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The Carolina Liquid Chemistries Cocaine Metabolite Enzyme Immunoassay (COCM) Test System is intended for the qualitative determination of benzoylecgonine (cocaine metabolite) in human urine at a cutoff value of 300 ng/mL. The assay is designed for professional use with a Carolina Liquid Chemistries CLC6410 automated clinical chemistry analyzer. For in vitro diagnostic use only. The assay provides a rapid screening procedure for determining the presence of benzoylecgonine in urine. The assay provides only a preliminary analytical result. A more specific alternative chemical method must be used to obtain a confirmed analytical result. Gas or Liquid Chromatography/Mass Spectrometry (GC/MS or LC/MS) is the preferred confirmatory method. Clinical considerations and professional judgment should be exercised with any drug of abuse test result, particularly when the preliminary test result is positive.

The Carolina Liquid Chemistries Cocaine and Cocaine Metabolite Enzyme Immunoassay (COCM) Test System is a ready-to-use, liquid reagent homogeneous enzyme immunoassay for qualitatively determining the presence of cocaine metabolite (benzoylecgonine) in human urine. The assay uses specific antibody that can detect benzoylecgonine in human urine with minimal cross-reactivity to various, common prescription drugs and abused drugs. The assay is based on competition between benzoylecgonine labeled with the enzyme glucose-6phosphate dehydrogenase (G6PDH) and free drug from the urine sample, for a fixed amount of antibody. In the absence of free drug from the urine sample, the specific antibody binds to the drug labeled with G6PDH causing a decrease in enzyme activity. The G6PDH enzyme activity is determined spectrophotometrically at 340 nm by measuring its ability to convert nicotinamide adenine dinucleotide (NAD+) to NADH.

Here's a breakdown of the acceptance criteria and the study that proves the device meets them, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

• 0 ng/mL, 75 ng/mL, 150 ng/mL, 225 ng/mL: 4/4 Negative results.
• 300 ng/mL (Cutoff): 3/1 Neg/Pos (3 Negative, 1 Positive).
• 375 ng/mL, 450 ng/mL, 525 ng/mL, 600 ng/mL: 4/4 Positive results.
  Run-to-Run:
• 0 ng/mL, 75 ng/mL, 150 ng/mL, 225 ng/mL: 88/88 Negative results.
• 300 ng/mL (Cutoff): 53/35 Neg/Pos (53 Negative, 35 Positive).
• 375 ng/mL, 450 ng/mL, 525 ng/mL: 88/88 Positive results. |
  | Specificity | Supported by cross-reactivity studies that supported the predicate device (K020763). (No specific numerical data provided in this document, but stated as acceptable by reference to predicate) |
  | Interference (pH) | No substantial interference noted.
• 225 ng/mL Target: All samples from pH 3.1 to 11.1 tested Negative.
• 375 ng/mL Target: All samples from pH 3.1 to 11.1 tested Positive. |
  | Interference (Specific Gravity) | No substantial interference noted.
• 225 ng/mL Target: All samples from SG 1.000 to 1.029 tested Negative.
• 375 ng/mL Target: All samples from SG 1.001 to 1.028 tested Positive. |
  | Carryover | No carryover was noted during testing with alternating high (1000 ng/mL) and low (0 ng/mL) samples. |
  | Method Comparison and Accuracy | Agreement among positives: 100% (40/40 samples correctly identified).
  Agreement among negatives: 100% (41/41 samples correctly identified).
  No discordant samples identified. |

2. Sample Sizes Used for the Test Set and Data Provenance

• Precision:
  • Within Run: 4 replicates per concentration.
  • Run-to-Run: 88 replicates per concentration (2 samples/day for 22 non-consecutive days).
• Interference (pH): 18 real human urine samples (9 pH pools, each split and spiked at two concentrations).
• Interference (Specific Gravity): 20 real human urine samples (10 SG pools, each split and spiked at two concentrations).
• Carryover: 21 samples (10 "High" at 1000 ng/mL, 11 "Low" at 0 ng/mL).
• Method Comparison and Accuracy: 81 samples total.
  • 41 LC/MS Confirmed Negative Samples (20 drug-free, 21 between 0-300 ng/mL, with 8 between 150-300 ng/mL).
  • 40 LC/MS Confirmed Positive Samples (at least 8 between 300-450 ng/mL, remaining >450 ng/mL).

