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The Randox Direct LDL/HDL Cholesterol Calibrator is intended for in vitro diagnostic use in the calibration of Randox HDL and LDL Cholesterol methods. This in vitro diagnostic device is intended for prescription use only and can only be used by professionals.

The Randox Direct LDL/HDL Cholesterol Calibrator is supplied in a kit containing 3x1mls vials. The calibrator contains the analytes LDL and HDL. The base matrix used for the manufacture of Randox Direct LDL/HDL Cholesterol Calibrator is Human Serum. The calibrator contains lipoproteins from the various lipoprotein classes including high density lipoproteins.

Here's an analysis of the provided text regarding the acceptance criteria and study for the Randox Direct LDL/HDL Cholesterol Calibrator:

Acceptance Criteria and Device Performance Study for Randox Direct LDL/HDL Cholesterol Calibrator

Based on the provided K1221266 document, the device described is a calibrator, not a diagnostic device that measures patient samples directly. Therefore, the "acceptance criteria" and "device performance" are focused on its role as a calibration standard and its ability to maintain stability and assignable values. The document primarily describes the characteristics of the calibrator and how its values are assigned, rather than presenting a traditional clinical study with outcome-based performance metrics like sensitivity, specificity, or reader improvement.

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state "acceptance criteria" in the typical sense for a diagnostic device (e.g., meeting a certain accuracy threshold against a reference standard). Instead, the performance is demonstrated through its stability and the value assignment process, ensuring it reliably provides known concentrations of analytes for instrument calibration.

Acceptance Criteria (Implied from the document's content):

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

For a calibrator, a "test set" in the traditional sense of patient samples is not applicable. The "test set" for this device would refer to the samples used during the value assignment process.

• Sample Size: The document does not specify a distinct "sample size" of individual samples used to determine the values. Instead, it refers to "multiple analysers with reference to a master lot." This implies the calibrator was run numerous times on various instruments. The explicit number of replicates or individual calibrator vials tested for value assignment is not stated.
• Data Provenance: Not explicitly stated, but given Randox Laboratories is a UK-based company and the predicate device comparison table includes international analyzer brands, the testing likely occurred in a controlled laboratory setting (likely in the UK or a partner lab). The data is inherent to the manufacturing and quality control process of the calibrator itself, rather than external patient data. It is a prospective study in the sense that the testing was performed to assign values to the newly manufactured calibrator lots.

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

For a calibrator, the "ground truth" is established through a hierarchical metrological process, not typically by "experts" reviewing results in the way a radiologist reviews images.

• Number of Experts: Not applicable. The "ground truth" (assigned values) is traceable to established reference materials and methods, often from organizations like the CDC or a certified reference material producer. The document states values are established "with reference to a master lot," which would have its own established traceable values.
• Qualifications of Experts: Not specified or applicable in the context of expert review. The "experts" would be the metrologists and analytical chemists involved in establishing the master lot's values and performing the value assignment on specific instruments, ensuring adherence to rigorous analytical standards.

4. Adjudication Method for the Test Set

Not applicable. As discussed above, the "test set" refers to the value assignment process, which relies on analytical measurements and metrological traceability, not consensus-based adjudication.

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

No. An MRMC study is relevant for diagnostic devices where human readers interpret medical images or data. This is a calibrator, an in-vitro diagnostic reagent, so an MRMC study is not appropriate or presented.

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

This question is not applicable to a calibrator. A calibrator does not have an "algorithm" in the sense of an AI or software processing data. Its function is to provide known concentrations for instrument calibration. The "performance" is its ability to consistently deliver these known concentrations and be stable over time.

7. The Type of Ground Truth Used

The "ground truth" for the calibrator's values is established by metrological traceability to a master lot, which in turn is traceable to higher order reference materials and methods. The document explicitly mentions "The assigned values for the direct LDL/HDL Cholesterol Calibrator are established on multiple analysers with reference to a master lot." And the "Traceability" section identifies the specific human plasma products (Creative Labs) as the origin for the analytes.

8. The Sample Size for the Training Set

Not applicable. This device is a calibrator, not an algorithm that requires a "training set" of data.

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

Not applicable. No training set is used for this type of device.

