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510(k) Data Aggregation
(51 days)
EXIGENT DIAGNOSTICS, INC.
For in vitro diagnostic use with Exigent Diagnostics' CARESIDE™ Analyzer to measure total cholesterol from anti-coagulated whole blood, plasma or serum specimens to aid in the diagnosis and treatment of patients with disorders of lipid and lipoprotein metabolism
CARESIDE™ Total Cholesterol cartridges are used with the Exigent Diagnostics CARESIDE™ Analyzer to measure total cholesterol concentration in anti-coagulated whole blood, plasma or serum specimens. The CARESIDE™ Total Cholesterol cartridge, a single use disposable in vitro diagnostic test cartridge, aids in specimen separation and delivers a measured volume of plasma or serum to a dry film to initiate the measurement of total cholesterol concentration. The film cartridge (patent pending) contains all reagents necessary to measure total concentration of cholesterol.
The Exigent Diagnostics CARESIDE™ Total Cholesterol device is a quantitative in vitro diagnostic system for measuring total cholesterol in anti-coagulated whole blood, plasma, or serum specimens when used with the CARESIDE™ Analyzer. The device's performance was evaluated by comparing it to the legally marketed predicate device, Johnson and Johnson’s Vitros CHOL Slides for the Vitros DT 60 II. The study focused on accuracy, precision, and method comparison.
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria for this device are not explicitly defined in terms of specific performance targets (e.g., "accuracy must be >95%"). Instead, the document demonstrates substantial equivalence by presenting comparative performance characteristics against a predicate device. The implicit acceptance criterion is that the CARESIDE™ device performs as well as or better than the predicate device for key metrics.
| Performance Characteristic | Acceptance Criteria (Implicit: As good as or better than predicate) | CARESIDE™ Total Cholesterol Performance | Predicate Device (Vitros CHOL DT Slides) Performance |
|---|---|---|---|
| Detection Limit | 50 mg/dL | 50 mg/dL | 50 mg/dL |
| Reportable Range | At least 50 to 325 mg/dL | 50 to 450 mg/dL | 50 to 325 mg/dL |
| Accuracy | Not explicitly defined, but assumed to be acceptable | Mean recovery 106% | Not provided |
| Precision | Comparable to predicate (e.g., CV%) | Total CV, 203 mg/dL, 5.2% | Total CV, 202 mg/dL, 3.4% |
| Method Comparison | Strong correlation with predicate | CARESIDE™ = 1.04 (Vitros CHOL DT) + 23 mg/dL, r = 0.94 | Not provided |
| Linearity | Within acceptable limits | Linearity by mixing and by dilution yielded slope and correlation coefficient within acceptable limits | Not provided |
| Interference | No significant interference at specified concentrations | No significant interference observed at: | |
| Ascorbic acid 1 mg/dL | |||
| Bilirubin 10 mg/dL | |||
| Hemoglobin 250 mg/dL | |||
| Protein 5 to 9 g/dL | |||
| Triglyceride 600 mg/dL | Very high protein > 10 mg/dL |
The study concludes that the nonclinical and clinical data provided demonstrate that the CARESIDE™ Total Cholesterol product is as safe, effective, and performs as well as or better than the legally marketed 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 test set in the provided sections. Details regarding the number of patient samples (e.g., for accuracy, precision, or method comparison studies) are not given.
The data provenance is not explicitly stated in terms of country of origin or whether it was retrospective or prospective. Given the context of a 510(k) summary for a diagnostic device seeking U.S. market clearance, it is highly probable that the studies were conducted in the U.S. or followed U.S. regulatory guidelines for clinical data. The studies would typically be prospective for clinical performance evaluations.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not applicable to this type of device and study. The Exigent Diagnostics CARESIDE™ Total Cholesterol is an in vitro diagnostic (IVD) device for quantitative measurement of a biochemical analyte (total cholesterol). The "ground truth" for measuring cholesterol concentration is established by a reference method (Abell Kendall in this case) and validated laboratory procedures, not by expert consensus or interpretation of images.
4. Adjudication Method for the Test Set
This is not applicable as the ground truth is based on quantitative chemical measurements against a reference method (Abell Kendall), not subjective interpretations requiring adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study is relevant for diagnostic imaging devices where human readers interpret medical images. The CARESIDE™ device is an automated in vitro diagnostic test for measuring a chemical concentration; therefore, MRMC studies are not applicable.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done
Yes, the performance presented for the CARESIDE™ device is standalone performance. The device automatically measures cholesterol concentration by processing the sample and uses its internal algorithm (based on reflectance measurements and a lot-specific standard curve) to calculate the total cholesterol concentration. The performance metrics (accuracy, precision, linearity, method comparison, interference) represent the device's capability to provide measurements independently of human interpretation of the final result, beyond the initial sample application and instrument operation.
7. The Type of Ground Truth Used
The ground truth for the performance evaluation of the CARESIDE™ Total Cholesterol device typically relies on established reference methods and laboratory standards. Specifically, the document states:
- Reference Method: Abell Kendall. This method is a widely accepted and rigorous chemical method for determining cholesterol concentration and serves as the gold standard for accuracy comparisons.
- Comparative Method: Vitros CHOL DT Slides (predicate device), which itself is compared to and validated against established reference methods.
Therefore, the ground truth is primarily based on chemical reference methods/laboratory standards.
8. The Sample Size for the Training Set
The document does not provide information on the sample size used for the training set. For an IVD device, the "training set" would typically refer to data used during the development and calibration of the device's algorithms and standard curves. This information is generally part of the internal development process and not always detailed in the 510(k) summary unless specific machine learning components require it for regulatory review, which is less common for enzymatic assays like this.
9. How the Ground Truth for the Training Set Was Established
The document does not explicitly state how the ground truth for the training set was established. However, based on typical IVD development, the ground truth for establishing calibration curves and optimizing the enzymatic reactions would involve:
- Known concentration standards: Using commercially available or internally prepared solutions with precisely known cholesterol concentrations.
- Reference laboratory measurements: Analyzing samples using established reference methods (like Abell Kendall or other highly accurate laboratory methods) to determine their true cholesterol levels, which are then used to develop and validate the device's calibration.
This process ensures that the device's measurements are accurate across its reportable range.
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(43 days)
EXIGENT DIAGNOSTICS, INC.
The CARESIDE™ HDL-Cholesterol cartridge is intended for in vitro diagnostic use in conjunction with the Exigent Diagnostics CARESIDE™ Analyzer to quantitatively measure HDL-cholesterol concentration in pre-treated serum or plasma. This product is indicated for use in the diagnosis and treatment of patients with disorders of lipid and lipoprotein metabolism.
