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ST AIA-PACK CEA is designed for IN VITRO DIAGNOSTIC USE ONLY for the quantitative measurement of Carcinoembryonic Antigen (CEA) in human serum to aid in the management of cancer patients in whom changing concentrations of CEA are observed on specific TOSOH AIA System Analyzers.

The ST AIA-PACK CEA is a two-site immunoenzymometric assay which is performed entirely in the AIA-PACK. CEA present in the test sample is bound with monoclonal antibody immobilized on a magnetic solid phase and enzyme-labeled monoclonal antibody in the AJA-PACK. The magnetic beads are washed to remove unbound enzyme-labeled monoclonal antibody and are then incubated with a fluorogenic substrate, 4-methylumbelliferyl phosphate (4MUP). The amount of enzyme-labeled monoclonal antibody that binds to the beads is directly proportional to the CEA concentration in the test sample. A standard curve is constructed, and unknown sample concentrations are calculated using this curve.

The provided text is a 510(k) summary for the ST AIA-PACK CEA device. This type of document focuses on establishing substantial equivalence to a predicate device for regulatory clearance, rather than presenting a detailed study proving the device meets specific acceptance criteria in the way a clinical trial report would.

Therefore, much of the requested information (acceptance criteria table, sample sizes, ground truth establishment, expert qualifications, adjudication methods, MRMC studies, standalone performance details) is not available in the provided text.

Based on the available information, here's what can be extracted:

1. Table of acceptance criteria and the reported device performance

The document does not specify quantitative acceptance criteria. Instead, it relies on the concept of "substantial equivalence" to a predicate device.

2. Sample sized used for the test set and the data provenance

• Sample size for test set: Not mentioned.
• Data provenance: Not mentioned. The document states "performance characteristics of both assays are equivalent," implying that the original predicate device's performance data is being referenced, but no new test set data is provided for the modified device.

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

Not applicable. The document does not describe a new study with a test set requiring expert ground truth establishment.

4. Adjudication method for the test set

Not applicable. No new test set data is described.

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 immunoassay for quantitative measurement of CEA, not an AI-assisted diagnostic imaging or interpretation device that would involve human readers.

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

This refers to the performance of the immunoassay itself. The document explicitly states: "The performance characteristics of both assays are equivalent." This implies that the standalone performance of the modified device is considered equivalent to the previously cleared predicate device (Tosoh AIA-PACK CEA, P910053). Specific new standalone performance data for the modified device is not provided in this summary.

7. The type of ground truth used

The concept of "ground truth" as typically used in AI/diagnostic imaging studies (e.g., pathology, outcomes data) is not directly applicable here. For an immunoassay, the "ground truth" would be the true concentration of CEA in a sample, established through highly accurate reference methods or certified reference materials during the development and validation of the original predicate device. The current document asserts equivalence in performance characteristics.

8. The sample size for the training set

Not applicable. This is not an AI/machine learning device that requires a training set.

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

Not applicable. This is not an AI/machine learning device.

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ST AIA-PACK Testosterone is intended for IN VITRO DIAGNOSTIC USE ONLY for the quantitative measurement of testosterone in human serum on specific TOSOH AIA System analyzers. Measurement of testosterone is used to aid in the diagnosis and management of conditions involving excess or deficiency of this androgen. This device is intended "For Professional Use" only.

The ST AIA-PACK Testosterone is a competitive immunoenzymometric assay which is performed entirely in the AIA-PACK. Testosterone present in the test sample competes with enzyme-labeled testosterone for a limited number of binding sites on a testosterone-specific monoclonal antibody, immobilized on a magnetic solid phase. The magnetic beads are washed to remove urbound enzyme-labeled testosterone and are then incubated with a fluorogenic substrate, 4methylumbelliferyl phosphate (4MUP). The amount of enzyme-labeled testosterone that binds to the beads is inversely proportional to the testosterone concentration in the test sample. A standard curve is constructed, and unknown sample concentrations are calculated using this curve.

Here's a breakdown of the acceptance criteria and study information for the ST AIA-PACK Testosterone device, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document doesn't explicitly state "acceptance criteria" in a numerical or categorical format for specific metrics. Instead, it presents performance characteristics and compares them to a predicate device to establish substantial equivalence.

