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The LDL-Cholesterol Gen. 3 assay is an in-vitro test for the quantitative determination of LDL-cholesterol in human serum and plasma on Roche/Hitachi cobas c systems. Lipoprotein measurements are used in the diagnosis and treatment of lipid disorders (such as diabetes mellitus), atherosclerosis, and various liver and renal diseases.

The LDL-Cholesterol Gen. 3 assay is a homogeneous enzyme colorimetric assay which provides the quantitative measurement of LDL-cholesterol in human serum and plasma. Reagents are packaged in a cassette labeled with their instrument positioning R1 (Reagent 1) and R2 (Reagent 2).

R1 contains Bis-trisb) buffer: 20.1 mmol/L, pH 7.0; 4-aminoantipyrine:0.98 mmol/L; ascorbic oxidase (AOD, Acremonium spec.): ≥ 66.7 µkat/L; peroxidase (recombinant from Basidiomycetes): ≥ 166.7 µkat/L; BSA: 4.0 g/L; preservative R2 contains MOPSC) buffer: 20.1 mmol/L, pH 7.0; EMSE: 2.16 mmol/L, cholesterol esterase (Pseudomonas spec.): ≥ 33.3 µkat/L; cholesterol oxidase (recombinant from E.coli)): ≥ 31.7 µkat/L; peroxidase (recombinant from Basidiomycetes): ≥ 333.3 µkat/L; BSA: 4.0 g/L; detergents; preservative

Here's a breakdown of the acceptance criteria and study information for the LDLC3 LDL-Cholesterol Gen.3 device, organized as requested:

Acceptance Criteria and Device Performance Summary

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The Diazyme LDL-Cholesterol Assay is intended for the in vitro quantitative determination of Low Density Lipoprotein Cholesterol in human serum or plasma. The reagents can assist in the diagnosis and treatment of patients at risk of developing coronary heart disease. Elevated LDL cholesterol is the primary target of cholesterol-lowering therapy.

The assay is based on a modified polyvinyl sulfonic acid (PVS) and polyethylene-glycol methyl ether (PEGME) coupled classic precipitation method with the improvements in using optimized quantities of PVS/PEGME and selected detergents. LDL, VLDL. and chylomicron (CM) react with PVS and PEGME and the reaction results in inaccessibility of LDL, VLDL and CM by cholesterol oxidase (CHOD) and cholesterol esterase (CHER), whereas HDL reacts with the enzymes. Addition of R2 containing a specific detergent releases LDL from the PVS/PEGME complex. The released LDL reacts with the enzymes to produce H2O2 which is quantified by the Trinder reaction.

Here's an analysis of the acceptance criteria and study details for the Diazyme LDL-Cholesterol Reagent, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The submission does not explicitly state "acceptance criteria" as distinct, quantifiable thresholds that the device must meet on its own for approval. Instead, the performance of the Diazyme LDL-Cholesterol Reagent is presented and compared primarily to a legally marketed predicate device (Genzyme N-Geneous LDL Cholesterol Reagent, K971573) to demonstrate substantial equivalence. The implication is that performance comparable to the predicate (and within generally accepted clinical laboratory standards for such assays) constitutes the acceptance.

Therefore, the table below reflects the reported performance of the Diazyme device and, for comparison, the predicate device as presented in the submission. The "acceptance criteria" are inferred as comparable performance to the predicate and generally good laboratory practice for quantitative assays.

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

• Sample Size: The document repeatedly mentions "samples tested with Diazyme LDL-Cholesterol Reagent showed good correlation with Genzyme N-geneous LDL Cholesterol Reagent (K971573) with correlation coefficients of 0.996 for serum samples" and refers to "clinical patient samples." However, the exact number of samples used for the method comparison (test set) is not explicitly stated in the provided text.
• Data Provenance: The text does not specify the country of origin of the data. It is implied that the data is retrospective, as it involves "samples tested" and a comparison was made using these samples. The term "clinical patient samples" also suggests that these were real-world samples collected from patients.

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 document. For an in vitro diagnostic reagent like this, the "ground truth" for the test set is established by testing the same samples using a well-established, often reference, method or a legally marketed predicate device. The expertise lies in the laboratory performing the tests and ensuring proper execution, not typically in a panel of experts reviewing the results in the same way as, for example, image-based diagnostics.

