Search Results
Found 8 results
510(k) Data Aggregation
(525 days)
The Acetaminophen assay is used for the quantitative determinophen in human serum or plasma on the ARCHITECT c Systems.
The Acetaminophen assay is to be used as an aid in the diagnosis and treatment of acetaminophen overdose toxicity.
The Acetaminophen assay is an enzymatic, spectrophotometric assay for the measurement of acetaminophen concentration in human serum and plasma. The assay consists two working reagents, an enzyme reagent and a color reagent.
The enzyme reagent contains aryl acylamidase, which cleaves the amide bond of acetaminophen, forming p-aminophenol which then reacts with the 2,5-dimethylphenol (contained the color reagent) in the presence of manganese. The product of that reaction causes increased absorbance at 660 nm which is directly proportional to the acetaminophen concentration in the sample.
Testing is performed on the ARCHITECT c8000 clinical chemistry analyzers in conjunction with a calibrator (510(k) exempt) which is provided separately.
The provided text describes a 510(k) premarket notification for an Acetaminophen assay (K202644). The document details various performance studies conducted to demonstrate the device's substantial equivalence to a legally marketed predicate device.
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
| Performance Metric | Acceptance Criteria (Stated or Implied) | Reported Device Performance |
|---|---|---|
| Precision (Within-Run %CV) | Not explicitly stated as acceptance criteria, but typically within acceptable laboratory limits for clinical assays. For example, for Control Level 1, %CV (0.9) is excellent; for Panel A, %CV (5.6) is higher but likely acceptable for low concentrations. | Control Level 1: Mean 15 µg/mL, SD 0.1, %CV 0.9Control Level 2: Mean 73 µg/mL, SD 0.5, %CV 0.6Control Level 3: Mean 227 µg/mL, SD 0.8, %CV 0.3Panel A: Mean 5 µg/mL, SD 0.3, %CV 5.6Panel B: Mean 51 µg/mL, SD 0.3, %CV 0.6Panel C: Mean 84 µg/mL, SD 0.4, %CV 0.4Panel D: Mean 278 µg/mL, SD 1.0, %CV 0.4Panel E: Mean 362 µg/mL, SD 1.6, %CV 0.4 |
| Precision (Within-Laboratory %CV) | Not explicitly stated as acceptance criteria, but typically within acceptable laboratory limits. | Control Level 1: SD 0.2, %CV 1.3Control Level 2: SD 0.6, %CV 0.8Control Level 3: SD 1.3, %CV 0.6Panel A: SD 0.5, %CV 9.1Panel B: SD 0.4, %CV 0.7Panel C: SD 0.6, %CV 0.7Panel D: SD 2.0, %CV 0.7Panel E: SD 2.6, %CV 0.7 |
| Reproducibility (%CV) | Not explicitly stated as acceptance criteria, but typically within acceptable laboratory limits. | Control 1: Mean 14 µg/mL, SD 0.5, %CV 3.2Control 2: Mean 68 µg/mL, SD 0.6, %CV 0.9Control 3: Mean 208 µg/mL, SD 1.6, %CV 0.8Panel: Mean 163 µg/mL, SD 1.2, %CV 0.7 |
| Limit of Blank (LoB) | Not explicitly stated, but should ideally be very low. | 0 µg/mL (0 µmol/L) |
| Limit of Detection (LoD) | The sponsor chose to use 1 µg/mL (7 µmol/L) for reporting purposes. | Scientific LoD: 0.2 µg/mL (1.3 µmol/L)Reporting LoD: 1 µg/mL (7 µmol/L) |
| Limit of Quantitation (LoQ) | The sponsor chose to use 3 µg/mL (20 µmol/L) for reporting purposes. This is the lower end of the analytical measuring interval. | Scientific LoQ: 1.9 µg/mL (12.6 µmol/L)Reporting LoQ (lower end of AMI): 3 µg/mL (20 µmol/L) |
| Linearity/Assay Range | Device demonstrated linearity across the range of 0 to 386 µg/mL, which spans the analytical measuring interval of 3 to 377 µg/mL. Implicit acceptance is that the assay is linear across its claimed analytical measuring interval. | Linear across 0 to 386 µg/mL. Analytical Measuring Interval: 3 to 377 µg/mL (20 to 2496 µmol/L). |
| Analytical Specificity (Interference) | Interference within ± 7.5% for acetaminophen samples > 20 µg/mL, ORwithin ± 1.50 µg/mL for acetaminophen samples < 20 µg/mL. | Specific endogenous and exogenous substances (e.g., conjugated bilirubin ≤ 14 mg/dL, hemoglobin ≤ 570 mg/dL, N-Acetylcysteine ≤ 1663 mg/L) tested and demonstrated to meet the acceptance criteria at the specified interferent levels. |
| Method Comparison (Correlation) | Not explicitly stated, but the predicate device has a strong correlation (0.9993) with the candidate. Implicit acceptance would be a high correlation coefficient (e.g., >0.975 or >0.98), slope close to 1, and intercept close to 0. | Correlation Coefficient: 0.9993Slope: 1.042Intercept: -0.034(Comparing 3.50 - 356.26 µg/mL (predicate) to 3.58 - 375.28 µg/mL (candidate)) |
| Matrix Comparison | Recovered within ± 7.5% for values ≥ 20 µg/mL, ORwithin ± 1.50 µg/mL for values < 20 µg/mL. | Serum, lithium heparin, lithium heparin mechanical separator, lithium heparin (separator tube), serum (separator tube), and sodium heparin tube types were found suitable for analysis. |