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

• Sample Size: 71 serum samples
• Data Provenance: Not explicitly stated, but given the context of a 510(k) submission to the FDA, it is highly likely that the data was collected in a prospective manner for the purpose of demonstrating device performance. The country of origin for the data is also not specified.

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

This type of information is not applicable to this submission. The "ground truth" for a quantitative diagnostic assay like this is typically established by the results of a validated reference method (in this case, the predicate device, DPC Coat-A-Count Total Testosterone assay) or a highly accurate laboratory standard, rather than expert consensus on interpretive tasks.

4. Adjudication Method for the Test Set

This is not applicable. Adjudication methods (like 2+1 or 3+1) are common in studies involving human interpretation (e.g., imaging studies) where there might be disagreement among experts. For a quantitative assay, the "adjudication" is inherent in the direct measurement and comparison to a reference.

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

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This type of study is relevant for devices that assist human readers in making interpretations, such as medical imaging AI. The ST AIA-PACK Testosterone is a standalone quantitative assay device.

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

Yes, a standalone study was done. The entire comparative analysis and performance characteristics (precision, recovery) described are for the ST AIA-PACK Testosterone assay functioning as a standalone device, directly measuring testosterone in serum. There is no human interpretative component that the device assists.

7. The Type of Ground Truth Used

The ground truth was established by comparison to a predicate device, the DPC Coat-A-Count Total Testosterone assay. This technically represents a "comparative ground truth" where the reference standard is another legally marketed and accepted diagnostic test, rather than a gold standard like pathology or long-term outcomes data.

8. The Sample Size for the Training Set

The document does not specify a separate training set. For in vitro diagnostic assays, especially those based on immunoassay principles, the development and optimization (which could be considered analogous to "training") typically involve iterative design, reagent formulation, and analytical validation experiments using characterized samples, but not necessarily a distinct "training set" in the machine learning sense. The 71 serum samples mentioned are for the comparative analysis (test set) against the predicate.

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

Since a distinct "training set" is not explicitly mentioned in the context of this 510(k) summary, the method for establishing its "ground truth" is not available in the provided text. The development of the assay itself would have relied on established biochemical principles and extensive internal validation to ensure accuracy and precision, using well-characterized calibrators and controls.

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ST AIA-PACK AFP is designed for IN VITRO DIAGNOSTIC USE ONLY for the quantitative measurement of Alpha-Fetoprotein (AFP) in serum to aid in the management of patients with nonseminomatous testicular carcinoma.

The ST AIA-PACK AFP is a two-site immunoenzymometric assay which is performed entirely in the AIA-PACK. AFP present in the test sample is bound with monoclonal antibody immobilized on a magnetic solid phase and enzyme-labeled monoclonal antibody in the AIA-PACK. The magnetic beads are washed to remove unbound enzyme-labeled monoclonal antibody and are then incubated with a fluorogenic substrate, 4-methylumbelliferyl phosphate (4MUP). The amount of enzyme-labeled monoclonal antibody that binds to the beads is directly proportional to the AFP concentration in the test sample. A standard curve is constructed, and unknown sample concentrations are calculated using this curve.

The provided text is a 510(k) summary for the ST AIA-PACK AFP device, which is an in vitro diagnostic for measuring Alpha-Fetoprotein (AFP) in human serum. This submission is a "Special 510(k)" for a modification to an already cleared device (P910006).

Based on the information provided in the document, here's an analysis 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 states: "This Special 510(k) is for a modification in the packaging, incubation period and certain components of the conjugate diluent of the AIA-PACK AFP, which was previously cleared as P910006 on December 18, 1992. The intended use, assay principles, antibody type, analyte detected, and performance characteristics of both assays are equivalent."

This statement implies that the acceptance criteria for the modified device are the same as those established for the original P910006 device and that the modified device's performance is equivalent to the predicate. However, the document does not explicitly list the acceptance criteria (e.g., specific thresholds for accuracy, precision, linearity, etc.) or detailed reported performance data for the ST AIA-PACK AFP itself. Instead, it relies on the predicate device's established performance.

