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The ARCHITECT iValproic Acid assay is an in vitro chemiluminescent microparticle immunoassay (CMIA) for the quantitative measurement of valproic acid, an anticonvulsant drug, in human serum or plasma on the ARCHITECT i System with STAT protocol capability. The measurements obtained are used in monitoring levels of valproic acid to help ensure appropriate therapy.

The ARCHITECT iValproic Acid Calibrators are for the calibration of the ARCHITECT i System with STAT protocol capability when used for the quantitative determination of valproic acid in human serum or plasma.

The ARCHITECT iValproic Acid assay is a one-step STAT immunoassay for the quantitative measurement of valproic acid in human serum or plasma using CMIA technology with flexible assay protocols, referred to as Chemiflex. Sample, antivalproic acid coated paramagnetic microparticles, and valproic acid acridiniumlabeled conjugate are combined to create a reaction mixture. The anti-valproic acid coated microparticles bind to valproic acid present in the sample and to the valoroic acid acridinium-labeled conjugate. After washing, pre-trigger and trigger solutions are added to the reaction mixture. The resulting chemiluminescent reaction is mcasured as relative light units (RLUs). An indirect relationship exists between the amount of valproic acid in the sample and the RLUs detected by the ARCHITECT i System optics.

Here's a breakdown of the acceptance criteria and study information based on the provided text for the ARCHITECT iValproic Acid assay:

1. Table of Acceptance Criteria and Reported Device Performance

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

The provided text does not explicitly state the sample size used for the clinical performance study (test set) or the data provenance (e.g., country of origin, retrospective/prospective). It only mentions that clinical performance demonstrated substantial equivalency with a correlation coefficient of 0.986.

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

The provided text does not include information on experts, ground truth establishment, or their qualifications for the clinical performance study. This type of information is typically not required for an immunoassay 510(k) where the comparison is against an existing, legally marketed device. The "ground truth" in this context would likely be the measurements from the predicate device itself.

4. Adjudication Method for the Test Set

The provided text does not mention any adjudication method. This is expected as the study is a comparison between two quantitative assays, not a study involving subjective interpretations that would require adjudication.

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

A Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not performed as this device is a quantitative immunoassay meant for direct measurement, not an imaging device or diagnostic tool that involves human readers interpreting results in a comparative effectiveness setting. The study focused on the analytical performance of the new assay compared to a predicate device.

6. Standalone Performance

The clinical performance summary describes the standalone performance of the ARCHITECT iValproic Acid assay by demonstrating its correlation with the predicate AxSYM Valproic Acid assay. The correlation coefficient of 0.986 directly reflects the algorithm's (immunoassay's) performance in measuring valproic acid.

7. Type of Ground Truth Used

The "ground truth" for the clinical performance study was the measurements obtained from the legally marketed predicate device, the AxSYM Valproic Acid assay. The study aimed to show substantial equivalency of the new device's measurements to those of the predicate device.

8. Sample Size for the Training Set

The provided text does not specify a sample size for the training set. Immunoassay development typically involves extensive internal validation and optimization, but the regulatory submission focuses on the performance of the final assay.

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

The provided text does not detail how ground truth was established for a training set. For an immunoassay, training would involve optimizing reagents, protocols, and calibration curves using known concentrations or reference materials. The "ground truth" for these processes would be the expected or known concentrations of valproic acid in standards and controls used during development and calibration, rather than expert consensus on patient data.

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A creatinine test system is a device intended to measure creatinine levels in serum. plasma, and urine. Creatinine measurements are used in the diagnosis and treatment of renal diseases, in monitoring renal dialysis, and as a calculation basis for measuring other urine analytes

Creatinine is an in vitro diagnostic assay for the quantitative analysis of creatinine in human serum, plasma, or urine. At an alkaline pH, creatinine in the sample reacts with picrate to form a creatinine-picrate complex. The rate of increase in absorbance at 500 nm due to the formation of this complex is directly proportional to the concentration of creatinine in the sample.

This submission describes the Abbott Laboratories Creatinine assay. This is an in vitro diagnostic assay used for the quantitative analysis of creatinine in human serum, plasma, or urine and is substantially equivalent to the Roche Creatinine assay (K941837) on the Hitachi 917 Analyzer.

