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ALFIS Vitamin D in conjunction with ALFIS-3 Analyzer is an enzyme-linked fluorescence immunoassay intended for in vitro diagnostic use at clinical laboratories for the quantitative measurement of Total 25-hydroxy Vitamin D (25-OH Vitamin D) in human serum, lithium heparin plasma and sodium heparin plasma.

ALFIS Vitamin D is indicated to be used as an aid in the determination of Vitamin D sufficiency in adults.

ALFIS-3 Analyzer is a fluorescence-scanning instrument using magnetic beads and alkaline phosphatase enzyme system for in vitro diagnostic use in conjunction with various ALFIS immunoassays intended for measuring the concentration of designated analytes in human blood and other specimens.

ALFIS Vitamin D Test Cartridge is a plastic structure molded in the form of a disposable, self-contained, unitized device which houses the 'magnetic bead', 'antibody-alkaline phosphatase-conjugator (Ab-ALP)', 'sample diluent', 'diethanolamine (DEA)', '4-Methylumbelliferyl phosphate (MUP)', 'washing buffer'; all of which are integral components of ALFIS Vitamin D test.

ALFIS Vitamin D test cartridge is an elongated structure having 150.8 mm length, 17 mm width and 16 mm height.

'ALFIS Vitamin D Test ID Chip' is a flat, rectangular device with its main body measuring 23 mm × 27 mm. Half of the portion along the breadth of the main body is 5 mm thick while remaining half is 3 mm in thickness. Another rectangular portion measuring 12 mm × 10 mm × 2 mm protrudes out from the breadth of apical side of the 3 mm-thick portion of the main body.

ALFIS Vitamin D Test ID Chip is an electronic memory device fitted into a plastic matrix. Lot-specific 'ALFIS Vitamin D Test ID Chip' is an integral component of ALFIS Vitamin D test system.

ALFIS-3 analyzer is a compact, bench-top, automated, fluorometric analyzer measuring 422 mm (L) x 270 mm (W) x 292 mm (H). ALFIS-3 weighs 13.0 kg.

ALFIS-3 analyzer is a fluorometer instrument of closed-system analyzer type.

'ALFIS Vitamin D Calibrators' needs to be tested by user laboratories for periodic calibration of ALFIS Vitamin D test system.

'ALFIS Vitamin D Controls' needs to be tested by user laboratories periodically for monitoring the performance of ALFIS Vitamin D test system.

The provided text describes the performance evaluation studies for the ALFIS Vitamin D and ALFIS-3 Analyzer system, which is an in vitro diagnostic device for quantitative measurement of Total 25-hydroxy Vitamin D.

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

Acceptance Criteria and Device Performance

The document doesn't explicitly state "acceptance criteria" in a tabular format with specific numerical targets for each parameter (e.g., "LoD

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The hemochroma PLUS System is for the quantitative determination of hemoglobin concentration in non-anticoagulated capillary (finger-stick) whole blood or venous whole blood (K2-EDTA, sodium citrate, lithium heparin, or sodium heparin). The testing system is designed for point-of-care settings, hospitals, and medical lab facilities.

Estimation of hematocrit, as a function, is only for normal hemoglobin values, 12.0 to 180 g/dL) and in patients ≥ 6 months old.

The hemochroma PLUS Controls are intended for use as quality control material to assure the validity and performance of the hemochroma PLUS system in measuring the human hemoglobin concentration.

The hemochroma PLUS Microcuvettes are only used with hemochroma PLUS Analyzer. The hemochroma PLUS System is for in vitro diagnostic only.

The hemochroma PLUS Analyzer calculates the test result automatically and displays hemoglobin concentration in terms of g/dL.

The hemochroma PLUS Analyzer is a battery powered, hand-held device to measure the concentration of total hemoglobin in blood in 3 seconds with 15uL of whole blood. Whole blood may be collected by fingerstick (capillary) or venipuncture and analyzed without preprocessing. The hemochroma PLUS Analyzer uses hemochroma PLUS Microcuvettes with dual ports where the user applies samples either through capillary action or direct volume pipetting.

The hemochroma PLUS Analyzer determines hemoglobin concentration in whole blood samples using a dual wavelength photo-absorption method and measures the degree of light absorption with a spectrophotometer. The optical distance between the hemochroma PLUS 3 Microcuvette walls is fixed and permits photometric determination of hemoglobin in undiluted blood samples. The computed end result is displayed on the LCD display and can be printed on an external printer (optional).

The hemochroma PLUS System consists of a hemochroma PLUS Analyzer, single-use hemochroma PLUS Microcuvettes, hemochroma PLUS ID Chip, optical System Check Microcuvette and hemochroma PLUS Controls.

Here's a breakdown of the acceptance criteria and the study details for the hemochroma PLUS System, based on the provided document:

Acceptance Criteria and Reported Device Performance

The acceptance criteria are generally established by meeting specific performance metrics determined by the manufacturer, often guided by CLSI (Clinical and Laboratory Standards Institute) guidelines, to ensure accuracy, precision, and reliability. The document details analytical performance studies. The results from the repeatability, reproducibility, linearity, detection limits, and method comparison studies demonstrate that the device meets the defined acceptance criteria, often by being "within the defined acceptance criteria" or showing "comparable performance."