To construct a table, we would need the original 510(k) (P910006) which is not provided, but based on the text, the performance "acceptance criteria" are implicitly met if the performance is "equivalent" to the predicate.

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

The document does not provide details on a specific "test set" and its sample size for the modified device. The submission relies on the concept of "substantial equivalence" to the predicate device P910006. The modifications are in "packaging, incubation period and certain components of the conjugate diluent." The implication is that these changes were not substantial enough to require a new, comprehensive clinical performance study to establish new performance criteria. Therefore, no specific sample size for a new test set is mentioned.

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 section is not applicable to the provided document. The device is an in vitro diagnostic for quantitative measurement of AFP in serum, not one that requires expert interpretation of images or other subjective data for ground truth establishment. The ground truth for such devices is typically established through reference methods or highly characterized calibrators, not human expert consensus, especially for a 510(k) modification where performance is asserted to be equivalent to a predicate.

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

This is not applicable for the same reasons as point 3. Adjudication methods like 2+1 or 3+1 are typically used in studies involving subjective human interpretation (e.g., radiology reads) where discrepancies between readers need resolution. For an in vitro diagnostic, performance is usually measured quantitatively against a reference, not through multi-reader adjudication.

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 not applicable. The device is an in vitro diagnostic for measuring AFP, not an AI-assisted diagnostic tool that aids human readers. Therefore, an MRMC study or assessment of AI assistance is irrelevant to this submission.

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

The device itself is a standalone immunoassay kit used on a specific analyzer (TOSOH AIA System analyzers). It operates as an "algorithm only" in the sense that the instrument performs the assay and calculates results without human intervention in the result determination phase. However, the document does not detail specific "standalone performance studies" beyond stating equivalence to the predicate. The "performance characteristics of both assays are equivalent" implies that the standalone performance metrics (e.g., precision, accuracy, sensitivity, specificity, linearity, etc.) were demonstrated to be similar to the predicate device, but these specific studies or their results are not presented in this summary.

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

For an in vitro diagnostic assay like this, the "ground truth" for validation studies (which led to the original P910006 clearance) would typically be established using:

• Reference materials/calibrators: Samples with known, accurately determined concentrations of AFP.
• Reference laboratory methods: Comparison with established, validated methods for AFP measurement.
• Clinical correlation: While not a direct "ground truth" for analytical performance, clinical utility is supported by correlation with disease status (e.g., in patients with nonseminomatous testicular carcinoma), often confirmed by pathology or clinical follow-up.

However, for this specific 510(k) modification, the document does not describe new ground truth establishment. It relies on the previously established ground truth for the predicate device, asserting that the modifications do not change the fundamental performance.

8. The sample size for the training set

This is not applicable. Immunoassays like the ST AIA-PACK AFP are not "trained" in the machine learning sense. Their performance is inherent in their biochemical design (antibodies, reagents, protocol). Therefore, there is no "training set" as understood in AI/ML contexts.

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

This is not applicable for the same reasons as point 8.

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ST AIA-PACK CA 125 is designed for IN VITRO DIAGNOSTIC USE ONLY for the quantitative measurement of CA 125 in human serum on specific TOSOH AIA System analyzers. ST AIA-PACK CA 125 is to be used as an aid in monitoring response to therapy for patients with epithelial ovarian cancer. Serial testing for patient CA 125 assay values should be used in conjunction with other clinical methods used for monitoring ovarian cancer.

The ST AIA-PACK CA 125 is a two-site immunoenzymometric assay which is performed entirely in the AIA-PACK. CA 125 present in the test sample is bound with monoclonal antibody immobilized on a magnetic solid phase and enzyme-labeled monoclonal antibody in the AIA-PACK. The magnetic beads are washed to remove unbound enzyme-labeled monoclonal antibody and are then incubated with a fluorogenic substrate, 4-methylumbellifery| phosphate (4MUP). The amount of enzyme-labeled monoclonal antibody that binds to the beads is directly proportional to the CA 125 concentration in the test sample. A standard curve is constructed, and unknown sample concentrations are calculated using this curve.

The provided document is a 510(k) summary for the ST AIA-PACK CA 125 device, which is an in vitro diagnostic assay. It primarily describes the device, its intended use, and its substantial equivalence to a predicate device.