Data Provenance: The document states "real human urine samples" for interference testing, and for precision and accuracy, samples were "drug free urine" or "spiked with benzoylecgonine." The document does not specify the country of origin of the data or whether the data was retrospective or prospective. It implies a controlled laboratory setting (spiking, adjusting pH/SG).

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

The document does not mention the use of experts to establish a ground truth. The ground truth for the test set (Method Comparison and Accuracy, Precision) was established through instrumental analysis: LC/MS (Liquid Chromatography/Mass Spectrometry), which is explicitly called the "confirmatory method" and "reference method."

4. Adjudication Method for the Test Set

No adjudication method (e.g., 2+1, 3+1) is mentioned, as the ground truth was established by instrumental methods (LC/MS) rather than human experts requiring consensus.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was Done

No MRMC study was done, as this device is an in vitro diagnostic (IVD) assay for laboratory use, not an AI-assisted diagnostic tool for human readers. Therefore, there is no mention of effect size for human readers improving with or without AI assistance.

6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was Done

This device is a standalone algorithm/assay in the sense that it performs the qualitative determination of benzoylecgonine without a human-in-the-loop for the primary result interpretation. The "professional use" mentioned refers to laboratory professionals operating the automated analyzer and interpreting the results within a clinical context, not interacting with AI for improved diagnostic performance. The performance data presented (precision, accuracy, etc.) represents the standalone performance of the assay.

7. The Type of Ground Truth Used

The primary ground truth used for performance evaluation (especially for accuracy and precision) is Gas or Liquid Chromatography/Mass Spectrometry (GC/MS or LC/MS). For the precision study, it states: "All sample concentrations were verified by a confirmatory method (LCMS)." For method comparison and accuracy, it states: "Qualitative Mode Accuracy study with LC-MS/MS as reference method." This is an instrumental, objective laboratory method.

8. The Sample Size for the Training Set

The document describes performance studies for a developed immunoassay. It does not mention a "training set" in the context of machine learning, as this is a chemical assay, not an AI/ML algorithm that requires training data in that sense. The reagents and parameters are developed through R&D, not trained on a dataset like a deep learning model.

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

As no training set (in the ML sense) is relevant for this type of immunoassay, this question is not applicable. The assay's analytical characteristics are determined by its chemical and biological components and detection principles, which are optimized during development and validated through the studies described.

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The Carolina Liquid Chemistries Cocaine and Cocaine Metabolite Test System (COCM) is for the qualitative determination of benzoylecgonine (cocaine metabolite) in human urine at a cutoff value of 300 ng/mL. The assay is designed for professional use with a clinical chemistry analyzer. For in vitro diagnostic use only.

This assay provides a rapid screening procedure for determining the presence of benzoylecgonine in urine. The assay provides only a preliminary analytical result. A more specific alternative chemical method must be used in order to obtain a confirmed analytical result. Gas or Liquid Chromatography/Mass Spectrometry (GC/MS or LC/MS) is the preferred confirmatory method. Clinical considerations and professional judgment should be exercised with any drug of abuse test result, particularly when the preliminary test result is positive.

Carolina Liquid Chemistries Cocaine Metabolite Test System (COCM) is a ready-to-use, liquid reagent, homogenous enzyme immunoassay. The assay uses a specific antibody that can detect benzoylecgonine (cocaine metabolite) in human urine with minimal cross-reactivity to various, common prescription drugs and abused drugs. The assay is based on competition between benzoylecgonine and glucose-6-phosphate dehydrogenase (G6PDH) enzyme, and free drug from the urine sample for a fixed amount of the specific antibody. In the absence of free drug from the urine sample the specific antibody binds to the drug labeled with G6PDH enzyme causing a decrease in enzyme activity. The G6PDH enzyme activity is determined spectrophotometrically and 340nm by measuring its ability to convert nicotinamide adenine dinucleotide (NAD) to NADH.