CARESIDE™ HDL-Cholesterol cartridges are used with the Exigent Diagnostics CARESIDE™ Analyzer to measure HDL-cholesterol concentration in pre-treated serum or plasma specimens. The CARESIDE™ HDL-Cholesterol cartridge, a single use disposable in vitro diagnostic test cartridge, delivers a measured volume of pre-treated serum or plasma to a dry film to initiate the measurement of HDL-cholesterol concentration. The film cartridge (patent pending) contains all reagents necessary to measure HDL-cholesterol concentration.
Here's a breakdown of the acceptance criteria and the study information for the CARESIDE™ HDL-Cholesterol device, based on the provided text:
Acceptance Criteria and Device Performance
| Criteria | Acceptance Criteria (Predicate) | Reported Device Performance (CARESIDE™ HDL-Cholesterol) |
|---|---|---|
| Detection Limit | 1 mg/dL | 10 mg/dL |
| Reportable Range | 1 to 110 mg/dL | 10 to 110 mg/dL |
| Accuracy | Not provided | Mean recovery 109% |
| Precision | Total CV, 41 mg/dL, 3.2% | Total CV, 33 mg/dL, 6.5% |
| Method Comparison (Correlation to Predicate) | N/A (Predicate vs. Unknown) | CARESIDE™ = 0.97 (Vitros HDLC DT) - 1.5 mg/dL, r = 0.97 |
| Linearity | Not provided | Linearity by mixing and by dilution yielded slope and correlation coefficient within acceptable limits. |
| Interference | Ascorbic Acid interferes (non-interfering concentration undefined) | No significant interference observed at tested concentration of interferent: Ascorbic Acid, 1 mg/dL; Bilirubin, 10 mg/dL; Hemoglobin, 250 mg/dL; Protein 5 - 9 g/dL; Triglycerides 1500 mg/dL |
Note: The acceptance criteria are inferred from the reported performance of the predicate device (Vitros HDLC DT Slides) where specific criteria for the new device are not explicitly stated, or from the new device's demonstrated performance exceeding or meeting expectations related to the predicate.
Study Information
-
Sample size used for the test set and the data provenance:
- The document does not explicitly state the sample size used for the test set.
- The document does not explicitly state the country of origin of the data.
- The document does not explicitly state if the data was retrospective or prospective.
-
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 device's measurements to a predicate device, not on expert-adjudicated ground truth.
-
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- This information is not applicable or provided. The study is a quantitative measurement comparison, not an analysis requiring adjudication of interpretations.
-
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 MRMC comparative effectiveness study was not done. This is a study comparing an in vitro diagnostic device's quantitative measurements to a predicate device, not an AI-assisted human reader study.
-
If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- Yes, a standalone study was done. The performance data presented (accuracy, precision, method comparison, linearity, interference) describes the algorithm's performance in measuring HDL-cholesterol concentration in pre-treated serum or plasma specimens, without human-in-the-loop performance influencing the measurement itself. The "CARESIDE™ HDL-Cholesterol" device, in conjunction with the CARESIDE™ Analyzer, performs the measurement automatically.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The primary ground truth for the comparative performance study was the measurements obtained from the predicate device, Vitros HDLC DT Slides. Additionally, some tests (like linearity) might have been assessed against theoretical expectations or known concentrations of reference materials. The "Reference Method" for the CARESIDE™ is stated as "Abell Kendall," implying this might be a recognized standard against which the predicate or even the new device could be ultimately traceable, though the direct comparison in the table is against the Vitros HDLC DT.
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The sample size for the training set:
- The document does not explicitly mention a "training set" or its sample size. This type of premarket notification for an IVD kit typically presents validation data, not a machine learning model's training details.
-
How the ground truth for the training set was established:
- As no training set is mentioned (see point 8), the method for establishing its ground truth is also not applicable or provided.
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(36 days)
EXIGENT DIAGNOSTICS, INC.
The CareSide™ Glucose cartridge is intended for in vitro diagnostic use in conjunction with the Exigent Diagnostics CareSide™ Analyzer to quantitatively measure glucose concentration in whole blood, plasma or serum by laboratory professionals. The CareSide™ Glucose test aids in the diagnosis and treatment of glucose regulation disorders such as diabetes.
For in vitro diagnostic use with Exigent Diagnostics' CareSide™ Analyzer to measure glucose from anti-coagulated whole blood, plasma or serum specimens to aid in the diagnosis and management of disorders of blood glucose regulation such as diabetes.
CareSide™ Glucose cartridges are used with the Exigent Diagnostics CareSide™ Analyzer to measure glucose concentration in whole blood, plasma or serum specimens. The CareSide™ Glucose cartridge, a single use disposable in vitro diagnostic test cartridge, aids in specimen separation and delivers a measured volume of plasma or serum to a dry film to initiate the measurement of glucose concentration. The film cartridge (patent pending) contains all reagents necessary to measure glucose concentration.
Each Exigent Diagnostics CareSide™ Glucose cartridge consists of a glucose-specific multi-layer reagent film mounted in a plastic base with a hinged lid. The user introduces the whole blood, serum, or plasma specimen into the cartridge sample deposition well, closes the lid and inserts the cartridge into the Exigent Diagnostics CareSide™ Analyzer.
Once loaded, the CareSide™ analyzer scans the cartridge barcode, spins the cartridge to move the sample from the sample deposition well into the cartridge channels and chambers, and brings the cartridge and the contained specimen to 37℃. As the cartridge continues to spin, the blood cells are separated from the plasma/serum and the cells accumulate in the separation well. Approximately ten microliters of plasma (or serum, as applicable) remain in the metering passage. Any excess sample flows into an overflow well.
The plasma (or serum, as applicable) is automatically dispensed onto the multi-layer reagent film. The spreading layer distributes the sample evenly on the film. Protein is removed before the glucose solution diffuses through the reflection layer and reaches the reaction layer. In the reaction layer glucose reacts with oxygen via a glucose oxidasecatalyzed reaction to produce hydrogen peroxide which in turn participates in a peroxidase-catalyzed reaction with the substrate to produce a red dye. The color intensity, as measured by the amount of light reflected at 505 nanometers, is directly related to the specimen glucose concentration.