| Automated/Manual Dilution | Not explicitly stated, but results showed % difference of 1.5% to 5.3%, implying these met specific internal criteria for analytical accuracy of diluted samples. The range of 1.5% to 5.3% is generally considered excellent for dilution recovery. | Demonstrated % difference results of 1.5% to 5.3% when measuring samples above the analytical measuring interval by 1:10 autodilution vs. manual dilution methods. |
2. Sample Size Used for the Test Set and Data Provenance
- Precision: 5 human serum panels and 3 control levels. Each assayed in a minimum of 2 replicates, twice per day on 20 days. N=120 for controls and panels.
- Reproducibility: 1 human serum panel and 3 control levels. Each assayed in a minimum of 3 replicates at 2 separate times per day on 5 different days. N=146-150 for controls and panel.
- Analytical Sensitivity (LoB, LoD, LoQ): Zero analyte samples and low analyte samples tested in replicates of 10.
- Linearity/Assay Reportable Range: One unique sample set, 13 sample levels, tested in a minimum of 2 replicates.
- Analytical Specificity (Interference): Test and reference samples tested in a minimum of 12 replicates.
- Method Comparison: 119 patient specimens (114 unaltered native samples, 5 contrived).
- Matrix Comparison: 78 matched specimen sets.
- Automated/Manual Dilution: 5 samples with high acetaminophen concentrations, tested in replicates of 42.
Data Provenance: The document does not explicitly state the country of origin of the data. The studies appear to be prospective as they were specifically designed and executed to evaluate the performance of the device for this submission (e.g., "A study was performed based on guidance...", "Testing was conducted according to CLSI EP05-A3...").
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This type of information (number and qualifications of experts) is typically associated with studies involving subjective interpretation, such as imaging or pathology studies. For an in vitro diagnostic (IVD) like this Acetaminophen assay, the "ground truth" is generally established using reference methods or gravimetric preparation of standards, rather than expert consensus on patient data.
- For Value Assignment: The Acetaminophen Calibrator is prepared gravimetrically from USP grade reference acetaminophen material to a specific concentration, and verified against a master calibrator (internal reference standard). This is the analytical "ground truth" for calibration.
- For Method Comparison: The predicate device is considered the "reference" for comparison, not a "ground truth" established by experts.
Therefore, the concept of "experts establishing ground truth" as you've defined it (e.g., radiologists) is not applicable to this type of IVD device performance study.
4. Adjudication Method for the Test Set
Adjudication methods (e.g., 2+1, 3+1) are typically used in clinical studies where multiple readers or experts provide independent assessments, and discrepancies need to be resolved. Since this is an IVD device measuring an analyte quantitatively, and the "ground truth" is established analytically (gravimetric, reference methods, or predicate device results), an adjudication method in the traditional sense is not applicable. The studies involve quantitative measurements from instruments and comparisons to established analytical standards or methods.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, If So, What Was the Effect Size of How Much Human Readers Improve with AI vs without AI Assistance
No, an MRMC comparative effectiveness study was not done. This is an in vitro diagnostic (IVD) device, specifically an assay for measuring acetaminophen levels, not an imaging or AI-assisted diagnostic tool that involves human readers. Therefore, the concept of "human readers improving with AI vs. without AI assistance" is not applicable.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
The device itself (the Acetaminophen assay on the ARCHITECT c Systems) is a standalone system for quantitative measurement. The performance studies detailed (precision, linearity, method comparison, etc.) represent the standalone performance of the algorithm/reagent system as it processes samples on the automated platform without human intervention beyond sample loading and system operation. There is no "human-in-the-loop" component for interpretation of results in the direct sense; the device provides a quantitative number.