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The Dimension Vista™ Total Iron Binding Capacity (TIBC) Calibrator is an in vitro diagnostic product for the calibration of the Total Iron Binding Capacity (TIBC) method on the Dimension Vista™ system.

The Dimension Vista™ Total Iron Binding Capacity (TIBC) Calibrator is a liquid, bovine albumin based product containing human transferrin. The kit consists of 3 vials, each containing 1.0 mL.

Here's an analysis of the provided text regarding the acceptance criteria and study information for the Dimension Vista™ Total Iron Binding Capacity (TIBC) Calibrator.

Please note: The provided text is a 510(k) summary for a calibrator, not a diagnostic device that performs interpretations. Therefore, many of the typical questions for AI/diagnostic device studies (like sample size for test/training sets, number of experts for ground truth, adjudication methods, MRMC studies, standalone performance, and ground truth types like pathology/outcomes data) are not applicable in this context. The document focuses on demonstrating **substantial equivalence** to a predicate device, primarily through comparison of their characteristics and intended use.

Acceptance Criteria and Device Performance

For a calibrator like the Dimension Vista™ TIBC Calibrator, the "acceptance criteria" isn't typically phrased in terms of sensitivity, specificity, or accuracy against a disease state. Instead, acceptance is based on demonstrating that its performance is equivalent to a legally marketed predicate device for its intended use (calibration). The "reported device performance" is implicitly shown through the comparison table and the conclusion of substantial equivalence.

Table of Acceptance Criteria and Reported Device Performance

Given this context, the "acceptance criteria" can be inferred as matching the key characteristics and performance expectations of the predicate device for calibrator functionality.

Study Information (Based on Available Text):

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

   • Not Applicable. This is a 510(k) submission for a calibrator, not a diagnostic device evaluating patient samples. The "test set" would refer to internal validation of the calibrator's performance against expected values, but details on sample size or provenance for such internal testing are not provided in this summary. The focus is on comparison to a predicate.

2. 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. There is no "ground truth" derived from expert consensus on patient data described for this calibrator submission. The ground truth for a calibrator relates to its chemical composition and its ability to produce expected instrument responses, which is typically validated through internal quality control and comparison to a primary standard (NIST Iron Standard SRM 937).

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

   • Not Applicable. No adjudication method for a "test set" of patient data is relevant here.

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

   • Not Applicable. This is not an AI-assisted diagnostic device.

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

   • Not Applicable. This is not an algorithm or AI device.

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

   • The "ground truth" for the calibrator's value is established by its primary standard: NIST Iron Standard SRM 937. This refers to a standard reference material from the National Institute of Standards and Technology, which provides a highly accurate and certified concentration of iron. The calibrator's assigned values are traceable to this primary standard.

7. The sample size for the training set

   • Not Applicable. This is a calibrator, not a machine learning device that requires a training set.

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

   • Not Applicable. No training set is used.

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The IRON Calibrator is an in vitro diagnostic product intended to be used to calibrate the IRON method for the Dimension® clinical chemistry system.

The IRON calibrator is an aqueous solution of iron wire dissolved in a dilute solution of HCl. The kit consists of 6 ampules, two at each of three levels.

Here's an analysis of the provided text regarding the Dimension® Iron Calibrator and its performance:

1. Acceptance Criteria and Reported Device Performance

The document describes the stability and traceability of the Dimension® Iron Calibrator (IRON Cal - DC 85). However, the specific quantitative acceptance criteria for performance (e.g., recovery percentages, maximum allowable drift) are not explicitly stated in a table format within the provided text. The document focuses on the methods used to assess stability and traceability, rather than specific results against pre-defined thresholds.

2. Sample Size for Test Set and Data Provenance

• Test Set Sample Size: For stability studies, "three lots of product" were used. For traceability and value assignment, it mentions "six working Iron Standard Solutions of NIST SRM 937" for assigning values, and the comparison of "new calibrator lot" against "Reference Lot" and "Control Calibrator Lot." The number of individual samples or measurements within these lots/solutions is not specified.
• Data Provenance: The data is generated internally by Dade Behring Inc. (the applicant). It is prospective data, as it describes studies conducted to support the device's claims (e.g., 13 months of real-time stability testing). The country of origin of the data is implicitly the United States, where Dade Behring Inc. is located.

