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Found 12 results
510(k) Data Aggregation
(49 days)
The Pointe Scientific, Inc. Ammonia / alcohol Control set is to be used for monitoring the accuracy and precision of various ammonia and / or ethanol assay methods and to validate quantitation of patient samples. The controls contain components of known concentrations and are an integral part of diagnostic procedures. Daily monitoring of control values establishes intralaboratory parameters for accuracy and precision of the test method.
Not Found
The provided text is a 510(k) premarket notification approval letter for the Pointe Scientific, Inc. Ammonia/Alcohol Control Set. This document does not contain information about acceptance criteria, device performance studies, or details relevant to AI/ML device testing.
Therefore, I cannot extract the requested information regarding:
- A table of acceptance criteria and the reported device performance
- Sample size used for the test set and the data provenance
- Number of experts used to establish the ground truth for the test set and their qualifications
- Adjudication method for the test set
- If a multi reader multi case (MRMC) comparative effectiveness study was done, and its effect size
- If a standalone performance study was done
- The type of ground truth used
- The sample size for the training set
- How the ground truth for the training set was established
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(83 days)
For the IN VITRO quantitative determination of Ammonia in plasma. Anmonia measurements are used in the clagaosis and treatment of severe liver disorders, such as circhosis, and Reve s Syndrome. For the IN VITRO quantitative dctermination of Anumonia in plasma
Ammonia-L3K @ Assay, Cat. No. 233
This document is a 510(k) clearance letter from the FDA for a device called "Ammonia-L-3K Assay." This type of document is a notification of the agency's decision that the device is substantially equivalent to a predicate device and can be legally marketed. It is not a study report and therefore does not contain information about acceptance criteria or specific study results as requested in the prompt.
Therefore, I cannot provide the requested information based on the provided text. The document focuses on regulatory approval rather than technical performance data.
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(28 days)
Ammonia/Ethanol/CO2 Calibrator is for use in the calibration of quantitative Roche methods on Roche clinical chemistry analyzers as specified in the enclosed value sheet.
Ammonia/Ethanol/CO2 Control is for use in quality control by monitoring accuracy and precision for the quantitative methods as specified in the enclosed value sheet.
The Ammonia/Ethanol/CO2 Calibrator is a liquid ready-for-use calibrator based on a buffered aqueous solution. The concentration of the calibrator The Ammonia/Ethanol/CO2 Controls are liquid ready-for-use controls based on a buffered aqueous solution. The adjusted concentrations of the control components are in the normal range for the Normal control and the pathological range for the Abnormal control.
This document is a 510(k) summary for a medical device (Ammonia/Ethanol/CO2 Calibrator and Controls) and does not contain information typically found in a study proving a device meets acceptance criteria for an AI or software-based medical device.
The provided text describes a calibrator and controls for in vitro diagnostic devices, which are reagents used to ensure the accuracy and precision of laboratory tests on clinical chemistry analyzers. These are physical products, not software/AI, and therefore the concepts of "acceptance criteria," "device performance," "sample size for test/training sets," "ground truth," "MRMC studies," or "standalone performance" as typically applied to AI/software devices are not directly applicable in the same way.
The document focuses on establishing substantial equivalence to existing legally marketed predicate devices, which is the regulatory pathway for this type of product. Substantial equivalence means the new device is as safe and effective as a legally marketed device that is not subject to PMA (Premarket Approval).
Here's a breakdown of the information in relation to your request, highlighting what's missing due to the nature of the device:
1. Table of Acceptance Criteria and Reported Device Performance:
This type of table is not present in the document because this is not a performance study of an AI/software device. For a calibrator/control, "performance" relates to its ability to accurately and precisely calibrate and control the analytical process of a clinical chemistry analyzer. The document states:
- Intended Use of Calibrator: "for use in the calibration of quantitative Roche methods on Roche clinical chemistry analyzers as specified in the enclosed value sheet."