7. The Type of Ground Truth Used
The ground truth for the performance studies is established via:
- Gravimetric Preparation/Reference Standards: For analytical performance characteristics like calibrator value assignment, LoB, LoD, LoQ, and linearity. For example, calibrators are "prepared gravimetrically from USP grade reference acetaminophen material."
- Predicate Device Results: For the method comparison study, the results from the legally marketed predicate device (SEKURE Acetaminophen L3K Assay on Hitachi 717) serve as the comparative "reference" or "ground truth" against which the new device's performance is measured.
- Controlled Samples: For interference studies, samples with known concentrations of acetaminophen and specific interferents are used.
8. The Sample Size for the Training Set
The document does not mention a training set because this is not a machine learning or artificial intelligence (AI) device that requires extensive supervised learning. This is an enzymatic spectrophotometric assay, which relies on chemical reactions and optical measurement principles, not statistical pattern recognition trained on a dataset.
9. How the Ground Truth for the Training Set Was Established
As there is no training set for this type of IVD device, this question is not applicable.
Ask a specific question about this device
(297 days)
For the quantitative measurement of acetaminophen in serum and plasma. Measurement of acetaminophen is used in the diagnosis and treatment of acetaminophen overdose toxicity.
For the quantitative measurement of acetaminophen in serum and plasma. Measurement of acetaminophen is used in the diagnosis and treatment of acetaminophen overdose toxicity. Excessive amounts of acetaminophen leads to hepatotoxicity and nephrotoxicity. In acute overdosage, acetaminophen can cause severe hepatic damage leading to hepatic failure if untreated. Reagent is a two-part liquid in plastic bottles packaged in the appropriate box.
Here's a breakdown of the acceptance criteria and study details for the Acetaminophen L3K® Assay, based on the provided 510(k) summary:
1. Table of Acceptance Criteria and Reported Device Performance
| Performance Metric | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|
| Serum Method Comparison | Strong correlation (e.g., correlation coefficient approaching 1), and a regression equation demonstrating close agreement with the predicate method (slope near 1, intercept near 0). | Correlation Coefficient: 0.9999 (between Acetaminophen L3K® Assay and a similar acetaminophen method) Deming Regression Equation: This method = 1.060 (reference method) + 4.6 µmol/L Confidence Interval: 95% Scatter around regression line: 8.9 |
| Plasma Method Comparison | Strong correlation (e.g., correlation coefficient approaching 1), and a regression equation demonstrating close agreement between serum and plasma measurements of the new device (slope near 1, intercept near 0). | Correlation Coefficient: 0.9999 (between serum and plasma measurements of Acetaminophen L3K® Assay) Linear Regression Equation: This method (plasma) = 0.999 [This method (serum)] -2.2 µmol/L |
Note: The acceptance criteria are "implied" because the document states "Testing results demonstrate that the Acetaminophen L3K® Assay is equivalent to the predicate device" and focuses on the high correlation coefficients and favorable regression results as proof of this equivalence, rather than explicitly listing numerical thresholds for acceptance. The core of the acceptance criteria for a 510(k) often revolves around demonstrating substantial equivalence to a predicate device, meaning the new device is as safe and effective as a legally marketed device.
2. Sample Size Used for the Test Set and Data Provenance
- Serum Test Set Sample Size: 100 samples
- Plasma Test Set Sample Size: 25 samples
- Data Provenance: Not explicitly stated regarding the country of origin. The submission is from Genzyme Diagnostics P.E.I. Inc. in Canada, so it's likely the data originated there or in a region where they conducted their studies. The data is retrospective as it involves comparing the new device's measurements against an existing "reference method" (presumably the predicate device or a clinical laboratory's established method).
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 given document. For an in vitro diagnostic (IVD) like this, "ground truth" would typically be established by comparing the device's results to a recognized reference method or a method already validated for clinical use, rather than expert consensus on individual cases. The "reference method" is the de facto "ground truth" here.
