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510(k) Data Aggregation
(75 days)
CIJ
This product is to be used in a diagnostic laboratory setting, by qualified laboratory technologists, for the quantitative determination of amylase in human serum. It is intended for in vitro diagnostic use only. The determination of amylase in serum is most commonly performed for the diagnosis and treatment of diseases of the pancreas.
Not Found
The document provided is a premarket notification (510(k)) letter from the FDA to Pointe Scientific, Inc. regarding their Amylase EPS-G7 (Liquid) Reagent Set. This type of document declares "substantial equivalence" to a predicate device, which allows the product to be marketed, but does not typically include detailed studies proving performance against acceptance criteria in the way a clinical trial for a novel AI device would.
Therefore, many of the specific details requested in the prompt, such as sample sizes for test and training sets, expert qualifications for ground truth, adjudication methods, or MRMC studies, are not applicable to this 510(k) submission for an in vitro diagnostic reagent kit.
However, I can extract the relevant information about the device and its intended use, and explain why other sections are not present:
1. A table of acceptance criteria and the reported device performance
This document (a 510(k) clearance letter) does not typically contain a table of detailed performance characteristics and acceptance criteria in the way a clinical study report for an AI device might. For in-vitro diagnostic products like this, the demonstration of "substantial equivalence" to a legally marketed predicate device is the primary regulatory hurdle. This means the device is shown to perform as well as, or comparably to, an existing device on the market.
While the letter doesn't explicitly state "acceptance criteria," the intended performance of the device is for the "quantitative determination of amylase in human serum" for the "diagnosis and treatment of diseases of the pancreas." Substantial equivalence implies that its performance (e.g., sensitivity, specificity, accuracy, precision, linearity, interfering substances) is comparable to, and not worse than, the predicate device.
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 510(k) clearance letter. For in vitro diagnostic reagents, performance studies are conducted, but their detailed results (including sample sizes, study design, and data provenance) are typically submitted to the FDA in a separate dossier and summarized or referenced in the 510(k) submission, rather than being fully reproduced in the publicly available clearance letter.
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 applicable/provided in this context. For a reagent test determining a quantitative analyte (amylase), the "ground truth" is typically established by reference methods, standard assays, or certified reference materials, not by expert consensus in the way a diagnostic imaging interpretation would be.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not applicable/provided. Adjudication methods are relevant for subjective interpretations (like radiology reads) where multiple experts might disagree. For quantitative assays, the "ground truth" is determined by objective laboratory measurements, not expert consensus requiring 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
This is not applicable. This device is a reagent set for laboratory testing, not an AI-assisted diagnostic tool that aids human readers. Therefore, an MRMC study comparing human performance with and without AI assistance is irrelevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This is not applicable. This is a laboratory reagent kit, not an algorithm. Its performance is inherent to the chemical reaction and analytical equipment, not an AI algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For an amylase reagent test, the "ground truth" would typically be established through:
- Reference methods: Highly accurate and validated analytical methods.
- Standardized calibrators: Materials with known, certified concentrations of amylase.
- Interlaboratory comparisons: Performance against other established and trusted assays.
The specific type of ground truth used is not detailed in this 510(k) clearance letter.
8. The sample size for the training set
This information is not applicable/provided. This device is a chemical reagent, not a machine learning model, so there is no "training set" in the AI sense. Performance validation involves testing the reagent's characteristics (e.g., linearity, precision, accuracy, reproducibility) across a range of samples and conditions, but this is distinct from training an AI model.
9. How the ground truth for the training set was established
This information is not applicable/provided for the reasons stated in point 8.
Ask a specific question about this device
(56 days)
CIJ
The Bayer ADVIA IMS Amylase assay is an in vitro diagnostic device intended to measure amylase activity in human serum, plasma or urine. Such measurements are used as an aid primarily in the diagnosis and treatment of pancreatitis (inflammation of the pancreas).
The Bayer ADVIA IMS Cortisol assay is an in vitro diagnostic device intended to quantitatively measure cortisol in human serum. Measurements of cortisol are used as an aid in the diagnosis and treatment of disorders of the adrenal gland.
The Bayer ADVIA IMS Iron assay is an in vitro diagnostic device intended to measure iron in human serum of plasma. Measurements of iron are used as an aid in the diagnosis, monitoring and treatment of a variety of diseases including iron deficiency anemias, hemochromatosis, hemosiderosis from excessive iron intake, and hemolytic anemias.