- Intended Use of Control: "for use in quality control by monitoring accuracy and precision for the quantitative methods as specified in the enclosed value sheet."
The "acceptance criteria" here would generally be related to the stability, homogeneity, and assigned values of the calibrator/control, and their ability to ensure the accuracy of the assay. These details are not within this summary. Substantial equivalence usually means that the new device performs similarly to the predicate in these aspects.
| Acceptance Criteria (Implied for Calibrator/Control) | Reported Device Performance (Implied from substantial equivalence claim) |
|---|---|
| Ability to accurately calibrate quantitative Roche methods | Substantially equivalent to predicate device (K952282) |
| Ability to monitor accuracy and precision for quantitative methods | Substantially equivalent to predicate device (K951595) |
| Performance characteristics (e.g., analyte concentrations, stability) | Equivalent to predicate devices (K952282 and K951595) |
Regarding items 2-9, these are generally not applicable to this type of device and submission:
2. Sample size used for the test set and the data provenance: Not applicable. There's no "test set" in the context of an AI/software algorithm. The device itself is a physical calibrator/control.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for an AI/software device is not relevant here. The ground truth for the calibrator/control would be the analytically determined true values of the analytes within the product, established through reference methods or highly accurate assays, not expert consensus on images or similar data.
4. Adjudication method for the test set: Not applicable.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done: Not applicable. This type of study is for evaluating human performance with and without AI assistance for tasks like diagnosis or detection.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an algorithm.
7. The type of ground truth used: For a calibrator/control, the "ground truth" refers to the assigned values or the true concentrations of the analytes (Ammonia, Ethanol, CO2) within the calibrator and control materials. This is typically established through a rigorous analytical process using reference methods and highly accurate instrumentation, not expert consensus, pathology, or outcomes data in the way these terms are used for AI/software devices.
8. The sample size for the training set: Not applicable. No training set for an AI/software algorithm.
9. How the ground truth for the training set was established: Not applicable.
Summary of what's provided for this type of device and submission:
- Device Name: Ammonia/Ethanol/CO2 Calibrator and Controls
- Intended Use: Calibration and quality control for quantitative Roche methods on Roche clinical chemistry analyzers.
- Predicate Device:
- Regulatory Conclusion: Substantial Equivalence to the predicate devices. This means the FDA has determined the new device is as safe and effective as the existing marketed devices. The "study that proves the device meets the acceptance criteria" in this context is the evidence presented by the manufacturer to the FDA demonstrating this substantial equivalence, which would include data on the formulation, stability, and characterization of the calibrator and controls, demonstrating they perform comparably to the predicate. These detailed data points are not typically included in the 510(k) Summary, but rather in the full 510(k) submission.
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(36 days)
The Bayer ADVIA 1650 Ammonia method and calibrator is an in vitro diagnostic device intended to quantitatively measure ammonia levels in human plasma (heparin or EDTA). Such measurements are used in assessing hepatic function and diagnosis of Reye's syndrome.
The Bayer ADVIA 1650 Ammonia assay is an in vitro diagnostic device intended to quantitatively measure Ammonia levels in human plasma (heparin or EDTA).
The provided document describes the safety and effectiveness summary for the Bayer ADVIA® 1650™ Ammonia assay. This device is an in vitro diagnostic device used to quantitatively measure ammonia levels in human plasma. The information pertains to an analytical performance study rather than an AI/ML medical device. Therefore, several sections of the requested output (2, 3, 4, 5, 6, 7, 8, and 9) related to AI/ML and human experts are not applicable.