3. Number of Experts and Qualifications for Ground Truth

The provided summary does not mention any human experts being used to establish ground truth for the performance studies of this calibrator device. The ground truth for a calibrator is typically established through a highly controlled and standardized reference material.

4. Adjudication Method for the Test Set

Since no human experts are mentioned for establishing ground truth, there is no adjudication method described or applicable in this context.

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

An MRMC study is not applicable to this device. This is an in vitro diagnostic calibrator, not a diagnostic imaging device or an AI algorithm intended to assist human readers. Therefore, no comparison of human readers with or without AI assistance was performed.

6. Standalone Performance Study

Yes, the studies described, particularly the stability studies and the traceability/value assignment studies, can be considered standalone performance studies for the calibrator device itself. These studies evaluate the calibrator's inherent properties (stability over time, accuracy of assigned values against a gold standard) independent of a human operator's interpretation. The calibrator's function is to provide a known reference point for the Dimension® clinical chemistry system, so its "performance" is evaluated on its ability to maintain that reference.

7. Type of Ground Truth Used

The primary ground truth used for this calibrator is NIST SRM 937 (National Institute of Standards and Technology - Standard Reference Material). This is a highly certified and recognized reference material, considered a "gold standard" for iron concentration.

8. Sample Size for the Training Set

This document describes a calibrator, not a machine learning model. Therefore, the concept of a "training set" in the context of AI or algorithms is not applicable. The calibrator itself does not learn from data; its values are assigned based on comparisons to a reference standard.

9. How Ground Truth for the Training Set Was Established

As explained above, there is no "training set" in the AI/machine learning sense for this device. The values of the calibrator are established through direct comparison and standardization against the NIST SRM 937, which is intrinsically the ground truth for iron concentration. The process involves:

• Preparing six working Iron Standard Solutions from NIST SRM 937.
• Assigning values to new lots of the calibrator by recovering these reference solutions.
• Ensuring acceptable recovery against the NIST SRM 937 (Reference Lot) and an approved Control Calibrator Lot.

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The Dimension® CCRP Calibrator is an in vitro diagnostic product intended to be used to calibrate the Dimension® CardioPhase® high sensitivity C-reactive protein (Cat. No. RC434) method for the Dimension® clinical chemistry system with the heterogeneous immunoassay module. This product was designed to meet the needs of users to assure accurate results over the assay range of this method.

The high sensitivity C-reactive protein Calibrator is a liquid bovine serum albumin-based product. Levels 2 -5 contain a human C-reactive protein.

Here's a breakdown of the acceptance criteria and study information for the Dimension® CardioPhase® high sensitivity CRP Calibrator (CCRP Calibrator - RC434), based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

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

The provided document does not explicitly define a "test set" in the traditional sense for assessing diagnostic performance against an external reference. Instead, the studies described are related to the calibrator's internal performance (stability, traceability, and value assignment).

• Stability Study:

  • Sample Size: "three lots of product" were used for real-time stability testing.
  • Data Provenance: The data is implicitly prospective, as it involves real-time monitoring of the product's stability. The country of origin of the data is not specified but is presumably where Dade Behring Inc. conducts its manufacturing and testing, which is in the USA (Newark, DE).

• Value Assignment Study:

  • Sample Size: "Three Dimension® clinical chemistry analyzers" and "different CCRP flex lots" (number of lots not specified beyond "different"), with "5 replicate test means of all 9 curves" implying a total of 45 measurements per calibrator level in this specific part of the assignment process.
  • Data Provenance: Implicitly prospective and internal to the manufacturer. Country of origin not specified, but likely USA.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
Not applicable. For a calibrator, the "ground truth" is established by its direct traceability to recognized international reference standards (IFCC/BCR/CAP CRM 470), not by expert consensus on clinical cases.

4. Adjudication Method for the Test Set
Not applicable, as there's no "test set" in the clinical diagnostic sense requiring expert adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done
No, an MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic devices that involve human interpretation of results (e.g., imaging devices, pathology slides). The device in question is a calibrator, which provides known concentrations for calibrating an automated assay.