The Baver ADVIA IMS Thyroxine assay is an in vitro diagnostic device intended to measure thyroxine (T4), both protein bound and free, in human serum and plasma. Measurements of T4 are used as an aid in the diagnosis and treatment of thyroid diseases.
The Baver ADVIA IMS Free Thyroxine (FT4) assay is an in vitro diagnostic device intended to quantitatively measure free thyroxine in human serum. Measurements of free thyroxine in conjunction with other thyroid tests and clinical indicators are used as an aid in the diagnostic discrimination and assessment of thyroid diseases.
The Bayer ADVIA IMS Triiodothyronine (T3) assay is an in vitro diagnostic device intended to quantitatively measure triiodothyronine (T3) in human serum. Measurements of triiodothyronine, in conjunction with other thyroid tests and clinical indicators, are used as an aid in the diagnostic discrimination and assessment of thyroid diseases.
The Bayer ADVIA IMS Free Triiodothyronine (FT3) assay is an in vitro diagnostic device intended to quantitatively measure free triiodothyronine in human serum. Measurements of free triodothyronine, in conjunction with other first-line thyroid tests such as Thyroid Stimulating Hormone (TSH) and Free Thyroxine (Free T4), as well as other clinical indicators, are used as an aid in the diagnostic discrimination and assessment of thyroid diseases.
The Bayer ADVIA IMS T Uptake (TUP) assay is an in vitro diagnostic device intended to quantitatively measure the total amount of available binding sites for thyroid hormone on the thyroxine-binding proteins, globulin, pre-albumin, and albumin in human serum. Measurements of T Uptake, in conjunction with other thyroid tests and clinical indicators, are used as an aid in the diagnostic discrimination and assessment of thyroid diseases.
The Bayer ADVIA IMS Urea Nitrogen (BUN) method is an in vitro diagnostic device intended to measure urea nitrogen in human serum, plasma and urine. Such measurements are used as an aid in the diagnosis and treatment of certain renal and metabolic diseases.
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The provided document describes the performance characteristics of various assays on the Bayer ADVIA IMS Systems, not an AI device. Therefore, several requested fields, such as "Multi-reader multi-case (MRMC) comparative effectiveness study," "Effect size of human readers improvement," "Standalone algorithm performance," "Number of experts for ground truth," "Qualifications of experts," "Adjudication method," and "Sample size for training set," are not applicable as they pertain to AI/ML device studies.
The document presents information comparing the performance of the ADVIA IMS assays to predicate devices. The acceptance criteria for these devices are implicitly demonstrated by showing comparable or superior performance to the legally marketed predicate devices, which is the basis for 510(k) clearance for in-vitro diagnostic devices, establishing substantial equivalence.
Acceptance Criteria and Device Performance (for each assay)
The acceptance criteria are generally demonstrated by showing strong correlation, comparable precision, and acceptable interference profiles relative to the predicate device.
1. Amylase (AMY) Method for the ADVIA IMS Systems (Section 0, 1)
| Acceptance Criteria Category | Acceptance Criteria (Implied by Predicate) | Reported Device Performance (ADVIA IMS) |
|---|---|---|
| Analytical Range | 10 to 3400 U/L (RA-XT) | 0 to 1500 U/L |
| Precision (Total) | Serum: 51 U/L: 2.2% CV; 179 U/L: 1.0% CV; 373 U/L: 0.6% CV (RA-XT) | Serum: 56 U/L: 2.5% CV; 113 U/L: 2.1% CV; 430 U/L: 1.5% CV |