Here's the breakdown of the available information:
1. Table of Acceptance Criteria and the Reported Device Performance:
The document doesn't explicitly state "acceptance criteria" but presents performance data for imprecision, correlation, and interfering substances, comparing the ADVIA 1650 to a predicate device (Roche Ammonia on Hitachi). The acceptance is implied by the presentation of the data itself against the predicate device's performance.
| Performance Metric | Acceptance Criteria (Implied by Predicate) | Reported Device Performance (ADVIA 1650) |
|---|---|---|
| Imprecision | CV(%) comparable to Roche Ammonia (e.g., 3.9%, 0.7%, 7.33%) | CV(%) at various levels: |
- 3.8% (at 69.7 ug/dL)
- 1.7% (at 150.6 ug/dL)
- 0.7% (at 387.9 ug/dL) |
| Correlation | Strong linear correlation (r value close to 1) and low Syx compared to Roche (On Hitachi) | $Y = 1.05x + 7.19$
(where Y = ADVIA 1650, X = Roche)
Syx = 62.18
r = 0.98 |
| Interfering Substances Recovery | Recovery % should be within an acceptable range (typically 90-110% or similar) despite interferents | Hemoglobin: 105.18%
Bilirubin conj: 95.30%
Bilirubin unconj: 100.48%
Intralipid: 91.06%
TRIG Concentrate: 108.98% |
| Analytical Range | 25 to 1300 ug/dL (This is the stated range, implying it meets internal criteria) | 25 to 1300 ug/dL (Serum/Plasma(Lithium heparin)) |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size for Correlation Test: 94 plasma specimens (N=94).
- Data Provenance: The document does not specify the country of origin of the data or whether it was retrospective or prospective.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
Not applicable. This is an analytical performance study of an in vitro diagnostic device, not an AI/ML medical device requiring expert ground truth for image interpretation or diagnosis. The "ground truth" (or reference method) for comparison is the predicate device's measurement.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. This is an analytical performance study of an in vitro diagnostic device. Adjudication methods are relevant for subjective interpretations, typically in diagnostic imaging or clinical trials with human readers.
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 analytical performance study of an in vitro diagnostic device, not an AI/ML assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
Yes, the study describes the standalone analytical performance of the ADVIA 1650 Ammonia assay. The performance metrics (imprecision, correlation, interference) are inherent to the device's measurement capabilities.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
The "ground truth" or reference for comparison in this analytical study is the measurements obtained from the predicate device, the Roche Ammonia assay (on Hitachi).
8. The sample size for the training set
Not applicable. This is not an AI/ML device, so there is no "training set" in the context of machine learning. The device is a chemical analyzer.
9. How the ground truth for the training set was established
Not applicable. Refer to point 8.
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(94 days)
The Bayer ADVIA IMS Ammonia (NH3) assay is an in vitro diagnostic device intended to measure Ammonia in human plasma (K3EDTA). Measurements of ammonia are used as an aid in the diagnosis and treatment of several hepatic diseases such as cirrhosis, hepatic failure, hepatitis and Reye's syndrome.
The Bayer ADVIA IMS Ammonia method is an in vitro diagnostic device intended to measure ammonia levels in human plasma. Such measurements are used in the diagnosis and treatment of several hepatic diseases such as cirrhosis, hepatic failure, hepatitis and Reye's syndrome.
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Here's a breakdown of the acceptance criteria and the study details for the Ammonia method for ADVIA® IMS™, based on the provided text:
Acceptance Criteria and Reported Device Performance
The acceptance criteria are implied by the comparison to the predicate device (Sigma Ammonia) and the determination that the ADVIA IMS Ammonia Assay's performance is "equivalent" and "within proposed manufacturing specifications." The provided data serves as the basis for demonstrating this equivalency.