• Within Run: SD (0.09-0.11), %CV (0.47-1.68) for Hgb concentrations 5.6-23.7 g/dL.
• Total: SD (0.20-0.25), %CV (1.06-3.67) for Hgb concentrations 5.6-23.7 g/dL.
  Reproducibility (Across sites, operators, and days):
• Site 1: Total %CV (1.08-1.99) for Hgb controls 8.5-15.8 g/dL.
• Site 2: Total %CV (1.08-1.74) for Hgb controls 8.5-15.8 g/dL.
• Site 3: Total %CV (1.14-2.10) for Hgb controls 8.5-15.8 g/dL.
• Combined Sites: Total %CV (1.23-2.30) for Hgb controls 8.4-15.8 g/dL. Performance results were "within the defined acceptance criteria." |
  | Linearity/Assay Range | Linearity across the claimed measuring range | Linear regression demonstrating acceptable correlation. | Linearity: Linear regression performed on eleven hemoglobin concentration levels (2.5-25.6 g/dL) demonstrated linearity over the claimed measuring range of 5.0-25.6 g/dL. |
  | Detection Limits | Limit of Blank (LoB) | Explicit acceptance criteria not given, but a calculated value is provided. | LoB: 0.23 g/dL |
  | | Limit of Detection (LoD) | Explicit acceptance criteria not given, but a calculated value is provided. | LoD: 1.66 g/dL |
  | | Limit of Quantitation (LoQ) | % Total-error smaller than the desired total error for the measurand. | LoQ: 4.5 g/dL (data considered acceptable as % Total-error was smaller than desired total error). |
  | Analytical Specificity | Interference by exogenous and endogenous substances | Non-significant interference up to specified concentrations. | Interference Study: All tested interference substances (endogenous and exogenous) showed non-significant interference up to the specified concentrations. |
  | Method Comparison | Agreement with predicate device (HemoCue Hb 301 System) | Linear regression demonstrating comparable performance (implied acceptance within a certain slope, intercept, and R-value). | Method Comparison: Linear regression analyses showed comparable performance. Example (Site 1 Capillary): Slope = 0.9942 (95% CI: 0.941-1.048), Intercept = 0.1214 (95% CI: -0.650-0.892), r = 0.980. The study demonstrated that analytical performance is "substantially equivalent" to the predicate device. |
  | Matrix Comparison | Comparability between venous and capillary whole blood samples | Results of Bland-Altman plot analysis and % difference meeting acceptance criteria. | Matrix Comparison: Results of Bland-Altman plot analysis and % difference between venous whole blood samples and capillary whole blood samples met the acceptance criteria. |
  | Sample Stability | Stability of blood samples stored at 2-8°C | Not explicitly stated, but based on recovery. | Sample Stability: Supports a stability claim of 24 hours when stored at 2-8°C. |
  | Anticoagulant Comparison | Agreement between K2EDTA and other anticoagulants | Results of Bland-Altman plot analysis and % difference meeting acceptance criteria. | Anticoagulant Comparison: Results of Bland-Altman plot analysis and % difference between K2EDTA and 4 other anticoagulant tubes were "within the defined acceptance criteria." |

Study Details:

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

   • Repeatability: 5 test samples (ranging from 5.6 g/dL to 23.7 g/dL) were tested 84 times each (total of 420 measurements per study). Data Provenance: In-house (presumably Republic of Korea, where the sponsor is located) and retrospective (prepared samples).
   • Reproducibility: 3 control levels (low, middle, high) were tested with 160 results per control level per site (total 480 results per control level across all 3 sites). Data Provenance: Three point-of-care clinical sites in the United States. Prospective.
   • Linearity/Assay Reportable Range: 11 hemoglobin concentration levels tested in triplicate. Data Provenance: Not explicitly stated, but in-house testing. Retrospective.
   • Detection Limit (LoB, LoD, LoQ):
     • LoB: 5 blank samples, 5 replicates, 3 days, 3 microcuvette lots, 3 analyzers (total 75 results per microcuvette lot).
     • LoD: 6 Hgb-low samples, 5 replicates, 3 days, 3 microcuvette lots, 1 analyzer (total 90 results per microcuvette lot).
     • LoQ: 6 low Hgb samples, 5 replicates, 3 days, 3 microcuvette lots, 1 analyzer (total 90 results per microcuvette lot).
       Data Provenance: Not explicitly stated, but in-house testing. Retrospective/prepared samples.
   • Analytical Specificity (Interference): 3 hemoglobin levels of human whole blood samples, tested in 5 replicates. Data Provenance: Not explicitly stated, but in-house testing. Retrospective/prepared samples.
   • Method Comparison: 60 capillary finger-stick blood samples and 70 venous blood samples (including 10 spiked extreme range samples). Data Provenance: Three point-of-care clinical sites in the United States. Prospective.
   • Matrix Comparison: 80 study participants (venous and capillary whole blood). Data Provenance: Not explicitly stated, likely clinical sites in the United States. Prospective.
   • Sample Stability: 37 fresh venous blood samples. Data Provenance: Not explicitly stated, but in-house testing. Prospective.
   • Anticoagulant Comparison: Venous blood collected from 50 study participants. Data Provenance: Not explicitly stated. Prospective.
   • Disease Conditions Comparison: 3 specimens from Polycythemia, 2 from hypochromia, 3 from high WBC count, 2 from sickle cell donors. Each tested 5 times. Data Provenance: Not explicitly stated. Retrospective.

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

   • For most analytical performance studies (precision, linearity, detection limits, interference), the "ground truth" is typically established by the carefully prepared samples/controls according to standardized procedures (e.g., using reference materials or precise spiking methods) rather than expert consensus on individual case interpretation.
   • For Method Comparison and Anticoagulant Comparison, the predicate device (HemoCue Hb 301 System) serves as the reference ("ground truth") for comparison. The document does not mention the use of human experts to establish ground truth for individual cases, but rather relies on the established accuracy of the predicate device.
   • For Reproducibility at clinical sites, data was collected by "three operators (one at each site)," but their qualifications are not specified beyond being operators.