4. Adjudication Method for the Test Set
- This information is not applicable for this type of IVD performance study. Adjudication methods (like 2+1, 3+1) are typically used in imaging studies or clinical trials where human interpretation or endpoint determination requires consensus among multiple experts. For a quantitative assay, the comparison is directly numerical against a reference method.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- No, this was not done. The Acetaminophen L3K® Assay is an in vitro diagnostic device for quantitative measurement, not an AI-assisted diagnostic imaging or interpretation tool. Therefore, MRMC studies and concepts of human reader improvement with AI assistance are not relevant to this submission.
6. If a Standalone (i.e. algorithm only without human-in-the loop performance) was done
- Yes, this was a standalone performance study. The Acetaminophen L3K® Assay is a laboratory assay that produces quantitative results directly. Its performance was evaluated purely on its analytical capabilities (accuracy, correlation) when measuring acetaminophen in samples, without any human-in-the-loop interpretation beyond standard laboratory procedures and result reporting.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- The ground truth was established by a "similar acetaminophen method" referred to as the "reference method" in the serum comparison and the "This method (serum)" in the plasma comparison. This implies an existing, validated laboratory method. For IVDs, this is often a widely accepted and validated analytical method or the predicate device itself.
8. The sample size for the training set
- This information is not provided as this is not an AI/ML device that requires a distinct "training set" in the conventional sense. The studies described are validation (test) studies to demonstrate performance. The "training" for such an assay would be its initial development and optimization, which isn't typically detailed in a 510(k) summary for a chemical assay.
9. How the ground truth for the training set was established
- This information is not applicable as there is no mention of a "training set" in the context of an AI/ML device. For the development of the assay, standard analytical chemistry principles, method development, and optimization techniques would have been employed to ensure accuracy, but this is distinct from establishing ground truth for machine learning.
Ask a specific question about this device
(133 days)
The Diagnostic Chemicals Limited's Acetaminophen-SL Assay is an in vitro diagnostic device intended to measure acetaminophen levels in human serum or plasma (Lithium heparin). Such measurements are used in the diagnosis of acetaminophen toxicity and overdose. This assay consists of two reagents and a calibrator.
This assay consists of two reagents and a calibrator.
I am sorry, but the provided text is a 510(k) clearance letter from the FDA for a device called "Acetaminophen-SL Assay". This document primarily focuses on the regulatory approval process, stating that the device is substantially equivalent to legally marketed predicate devices.
The information required to answer your request, such as detailed acceptance criteria, specific study designs, sample sizes for test and training sets, expert qualifications, and detailed performance metrics, is not present within this regulatory letter.
Therefore, I cannot extract the requested information from the provided text.
Ask a specific question about this device
(122 days)
The Bayer ADVIA IMS Acetaminophen method is an in vitro diagnostic device intended to measure acctaminophen levels in human serum or plasma (Lithium heparin). Such measurements are used in the diagnosis of acetaminophen toxicity and overdose.
This in-vitro diagnostic method is intended to measure acetaminophen in human serum and plasma using lithium heparin as the anticoagulant on ADVIA® IMS™. Acetaminophen (Tylenol, paracetamol, p-hydroxyacetanilide) is used in many formulations as an analgesic, generally with no adverse effects. Measurement of acetaminophen is used in the diagnosis and treatment of severe liver damage caused by overdose through chronic usage, accident or self-infliction.