1. Acceptance Criteria and Device Performance

Note: The acceptance criteria are "implied" as the document primarily focuses on demonstrating substantial equivalence to the predicate device (Roche Creatinine assay on Hitachi 917 Analyzer) by showing comparable performance characteristics rather than specifying explicit numeric thresholds for the Abbott device to meet independently.

2. Sample Size and Data Provenance (Test Set)

• Sample Size: Not explicitly stated for specific test sets in correlation or precision studies. The document refers to "comparative performance studies" and "precision studies." No specific number of patient samples or replicates is provided.
• Data Provenance: Not specified. It is likely that the data was generated internally by Abbott Laboratories during the development and validation of the assay, but the country of origin or whether it was retrospective or prospective is not mentioned.

3. Number and Qualifications of Experts for Ground Truth (Test Set)

Not applicable. This is an in vitro diagnostic assay for creatinine measurement, not an imaging device or a diagnostic algorithm requiring expert interpretation of complex data for ground truth establishment. The ground truth for this type of device is typically established by comparing its measurements to a legally marketed predicate device (as done here) or to a recognized reference method.

4. Adjudication Method (Test Set)

Not applicable. As described above, this is an in vitro diagnostic assay and does not involve human interpretation or adjudication processes for its test set.

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

Not applicable. This is an in vitro diagnostic assay, not a device designed to assist human readers in interpreting medical images or other findings where an MRMC study would be relevant.

6. Standalone Performance Study

Yes, standalone performance studies were conducted to evaluate the Abbott Creatinine assay on the AEROSET and ARCHITECT c8000 Systems.

• Correlation Studies: Demonstrated the assay's performance against the predicate device (Roche Creatinine assay on Hitachi 917 Analyzer) by reporting correlation coefficients, slopes, and Y-intercepts.
• Precision Studies: Evaluated the reproducibility of the assay by reporting total %CV at different concentration levels.
• Linearity Studies: Established the range over which the assay provides accurate measurements.
• Limit of Quantitation (Sensitivity): Determined the lowest concentration that can be reliably measured.

These studies assess the algorithm's (or assay's) performance independently of human intervention.

7. Type of Ground Truth Used

The ground truth or reference standard for the comparative performance studies was the Roche Creatinine assay on the Hitachi 917 Analyzer (K941837), which is a legally marketed predicate device. For precision, linearity, and sensitivity, the ground truth would be expected values from reference materials or defined concentration levels.

8. Sample Size for the Training Set

Not applicable. This is an in vitro diagnostic assay based on a chemical reaction (modified Jaffe method), not a machine learning or AI-based device that requires a training set in the conventional sense. The "training" of such assays involves method development, optimization, and calibration using reference materials and quality controls.

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

Not applicable, as this device does not utilize a "training set" in the context of AI/machine learning. The assay's chemical principles and performance are established through laboratory experimentation, calibration using known standards, and validation studies.

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The Precision Xtra / MediSense Optium / Precision Easy / MediSense Optium Easy Blood Glucose Test Strip is intended for outside-of-the-body (in-vitro diagnostic) use. The strip is indicated for the quantitative measurement of glucose in fresh capillary blood for self-testing by lay users (e.g., from the finger, forearm, upper arm or base of thumb), or by health care professionals. The test strip is to be used for monitoring blood glucose concentrations in persons with diabetes and other conditions.

The Precision Xtra™ Advanced Diabetes Management System utilizes amperometric biosensor technology to generate a current. The size of the current is proportional to the amount of glucose present in the sample, providing a quantitative measure of glucose in whole blood and control solutions.

The provided text describes a 510(k) submission for Abbott Laboratories' MediSense Optium Plus and Precision Xtra Plus Blood Glucose Test Strips. This submission is for a modified version of an already cleared device, indicating an updated or improved iteration. Therefore, the "acceptance criteria" and "device performance" are framed in the context of demonstrating substantial equivalence to the predicate device rather than meeting specific performance thresholds against a gold standard in a standalone study.

Here's an analysis of the requested information based on the provided text:

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

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

• Sample Size: The document does not specify the sample size used for the performance studies.
• Data Provenance: The document does not specify the country of origin of the data or whether the studies were retrospective or prospective. It only states that "The performance of the strips using various diabetes monitoring systems was studied in the laboratory."

