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510(k) Data Aggregation
(101 days)
The Vitros® PSA is an in vitro assay intended for the quantitative measurement of prostate specific antigen (PSA) in human serum or plasma (EDTA or heparin) to aid in the management of patients with prostate cancer.
The VITROS Immunodiagnostic System uses luminescence as the signal in the quantitative and semi-quantitative determination of selected analytes in human body fluids, commonly serum, plasma or urine. Coated microwells are used as the solid phase separation system.
The system is comprised of three main elements:
- The VITROS Immunodiagnostic Products (in this case VITROS Immunodiagnostic Products PSA Reagent Pack, VITROS Immunodiagnostic Products PSA Calibrators, which are combined by the VITROS Immunodiagnostic System to perform the VITROS PSA assay).
- The VITROS Immunodiagnostic System instrumentation, which provides automated use of the immunoassay kits.
- Common reagents used by the VITROS System in each assay.
Here's an analysis of the provided text regarding the VITROS® Immunodiagnostic Products PSA assay, focusing on acceptance criteria and study details:
1. Table of Acceptance Criteria and Reported Device Performance
The submission doesn't explicitly define formal "acceptance criteria" in a table format with specific numerical targets. Instead, the demonstration of substantial equivalence is the primary acceptance criterion, and this is shown through comparison with a predicate device across various performance aspects.
| Device Characteristic | Predicate Performance (Hybritech Tandem-R PSA) | VITROS PSA assay Performance | Acceptance (Substantial Equivalence) |
|---|---|---|---|
| Calibration Range | 0 - 100 ng/mL | 0 - 100 ng/mL | Equivalent |
| Basic Principle | Solid phase immunoradiometric assay | Solid phase immunoassay | Similar (both solid phase immunoassay) |
| Sample Type | Serum | Serum, plasma (heparin or EDTA) | Similar (expanded for plasma) |
| Antibody | 1) Mouse monoclonal anti-PSA antibody coated onto plastic beads 2) Radiolabeled mouse monoclonal anti-PSA in protein matrix | 1) Two mouse monoclonal anti-PSA antibodies in biotinylated antibody reagent 2) Goat polyclonal anti-PSA antibody in conjugate reagent | Different (but both anti-PSA antibodies) |
| Sample Volume | 50 uL | 15 uL | Different (VITROS uses less sample) |
| Analytical Sensitivity | 0.1 ng/mL | 0.02 ng/mL | Better (VITROS is more sensitive) |
| Correlation with Predicate Device | N/A | Correlation Coefficient: 0.989 | Strong correlation |
| Regression Equation (VITROS vs. Predicate) | N/A | VITROS PSA assay = 1.028 x [the Tandem-R PSA assay] -- 0.089 (ng/mL) | Close to 1:1 relationship |
| Clinical Equivalence in various patient types (normal, malignant, non-malignant diseases) | Expected distributions | Exhibited distribution results that parallel expected distributions | Equivalent |
| Serial monitoring in treated prostate cancer patients | Substantially equivalent | Demonstrated substantial equivalence | Equivalent |
2. Sample Size Used for the Test Set and Data Provenance
The exact sample sizes for the various comparative tests are not explicitly stated in the provided text. The document mentions:
- "Comparisons of the VITROS PSA assay and the predicate device were performed with samples from a variety of clinical categories."
- "In clinical studies of apparently healthy individuals, patients with malignant disease and patients with a variety of non-malignant diseases..."
- "The serial monitoring study demonstrated that the VITROS PSA assay is substantial equivalent to the predicate device in patients previously treated for prostate cancer."
Data Provenance: The data is retrospective, relying on "patient specimens" and "currently commercially available reagents" (for the predicate device). The country of origin is not specified, but the submission is to the FDA, suggesting a US-centric regulatory context.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not provided in the text. As this is an in vitro diagnostic (IVD) assay for quantitative measurement of PSA, the "ground truth" would likely be the quantitative values obtained from the predicate device (Hybritech Tandem-R PSA) as the reference, rather than expert consensus on image interpretation or clinical diagnosis. The predicate device itself (which was FDA-approved) serves as the established gold standard for comparison.
4. Adjudication Method for the Test Set
This information is not applicable/provided. Adjudication methods (like 2+1 or 3+1) are typically used in studies involving human interpretation of diagnostic results (e.g., radiology, pathology) to establish a consensus ground truth. For a quantitative IVD assay like PSA, the ground truth is a numerical value, and the comparison is statistical (correlation, regression) rather than based on expert consensus of discrete diagnostic labels.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance
This information is not applicable. This submission describes an in vitro diagnostic assay, not an AI-assisted diagnostic tool that would be used by human readers (e.g., radiologists, pathologists) to interpret complex data. Therefore, an MRMC study and effects on human reader performance are not relevant to this device.
6. If a Standalone (i.e., Algorithm Only Without Human-in-the-Loop Performance) Was Done
Yes, this study represents a standalone performance evaluation of the VITROS PSA assay. The device itself (the immunoassay system) produces a quantitative result, and its performance is assessed against an established predicate device. There is no human interpretation or human-in-the-loop component being evaluated for improvement.
7. The Type of Ground Truth Used
The primary "ground truth" for the test set is the quantitative measurement of PSA obtained from the predicate device, Hybritech Tandem-R PSA. This is implied by the extensive comparison using Bablock Passing regression, which calculates the relationship between the new device's readings and the predicate's readings. The predicate device itself serves as the reference standard for established diagnostic values.
8. The Sample Size for the Training Set
The document does not explicitly state any "training set sample size" or a clear distinction between training and test sets in the modern machine learning sense. For an immunoassay, the development process (which could be analogous to "training") would involve extensive R&D, optimization, and characterization using various reagent lots, controls, and calibration materials, rather than a distinct "training set" of patient data for an algorithm. The submitted data focuses on the validation or test set performance against the predicate.
9. How the Ground Truth for the Training Set Was Established
As there's no explicitly defined "training set" in the context of an algorithm, the concept of establishing ground truth for it doesn't directly apply. The immunoassay itself is designed and optimized based on known biochemical principles and analytical performance targets. The "ground truth" for developing the assay would involve purified PSA standards, established reference methods, and internal characterization studies to ensure accurate and precise measurement.
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(77 days)
- & 2. The VITROS Immunodiagnostic Products Folate Reagent Pack 1/2 and the VITROS Immunodiagnostic Products Vitamin B12/Folate Reagent Pack 3 - for the in vitro quantitative measurement of folate in human serum and plasma (heparin) and whole blood (red cell folate), to aid in the differential diagnosis of anemia.
- The VITROS Immunodiagnostic Products Folate Calibrators - for in vitro use in the calibration of the VITROS Immunodiagnostic System for the quantitative measurement of folate in human serum and plasma (heparin).
- The VITROS Immunodiagnostic Products Red Cell Folate Pack - for whole blood sample preparation, to allow the in vitro quantitative measurement of red cell folate using the VITROS Immunodiagnostic System.
The VITROS Immunodiagnostic System uses luminescence as the signal in the quantitative and semi-quantitative determination of selected analytes in human body fluids, commonly serum, plasma and urine. Coated microwells are used as the solid phase separation system.