Here's an analysis of the provided text to extract the acceptance criteria and study details:
1. Table of Acceptance Criteria and Reported Device Performance
The document doesn't explicitly state "acceptance criteria" in a formal, enumerated list. However, based on the performance data presented and the conclusion of equivalence to a predicate device, we can infer the implied acceptance criteria were met by showing comparable or better performance in the following areas:
| Criteria Category | Implied Acceptance Criterion | Reported Device Performance (ADVIA IMS) |
|---|---|---|
| Imprecision (CV%) | CV% should be comparable to or better than the predicate device (Abbott/TDx) at similar levels. | |
| Level 1.5 mg/dL | ≤ 4.9% (Predicate device value) | 2.6% |
| Level 5.0 mg/dL (approx) | ≤ 3.0% (Predicate device 3.5 mg/dL) | 1.5% |
| Level 14.9-15 mg/dL | ≤ 3.9% (Predicate device 15 mg/dL) | 1.3% |
| Correlation (Regression) | Strong correlation with the predicate device (Y=ADVIA IMS, X=comparison system) with an R-value close to 1 and a regression equation close to Y=X. | |
| Serum (vs Abbott/TDx) | R-value close to 1, slope close to 1, intercept close to 0. | R=0.999, Y=1.05X - 0.25 |
| Plasma (y) vs Serum (x) (within ADVIA IMS) | R-value close to 1, slope close to 1, intercept close to 0. | R=0.998, Y=1.00X + 0.05 |
| Correlation (Syx) | Syx (standard error of the estimate) should be low, indicating good agreement. | |
| Serum (vs Abbott/TDx) | Low value (e.g., <0.5 mg/dL) | 0.31 mg/dL |
| Plasma (y) vs Serum (x) | Low value (e.g., <0.5 mg/dL) | 0.32 mg/dL |
| Interference | Limited significant interference (e.g., % change < ±10-15%) from common substances. | |
| Bilirubin (unconjugated) | <+15% | +9% |
| Bilirubin (conjugated) | <+15% | +4% |
| Hemoglobin | >-15% | -4% |
| Lipids (Triglycerides) | >-15% | -9% |
| Analytical Range | Sufficient range for clinical use (0-20 mg/dL). | 0 to 20 mg/dL |
2. Sample Sizes and Data Provenance
- Test Set Sample Sizes:
- Imprecision (Serum): Not explicitly stated how many samples per level were used for CV calculation, but generally, this involves replicate measurements on multiple samples.
- Correlation (Serum vs Abbott/TDx): 46 specimens
- Correlation (Plasma vs Serum on ADVIA IMS): 50 specimens
- Interfering Substances: A single Acetaminophen concentration was tested for each interferent, but the number of unique samples is not specified.
- Data Provenance: The document does not specify the country of origin of the data or whether the study was retrospective or prospective. It implies the studies were conducted by Bayer Corporation for regulatory submission.
3. Number of Experts and Qualifications for Ground Truth
This type of in-vitro diagnostic device (an assay for a chemical compound) typically does not rely on human experts to establish "ground truth" for the test set in the same way imaging devices do. The ground truth for such assays is established through:
- Reference Methods: Highly accurate and precise analytical methods (e.g., GC-MS, HPLC) or certified reference materials are used to assign true values to samples.
- Predicate Device Measurements: For comparison studies, the predicate device itself serves as a "ground truth" for the new device, assuming the predicate device is already validated and accepted.
The document does not mention any human experts or their qualifications for establishing ground truth.
4. Adjudication Method for the Test Set
Not applicable. As described in point 3, this device's performance evaluation does not involve subjective interpretations requiring adjudication by experts. The ground truth for quantitative assays is based on analytical measurements.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No. This is an in-vitro diagnostic assay for measuring acetaminophen concentrations, not an imaging device or a device requiring human interpretation of results in a diagnostic imaging workflow. Therefore, an MRMC study is not relevant or performed for this type of device.
6. Standalone Performance
Yes, the studies presented (Imprecision, Correlation, Interfering Substances, Analytical Range) represent the standalone performance of the ADVIA IMS Acetaminophen method. The "Correlation" section specifically compares the new device's measurements (Y) against a known comparison system (X), which serves as a benchmark for its standalone accuracy.
7. Type of Ground Truth Used
The ground truth used for this device's evaluation is primarily comparison to a legally marketed predicate device (Abbott/TDx) and likely reference methods or certified materials for establishing the validity of the predicate device and the new device's calibration and analytical range. For the interference study, the "true" acetaminophen concentration would have been precisely known when the interfering substance was added.
8. Sample Size for the Training Set
The document does not provide information about a "training set" or its sample size. For an in-vitro diagnostic assay of this nature, the development process typically involves:
- Method development and optimization.
- Calibration using a set of calibrators (the calibrator part number 04919015 is mentioned).
- Verification and validation studies using various types of samples to assess precision, accuracy, linearity, interference, etc.
There typically isn't a "training set" in the machine learning sense, as this is a chemical assay, not an AI/ML algorithm.
9. How the Ground Truth for the Training Set was Established
Not applicable, as there is no mention of a "training set" in the context of an AI/ML algorithm. The calibration process for the assay would establish its measurement curve, and this would be based on precisely known concentrations of acetaminophen.