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)

• The concept of "experts" establishing ground truth in the context of blood glucose test strips is not directly applicable in the same way it would be for image analysis or diagnostic decision-making. For these devices, the "ground truth" would typically refer to a reference method of blood glucose measurement (e.g., a laboratory analyzer).
• The document does not provide details on specific experts or their qualifications for establishing any reference values. It refers to "current methods for blood glucose measurements" as the comparator.

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

• Adjudication methods like 2+1 or 3+1 are typically used when multiple human readers are interpreting data, and their decisions need to be reconciled. This is not mentioned or relevant for the type of performance study described for blood glucose test strips, which would likely involve direct comparison to a reference analytical method.

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

• No, an MRMC comparative effectiveness study was not done. This type of study is not relevant for blood glucose test strips, which do not involve human "readers" interpreting results in the same way as, for example, radiologists interpreting medical images. The device itself performs the measurement.

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

• Yes, performance studies are inherently "standalone" in the sense that the device's analytical performance (how well it measures glucose) is evaluated. The phrase "algorithm only without human-in-the-loop performance" isn't directly applicable as there isn't a complex diagnostic "algorithm" in the AI sense, but rather a chemical reaction and electrochemical detection process. The studies focused on the performance of the strips when used with various diabetes monitoring systems. The core evaluation is the device's ability to produce accurate glucose readings.

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

• The ground truth would be established by a reference method for blood glucose measurement, typically a laboratory-grade analyzer (e.g., a YSI analyzer or similar hospital-grade instrument) that is considered highly accurate and precise. The document refers to "current methods for blood glucose measurements" as the benchmark for substantial equivalence.

8. The sample size for the training set

• The document does not mention a "training set" in the context of a statistical model or algorithm development. For a chemical-based test strip, "training" isn't typically applicable in this way. The performance studies evaluate the final product.

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

• As there is no mention of a "training set" in the context of algorithm development, this question is not applicable. For quality control and manufacturing, the strips would be tested against known glucose concentrations to ensure they meet specifications, but this is part of manufacturing quality, not a "training set" for an AI algorithm.

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The Fox Plus PTA Catheter is intended for dilatation of lesions in the femoral, renal, iliac, popliteal, peroneal, and profunda arteries and native or synthetic arteriovenous dialysis fistulae. This catheter is not intended for the expansion or delivery of stents.

The Fox Plus PTA Catheter is a standard over-the-wire PTA catheter. The double lumen catheter has a balloon located near the distal tip. One lumen is used for inflation of the balloon, while the second lumen allows access to the distal tip of the catheter for guidewire insertion (max 0.035"). The balloon material expands to a known diameter at specific pressure.

This document is a 510(k) summary for a medical device called the Fox Plus PTA Catheter. It describes the device, its intended use, and its substantial equivalence to a predicate device. However, it does not contain information about acceptance criteria, device performance results, sample sizes for testing or training, ground truth establishment, or any comparative effectiveness studies as requested in the prompt.

Therefore, I cannot provide the requested table and information based on the provided text. The submission focuses on demonstrating substantial equivalence through non-clinical testing, but the details of those tests and their outcomes are not included here.

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The AxSYM Cyclosporine assay is a Fluorescence Polarization Immunoassay (FPIA) in vitro reagent system for the quantitative measurement of cyclosporine (cyclosporine A) in human whole blood as an aid in the management of cardiac, liver, and renal transplant patients.

The AxSYM Cyclosporine assay requires the use of the AxSYM System, a random and continuous access immunoassay analyzer performs all sample and reagent transfers, incubations, and data processing, and completes the assay with a printed report. Samples (calibrators, controls, and specimens) are pretreated to minimize interference from endogenous protein-bound fluorescent compounds. Sample pretreatment consists of lysing the erythrocytes in the whole blood with Solubilization Reagent and precipitating protein with Precipitation Reagent. Cyclopsorine is dissolved into the liquid phase. The mixture is centrifuged to generate a clarified extract. The AxSYM Cyclopsorine assay is performed on the clarified extract. The AxSYM Cyclosporine Reagents and pretreated sample are pipetted in the following sequence:

• Pretreated sample, Cyclosporine Antibody, Cyclosporine Pretreatment and Solution 4 (Line Diluent) required for one test are pipetted by the Sample Probe into one well of a Reaction Vesssel (RV) to form a Sample Solution,
• Cyclosporine Fluorescein Tracer is added to a second well of the RV.
• The RV is immediately transferred into the Processing Center. Further pipetting is done in the Processing Center by the Processing Probe.
• Aliquots of Solution 4 and Sample Solution are dispensed into the RV curvette.
• The polarized fluorescent background is measured by the FPIA optical assembly.
• Second aliquots of Solution 4 and Sample Solution, and an aliquot of . Cyclosporine Fluorescein Tracer are dispensed into the same RV curvette.
• The intensity of polarized fluorescent light is measured by the FPIA optical assembly.

The Abbott AxSYM® Cyclosporine assay is a new device, and its performance was evaluated by comparing it to a predicate device, the Abbott TDx®/TDxFLx® Cyclosporine Monoclonal Whole Blood assay.

1. Table of Acceptance Criteria and Reported Device Performance

The submission does not explicitly state pre-defined acceptance criteria (e.g., minimum correlation coefficient, slope range, intercept range). Instead, it presents the results of a comparison study and concludes that the device is "substantially equivalent" to the predicate. The performance is reported in terms of a linear regression analysis.

2. Sample Size and Data Provenance

• Test Set Sample Size: 754 specimens.
  • Heart transplant patients: 194
  • Kidney transplant patients: 330
  • Liver transplant patients: 230
• Data Provenance: Not explicitly stated regarding country of origin. The study appears to be retrospective, comparing the new device against the existing predicate device on collected samples.

3. Number of Experts and Qualifications for Ground Truth

This study compares a new quantitative assay (Abbott AxSYM Cyclosporine) against an existing, legally marketed quantitative assay (Abbott TDx/TDxFLx Cyclosporine Monoclonal Whole Blood). In such analytical performance studies for quantitative in vitro diagnostic devices, the "ground truth" is established by the reference method (the predicate device in this case) or a highly accurate laboratory method, rather than through expert human interpretation. Therefore, experts in the traditional sense (e.g., radiologists interpreting images) are not typically involved in establishing ground truth for this type of test.

4. Adjudication Method

Not applicable. As described above, this is an analytical comparison of two quantitative assays. Adjudication methods (like 2+1 or 3+1) are typically used when human interpretation of complex data (e.g., medical images) is involved to establish a consensus ground truth.

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

Not applicable. This is an analytical performance study of an in vitro diagnostic device, not a study involving human readers interpreting cases. Therefore, there is no discussion of how human readers improve with or without AI assistance.

6. Standalone Performance

Yes, a standalone performance study was done in the sense that the AxSYM Cyclosporine assay was run independently on the test samples, and its results were then compared to those generated by the predicate device. The performance metrics (correlation, slope, intercept) describe this standalone algorithm's (the AxSYM assay's) agreement with the predicate device.

7. Type of Ground Truth Used

The "ground truth" for comparison was the measurements obtained from the predicate device, the Abbott TDx®/TDxFLx® Cyclosporine Monoclonal Whole Blood assay. This is a common approach for demonstrating substantial equivalence for new in vitro diagnostic devices to existing, legally marketed ones.

8. Sample Size for the Training Set

The document does not provide details about a specific "training set" for the AxSYM Cyclosporine assay. Immunoassays like this are developed using established chemical and immunological principles, and calibration (using calibrators provided with the kit) is a standard part of their operation, not a "training set" in the machine learning sense. The linearity and operating range of the assay would typically be established during the development phase using various concentrations of cyclosporine.

9. How Ground Truth for the Training Set was Established

Not applicable in the machine learning context. For an immunoassay, the "ground truth" for calibrators (which function somewhat analogously to training data by defining the response curve) is established by precise preparations of known concentrations of the analyte (cyclosporine) using highly accurate methods, often traceable to international standards. The document mentions a calibrator range of 0 ng/mL to 800 ng/mL for the AxSYM Cyclosporine.

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The Abbott GemStar® Infusion Pump is intended for use in intravenous, arterial, short-term epidural, and parenteral administration of general I.V. fluids, medications, nutritional fluids, and blood/blood products to patients in hospital and home care environments.