The system is comprised of three main elements:
- The VITROS Immunodiagnostic Products range of products, in this case VITROS Immunodiagnostic Products Folate Reagent Pack, VITROS Immunodiagnostic Products Folate Calibrators and the VITROS Immunodiagnostic System. The VITROS Folate Reagent Pack consists of: The VITROS Immunodiagnostic Products Folate Reagent Pack 1/2 and the VITROS Immunodiagnostic Products Vitamin B12/Folate Reagent Pack 3
- The VITROS Immunodiagnostic System instrumentation, which provides automated use of the immunoassay kits.
- Common reagents used by the VITROS System in each assay. The VITROS Immunodiagnostic Products Signal Reagent and VITROS Immunodiagnostic Products Universal Wash Reagent were cleared as part of the VITROS Immunodiagnostic Products Total T3 510(k) pre-market notification (K984310).
The VITROS System and common reagents are dedicated specifically only for use with the VITROS Immunodiagnostic Products range of immunoassay products.
Here's an analysis of the provided text, focusing on acceptance criteria and the study proving the device meets them. It's important to note that the document is a 510(k) summary, which often
focuses on substantial equivalence to a predicate device rather than exhaustive performance studies with strict "acceptance criteria" as might be defined for a novel device. The "acceptance
criteria" here are primarily implied by the demonstration of substantial equivalence and correlation to the predicate.
Acceptance Criteria and Performance Comparison
The document describes two devices:
- (a) VITROS Folate assay (for serum and plasma folate)
- (b) VITROS Red Cell Folate Pack (for red cell folate)
Both are compared to the Bio-Rad Quantaphase II Folate Radioassay (K935286) as the predicate device. The primary "acceptance criterion" appears to be demonstrating substantial equivalence
to this predicate device by showing a good correlation and acceptable bias in measurements.
Table of Acceptance Criteria (Implied) and Reported Device Performance
| Criterion Type | Specific Criterion (Implied/Predicate Performance) | VITROS Folate Assay (Serum/Plasma) Performance | VITROS Red Cell Folate Pack Performance |
|---|---|---|---|
| Substantial Equivalence | Demonstrated by strong correlation and acceptable bias to predicate. | Relationship: VITROS = 0.999 x Bio-Rad + 0.676 ng/mL | Relationship: VITROS = 1.17 x Bio-Rad + 4.0 ng/mL |
| Correlation (r): 0.979 | |||
| Bias: 17% overall positive bias. (Acknowledged as "true numerical differences") | |||
| Calibration Range | 0 – 20 ng/mL (matches predicate) | 0 – 20 ng/mL | 0 – 20 ng/mL |
| Basic Principle | To be consistent with predicate method or clinically acceptable alternative. | Solid phase assay (different from predicate's radioassay, but deemed acceptable) | Solid phase assay (different from predicate's radioassay, but deemed acceptable) |
| Tracer | To be consistent with predicate method or clinically acceptable alternative. | Enzyme labeled (different from predicate's 125Iodine, but deemed acceptable) | Enzyme labeled (different from predicate's 125I, but deemed acceptable) |
| Instrumentation | To be consistent with predicate method or clinically acceptable alternative. | VITROS Immunodiagnostic System (different from predicate's Gamma Counter, but deemed acceptable) | VITROS Immunodiagnostic System (different from predicate's Gamma Counter, but deemed acceptable) |
| Sample Type | Serum or plasma (EDTA) | Serum, plasma (heparin) (Broader than predicate, includes heparin plasma) | Whole blood (EDTA or heparin) (Broader than predicate, includes heparin) |
| Binding protein | Folate binding protein | Folate binding protein, purified from bovine milk (More specific description, but functionally equivalent) | Folate binding protein |
| Sample volume | 200 µL | 53 µL (Significantly lower than predicate) | 53 µL (Significantly lower than predicate) |
| Incubation time/temp | 1 hour at room temperature. | 73 mins at 37 °C (Different from predicate, but within acceptable limits for a new method) | Whole blood prep: 90 mins room temp; Folate assay: 73 mins at 37°C (Different from predicate, but deemed acceptable) |
| Analytical Sensitivity | Implied to be adequate for intended use (not explicitly stated). | Tested, results referred to package insert. | Not explicitly mentioned for Red Cell Folate. |
| Specificity | Implied to be adequate for intended use (not explicitly stated). | Tested, results referred to package insert. | Not explicitly mentioned for Red Cell Folate. |
| Precision | Implied to be adequate for intended use (not explicitly stated). | Tested, results referred to package insert. | Tested, results referred to package insert. |
| Dilution (Linearity) | Implied to be adequate for intended use (not explicitly stated). | Tested, results referred to package insert. | Tested, results referred to package insert. |
| Expected Values | Implied to be established. | Tested, results referred to package insert. | Tested, results referred to package insert. |
Study Details
The studies performed for both the VITROS Folate assay and the VITROS Red Cell Folate Pack
are primarily comparative effectiveness studies against the predicate device.
-
Sample size for the test set and data provenance:
- Test Set Sample Size: Not explicitly stated as a number of samples. The document mentions "samples from a variety of clinical categories" and "patient specimens covering a variety
of clinical categories." This suggests a diverse patient population was used, but the exact count is not provided. - Data Provenance: Not explicitly stated (e.g., country of origin, retrospective/prospective). However, the use of "patient specimens" and "currently commercially available reagents"
implies real-world samples from a clinical setting. It's likely a retrospective collection as is common for these types of studies comparing new assays to established ones.
- Test Set Sample Size: Not explicitly stated as a number of samples. The document mentions "samples from a variety of clinical categories" and "patient specimens covering a variety
-
Number of experts used to establish the ground truth for the test set and their qualifications:
- Not Applicable. For an in vitro diagnostic (IVD) quantitative assay, the "ground truth" is typically defined by the measurement results from a recognized reference method or a
well-established predicate device, not by expert interpretation. In this case, the predicate device (Bio-Rad Quantaphase II Folate Radioassay) serves as the de facto "ground truth"
for comparison purposes.
- Not Applicable. For an in vitro diagnostic (IVD) quantitative assay, the "ground truth" is typically defined by the measurement results from a recognized reference method or a
-
Adjudication method for the test set:
- Not Applicable. As per the point above, adjudication by multiple experts is not relevant for establishing ground truth for a quantitative chemical assay. The comparison is made
between the new device's readings and the predicate device's readings.
- Not Applicable. As per the point above, adjudication by multiple experts is not relevant for establishing ground truth for a quantitative chemical assay. The comparison is made
-
If a multi reader multi case (MRMC) comparative effectiveness study was done, and the effect size of how much human readers improve with AI vs without AI assistance:
- Not Applicable. This is an in vitro diagnostic device (quantitative assay), not an AI-assisted diagnostic imaging or interpretation system. Therefore, MRMC studies and human reader
improvement with AI assistance are not relevant.
- Not Applicable. This is an in vitro diagnostic device (quantitative assay), not an AI-assisted diagnostic imaging or interpretation system. Therefore, MRMC studies and human reader
-
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Yes, implicitly. The VITROS Folate assay and Red Cell Folate Pack are standalone automated IVD systems. Their performance metrics (correlation, bias, analytical characteristics)
are measured inherently without human interpretation of the result itself. Human involvement is in sample preparation, loading, and reviewing the reported numerical values, but the
measurement process is automated.
- Yes, implicitly. The VITROS Folate assay and Red Cell Folate Pack are standalone automated IVD systems. Their performance metrics (correlation, bias, analytical characteristics)
-
The type of ground truth used:
- Predicate Device Measurements: The ground truth for this substantial equivalence argument is the measurement results obtained from the Bio-Rad Quantaphase II Folate Radioassay
(K935286). - Analytical Performance: Additional "ground truths" are established internally for analytical performance characteristics (precision, linearity, expected values) using laboratory
standards and methods, but the primary comparison is to the predicate.