Crucially, this document does NOT contain information about acceptance criteria or a study proving the device meets those criteria, as typically found in clinical validation studies.

The 510(k) is for a modification to an already cleared device (K990431), specifically concerning changes in packaging and incubation period. The submission argues that these modifications "are not substantial changes and do not affect the safety and effectiveness of the device." Therefore, it likely relies on the performance data of the original predicate device rather than presenting new, detailed performance studies for clinical acceptance criteria.

Without this information, I cannot complete the table or answer the specific questions thoroughly. However, I can infer some general aspects from the document’s purpose.

Here's an attempt to answer based on the lack of information in the provided text and what a 510(k) generally entails:

1. Table of Acceptance Criteria and Reported Device Performance

(This information is not explicitly provided in the document. A 510(k) summary for a modification often refers to the performance of the predicate device rather than presenting new data. For a full new device clearance, such data would be expected.)

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

• Sample Size: Not specified.
• Data Provenance: Not specified. Given it's a 510(k) for a modification (packaging and incubation period) and refers to "substantial equivalence" to a predicate, it's highly probable that new clinical test sets were not used. The focus is on demonstrating that the modification does not alter the established performance of the predicate device.

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

• Number of Experts: Not applicable/not specified. For an in vitro diagnostic (IVD) assay like this, "ground truth" typically refers to the analytical performance (e.g., accuracy against a reference method or established clinical cut-offs), not expert consensus on images or clinical diagnoses for a test set.
• Qualifications of Experts: N/A.

4. Adjudication method for the test set

• Adjudication Method: Not applicable/not specified. This method is usually relevant for human-interpreted data (e.g., radiology reads) where discrepancies between reviewers need to be resolved. For an automated IVD assay, the 'judgment' is algorithmic based on predefined analytical parameters.

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

• MRMC Study: No. This is an IVD assay measuring a biomarker (CA 125), not an imaging device or AI-assisted diagnostic tool that involves human interpretation.

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

• Standalone Performance Study: The device is a standalone diagnostic assay (an immunoenzymometric assay). Its performance is evaluated analytically (accuracy, precision, etc.) and its use is "as an aid in monitoring response to therapy." The document implies that the performance characteristics (which would have been established for the predicate device) remain unchanged with the modification. However, specific standalone performance study results for the modified device are not provided in this summary.

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

• Type of Ground Truth: Not specified in this document. For a CA 125 assay, the "ground truth" for analytical performance studies typically involves:
  • Reference materials/calibrators: Samples with known concentrations of CA 125 for accuracy and linearity.
  • Patient samples: Often used in method comparison studies against a legally marketed predicate device or a gold standard method.
  • Clinical correlation: Evaluating the assay's ability to monitor therapeutic response in patients with ovarian cancer, often in conjunction with other clinical methods and patient outcomes.

8. The sample size for the training set

• Sample Size for Training Set: Not applicable/not specified. As an immunoenzymometric assay, it is not an AI/machine learning model that requires a "training set" in the conventional sense. The assay works based on established biochemical principles and reagents.

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

• Ground Truth for Training Set: Not applicable. (See answer to #8). The device's operational parameters (e.g., standard curve construction) are established through a calibration process, not "training" with a labeled dataset.

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The G7 Automated HPLC Analyzer: Beta-thalassemia Mode is intended for IN VITRO DIAGNOSTIC USE ONLY for the separation and area percent determinations of hemoglobins A2 and F and as an aid in the detection and presumptive identification of abnormal hemoglobins in whole blood using ion-exchange high performance liquid chromatography (HPLC).

The G7 Automated HPLC Analyzer: Beta-thalassemia Mode reagents and software are intended only for use on the Tosoh G7 Automated HPLC Analyzer.

The G7 Automated HPLC Analyzer - Beta-thalassemia Mode is an automated High Performance Liquid Chromatography (HPLC) system that separates and reports HbF and HbA2 quantitative percentages in whole blood. A chromatographic tracing of the hemoglobin products found in the sample is also produced which allows for the comparison of an individual chromatogram with standard patterns of known composition. The operational portion of the G7 Beta-thalassemia Mode is composed of a sampling unit, liquid pump, degasser, detector, microprocessors, sample loader, floppy disk drive unit, operational panel and a printer all of which have already been cleared by the FDA (K011434). The reagents and software program specific to the Beta-thalassemia Mode consist of calibrators, elution buffers, column and software only.