| Urine: 57 U/L: 3.4% CV; 172 U/L: 1.3% CV; 510 U/L: 1.3% CV (RA-XT) | Urine: 50 U/L: 1.3% CV; 218 U/L: 1.1% CV; 493 U/L: 1.6% CV | |
| Correlation (Serum) | Strong correlation to RA-XT | y = 1.01x - 5.7 (r = 0.999, Sy.x = 11.9) |
| Correlation (Plasma equiv.) | Strong correlation to serum (reference method) | y = 1.00x - 0.2 (r = 0.999, Sy.x = 1.0) |
| Correlation (Urine) | Strong correlation to RA-XT | y = 1.01x - 5.7 (Note: discrepancy - original table shows range, not equation. This might be a typo in the original document, as the serum equation is repeated but with urine range criteria) |
| Interference (Serum) | Minimal effect (e.g., within a few % change) | Hemoglobin: +2%; Bilirubin (conj): -4%; Bilirubin (unconj): -2%; Lipemia: +3% |
| Interference (Urine) | Minimal effect (e.g., within a few % change) | Ascorbic Acid: 1%; Acetaminophen: -1%; Salicylate: -2% |
2. Cortisol Method for Bayer ADVIA® IMS™ (Section 2)
| Acceptance Criteria Category | Acceptance Criteria (Implied by Predicate) | Reported Device Performance (ADVIA Cortisol) |
|---|---|---|
| Minimum Detectable Conc. | 0.2 µg/dL (Immuno 1) | 0.1 µg/dL |
| Precision (Total CV%) | 3.2 µg/dL: 7.9%; 20.1 µg/dL: 4.5%; 33.3 µg/dL: 4.7% (Immuno 1) | 4.4 µg/dL: 6.0%; 17.3 µg/dL: 5.0%; 37.5 µg/dL: 3.8% |
| Correlation | Strong correlation to Immuno 1 | y = 1.013 x - 0.142 (r = 0.996, Syx = 0.961 µg/dL) |
| Interference | Minimal effect (e.g., within a few % change) | Hemoglobin: -4.8%; Lipids: -4.5%; Bilirubin: -1.9%; Urea Nitrogen: -4.4% |
3. Iron Method for the Bayer ADVIA Integrated Modular System (IMS) (Section 3, 4)
| Acceptance Criteria Category | Acceptance Criteria (Implied by Predicate) | Reported Device Performance (ADVIA IMS Iron) |
|---|---|---|
| Analytical Range | 0 to 1200 ug/dL (CHEM 1) | 0 to 800 ug/dL |
| Precision (Total) | 96 ug/dL: 1.9%; 211 ug/dL: 1.3%; 383 ug/dL: 1.2% (CHEM 1) | 50.7 ug/dL: 2.8%; 230.1 ug/dL: 1.1%; 438.3 ug/dL: 0.7% |
| Correlation | Strong correlation to CHEM 1 | Y=0.93X+10.8 ug/dL (r=0.998, Sy.x=9.75 ug/dL) |
| Plasma/Serum Equivalence | Strong correlation to serum (reference method) | Y=0.98X+0.46 ug/dL (r=0.99, Sy.x=3.12 ug/dL) |
| Interference | Minimal effect (e.g., within a few % change) | Bilirubin (unconj): 7.0%; Bilirubin (conj): -1.0%; Hemoglobin: 44.0%; Lipemia: -20.0% |
4. T4 Method for the Bayer ADVIA® IMS Systems (Section 5, 6)
| Acceptance Criteria Category | Acceptance Criteria (Implied by Predicate) | Reported Device Performance (ADVIA IMS T4) |
|---|---|---|
| Minimum Det. Conc. | 0.4 µg/dL (Immuno 1) | 0.25 µg/dL |
| Precision (Total) | 4.7 µg/dL: 3.6%; 8.2 µg/dL: 2.6%; 15.7 µg/dL: 2.5% (Immuno 1) | 3.5µg/dL: 6.0%; 7.9 µg/dL: 5.1%; 14.9 µg/dL: 4.7% |
| Correlation (SERUM) | Strong correlation to Immuno 1 | y = 1.06 x +0.11 (r = 0.994, Syx = 0.65 µg/dL) |
| Correlation (PLASMA) | Strong correlation to serum (reference method) | y = 0.98X + 0.06 (r = 0.977, Syx = 0.36) |
| Interference | Minimal effect (e.g., within a few % change) | Bilirubin (unconj): 0%; Bilirubin (conj): -2%; Hemoglobin: -3%; Lipemia: +3% |
5. Free T4 Assay for Bayer ADVIA® Integrated Modular System (Section 7)
| Acceptance Criteria Category | Acceptance Criteria (Implied by Predicate) | Reported Device Performance (ADVIA FREE T4 Assay) |
|---|---|---|
| Minimum Detectable Conc. | 0.10 ng/dL (Immuno 1) | 0.05 ng/dL |
| Precision (Total CV) | 0.94 ng/dL: 4.9%; 1.76 ng/dL: 3.5%; 4.68 ng/dL: 2.2% (Immuno 1) | 0.85 ng/dL: 4.5%; 1.46 ng/dL: 4.8%; 3.04 ng/dL: 3.0% |