6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was Done
Yes, the performance characteristics described are "standalone" in the sense that they evaluate the calibrator material itself and its interaction with the Dimension® clinical chemistry system, without direct human intervention in the result generation or interpretation after the initial setup. The calibrator's function is to provide known reference points for an automated assay.

7. The Type of Ground Truth Used

The ground truth for the calibrator's values is based on traceability to internationally recognized reference materials.

• For the Calibrator values: IFCC/BCR/CAP reference preparation for 14 human serum proteins (Lot No. 91/0619=CRM470=RPPHS 91/0619). This is a highly standardized and globally accepted reference material.

8. The Sample Size for the Training Set
Not applicable. The concept of a "training set" is generally used for machine learning algorithms. This device is a calibrator for a traditional immunoassay system and does not involve an algorithm that requires a training set.

9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no training set for this device.

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The Dimension® Total Triiodothyronine (T3) Calibrator (RC414) is intended for use in the calibration of the Total Triiodothyronine (T3) method on the Dimension® clinical chemistry system with the Heterogeneous Immunoassay Module.

The Dimension® Total Triiodothyronine (T3) Calibrator (RC414) is a liquid product. The kit consists of 10 vials, two each at levels 1 through 5. Level 1 vials contain 2 mL of stripped human serum. Vials for levels 2 through 5, contain 1 mL with concentrations of L-triiodothyronine in a stripped human serum base.

The provided document, K032697, is a 510(k) premarket notification for a medical device (Dimension® Total Triiodothyronine (T3) Calibrator (RC414)). This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than presenting extensive performance studies against specific acceptance criteria for a novel device.

Therefore, the document does not contain the detailed information requested regarding acceptance criteria, study design, sample sizes for test and training sets, expert qualifications, adjudication methods, MRMC studies, or standalone algorithm performance.

Here's an explanation of why the requested information is absent based on the document's content:

• Acceptance Criteria and Reported Device Performance: Instead of performance criteria, the document focuses on comparing the proposed device to a predicate device based on characteristics like intended use, analyte, matrix, form, volume, and levels.
• Study That Proves the Device Meets Acceptance Criteria: No such specific study is described. Substantial equivalence is concluded based on the comparison table and the similarities in intended use.
• Sample Size for Test Set and Data Provenance: Not applicable in a substantial equivalence filing of this type for a calibrator. There isn't a "test set" in the context of evaluating diagnostic accuracy as would be for an AI algorithm.
• Number of Experts Used to Establish Ground Truth and Qualifications: Not applicable. Ground truth for a calibrator is established through its manufacturing process and chemical properties, not by expert interpretation.
• Adjudication Method: Not applicable for a calibrator's performance evaluation.
• Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study: Not applicable. These studies are relevant for diagnostic devices where human readers interpret medical images or data, and an AI might assist them. This is a calibrator, a chemical product used to standardize measurements.
• Standalone (algorithm only without human-in-the-loop performance) study: Not applicable, as this device does not involve an algorithm or AI.
• Type of Ground Truth Used: The "ground truth" for a calibrator is its accurately determined concentration of the analyte (T3 in this case). This is established through analytical chemistry methods during manufacturing, not expert consensus, pathology, or outcomes data in the usual sense for a diagnostic device.
• Sample Size for the Training Set: Not applicable. This device is a chemical calibrator, not a machine learning model that requires a training set.
• How the Ground Truth for the Training Set Was Established: Not applicable.

In summary, the provided K032697 document is for a medical device calibrator and demonstrates substantial equivalence to a predicate device. It does not involve AI or diagnostic interpretation, and therefore, the requested information regarding performance studies, ground truth establishment for AI models, and human reader-AI interactions is not present.

The crucial information in the document for K032697 relates to its comparison to a predicate device to establish substantial equivalence.

Here's a table based on the comparison provided in the document:

The "acceptance criteria" for this submission are the demonstration of substantial equivalence to the predicate device based on these comparative characteristics. The study demonstrating this is the comparison table and discussion provided in the document, which identifies the similarities and any minor differences. The document concludes that based on this comparison, the Dimension® Total Triiodothyronine (T3) Calibrator (RC414) is substantially equivalent to the Opus Total T3 Calibrators.