The G7 Automated HPLC System - Beta-thalassemia Mode uses a cation exchange column and separates the hemoglobin in the blood into fractions. The separation is accomplished by eluting the hemoglobins from the column with a gradient of three elution buffers containing increasing salt concentrations. The resulting report is printed out on the on-board printer and can be stored on a floppy disk in the on-board floppy disk drive. The data can also be transmitted to a host computer through the RS232 port. The result report includes a sample ID, date, time, area percentages and retention time in minutes of each individual peak detected. Peaks that meet the retention time "windows" pre-set in the software are labeled as F, A0, A2, D+, S+, C+. All others are designated in order of appearance as PXX and are listed in order of appearance.

All automated processes in the G7 Beta-thalassemia Mode are controlled by internal microprocessors using software downloaded via the on-board floppy disk drive.

The Tosoh G7 Automated HPLC Analyzer: Beta-thalassemia Mode is intended for in vitro diagnostic use for the separation and area percent determinations of hemoglobins A2 and F, and as an aid in detecting and presumptively identifying abnormal hemoglobins in whole blood using ion-exchange high-performance liquid chromatography (HPLC).

Here’s a breakdown of the acceptance criteria and the study proving the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are implied by the comparison to predicate devices, where the device's performance (correlation, imprecision) should be comparable to or better than the predicate.

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

• Quantitative HbA2 Test Set:
  • Sample Size: 75 patient specimens.
  • Data Provenance: Not explicitly stated, but "Patient specimens were analyzed" suggests clinical samples. The type of study (retrospective/prospective) is not specified, but typically, these comparative studies are conducted prospectively or using archived clinical samples.
• Quantitative HbF Test Set:
  • Sample Size: 57 patient specimens.
  • Data Provenance: Not explicitly stated, but "Patient specimens were analyzed" suggests clinical samples. The type of study is not specified.
• Qualitative Hemoglobin Identification Test Set:
  • Sample Size: 155 total comparisons (patient whole blood samples).
  • Data Provenance: Whole blood from patients "suspected of having hemoglobinopathies" were tested. This suggests clinical samples with a range of conditions. The type of study is not specified.

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

The ground truth for the test set was not established by human experts in the traditional sense. Instead, it was established by predicate devices that are already commercially available and considered legally marketed for their respective intended uses.

• For quantitative HbA2, the predicate device was Helena Laboratories' Beta-Thal HbA2 Quik Column™.
• For quantitative HbF, the predicate device was Bio-Rad Laboratories VARIANT™ BETA-THALASSEMIA SHORT PROGRAM.
• For qualitative hemoglobin identification, the predicate device was Beckman Paragon® Hemoglobin Electrophoresis.

4. Adjudication Method for the Test Set

There was no human "adjudication method" in the context of resolving disagreements between multiple human readers. The comparison was directly between the Tosoh G7 device and the predicate laboratory devices. The "ground truth" for each sample was implicitly determined by the result from the predicate device (or in the case of qualitative identification, agreement with the predicate result).

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 MRMC comparative effectiveness study was done. This device is an automated in vitro diagnostic analyzer, not an AI-assisted diagnostic tool designed to improve human reader performance. The study focuses on the device's analytical performance compared to established laboratory methods.

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

Yes, a standalone performance study was done. The G7 Automated HPLC Analyzer: Beta-thalassemia Mode operated as an algorithm-only device (i.e., automated instrument) to process samples and generate results, which were then compared against established predicate devices. There is no human interaction described as part of its performance in these studies, only in the interpretation of its results.

7. The Type of Ground Truth Used (Expert Consensus, Pathology, Outcomes Data, etc.)

The ground truth for the performance studies was based on results obtained from legally marketed predicate laboratory devices. These predicate devices represent established and accepted methods for measuring HbA2, HbF, and identifying abnormal hemoglobins.