This document describes the validation of the Carolina Liquid Chemistries Cocaine and Cocaine Metabolite Test System (COCM), an enzyme immunoassay for the qualitative detection of benzoylecgonine (cocaine metabolite) in human urine at a cutoff value of 300 ng/mL. The study aims to demonstrate substantial equivalence to a legally marketed predicate device (Lin-Zhi International, Inc. Cocaine Metabolite Enzyme Immunoassay).

Based on the provided information, here's a breakdown of the acceptance criteria and the study that proves the device meets them:

1. A table of acceptance criteria and the reported device performance

The document implicitly uses the performance of the predicate device and LCMS/GCMS as the "acceptance criteria" for demonstrating substantial equivalence. The key performance characteristics evaluated for the candidate device are Accuracy, Interfering Substances/Cross-Reactivity, and Precision.

- Drug Free (0.00 ng/mL): 30 Negative (100% negative)
-  50 to  100 to  150% of cutoff (>= 450 ng/mL): 26 Positive (100% positive)
- Overall: All 100 samples matched LCMS results (100% agreement). |

| Interfering Substances/Cross-Reactivity/Specificity | Demonstrate a specific antibody that can detect benzoylecgonine with minimal cross-reactivity to various common prescription and abused drugs. pH (3-11) and specific gravity (1.000-1.030) should not interfere. | - Specific Gravity & pH: "Study results show that neither pH (range tested: 3-11), nor specific gravity conditions (range tested 1.000-1.030) will interfere with this assay."

• Specificity (Cross-Reactivity):
  • Structurally Related Cocaine Compounds showed cross-reactivity (e.g., Cocaine (30 µg/mL), Norcocaine (60 µg/mL), Ecgonine, Methyl Ester (350 µg/mL) were "Positive"). Benzoylecgonine (0.3 µg/mL) also positive, as expected.
  • Numerous other common drugs/substances (e.g., Acetaminophen, Amphetamine, Codeine, Morphine, Nicotine, etc.) tested up to 1000-2000 µg/mL showed "Negative" cross-reactivity. |
    | Precision | Consistent and reproducible results across runs and within runs, especially around the cutoff concentration. | - Within Run (Qualitative Analysis): 20 replicates of spiked human urine at 9 concentrations. At the 300 ng/mL cutoff, 15 Negative / 5 Positive results were obtained (implies some borderline results). All other concentrations (0-225 ng/mL and 375-600 ng/mL) showed 100% agreement with expected negative/positive results.
• Run-to-Run (Qualitative Analysis): 90 replicates of spiked human urine at 9 concentrations. At the 300 ng/mL cutoff, 84 Positive / 6 Negative results were obtained (implies some borderline results). All other concentrations (0-225 ng/mL and 375-600 ng/mL) showed 100% agreement with expected negative/positive results.
• Within/Run-to-Run (ΔmA/min): Provided mean, SD, %CV for different concentrations, indicating good precision (e.g., %CV

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The Carolina Liquid Chemistries CLC 6410 chemistry analyzer is an automated clinical analyzer for in vitro diagnostic use only in clinical laboratories. It is intended to be used for a variety of assay methods. The analyzer provides in vitro quantitative determinations for glucose, sodium, potassium, and chloride in serum and plasma samples.

The Carolina Liquid Chemistries Glucose Reagent is for use with the Carolina Liquid Chemistries CLC 6410 Chemistry Analyzer for the measurement of glucose in serum and plasma. Glucose measurements are used in the diagnosis and treatment of carbohydrate metabolism disorders including diabetes mellitus, neonatal hypoglycemia, and of pancreatic islet cell carcinoma.