3. Adjudication Method for the Test Set:

   • No adjudication method (like 2+1 or 3+1 consensus) is described, as the studies primarily involve quantitative measurements and comparison to a reference method (predicate device) or internally established values for controls/calibrators, rather than subjective interpretations by multiple experts.

4. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done:

   • No. The studies described are primarily analytical performance studies comparing the device's measurements to a reference method (the predicate device) or established laboratory standards. There is no mention of a human-in-the-loop study assessing improved reader performance with or without AI assistance. This device is an automated hemoglobin analysis system, not an AI interpretation tool for imaging or other diagnostic data that typically involves human readers.

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

   • Yes, all the described analytical and clinical performance studies (precision, linearity, detection limits, interference, method comparison, matrix comparison, stability studies, anticoagulant comparison, disease conditions comparison) are conducted to assess the performance of the device itself (algorithm + hardware) in a standalone manner, without explicit human interpretive involvement in the result generation or assessment beyond operating the device.

6. The Type of Ground Truth Used:

   • Reference Method: For method comparison, the HemoCue Hb 301 System was used as the reference method.
   • Prepared Samples/Controls: For precision, linearity, detection limits, and interference studies, ground truth was implicitly established through the careful preparation of samples with known hemoglobin concentrations or the use of quality control materials with assigned values.
   • Natural Samples: Many studies utilized "natural human whole blood samples" or "fresh venous blood samples," for which the "ground truth" would be the measured value by the hemochroma PLUS in initial readings, or by the predicate device for comparative studies.

7. The Sample Size for the Training Set:

   • The document primarily describes validation studies for a device, not the development of an AI algorithm which requires a separate training set. The device itself uses a "pre-programmed calibration" and an "ID chip" with "calibration data/information." The "Value Assignment" section for the hemochroma PLUS Controls used 15 replicates for each control level to set the mean values, and then 10 replicates on each of three analyzers with three microcuvette lots to verify these values. This isn't a "training set" in the context of machine learning, but rather establishing performance characteristics for physical controls used with a calibrated instrument.

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

   • As noted above, this device is not an AI/machine learning system that requires a "training set" in the conventional sense. Its "ground truth" for calibration and control value assignment is established through standard laboratory practices, including testing in multiple replicates, using multiple lots of reagents/devices, and setting mean values through statistical analysis. The device uses "pre-programmed calibration" and calibration data from its ID chip, which would have been established by the manufacturer using reference methods and standard calibration procedures.

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The hemochroma PLUS System is for the quantitative determination of hemoglobin concentration in non-anticoagulated capillary (finger-stick) whole blood or venous whole blood (K.2-EDTA, sodium citrate, lithium heparin, or sodium heparin) of adults. The testing system is designed for point-of-care use in primary care settings, hospitals, and medical lab facilities. Estimation of hematocrit, as a function, is only for normal hemoglobin values from 12.0 to 18.0 g/ dL (120 to 180 g/L).

The hemochroma PLUS Controls are intended for use as quality control material to assure the validity and performance of the hemochroma PLUS system in measuring the human hemoglobin concentration.

The hemochroma PLUS Microcuvettes are only used with hemochroma PLUS Analyzer. This device has not been evaluated for pediatric samples. The device has been evaluated for individuals ranging in age from 18 to 96 years old. The hemochroma PLUS System is for in vitro diagnostic only.

The hemochroma PLUS Analyzer is a battery powered, hand-held device to measure the concentration of total hemoglobin in blood in 3 seconds with 15ul of whole blood. Whole blood may be collected by fingerstick (capillary) or venipuncture and analyzed without pre-processing. The hemochroma PLUS Analyzer uses hemochroma PLUS Microcuvettes with dual ports where the user applies samples either through capillary action or direct volume pipetting.

The hemochroma PLUS Analyzer determines hemoglobin concentration in whole blood samples using a dual wavelength photo-absorption method and measures the degree of light absorption with a spectrophotometer. The optical distance between the hemochroma PLUS Microcuvette walls is fixed and permits photometric determination of hemoglobin in undiluted blood samples. The computed end result is displayed on a LCD display and can be printed on an external printer (optional).

The hemochroma PLUS System consists of a hemochroma PLUS Analyzer, single-use hemochroma PLUS Microcuvettes, hemochroma PLUS ID Chip, optical System Check Microcuvette and hemochroma PLUS Controls.

1. hemochroma PLUS Microcuvette
   The hemochroma PLUS Microcuvettes are specially designed for use with the hemochroma PLUS Analyzer. The microcuvettes function as measuring devices specifically holding 15 uL of blood and are inserted into the hemochroma PLUS Analyzer by placing it into the cuvette holder. The optical distance between the hemochroma PLUS Microcuvette walls is fixed and by measuring the degree of light absorption permits photometric determination of the hemoglobin in undiluted blood samples.

2. hemochroma PLUS ID Chip
   The hemochroma PLUS ID chip contains encoded memory with the calibration data/information. With the ID chip inserted in the designated port, the hemochroma PLUS Analyzer reads and utilizes the calibration data regarding the lot under consideration and applies appropriate correction to the conversion formula while computing the test result.

3. hemochroma PLUS Optical System Check Microcuvette
   hemochroma PLUS Optical System Check Microcuvette is designed for use with the hemochroma PLUS Analyzer only. The Optical System Check Microcuvette is a special glass filter used to measure the degree of light absorption with the spectrophotometric method. If the result is between 11.7-12.3 g/dL, the optic system is working properly according to specification.