- Predicate Device Measurements: The ground truth for this substantial equivalence argument is the measurement results obtained from the Bio-Rad Quantaphase II Folate Radioassay
-
The sample size for the training set:
- Not Applicable/Not Provided. For an IVD assay, there isn't typically a "training set" in the machine learning sense. The assay is developed using analytical chemistry principles,
reagent formulation, and instrument calibration. The studies described are performance verification or validation tests rather than model training.
- Not Applicable/Not Provided. For an IVD assay, there isn't typically a "training set" in the machine learning sense. The assay is developed using analytical chemistry principles,
-
How the ground truth for the training set was established:
- Not Applicable. As there's no "training set" in the machine learning context, this question is not relevant. The development of the assay relies on established scientific principles
and internal validation of reagents and methods.
- Not Applicable. As there's no "training set" in the machine learning context, this question is not relevant. The development of the assay relies on established scientific principles
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(104 days)
The VITROS®CA 15-3 is an in vitro assay intended for the quantitative measurement of DF3 defined antigen in serum or plasma (EDTA or heparin) from patients previously treated for stage II or stage III breast cancer. Serial test results obtained with the VITROS CA 15-3 assay, in patients who are clinically free of disease, should be used in conjunction with all relevant information derived from diagnostic test, physical examination and full medical history in accordance with appropriate patient management procedures used for early detection of recurrence. The test is also intended for use as an aid in the management of breast cancer patients with metastatic disease by monitoring progression or response to treatment.
The VITROS Immunodiagnostic System uses luminescence as the signal in the quantitative and semi-quantitative determination of selected analytes in human body fluids, commonly serum and plasma. Coated microwells are used as the solid phase separation system. The system is comprised of three main elements: 1. The VITROS Immunodiagnostic Products (in this case VITROS Immunodiagnostic Products CA 15-3 Reagent Pack, VITROS Immunodiagnostic Products CA 15-3 Calibrators, which are combined by the VITROS Immunodiagnostic System to perform the VITROS CA 15-3 assay). 2. The VITROS Immunodiagnostic System instrumentation, which provides automated use of the immunoassay kits. 3. Common reagents used by the VITROS System in each assay.
The provided text does not contain acceptance criteria in the traditional sense of performance metrics (e.g., sensitivity, specificity, accuracy thresholds) for a diagnostic device.
Instead, the document focuses on demonstrating substantial equivalence to a previously cleared predicate device (Centocor CA 15-3 RIA) for regulatory approval (510(k)). This means the study aims to show that the new device performs similarly and is as safe and effective as the existing one, rather than meeting specific predefined performance targets set independently.
Here's an analysis based on the information provided, addressing as many of your points as possible:
1. Table of Acceptance Criteria and Reported Device Performance
As noted, explicit acceptance criteria (e.g., "sensitivity must be >X%") are not provided in the document. The primary criterion is demonstrating substantial equivalence to the predicate device.
| Device Characteristic | Acceptance Criteria (Implied by Substantial Equivalence) | Reported Device Performance (VITROS CA 15-3 assay) |
|---|---|---|
| Calibration Range | Should be comparable to or improve upon the predicate device for clinical utility. | 0 - 500 U/mL (Predicate: 0 - 200 U/mL, showing an expanded range) |
| Basic Principle | Similar immunoassay principle. | Solid phase immunoassay (Predicate: Solid phase radioimmunoassay - similar but different tracer) |
| Tracer | Functionally equivalent to quantify the analyte. | Enzyme labeled (Predicate: Radioactive tracer - different, but deemed equivalent in function) |
| Sample Type | Same or broader range of clinically relevant sample types. | Serum, plasma (heparin or EDTA) (Predicate: Serum, plasma - broader for plasma type) |
| Antibody | Should detect the same antigen (DF3) effectively. | 1) Mouse monoclonal anti-DF3 antigen antibody in biotinylated antibody reagent; 2) Mouse monoclonal anti-DF3 antigen antibody in conjugate reagent (Predicate: 1) Mouse monoclonal 115D8 antibody coated onto beads; 2) Mouse monoclonal DF3 antibody labeled with I125 - different antibodies but target same antigen) |
| Sample Volume | Clinically reasonable and practical. | 10 µL (Predicate: 20 µL - improvement in sample efficiency) |
| Incubation Time & Temp | Clinically reasonable and practical, ideally improving throughput. | First incubation 16 minutes at 37°C with shaking; Second incubation 16 minutes at 37°C with shaking (Predicate: First incubation 2 hours at room temperature; Second incubation 3 hours at room temperature - significant improvement in speed) |
| Correlation | Strong positive correlation (e.g., correlation coefficient > 0.9) with the predicate. | Bablock Passing regression: VITROS CA 15-3 assay = 0.945 x [Centocor CA 15-3 RIA] + 1.55 (U/mL); Correlation coefficient: 0.978 |
| Clinical Utility | Expected to demonstrate similar clinical utility for monitoring recurrence and treatment response. | "The serial monitoring study demonstrated the clinical utility of the VITROS CA 15-3 assay for monitoring for recurrence of disease in patients previously treated for stage II or stage III breast cancer and for monitoring response to treatment of breast cancer patients with metastatic disease." |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: The document states that comparisons were performed with "samples from a variety of clinical categories" and "patient specimens from patients who are normal, undergoing therapeutic and/or undergoing diagnostic evaluation." However, specific sample sizes for the test set are not provided in the excerpt.
- Data Provenance: The document does not specify the country of origin of the data. The data appears to be retrospective as it involves "patient specimens" and "clinical studies of apparently healthy individuals, patients with cancer and patients with a variety of non-malignant diseases," indicating samples collected prior to the study for the VITROS assay.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
There is no mention of experts being used to establish ground truth in the context of this diagnostic assay. For an in vitro diagnostic test that measures a biomarker (CA 15-3 antigen), the "ground truth" is typically the quantitative value obtained from the reference method (the predicate device) or from established analytical assays. The study aims to correlate the new device's measurements with those of the predicate.
4. Adjudication Method for the Test Set
Not applicable. As described above, this is a quantitative in vitro diagnostic assay comparing its results to a predicate device, not a qualitative assessment requiring expert adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done, If so, What was the Effect Size of How Much Human Readers Improve with AI vs without AI Assistance
Not applicable. This is an in vitro diagnostic device, not an AI or imaging device involving human readers/interpreters.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was Done
This device is a standalone diagnostic kit/system. Its performance is evaluated directly through its quantitative measurements, rather than as an assistant to a human. The "standalone" performance is essentially what the comparability study demonstrates.
7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)
The primary ground truth/reference standard used for comparison is the results obtained from the legally marketed predicate device, the Centocor CA 15-3 RIA. This is implicitly considered the "truth" for establishing substantial equivalence. Additionally, "clinical utility" was demonstrated via a "serial monitoring study" for recurrence and response to treatment, which would likely involve outcomes data (e.g., disease recurrence, treatment response status) but the methodology for determining these outcomes is not detailed.
8. The Sample Size for the Training Set
Not applicable. This document describes a traditional in vitro diagnostic assay, not a machine learning or AI-based device that typically has a distinct "training set." The development of such assays often involves optimization and calibration using various samples, but these are not usually referred to as a "training set" in the context of AI.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no mention of a "training set" for an AI or machine learning model. The assay's development would involve establishing accurate measurements against known standards and optimizing chemical/biological parameters, but this is a different process than establishing "ground truth" for machine learning training.