The Carolina Liquid Chemistries ISE Kit is intended to be used with the Carolina Liquid Chemistries CLC 6410 Chemistry Analyzer for measurement of sodium, potassium, and chloride in serum and plasma. The ISE Kit consists of ISE Buffer, internal reference solution, and reference solution. Sodium measurements are used in the diagnosis and treatment of diseases involving electrolyte imbalance. Potassium measurements monitor electrolyte balance and in the diagnosis and treatment of disease conditions characterized by low or high blood potassium levels. Chloride measurements are used for the diagnosis and treatment of electrolyte and metabolic disorders.

The Carolina Liquid Chemistries ISE Calibrator Kit consists of Calibrator 1, Calibrator 2, and Selectivity Check. It is used with the ISE Module on the Carolina Liquid Chemistries CLC 6410 Chemistry Analyzer for the calibration of the Sodium, Potassium and Chloride assays.

For in vitro diagnostic use only.

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This document is an FDA 510(k) clearance letter for the Carolina Liquid Chemistries CLC 6410 Chemistry Analyzer, along with associated reagents and calibrators, for measuring glucose, sodium, potassium, and chloride in serum and plasma. The letter does not contain the detailed study information (acceptance criteria, performance data, sample sizes, ground truth establishment, expert qualifications, adjudication methods, or MRMC studies) that would typically be required to fully answer your request.

The letter explicitly states: "We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976..." This means the FDA has deemed the device substantially equivalent to existing devices, implying that the performance presented in the 510(k) submission met the acceptance criteria by demonstrating performance comparable to the predicate device. However, the specific acceptance criteria and detailed study findings are not included in this publicly available letter.

Therefore,Based on the provided document, I cannot fulfill your request as it does not contain the detailed study information regarding acceptance criteria, reported device performance, sample sizes, data provenance, expert qualifications, adjudication methods, MRMC studies, standalone performance, type of ground truth, or how ground truth was established for training and test sets.

The document is a 510(k) clearance letter from the FDA, stating that the device is substantially equivalent to legally marketed predicate devices. It includes the indications for use but does not provide the underlying performance studies or the specific acceptance criteria and results from those studies.

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For the quantitative determination of high-density lipprotein cholesterol (HDL-C) in serum using the Carolina Liquid Chemistries CLC720® Clinical Chemistry Analyzer. Lipoprotein measurements are used in the diagnosis and treatment of lipid disorders (such as diabetes mellitus), atherosclerosis, and various liver and renal diseases. For in vitro diagnostic use only.

Not Found

This document is a 510(k) clearance letter for the Carolina Liquid Chemistries HDL Cholesterol Reagent. It is not a study report demonstrating device performance against acceptance criteria. Therefore, most of the requested information cannot be extracted from this document.

However, I can provide what is explicitly stated in the document:

1. A table of acceptance criteria and the reported device performance

This document does not contain a table of acceptance criteria or reported device performance. It is a clearance letter, indicating that the FDA has determined the device is substantially equivalent to legally marketed predicate devices. Performance data would typically be found in the 510(k) submission itself, not the clearance letter.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

This information is not available in the provided document.

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 available in the provided document.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This information is not available in the provided document.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

This information is not available in the provided document. The device is a "HDL Cholesterol Reagent" and a "Clinical Chemistry Analyzer," which suggests it's an in-vitro diagnostic test for quantitative determination of HDL-C, not an imaging device typically associated with human reader interpretation in the context of MRMC studies.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

This information is not available in the provided document. Given the nature of the device (a reagent for an analyzer), its performance would inherently be "standalone" in the sense that the analyzer provides a quantitative result without human "interpretation" in the way an imaging algorithm might. However, this document does not detail performance studies.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

This information is not available in the provided document. For a quantitative diagnostic test like this, ground truth would typically be established through a reference method or comparison to other established methods for HDL-C measurement.

8. The sample size for the training set

This information is not available in the provided document.