4. hemochroma PLUS Controls
   The hemochroma PLUS Controls: Level 1 (Low), Level 2 (Middle), and Level 3 (High), are external quality controls designed for use with hemochroma PLUS Analyzer only.

Here's an analysis of the provided text, focusing on the acceptance criteria and study proving the device's performance:

The document is a 510(k) Summary for the "hemochroma PLUS System," an automated hemoglobin system. It outlines the analytical performance studies conducted to establish substantial equivalence to a predicate device.

Acceptance Criteria and Reported Device Performance

The document doesn't explicitly list "acceptance criteria" for each study in a table format. Instead, it states for each analytical study that the "results were within the defined acceptance criteria" or "met the acceptance criteria." This implies that internal acceptance criteria were pre-established by the manufacturer for each test (e.g., repeatability, reproducibility, linearity, interference, method comparison, stability, detection limits) and the observed performance successfully satisfied them.

However, based on the provided results, we can infer some performance metrics:

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AFIAS iFOB in conjunction with AFIAS 50 is a fluorescence immunoassay system for qualitative detection of fecal occult blood (FOB) in human fecal samples. AFIAS iFOB is an in vitro diagnostic test used by professional clinical laboratories and clinical reference laboratories for routine physical examination when gastrointestinal bleeding may be suspected. Intended users/operators for AFIAS iFOB is professional medical personnel.

AFIAS iFOB in conjunction with AFIAS-50 is a fluorescence immunoassay system for qualitative detection of fecal occult blood (FOB) in human fecal samples.
Components of AFIAS iFOB: AFIAS iFOB consist of a test cartridge, ID chip, sample collection tube contain the extraction buffer, package insert, applicator sticks, collection slide, mailing envelope, sample collection tissues, instruction for use and patient instructions.
The AFIAS iFOB test cartridge contains a test strip; with a nitrocellulose membrane of which, mouse monoclonal anti hemoglobin labeled with fluorescence and anti rabbit IgG labeled fluorescence have been immobilized at the glaze line, mouse monoclonal anti hemoglobin at the test line and rabbit IgG at the control line. Each test cartridge is individually sealed in an aluminum foil pouch containing a desiccant. Twenty-five sealed test cartridges are packed in a box which also contains an ID chip and 25 mailing envelopes which contain a collection slide, applicator sticks and sample collection tissues.
The ID chip contains a memory device that contains encoded calibration data/information for the batch (lot-to-lot) variation. With the ID chip inserted in the designated port, AFIAS-50 reads and utilizes the calibration data regarding the batch/lot under consideration and applies appropriate correction to the conversion formula while computing the test result.
The AFIAS iFOB extraction buffer tube with extraction buffer is sealed with plastic caps. The upper side is capped with a plastic cap without a sampling stick. The bottom side is capped with a plastic cap with a sampling stick. The extraction buffer contains bovine serum albumin (BSA) as a stabilizer, tween 20 as a surfactant and sodium azide in phosphate buffered saline (PBS) as a preservative. Each extraction buffer tube contains 1 mL extraction buffer. Twenty-five pre-filled extraction buffer tubes are packed in a test cartridge box.
Components of AFIAS-50: Power cable, Barcode reader, Thermal printer paper, Collection tube rack holder, Sample tips, Test cartridge magazine, Waste bin, System check cartridge set.

The provided text describes the performance characteristics of the AFIAS iFOB device, including precision, prozone effect, specificity, cross-reactivity, interference, stability studies, assay cut-off, and method comparison with a predicate device.

Here's the information extracted and organized according to your request:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly define "acceptance criteria" in a separate section with specific numerical thresholds for each performance characteristic. Instead, it presents study results and then generally states whether the results "passed acceptance criteria" or demonstrated "acceptable overall percent agreement." For the purpose of this response, I will interpret the reported performance as meeting implicit acceptance criteria due to phrases like "passed acceptance criteria" or "acceptable overall percent agreement."