| Characteristic | Acceptance Criteria (Implied by Predicate Performance) | Reported Device Performance (ADVIA IMS) |
|---|---|---|
| Imprecision (Total CV%) | Comparable to Sigma Ammonia's CV% at similar levels (e.g., 4.2% at 52.9 umol/L, 1.7% at 323 umol/L, 1.8% at 490 umol/L) | 15.8% at 21.4 umol/L, 3.5% at 112 umol/L, 4.3% at 234 umol/L |
| Correlation (to predicate) | High correlation (R ~0.998), low Syx (9.7 umol/L), and regression equation (Y=0.93X+14.8) indicating close agreement. | Y=0.93X+14.8, Syx = 9.7 umol/L, R = 0.998 |
| Interfering Substances | Acceptable effect on ammonia concentration (e.g., small % change for specified interfering substances at given concentrations). | Bilirubin (unconjugated) 18.8 mg/dL: -8.0% |
| Bilirubin (conjugated) 25 mg/dL: +3.0% | ||
| Hemoglobin 500 mg/dL: +11.0% | ||
| Lipids (Triglycerides) 500 mg/dL: -12.0% | ||
| Analytical Range | Comparable to clinically relevant range. | 5 - 500 umol/L |
Study Details
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Sample size used for the test set and the data provenance:
- Sample Size: 51 specimens for the correlation study.
- Data Provenance: Not explicitly stated whether retrospective or prospective, or country of origin. The specimens are "human plasma (K3EDTA)".
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable/Not provided. This device is a quantitative assay, and the "ground truth" for the test set is established by the comparative system (predicate device), not expert consensus.
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Adjudication method for the test set:
- Not applicable. As a quantitative assay compared to a predicate device, adjudication methods by experts are not relevant here.
-
If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- No, an MRMC study was not done. This is a submission for an in vitro diagnostic device, not an AI-assisted diagnostic tool involving human readers.
-
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Yes, this is a standalone device performance study. The "algorithm" here refers to the chemical assay method performed by the ADVIA IMS system. The performance metrics (imprecision, correlation, interference, analytical range) reflect the device's capability without human interpretation or intervention in the results beyond standard laboratory operation.
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The type of ground truth used:
- Comparative Reference Method: The predicate device, Sigma Ammonia, run on a Fara II system, served as the comparative reference for establishing the performance characteristics, particularly for correlation. The performance is deemed "equivalent" to this predicate.
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The sample size for the training set:
- Not applicable/Not provided. This is a conventional chemical assay, not a machine learning or AI-based device that would typically have a separate "training set" in the computational sense. The development of the assay would involve various experimental and optimization phases, but these are not referred to as a "training set" in this context.
-
How the ground truth for the training set was established:
- Not applicable. See point 7. The development of the assay would rely on established biochemical principles and analytical chemistry methodologies.
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(42 days)
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(51 days)
The Ammonia assay is used for the quantitation of ammonia in human plasma. Ammonia measurements are used in the diagnosis and treatment of severe liver disorders, such as cirrhosis, hepatitis, and Reye's syndrome.
Ammonia is an in vitro diagnostic assay for the quantitative determination of ammonia in human plasma. The Ammonia assay is a clinical chemistry assay which utilizes the amination of x-ketoglutarate by ammonia (NH3) along with the concomitant oxidation of NH2DPH. These reactions, catalyzed by glutamate dehydrogenase (GLDH), produce glutamate and NHxDP+ The oxidation of NHxDPH produces a decrease in absorbance at 340 nm which is directly proportional to the concentration of ammonia in the sample.
The provided document K981920 describes the Abbott Laboratories Ammonia (Amm) assay. This is an in vitro diagnostic assay for the quantitative determination of ammonia in human plasma, used in the diagnosis and treatment of severe liver disorders. This device is not an AI/ML powered device, therefore, some of the requested information (e.g. effect size of human readers with vs without AI assistance) is not applicable.
Here's a breakdown of the acceptance criteria and study information:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria for the Ammonia assay are implicitly stated by its substantial equivalence to the predicate device, the A-GENT® Ammonia assay (K870787) on the ABBOTT SPECTRUM® Series II™ System. The performance characteristics of the Ammonia assay are presented and deemed "acceptable" and "substantially equivalent" when compared to the predicate.
