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Intended for the in vitro quantitative measurement of acetaminophen in serum, lithium heparin plasma. Measurement of acetaminophen is used in the diagnosis and treatment of acetaminophen overdose toxicity.

The SEKURE Acetaminophen L3K assay is an enzymatic, spectrophotometric assay for the measurement of acetaminophen concentration in serum, lithium heparin plasma and sodium heparin plasma. The assay consists two working reagents, an enzyme reagent and a color reagent. The enzyme reagent contains acyl amidohydrolase, which cleaves the amide bond of the 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 605 nm which is directly proportional to the acetaminophen concentration in the sample. Testing is performed on open system clinical chemistry analyzers, such as the Hitachi 717 (K872494) in conjunction with a calibrator (510(k) exempt) which is included and controls which are provided separately.

The provided document is a 510(k) Pre-market Notification for a medical device called the "SEKURE Acetaminophen L3K Assay." This document describes the analytical studies conducted to demonstrate the device's performance and substantial equivalence to a predicate device, rather than a study involving human readers or AI assistance in image interpretation. Therefore, many of the requested points related to AI, human reader performance, expert consensus, and MRMC studies are not applicable to this type of device submission.

Here's an analysis based on the available information:

Device Type: In vitro diagnostic device (IVD) for quantitative measurement of acetaminophen in biological samples.

Focus of the Document: Analytical performance studies (precision, analytical sensitivity, linearity, interference, method comparison, matrix comparison) to demonstrate the assay's accuracy and reliability.

Information NOT Applicable to this Document Type:

• Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective) - Data provenance is typically not detailed for IVD analytical studies in this manner; samples are clinical specimens or prepared materials.
• 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) - Ground truth for IVDs is established by reference methods or gravimetric preparation, not expert review of images.
• Adjudication method (e.g. 2+1, 3+1, none) for the test set - Not applicable for IVD analytical studies.
• 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 not an AI-assisted diagnostic imaging device.
• If a standalone (i.e. algorithm only without human-in-the-loop performance) was done - Not applicable; this is not an AI algorithm.
• The type of ground truth used (expert consensus, pathology, outcomes data, etc) - Ground truth is established by reference methods, gravimetric preparation, or theoretical values.
• The sample size for the training set - Not applicable; this device does not use an AI training set.
• How the ground truth for the training set was established - Not applicable.

Acceptance Criteria and Reported Device Performance

The device is an in vitro diagnostic assay, and its performance is evaluated through various analytical studies. The acceptance criteria are therefore analytical performance specifications, not clinical outcomes directly.

Here's a table summarizing the acceptance criteria and a selection of reported performance data from the document:

Table of Acceptance Criteria and Reported Device Performance

Study that Proves the Device Meets the Acceptance Criteria

The study that proves the device meets the acceptance criteria is a series of Non-Clinical Performance Data studies, as detailed in the "510(k) Summary" document. These are analytical studies, typically following CLSI (Clinical and Laboratory Standards Institute) guidelines, to characterize the performance of the in vitro diagnostic assay.

1. Sample Sized Used for the Test Set and Data Provenance:

• Precision: 80 measurements per sample/control per lot (assayed in duplicate twice a day for 20 days). This included two unaltered patient serum samples, two spiked patient serum samples, and three levels of controls. Data is likely from laboratory samples, not specified by country.
• Analytical Sensitivity (LoB/LoD): 60 measurements per lot (five blank samples and five low concentration samples in quadruplicate over three operating days).
• Analytical Sensitivity (LoQ): 40 replicates per low concentration sample per lot (five low concentration samples tested in 40 replicates over five runs across three operating days).
• Linearity/Assay Reportable Range: 4 replicates per sample per lot (nine internally prepared samples across the measuring range).
• Analytical Specificity (Interference): 5 replicates per interferent concentration per acetaminophen concentration (tested at 3-4 acetaminophen concentrations).
• Method Comparison: 105 patient specimens, tested in duplicate, over seven operating days. Samples were distributed evenly throughout the assay range.
• Matrix Comparison: 40 matched sets of patient specimens.

Data Provenance: The document does not explicitly state the country of origin for patient samples or whether they were retrospective or prospective. However, for analytical performance, samples are typically collected from a pool of patient samples or are internally prepared clinical matrix materials.