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IVD DEVICE CALIBRATION IS MOST COMMONLY PERFORMED USING CALIBRATORS (REFERENCE MATERIALS) SPECIFICALLY INTENDED TO BE USED AS A STANDARD CURVE OR CUT-OFF POINT FOR AN ASSAY.

A CALIBRATOR HAS AN ASSIGNED VALUE THAT IS ESTABLISHED BY THE MANUFACTURER BY A REFERENCE METHOD. CALIBRATORS EXIST IN A VARIETY OF MATRICES SUCH AS SIMULATED AQUEOUS, SERUM. PLASMA OR OTHER TYPES OF SPECIMENS.

PRIMARY REFERENCE CALIBRATORS ARE HIGHLY PURIFIED CHEMICALS THAT CAN BE DIRECTLY WEIGHED OR MEASURED TO PRODUCE A SOLUTION OF KNOWN CONCENTRATION. ALTERNATIVELY, THEY MAY BE MORE COMPLEX BIOLOGICAL MATERIALS HAVING RECEIVED A VALUE ASSIGNMENT USING REFERENCE (STANDARD) METHODOLOGY. THEY ARE SUPPLIED WITH A CERTIFICATE OF ANALYSIS FOR EACH LOT (FOR EXAMPLE, STANDARD REFERENCE MATERIALS (SRMS) FROM THE U.S. NATIONAL INSTITUTE OF STANDARDS AND TECHNOLOGY (NIST)).

THE PRIMARY CALIBRATOR "CALIBRATION SOLUTION FOR OSMOMAT 010 / 030 / auto" IS USED TO CALIBRATE THE OSMOMETERS "OSMOMAT 030" AND "OSMOMAT AUTO", WHICH BOTH ARE FREEZING-POINT OSMOMETERS FOR USE IN CLINICAL CHEMISTRY. THE OSMOLALITY OF THE CALIBRATOR IS EQUAL TO THE OSMOLALITY OF BODY-FLUIDS (ISOTONIC SOLUTION), PROVIDING THAT THE OSMOMETER WILL BE CALIBRATED CORRECTLY FOR THE FLUIDS TO BE MEASURED FOR MEDICAL PURPOSES.

A FREEZING-POINT OR CRYOSCOPIC OSMOMETER IS A DEVICE TO MEASURE THE NUMBER OF MOLECULES OR IONS DISSOLVED IN A FLUID, IN THIS CASE, WATER. THE PHYSICAL EFFECT THE MEASUREMENT IS BASED ON IS THAT DISSOLVED SUBSTANCES IN WATER DEPRESS THE FREEZING POINT OF THE SOLUTION. THIS DEPRESSION IN THE FREEZING TEMPERATURE ITSELF, MEASURED EXACTLY, GIVES AN EXACT MEASURE FOR HOW MANY MOLECULES OR IONS ARE DISSOLVED IN THE AQUEQUS CALIBRATOR OR SPECIMEN. THIS EFFECT IS PHYSICAL, WHICH MEANS THAT THE CHEMICAL PROPERTIES OF THE CALIBRATOR OR SPECIMEN REMAIN UNCHANGED. AS ANY DISSOLVABLE SUBSTANCE CAUSES THIS EFFECT, THE RESULT OF THE MEASUREMENT GIVES NO INFORMATION ABOUT THE IDENTITY AND/OR COMPOSITION OF THE SUBSTANCES DISSOLVED, IF THERE SHOULD BE SEVERAL. THE MEASURED VALUE EXPRESSES IF THE RANGE OF OSMOLALITY OF THE SPECIMEN IS TO BE EXPECTED AS BEING NORMAL FOR A SPECIMEN FROM A HEALTHY HUMAN BEING. OR THE OSMOLALITY SHOWS THAT SOMETHING IS WRONG WITH THE PATIENT. FURTHER MEDICAL EXAMINATIONS WOULD FOLLOW. IN THE CALIBRATOR THE ONLY SUBSTANCE DISSOLVED IS SODIUM CHLORIDE. SO THE VALUE OF THE OSMOLALITY ALSO REPRESENTS THE CONCENTRATION OF SODIUM CHLORIDE.