In this case, the predicate device (Genzyme N-geneous LDL Cholesterol Reagent) serves as the comparator or "reference" for demonstrating substantial equivalence. The ground truth for the predicate device itself is stated to be traceable to the CDC HDL reference method, which is a highly standardized and rigorous method.

4. Adjudication Method for the Test Set

This is not applicable in the context of this type of quantitative diagnostic assay. Adjudication methods (like 2+1 or 3+1) are typically used in studies involving subjective interpretation, such as image analysis where multiple readers might disagree, and a consensus needs to be formed for the ground truth. Here, the "truth" is a quantitative value obtained from a chemical reaction. The comparison is statistical, between two quantitative results.

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, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study is relevant for AI-powered diagnostic devices, especially in imaging, where human readers interpret results with and without AI assistance. The Diazyme LDL-Cholesterol Reagent is a laboratory reagent for quantitative chemical analysis, not an AI-assisted diagnostic tool that aids human readers.

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

The entire performance evaluation described for the Diazyme LDL-Cholesterol Reagent is a standalone (algorithm/reagent only) performance. The device is a reagent system that produces a quantitative result. There is no "human-in-the-loop" in the interpretation of the final quantitative value (though humans operate the instruments and handle the samples). The accuracy and precision data presented are reflective of the reagent's performance on its own.

7. The Type of Ground Truth Used

The ground truth used for comparison (and thus, implicitly, for evaluating the Diazyme device) is derived from the results obtained from a legally marketed predicate device (Genzyme N-geneous LDL Cholesterol Reagent, K971573). The submission states: "Genzyme N-geneous LDL Cholesterol Reagent (K971573) was selected for comparing serum samples with to the results generated by Diazyme LDL-Cholesterol Reagent." The predicate device itself traces its calibrator to the NIST SRM 1915b and its method to the CDC HDL reference method, indicating a robust underlying ground truth reference.

8. The Sample Size for the Training Set

This information is not applicable and therefore not provided in the document. The Diazyme LDL-Cholesterol Reagent is a chemical reagent assay, not an AI/machine learning model that requires a "training set." Its operating parameters (e.g., reagent concentrations, reaction times) would be optimized during its development process, but this is a different concept from training an algorithm.

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

This information is not applicable as there is no "training set" in the context of this chemical reagent device.

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Teco Direct HDL/LDL Calibrator is used for the calibration of Teco Diagnostics' Direct HDL and Direct LDL Cholesterol Reagent Set in serum or plasma and with Teco Direct HDL Cholesterol Reagent for the quantitative determination of high density lipoprotein cholesterol (HDL-C) in human serum or plasma. HDL quantitative determination is used in identifying patients who are at a higher risk for coronary heart diseases. Low HDL cholesterol levels are associated with an increased risk. This reagent set is intended for in vitro diagnostic use only.

Direct HDL Cholesterol Reagent and Direct HDL/LDL Calibrator

This document is a 510(k) premarket notification for a diagnostic reagent and calibrator (Direct HDL Cholesterol Reagent and Direct HDL/LDL Calibrator). As such, it is not a study document that details acceptance criteria and performance of a device in the way a clinical trial or AI/ML device study would.

Therefore, the requested information elements (1-9) which are typically associated with performance studies of medical devices, especially AI/ML-driven ones, cannot be extracted from this regulatory approval letter.

Instead, this document confirms that the device is "substantially equivalent" to legally marketed predicate devices, which is the basis for its approval. The "Indications for Use" section specifies the intended purpose of the device: "quantitative determination of high-density lipoprotein cholesterol (HDL-C) in human serum or plasma." It also mentions that "Low HDL cholesterol levels are associated with an increased risk" for coronary heart diseases, and the reagent set is intended for "in vitro diagnostic use only."

To provide the kind of detail requested about acceptance criteria and study performance, one would need to refer to the original 510(k) submission document (K050623), which would contain the performance data and equivalence claims against the predicate device. This approval letter references that submission but does not contain the detailed study information itself.

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Raichem Cholesterol Rapid Liquid Reagent may be used with the CANTROL® HDL Cholesterol Precipitating Reagent Tubes to separate and determine HDL cholesterol in serum or EDTA plasma on the Cobas Mira chemistry systems. High-density lipoprotein measurement in conjunction with other lipid determinations has been shown to be useful in assessing the risk of coronary artery disease. For In Vitro Diagnostic Use Only.