Test Reaction Sequence:
B-D-glucose + O2 + H2O __ slucoseoxidase > D-gluconic acid + H2O2 peroxiduse > Red dye 1,7-dihydroxynaphthalene + 4-aminoantipyrine + 2 H2O2-
As the cartridges spin, photodiodes measure reflectance of light emitted by wavelengthspecific light emitting diodes (LEDs) at a fixed time. The analyzer uses the reflectance measurements and the lot-specific standard curve to calculate glucose concentration.
The provided text describes the CareSide™ Glucose device and its premarket notification, including a comparison to a predicate device. Here's a breakdown of the requested information:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state "acceptance criteria" in a separate section with specific numerical thresholds for various performance metrics. Instead, it presents performance characteristics and compares them to a predicate device, implying that performance "as well as or better than" the predicate device is the de facto acceptance criterion for substantial equivalence.
| Performance Characteristic | Acceptance Criteria (Implied) | Reported CareSide™ Glucose Performance | Predicate Device (Vitros Glucose DT) Performance |
|---|---|---|---|
| Detection Limit | ≥ 20 mg/dL | 20 mg/dL | 20 mg/dL |
| Reportable Range | ≥ 20 to 450 mg/dL | 20 to 600 mg/dL | 20 to 450 mg/dL |
| Accuracy | Comparable to Predicate | Mean recovery 98% | Not provided |
| Precision | Comparable to Predicate | Total CV, 94 mg/dL, 5.8% | Total CV, 117 mg/dL, 1.4% |
| Method Comparison | High correlation with Predicate | CareSide™ = 1.04 (Vitros Glucose DT) - 7.0 mg/dL, r = 1.00 | N/A |
| Linearity | High correlation | Mean deviation approx 99%, r = 1.00 | Not provided |
| Interference | Less or equal interference | No significant interference observed at tested concentrations of: Ascorbic Acid, Bilirubin, Creatinine, Hemoglobin, Protein, Triglycerides, Uric Acid | Interference observed for: Ascorbic acid, Hemoglobin @ 250 mg/dL, Protein 10 g/dL |
| Specimen Types & Anticoagulants | Comparable utility | No clinically significant difference between heparinized whole blood, serum, heparin plasma, and EDTA plasma. | No clinically significant difference between serum, heparin plasma, or EDTA plasma. Whole blood is unsuitable. |
| Expected Values | Comparable to Predicate | 68 to 101 mg/dL (fasting) | 65 - 110 mg/dL (fasting) |
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. The data provenance is not specified, but it's implied to be retrospective as part of a 510(k) submission showcasing performance data that has already been collected. The studies appear to be laboratory-based evaluations rather than specific patient trials with details on country of origin.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
The document does not provide information on the number of experts or their qualifications used 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 performance data presented appears to be direct measurements and comparisons rather than subjective interpretations requiring adjudication.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No multi-reader, multi-case (MRMC) comparative effectiveness study is mentioned. The device is an in vitro diagnostic (IVD) for quantitative measurement of glucose, not an imaging device or one requiring human reader interpretation in the same way. Therefore, the concept of "human readers improve with AI vs without AI assistance" is not applicable in this context.
6. Standalone (Algorithm Only) Performance Study
Yes, the entire document is essentially a description of the standalone performance of the CareSide™ Glucose device (algorithm and integrated system) without human-in-the-loop performance influencing the measurement itself. The device is designed to quantitatively measure glucose.
7. Type of Ground Truth Used
The ground truth used for performance evaluation is established by a "Reference Method" which is Hexokinase. This is a well-established enzymatic method for glucose measurement, considered a gold standard in clinical chemistry.
8. Sample Size for the Training Set
The document does not provide information on the sample size used for the training set. As it refers to a device for quantitative chemical analysis, the "training set" might refer to samples used for initial calibration, method development, and optimization rather than a dataset for machine learning in the conventional sense.
9. How the Ground Truth for the Training Set Was Established
The document does not explicitly state how the ground truth for the training set was established. However, given the nature of the device (quantitative glucose measurement), it is highly probable that the ground truth for both training/development and testing would be established using a recognized reference method like the Hexokinase method, as indicated for the "Reference Method."
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(83 days)
EXIGENT DIAGNOSTICS, INC.
For in vitro diagnostic use with Exigent Diagnostics CareSide Analyzer to measure creatinine in whole blood, plasma or serum specimens by professionals to aid in the diagnosis and treatment of renal diseases.
CareSide™ Creatinine cartridges are used with the Exigent Diagnostics CareSide™ Analyzer to measure creatinine concentration in anti-coagulated whole blood, plasma or serum specimens. The CareSide™ Creatinine cartridge, a single use disposable in vitro diagnostic test cartridge, aids in specimen separation and delivers a measured volume of plasma or serum to a dry film to initiate the measurement of creatinine concentration. The film cartridge (patent pending) contains all reagents necessary to measure creatinine concentration. When used in conjunction with the CareSideTM BUN cartridge on the CareSide™ Analyzer, the analyzer calculates a BUN to creatinine ratio.
Here's an analysis of the provided text regarding the CareSide™ Creatinine device, structured according to your requested information:
CareSide™ Creatinine Device Performance Study Analysis
1. Table of Acceptance Criteria and Reported Device Performance
The provided document primarily focuses on demonstrating substantial equivalence to a predicate device rather than explicitly defining "acceptance criteria" against which to measure the device's performance in a standalone context. However, it does present comparative performance characteristics between the CareSide™ Creatinine and the predicate device (Vitros Creatinine DT Slides). We can infer "performance standards" or expected performance based on these comparisons and the predicate device's characteristics.
| Performance Metric | CareSide™ Creatinine Reported Performance | Predicate Device Performance / Implied Acceptance Criteria |
|---|---|---|
| Detection Limit | 0.2 mg/dL | Not provided for predicate (but assumed to be comparable or better) |
| Reportable Range | 0.2 to 16 mg/dL | 0.01 to 15 mg/dL (CareSide™ exceeds on high end, slightly less on low end) |
| Accuracy (Mean Recovery) | 99% | Not provided for predicate (but an implied expectation of high accuracy) |
| Precision (Total CV) | 4.2% at 9 mg/dL | 3.3% at 10 mg/dL (Predicate device shows slightly better precision) |
| Method Comparison (vs. Predicate) | CareSide™ = 1.08 (Vitros Creatinine DT) - 0.38, r=0.99 | Strongly correlated (r=0.99) with predicate, indicating substantial agreement. |
| Linearity | Mean deviation approx 4%, r>0.99 | Not provided for predicate (but implied expectation of good linearity across the reportable range) |
| Interference | No significant interference observed at tested concentration of interferents (Ammonium PO₄, Ascorbic Acid, Bilirubin, 5-fluorocytosine, Glucose, Hemoglobin, Triglycerides, Urea Nitrogen) | Not provided for predicate (but implied expectation of minimal interference for common substances) |
| Specimen Types & Anticoagulants | No clinically significant difference between heparinized whole blood, serum, heparin plasma, and EDTA plasma. | No clinically significant difference between serum and heparin plasma. Whole blood is unsuitable for predicate. |
| Expected Values | 0.4 to 0.9 mg/dL (female); 0.6 to 1.3 mg/dL (male) (Central 95% interval) | 0.5 to 1.2 mg/dL (female); 0.7 to 1.4 mg/dL (male) (Central 95% interval) |
Study Proving Acceptance Criteria:
The document describes several "Comparative Performance Characteristics" that serve as the basis for proving the device meets the implied acceptance criteria for substantial equivalence to the predicate device. These include:
- Detection Limit: Directly reported.