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(101 days)
Vitros NTx Reagent Pack - For in-vitro quantitative measurement of cross linked N-telopeptides of type I collagen (NTx) in human urine as an indicator of human bone resorption. A single NTx value cannot provide the rate of bone resorption as reported results do not contain a measure of time. Use of this test has not been established in primary hyperparathyroidism or hyperthyroidism.
Vitros NTx Calibrators - For in-vitro use in the calibration of the VITROS Immunodiagnostic System for the quantitative measurement of NTx in human urine.
Vitros NTx Controls - For in-vitro use in the monitoring of the performance of the VITROS Immunodiagnostic System when used for the quantitative measurement of NTx in human urine.
The VITROS Immunodiagnostic System uses luminescence as the signal in the quantitative and semi-quantitative determination of selected analytes in human body fluids, commonly serum, plasma and urine. Coated microwells are used as the solid phase separation system. The system is comprised of three main elements: 1. The VITROS Immunodiagnostic Products (in this case VITROS Immunodiagnostic Products NTx Reagent Pack, VITROS Immunodiagnostic Products NTx Calibrators, which are combined by the VITROS Immunodiagnostic System to perform the VITROS NTx assay). 2. The VITROS Immunodiagnostic System - instrumentation, which provides automated use of the immunoassay kits. 3. Common reagents used by the VITROS System in each assay.
The provided text describes a 510(k) summary for the VITROS Immunodiagnostic Products NTx assay, asserting its substantial equivalence to a predicate device, the Osteomark NTx Test. The study primarily focuses on demonstrating this equivalence by comparing the performance of the new device against the predicate.
Here's an analysis of the acceptance criteria and study details based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The text does not explicitly state formal "acceptance criteria" with quantitative targets for accuracy, precision, sensitivity, or specificity in the way one might see for a completely novel device. Instead, the primary acceptance criterion is substantial equivalence to the predicate device, K980518.
The device performance is reported in the context of this equivalence:
| Device Characteristic | Acceptance Criteria (Implicit: Substantially Equivalent to Predicate) | Reported Device Performance (VITROS NTx assay) | Comparison to Predicate Device (Osteomark NTx Test) |
|---|---|---|---|
| Calibration Range | Similar to predicate (20-3000 nM BCE) | 0 - 3000 nM BCE | The VITROS assay has a wider lower range (0 vs 20). |
| Basic principle | Solid phase immunoassay | Solid phase immunoassay | Identical |
| Tracer | Enzyme labeled | Enzyme labeled | Identical |
| Instrumentation | Compatible with typical immunoassay readers | VITROS Immunodiagnostic System | Microwell plate reader (different specific instrument, but same type of system) |
| Sample type | Urine | Urine | Identical |
| Antibody | Mouse monoclonal anti-NTx antibody in conjugate reagent | Mouse monoclonal anti-NTx antibody in conjugate reagent | Identical |
| Sample volume | 25 µL | 25 µL | Identical |
| Incubation time & temperature | Similar incubation conditions | 30 minutes at 37° C | 18-28° C for 90 minutes (± 5 minutes) (Different, but likely within acceptable clinical range) |
| Correlation to Predicate | Strong linear relationship | VITROS NTx assay = 0.957 x Osteomark NTx test + 6.5 (nM BCE/mM creatinine) | Demonstrated through Deming's Regression |
| Clinical Performance | Equivalent performance across clinical categories | Comparisons performed with samples from a variety of clinical categories | Demonstrated equivalence |
| Analytical Studies | Satisfactory performance | Tests performed for analytical sensitivity, specificity, precision, dilution, and expected values | Results refer to the package insert |
2. Sample Size Used for the Test Set and Data Provenance
- Test Set Sample Size: The text states, "Comparisons of the VITROS NTx assay and the predicate device were performed with samples from a variety of clinical categories." It also mentions "patient specimens covering a variety of clinical categories." However, no specific number or range for the sample size of the test set is provided.
- Data Provenance: The text does not explicitly state the country of origin. It indicates that "currently commercially available reagents along with patient specimens" were used, implying the data
- Retrospective/Prospective: Not specified.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This type of information is not applicable to this study. The study focuses on the analytical performance and correlation of a diagnostic assay (measuring NTx levels in urine) against a legally marketed predicate device. The "ground truth" for each sample is assumed to be the measurement obtained by the predicate device and/or the actual NTx concentration in the urine sample, rather than an expert's interpretation of an image or clinical condition. Therefore, no experts were used to establish a ground truth in the context of interpretation or diagnosis.
4. Adjudication Method for the Test Set
Not applicable. As the study involves quantitative laboratory measurements and comparison to a predicate device, adjudication by a panel of human experts is not relevant. The comparison is based on numerical results and statistical correlation methods like Deming's Regression.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
No, a MRMC comparative effectiveness study was not done. This type of study is typically associated with imaging diagnostics or clinical assessments requiring human interpretation. This submission is for an in-vitro diagnostic (IVD) assay where performance is objectively measured by the instrument.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
Yes, this is essentially a standalone performance study. The VITROS Immunodiagnostic System, which performs the NTx assay, operates as an automated system without direct human-in-the-loop performance affecting the measurement itself. The results are quantitative measurements generated by the instrument. The comparison to the predicate device is also a standalone comparison between two analytical methods.
7. The Type of Ground Truth Used
The ground truth used for this study is primarily the measurements obtained from the predicate device (Osteomark NTx Test) for the purpose of demonstrating substantial equivalence. Additionally, typical "ground truth" for analytical studies of IVDs would involve:
- Reference materials/standards with known concentrations: Used for analytical sensitivity, specificity, and calibration.
- Split samples analyzed by both devices: Demonstrating correlation between the new device and the predicate.
Pathology or outcomes data are not mentioned as direct ground truth for this specific 510(k) submission, whose primary goal is substantial equivalence for an analytical test.
8. The Sample Size for the Training Set
The text does not explicitly mention a "training set" or its size. For an IVD assay like this, the development process would involve extensive analytical characterization and optimization, which could be considered an internal "training." However, the document focuses on the validation against the predicate, not the internal development data.
9. How the Ground Truth for the Training Set was Established
Since no explicit "training set" is described, the method for establishing its ground truth is not provided. In the context of IVD development, ground truth during internal development (analogous to training) would typically involve:
- Using international reference materials.
- Comparing results to established laboratory methods.
- Verifying against carefully characterized samples to ensure accuracy across the assay's dynamic range.
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(50 days)
1 & 2. The VITROS Immunodiagnostic Products Vitamin B12 Reagent Pack 1/2 and the VITROS Immunodiagnostic Products Vitamin B12/Folate Reagent Pack 3 - for the in vitro quantitative measurement of vitamin B12 in human serum and plasma (EDTA or heparin) to aid in the differential diagnosis of anemia.
- The VITROS Immunodiagnostic Products Vitamin B12 Calibrators - for in vitro use in the calibration of the VITROS Immunodiagnostic System for the quantitative measurement of vitamin B12 in human serum and plasma (EDTA or heparin).
The VITROS Immunodiagnostic System uses luminescence as the signal in the quantitative and semi-quantitative determination of selected analytes in human body fluids, commonly serum, plasma and urine. Coated microwells are used as the solid phase separation system.