Not Found

This is a 510(k) premarket notification for a Class I in vitro diagnostic device, not an AI/ML medical device. Therefore, the questions related to AI/ML device studies, such as acceptance criteria, sample sizes for test/training sets, expert involvement, and ground truth establishment, are not applicable.

The document indicates that the device, "Raichem HDL Cholesterol using Cantrol HDL Precipitating Tubes on the Cobas Mira Analyzer," has been determined to be substantially equivalent to legally marketed predicate devices. This means that the FDA has agreed that the device is as safe and effective as a device already on the market.

Here's a breakdown of the relevant information provided for this specific submission:

1. A table of acceptance criteria and the reported device performance:
   Not applicable in this document. Substantial equivalence for this type of device typically relies on demonstrating comparable performance to a predicate device, as opposed to meeting pre-defined acceptance criteria for novel AI/ML performance metrics.

2. Sample size used for the test set and the data provenance:
   Not applicable in this document. This submission does not detail a clinical study with a "test set" in the context of AI/ML validation data. Performance is likely demonstrated through analytical studies (e.g., accuracy, precision, linearity) comparing the device to a predicate, not through a prospective clinical study using a specified patient sample size.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
   Not applicable. The concept of "ground truth" established by experts for a diagnostic algorithm is not relevant for this Class I lipoprotein test system.

4. Adjudication method for the test set:
   Not applicable.

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 device is an in vitro diagnostic assay, not an AI-powered diagnostic imaging or interpretation tool.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
   Not applicable.

7. The type of ground truth used:
   Not applicable. The performance of this device would be evaluated against established analytical methods and reference standards for HDL cholesterol measurement, not against an "expert consensus" or "pathology" ground truth as understood in AI/ML validation.

8. The sample size for the training set:
   Not applicable. This is not an AI/ML device that requires a training set.

9. How the ground truth for the training set was established:
   Not applicable.

Summary of the K023784 Submission:

• Device Name: Raichem HDL Cholesterol using Cantrol HDL Precipitating Tubes on the Cobas Mira Analyzer
• Indication(s) For Use: To separate and determine HDL cholesterol in serum or EDTA plasma on the Cobas Mira chemistry systems. High-density lipoprotein measurement in conjunction with other lipid determinations has been shown to be useful in assessing the risk of coronary artery disease.
• Regulatory Class: Class I
• Product Code: LBR (Lipoprotein test system)
• Decision: Substantial Equivalence to legally marketed predicate devices.
• Date: December 10, 2002

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For in vitro diagnostic use only.
The VITROS Magnetic HDL-Cholesterol Reagent and VITROS CHOL Slides quantitatively measure HDL cholesterol (HDLC) concentration in serum and plasma.
VITROS Calibrator Kit 2
For in vitro diagnostic use only.
VITROS Calibrator Kit 2 is intended for use in calibration of the VITROS Chemistry Systems for the quantitative measurement of CHOL, Cl-, ECO2, HDLC, K+, Na+, and TRIG.

The VITROS Chemistry Products Magnetic HDL-Cholesterol Reagent and VITROS CHOL Slides (modified) and VITROS Chemistry Products Calibrator Kit 2

The provided 510(k) summary describes a Special 510(k) submission for modifications to existing devices, specifically the VITROS Chemistry Products Magnetic HDL-Cholesterol Reagent and VITROS CHOL Slides, and VITROS Chemistry Products Calibrator Kit 2. The focus of this submission is to demonstrate substantial equivalence to the predicate device, not necessarily to establish new comprehensive performance criteria from scratch.

Therefore, the information available is primarily a comparison against the existing, cleared predicate device rather than presenting entirely new acceptance criteria and a standalone validation study that would typically be detailed for a novel device.

Here's an analysis based on the available text:

Acceptance Criteria and Study to Prove Device Meets Acceptance Criteria

1. Table of Acceptance Criteria and Reported Device Performance

The submission does not explicitly list "acceptance criteria" for the modified device in terms of specific performance metrics (e.g., accuracy, precision targets). Instead, the demonstration of equivalence relies on showing that the modified device performs similarly to the predicate device across relevant characteristics and through comparative studies. The table presented focuses on the differences in device characteristics between the predicate and new device, rather than performance criteria.