- Reportable Range: Compared against the predicate.
- Accuracy: Mean recovery study reported.
- Precision: Total CV reported.
- Method Comparison: A regression analysis (CareSide™ vs. Vitros Creatinine DT) showing strong correlation (r=0.99). This is a primary study for demonstrating equivalence.
- Linearity: Reported with mean deviation and correlation coefficient.
- Interference: A study testing various common interferents at specified concentrations.
- Specimen Types & Anticoagulants: A study assessing performance across different sample types.
- Expected Values: Clinical range established.
2. Sample Size Used for the Test Set and Data Provenance
The provided text does not explicitly state the sample sizes used for the various tests (e.g., accuracy, precision, method comparison, linearity, interference, specimen type studies). Similarly, the data provenance (country of origin, retrospective/prospective) is not mentioned. These details would typically be found in more comprehensive study reports or validation binders.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts
The document does not mention the use of experts to establish ground truth in the context of radiologists or similar clinical reviewers. This device is an in vitro diagnostic (IVD) for measuring a biochemical marker. Ground truth for such devices is typically established through a reference method, which is stated as HPLC (High-Performance Liquid Chromatography) for both the CareSide™ and the predicate device. Therefore, the "ground truth" is analytical, not based on expert consensus of interpretive results.
4. Adjudication Method for the Test Set
As the ground truth is established analytically (via HPLC) rather than by expert interpretation, an "adjudication method" in the sense of reconciling differing expert opinions (e.g., 2+1, 3+1) is not applicable or described.
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 MRMC comparative effectiveness study was done or is applicable. This device is an automated in vitro diagnostic system for measuring creatinine levels from blood samples. It is not an AI-assisted diagnostic imaging tool that would involve human readers or interpretation of complex medical images.
6. If a Standalone (i.e. algorithm only without human-in-the loop performance) was done
Yes, this is essentially a standalone (algorithm only) device. The CareSide™ Creatinine cartridge and CareSide™ Analyzer automatically measure creatinine concentration. While a laboratory professional introduces the sample and operates the device, the measurement itself is automated and does not involve human interpretation of the analytical result (e.g., a "human-in-the-loop" for image review). The performance metrics reported (accuracy, precision, linearity, etc.) describe the standalone analytical performance of the device system.
7. The Type of Ground Truth Used
The ground truth used for performance comparison and validation is analytical measurement by High-Performance Liquid Chromatography (HPLC). HPLC is explicitly listed as the "Reference Method" (Page 13b). This is a gold standard laboratory technique for quantifying substances like creatinine.
8. The Sample Size for the Training Set
The document does not provide information on a "training set" sample size. This is common for IVD devices of this nature from this era (1998). While the device's internal algorithms (e.g., for calculating creatinine concentration from reflectance measurements) would have been developed and optimized, the concept of a distinct, labeled "training set" in the context of modern machine learning validation protocols is not explicitly addressed here. The reported "Calibration" mentions "Calibration information bar-coded on each cartridge" and that "Calibration information may change with each lot," implying a continuous process rather than a fixed training set used for a singular AI model.
9. How the Ground Truth for the Training Set was Established
As there is no explicit mention of an identifiable "training set" in the modern AI sense, the method for establishing its ground truth is not described. For the underlying analytical methodology, calibration materials with known creatinine concentrations (traceable to a reference method like HPLC) would be used to establish the relationship between the reflectance signal and creatinine concentration.
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(59 days)
EXIGENT DIAGNOSTICS, INC.
This product is intended for use with Exigent Diagnostics Cartridges when used by laboratory professionals for the in vitro measurement of various clinical chemistry analytes in human blood.
This product is indicated for in vitro measurement of various clinical chemistry analytes in human blood.
The Exigent Diagnostics CareSide™ System utilizes individual (analyte specific) test cartridges to perform a variety of clinical blood tests. The user introduces the whole blood, serum, or plasma specimen into the cartridge sample deposition well, closes the lid and inserts the cartridge into the Exigent Diagnostics CareSide™ Analyzer. The Exigent Diagnostics CareSide™ Analyzer automatically performs up to 6 quantitative test results in approximately ten minutes using approximately 85 microliters of human blood per test. Results are provided on-screen, and may be transferred to a floppy disk for subsequent uploading to a laboratory information system. The Exigent Diagnostics CareSide™ System components include: CareSide™ Analyzer and Analyte-specific Cartridge(s).
The CareSide™ Analyzer is a compact tabletop chemistry analyzer that performs multiple discrete analyses on human whole blood, plasma, or serum specimens. The CareSide™ analyzer is semi-automated: the only operator intervention is the addition of the specimen to the test cartridge and the insertion of the dosed cartridge into the analyzer. The CareSide™ Analyzer automatically warms, separates, meters, dispenses, and incubates the specimen before reading the signal and calculating results. The CareSide™ Analyzer is intended only for use with Exigent Diagnostics CareSide™ test cartridges.
The provided text describes a 510(k) summary for the Exigent Diagnostics CareSide™ Analyzer, submitted on February 23, 1998. It details the device's characteristics and compares its performance to a predicate device, the Vitros DT 60 II System, to establish substantial equivalence.
Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are implicitly defined by the comparison to the predicate device, Vitros DT 60 II System, aiming for "as safe, effective, and performs as well as or better than" the predicate. The performance characteristics evaluated are Precision, Relative Accuracy, Linearity, Interference, and Detection Limit.
| Performance Metric | Acceptance Criteria (Implied by Predicate) | Reported CareSide™ Performance |
|---|---|---|
| Precision | Typical total CV 1.5% to 5.2% (for 4 tests evaluated by predicate) | Typical total CV 3.1% to 8.5% (for 4 tests evaluated) |
| Relative Accuracy | Not explicitly stated for predicate; implied to be acceptable for predicate | Mean difference [Vitros - CareSide™] from method comparison means is test specific (3% for 4 tests evaluated) |
| Linearity | Not provided for predicate; implied to be acceptable for predicate | Correlation coefficient >= 0.95 |
| Interference | Not provided for predicate; implied to be acceptable for predicate | Susceptibility to interference is test specific. |
| Detection Limit | Not provided for predicate; implied to be acceptable for predicate | Test specific. |
Note: The phrasing "as safe, effective, and performs as well as or better than the legally marketed predicate device" suggests that matching or improving upon the predicate's performance is the acceptance criterion. However, for "Precision," the CareSide™'s reported CV range (3.1% to 8.5%) is wider than the predicate's (1.5% to 5.2%), which might indicate worse precision. The submission, nonetheless, concludes that the data "demonstrate that the CareSide™ Analyzer is as safe, effective, and performs as well as or better than" the predicate, implying the FDA accepted these differences as not impacting substantial equivalence for the intended use.
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the sample size used for the test set in the comparative performance studies (Precision, Relative Accuracy, Linearity, Interference, Detection Limit). It mentions "4 tests evaluated" for Precision and Relative Accuracy, but this refers to the number of different types of chemical analytes for which performance was assessed, not the number of samples used for each evaluative test.
The data provenance (e.g., country of origin, retrospective or prospective) is not specified in the provided text.
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. Given that this is a clinical chemistry analyzer, the "ground truth" would typically come from a reference method run by a certified clinical laboratory, rather than expert interpretation of images or clinical findings.
4. Adjudication Method for the Test Set
The document does not describe any adjudication method. This type of device (a micro chemistry analyzer) does not typically involve expert adjudication in the way, for example, a diagnostic imaging device might. Its performance is measured against reference methods, not subjective expert opinion.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, a multi-reader, multi-case (MRMC) comparative effectiveness study was not performed. MRMC studies are typically relevant for diagnostic devices where human interpretation is a key component, such as radiology or pathology imaging, to assess how AI assistance impacts human reader performance. This device is an automated analyzer, so such a study would not be applicable.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done
Yes, the data presented ("Comparative Performance Characteristics") are for the standalone performance of the CareSide™ Analyzer. The device is described as "semi-automated" requiring only operator intervention for specimen addition and cartridge insertion, with the analyzer then automatically performing all steps and calculating results. The performance metrics (Precision, Accuracy, Linearity) reflect the algorithm's direct output compared to standard methods.
7. The Type of Ground Truth Used
The ground truth for assessing the CareSide™ Analyzer's performance implicitly comes from comparison to a legally marketed predicate device (Vitros DT 60 II System) and established laboratory reference methods.
- For Relative Accuracy, the comparison is directly stated: "Mean difference [Vitros - CareSide™]". This implies the Vitros results are considered a form of "ground truth" or a highly correlated reference.
- For Precision, this is measured inherently by repeated tests on the same sample, with the expectation that results should be tightly clustered.
- For Linearity and Detection Limit, these would be established by testing samples with known, varied concentrations or concentrations near the expected limit, using reference methods to determine the true values.
Therefore, the ground truth is based on established reference laboratory methods and comparison to a predicate device's performance.
8. The Sample Size for the Training Set
The document does not provide any information about a "training set" or its sample size. This submission is for a device based on established chemical principles and reflectance photometry, not a machine learning or AI algorithm that would typically require a distinct training set in the modern sense. The "master dose-response curve" used for calculation is likely derived from validation studies during the device's development, but specific details on the dataset used for this are not given.
9. How the Ground Truth for the Training Set Was Established
As noted above, the concept of a separate "training set" in the context of modern AI/ML development isn't explicitly described for this device. The "master dose-response curve" and "lot-specific coefficients" are central to the analyzer's calculations. These would have been established during the development and manufacturing process using samples with known analyte concentrations, validated through standard laboratory reference methods, to ensure accurate quantification of reflectance to concentration. However, the exact methodology and ground truth establishment for these internal calibration curves are not detailed in this 510(k) summary.
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(30 days)
EXIGENT DIAGNOSTICS, INC.
The CareSide™ BUN cartridge is intended for in vitro diagnostic use in conjunction will the Exigent Diagnostics CareSidc™ Analyzer to quantitatively measure urea nitrogen from whole blood, plasma or serum by laboratory professionals. When used in conjunction with the Exigent Diagnostics CareSideTM Creatinine test cartridge on the Exigent Diagnostics CareSide™ Analyzer, the BUN product may be used to calculate a BUN to creatinine ratio. The CareSide™ BUN test aids in the diagnosis and treatment of various renal and metabolic diseases.
This product is indicated for use with patients with various renal and metabolic diseases.
CareSide™ BUN cartridges are used with the Exigent Diagnostics CareSide™ Analyzer to measure BUN concentration in whole blood, plasma or scrum specimens. The CareSide™ BUN cartidge, a single use disposable in viro diagnostic test cartridge, aids in specimen separation and delivers a measured volume of plasma or serum to a dry film to initiate the measurement of BUN concentration. The film cartridge (patcht pending) contains all reagents necessary to measure Concentration. "The min and in conjunction with the CareSide™ Creatinine cartridge on the CareSide™ Analyzer, the analyzer calculates a BUN to creatinine ratio.
Each Exigent Diagnostics CareSide™ BUN cartridge consists of a BUN-specific multi-Jayer reagent film mounted in a plastic base with a hinged lid. The user introduces the whole blood, serum, or plasma specimen into the cartridge sample deposition well, closes the lid and inserts the cartridge into the Exigent Diagnostics CareSide™ Analyzer.
Once loaded, the CareSide™ analyzer scans the carridge barcode, brings the cartidge and the contained speciment to 37℃, and spins the cartidge to move the sample from the sample deposition well into the cartridge channels and chambers. As the cartridge continues to spin, the blood culls are separated from the plasmalscrum and the cells accumulate in the separation well. Ten microliters of plasma (or serum, as applicable) remain in the metering passage. Any excess sample flows into an overflow well,
The ten microliters of plasma (or serum, as applicable) is automatically dispensed onto the multi-layer reagent film. The spreading layer distributes the sample evenly on the film and filters large molecular weight components such as protein and dye fragments hefore the specimen enters the reaction layer. Urea then reacts with water in a urcasccatalyzed reaction to produce carbon dioxide and ammonia gas in the alkaline unvironment. The arnmonia gas permeates the porous gas permeation layer to reach the detection layer where it then reacts non-cazymatically with the yellow dye, hromocresol green, to form a green dye.