The system is comprised of three main elements:
- The VITROS Immunodiagnostic Products range of products, in this case VITROS Immunodiagnostic Products Vitamin B12 Reagent Pack 1/2, VITROS Immunodiagnostic Products Vitamin B12/Folate Reagent Pack 3, VITROS Immunodiagnostic Products Vitamin B12 Calibrators and the VITROS Immunodiagnostic System.
- The VITROS Immunodiagnostic System instrumentation, which provides automated use of the immunoassay kits.
- Common reagents used by the VITROS System in each assay. The VITROS Immunodiagnostic Products Signal Reagent and VITROS Immunodiagnostic Products Universal Wash Reagent.
The VITROS System and common reagents are dedicated specifically only for use with the VITROS Immunodiagnostic Products range of immunoassay products.
The provided text describes the VITROS Immunodiagnostic Products Vitamin B12 assay, an in vitro diagnostic device for the quantitative measurement of vitamin B12. The data outlines a substantial equivalence study rather than a traditional clinical study with acceptance criteria often seen for imaging or AI devices.
Here's an analysis based on the provided text:
Acceptance Criteria and Device Performance:
The primary acceptance criterion is substantial equivalence to a predicate device. This is demonstrated by comparing key characteristics and performing a regression analysis.
| Acceptance Criterion | Reported Device Performance (VITROS Vitamin B12 assay) |
|---|---|
| Substantial Equivalence to Predicate Device | Demonstrated through comparison of device characteristics and Deming's Regression analysis. |
| Calibration Range | 0 - 2000 pg/mL (Matches predicate) |
| Basic Principle | Solid phase immunoassay (Different from predicate's radioassay, but equivalent for purpose) |
| Tracer | Enzyme labeled (Different from predicate's 57Co, but equivalent for purpose) |
| Instrumentation | VITROS Immunodiagnostic System (Different from predicate's Gamma Counter, but equivalent for purpose) |
| Sample Type | Serum, plasma (EDTA or heparin) (Broader than predicate's serum, plasma (EDTA)) |
| Sample Volume | 30 μL (Matches predicate) |
| Incubation Time & Temperature | 58 minutes at 37° C (Different from predicate's 1 hour at room temperature, but equivalent for purpose) |
| Correlation with Predicate Device (Deming's Regression) | VITROS Vitamin B12 assay = 0.984 x Bio-Rad Quantaphase II B12 Radioassay + 9.59 (pg/mL) |
| Analytical Sensitivity | Performed (Specific value not provided in this summary) |
| Specificity | Performed (Specific value not provided in this summary) |
| Precision | Performed (Specific value not provided in this summary) |
| Dilution | Performed (Specific value not provided in this summary) |
| Expected Values | Performed (Specific value not provided in this summary) |
Study Details:
The study conducted is a substantial equivalence study for an in vitro diagnostic (IVD) device, not a multi-reader multi-case (MRMC) comparative effectiveness study or a standalone algorithm performance study typical for AI/imaging devices.
-
Sample size used for the test set and the data provenance:
- The text states: "Comparisons of the VITROS Vitamin B12 assay and the predicate device were performed with samples from a variety of clinical categories."
- It also mentions: "Equivalence was demonstrated using currently commercially available reagents along with patient specimens covering a variety of clinical categories."
- Specific sample size is not provided in this summary.
- Data provenance: Not explicitly stated, but the reference to "patient specimens" suggests human biological samples. The geographical origin (country) and whether the data was retrospective or prospective are not mentioned.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This is not applicable in the context of this type of IVD device study. The "ground truth" for an IVD assay like this is typically established by the predicate device's measurement, against which the new device is compared. There are no human "experts" establishing annotated ground truth for diagnosing B12 deficiency from images or clinical data in this document.
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Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not applicable. This is not a study involving human readers' interpretations that require adjudication.
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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 comparative effectiveness study was not done. This device is an in vitro diagnostic assay, not an AI or imaging device that assists human readers.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- The VITROS Immunodiagnostic System itself, which performs the assay, operates in a standalone manner for generating the quantitative B12 result. The performance data presented (calibration range, correlation with predicate, analytical sensitivity, etc.) are inherent to the assay and instrumentation, without human interpretation in the measurement process. However, this is not "standalone AI algorithm performance." It's standalone device performance.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- The "ground truth" for comparison in this substantial equivalence study is the measurement obtained from the legally marketed predicate device (Bio-Rad Quantaphase II B12 Radioassay) for the same patient samples. The intent is to show the new device provides comparable quantitative results.
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The sample size for the training set:
- This concept of a "training set" is not directly applicable to an IVD analytical performance study like this. The device itself (reagents, calibrators, and instrumentation) is developed and manufactured, and then its performance is validated. There isn't an "algorithm" being trained on a dataset in the way an AI model is.
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How the ground truth for the training set was established:
- Not applicable as there is no "training set" in the context of AI model development for this type of IVD device. The reagents and assay method are developed based on scientific principles and validated through internal studies and often external clinical sample comparisons.
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(50 days)
For in vitro quantitative measurement of cortisol in human serum, plasma (EDTA or heparin) or urine.
For in vitro use in monitoring the performance of the VITROS Immunodiagnostic System when used for the measurement of cortisol in human serum, plasma (EDTA or heparin) or urine.
The VITROS Immunodiagnostic Products Cortisol assay is an in vitro quantitative measurement of cortisol in human serum or plasma (EDTA or heparin) or urine. The system is comprised of three main elements: The VITROS Immunodiagnostic Products (Reagent Pass, Calibrators, and Controls), the VITROS Immunodiagnostic System instrumentation, and common reagents used by the VITROS System in each assay.
Acceptance Criteria and Study for VITROS CORTISOL assay (K983990)
This submission describes the VITROS CORTISOL assay which is intended for the in vitro quantitative measurement of cortisol in human serum or plasma (EDTA or heparin) or urine. The study presented aims to demonstrate substantial equivalence to the predicate device, the ABBOTT TDx Cortisol assay.
1. Acceptance Criteria and Reported Device Performance
The provided document details a comparison between the VITROS CORTISOL assay and the predicate device, ABBOTT TDx Cortisol assay, rather than explicit acceptance criteria with pre-defined thresholds. The primary method for demonstrating substantial equivalence was a Deming's Regression analysis and a comparison of analytical characteristics.
| Device Characteristic | Acceptance Criteria (Implied by Predicate) | Reported Device Performance (VITROS CORTISOL assay) |
|---|---|---|
| Calibration Range | Comparable to predicate (3 - 1655 nmol/L) | 3 - 1700 nmol/L (Comparable to predicate) |
| Basic Principle | Solid phase immunoassay (Same as predicate) | Solid phase immunoassay (Same as predicate) |
| Tracer | No specific numerical criterion, but expected to be effective. | Enzyme labeled (Predicate is Fluorescein labeled - a difference but deemed acceptable) |
| Instrumentation | Immunodiagnostic System (Named Abbott TDx for predicate) | VITROS Immunodiagnostic System (Specific to device) |
| Sample Type | Serum, plasma or urine (Same as predicate) | Serum, plasma (EDTA or heparin) or urine (Same as predicate, with specific anticoagulants mentioned) |
| Antibody | No specific numerical criterion, but expected to be effective. | Sheep polyclonal anti-cortisol antibody biotinylated antibody reagent (Predicate uses Mouse monoclonal and Goat polyclonal anti-cortisol antibody reagent) |
| Regression Analysis | Correlation and close agreement with predicate. | VITROS Cortisol assay = 0.83 x Abbott TDx Cortisol assay = 16.1 nmol/L |
| Analytical Performance | Demonstrated analytical sensitivity, specificity, precision, dilution, and expected values comparable to predicate. | Tests were performed to obtain analytical sensitivity, specificity, precision, dilution, and expected values. (Specific results not provided in this summary, but referenced in the package insert). |
Note on Acceptance Criteria: The document primarily focuses on demonstrating "substantial equivalence" rather than pre-defined quantitative acceptance criteria. The performance of the VITROS Cortisol assay, as described by the Deming's Regression and the qualitative comparisons, was deemed sufficiently similar to the predicate to establish equivalence.