2. Number of Experts and Qualifications:

• Not applicable. This device is an analytical chemistry assay, not one that relies on human experts for interpretation or ground truth establishment. The performance is assessed against quantitative analytical standards and a predicate device.

3. Adjudication Method:

• None. Not applicable for analytical performance studies of an IVD assay.

4. MRMC Comparative Effectiveness Study:

• No. Not applicable as this is not an imaging device or an AI-assisted diagnostic device.

5. Standalone Performance:

• Yes (in the context of an IVD). The performance data presented (e.g., precision, analytical sensitivity, linearity, interference) represent the standalone performance of the SEKURE Acetaminophen L3K Assay itself, without a "human-in-the-loop" in the artificial intelligence sense. The assay quantitatively measures acetaminophen concentration.

6. Type of Ground Truth Used:

• Reference Methods / Gravimetric Preparation / Theoretical Values / Predicate Device Comparison.
  • Precision: Relative to the mean of repeat measurements.
  • Analytical Sensitivity: Derived statistically from blank and low-level samples.
  • Linearity: Compared to theoretical concentrations of gravimetrically prepared standards.
  • Interference: Compared to control samples without interferent.
  • Method Comparison: Compared to measurements obtained using a legally marketed predicate device (SEKURE Acetaminophen L3K Assay, K081938). This is a common form of "ground truth" for demonstrating substantial equivalence for IVDs.
  • Matrix Comparison: Compared to serum samples (considered the reference matrix).

7. Sample Size for the Training Set:

• Not applicable. This device is an in vitro diagnostic assay, not an AI algorithm that requires a training set.

8. How the Ground Truth for the Training Set Was Established:

• Not applicable. See above.

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The Synermed Glucose Reagent is for the in vitro quantitative measurement of glucose in serum on the Synermed IR-1200 Chemistry Analyzer. Glucose measurements are used in the diagnosis and treatment of carbolygrate metabolism disorders including diabetes mellitus, neonatal hypoglycemia and of pancreatic islet cell carcinoma.

The Synermed IR-1200 Chemistry Analyzer is intended for in vitro diagnostic use as a multiparameter chemistry instrument that quantitates the levels of constituents in serum. The analyzer is an automated, random eccess, computer controlled, clinical chemistry analyzer for clinical chemistry tests. The instrument provides in vitro quantitative measurements for glucose in serum. The device is intended for use only in clinical laboratories.

Synermed IR-1200 Glucose Reagent

The Synermed Glucose is ready to use. The composition of the Synermed Glucose Oxidase Reagent is as follows: 280 umol/L N-sulfopropyl-N-ethyl-3, 5-dimethylaniline, 280 umol/L ampyrone, 1400 U/L peroxidase (horseradish) and 18,000 U/L glucose oxidase.

Synermed IR-1200 Chemistry Analyzer

The IR-1200 Chemistry Analyzer is a multiparameter chemistry instrument that quantitates the levels of analytes in serum using spectrophotometric measurement. The system uses Synermed liquid-stable reagent systems that have been previously cleared by FDA.

The IR-1200 Chemistry Analyzer is a discrete analyzer with STAT priority capabilities and an externalized computer. The instrument features a user-friendly software operating system, optical unit, precision pipetting and electronic system. Twelve wavelengths are included ranging from 340 nm to 800 nm. The instrument's capabilities include: sample pipetting, reagent pipetting, anti-interference, mixing, pre-heating, reaction monitoring, calculation, display and printing of results. After the measurement is complete, the system rinses and dries the cuvettes. The system automates the manual functions and, as a result, it enhances efficiency, diminishes errors, thus improving the accuracy and precision of test results.

Here's an analysis of the provided text regarding the acceptance criteria and study for the Synermed Glucose Reagent and Synermed IR-1200 Chemistry Analyzer:

1. Table of Acceptance Criteria and Reported Device Performance:

The document describes the performance of the Synermed Glucose Reagent on the Synermed IR-1200 Chemistry Analyzer. While it doesn't explicitly list "acceptance criteria" as a separate, pre-defined column, the "Results" sections and the discussions of "non-significant interference" imply the criteria used for evaluation. Therefore, I will reconstruct the table with implied acceptance criteria based on the reported results.