9. How the ground truth for the training set was established

This information is not available in the provided document.

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Calcium Reagent is intended for the quantitative determination of serum calcium using the Beckman SYNCHRON CX Clinical Systems. The results are used in the diagnosis and treatment of hyperparathyroidism, hypoparathyroidism, multiple myeloma, nephrosis, nephritis, pancreatitis and hypervitaminosis D.

Calcium Reagent

The provided text is a 510(k) premarket notification letter from the FDA regarding a Calcium Reagent device. It does not contain the information requested about acceptance criteria, device performance studies, sample sizes, expert qualifications, or ground truth establishment.

This document is a regulatory approval letter, explicitly stating "We have reviewed your Section 510(k) notification...and we have determined the device is substantially equivalent...You may, therefore, market the device..." It confirms the device's classification, product code, and indications for use.

Therefore, I cannot fulfill the request to describe the acceptance criteria and the study that proves the device meets them based on the provided text.

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Total Bilirubin is intended for the quantitative determination of total bilirubin in serum using Beckman SYNCHRON CX Clinical Systems. The results are used in the diagnosis and treatment of liver, hemolytic hematological, and metabolic disorders, including hepatitis and gall bladder block.

Total Bilirubin Reagent

This document is a 510(k) clearance letter from the FDA for a Total Bilirubin Reagent. This type of document does not contain the detailed study information required to answer your questions about acceptance criteria and device performance.

The letter explicitly states: "We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent... to devices marketed in interstate commerce prior to May 28, 1976..."

This means the device's performance was compared to a predicate device already on the market, and the FDA determined it was substantially equivalent, allowing it to be marketed. The detailed study results, acceptance criteria, sample sizes, and ground truth information are typically found in the 510(k) submission itself, which is a much larger document and not provided here.

Therefore, I cannot provide the requested information from this document.

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The Triglycerides Reagent is intended for the quantitative determination of serum triglycerides using the Beckman SYNCHRON CX Clinical System:s. Elevated serum triglyceride levels are associated with increased risk of coronary artery disease, pancreatitis, and numerous genetic lipoprotein disorders.

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Due to the limited information in the provided document, I cannot fulfill all parts of your request. This document is a 510(k) clearance letter for a medical device (Triglycerides Reagent) and does not contain detailed study information regarding acceptance criteria or performance data.

Here's what I can extract and what is missing:

1. Table of Acceptance Criteria and Reported Device Performance:

• Acceptance Criteria: Not explicitly stated in the document. The FDA letter confirms the device is "substantially equivalent" to predicate devices, implying it meets general performance expectations for this type of in-vitro diagnostic. Specific numerical acceptance criteria (e.g., accuracy, precision limits) are not provided.
• Reported Device Performance: Not included in the document. The letter acknowledges that the manufacturer provided information to support substantial equivalence, but the actual performance data is not detailed here.

2. Sample size used for the test set and the data provenance:

• Sample size: Not mentioned in this document.
• Data provenance: Not mentioned in this document.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

• Not mentioned in this document.

4. Adjudication method for the test set:

• Not mentioned in this document.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

• This device is a Triglycerides Reagent, an in-vitro diagnostic (IVD) for quantitative determination of serum triglycerides. It is not an AI-assisted diagnostic imaging device or a device involving human "readers" in the context of imaging interpretation. Therefore, an MRMC study comparing human readers with and without AI assistance is not applicable to this type of device.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:

• This question also appears to be framed from the perspective of an AI/algorithm-based diagnostic device. As a chemical reagent, the concept of "standalone algorithm performance" doesn't directly apply. The performance of the reagent would be assessed through analytical and clinical validation studies, but not in the sense of a standalone algorithm for image analysis.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

• For an in-vitro diagnostic like a triglycerides reagent, the "ground truth" would typically be established through:
  • Reference methods: Comparing the device's results to a more established, highly accurate reference method for triglyceride measurement.
  • Clinical correlation: Showing that the triglyceride levels determined by the device correlate with clinical conditions (e.g., risk of coronary artery disease, pancreatitis) or patient outcomes as expected.
  • Known concentration controls: Testing the device with samples of known triglyceride concentrations.
  • This document does not specify which type of ground truth was used for the submission.