| Performance Metric | Acceptance Criteria (Implied by Substantial Equivalence to Predicate) | Reported Device Performance |
|---|---|---|
| Method Comparison | Acceptable correlation with predicate device | Correlation Coefficient = 0.9957 |
| Slope = 0.971 | ||
| Y-intercept = -2.083 umol/L | ||
| Precision | Acceptable within-run, between-run, and between-day precision | Level 1/Panel 103: 11.7% Total %CV |
| Level 2/Panel 104: 4.0% Total %CV | ||
| Level 3/Panel 105: 5.5% Total %CV | ||
| Linearity | Acceptable linearity up to a specified concentration | Linear up to 1,574.9 umol/L |
| Limit of Quantitation (Sensitivity) | Acceptable sensitivity | 20.6 umol/L |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the sample size used for the test set in terms of the number of patient samples. It mentions "Comparative performance studies were conducted using the AEROSET™ System" and "Precision studies were conducted using the Ammonia assay... using three levels of control material."
- Sample Size: Not explicitly stated for patient equivalence studies. For precision studies, it mentions "three levels of control material." The number of replicates or runs for these controls is not specified.
- Data Provenance: Not explicitly stated. There is no information regarding the country of origin of the data or whether the studies were retrospective or prospective.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
Not applicable. This device is a quantitative diagnostic assay. The "ground truth" for method comparison and precision is typically established by the reference method (predicate device) and analytical standards, respectively, rather than by human expert consensus or adjudication.
4. Adjudication Method for the Test Set
Not applicable. As a quantitative assay, adjudication by experts for ground truth is not relevant.
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 assay, not an AI/ML powered device that would involve human readers interpreting results with or without AI assistance.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
Yes, in essence, the described performance characteristics (method comparison, precision, linearity, sensitivity) represent the standalone performance of the Ammonia assay without human intervention influencing the measurement itself. The output is a quantitative value.
7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)
For the comparative performance studies, the "ground truth" was established by the predicate device, the A-GENT® Ammonia assay on the ABBOTT SPECTRUM® Series II™ System. The goal was to show similarity in results.
For precision, linearity, and sensitivity, the ground truth is based on analytical standards and control materials with known concentrations.
8. The Sample Size for the Training Set
Not applicable. This diagnostic assay is not an AI/ML model that requires a "training set." It is a chemical-based assay.
9. How the Ground Truth for the Training Set was Established
Not applicable. As this is not an AI/ML model, there is no training set or ground truth in that context.
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(56 days)
An Abbott Clinical Chemistry Calibrator is a device intended for medical purposes for use in a test system to establish points of reference that are used in the determination of values in the measurement of substances in human specimens.
Abbott Clinical Chemistry Calibrators were used for the calibration of each clinical chemistry reagent on the ALCYON 300/300i. The calibration curve generated was used for the quantitation of each analyte for the purpose of collecting performance data in support of the reagent 510(k) as outlined on the next page.
The provided text describes the submission of a 510(k) for Abbott Clinical Chemistry Calibrators. These are in vitro diagnostic devices intended for use in clinical chemistry assays to establish points of reference for the measurement of substances in human specimens.
However, the document does not contain a detailed study proving the device meets specific acceptance criteria in the way described in your request for AI/medical imaging devices. This is because calibrators, unlike diagnostic algorithms, are typically evaluated through different validation processes.