However, the "Conclusions" section states: "Equivalence was demonstrated using magnetic HDL-Cholesterol Reagent and manufactured slides along with patient and quality control samples with measured HDL-cholesterol values spanning the assay range." This implies that the de facto acceptance criteria were that the performance characteristics (e.g., accuracy, precision) of the modified device, when measured with patient and QC samples across the assay range, were within acceptable limits of the predicate device's established performance, demonstrating "substantial equivalence."

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

The summary states: "Equivalence was demonstrated using magnetic HDL-Cholesterol Reagent and manufactured slides along with patient and quality control samples with measured HDL-cholesterol values spanning the assay range."

However, specific numerical sample sizes for the test set (number of patient samples, number of QC samples) are not reported in this 510(k) summary.

Data provenance (e.g., country of origin, retrospective/prospective) is not explicitly mentioned. Typically for IVDs, samples would be of human origin, and often from diverse populations to ensure generalizability, but this detail is absent. The study appears to be a laboratory validation study, likely prospective for the purpose of this submission if new lots were manufactured and tested.

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

This is an in vitro diagnostic (IVD) device designed to quantitatively measure a biomarker (HDL-Cholesterol). The "ground truth" for such devices is established by reference methods or comparison to a legally marketed predicate device, as opposed to expert human interpretation of images or clinical assessments.

Therefore, the concept of "experts used to establish ground truth" in the way it applies to imaging AI (e.g., radiologists) is not applicable here. The ground truth would be the actual HDL-Cholesterol concentration as determined by a highly accurate or reference method, against which the device's measurements are compared. The expertise involved would be in clinical chemistry and laboratory professionals performing the reference measurements and statistical analysis.

4. Adjudication Method for the Test Set

As this is an IVD device measuring a quantitative biomarker, an "adjudication method" in the sense of reconciling disagreements between multiple human readers (as in imaging studies) is not applicable. The "adjudication" of results would involve standard laboratory quality control procedures, statistical analysis of agreement between the modified device and the predicate/reference method, and assessment against predefined analytical performance specifications. No specific method beyond general "demonstration of equivalence" is detailed in this summary.

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 question is not applicable as this is an in vitro diagnostic (IVD) device for quantitative measurement of HDL-Cholesterol, not an AI-based imaging diagnostic device assisting human readers.

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

This question is not entirely applicable in the AI sense. This device is a reagent and slide system that, when used with an analyzer (VITROS 250, 550, 750, and 950 Series Analyzers), quantitatively measures HDL-Cholesterol. The "standalone" performance is the device's ability to accurately measure the analyte. The study demonstrated the performance of the modified reagent/slides with the analyzer systems, demonstrating equivalence to the predicate. There isn't a separate "human-in-the-loop" component in the direct measurement process of this type of IVD, beyond a laboratory technician operating the instrument and interpreting the numerical output.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)

For this IVD device, the "ground truth" would implicitly be the measured HDL-Cholesterol values obtained from the predicate device (K984303) or potentially a recognized reference method, as indicated by the statement: "Equivalence was demonstrated... along with patient and quality control samples with measured HDL-cholesterol values spanning the assay range." This implies a comparison against established, presumably accurate, values.

8. The Sample Size for the Training Set

This type of device (reagents and slides for chemical measurement) does not typically involve a "training set" in the machine learning/AI sense. Its performance is based on the chemical reactions and optical measurement principles. The development and optimization of the reagent formulation might involve experimental testing, but it's not a "training set" for an algorithm. Therefore, this information is not provided.

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

Since there is no "training set" in the AI sense for this IVD device, this question is not applicable.

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The ATAC Direct HDL Cholesterol Reagent Kit and the ATAC HDL-C Calibrator are intended for the quantitative determination of high density lipoprotein cholesterol in serum on the ATAC 6000 Chemistry Analyzer. HDL-cholesterol results are used in the diagnosis and treatment of lipid disorders and various liver and renal diseases, and as a tool to assess the risk of developing and managing the progression of cardiovascular disease.

The ATAC Direct HDL Cholesterol Reagent determines HDL-cholesterol through the enzymatic action of cholesterol esterase, cholesterol oxidase and peroxidase after the selective removal non-HDL sources of cholesterol. The resulting increase in absorbance at 578 nm is proportional to the HDL cholesterol concentration in the sample.