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: The document states that "samples from a variety of clinical categories" were used for the regression analysis and other performance tests. However, the exact numerical sample size for the test set is not explicitly provided in the summary.
- Data Provenance: The document does not specify the country of origin for the data. The data is stated to be from "patient specimens covering a variety of clinical categories," implying retrospective clinical samples were likely used for method comparison and validation.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
This specific study is an in vitro diagnostic device (IVDD) assay for measuring a biochemical analyte (cortisol). The "ground truth" for such assays is typically established by reference methods or comparison to a cleared predicate device, rather than expert human interpretation of images or clinical assessments.
Therefore, the concept of "number of experts used to establish the ground truth" and their "qualifications" as it applies to image-based diagnostics does not apply in the same way to this type of IVDD study. The accuracy of the measured cortisol level itself is the ground truth, assessed through its correlation with the predicate device and other analytical validations.
4. Adjudication Method for the Test Set
Given that this is an IVDD assay for quantitative measurement of cortisol, and the "ground truth" is established by comparison to a predicate device and analytical validation, an "adjudication method" in the context of expert review (e.g., 2+1, 3+1 for imaging studies) is not applicable. The comparison is based on quantitative analytical results.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No. A Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not conducted for this device. This type of study is relevant for diagnostic devices where human readers interpret results, such as imaging or pathology, and the AI's role is to assist or replace human interpretation. The VITROS CORTISOL assay is an automated in vitro quantitative measurement system, not a device requiring human interpretation in the same manner. Therefore, the effect size of human readers improving with AI assistance is not relevant or measurable in this context.
6. Standalone Performance Study (Algorithm Only Without Human-in-the-Loop Performance)
Yes, in essence. The entire evaluation of the VITROS CORTISOL assay, as described, is a standalone performance assessment of the an algorithm/system only (the immunoassay process and instrumentation). There is no "human-in-the-loop" once the sample is loaded and the assay begins. The performance characteristics (regression, analytical sensitivity, specificity, etc.) are inherent to the device and its reagents operating independently.
7. Type of Ground Truth Used
The "ground truth" for the test set was implicitly established by:
- Comparison to a legally marketed predicate device: The ABBOTT TDx Cortisol assay's measurements served as the primary reference for demonstrating agreement (via Deming's regression).
- Analytical validation: The study also conducted tests to obtain "analytical sensitivity, specificity, precision, dilution and expected values." These analytical performance characteristics, based on established reference materials and methods, contribute to the determination of the assay's accuracy and reliability, forming a scientific basis for its performance.
8. Sample Size for the Training Set
The document does not explicitly mention a training set or its sample size. This is common for predicate-based IVDD submissions that rely on established biochemical principles and comparisons rather than machine learning algorithms requiring explicit training data. The development of such an assay involves extensive formulation, reagent optimization, and internal validation, but this is not typically referred to as a "training set" in the same way as for AI/ML algorithms.
9. How the Ground Truth for the Training Set Was Established
As no explicit "training set" is mentioned in the context of an AI/ML algorithm, the question of how its ground truth was established is not applicable. The "ground truth" for establishing the assay's performance was, as described above, based on comparison with a predicate device and rigorous analytical validation.
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(109 days)
VITROS AFP Reagent Pack - For the in vitro quantitative measurement of alpha-fetoprotein (AFP) in human serum to aid in the management of patients with non-seminomatous testicular cancer. VITROS AFP Calibrators - For in vitro use in the calibration of the VITROS Immunodiagnostic System for the quantitative measurement of AFP in human serum.
The VITROS Immunodiagnostic System uses luminescence as the signal in the quantitative and semi-quantitative determination of selected analytes in human body fluids, commonly serum. Coated microwells are used as the solid phase separation system. The system is comprised of three main elements: The VITROS Immunodiagnostic Products (in this case VITROS Immunodiagnostic Products AFP Reagent Pack, VITROS Immunodiagnostic Products AFP Calibrators, which are combined by the VITROS Immunodiagnostic System to perform the VITROS AFP assay). The VITROS Immunodiagnostic System - instrumentation, which provides automated use of the immunoassay kits. Common reagents used by the VITROS System in each assay.
Here's an analysis of the provided text regarding the VITROS AFP assay's acceptance criteria and the study proving its performance:
1. Table of Acceptance Criteria and Reported Device Performance:
The document doesn't explicitly state quantitative acceptance criteria in the typical "pass/fail" format. Instead, it demonstrates "substantial equivalence" to a predicate device. The performance is primarily shown through a correlation study and analytical performance characteristics.
| Acceptance Criterion (Implicit) | Reported Device Performance (VITROS AFP assay) |
|---|---|
| Substantial Equivalence to Predicate Device (Abbott AxSYM AFP) | Correlation: |
| VITROS AFP assay = 0.889 x [AxSYM AFP assay] + 2.60 (IU/mL) | |
| with a correlation coefficient of 0.991. | |
| Clinical Utility (Serial Monitoring): | |
| "The serial monitoring study demonstrated the clinical utility of the VITROS AFP assay as an aid in the management of patients with non-seminomatous testicular cancer." | |
| Distribution of Results: | |
| "In clinical studies of apparently healthy individuals, patients with cancer and patients with a variety of non-malignant diseases, the VITROS AFP assay exhibited distribution results that parallel expected distributions for these patient types." | |
| Analytical Sensitivity (Specificity, Precision, Dilution) | "tests were performed to obtain analytical sensitivity, specificity, precision, dilution and expected values. Refer to the VITROS AFP assay package insert for VITROS AFP assay results." (Specific values are not provided in this summary.) |
2. Sample Size Used for the Test Set and Data Provenance:
- Sample Size: The document mentions "samples from serially monitored patients diagnosed and treated for testicular cancer" and "patient specimens covering the normal, therapeutic and diagnostic range." It also refers to "clinical studies of apparently healthy individuals, patients with cancer and patients with a variety of non-malignant diseases."
- Specific sample sizes are NOT provided in this summary.
- Data Provenance: The data appears to be retrospective as it compares the new device results with those from an already approved predicate device using existing "patient specimens." The country of origin is not specified, but the submission is to the US FDA.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications:
This is a lab assay, not a diagnostic imaging device that typically uses expert readers for ground truth.
- Not applicable in the context of this in vitro diagnostic (IVD) assay for AFP levels. The "ground truth" for an IVD assay typically refers to the accuracy of its measurement of the analyte. In this case, the predicate device (Abbott AxSYM System AFP) served as the reference standard for the comparison.
4. Adjudication Method for the Test Set:
- Not applicable for this type of IVD assay. Adjudication methods like 2+1 or 3+1 are typically used in studies involving human interpretation (e.g., radiology reads) where there can be disagreement among experts.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done:
- No, an MRMC study was not done. This type of study is relevant for AI-assisted diagnostic tools where human readers are involved. The VITROS AFP assay is an automated in vitro diagnostic test.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:
- Yes, in essence, the study is a standalone performance assessment. The VITROS AFP assay is an automated system designed to quantitatively measure AFP levels. Its performance is evaluated directly against a predicate device without human interpretation being the primary variable. The results are compared directly to the predicate device's output.