Here's an breakdown based on the information available and why certain sections of your request cannot be fulfilled:
Acceptance Criteria and Device Performance (Based on provided text)
| Criterion | Reported Device Performance |
|---|---|
| Intended Use Fulfillment | The calibrators (Amm Cal, Bil Cal, CO2 Cal, HDL Cal, Iron/Mg Cal, LDL Cal, MC Cal, UPro Cal, and ISE Calibrator Levels 1 and 2) are intended for in vitro diagnostic use in specific clinical chemistry assays (e.g., Ammonia, Bilirubin, Carbon Dioxide, HDL, Iron, Magnesium, LDL, etc.). |
| Calibration Curve Generation | Abbott Clinical Chemistry Calibrators were used for the calibration of each clinical chemistry reagent on the ALCYON 300/300i. The calibration curve generated was used for the quantitation of each analyte for the purpose of collecting performance data in support of the reagent 510(k). |
| Substantial Equivalence (Regulatory) | The FDA determined the device is substantially equivalent to legally marketed predicate devices for the stated indications for use (K981706). |
| Compliance with General Controls | The device is subject to general controls provisions of the Act (annual registration, listing of devices, good manufacturing practice, labeling, prohibitions against misbranding and adulteration). |
| Compliance with QS Regulation (GMP) | A substantially equivalent determination assumes compliance with Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices (21 CFR Part 820). |
Study Information (Based on provided text)
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not provided. The document describes the calibrators' intended use in supporting the performance data for reagents, rather than a direct study on the calibrators themselves with a test set of human specimens. The 510(k) process for calibrators often focuses on their stability, traceability, and ability to produce expected values when used with their respective reagents, which involves different types of testing.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Not applicable/Not provided. This type of information is relevant for AI algorithms that diagnose or interpret medical images. For a calibrator, "ground truth" would relate to the accuracy and traceability of the calibrator's assigned values, which is typically established through metrological methods, reference materials, and laboratory testing, not expert consensus on patient data.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable/Not provided. Pertains to expert review of discrepancies in AI performance evaluation.
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/Not provided. Pertains to AI diagnostic algorithms.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- Not applicable/Not provided. Pertains to AI diagnostic algorithms.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not explicitly detailed in the document. For calibrators, "ground truth" refers to the highly accurate and traceable assigned values for each analyte within the calibrator. This is established through rigorous laboratory methods, often traceable to international reference materials or definitive methods (e.g., mass spectrometry for small molecules). The document states the calibrators generate curves for "quantitation of each analyte," implying their values serve as the reference.
8. The sample size for the training set
- Not applicable/Not provided. This refers to machine learning models.
9. How the ground truth for the training set was established
- Not applicable/Not provided. This refers to machine learning models.
Summary regarding the nature of this submission:
This 510(k) submission is for calibrators, which are reference materials used to ensure the accuracy of other diagnostic tests (reagents). The "study" referenced in the text is not a clinical trial or an AI performance study with patient data, but rather the internal validation demonstrating that these calibrators can successfully generate "calibration curves" for specific reagents on a particular instrument (ALCYON 300/300i). The performance data collected using these calibrators would then be submitted as part of the 510(k) for the individual reagents themselves (as indicated by the list of K numbers for each reagent).
Therefore, the type of detailed performance evaluation requested, particularly concerning expert review and AI-specific metrics, is not present because it's not relevant for this type of in vitro diagnostic calibrator.
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(60 days)
The Ammonia assay is used for the quantitation of ammonia in human plasma. Ammonia measurements are used in the diagnosis and treatment of severe liver disorders, such as cirrhosis, hepatitis, and Reye's syndrome.
Ammonia is an in vitro diagnostic assay for the quantitative determination of ammonia in human plasma. The Ammonia assay is a clinical chemistry assay which utilizes the amination of x-ketoglutarate by ammonia (NH3) along with the concomitant oxidation of NH2DPH. These reactions, catalyzed by glutamate dehydrogenase (GLDH), produce glutamate and NHzDP*. The oxidation of NHzDPH produces a decrease in absorbance at 340 nm which is directly proportional to the concentration of ammonia in the sample.