Acceptance Criteria and Device Performance for ATAC Direct HDL Cholesterol Reagent Kit and ATAC HDL-C Calibrator

The ATAC Direct HDL Cholesterol Reagent Kit and ATAC HDL-C Calibrator are intended for the quantitative determination of high-density lipoprotein cholesterol (HDL-C) in serum on the ATAC 6000 Chemistry Analyzer. HDL-C results are used in the diagnosis and treatment of lipid disorders, atherosclerosis, and various liver and renal diseases, and as a tool to assess the risk of developing and managing the progression of cardiovascular disease.

1. Table of Acceptance Criteria and Reported Device Performance

• Serum 1 (mean 35.4 mg/dL): 1SD = 0.84, %CV = 2.4%
• Serum 2 (mean 45.1 mg/dL): 1SD = 0.89, %CV = 2.0%
  Total:
• Serum 1 (mean 32.7 mg/dL): 1SD = 2.47, %CV = 7.6%
• Serum 2 (mean 45.1 mg/dL): 1SD = 3.30, %CV = 7.3% |
  | Method Comparison | Strong correlation with an accepted clinical method. | y = - 2.4 mg/dL + 1.077x (where y = ATAC 6000 results, x = accepted clinical method). Correlation coefficient (r) = 0.962. |
  | Detection Limit | Claimed detection limit of 2 mg/dL should be met or exceeded by observed detection limit. | Observed detection limit = 1.3 mg/dL. This is below the claimed limit of 2 mg/dL, indicating the device meets the criterion. |

2. Sample Sizes and Data Provenance

• Test Set (Method Comparison): 131 serum specimens.
  • Data Provenance: The specimens were collected from adult patients. The country of origin is not explicitly stated, but the submission is from Elan Diagnostics in Brea, California, USA, suggesting the data is likely from the USA. The study design appears to be prospective due to the nature of comparing a new device against an existing method using collected specimens, though the exact timing of collection relative to the study is not specified in detail.
• Test Set (Linearity): 8 linearity standards.
• Test Set (Precision - Within Run): 22 replicates for each of 2 control sera.
• Test Set (Precision - Total): 40 replicates for each of 2 control sera.
• Test Set (Detection Limit): 22 replicates of a diluted HDL-C control.

3. Number of Experts and Qualifications for Ground Truth

Not applicable for this type of in vitro diagnostic device study. The ground truth for chemical analytes like HDL-C is established through reference methods or precisely prepared standards, not typically through human expert consensus in the same way an imaging or clinical diagnostic algorithm would be.

4. Adjudication Method for the Test Set

Not applicable. As described above, the ground truth for these studies relies on analytical measurements rather than expert human interpretation requiring adjudication.

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

No, an MRMC comparative effectiveness study was not done. This type of study is primarily relevant for diagnostic imaging or interpretation tasks where human readers' performance is being evaluated and potentially enhanced by AI. This submission is for an in vitro diagnostic reagent kit.

6. Standalone Performance Study

Yes, the studies described represent the standalone performance of the ATAC Direct HDL Cholesterol Reagent Kit and ATAC HDL-C Calibrator when used on the ATAC 6000 Chemistry Analyzer. The reported linearity, precision, and detection limit are intrinsic performance characteristics of the assay and the analyzer system. The method comparison study also evaluates the algorithm (reagent kit + analyzer) performance against an established clinical method.

7. Type of Ground Truth Used

• Linearity: Based on "standard values" of linearity standards, which are known, precise concentrations.
• Precision: Based on the measured values of "commercially available control sera" at different concentration levels, where the 'true' value is often derived from extensive inter-laboratory studies or established reference values.
• Method Comparison: The "accepted clinical method" serves as the reference or 'gold standard' for comparison.
• Detection Limit: Derived from repetitive assay of a "diluted HDL-C control" with a known low concentration.

8. Sample Size for the Training Set

The document does not explicitly mention a separate "training set" in the context of an algorithm or machine learning model. This is an in vitro diagnostic (IVD) reagent kit, where the "training" is more akin to assay development and optimization rather than machine learning. The studies described are performance studies demonstrating the final product's characteristics.

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

As noted above, a distinct "training set" with ground truth in the conventional machine learning sense is not applicable here. The development and optimization of the reagent kit would involve formulating the reagent to achieve specific chemical reactions and analytical performance characteristics, which is guided by established chemical principles and perhaps empirical testing against known standards and samples, rather than a formal machine learning training process with a labeled dataset.