7. The Type of Ground Truth Used:
- The primary "ground truth" or reference standard used for comparison was the predicate device, the Abbott AxSYM System AFP assay. The performance of the VITROS AFP assay was evaluated based on its correlation and agreement with readings obtained from this established, FDA-approved device. Additionally, the clinical utility was assessed through "serial monitoring" of actual cancer patients, implying clinical outcomes were considered in relation to AFP levels.
8. The Sample Size for the Training Set:
- Not applicable/Not explicitly stated. This document describes a traditional medical device (an immunoassay kit and system), not a machine learning or AI-driven device that requires a distinct "training set" in the common AI sense. The development of such assays involves extensive R&D and calibration, but not typically a separate "training set" as defined for AI models.
9. How the Ground Truth for the Training Set Was Established:
- Not applicable/Not explicitly stated. As this is not an AI/ML device, the concept of a training set ground truth doesn't directly apply in the same way. The assay's analytical characteristics (calibration, sensitivity, etc.) are established through laboratory procedures and reference materials.
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(27 days)
For in vitro use in verifying the calibration range of the VITROS Immunodiagnostic System, when used for the measurement of immunoassays which include Cortisol.
The VITROS Immunodiagnostic System uses luminescence as the signal in the quantitative and semi-quantitative determination of selected analytes in human body fluids, commonly serum, plasma and urine. Coated microwells are used as the solid phase separation system. The system is comprised of three main elements: 1. The VITROS Immunodiagnostic Products (in this case VITROS Immunodiagnostic Products Reagent Pack, VITROS Immunodiagnostic Products Calibrators, which are combined by the VITROS Immunodiagnostic System to perform a VITROS assay). 2. The VITROS Immunodiagnostic System instrumentation, which provides automated use of the immunoassay kits. 3. Common reagents used by the VITROS System in each assay. The VITROS Immunodiagnostic Products Signal Reagent and VITROS Immunodiagnostic Products Universal Wash Reagent were cleared as part of the VITROS Immunodiagnostic Products Total T3 510(k) pre-market notification (K984310). The VITROS System and common reagents are dedicated specifically only for use with the VITROS Immunodiagnostic Products range of immunoassay products. The VITROS Immunodiagnostic Products Cortisol Range Verifiers are a base matrix of freeze-dried human plasma spiked with analyte (Cortisol) at low and high levels.
The provided text describes a 510(k) summary for the VITROS Immunodiagnostic Products Cortisol Range Verifiers. However, it does not contain the detailed information necessary to fully answer all aspects of your request regarding acceptance criteria and a study proving device performance.
The document focuses on demonstrating substantial equivalence to a predicate device, as required for a 510(k) submission, rather than presenting a detailed performance study with acceptance criteria.
Here's what can be extracted and what is missing:
1. Table of acceptance criteria and the reported device performance:
This information is not provided in the document. The text compares the intended use and matrix of the subject device to its predicate, but it does not specify any quantitative acceptance criteria or performance metrics for the VITROS Cortisol Range Verifiers themselves.
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not specified in the document | Not specified in the document |
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 provided in the document. The 510(k) summary focuses on substantial equivalence based on device characteristics rather than a new performance study with a test set.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):
This information is not provided in the document. As no detailed performance study with a test set is described, there's no mention of ground truth establishment or experts involved.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
This information is not provided in the document.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
This information is not applicable and not provided in the document. This device (range verifiers for an immunoassay system) is an in vitro diagnostic product, not an AI-assisted diagnostic tool that would involve human readers and MRMC studies.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
This information is not applicable and not provided in the document. This is not an algorithm, but a physical diagnostic product. The document describes the "VITROS Immunodiagnostic System" as the instrumentation, but the subject device is the "Cortisol Range Verifiers" used with that system.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
This information is not provided in the document.
8. The sample size for the training set:
This information is not provided in the document.
9. How the ground truth for the training set was established:
This information is not provided in the document.
Summary of the Study (as described in the document):
The document does not describe a clinical performance study with defined acceptance criteria and detailed quantitative results. Instead, it discusses a substantial equivalence comparison study to a predicate device (VITROS Immunodiagnostic Products FSH Range Verifiers, K973517).
- Study Goal: To demonstrate that the VITROS Immunodiagnostic Products Cortisol Range Verifiers are substantially equivalent to the predicate device.
- Methodology: Equivalence was demonstrated by comparing the physical properties and intended uses of the subject device with the predicate device and other commercially available reagents.
- Key Comparisons (from Table 1):
- Intended Use: Both devices are for verifying the calibration range of the VITROS Immunodiagnostic System for the measurement of a particular analyte (Cortisol for the subject device, FSH for the predicate).
- Matrix of Range Verifiers: Both use a base matrix of freeze-dried human plasma spiked with the respective analyte.
- Range Verifier Levels: Both have "Low and high" levels.
- Conclusion: The information presented in the pre-market notification (including these comparisons) was deemed sufficient to provide reasonable assurance that the VITROS Cortisol Range Verifiers are safe and effective for their stated intended use and are substantially equivalent to the predicate device.
In essence, the "study" described here is primarily a comparative analysis for regulatory clearance (510(k)) rather than a detailed performance validation study with specific acceptance criteria beyond demonstrating equivalence.
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(28 days)
The VITROS TESTOSTERONE assay is intended for the in vitro quantitative measurement of testosterone in human serum or plasma (EDTA or heparin).
The VITROS Immunodiagnostic System uses luminescence as the signal in the quantitative and semi-quantitative determination of selected analytes in human body fluids, commonly serum, plasma and urine. Coated microwells are used as the solid phase separation system. The system is comprised of three main elements: 1. The VITROS Immunodiagnostic Products (in this case VITROS Immunodiagnostic Products TESTOSTERONE Reagent Pack, VITROS Immunodiagnostic Products TESTOSTERONE Calibrators, which are combined by the VITROS Immunodiagnostic System to perform the VITROS TESTOSTERONE assay). 2. The VITROS Immunodiagnostic System instrumentation, which provides automated use of the immunoassay kits. 3. Common reagents used by the VITROS System in each assay.
The provided text describes the 510(k) summary for the VITROS Immunodiagnostic Products TESTOSTERONE assay, which seeks to establish substantial equivalence to a predicate device, the DPC Coat-A-Count Testosterone assay.
Here's an analysis of the acceptance criteria and study information based on the provided text:
1. Table of acceptance criteria and the reported device performance
The document does not explicitly state numerical acceptance criteria in the typical sense (e.g., minimum sensitivity, specificity, or agreement percentages). Instead, the primary "acceptance criterion" appears to be substantial equivalence to the predicate device, the DPC Coat-A-Count Testosterone assay.