Test Reaction Sequence:
Urea + H2O - "Pease > 2NH3 + CO2
Bromocresol green (yellow) + NH3-> Green dye
As the cartridges spin, photodiodes measure reflectance of light emitted by wavelengthspecific light cmitting diodes (LEDs) at a lixed time. The analyzer uses the reflectance measurements and the lot-specific standard curve to calculate BUN concontration.
Here's an analysis of the provided text regarding the acceptance criteria and study for the CareSide™ Urea Nitrogen (BUN) device:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are implicitly defined by demonstrating substantial equivalence to the predicate device, Vitros BUN DT Slides. The "Comparative Performance Characteristics" section provides the data to support this.
| Acceptance Criterion (Implicit) | CareSide™ BUN Reported Performance | Predicate Device (Vitros BUN DT Slides) Reported Performance |
|---|---|---|
| Detection Limit | 5 mg/dL | 1 mg/dL |
| Reportable Range | 5 to 140 mg/dL | 1 to 100 mg/dL |
| Accuracy (compared to predicate) | Mean recovery 100% | Not provided |
| Precision (Total CV at approx. 26-27 mg/dL) | Total CV, 26 mg/dL, 3.3% | Total CV, 27 mg/dL, 3.3% |
| Method Comparison (correlation with predicate) | CareSide™ = 1.00 (Vitros BUN DT) - 3.0, r=0.99 | (N/A - used as reference) |
| Linearity | Mean deviation approx -6%, r>0.99 | Not provided |
| Interference (Ascorbic Acid, Bilirubin, Hemoglobin, Triglycerides) | No significant interference observed at tested concentration | Not provided |
| Specimen Types & Anticoagulants Compatibility | No clinically significant difference between heparinized whole blood, serum, heparin plasma, and EDTA plasma. | No clinically significant difference between serum and heparin plasma. Whole blood is unsuitable. |
| Expected Values (Central 95% interval) | 6 to 16 mg/dL (combined male and female) | 9 to 20 mg/dL (male), 7 to 17 mg/dL (female) |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: The document does not explicitly state the specific sample sizes used for each performance characteristic study (e.g., accuracy, precision, linearity, interference, method comparison). It only presents the results.
- Data Provenance: The document does not specify the country of origin of the data nor if the studies were retrospective or prospective. Given the context of a 510(k) submission to the FDA, it is highly likely the studies were conducted in a manner consistent with U.S. regulatory expectations, implying prospective clinical (or laboratory equivalent) evaluations.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
This information is not provided in the document. For a diagnostic device measuring a quantitative analyte like BUN, ground truth is typically established by reference laboratory methods, not by expert consensus in the way a qualitative diagnostic (e.g., image interpretation) might be.
4. Adjudication Method for the Test Set
This information is not applicable and therefore not provided. Adjudication methods like "2+1" or "3+1" are relevant for qualitative assessments, particularly in imaging or pathology where multiple experts may disagree. For a quantitative chemical measurement, discrepancies are typically resolved through re-testing or using a more definitive reference method.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
A MRMC comparative effectiveness study was not performed and is not applicable for this device. This type of study is specifically for evaluating the effectiveness of a device (often AI-assisted) on human reader performance, common in medical imaging. The CareSide™ BUN device is a standalone in vitro diagnostic system for chemical measurement.
6. Standalone Performance Study (Algorithm Only Without Human-in-the-Loop Performance)
Yes, a standalone performance study was done. The entire "Comparative Performance Characteristics" section describes the performance of the CareSide™ BUN device as a standalone algorithm/system, comparing its quantitative output to the predicate device and established analytical expectations. The device takes a sample and produces a BUN concentration without direct human interpretation of the result (beyond reading the reported number).
7. Type of Ground Truth Used
The ground truth used for these studies appears to be:
- Reference Method/Predicate Device: For method comparison, the "Vitros BUN DT" predicate device and/or an "Urease conversion to ammonia. Glutamic dehydrogenase linked NADH oxidation of ammonia" reference method serves as the ground truth.
- Known Concentrations: For studies like linearity, accuracy (mean recovery), and interference, control samples with known, established BUN concentrations would have been used.
8. Sample Size for the Training Set
The document does not provide information regarding a training set sample size. This is typical for in vitro diagnostic (IVD) devices that are not "AI-driven" in the contemporary sense. The device relies on a pre-programmed algorithm based on chemical reactions and optical detection, calibrated using lot-specific standard curves, rather than a machine learning model that requires a distinct training phase with a large dataset.
9. How the Ground Truth for the Training Set Was Established
As there is no mention of a "training set" in the context of machine learning, this information is not provided and is not applicable. The device's operational parameters are based on scientific principles of the chemical reaction and optical properties, and calibration is performed with standard laboratory calibrators (referred to as "lot-specific standard curve" in the device description).
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(29 days)
EXIGENT DIAGNOSTICS, INC.
For in vitro diagnostic use with Exigent Diagnostics CareSide Analyzer to measure albumin from whole blood, plasma or serum specimens by professionals to aid in the diagnosis and treatment of a variety of numerous diseases involving mainly the liver or kidneys.
CareSide™ Albumin cartridges are used with the Exigent Diagnostics CareSide™ Analyzer to measure albumin concentration in whole blood, plasma or serum specimens. The Careshie Albumin carridge, a single use disposable in virro diagnostic test carridge, aids in speciment separation and delivers a measured volume of plasma or sorum to a dry film to initiate the moasuroment of albumin concentration. The film cartidge (patent pending) contains all reagons and necessary to measure albumin concentration. When used in conjunction with the CareSide™ Total Protein carridge on the CareSidorM Analyzer calculates globulin (as the I vial Prolent Caral go on the and albumin concentrations) and the albumin/globulin ratio (A/G ratio).
This document describes the validation of the CareSide™ Albumin device for measuring albumin concentration in whole blood, plasma, or serum specimens.