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This product is to be used in a diagnostic laboratory setting, by qualified laboratory technologists, for the quantitative determination of high density lipoprotein (HDL) cholesterol in serum or plasma. HDL cholesterol is recognized as a useful tool in identifying patients who are at a higher risk for coronary heart disease. Low HDL cholesterol levels are associated with an increased risk. This reagent set is intended for in vitro diagnostic use only.

Not Found

This document is a 510(k) clearance letter for the autoHDL™ Cholesterol Reagent Set, which is an in vitro diagnostic device. The letter establishes its substantial equivalence to a legally marketed predicate device. As such, it does not contain the specific technical acceptance criteria or the study details that would typically be found in a performance study report for a novel medical device.

Therefore, many of the requested details about acceptance criteria and study design are not available in the provided text.

Based on the provided text, here's what can be extracted and what information is missing:

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

   • Not Available. The letter grants clearance based on substantial equivalence, implying that the device performance and characteristics are comparable to a predicate device, but it does not detail specific acceptance criteria or performance metrics (like accuracy, precision, linearity, etc.) for the autoHDL™ Cholesterol Reagent Set.

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

   • Not Available. The letter does not describe any specific test sets or studies performed with the autoHDL™ Cholesterol Reagent Set.

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 Available. This device is an in vitro diagnostic reagent set. Ground truth for such devices is typically established through reference methods or certified control materials, not expert consensus on images. The document does not provide details on how the performance was verified.

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

   • Not Applicable / Not Available. Adjudication methods like 2+1 or 3+1 are typically used in imaging studies where subjective interpretation is involved. This is not relevant for an in vitro diagnostic device.

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 Available. MRMC studies are not relevant for this type of in vitro diagnostic reagent. This device is not an AI-assisted diagnostic tool that would involve human reader improvement.

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

   • Not Applicable. This is an in vitro diagnostic reagent, not an algorithm.

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

   • Not Available from the document. For an in vitro diagnostic, ground truth for performance studies typically involves comparison to a recognized reference method or use of certified reference materials with known analyte concentrations. The letter does not specify this.

8. The sample size for the training set:

   • Not Applicable. This is a chemical reagent set, not a machine learning algorithm that requires a "training set."

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

   • Not Applicable. As above, no training set for a machine learning model is involved.

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The ATAC-PAK Direct HDL Cholesterol Reagent Kit, the ATAC HDL-C Calibrator and the ATAC 8000 Random Access Chemistry System are intended for use as a system for the quantitative determination of high density in serum. HDL-cholesterol results are used in the diagnosis and treatment of lipid disorders, atherosclerosis and various liver and renal diseases, and as a tool to assess the risk of developing and managing the progression of cardiovascular disease. This reagent is intended to be used by trained personnel in a professional setting and is not intended for home use.

The ATAC-PAK Direct HDL Cholesterol Reagent Kit, the ATAC HDL-C Calibrator and the ATAC 8000 Random Access Chemistry System are used as a system for the quantitative analysis of high density lipoprotein cholesterol (HDL-C) in serum. HDL-cholesterol results are used in the diagnosis and treatment of lipid disorders and various liver and renal diseases, and as a tool to assess the risk of developing and managing the progression of cardiovascular disease. The ATAC-PAK Direct HDL Cholesterol Reagent determines HDL-cholesterol through the enzymatic action of cholesterol esterase, cholesterol oxidase and peroxidase after the selective removal non-HDL sources of cholesterol. The resulting increase in absorbance at 578 nm is proportional to the HDL cholesterol concentration in the sample.

Here's a breakdown of the acceptance criteria and study information for the ATAC-PAK Direct HDL Cholesterol Reagent Kit, ATAC HDL-C Calibrator, and ATAC 8000 Random Access Chemistry System:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Linearity/Recovery: Regression statistics were based on standard recoveries ranging from 0.6 to 155.5 mg/dL. The number of unique standards is not explicitly stated, but di = 8 is mentioned, which often refers to the degrees of freedom in a regression, suggesting at least 9 data points.
• Precision:
  • Serum control 1: n = 40 (replicates)
  • Serum control 2: n = 40 (replicates)
• Method Comparison: One hundred and thirty-eight (n = 138) serum specimens.
• Detection Limit: 22 replicates were used for the within-run precision study to calculate the observed detection limit.
• Reagent and Calibration Stability: Not explicitly stated, but involved assays of "serum controls over the claimed periods."