The reported device performance is demonstrated through a statistical correlation:
| Acceptance Criterion | Reported Device Performance (VITROS TESTOSTERONE assay) |
|---|---|
| Substantial Equivalence to Predicate Device (DPC Coat-A-Count Testosterone assay) | Relationship determined by Deming's Regression: |
| VITROS TESTOSTERONE assay = 0.9222 x DPC Coat-A-Count Testosterone assay - 2.25 nmol/L | |
| Analytical Sensitivity | "tests were performed to obtain analytical sensitivity" (specific values not provided in this summary) |
| Specificity | "tests were performed to obtain ... specificity" (specific values not provided in this summary) |
| Precision | "tests were performed to obtain ... precision" (specific values not provided in this summary) |
| Dilution and Expected Values | "tests were performed to obtain ... dilution and expected values" (specific values not provided in this summary) |
2. Sample size used for the test set and the data provenance
- Sample Size: The text states, "Comparisons of the VITROS TESTOSTERONE assay and the predicate device were performed with samples from a variety of clinical categories." However, the specific sample size (N) used for this comparison is not mentioned in the provided summary.
- Data Provenance: The samples were "patient specimens covering a variety of clinical categories." The country of origin is not specified, and it is described as a comparative study against a predicate device, implying these are real-world patient samples. The information provided does not specify if the data 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. For an immunoassay, "ground truth" is typically established by the reference method (in this case, the predicate device) or a gold standard method. The summary doesn't detail how the predicate device's results were established as "ground truth" (e.g., if multiple expert clinical review was involved), nor does it mention any external expert review of the samples used for comparison.
4. Adjudication method for the test set
This information is not applicable/provided. For an immunoassay comparison, adjudication would typically not be a factor in the same way it would be for image-based diagnostic or subjective clinical assessments. The comparison relies on the quantitative measurements of the two 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
This is not applicable. The device is an in vitro diagnostic (IVD) assay for measuring testosterone, not an AI-based imaging or interpretive device that would involve human readers or AI assistance in the way an MRMC study evaluates.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
This is implicitly a standalone performance evaluation. The VITROS TESTOSTERONE assay is an automated immunoassay system. Its performance (as measured by correlation with the predicate, analytical sensitivity, specificity, etc.) is the performance of the system itself, without direct human intervention in the result generation or interpretation beyond operating the instrument and following its protocol. There isn't an "algorithm" in the typical sense of AI, but rather a chemical and photometric measurement system.
7. The type of ground truth used
The "ground truth" for the performance evaluation is the results obtained from the predicate device, DPC Coat-A-Count Testosterone assay (K813401). The study aims to show substantial equivalence to this already approved device. Additional analytical tests like sensitivity, specificity, and precision were also performed against defined standards or reference materials, which would represent their respective ground truths.
8. The sample size for the training set
This is not provided and is likely not applicable in the context of this type of immunoassay. Immunoassays are "trained" or developed through extensive laboratory work to establish optimal reagent concentrations, reaction conditions, and calibration curves. They are not "trained" on data sets in the way a machine learning algorithm is. The summary refers to "calibration range" and "calibrators" which are used to set up the assay, but not in the sense of a machine learning training set size.
9. How the ground truth for the training set was established
As noted above, a "training set" in the machine learning sense is not applicable. The "ground truth" for establishing the assay's performance and calibration is derived from:
- Reference materials and standards: For analytical sensitivity, specificity, and precision.
- Predicate device measurements: For establishing substantial equivalence using patient samples.
- VITROS Immunodiagnostic Products TESTOSTERONE Calibrators: These are likely standardized materials with known testosterone concentrations used to "train" or calibrate the instrument for accurate measurements within its reportable range. How these calibrator values themselves were established is not detailed but would involve rigorous laboratory methods and reference standards.
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(27 days)
For in vitro use in verifying the calibration range of the VITROS Immunodiagnostic System when used for the measurement of immunoassays which include Testosterone and NTx.
The VITROS Immunodiagnostic System uses luminescence as the signal in the quantitative and semi-quantitative determination of selected analytes in human body fluids, commonly serum, plasma and urine. Coated microwells are used as the solid phase separation system.
The system is comprised of three main elements:
-
- The VITROS Immunodiagnostic Products (in this case VITROS Immunodiagnostic Products Reagent Pack, VITROS Immunodiagnostic Products Calibrators, which are combined by the VITROS Immunodiagnostic System to perform a VITROS assay).
-
- The VITROS Immunodiagnostic System instrumentation, which provides automated use of the immunoassay kits. The VITROS Immunodiagnostic System was cleared for market by a separate 510(k) pre-market notification (K962919).
-
- Common reagents used by the VITROS System in each assay. The VITROS Immunodiagnostic Products Signal Reagent and VITROS Immunodiagnostic Products Universal Wash Reagent were cleared as part of the VITROS Immunodiagnostic Products Total T3 510(k) pre-market notification (K984310).
The VITROS System and common reagents are dedicated specifically only for use with the VITROS Immunodiagnostic Products range of immunoassay products.
The provided text describes a 510(k) pre-market notification for VITROS Immunodiagnostic Products Testosterone Range Verifiers and NTx Range Verifiers. The submission aims to demonstrate substantial equivalence to a predicate device. However, the document does not contain specific acceptance criteria, a detailed study proving performance against acceptance criteria, or most of the requested information about test sets, expert adjudication, or training sets for a device utilizing AI.
The device in question is a "Range Verifier," which is used to verify the calibration range of an immunodiagnostic system. This is a quality control product, not an AI-powered diagnostic device. Therefore, the questions related to AI-specific performance, human reader improvement, and extensive data set details are not applicable or not present in the provided text.
Based on the provided text, here's what can be extracted and inferred:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly state numerical acceptance criteria for performance (e.g., sensitivity, specificity, accuracy) because it is a range verifier, not a diagnostic test. Its performance is demonstrated by its "substantial equivalence" to a predicate device based on its characteristics and intended use.
| Acceptance Criteria (Inferred from "Substantial Equivalence") | Reported Device Performance |
|---|---|
| Intended Use | For in vitro use in verifying the calibration range of the VITROS Immunodiagnostic System when used for the measurement of immunoassays which include Testosterone and NTx. (Matches predicate in function, differs in specific analytes verified) |
| Matrix of Range Verifiers | A base matrix of freeze-dried human plasma or buffered matrix spiked with analyte (Testosterone, NTx). (Similar to predicate: freeze-dried human plasma spiked with human pituitary FSH) |
| Range Verifier levels | Low and high (Matches predicate) |
| Safety and Effectiveness | The data presented provides a reasonable assurance that the VITROS Testosterone and NTx Range Verifiers are safe and effective for the stated intended use, demonstrated through comparison to a legally marketed predicate device. |
2. Sample size used for the test set and the data provenance
Not applicable/Not provided for this type of device. The document mentions "data presented in the pre-market notification" but does not detail a specific test set, its size, or provenance for performance evaluation in the context of sensitivity/specificity that would be relevant for a diagnostic or AI device. The equivalence is primarily based on device characteristics and intended use comparison.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable/Not provided. The device is a range verifier, not a diagnostic interpretation tool, so "ground truth" in the clinical diagnostic sense with expert review is not relevant here.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable/Not provided.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not applicable. This device is a quality control product for an immunoassay system, not an AI-assisted diagnostic tool involving human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. The device is not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
Not explicitly stated in terms of a clinical ground truth. The "ground truth" for a range verifier would be its ability to correctly verify the expected range of the VITROS Immunodiagnostic System. This would be established by the manufacturer through internal quality control and analytical validation, ensuring the spiked analytes are at known concentrations and that the verifier performs consistently within established tolerance limits for its intended purpose. The document primarily focuses on demonstrating equivalence to another verifier product.
8. The sample size for the training set
Not applicable. This device does not involve a training set as it is not an AI/machine learning model.
9. How the ground truth for the training set was established
Not applicable.
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