each pool was divided into two aliquots (spiked with interferent vs. solvent control). A dilution series of 11 steps was prepared and 3 aliquots per level were tested.
• Exogenous Interferences – Drugs: Two human urine sample pools (spiked with approximately 0.433 and 2.48 mg/dL transferrin concentrations) were used for each drug. Each pool was divided into two aliquots (drug spiked vs. solvent control), measured in triplicate.
• Method Comparison to Predicate: One hundred and seven (107) routine fresh, never-frozen human urine samples. Two samples were excluded (pH >8, value outside measuring range), so 107 samples were truly used in the comparison.
• Data Provenance: The document explicitly states "human urine samples" or "human urine sample pools." For the method comparison, samples were "routine fresh, never-frozen human urine samples." There is no specific mention of the country of origin, but Roche Diagnostics Operations (RDO) is located in Indianapolis, Indiana, USA, and Roche Diagnostics GmbH, Mannheim, Germany is also mentioned as having the establishment registration. The studies are prospective analytical validation studies conducted with collected samples, not retrospective analysis of clinical patient data in the typical sense for imaging.

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

This type of in vitro diagnostic device (IVD) aims for quantitative measurement of a biomarker. Therefore, the "ground truth" is established through analytical reference methods, certified reference materials, or highly rigorous internal validation processes tied to metrological traceability, rather than human expert consensus on subjective findings (as would be the case for an imaging AI).

• The ground truth for the test set is established by the analytical measurement on the reference method (for method comparison study), and by the known concentrations/dilutions of samples prepared for analytical studies (e.g., linearity, sensitivity, interference).
• No "experts" in the sense of radiologists interpreting images were involved in establishing the ground truth for these analytical performance studies. The accuracy of measurements is verified against the reference standard or predetermined analytical values.

4. Adjudication Method for the Test Set

Not applicable for this type of analytical performance study. Adjudication methods (e.g., 2+1, 3+1) are common in clinical studies where multiple human readers independently assess data (like images) and then a consensus or tie-breaking mechanism is needed to establish ground truth or assess agreement. For an IVD, the "truth" is typically defined by the analytical method itself or a reference method.

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 quantitative laboratory assay (a reagent for measuring transferrin in urine), not an AI imaging algorithm that assists human readers. No MRMC study was performed as it is irrelevant to the device's function.

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

Yes, the analytical performance studies (Precision, Analytical Sensitivity, Linearity, Interference, Method Comparison) represent the "standalone" performance of the assay itself (the reagent/instrument system) without human intervention in the result generation beyond operating the analyzer according to instructions. This is the primary form of performance evaluation for an IVD.

7. The Type of Ground Truth Used

• For Precision, Analytical Sensitivity, Linearity, and Interference studies: The ground truth is effectively derived from known concentrations in prepared samples (e.g., analyte-free samples, low-concentration samples, dilution series, spiked samples) or reference materials/controls with established values.
• For Method Comparison: The ground truth is the measurement obtained from the predicate device, the "N Antisera to Human Transferrin (Siemens) on the BN ProSpec analyzer." This establishes substantial equivalence to an already legally marketed device.

8. The Sample Size for the Training Set

Not applicable. This is not an AI/machine learning device that requires "training data" in the conventional sense. It's a chemical reagent for an established analytical method (immunoturbidimetry). The development process would have involved formulation and optimization, but not "training" on a data set in the way an AI model would be.

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

Not applicable, as there is no "training set" for this type of IVD, which relies on chemical and immunological principles rather than machine learning from data.

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The EZCD4 Assay is intended to be performed on a Guava PCA System with CytoSoft 2.3 version software which includes three modules; EZCD4, Guava Check and Clean and Shutdown. The system is intended to identify and quantify the absolute counts of CD4 T-Lymphocytes in EDTA whole blood. The GuavaEZCD4 system is intended for the ongoing monitoring of patients with documented diagnosis of an immunodeficiency disease. The Guava EZCD4 system is intended for use only by trained laboratory professionals.