TO MEASURE THE FREEZING-POINT-DEPRESSION. THE SAMPLE IS FROZEN CAREFULLY. THE EXACT TEMPERATURE OF THE FLUID IS MEASURED AT ANY TIME WHILE THE SAMPLE IS COOLED DOWN. THE TEMPERATURE AT WHICH THE FLUID FREEZES TO ICE IS DETERMINED EXACTLY AND THE INTERNAL CALCULATOR OF THE OSMOMETER CALCULATES AND DISPLAYS THE EQUIVALENT OSMOLALITY OF THE LIQUID. IN MATRICES LIKE URINE THE MEASUREMENT SHOWS IF THE KIDNEYS WORK PROPERLY ASSUMABLY.

Here's an analysis of the provided 510(k) summary regarding the calibration solution, structured to address your specific questions.

Based on the provided text, it's crucial to understand that this submission is for a calibration solution, not a diagnostic device that performs measurements or generates diagnostic outputs in the way an AI algorithm would. Therefore, many of your questions, particularly those related to clinical studies, human reader performance, ground truth establishment for AI, and sample sizes for training/test sets, are not applicable to this type of device and are not addressed in the provided 510(k) summary.

The 510(k) summary focuses on demonstrating that the calibration solution is substantially equivalent to a legally marketed predicate device, primarily through its intended use and performance as a calibrator.

Acceptance Criteria and Device Performance for Calibration Solution

Given the nature of the device (a primary calibrator), the "acceptance criteria" relate to its ability to accurately provide a known osmolality for the osmometer to be calibrated against, and its similarity to the predicate device. The performance is assessed against the established value of the calibrator itself.

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)

This information is not applicable and not provided in the 510(k) summary because the device is a calibrator, not a diagnostic test. There isn't a "test set" of patient data in the context of clinical studies for an AI-powered device. The "test" for a calibrator involves verifying its stated value and stability, which would be done internally by the manufacturer using laboratory methods.

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 is not applicable and not provided. The "ground truth" for a calibrator is its assigned osmolality value, which is established by the manufacturer through rigorous analytical methods (e.g., gravimetric preparation, reference measurement systems), not by clinical expert consensus.

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

This is not applicable and not provided. Adjudication methods are relevant for resolving discrepancies in expert interpretations of clinical data, which is not relevant for a calibration solution.

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 and not provided. MRMC studies are for evaluating the performance of diagnostic systems (often AI-assisted) and their impact on human reader performance. This device is a calibrator, not a diagnostic system.

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

This is not applicable and not provided. This question pertains to the performance of an AI algorithm in isolation. The device is a physical calibration solution, not an algorithm.

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

The "ground truth" for this device is its assigned osmolality value, which is established by the manufacturer using reference analytical methodologies (e.g., gravimetric methods, comparison to NIST traceable standards if available, or other validated laboratory methods) for highly purified chemicals like sodium chloride. The document states: "A CALIBRATOR HAS AN ASSIGNED VALUE THAT IS ESTABLISHED BY THE MANUFACTURER BY A REFERENCE METHOD." and "PRIMARY REFERENCE CALIBRATORS ARE HIGHLY PURIFIED CHEMICALS THAT CAN BE DIRECTLY WEIGHED OR MEASURED TO PRODUCE A SOLUTION OF KNOWN CONCENTRATION."

8. The sample size for the training set

This is not applicable and not provided. There is no "training set" for a calibration solution. This concept applies to machine learning algorithms.

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

This is not applicable and not provided. As there is no training set, there's no ground truth to establish for it in this context.

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VITROS Progesterone Reagent Pack
For in vitro diagnostic use only.
The Vitros Progesterone Reagent Pack quantitatively measures progesterone concentration in human serum and plasma.

VITROS Progesterone Calibrators
For in vitro use in the calibration of the VITROS Immunodiagnostic System for the quantitative measurement of progesterone in human serum and plasma (EDTA or heparin).