8. The Sample Size for the Training Set

The document does not provide information about a "training set" for the device's software or analytical methods. This is a traditional in vitro diagnostic device, not a machine learning or AI algorithm that typically goes through a distinct training phase with a labeled dataset. The instrument and its software, including elution protocols and peak "windows," are developed and validated by the manufacturer internally, but a dedicated "training set" in the AI sense is not usually disclosed or relevant for such devices in an FDA submission of this nature.

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

As noted above, a "training set" in the context of, for example, a machine learning model is not applicable here. The ground truth for the development and internal validation of the instrument's operational parameters (e.g., software "windows" for hemoglobin components) would have been established through extensive analytical testing by the manufacturer, likely using characterized samples and reference methods. However, the details of this internal development and validation are not part of this 510(k) summary, which focuses on the comparative study for substantial equivalence.

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AIA-PACK cTnl 2nd-Gen is designated for IN VITRO DIAGNOSTIC USE ONLY for the quantitative measurement of cardiac troponin I (cTnl) in human heparinized plasma on specific TOSOH AIA System analyzers. Cardiac troponin I measurements are used as an aid in the diagnosis of acute myocardial infarction (AMI).

Not Found

This document is a 510(k) premarket notification decision letter from the FDA for an in-vitro diagnostic device, the AIA-PACK® cTNI 2nd Gen Troponin I Assay. It states that the device is substantially equivalent to legally marketed predicate devices.

However, the provided text does not contain any information about acceptance criteria, device performance studies, sample sizes, ground truth establishment, or expert reviews as requested in your prompt. This type of information is typically found in the 510(k) summary or the full submission, which is not included here. The letter only confirms the FDA's decision to allow the device to be marketed.

Therefore, I cannot fulfill your request for the specific details of acceptance criteria and study design based solely on the provided FDA letter.

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The G7 Automated HPLC Analyzer is a high pressure liquid chromatography system intended for IN VITRO DIAGNOSTIC USE ONLY. Glycosylated system intended for wents obtained by this device are used in the management and treatment of diabetes.

The G7 Automated HPLC Analyzer: HbA1c Variant Analysis Mode is an automated High Performance Liquid Chromatography (HPLC) system that separates and reports stable A1c (SA1c) percentage in whole blood. The operational portion of the HPLC G7 is composed of a sampling unit, liquid pump, degasser, column, detector, microprocessors, sample loader, floppy disk drive unit, operation panel and a printer.

The G7 uses a cation exchange column and separates the usual hemoglobin components in the blood into six fractions, A1a, A1b, F, L-A1c, SA1c and A0. The separation is done by eluting the hemoglobins from the column with a gradient of three elution buffers containing different salt concentrations. The result report is printed out from the on-board printer and can be stored on a floppy disk from the on-board floppy disk drive. The data can be transmitted to a host computer. The result report includes a sample ID, date, percentage and retention time of each fraction, SA1c percentage and total A1 percentage (A1a + A1b + SA1c) along with a chromatogram of the elution pattern of the hemoglobin fractions. If a sample contains a hemoglobin variant, the column elutes the material depending upon its charge. The software compares the retention times to "known windows" and designates the material as P0X or H-VX if it does not match a defined window.

All automated processes in the G7 are controlled by internal microprocessors, using software downloaded via the on-board floppy disk drive.

This summary describes the Tosoh G7 Automated HPLC Analyzer in its HbA1c Variant Analysis Mode.

1. Table of Acceptance Criteria and Reported Device Performance:

The document doesn't explicitly state "acceptance criteria" with numerical thresholds. Instead, it demonstrates substantial equivalence to a predicate device (Tosoh A1c 2.2 Plus) by showing high correlation and precision. Therefore, the "acceptance criteria" are implied by the comparison to the predicate device and satisfactory statistical results.

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

• Sample Size: 230 patient samples
• Data Provenance: The document states "patient samples obtained from 230 patients." This implies clinical samples, likely from a patient population relevant to diabetes management. Given that the manufacturer is Tosoh Medics, Inc. based in South San Francisco, California, the data is likely from the United States, and it is almost certainly retrospective as samples were "obtained" and then assayed.