| Correlation | Strong correlation to Immuno 1 | y = 0.998 x + 0.2179 (r = 0.9928, Syx = 0.1368 ng/dL) |
| Interference | Minimal effect (e.g., within a few % change) | Hemoglobin: 3.8%; Lipids: 2.2%; Bilirubin: 0.6%; Urea Nitrogen: 1.1% |
6. Total T3 Assay for Bayer ADVIA® Integrated Modular System (Section 8)
| Acceptance Criteria Category | Acceptance Criteria (Implied by Predicate) | Reported Device Performance (ADVIA T3 Assay) |
|---|---|---|
| Minimum Detectable Conc. | 0.06 ng/mL (Immuno 1) | 0.13 ng/mL |
| Precision (Total CV) | 0.46 ng/mL: 13.3%; 1.34 ng/mL: 6.0%; 3.43 ng/mL: 3.9% (Immuno 1) | 0.67 ng/mL: 10.3%; 1.74 ng/mL: 4.9%; 2.89 ng/mL: 3.6% |
| Correlation | Strong correlation to Immuno 1 | y = 1.014x + 0.1368 (r = 0.996) |
| Interference | Minimal effect (e.g., within a few % change) | Hemoglobin: 3.7%; Lipids: 5.5%; Bilirubin: 3.0%; Urea Nitrogen: (data partially illegible but likely similar minimal effect) |
7. Free T3 Assay for Bayer ADVIA® Integrated Modular System (Section 9)
| Acceptance Criteria Category | Acceptance Criteria (Implied by Predicate) | Reported Device Performance (ADVIA Free T3 Assay) |
|---|---|---|
| Minimum Detectable Conc. | 0.3 pg/mL (Immuno 1) | 0.4 pg/mL |
| Precision (Total CV) | 1.8 pg/mL: 8.5%; 5.4 pg/mL: 3.8%; 10.8 pg/mL: 2.9% (Immuno 1) | 2.0 pg/mL: 10.0%; 4.88 pg/mL: 5.0%; 9.35 pg/mL: 4.1% |
| Correlation | Strong correlation to Immuno 1 | y = 0.97x + 0.41 (r = 0.998, Syx = 0.427 pg/mL) |
| Interference | Minimal effect (e.g., within a few % change) | Hemoglobin: 6.4% (value partially illegible/corrupted); Lipids: 9.4% (value partially illegible/corrupted); Bilirubin: -3.4%; Urea Nitrogen: 2.1% |
8. T-Uptake Assay for Bayer ADVIA® Integrated Modular System (Section 10)
| Acceptance Criteria Category | Acceptance Criteria (Implied by Predicate) | Reported Device Performance (ADVIA T-Uptake Assay) |
|---|---|---|
| Precision (Total CV) | 0.71: 2.8%; 1.03: 2.6%; 1.41: 2.4% (Immuno 1) | 0.96: 3.2%; 0.89: 2.6%; 1.14: 2.3% |
| Correlation | Strong correlation to Immuno 1 | y = 0.96x + 0.0003 (r = 0.987) |
| Interference | Minimal effect (e.g., within a few % change) | Hemoglobin: 0.88%; Lipids: 0.90%; Bilirubin: 1.74%; Urea Nitrogen: 0.91% |
9. Urea Nitrogen method for ADVIA® 400 (Section 11, 12)
| Acceptance Criteria Category | Acceptance Criteria (Implied by Predicate) | Reported Device Performance (ADVIA 400 Urea Nitrogen) |
|---|---|---|
| Analytical Range | (Not explicitly stated for CHEM 1, assumed to cover relevant clinical range) | Serum/Plasma: 0 to 150 mg/dL; Urine: 2 to 1030 mg/dL |
| Imprecision (SERUM) | 21 mg/dL: 3%; 54 mg/dL: 3%; 97 mg/dL: 3% (CHEM 1) | 7.3 mg/dL: 4.3%; 17 mg/dL: 2.5%; 52 mg/dL: 1.6% |
| Imprecision (URINE) | 478 mg/dL: 2.6%; 648 mg/dL: 2.5% (CHEM 1) | 69 mg/dL: 3.9%; 212 mg/dL: 2.1%; 404 mg/dL: 2.0% |
| Correlation (Serum) | Strong correlation to CHEM 1 | Y=1.03X-0.6 (r=0.997, Syx=2.8 mg/dL) |
| Correlation (Plasma equiv.) | Strong correlation to serum (reference method) | Y=0.96X+0.6 (r=0.975, Syx=1.1) |
| Correlation (Urine) | Strong correlation to CHEM 1 | Y=1.08X-8.9 (r=0.997, Syx=22.5) |
| Interference | Minimal effect (e.g., within a few % change) | Bilirubin: -4.0%; Hemoglobin: +4.4%; Lipids: +23.0%; Ascorbic Acid: +3.2%; Salicylate: -2.4%; Glucose: +9.5%; Acetominophen: +4.5% |
Study Details
This document describes a series of performance studies for multiple in-vitro diagnostic assays on the Bayer ADVIA IMS Systems. The studies aim to demonstrate "substantial equivalence" to predicate devices, which is a regulatory pathway for marketing these devices.