The VITROS Immunodiagnostic System uses luminescence as the signal in the quantitative and semi-quantitative determination of selected analytes in human body fluids, commonly serum and plasma. Coated microwells are used as the solid phase separation system.

The system is comprised of three main elements:

1. The VITROS Immunodiagnostic Products range of immunoassay products (in this case VITROS Immunodiagnostic Products Progesterone Reagent Pack, VITROS Immunodiagnostic Products Progesterone Calibrators, which are combined by the VITROS Immunodiagnostic System to perform the VITROS Progesterone assay).
2. The VITROS Immunodiagnostic System instrumentation, which provides automated use of the immunoassay kits. The VITROS Immunodiagnostic System was cleared for market by a separate 510(k) premarket notification (K962919/S1).
3. Common reagents used by the VITROS System in each assay. The VITROS Immunodiagnostic Products Signal Reagent and VITROS Immunodiagnostic Products Universal Wash Reagent were cleared as part of the VITROS Immunodiagnostic Products Total T3 Reagent Pack and VITROS Immunodiagnostic Products Total T3 Calibrators 510(k) premarket notification (K964310).

The VITROS System and common reagents are dedicated specifically for use only with the VITROS Immunodiagnostic Products range of immunoassay products.

This submission describes the VITROS Immunodiagnostic Products Progesterone Reagent Pack and VITROS Immunodiagnostic Products Progesterone Calibrators (modified), which is a progesterone assay. The device is intended for in vitro diagnostic use to quantitatively measure progesterone concentration in human serum and plasma. The study presented aims to demonstrate substantial equivalence to a legally marketed predicate device (VITROS Immunodiagnostic Products Progesterone Reagent Pack and VITROS Immunodiagnostic Products Progesterone Calibrators).

1. Table of Acceptance Criteria and Reported Device Performance

The provided document details a comparison of assay characteristics between the predicate and the new device. It does not explicitly state quantitative acceptance criteria or detailed performance metrics. Instead, it focuses on substantial equivalence based on comparable characteristics.

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

The provided document does not specify the sample size used for the test set or the data provenance (e.g., country of origin, retrospective or prospective nature of the study). The submission focuses on comparing the modified device's characteristics to a predicate device, rather than providing detailed clinical study results with a test set.

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

Not applicable. This is an in vitro diagnostic device for quantitative measurement, and the ground truth would typically be established by established reference methods or primary analytical measurements, not by expert interpretation in the same way imaging or diagnostic algorithms are validated. The document does not mention the use of experts for ground truth establishment.

4. Adjudication Method for the Test Set

Not applicable. As noted above, the assessment is based on analytical performance and comparison to a predicate, not on subjective interpretations requiring 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

Not applicable. This is an in vitro diagnostic device, not an AI-assisted diagnostic tool that involves human readers interpreting results.

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

The device itself is a standalone immunoassay system. The document implies that the performance of the VITROS Progesterone assay (modified) was evaluated on its own analytical capabilities to demonstrate substantial equivalence to the predicate. There is no mention of human interaction beyond the operation of the instrument.

7. The Type of Ground Truth Used

The ground truth for this type of in vitro diagnostic device would typically be established through highly accurate and precise analytical reference methods, or by comparing agreement with the predicate device's established performance, rather than pathology, outcomes data, or expert consensus in an observational or interpretive sense. The document states that "the information presented in the pre-market notification demonstrates that the performance of the VITROS Progesterone assay (modified) for use with human serum and plasma is substantially equivalent to the cleared predicate device." This implies that the 'ground truth' or benchmark for performance comparison is the predicate device's established performance using recognized analytical methods.

8. The Sample Size for the Training Set

The document does not provide details on a "training set" in the context of machine learning. This device is an immunoassay, not an AI/ML-based algorithm that typically requires a training set. The development of such assays involves analytical validation, linearity studies, precision, accuracy, and interference studies, but these do not fall under the conventional definition of a "training set" for AI.

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

Not applicable, as this device does not utilize a "training set" in the AI/ML sense. The "ground truth" for developing and validating immunoassay performance would be derived from rigorous analytical testing using known concentrations of analytes, reference materials, and comparison with established methods.