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

• Precision/Reproducibility:
  • Sample Size: Seven fecal hemoglobin concentrations (4 µg Hb/g stool to 80 µg Hb/g stool or equivalent ng/mL). Fourteen replicates were performed for each sample and concentration level per study (repeatability, lot-to-lot, between-run, between-device, between-site, combined). Totaling 98 samples for repeatability and 294 for each reproducibility component, and 1274 for combined reproducibility results shown in the table.
  • Data Provenance: Not explicitly stated, but implies laboratory-controlled spiked fecal samples. Conducted at "one intended use site" for repeatability, and "three intended use sites" for reproducibility. Locations of these sites (e.g., country of origin) are not specified. The study design (spiked samples) suggests a controlled laboratory setting rather than direct patient samples.
• Prozone (Hook Effect):
  • Sample Size: Twelve hemoglobin concentrations (700 ng/mL to 2000 ng/mL). Twenty aliquots of each sample mixed with extraction buffer.
  • Data Provenance: Spiked stool specimens with human blood (controlled laboratory setting).
• Specificity & Cross-Reactivity:
  • Sample Size: Not explicitly stated for each test, but involved testing with specific animal hemoglobin concentrations and a 'Hemoglobin S' human variant.
  • Data Provenance: Spiked test samples (controlled laboratory setting).
• Interference:
  • Sample Size: Not explicitly stated for each test, but involved testing with specific biomolecule concentrations.
  • Data Provenance: Spiked test samples (controlled laboratory setting).
• Stability Studies (Test Kit, Stool Sample on Slide, Stool Sample in Buffer Tube, Stool Sample in Cups):
  • Sample Size: Nine hemoglobin concentrations (25 ng/mL to 500 ng/mL) for test kit, slide, and buffer tube stability. Twenty-one aliquots of each concentration for slide and buffer tube stability. Six hemoglobin concentrations (50 ng/mL to 150 ng/mL), with 384 specimen cups (64 cups x 6 concentrations x 4 storage temperatures) for stool sample in cups stability.
  • Data Provenance: Spiked Hb-free stool samples with human blood (controlled laboratory setting).
• Stability of i-CHROMA iFOB Controls:
  • Sample Size: Ten aliquots of each control level. Three lots of i-CHROMA iFOB Controls (negative and positive).
  • Data Provenance: Not entirely clear if these are spiked or internal controls themselves, implying a controlled laboratory evaluation.
• Humidity Effect Stability Study:
  • Sample Size: Seven hemoglobin concentrations (50 ng/mL to 1,000 ng/mL). 50 AFIAS iFOB test cartridges.
  • Data Provenance: Spiked Hb-free stool samples with human blood (controlled laboratory setting).
• Assay Cut-off:
  • Sample Size: Seven fecal hemoglobin concentrations (50 ng/mL to 150 ng/mL). Forty aliquots of each concentration.
  • Data Provenance: Spiked stool samples with human blood (controlled laboratory setting).
• Method Comparison:
  • Sample Size: 522 patient samples (165 positive, 357 negative).
  • Data Provenance: Patient samples. Conducted at "one professional medical laboratory in the U.S. and two international professional medical laboratories." The document does not specify if these were retrospective or prospective, but the phrasing "patient samples" and "method comparison" often implies prospective or a mix.
• Specimen Collection Verification:
  • Sample Size: Eight hemoglobin concentrations (25 ng/mL to 1,000 ng/mL). Twenty aliquots of each concentration.
  • Data Provenance: Spiked Hb-free fecal samples with human blood (controlled laboratory setting).

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

• For Precision, Prozone, Specificity, Cross-Reactivity, Interference, Stability, Humidity Effect, Assay Cut-off, and Specimen Collection Verification studies: The "ground truth" was established by creating spiked fecal samples with known hemoglobin concentrations. This means the "expert" here is the precise control over the spiking process and analytical methods to determine the exact hemoglobin levels. Human experts were not involved in establishing this ground truth, rather the experimental design.
• For Method Comparison: The ground truth for the 522 patient samples was established by the predicate device, i-CHROMA iFOB test (K132167). This study compared the new device's results to the predicate device's results. No explicit mention of human experts defining the "true" positive or negative status of these patient samples beyond the predicate device's output.

4. Adjudication Method for the Test Set

• For Precision, Prozone, Specificity, Cross-Reactivity, Interference, Stability, Humidity Effect, Assay Cut-off, and Specimen Collection Verification studies: No adjudication method was mentioned as the ground truth was based on known, spiked concentrations or direct comparison to the predicate's established output for comparison.
• For Method Comparison: No specific adjudication method (like 2+1 or 3+1) is mentioned. The comparison was directly between the AFIAS iFOB and the predicate i-CHROMA iFOB device.

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

• No, a Multi Reader Multi Case (MRMC) comparative effectiveness study was not done. This device is an in vitro diagnostic (IVD) fluorescence immunoassay system for qualitative detection of fecal occult blood (FOB), which automatically produces a result (positive or negative) without human interpretation of images or complex data where an "AI assistant" would typically improve a human reader's performance. The studies performed were analytical performance studies and a method comparison with a predicate device.

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

• Yes, the performance studies described are essentially standalone. The AFIAS iFOB system (device with its instrument AFIAS-50) is an automated system. The performance characteristics (precision, stability, cut-off, method comparison) evaluate the device's ability to accurately detect FOB based on its internal algorithms and fluorescence detection, without human interpretation of the final result. The professional medical personnel are "users/operators," not "interpreters" who then make a diagnostic decision on top of what the device outputs.

7. The Type of Ground Truth Used

• For most performance studies (Precision, Prozone, Specificity, Cross-Reactivity, Interference, Stability, Humidity Effect, Assay Cut-off, Specimen Collection Verification): The ground truth was spiked samples with known, carefully defined concentrations of human hemoglobin or other target analytes/interferents. This is a form of analytical ground truth.
• For Method Comparison: The ground truth for the patient samples was established by the predicate device (i-CHROMA iFOB test). This means the new device was compared against a previously cleared and accepted device's results.

8. The Sample Size for the Training Set

The document does not mention a "training set" or machine learning in the context of device development. This type of IVD device (fluorescence immunoassay) typically relies on pre-programmed calibration data and antigen-antibody reactions, not on machine learning algorithms that require explicit training sets. The "ID chip" contains encoded calibration data, which serves a similar function to calibration in traditional assays rather than training in machine learning.

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

As no "training set" is mentioned or implied for machine learning, this question is not applicable. The device's operation is based on established immunochemistry principles and factory-calibrated parameters transmitted via an "ID chip" for each lot.