The Abbott GemStar® Infusion Pump can function as both a pole-mounted and an ambulatory infusion pump and it is intended for use in hospital, ambulatory and home care environments. All GemStar® pumps are single channel pumps and they are offered for sale in the following configurations: 7 Therapy Pump, 6 Therapy Pump, Pain Management Pump. The Abbott GemStar® Infusion Pump is an electromechanical infusion pump that functions on a volumetric, piston driven, fluid displacement principle. The pump delivers I.V. fluids through an intravenous administration set that is also manufactured and distributed by Abbott Laboratories. The sets are described as "GemStar Pump Sets" because they are dedicated for use in this system. The user interface of the infusion pump allows the healthcare practitioner to program fluid delivery through a variety of weight and medication based units including grams. micrograms, milliliters and other units per specified time interval. The display on the pump provides visible indication of multiple functions including active pump operations, alarm and program status and the parameters of fluid flow. The pump can also be used for standard or piggyback fluid delivery. The administration set incorporates integral, set-based free flow protection through a flow stop cassette and other free flow protection measures such as a roller or slide clamp, and an anti-siphon valve. The pump includes a check cassette software function in all modes. Lastly, the labeling for both the sets and the user manual has been revised to highlight these features.

Here's an analysis of the provided text regarding the Abbott GemStar® Infusion Pump System, focusing on acceptance criteria and study details:

This document is a 510(k) Summary for a device modification, not an initial market clearance. Therefore, the "study" described is a design validation and verification rather than a full clinical trial establishing initial safety and efficacy for a novel device. The core argument for clearance is substantial equivalence to a predicate device.

1. Table of Acceptance Criteria and Reported Device Performance

The provided text does not explicitly list specific numerical acceptance criteria or detailed quantitative performance metrics for the modified device. Instead, it makes a general statement about the outcome of testing.

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

• Sample Size: Not specified. The document states "Data regarding the functional performance... has been generated and reviewed" and "results of testing conducted to validate and verify the design modifications." This implies a series of engineering and functional tests rather than a patient-based clinical study with a defined sample size.
• Data Provenance: Not specified, but given the nature of a 510(k) for a device modification involving mechanical and software changes, the testing would almost certainly have been conducted retrospectively in a lab/engineering environment at Abbott Laboratories, rather than involving prospective patient data acquisition. The country of origin of the data is not mentioned and likely not relevant for this type of submission.

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

Not applicable. This was a technical validation and verification of device modifications, not a study requiring expert clinical assessment to establish ground truth for a test set. The "ground truth" would have been defined by the device's technical specifications and intended functional performance.

4. Adjudication Method for the Test Set

Not applicable. This was a technical validation, not a multi-expert review or adjudication scenario.

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

No. This document describes a 510(k) submission for a modification to an existing infusion pump, focused on technical validation. MRMC studies are typically performed for diagnostic imaging devices or AI algorithms where human interpretation is involved, which is not the case here.

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

The device is an infusion pump, which inherently involves human interaction for programming and operation. While there are software enhancements mentioned ("modifying and enhancing the software to incorporate changes requested by users"), the term "standalone performance" in the context of AI algorithms is not directly applicable. The device's software performs its functions (e.g., controlling fluid delivery, displaying information) in a "standalone" computational sense, but it operates within a system where a human programs and oversees its use. The "testing" referred to would have evaluated the software's functional correctness.

7. The Type of Ground Truth Used

The ground truth for this submission would have been established by:

• Engineering Specifications: The design requirements and specifications for the modified mechanical parts and enhanced software.
• Predicate Device Performance: The established, acceptable performance of the original Abbott GemStar™ I.V. Infusion Pump served as the baseline for substantial equivalence.
• Regulatory Standards: Adherence to relevant performance standards for infusion pumps.
  The documentation relies on "functional performance" as the basis for acceptability.

8. The Sample Size for the Training Set

Not applicable. This project involves a medical device (infusion pump) with embedded software, not a machine learning or AI algorithm that requires a training set in the conventional sense. The software changes were enhancements and modifications, likely developed and tested against defined engineering requirements rather than trained on a dataset.

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

Not applicable, as there was no training set in the context of machine learning. The "ground truth" for the software development (if one were to loosely interpret it) would be the correct implementation of the new features and modifications as per design specifications and user requirements.

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