The Guava EZCD4 System is an optimized cell analysis system consisting of the Guava PCA instrument, EZCD4 software for data acquisition and analysis and an EZCD4 Reagent Kit consisting of optimized reagents and protocols. The Guava EZCD4 Reagent Kit is a two-color direct immunofluorescence kit used for the enumeration of mature CD4 T lymphocytes in human blood. It consists of a monoclonal anti-human CD3 antibody conjugated to the tandem dye, phycoerythrin (PE)-Cy5 (PECy5) and a monoclonal anti-human CD4 antibody conjugated to PE. Guava 1X Lysing Solution and Guava Fixative are available in separate packaging and are added, after staining, to lyse erythrocytes and to preserve cells respectively. The Guava PCA instrument includes a laptop computer. The Guava PCA incorporates a new technology termed micro capillary cytometry. The device is a 3-parameter flow cytometer that utilizes a solid state 532 nm green laser, a fixed optical & fluidic system, a self-aligning flow cell and a micro capillary delivery system to perform cell analysis. The micro-syringe stepper pump allows the use of small sample volumes and volumetric measurements for the determination of absolute counts per microliter. The Guava PCA optic system detects forward scatter and two different wavelengths of fluorescence, 580/20 nm and 675/20 nm. It has a small foot print, 21.6 cm x 32 cm x 36.3 cm and is equipped with a network ready laptop computer with a 10GB hard drive and Windows 2000 operating system. The software is application specific with onscreen messaging enabling ease of use and facilitates short, effective training programs. Data is readily analyzed immediately after acquisition and is stored as electronic files on the hard drive.