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The Hema-Screen TM Specific Gold is for the rapid and qualitative determination of Human Blood fecal samples. It is intended for professional and laboratory use only. It is also useful for determining gastrointestinal bleeding due to a number of gastrointestinal (GI) disorders such as diverticulitis, colitis, polyps and colorectal cancer. This test is recommended for use in routine physical examines, hospital monitoring of bleeding in patients, and for screening for colorectal cancer or gastrointestinal (GI) bleeding from any source.

hema-screen™ SPECIFIC Gold is a qualitative, sandwich dye conjugate immunoassay that employs a unique combination of monoclonal antibodies to selectively identify the globin component of human hemoglobin in fecal specimens with a high degree of analytical sensitivity. Two samples of feces, collected using the unique DEVEL-A-TAB Sampler, are dispersed in a single tube containing a known volume of buffer. The unique design of the Sampler ensures that a controlled amount of feces is added to the specimen preparation tube. Then, the feces in buffer is transferred to the test cassette detection system using the tube itself as the delivery system. In less than five minutes, unusually elevated concentrations of human hemoglobin in feces can be detected and positive results for abnormal concentrations of hemoglobin can be seen in the test cassette detection system as early as two or three minutes after application of specimen. As the feces in buffer specimen flows up through the absorbent device, the labeled antibody-dye conjugate binds to the globin of hemoglobin in the specimen forming an antibody-antigen complex. This complex binds to anti-globin antibody in the positive test reaction zone and produces a pink-rose color band. In the absence of hemoglobin, there is no line in the test reaction zone. The pink-rose color bands in the control reaction zone demonstrate that the reagents and devices are functioning correctly. In the extremely rare event of operator or test cassette failure, sufficient specimen is available in the tube to repeat the procedure with another test cassette.

The provided text describes a 510(k) submission for a medical device called "hema-screen™ SPECIFIC Gold," which is a Fecal Immunochemical Test (FIT) for detecting human blood in fecal samples. The submission asserts substantial equivalence to a previously cleared predicate device, "hema-screen™ SPECIFIC."

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

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

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

• Sample Size: The document does not specify the exact number of patient fecal samples used in the "Summary of Patient Fecal Sample Testing." It only states that "Each of the three lots of hema-screen™ SPECIFIC Gold were 100% agreement with predicate..." This implies that multiple samples were tested across different manufacturing lots, but the specific count is not provided.
• Data Provenance: The document does not explicitly state the country of origin of the data or whether the study was retrospective or prospective.

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. Given that this is a comparison to a predicate device (hema-screen™ SPECIFIC), the "ground truth" for the test set appears to be the results obtained from the predicate device itself, rather than external expert assessment.

4. Adjudication method for the test set

• None specified. The study's focus was a direct comparison between the subject device and the predicate device, not on independent expert re-assessment of results.

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 qualitative diagnostic kit (a Fecal Immunochemical Test), not an AI-powered image analysis system or a device that involves human readers interpreting complex data. Therefore, an MRMC study is not relevant to this type of device.

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

• Yes, in essence. The "Summary of Patient Fecal Sample Testing" describes the performance of the device itself (hema-screen™ SPECIFIC Gold) compared to the predicate. While the device is a diagnostic kit used by professionals, the performance metrics (agreement, PPA, NPA) reflect the device's inherent ability to detect human hemoglobin in fecal samples. There isn't an "algorithm" in the typical sense of AI, but the device's chemical and physical principles determine its standalone performance.

7. The type of ground truth used

• The ground truth used was comparison to a legally marketed predicate device (hema-screen™ SPECIFIC). The assumption is that the predicate device's results serve as the accurate reference point for comparison.

8. The sample size for the training set

• Not applicable. This device is a diagnostic kit, not a machine learning algorithm that requires a training set. The development of the device would involve chemical formulation and validation, not data-driven training.

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

• Not applicable. As stated above, there is no "training set" for this type of device.

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hema-screen ER XCEL™ Enhanced Readability Fecal Occult Blood Test is a rapid, convenient, and non-offensive qualitative method for detecting occult blood in the stool. It is intended for professional use as an aid in the diagnosis of asymptomatic gastrointestinal conditions that may manifest themselves by the presence of occult blood in the stool. This test is recommended for use in routine hospital testing, mass screening programs for colorectal cancer, and in testing of postoperative patients and newborn infants.

hema-screen ER XCEL™ in its original concept as slides and tape was designed to offer the hospital, mass screening programs and clinical laboratories a convenient rapid method for handling fecal specimens in testing for occult blood. hema-screen ER XCEL™ is especially useful for mass screening programs as its enhanced readability feature facilitates the technicians' ability to make a determination.

hema-screen ER XCEL™ eliminates the mess and odors associated with the collection and transport of fecal specimens. Slides can be prepared at the patient's bedside and placed in a sealed envelope or by the patient at home and mailed to the hospital or laboratory in an inoffensive manner for development and evaluation.

hema-screen ER XCEL™ single slides are convenient for use when single stool specimens are to be tested. A single test is indicated when blood loss in the gastrointestinal tract is strongly suspected, for example, in persons with symptoms of ulcers, anemia, black stools or postoperative patients.

hema-screen ER XCEL™ Enhanced Readability Patient Packs are to be utilized so the patient can serially collect specimens at home over the course of three bowel movements. Patients should be instructed to follow the directions exactly, as the potential for false positive results exists due to improper diet, blood on the hands, hemorrhoids or if the test is used during menstrual bleeding. After all three slides are prepared, the slides may be sent back to the hospital laboratory for developing and evaluation. Preparation of three consecutive slides is recommended for screening asymptomatic patients by the American Cancer Society.

When stool specimens containing occult blood are applied hema-screen ER XCEL™ test paper, the hemoglobin portion of the occult blood comes in contact with the guaiac. When the hema-screen ER XCEL™ peroxide developing solution is added, a guaiac-peroxidase like reaction occurs. The chemical reaction becomes visible by the appearance of a blue-green color between 30 seconds and 60 seconds if occur blood is present.

This document describes the hema-screen ER XCEL™ Enhanced Readability Fecal Occult Blood Test, which is a qualitative method for detecting occult blood in stool. The application is a 510(k) premarket notification claiming substantial equivalence to the predicate device hema-screen™ ER (K102664).