8. The sample size for the training set:

• Not mentioned in this document. (Training sets are more relevant for machine learning algorithms, which this device is not).

9. How the ground truth for the training set was established:

• Not applicable as this is not an AI/ML device requiring a "training set" in that context.

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BUN Reagent is intended for the quantitative determination of urea nitrogen in serum using Beckman SYNCHRON CX Clinical Systems. The results are used in the diagnosis and treatment of certain renal and metabolic diseases.

Not Found

The provided text is a 510(k) premarket notification letter from the FDA regarding a Blood Urea Nitrogen (BUN) Reagent. This document is a regulatory approval letter for an in vitro diagnostic (IVD) device, not an AI/ML medical device. Therefore, the specific questions regarding acceptance criteria, study details, ground truth, and expert involvement for AI/ML performance evaluation are not applicable to this document.

The letter explicitly states: "We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act)."

This indicates a process of demonstrating substantial equivalence to a predicate device, which relies heavily on comparing the new device's characteristics and performance to an already legally marketed device, often through analytical and clinical performance studies specific to IVDs (e.g., precision, accuracy, linearity, interferences).

Therefore, I cannot provide the requested information as it pertains to AI/ML device evaluation, as this document is not about such a device.

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Creatinine Reagent is intended for the quantitative determination of serum creatinine using the Beckman SYNCHRON CX Clinical Systems. The results are used in the diagnosis and treatment of renal malfunction.

Creatinine Reagent

I am sorry, but the provided text from the FDA 510(k) summary does not contain the detailed information necessary to complete all sections of your request regarding acceptance criteria and a study proving the device meets them.

The document is a letter from the FDA stating that the "Creatinine Reagent" device is substantially equivalent to legally marketed predicate devices, and it allows the manufacturer to begin marketing the device. It also includes the "Indications For Use." However, it does not contain any information about specific acceptance criteria (performance metrics), the details of any study that was conducted (sample sizes, data provenance, ground truth establishment, expert qualifications, adjudication methods, or MRMC studies), or standalone algorithm performance.

Therefore, I cannot generate the table or the other requested points based solely on the provided text. The 510(k) summary typically points to a separate document (which is not provided here) that would contain such study details.

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Glucose Reagent is intended for the quantitative determination of serum glucose using the Beckman SYNCHRON CX Clinical Systems. The results are used in the diagnosis and treatment of diabetes mellitus, neonatal and idiopathic hypoglycemia, and of pancreatic islet cell carcinoma.

Not Found

This letter is a 510(k) clearance for the SYNCHRON CX Systems Glucose Reagent (GLU) and does not contain the detailed study information required to fully answer the request. The document states that the device is "substantially equivalent" to predicate devices, but it does not provide acceptance criteria, performance data, or details about the studies conducted. Therefore, I cannot extract the information requested in points 1 through 9.

Here's why some of the specific points cannot be addressed:

• 1. A table of acceptance criteria and the reported device performance: This information is not present. The letter only grants clearance based on substantial equivalence.
• 2. Sample sized used for the test set and the data provenance: Not available in this document.
• 3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not available.
• 4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not available.
• 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 a glucose reagent, not an AI-assisted diagnostic imaging device for human readers. This question is not applicable.
• 6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: As this is a reagent, it functions in conjunction with a laboratory instrument, not as a standalone algorithm in the sense of AI.
• 7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not available.
• 8. The sample size for the training set: Not available. This is a reagent, not typically "trained" in the AI sense.
• 9. How the ground truth for the training set was established: Not available.

To get the requested information, one would need to refer to the original 510(k) submission document (K971467) itself, which would contain the scientific and clinical data supporting the substantial equivalence claim.

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