Ask a specific question about this device
(50 days)
For the determination of acetaminophen in human serum. Acetaminophen (paracetamol) is used as an analgesic in many different formulations (1). While therapeutic doses rarely cause adverse side effects, the effect of long term treatment with acetaminophen is unclear. Cases have been reported where chronic excessive use of acetaminophen has led to hepatotoxicity and nephrotoxicity (2,3). In cases of acute overdosage, acetaminophen can cause severe hepatic damage leading to hepatic failure if untreated (4,5,6).
The management of acetaminophen overdose requires early recognition of the drug in the bloodstream. Toxicity is generally reported at concentrations over 1324 umol/L (20 mg/dL). Nacetylcysteine has been used as an antidote in conjunction with intensive support care. Early diagnosis of acetaminophen-induced hepatotoxicity is important since initiation of therapy within 8 hours of ingestion lessens the potential for hepatic injury, and decreases the mortality rate (7).
For quantitative, in vitro, diagnostic use.
Not Found
This document is an FDA 510(k) clearance letter for the "Acetaminophen-SL Assay" and does not contain the detailed information required to describe the acceptance criteria and the study that proves the device meets those criteria. The letter primarily states that the device has been found substantially equivalent to previously marketed devices.
Therefore, I cannot provide the requested information based on the provided text. To answer your questions, I would need access to the actual 510(k) submission or a performance study report for the Acetaminophen-SL Assay.
Ask a specific question about this device
(57 days)
For the quantitative determination of acetaminophen in serum. For IN VITRO diagnostic use. Acetaminophen (paracetamol) is used as an analgesic in many different formulations (1). While therapeutic doses rarely cause adverse side effects, the effect of long term treatment with acetaminophen is unclear. Cases have been reported where chronic excessive use of acetaminophen has led to hepatotoxicity and nephrotoxicity (2,3). In cases of acute overdosage, acetaminophen can cause severe hepatic damage leading to hepatic failure if untreated (4,5,6). The management of acetaminophen overdose requires early recognition of the drug in the bloodstream. Toxicity is generally reported at concentrations over 20 mg/dL. N-acetylcysteine has been used as an antidote in conjunction with intensive support care. Early diagnosis of acetaminophen-induced hepatotoxicity is important since initiation of therapy within 8 hours of ingestion lessens the potential for hepatic injury, and decreases the mortality rate (7). The majority of methods for measuring acetaminophen are based on spectrophotometric or chromatographic principles. Chromatographic methods are specific for the parent compound, however, they are not well suited to emergency laboratories. Spectrophotometric methods are simpler and more rapid, but do not always offer the desired specificity. This spectrophotometric method is rapid, reliable, convenient, and specific for acetaminophen.
Not Found
This is a 510(k) premarket notification for an Acetaminophen Assay. As such, it does not describe a study involving an "AI device" or its "acceptance criteria" in the way that current AI/ML medical devices do. The document pertains to a traditional in vitro diagnostic device, and the evaluation is for substantial equivalence to a legally marketed predicate device rather than a performance study against specific acceptance criteria.
Therefore, most of the requested information regarding AI device performance, sample sizes, expert ground truth, MRMC studies, training sets, etc., is not applicable to this document.
However, I can extract information related to the device and its intended use:
Device Name: Acetaminophen Assay (ACE)
Indications for Use: For the quantitative determination of acetaminophen in serum. For IN VITRO diagnostic use.
The document discusses the clinical relevance of measuring acetaminophen levels due to its use as an analgesic and the potential for hepatotoxicity and nephrotoxicity in cases of chronic excessive use or acute overdosage. It highlights the importance of early diagnosis for managing acetaminophen overdose, with toxicity generally reported at concentrations over 20 mg/dL.
The method used by the device is described as a "spectrophotometric method" which is "rapid, reliable, convenient, and specific for acetaminophen."
Regarding acceptance criteria and study data:
Traditional 510(k) submissions for in vitro diagnostic assays typically demonstrate substantial equivalence through analytical and sometimes clinical performance studies. These studies would define performance characteristics such as:
- Accuracy: Comparison to a reference method or known concentrations.
- Precision: Repeatability and reproducibility.
- Linearity/Measuring Range: The range over which the assay provides accurate results.
- Interference: Evaluation of substances that might falsely elevate or depress results.
- Specificity: How well the assay distinguishes acetaminophen from other compounds.
The document does not provide the detailed results of these studies or explicit "acceptance criteria" in the format of a table as requested for an AI device. Instead, the FDA's "substantial equivalence" determination implies that the device's performance is comparable to a predicate device, which would have met its own established performance specifications.