2. Sample size used for the test set and the data provenance:
- AMY Method:
- Serum Correlation: n = 72
- Plasma Qualification: n = 60
- Urine Correlation: n = 72
- Provenance: Not explicitly stated, but typically these studies are conducted with clinical samples from various sources (e.g., hospitals, labs) within the country where the manufacturer is seeking clearance or where R&D is conducted. It's retrospective in the sense that samples are collected and then analyzed.
- Cortisol Method:
- Correlation: n = 57
- Provenance: Not explicitly stated.
- Iron Method:
- Correlation: n = 65
- Plasma/Serum Equivalence: n = 56
- Provenance: Not explicitly stated.
- T4 Method:
- Serum Correlation: n = 72
- Plasma Correlation: n = 24
- Provenance: Not explicitly stated.
- Free T4 Assay:
- Correlation: n = 50
- Provenance: Not explicitly stated.
- Total T3 Assay:
- Correlation: n = 50
- Provenance: Not explicitly stated.
- Free T3 Assay:
- Correlation: n = 56
- Provenance: Not explicitly stated.
- T-Uptake Assay:
- Correlation: n = 51
- Provenance: Not explicitly stated.
- Urea Nitrogen Method:
- Serum Correlation: n = 50
- Plasma (y), Serum (x) Correlation: n = 58
- Urine Correlation: n = 53
- Provenance: Not explicitly stated.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
Not applicable. These are in-vitro diagnostic tests for quantitative measurement of analytes. "Ground truth" is established by laboratory reference methods or predicate devices, not human expert interpretation.
4. Adjudication method for the test set:
Not applicable. Ground truth for quantitative chemical assays is determined by analytical methods, not human 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 document is for in-vitro diagnostic assays, not AI/ML devices requiring human reader studies.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Not applicable. These are automated laboratory assays, and their performance is inherently "standalone" in a laboratory setting, meaning the instrument and reagents produce a result without human interpretation of raw data points, beyond quality control and review of final numerical results.
7. The type of ground truth used:
For each assay, the "ground truth" (or reference method) for analytical performance comparison is the predicate device (e.g., Bayer RA-XT Amylase method, Immuno 1 Cortisol assay, Technicon CHEM 1 Iron-II method, etc.) or a well-established reference method (e.g., serum for plasma equivalence studies). The performance is assessed by comparison (correlation, regression) against results obtained from these predicate devices on the same samples.
8. The sample size for the training set:
Not applicable. These are traditional IVD assays, not machine learning models that require a separate training set. The "development" of the assay involves optimizing reagents and instrument parameters, not training on a dataset in the AI sense.
9. How the ground truth for the training set was established:
Not applicable. As there is no training set in the AI/ML sense, no ground truth was established for it.
Ask a specific question about this device
(33 days)
CIJ
The Amylase Reagent is to be used in the assessment of pancreatitis.
Not Found
The provided text is related to a 510(k) clearance letter for an Amylase Reagent, an in vitro diagnostic device used for the assessment of pancreatitis. This type of document, particularly a 510(k) summary (which is not fully provided here but implied by the clearance letter), typically focuses on demonstrating substantial equivalence to a predicate device rather than providing a detailed study description with acceptance criteria and device performance results as would be found in a clinical study report or a more comprehensive premarket approval (PMA) application.
Therefore, the requested information elements related to detailed study design, sample sizes, ground truth establishment, expert qualifications, and specific performance metrics are not available in the provided document. The document states "we have determined the device is substantially equivalent...to devices marketed in interstate commerce prior to May 28, 1976." This implies that the device's performance was compared to a legally marketed predicate device, and the specifics of that comparison, including the criteria and results, would be in the full 510(k) submission, not typically summarized in the clearance letter itself.
Given this, I cannot fill out the requested table and answer the specific questions about acceptance criteria and study details.
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(347 days)
CIJ
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