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

The document does not mention the use of experts to establish a "ground truth" for the test set in the traditional sense of consensus readings. Instead, the "ground truth" for the comparative analysis is implicitly the results obtained from the predicate device, the Tosoh A1c 2.2 Plus Automated Glycohemoglobin Analyzer. The study aims to show equivalence between the new device and the existing, cleared device, rather than establishing a completely independent ground truth.

4. Adjudication Method for the Test Set:

Not applicable. There was no expert "adjudication" in the traditional sense. The comparison was statistical against the predicate device's results.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done:

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This study is for an automated in vitro diagnostic device, not an imaging device requiring human interpretation, so MRMC studies are not relevant.

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

Yes, the study described is a standalone performance assessment of the G7 Automated HPLC Analyzer. It evaluates the device's analytical performance (comparative analysis, precision, recovery) in producing HbA1c results, without human interpretation of the chromatograms being the primary endpoint for clinical decision-making within the study design. The device is fully automated.

7. The Type of Ground Truth Used:

The "ground truth" for the performance evaluation was the results obtained from the predicate device (Tosoh A1c 2.2 Plus Automated Glycohemoglobin Analyzer). The study's objective was to demonstrate substantial equivalence to this already cleared device.

8. The Sample Size for the Training Set:

The document does not specify a separate "training set" or its sample size. For an IVD device like this, the development and training (calibration, algorithm optimization) would likely be an internal process before the equivalence study. The "230 patient samples" refer to the test set used for demonstrating substantial equivalence.

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

Not specified. As mentioned above, a separate training set is not explicitly detailed. The device likely uses internal calibration methods which would be established during development, rather than a "ground truth" for a machine learning training process described in the document. The device's operation relies on established HPLC principles and a "cation exchange column" with "three elution buffers." The software compares retention times to "known windows," implying pre-defined chemical properties rather than data-driven machine learning ground truth establishment.

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AIA-PACK FOLATE is intended for IN VITRO DIAGNOSTIC USE ONLY for the quantitative measurement of folate in human serum on TOSOH AIA System analyzers.

Not Found

The provided document is an FDA 510(k) clearance letter for the "AIA-PACK FOLATE Assay". This type of document declares a device substantially equivalent to a legally marketed predicate device, allowing it to be marketed. It does not inherently contain the detailed study information, acceptance criteria, or performance data that would typically be found in the manufacturer's 510(k) submission itself.

Therefore,Based on the text provided, I cannot provide descriptions for the following points as they are not contained within the FDA clearance letter:

• A table of acceptance criteria and the reported device performance
• Sample sizes used for the test set and data provenance
• Number of experts and their qualifications for ground truth
• Adjudication method for the test set
• Whether a multi-reader multi-case (MRMC) comparative effectiveness study was done, or its effect size
• Whether a standalone (algorithm only) performance study was done
• The type of ground truth used
• Sample size for the training set
• How ground truth for the training set was established

However, I can provide the following information from the document:

The device is the AIA-PACK FOLATE Assay, intended for "IN VITRO DIAGNOSTIC USE ONLY for the quantitative measurement of folate in human serum on TOSOH AIA System analyzers."

The document states that the FDA has determined the device is "substantially equivalent" to legally marketed predicate devices. This determination is based on the manufacturer's submission (K992365), which would have included data demonstrating this equivalence, but this specific data is not present in the provided FDA clearance letter.

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AIA-PACK CA 125 is intended for IN VITRO DIAGNOSTIC USE ONLY for the quantitative measurement of CA 125 in human serum on TOSOH AIA System analyzers. AIA-PACK CA 125 is to be used as an aid in monitoring response to therapy for patients with epithelial ovarian cancer. Serial testing for patient CA 125 assay values should be used in conjunction with other clinical methods used for monitoring ovarian cancer.

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The provided text is an FDA 510(k) clearance letter for the AIA-PACK CA 125 Assay. It states that the device is substantially equivalent to legally marketed predicate devices and can be marketed subject to general controls. However, the document does NOT contain a study or data proving the device meets specific acceptance criteria, nor does it detail any of the requested information regarding sample sizes, ground truth establishment, or expert involvement in a study.

Therefore, I cannot provide the requested table and study details from the provided text. The document is an administrative clearance, not a scientific study report.

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