- Table of Acceptance Criteria and Reported Device Performance:
| Performance Characteristic | Acceptance Criteria (implied by predicate) | Reported Device Performance (Ammonia assay) |
|---|---|---|
| Correlation with Predicate | "Similar Performance Characteristics" to Roche Cobas Mira Plus | Correlation coefficient = 0.9969 |
| Slope (Method Comparison) | Close to 1.0 | 1.044 |
| Y-intercept (Method Comparison) | Close to 0 (or within acceptable clinical limits) | 12.020 umol/L |
| Precision (Total %CV - Level 1) | Acceptable for clinical use (implied by predicate) | 13.8% |
| Precision (Total %CV - Level 2) | Acceptable for clinical use (implied by predicate) | 5.2% |
| Precision (Total %CV - Level 3) | Acceptable for clinical use (implied by predicate) | 3.0% |
| Linearity | Up to the predicate's range (implied by predicate) | Up to 630 µmol/L |
| Limit of Quantitation (Sensitivity) | Comparable to predicate (implied by predicate) | 19 µmol/L |
| Assay Range | Similar to predicate | "minor difference" from predicate |
Note: The acceptance criteria are largely implied by the claim of substantial equivalence to the Roche Cobas Mira Plus Automated Chemistry System Ammonia assay (K914750). The FDA's clearance of K914750 would have established acceptable performance limits. The Ammonia assay demonstrates comparable and statistically similar performance to that predicate.
-
Sample Size Used for the Test Set and Data Provenance:
- Sample Size: The document does not explicitly state the sample size used for the comparative performance studies (method comparison and precision studies). It mentions "three levels of control material" for precision studies. For the method comparison, it refers to "comparative performance studies" which likely involved patient samples, but the number is not specified.
- Data Provenance: Not explicitly stated, but clinical chemistry assays typically use human plasma. The document does not specify the country of origin, or if the study was retrospective or prospective.
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Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts:
- This information is not applicable to this submission. The Ammonia assay is an in vitro diagnostic (IVD) clinical chemistry assay where the "ground truth" is established by a reference method (the predicate device) or by measuring known concentrations in control materials. It does not involve human interpretation of images or other subjective data that would require expert consensus.
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Adjudication Method for the Test Set:
- This information is not applicable. As an IVD clinical chemistry assay, there is no need for an adjudication method for a test set in the way it's used for image-based diagnostics. The performance is assessed by direct comparison of numerical results.
-
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. This is an in vitro diagnostic assay and does not involve human readers interpreting images or data, nor does it incorporate AI.
-
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- This is a standalone device in the sense that the assay measures ammonia in a sample without direct human intervention in the result generation once the sample is loaded and the assay begins on the ALCYON™ Analyzer. The performance characteristics described (correlation, precision, linearity, sensitivity) are all "algorithm only" or "device only" performance.
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The Type of Ground Truth Used:
- The primary "ground truth" for the comparative performance studies was the Roche Cobas Mira Plus Automated Chemistry System Ammonia assay (K914750), which served as the legally marketed predicate device. For precision, the ground truth was implied by the known concentrations in the three levels of control material.
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The Sample Size for the Training Set:
- This information is not applicable for this type of device. The Ammonia assay is a chemical reaction-based in vitro diagnostic assay, not a machine learning or AI algorithm that requires a "training set" in the conventional sense. The assay's parameters are derived from scientific principles and optimized through experimental design, not statistical training on a large dataset.
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How the Ground Truth for the Training Set was Established:
- This information is not applicable for the reasons stated above (point 8). There is no "training set" for this chemical assay.
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(22 days)
Intended for the the In Vitro, quantitative determination of Ammonia (NH,) in human plasma on automated systems.
Ammonia measurements are used in the diagnosis and treatment of severe liver disorders such as circhosis, hepatitus, and Reye's syndrome. " CFR 862.1065
Ammonia-Incorporating Dynamic Stabilization Technology (DST)
The provided text is a 510(k) clearance letter from the FDA for the device "Ammonia-Incorporating Dynamic Stabilization Technology (DST)". It outlines that the device is intended for "the In Vitro, quantitative determination of Ammonia (NH,) in human plasma on automated systems." and that "Ammonia measurements are used in the diagnosis and treatment of severe liver disorders such as circhosis, hepatitus, and Reye's syndrome."
However, this document does not contain any information regarding acceptance criteria, study details, performance data, sample sizes, or ground truth establishment. It is a regulatory clearance document, not a clinical study report. Therefore, I cannot generate the requested information based on the provided text.
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