Data Provenance:
The data provenance is not explicitly stated in terms of country of origin. The specimens for method comparison were "collected from adult patients," suggesting the data is retrospective as samples would have been collected prior to the study.

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

Not applicable for this type of device. This device is an in-vitro diagnostic (IVD) quantitative assay, where the "ground truth" is typically established by comparing its results to a validated reference method or known concentrations of analytes (standards/calibrators). There are no human "experts" establishing qualitative ground truth for diagnostic images or interpretations.

4. Adjudication Method for the Test Set

Not applicable. As noted above, this device is a quantitative assay, not one requiring expert adjudication of results.

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

No. This is a standalone in-vitro diagnostic device, not an imaging device or medical AI intended for human reader assistance.

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

Yes, the studies presented are all standalone performance evaluations of the ATAC-PAK Direct HDL Cholesterol Reagent Kit and ATAC HDL-C Calibrator when used on the ATAC 8000 Random Access Chemistry System. The device performs the quantitative analysis automatically.

7. The Type of Ground Truth Used

• Linearity/Recovery: Known concentrations of linearity standards.
• Precision: Commercially available control sera with established target values.
• Method Comparison: Results from an "accepted clinical method" as the reference for comparison. While not explicitly defined, an "accepted clinical method" implies a well-established and validated laboratory method for HDL-C measurement.
• Detection Limit: A diluted HDL-C control and the statistical calculation based on its variability.
• Stability: Serum controls with known properties over time.

8. The Sample Size for the Training Set

Not applicable. This device is a chemical reagent kit and an associated analyzer, not a machine learning or AI algorithm that requires a "training set" in the conventional sense. The "training" for such a system would involve method development and optimization by the manufacturer to achieve the stated performance specifications.

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

Not applicable, as there is no "training set" in the context of an AI/ML algorithm. The "ground truth" for the development of the reagent and system would have been established through extensive chemical and analytical testing against reference materials and methods during its design and optimization phases.

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The MTM BioScanner HDL Test Strip is intended for the in-vitro-diagnostic quantitation of HDL Cholesterol in whole blood when used with the MTM BioScanner 1000. This system is intended to be used to assist the healthcare professional in screening for decreased levels of HDL Cholesterol as a risk factor in coronary artery disease.

Not Found

The provided text is a 510(k) clearance letter from the FDA for the MTM BioScanner HDL Test Strips. This type of document declares that a new medical device is "substantially equivalent" to an existing legally marketed device. It acknowledges the device's acceptable performance, but it does not contain the detailed study results, acceptance criteria, or ground truth information that you are requesting.

Therefore, I cannot fulfill your request for the specific details regarding acceptance criteria, reported performance, sample sizes, expert qualifications, adjudication methods, or ground truth establishment based on the provided text. This information would typically be found in the manufacturer's 510(k) submission document itself, which is not included here.

The document only states the device's intended use:
Indications for Use: The MTM BioScanner HDL Test Strip is intended for the in-vitro-diagnostic quantitation of HDL Cholesterol in whole blood when used with the MTM BioScanner 1000. This system is intended to be used to assist the healthcare professional in screening for decreased levels of HDL Cholesterol as a risk factor in coronary artery disease.

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For in vitro diagnostic use only. The VITROS Magnetic HDL reagent and VITROS Cholesterol slides quantitatively measure HDL-cholesterol (HDLC) in serum and plasma.

Not Found

I am sorry, but based on the provided text, I cannot provide the requested information. The document is a 510(k) clearance letter from the FDA for a medical device (VITROS Chemistry Products Magnetic HDL Cholesterol Reagents and VITROS Chemistry Products Calibrator Kit 2).

This type of document confirms that the FDA has found the device to be substantially equivalent to a legally marketed predicate device. It does not typically contain:

• Details about specific acceptance criteria and detailed device performance studies.
• Information on sample sizes for test sets, data provenance, number or qualifications of experts for ground truth, or adjudication methods.
• Results of multi-reader multi-case (MRMC) comparative effectiveness studies or standalone algorithm performance studies.
• Specifics about the type of ground truth used or the sample size and ground truth establishment for a training set.

The document primarily focuses on the regulatory clearance for the device's market entry based on substantial equivalence, rather than a detailed technical report of the studies performed to validate its performance against specific acceptance criteria.

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