Here's an analysis of the provided text to extract the requested information:
1. Table of Acceptance Criteria and Reported Device Performance
The document presents "Comparative Performance Characteristics" which serve as the acceptance criteria and the device's reported performance against them.
| Acceptance Criteria / Performance Characteristic | CareSide™ Albumin Reported Performance | Predicate Device (Vitros Albumin DT Slides) Reported Performance |
|---|---|---|
| Detection limit | 1 g/dL | 1 g/dL |
| Reportable range | 1.0 to 6.0 g/dL | 1.0 to 6.0 g/dL |
| Accuracy | Mean recovery 107% | Not provided |
| Precision | Total CV, 4.3 g/dL 5.3% | Total CV, 4.2 g/dL 2.1% |
| Method comparison (vs. Vitros Albumin DT) | CareSide™ = 0.95 (Vitros Albumin DT) + 0.14, r=0.96 | Not applicable (this is the predicate) |
| Linearity | Mean deviation approx 5%. r > 0.99 | Not provided |
| Interference | No significant interference observed at tested concentration of interferent: Ascorbic Acid, 20 mg/dL; Bilirubin, 20 mg/dL; Hemoglobin, 250 mg/dL; Triglycerides 3000 mg/dL | Not provided |
| Specimen Types & Anticoagulants | No clinically significant difference between heparinized whole blood, serum, heparin plasma, and EDTA plasma. | No clinically significant difference between serum and heparin plasma. Whole blood is unsuitable. |
| Expected Values | 3.6 to 4.5 g/dL (combined male and female); Central 95% interval | 3.5 to 5.0 g/dL referenced from literature |
Conclusion from section VII.D: The nonclinical and clinical data provided demonstrate that the CareSide™ Albumin product is as safe, effective, and performs as well as or better than the legally marketed predicate device.
2. Sample size used for the test set and data provenance
The document states "The nonclinical and clinical data provided" but does not specify the sample size for the test set used in the comparative performance characteristics.
Data provenance (e.g., country of origin, retrospective/prospective) is also not mentioned.
3. Number of experts used to establish the ground truth for the test set and their qualifications
There is no information provided in the document about the number or qualifications of experts used to establish ground truth for the test set. Given this is an in vitro diagnostic device measuring a quantitative analyte, the "ground truth" would likely be established by a reference laboratory method or reference instrument, not by expert consensus on interpretations.
4. Adjudication method for the test set
No information is provided regarding an adjudication method for the test set. For a quantitative measurement device, an "adjudication method" in the sense of resolving conflicting interpretations by multiple readers (e.g., 2+1, 3+1) is not applicable. Accuracy is typically determined by comparing the device's measurements to a reference method or known concentrations.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and the effect size
No MRMC comparative effectiveness study was done or mentioned. This device is an in vitro diagnostic test for measuring an analyte, not an imaging device that would typically involve human readers interpreting cases with and without AI assistance. Therefore, human readers' improvement with AI assistance is not applicable here.
6. If a standalone (algorithm only without human-in-the-loop performance) was done
Yes, the performance data presented (detection limit, reportable range, accuracy, precision, linearity, interference) represent the standalone performance of the CareSide™ Albumin device (algorithm/system only). While a user initiates the test, the measurement and calculation of albumin concentration are automated by the device without human interpretation of the results through a human-in-the-loop process beyond reading the displayed concentration.
7. The type of ground truth used
The ground truth for the comparative performance was likely established by:
- Reference Method: For accuracy, precision, and linearity, the device's measurements would be compared against a recognized reference method (e.g., "Bromocresol green (wet)" is mentioned as a reference method in the technical characteristics table) or a highly accurate laboratory instrument.
- Known Concentrations: For assessing detection limit, reportable range, and linearity, samples with precisely known concentrations of albumin would be used.
- Predicate Device: The "Method comparison" section explicitly compares the CareSide™ Albumin to the "Vitros Albumin DT" slides, indicating the predicate device served as a reference for comparison in this aspect.
8. The sample size for the training set
The document does not specify the sample size for the training set.
9. How the ground truth for the training set was established
The document does not provide information on how the ground truth for any potential training set was established. For an in vitro diagnostic device like this, method development and calibration would typically involve using samples with known albumin concentrations, often verified by a reference method.
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(29 days)
EXIGENT DIAGNOSTICS, INC.
For in vitro diagnostic use with Exigent Diagnostics CareSide™ Analyzer to measure total protein from whole blood, heparinized plasma or serum specimens by professionals to aid in the diagnosis and treatment of a variety of diseases involving the liver, kidney, or bone marrow as well as other metabolic or nutritional disorders.
CareSide™ Total Protein cartridges are used with the Exigent Diagnostics CareSide™ Analyzer to measure total protein concentration in whole blood, plasma or serum specimens. The CareSide™ Total Protein cartridge, a single use disposable in vitro diagnostic test carridge, aids in specimen separation and delivers a measured volume of plasma or serum to a dry film to initiate the measurement of total protein concentration. The film cartridge (patent pending) contains all reagents necessary to measure total protein concentration. When used in conjunction with the CareSide™ Albumin cartidge on the CareSide™ Analyzer, the analyzer calculates globulin (as the difference between the total protein and albumin concentrations) and the albumin/globulin ratio (A/G ratio).
Here's a summary of the acceptance criteria and study information for the CareSide™ Total Protein device, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Performance Characteristic | Acceptance Criteria / Predicate Performance | CareSide™ Total Protein Performance |
|---|---|---|
| Detection Limit | 2 g/dL | 2 g/dL |
| Reportable Range | 2.0 to 11 g/dL | 2.0 to 11 g/dL |
| Accuracy | Not provided for predicate | Mean recovery 105% |
| Precision | Total CV, 4.5 g/dL: 2.5% (Vitros TP DT) | Total CV, 6.0 g/dL: 7.2% |
| Method Comparison | Not provided for predicate | CareSide™ = 0.9 (Vitros Total Protein DT) + 0.56, r=0.93 |
| Linearity | Not provided for predicate | Mean deviation approx 1%, r² ≥0.99 |
| Interference | Not provided for predicate | No significant interference observed at tested concentrations of Ascorbic Acid (20 mg/dL), Bilirubin (20 mg/dL), Hemoglobin (250 mg/dL), Triglycerides (1500 mg/dL). |
| Specimen Types & Anticoagulants | No clinically significant difference between serum and heparin plasma. Whole blood unsuitable (Vitros TP DT). | No clinically significant difference between heparinized whole blood, serum, heparin plasma, and EDTA plasma. |
| Expected Values (Reference Range) | 6.3 to 8.2 g/dL (combined male and female, Central 95% interval) (Vitros TP DT) | 6.3 to 8.4 g/dL (combined male and female, Central 95% interval) |
Note on Acceptance Criteria: The document primarily uses the predicate device's performance characteristics or a "not provided" statement as a benchmark. For some metrics like Accuracy, Linearity, and Interference, the CareSide™ device reports its own performance without a direct comparison to a specific quantitative acceptance criterion from the predicate, implying these met general expectations for such a device. The conclusion states the device "performs as well as or better than the legally marketed predicate device."