1. Table of Acceptance Criteria and Reported Device Performance:

   The document does not explicitly present a table of acceptance criteria with specific performance metrics (e.g., sensitivity, specificity, accuracy thresholds) and corresponding reported device performance values. The substantial equivalence claim is based on the assertion that the "fundamental scientific technology of the modified device has not changed" and "There is no change in analytical sensitivity of the new device." The changes primarily involve the addition of an optional patient sampling slide with a GRID design for enhanced readability and ease of use, rather than a change in the underlying diagnostic performance.

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

   The document does not provide details on a specific test set sample size or data provenance (e.g., country of origin, retrospective/prospective). The application relies on demonstrating that the modified device's analytical sensitivity has not changed compared to the predicate device, which would imply that its performance characteristics are comparable.

3. Number of Experts Used to Establish Ground Truth and Qualifications:

   The document does not specify the number or qualifications of experts used to establish ground truth. As this is a 510(k) for a modification (addition of a GRID design for readability) to a previously cleared device, the focus is on maintaining existing performance rather than re-establishing ground truth for diagnostic accuracy with a new study.

4. Adjudication Method for the Test Set:

   No adjudication method is described.

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

   No MRMC comparative effectiveness study is mentioned. The device is a qualitative test for occult blood, not an AI-assisted diagnostic tool for human readers.

6. Standalone Performance Study:

   The document does not describe a standalone (algorithm only) performance study as this is not an AI/algorithm-based device. The device itself is a qualitative chemical test. The "enhanced readability" feature refers to the physical design of the sampling slide.

7. Type of Ground Truth Used:

   The document implies that the ground truth for establishing the performance of the original predicate device (and by extension for demonstrating no change in the modified device) would be related to the presence or absence of occult blood, likely confirmed by established clinical methods or laboratory techniques. However, specific details on how this ground truth was used or established are not provided in this summary.

8. Sample Size for the Training Set:

   The document does not mention a training set sample size, as this is a chemical diagnostic test and not a machine learning or AI-based device that would typically involve a training set.

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

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

Summary of Device Modification and Basis for Substantial Equivalence:

The primary change in the hema-screen ER XCEL™ device from its predicate (hema-screen™ ER) is the addition of an optional patient sampling slide with a GRID design. The manufacturer states:

• "The fundamental scientific technology of the modified device has not changed."
• "The internal guaiac paper has neither been modified nor reformulated."
• "There is no change in analytical sensitivity of the new device."
• The modified design simply features a smaller surface area (small circles) on the outer cardboard to help prevent oversampling and ease of use for the patient, which facilitates readability for technicians.

Therefore, the application argues for substantial equivalence based on the technological characteristics being identical for the core diagnostic mechanism and that the design change related to readability does not impact the scientific principle, materials, intended use, operating principle, basic design, shelf life, or enhanced developing solution. The risk analysis indicated that the modifications were satisfactory and did not raise new issues of safety or effectiveness.

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hema-screen™ ER is a rapid, convenient, and non-offensive qualitative method for detecting occult blood in the stool. It is intended for professional use as an aid in the diagnosis of asymptomatic gastrointestinal conditions that may manifest themselves by the presence of occult blood in the stool. This test is recommended for use in routine hospital testing, mass screening programs for colorectal cancer, and in testing of postoperative patients and newborn infants.

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The provided text is an FDA 510(k) clearance letter for the Hema Screen™ ER occult blood test. It confirms that the device is substantially equivalent to legally marketed predicate devices. However, this document does not contain any information regarding acceptance criteria, study details, performance metrics, sample sizes, ground truth establishment, or expert qualifications.

Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them based on the provided text. The document primarily focuses on the regulatory clearance process and does not delve into the technical validation studies of the device itself.

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The Hema-Screen™ Specific is for the rapid and qualitative determination of Human Blood fecal samples. It is intended for professional and laboratory use only. It is also useful for determining gastrointestinal bleeding due to a number of gastrointestinal (GI) disorders such as diverticulitis, colitis, polyps and colorectal cancer. This test is recommended for use in routine physical examines, hospital monitoring of bleeding in patients, and for screening for colorectal cancer or gastrointestinal (GI) bleeding from any source.

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This is an FDA 510(k) clearance letter for the hema-screen™ SPECIFIC Immunochemical Fecal Occult Blood Test (FOBT) with DEVEL-A-TAB Sampler. While it confirms the device is substantially equivalent to a predicate device, it does not contain the detailed study information typically found in a clinical study report or a 510(k) summary (which might be a separate document). Therefore, I cannot provide all the requested information.

Based on the provided document, here's what can be extracted and what cannot:

1. Table of acceptance criteria and the reported device performance:

This information is not present in the provided document. The document is a clearance letter, not a performance study report.

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

This information is not present in the provided document.

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

This information is not present in the provided document.

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

This information is not present in the provided 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 immunochemical fecal occult blood test, which is a diagnostic kit, not an AI-powered image analysis system that would typically involve human readers interpreting results. Therefore, an MRMC study with human readers improving with AI assistance would not be applicable to this type of device.

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

Given this is a diagnostic test kit and not an algorithm, the concept of "standalone algorithm performance" as it applies to AI/software devices is not directly applicable. The performance would be based on the biochemical reaction and detection method of the kit itself. The document does not provide performance data for the kit.

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

This information is not present in the provided document. For a fecal occult blood test, ground truth would typically be established through colonoscopy/pathology results to confirm the presence or absence of GI bleeding or specific conditions like colorectal cancer.

8. The sample size for the training set:

This information is not present in the provided document. This device is not an AI/machine learning model that typically requires a "training set."

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

This information is not present in the provided document. As mentioned, the concept of a "training set" for an AI/ML model is not applicable here.