Therefore, I cannot fulfill your request in full for an "AI device" using this document. The information you're asking for is specific to AI/ML device evaluations, which involve different types of studies and reporting. This document is a regulatory approval letter for a chemical assay, not an AI product.
Ask a specific question about this device
(35 days)
The ACTM FLEX™ reagent cartridge used on the Dimension® clinical chemistry system is an in vitro diagnostic test intended to measure the drug acetaminophen in plasma and serum. Measurements obtained by this device are used in the diagnosis and treatment of acetaminophen overdose.
The ACTM method is based on the enzymatic hydrolysis of acetaminophen producing acetate and p-aminophenol. The amount of p-aminophenol is measured colorimetrically and is proportional to the acetaminophen concentration.
Here's an analysis of the provided K963244 document based on your request, focusing on acceptance criteria and supporting study details:
Device: Acetaminophen FLEX™ Reagent Cartridge
This document describes a submission for a reagent cartridge for an in vitro diagnostic test, not an AI-powered medical device. As such, many of the requested fields related to AI, such as "multi-reader multi-case comparative effectiveness study," "human-in-the-loop performance," "number of experts," and "adjudication method," are not applicable to this type of submission. The ground truth in this context typically refers to the reference method (the predicate device) or a gold standard chemical analysis, rather than expert consensus on images.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Substantial Equivalence to Predicate Device: | |
| - Correlation to aca® acetaminophen test pack | Correlation coefficient = 0.998 |
| - Agreement in measurement (slope and intercept relative to predicate) | Slope = 1.04Intercept = -3.27 |
| - Analytical range of detection | Range of samples tested = 10.2 - 295.0 µg/mL |
Note: The document does not explicitly state numerical acceptance criteria (e.g., "correlation coefficient must be ≥ 0.98"). Instead, it presents the results of a comparison study to a legally marketed predicate device (aca® acetaminophen test pack) to demonstrate substantial equivalence, which is the implicit acceptance criterion for 510(k) submissions. The reported values (slope, intercept, correlation coefficient) are strong indicators of analytical agreement between the new device and the predicate.
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: 154 serum or plasma samples.
- Data Provenance:
- Country of Origin: Not specified. (Typically assumed to be from within the country of the submitting company, in this case, the USA, but not explicitly stated).
- Retrospective or Prospective: Not specified. However, the nature of comparing sample results between two methods usually implies a prospective collection of samples analyzed by both, or retrospective analysis of banked samples. No information is given to definitively classify it.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
Not Applicable. For an in vitro diagnostic reagent, the "ground truth" for analytical performance studies is typically established by:
- Comparison to a legally marketed predicate device (as in this case).
- Reference methods (e.g., GC-MS, HPLC).
- Known concentration standards.
Expert interpretation (e.g., by radiologists) is not relevant for this type of device.
4. Adjudication Method for the Test Set
Not Applicable. Adjudication methods (like 2+1, 3+1) are used for resolving discrepancies in human expert interpretations, especially in image analysis studies. This is not relevant for an in vitro diagnostic analytical comparison.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No. An MRMC study is not relevant for an in vitro diagnostic reagent.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) Was Done
Yes (in principle, but framed differently). The study explicitly describes the performance of the "ACTM FLEX™ reagent cartridge on the Dimension® system" in measuring acetaminophen, independent of human interpretive steps beyond initial sample loading and result readout. The device itself (reagent + instrument) performs the measurement automatically. There is no human "in the loop" for interpreting the measurement result itself, though human clinicians use the result for diagnosis and treatment.
7. The Type of Ground Truth Used
The primary ground truth used was comparison to a legally marketed and FDA-cleared predicate device: the "aca® acetaminophen test pack on the aca® discrete clinical analyzer." This establishes "substantial equivalence" as the basis for clearance.
8. The Sample Size for the Training Set
Not Applicable. This document describes a traditional in vitro diagnostic device, not an AI/Machine Learning model. Therefore, there is no "training set" in the AI sense. The methods are based on established enzymatic reactions and colorimetric detection, not on learning from data.
9. How the Ground Truth for the Training Set Was Established
Not Applicable. As there is no training set for an AI model, this question is irrelevant. The chemical principles are inherent to the reagent's design.
Ask a specific question about this device
(90 days)
Ask a specific question about this device
Page 1 of 1