2. Sample Size Used for the Test Set and Data Provenance:

• Precision/Reproducibility:

  • Sample Size: 5 concentrations of pooled patient serum, with 80 measurements at each concentration (run in duplicate twice a day for twenty days). Total = 400 measurements (5 concentrations * 80 measurements/concentration). While 80 measurements per concentration are mentioned, it's 2 duplicates per day * 20 days.
  • Data Provenance: Not explicitly stated, but "pooled patient serum" suggests human biological samples. No mention of country of origin or whether it was retrospective/prospective.

• Linearity/Reportable Range:

  • Sample Size: 13 concentrations across the measuring range, with four replicates at each concentration. Total = 52 measurements (13 concentrations * 4 replicates). Sample preparation involved "intermixing a high serum pool with a low serum pool."
  • Data Provenance: Not explicitly stated. The use of "serum pool" implies human samples.

• Analytical Specificity (Interference):

  • Sample Size: Serum pools spiked with interferents at two analyte levels (80 mg/dL and 120 mg/dL glucose) and at two concentrations of interferent. Specific numbers of samples are not detailed beyond "serum pools."
  • Data Provenance: Not explicitly stated. Use of "serum pools" implies human samples.

• Detection Limit (LoB, LoD, LoQ):

  • Sample Size: Not explicitly stated, but the study "evaluated following CLSI EP17-A" suggests a scientifically rigorous approach with sufficient replicates, though the exact number isn't provided.
  • Data Provenance: Not explicitly stated.

• Comparison Studies (Method Comparison):

  • Sample Size: 115 samples for glucose. 15 of these were "modified to cover the entire claimed measuring range" by intermixing patient serum pools.
  • Data Provenance: Not explicitly stated, but "patient serum pools" and "patient serum samples" indicate human biological samples. No mention of country of origin or whether it was retrospective/prospective.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:

This document describes the performance of a quantitative laboratory diagnostic device (chemistry analyzer and reagent). For such devices, "ground truth" is typically established by:

• Reference Methods: Highly accurate and precise laboratory methods, often traceable to international standards (e.g., NIST).
• Predicate Devices: Comparison to an already FDA-cleared device provides a benchmark.

The studies presented here rely on these types of "ground truth":

• For linearity, the "expected values" are derived from known dilutions.
• For comparison studies, the "ground truth" is the measurement obtained from the predicate device (Hitachi 717 chemistry analyzer) using the same previously cleared reagent systems.

Therefore, no human experts were used to establish a subjective "ground truth" in the way they might be for interpreting medical images. The "ground truth" is analytical, derived from established laboratory methodologies and reference measurements. The Synermed IR Cal II calibrator is stated to be traceable to NIST standard number 917-C, which provides a form of metrological ground truth.

4. Adjudication Method for the Test Set:

Not applicable. As explained above, the "ground truth" is analytical/measurement-based, not based on human interpretation or consensus. There is no need for an adjudication method for these types of studies.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

No, an MRMC comparative effectiveness study was not done. This type of study involves multiple human readers interpreting cases/images, often with and without AI assistance, to assess the impact of AI on human performance. This document concerns a chemistry analyzer and reagents, which are distinct from image-based AI diagnostics.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study:

Yes, all presented studies are standalone (algorithm only). The Synermed IR-1200 Chemistry Analyzer is an automated instrument. The performance reported (precision, linearity, specificity, detection limits, method comparison) reflects the intrinsic analytical capabilities of the device itself, without human interpretation or intervention affecting the measurement results. The results are quantitative outputs directly from the instrument.

7. Type of Ground Truth Used:

The ground truth used is primarily measurement-based and comparative:

• Reference Values/Standards: For linearity, expected values from known dilutions. For calibration, traceability to NIST standards.
• Predicate Device Measurements: In the method comparison study, the measurements from the predicate Hitachi 717 chemistry analyzer serve as the comparative ground truth.
• Defined Analytical Procedures: Ground truth for precision, linearity, and detection limit studies are established through rigorous adherence to CLSI (Clinical and Laboratory Standards Institute) protocols, which are industry standards for analytical validation.

8. Sample Size for the Training Set:

This document describes the validation of a chemistry analyzer and reagent, which are based on established chemical reactions and spectrophotometric measurements. There is no mention of a "training set" in the context of machine learning or AI model development because the device does not employ a learning algorithm that requires training. Its operational parameters are based on fixed scientific principles and engineering designs.

9. How the Ground Truth for the Training Set Was Established:

Not applicable, as there is no training set for this type of device.

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