{
  "acceptance_criteria_and_performance_table": {
    "title": "Summary of Guava EZCD4 System Performance Studies",
    "headers": [
      "Study Type",
      "Acceptance Criteria",
      "Reported Device Performance"
    ],
    "rows": [
      [
        "Correlation Study (vs. Predicate Devices)",
        "Not explicitly stated as numerical acceptance criteria, but implied demonstration of substantial equivalence via linear regression (R-squared, Slope, Intercept).",
        "**Site 2:** N=92, R-squared=0.95, Slope=+1.00, Intercept=18.64, Range=13-1465\n**Site 3:** N=91, R-squared=0.93, Slope=+0.96, Intercept=35.51, Range=17-1175\n**Site 4:** N=88, R-squared=0.98, Slope=+1.17, Intercept=18.46, Range=47-1439\n**Site 5:** N=94, R-squared=0.98, Slope=+0.95, Intercept=13.29, Range=8-1076\n(Conclusion: Results are substantially equivalent)"
      ],
      [
        "Linearity and Sensitivity Study",
        "Not explicitly stated as numerical acceptance criteria, but implied demonstration of linearity across a wide range of CD4+ T cell counts.",
        "Linear regression equation: y = 1.0118x - 45.237\nR-squared = 0.9866\n(Graph shows strong linearity from 0 to >2000 CD4+ T cells/µL)"
      ],
      [
        "Intra-Laboratory Reproducibility",
        "Not explicitly stated as numerical acceptance criteria (e.g., max CV%), but implied low variability across sites and ranges.",
        "**Site 2:** Low CV=13.50%, Mid CV=8.06%, High CV=4.75%\n**Site 3:** Low CV=10.45%, Mid CV=7.20%, High CV=4.92%\n**Site 4:** Low CV=11.05%, Mid CV=3.87%, High CV=3.56%\n**Site 5:** Low CV=4.69%, Mid CV=3.69%, High CV=3.23%"
      ],
      [
        "Carryover Study",
        "Absence of significant sample carryover, as determined by statistical comparison.",
        "Wilcoxon-Mann-Whitney test 1-sided p-value = 0.1474 (Conclusion: No significant sample carryover demonstrated)"
      ],
      [
        "Specificity Study (Guava anti-CD3)",
        "Expected specificity for peripheral blood lymphocytes.",
        "Mean % positive in Lymphocytes: 47.80%\nMean % positive in Monocytes: 3.52%\nMean % positive in Granulocytes: 1.52%\n(Conclusion: Expected specificity for lymphocytes)"
      ],
      [
        "Specificity Study (Guava anti-CD4)",
        "Expected specificity for peripheral blood lymphocytes, allowing for known weak positive staining of monocytes.",
        "Mean % positive in Lymphocytes: 23.58%\nMean % positive in Monocytes: 81.58%\nMean % positive in Granulocytes: 4.39%\n(Conclusion: Expected specificity for lymphocytes, with known weak positive for monocytes)"
      ],
      [
        "Blood Sample Aging (Pre-Staining)",
        "Storage of unstained EDTA whole blood for specific periods without significant impact on results.",
        "Unstained EDTA anti-coagulated whole blood specimens may be stored for periods up to and including 72 hours (at 18-25°C) prior to staining and analysis."
      ],
      [
        "Blood Sample Aging (Post-Staining)",
        "Storage of stained and fixed EDTA whole blood for specific periods without significant impact on results.",
        "Stained EDTA anti-coagulated whole blood specimens may be stored for periods up to and including 24 hours (at 18-25°C or 2-8°C) prior to analysis."
      ]
    ]
  },
  "study_details": {
    "test_set_sample_size": {
      "correlation_study": "365 abnormal whole blood samples (approximately 90 per site) from three CD4+ absolute count ranges (0-200, 201-500, 501-2000).",
      "linearity_sensitivity": "22 aliquots (11 pairs) prepared from bulk blood samples.",
      "intra_laboratory_reproducibility": "10 replicate whole blood samples from each of three abnormal donors (low, mid, high ranges) per site, across 4 sites. Total 120 samples (3 donors x 10 replicates x 4 sites).",
      "carryover_study": "21 low range sample replicates and 18 high range sample replicates in a specific alternating sequence.",
      "specificity_study": "5 healthy subjects, EDTA anti-coagulated whole blood samples, analyzed for 15,000 events per blood component for each donor.",
      "blood_sample_aging": "Pre-Staining: 5 healthy normal donors, 5 blood specimens each (total 25 specimens). Post-Staining: 5 healthy normal donors, 7 stained samples per blood sample, pooled (total 35 samples for 18-25°C and 35 for 2-8°C)."
    },
    "data_provenance": {
      "correlation_study": "Prospective, collected at four clinical trial sites in the US.",
      "specificity_study": "Prospective, collected from healthy subjects.",
      "blood_sample_aging": "Prospective, collected from healthy normal donors."
    },
    "number_of_experts_ground_truth_test_set": "Not applicable, as these studies primarily assessed device performance against predicate devices or expected biological/analytical characteristics rather than expert-derived ground truth.",
    "qualifications_of_experts": "Not applicable.",
    "adjudication_method": "Not applicable.",
    "mrmc_comparative_effectiveness_study": "No, a multi-reader multi-case (MRMC) comparative effectiveness study was not explicitly described, as this is a device for quantifying CD4+ T cells, not for image interpretation by human readers. The correlation study compared the device's output to predicate flow cytometry systems.",
    "standalone_performance_done": "Yes, various standalone performance metrics were evaluated, including linearity, reproducibility (intra-laboratory precision), carryover, and specificity. The correlation study also assessed its performance against predicate devices.",
    "type_of_ground_truth_test_set": {
      "correlation_study": "Reference measurements from predicate flow cytometry systems (Becton Dickinson FACSCalibur with MultiTest or TriTest reagents).",
      "linearity_sensitivity": "Known 'Expected values' derived from gravimetric preparation of blood cell aliquots with known high and low CD4+ T cell counts.",
      "intra_laboratory_reproducibility": "The device's own measurements across replicates and sites, assessing internal consistency; no external 'ground truth' in the context of diagnostic accuracy.",
      "carryover_study": "The device's own measurements of alternating low and high concentration samples, showing lack of influence.",
      "specificity_study": "The characteristic immunological staining patterns of known cell populations (lymphocytes, monocytes, granulocytes) as observed on a reference flow cytometer (FACSCalibur) with the study reagents.",
      "blood_sample_aging": "The device's own measurements at different time points, comparing to the initial (0 hour) measurement value as a reference for stability."
    },
    "training_set_sample_size": "Not specified. As this is a flow cytometer system with reagents and software for quantitative measurements, it's unlikely to have a 'training set' in the machine learning sense. The software's algorithms would likely be based on established flow cytometry principles and calibrated/validated during development.",
    "how_ground_truth_training_set_established": "Not applicable. The system's operation and algorithms for data acquisition and analysis are based on established principles of flow cytometry and are likely calibrated and validated through internal development and testing, rather than an external 'ground truth' for a machine learning training set."
  }
}