Summary of available information from the document:

• Device Name: hema-screen™ SPECIFIC Immunochemical Fecal Occult Blood Test (FOBT) with DEVEL-A-TAB Sampler
• Intended Use: Rapid and qualitative determination of Human Blood in fecal samples. Intended for professional and laboratory use only. Useful for determining gastrointestinal bleeding due to GI disorders (diverticulitis, colitis, polyps, colorectal cancer). Recommended for routine physical exams, hospital monitoring of bleeding, and screening for colorectal cancer or GI bleeding.
• Regulatory Class: Class II
• Predicate Device: The substantial equivalence determination is based on a comparison to legally marketed predicate devices, but specific details of those predicate devices or the comparison are not provided in this letter.

To obtain the detailed study information, one would typically need to review the 510(k) Summary that Immunostics, Inc. submitted to the FDA, which often contains abstracts of the performance studies. This clearance letter only confirms the FDA's decision, not the full dataset or methodology.

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The Immuno / hCG Detector™ - Urine is for the rapid and qualitative determination of Human Chorionic gonadotropin (hCG) in urine as an aid for the early detection of pregnancy. It is intended for professional and laboratory use only.

The Immuno / hCG Detector Stix is for the rapid and qualitative determination of Human Chorionic gonadotropin (hCG) in urine as an aid for the early detection of pregnancy. It is intended for professional and laboratory use only.

The Immuno / hCG Detector Combi™ is for the rapid and qualitative determination of Human Chorionic gonadotropin (hCG) in urine as an aid for the early detection of pregnancy. It is intended for professional and laboratory use only.

Not Found

I am sorry, but the provided text is a 510(k) clearance letter from the FDA for a medical device called "Immuno/hCG Detector™". It does not contain information about acceptance criteria, device performance studies, sample sizes, expert qualifications, or ground truth establishment. It primarily states that the device is substantially equivalent to legally marketed predicate devices for the detection of Human Chorionic Gonadotropin (hCG) in urine for early pregnancy detection, and that it is intended for professional and laboratory use only.

Therefore, I cannot extract the requested information from the given input.

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The RUBELLACOL™ TEST is to be used as an aid in the detection of anti-rubella virus antibodies in serum. This test is "For Professional Use Only".

Not Found

This document is a 510(k) clearance letter from the FDA for a device called "RUBELLACOL™ Test". It does not contain the information requested regarding acceptance criteria or a study proving device performance on several specific points.

Here's a breakdown of why the requested information cannot be extracted from this document:

• This is a regulatory clearance letter, not a scientific study report. It confirms that the device is "substantially equivalent" to a legally marketed predicate device, allowing it to be marketed. It does not detail the specific performance studies conducted for this equivalence determination.
• The letter refers to a "510(k) premarket notification" which would contain the study details, but that notification document itself is not provided.

Therefore, I cannot provide the requested table or answer most of the specific questions.

However, based on the context of what a 510(k) submission typically entails, I can infer some general information about the type of study that would have been done for a device like this, but this is inferential and not directly stated in the provided text.

Inference about a typical study for a device like this:

For an in vitro diagnostic device like the RUBELLACOL™ Test (a serological reagent for rubella virus antibodies), the acceptance criteria would typically revolve around its agreement with a reference standard, often another legally marketed and validated rubella antibody test. The study would generally assess sensitivity and specificity.

• Test Set Data & Ground Truth: The test set would consist of patient samples (serum) with known rubella antibody status. The ground truth would likely be established using a highly sensitive and specific reference method (e.g., another FDA-cleared rubella ELISA, or potentially a hemagglutination inhibition assay (HAI) if it was the established gold standard at the time).
• Sample Size: The sample size would be chosen to demonstrate statistically significant agreement with the reference method across relevant populations (e.g., pregnant women, those at risk of infection). While not specified, it's typically in the hundreds to low thousands for such assays.
• Adjudication: For serological tests, "adjudication" in the sense of multiple human readers for a single case is usually not applicable. The result is typically an objective measurement (e.g., optical density value) interpreted against a cutoff. Any discrepancies with the reference method would be investigated, perhaps by re-testing.
• No AI Involvement: This device, cleared in 2003, is a laboratory diagnostic kit, not an AI-powered diagnostic. Therefore, there would be no discussion of AI assistance, MRMC studies, or standalone algorithm performance.
• Training Set: While the term "training set" is more common with machine learning, for a traditional IVD, the development and optimization of the assay (e.g., antibody concentrations, incubation times, cutoff values) would be based on internal studies using well-characterized samples. The ground truth for this internal development would be established similarly to the test set, using reference methods.

Specific answers based only on the provided text:

1. A table of acceptance criteria and the reported device performance: Not provided. The document is a clearance letter, not a performance study report.
2. Sample size used for the test set and the data provenance: Not provided. This information would be in the 510(k) submission itself.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable/Not provided. For a serological test, ground truth is typically established by laboratory methods, not by expert consensus on primary data like images.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable/Not provided. This method is typically used for subjective interpretations (e.g., pathology slide reading, radiology image interpretation), not for objective laboratory assays.
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: No. This device is an in vitro diagnostic test, not an AI-powered image analysis or decision support system.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: No. This device is a manual or semi-automated laboratory assay, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not explicitly provided. However, for a serological test for antibodies, the ground truth would typically be established by a reference serological method (e.g., another validated rubella antibody test) or sometimes confirmation by culture/PCR in acute cases, though for antibody detection, the reference assay is most common.
8. The sample size for the training set: Not provided.
9. How the ground truth for the training set was established: Not provided. (See inference above for a typical approach).

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