2. Sample Size Used for the Test Set and Data Provenance
Specific sample sizes for each performance characteristic (accuracy, precision, method comparison, linearity, interference studies) are not explicitly provided in the given text.
- Data Provenance: The studies appear to be clinical performance evaluations conducted by Exigent Diagnostics, Inc. The location and whether they were retrospective or prospective are not specified.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Experts
This information is not provided in the document. The data presented is quantitative analytical performance, presumably compared against established laboratory methods or reference values, not expert interpretation of clinical images or data.
4. Adjudication Method for the Test Set
This information is not applicable as the studies described are for analytical performance, not for subjective interpretation or agreement between multiple readers.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done
No, an MRMC comparative effectiveness study was not done. The device is an in vitro diagnostic test for measuring total protein concentration, not a device requiring human interpretation of results in the way an imaging diagnostic device might.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was Done
Yes, implicitly. The reported performance characteristics (accuracy, precision, linearity, etc.) represent the performance of the CareSide™ Total Protein cartridge and CareSide™ Analyzer system as a standalone diagnostic device, without human interpretive input beyond following the operational instructions. The device directly measures and reports a quantitative result.
7. The Type of Ground Truth Used
The ground truth for the device's performance (e.g., accuracy, method comparison, linearity) would have been established using:
- Reference Methods: The "Reference Method" is stated as Biuret, which is a widely accepted laboratory method for total protein measurement.
- Predicate Device Data: For comparison, the predicate device (Vitros Total Protein DT Slides) served as a benchmark.
- Standard Calibrators/Controls: For linearity and precision studies, calibrated materials with known concentrations would have been used.
8. The Sample Size for the Training Set
This information is not applicable/not provided. This device is a chemical assay system with a fixed reaction sequence and measurement principle, not a machine learning or AI-based device that would typically involve a "training set" in the conventional sense of AI model development. The system uses a "lot-specific standard curve" for calculation, which implies calibration data for each lot, but this is distinct from training a machine learning model.
9. How the Ground Truth for the Training Set was Established
This information is not applicable/not provided for the same reasons as point 8. The device operates based on established chemical reactions and calibration curves rather than an AI training process.
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(22 days)
EXIGENT DIAGNOSTICS, INC.
For in vitro diagnostic use with Exigent Diagnostics CareSide Analyzer to calculate globulin and albumin/globulin ratio from albumin and globulin results generated on the CareSide Analyzer by professionals to aid in the diagnosis and treatment of patients with numerous illnesses including severe liver and renal disease, multiple myeloma, and other disorders of blood globulins.
The CareSide™ Analyzer uses the Total Protein and Albumin cartridge test results from a single patient sample to determine the globulin concentration and A/G Ratio. Globulin is calculated as the difference between the total protein and albumin concentrations.
The provided text describes the CarcSide™ Globulin and A/G Ratio calculation device, but it does not contain information about acceptance criteria or a study that proves the device meets specific performance criteria.
Instead, the document primarily focuses on:
- 510(k) Summary: This is a premarket notification to the FDA, demonstrating substantial equivalence to a predicate device.
- Device Description: Explaining how Globulin and A/G ratio are calculated from Total Protein and Albumin results using the CareSide™ Analyzer.
- Intended Use and Indications for Use: Defining what the device is for.
- Expected Values (Reference Interval): A study to establish a normal range for healthy individuals.
- FDA Clearance Letter: Confirming that the device has been found substantially equivalent to a predicate device.
Therefore, I cannot fulfill the request for information on acceptance criteria and a study proving their achievement, as this specific information is not present in the provided text.
However, I can extract the information that is present:
1. A table of acceptance criteria and the reported device performance:
- This information is not provided in the text. The document focuses on establishing substantial equivalence to a predicate device and defining an expected reference interval for healthy individuals, not on performance against specific acceptance criteria.
2. Sample sized used for the test set and the data provenance:
- Test Set (for establishing Expected Values/Reference Interval):
- Sample Size: 68 ambulatory, healthy adult workers (27 males, 41 females).
- Data Provenance: Not explicitly stated, but implies U.S. data (investigator used CareSide™ Total Protein and CareSide™ Albumin test cartridges). It is a prospective study for establishing reference intervals.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. The "ground truth" for the test set in this context is simply the measured Total Protein and Albumin values from healthy individuals using the CareSide™ system itself, which are then used to calculate Globulin and A/G ratio. There's no external expert consensus or pathological assessment described for these reference interval values.
4. Adjudication method for the test set:
- None described.
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, an MRMC study was not done. This device is an in vitro diagnostic (IVD) for calculating biochemical values, not an imaging or interpretive AI device where human readers are directly involved in interpretation that could be "assisted" by AI.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Yes, in essence. The CarcSide™ Globulin calculation is described as an "in vitro diagnostic product intended for the calculation of globulin" based on results from the Total Protein and Albumin cartridges. The "CareSide™ Analyzer automatically calculates the Globulin measurement and the Albumin to Globulin ratio." This is an algorithmic calculation, and its performance (in terms of accuracy of the calculation and consistency with known biochemical principles) is inherent to its function. The provided document, however, mainly demonstrates substantial equivalence for this calculation method to existing methods, rather than providing an independent standalone accuracy study against a "true" globulin value.
7. The type of ground truth used:
- For establishing the "Expected Values (Reference Interval)," the ground truth is biochemical measurement using the CareSide™ Total Protein and Albumin test cartridges on specimens from a healthy population. The calculated globulin and A/G ratio from these measurements are then presented as a reference interval.
- For the device's substantial equivalence claim, the "ground truth" implicitly relies on the established accuracy and clinical utility of the predicate devices (Vitros TP and Albumin DT Slides) for measuring total protein and albumin, from which globulin is calculated.
8. The sample size for the training set:
- Not explicitly stated. This document is a 510(k) summary, which focuses on substantial equivalence and intended use rather than detailed algorithm development and training data. The calculation itself (Globulin = Total Protein - Albumin) is a fundamental biochemical formula, not typically "trained" in the way a machine learning algorithm would be.
9. How the ground truth for the training set was established:
- Not applicable / not explicitly stated. Given that the device performs a simple calculation (Globulin = Total Protein - Albumin), there isn't a "training set" in the machine learning sense. The accuracy of the calculation relies on the accurate measurement of Total Protein and Albumin by the CareSide™ system, for which substantial equivalence to predicate devices (Vitros TP and Albumin DT Slides) is claimed. The underlying biochemical principles are the "ground truth" for the calculation itself.
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