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The Transbronchial Needle Aspiration Combination Cytology/Histology Procedural Kit is intended to retrieve and handle specimens and to prepare them for proper cytopathic and histological examination.

The Transbronchial Needle Aspiration Combination Cytology/Histology Procedural Kit contains items for obtaining and handling of cytologic and histological specimens in the context of a transbronchial aspirating needle procedure.

This submission describes a kit composed of several components, not a single device with a specific performance. The regulatory review (510(k)) found the kit substantially equivalent to legally marketed predicate devices because all its components were either already cleared, exempt from notification, or had undergone their own 510(k) process. This means the individual components were likely evaluated for their individual performance and safety, but there isn't a single study describing the overall performance of the kit in terms of specific acceptance criteria.

Therefore, many of the requested sections (e.g., sample size, expert qualifications, MRMC study, standalone performance) are not applicable to this particular 510(k) submission, as it focuses on the equivalence of a combination of components.

Here's an attempt to answer the questions based on the provided document, noting where information is not available or not applicable:

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

Based on the provided K983122 510(k) summary, there are no specific performance acceptance criteria or reported device performance metrics for the overall kit as a single device. The submission focuses on the substantial equivalence of its individual components to already legally marketed devices. The "performance" in this context refers to the intended function of each component, which is assumed to be met based on their prior clearances or exempt status.

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. This 510(k) is about substantial equivalence of a medical device kit composed of pre-existing components. There is no specific test set or clinical study described in this document for the kit itself. The performance and safety of the individual components would have been established in their respective original clearances or through their general purpose exemption status.

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. As there is no specific test set or clinical study for the kit's performance, there's no mention of experts establishing a ground truth for such a study in this submission.

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

Not applicable. No test set is described for the kit's performance.

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 submission is for a medical device kit for specimen collection and preparation, not an AI-assisted diagnostic tool.

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

Not applicable. This submission is for a medical device kit, not a standalone algorithm.

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

Not applicable. There is no explicit mention of a ground truth being established for the kit's performance in this document. The "ground truth" for each component implicitly relates to their established safety and efficacy for their individual intended uses, as determined during their original regulatory pathways.

8. The sample size for the training set

Not applicable. This submission does not involve a training set for an algorithm or model.

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

Not applicable. There is no training set mentioned in this submission.

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The Transbronchial Needle Aspiration Cytology Procedural Kit is intended to retrieve and handle specimens and to prepare them for proper cytopathic examination.

The Transbronchial Needle Aspiration Cytology Procedural Kit contains items for obtaining and handling of cytologic specimens in the context of a transbronchial aspirating needle procedure.

The provided text describes a 510(k) summary for a "TBNA Cytology Procedural Kit." This document is a premarket notification for a medical device to demonstrate its substantial equivalence to a legally marketed predicate device.

Crucially, the provided text does NOT contain any information about acceptance criteria, device performance studies, sample sizes, ground truth establishment, expert qualifications, or comparative effectiveness studies.

The document primarily focuses on:

• Identifying the submitter, contact, and proprietary name of the device.
• Stating the common name, classification name, and providing a statement of equivalence.
• Listing the components of the kit, their 510(k) status, and classification.
• Describing the device and its intended use.
• Asserting that the technological characteristics of the kit components do not vary from those used individually.
• An official FDA letter granting substantial equivalence.

Therefore, I cannot fulfill your request for the specific information regarding acceptance criteria, study details, and performance metrics as this information is not present in the provided document. This type of regulatory submission (510(k)) for a kit often relies on the established safety and effectiveness of its individual components rather than requiring a new clinical performance study for the assembled kit itself, especially if the components are already cleared or exempt.

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