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Calibration Plasma LMW Heparin is an in vitro diagnostic product intended as a tri-level calibrator to prepare calibration curves for use in chromogenic heparin assays.

Calibration Plasma LMW Heparin is an in vitro diagnostic product intended as a tri-level calibrator to prepare calibration curves for use in chromogenic heparin assays.

The provided text describes a 510(k) premarket notification for a medical device called "Calibration Plasma LMW Heparin," not an AI/ML SaMD product. Therefore, many of the requested categories related to AI/ML device studies (such as MRMC studies, ground truth establishment for training sets, number of experts, and adjudication methods) are not applicable to this submission.

However, I can extract information related to the device's performance study and acceptance criteria as presented in the document.

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

The document does not explicitly state "acceptance criteria" for the CV percentages, but it lists the performance data from a precision study. For this type of in vitro diagnostic calibrator, the reported precision (CV%) is the key performance metric. The predicate device's performance would typically serve as an implicit benchmark for substantial equivalence.

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

• Sample Size: The precision study was performed "over multiple days with multiple runs (n=60)" for each of the tri-level calibrators. This implies 60 technical replicates were used for the statistical calculation of CVs for each level.
• Data Provenance: The data was generated internally by Instrumentation Laboratory Company, in their labs, using "specific lots of IL reagents on IL instrumentation." The country of origin is implicitly the United States, where the company is located. The study is prospective in the sense that it was conducted specifically to evaluate the performance of this new calibrator.

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

This is not applicable as the device is an in vitro diagnostic calibrator. "Ground truth" for this device is defined by its manufacturing specifications and metrological traceability, not by expert interpretation. The "truth" is the assigned value of the calibrator.

4. Adjudication method for the test set

Not applicable for a precision study of an in vitro diagnostic calibrator.

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 calibrator, not an AI/ML-driven diagnostic system.

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

This concept does not apply to this device. The calibrator itself does not have an "algorithm" or "standalone performance" in the context of AI/ML. Its performance is measured by its precision and ability to establish a calibration curve.

7. The type of ground truth used

The "ground truth" for a calibrator is its assigned value, which is established through a rigorous process of metrological traceability, typically against international reference materials or methods. The document does not detail how the absolute 'Mean IU/mL' values (-0.03, 0.47, 0.80) were assigned, but it's understood to be part of the product's manufacturing and assay development process, following established metrological principles for calibrators.

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. This is not an AI/ML device.

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The CRP(II) Calibrators are intended to be used for the calibration of the CRP-Latex (II)X2 SEIKEN Assay kit for quantitating CRP (C-reactive protein) in human serum and EDTA or lithium heparinized plasma samples.

The CRP(II) Calibrator is intended to be used for the calibration of the CRP-Latex(II)X2 SEIKEN

The provided text describes a 510(k) submission for the "CRP(II) Calibrators" device. However, it does not include detailed acceptance criteria or a comprehensive study report with the specific information requested in your prompt (e.g., sample sizes for test and training sets, expert qualifications, adjudication methods, MRMC studies, effect sizes, etc.).

The document primarily focuses on the regulatory submission process and states that the calibrators are intended for use with the CRP-Latex(II)X2 SEIKEN assay kit. It mentions "Performance data" but then immediately states: "The CRP-Latex (II) "Seiken"X2 High Sensitivity Assay and the predicate device, N High Sensitivity CRP Assay have only minor difference that do not affect the performance, safety or effectiveness of the measurement." This implies that a detailed study demonstrating the calibrator's performance against specific acceptance criteria, as one would typically expect for a device, is not explicitly provided in this summary. Instead, it relies on substantial equivalence to a predicate device for the assay performance.

Therefore, for most of the requested points, the information is not available in the provided text.

Here's an attempt to answer based on the limited information given:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Not available. The document does not describe a specific test set for the calibrator's performance. It relies on the substantial equivalence of the CRP-Latex(II)X2 SEIKEN High Sensitivity Assay to a predicate device.

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

• Not available. There is no mention of a test set requiring expert ground truth establishment for the calibrator.

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

• Not available.

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

• Not applicable. This device is a calibrator for a laboratory assay, not an AI-assisted diagnostic tool that would involve human readers.

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

• Not applicable. This is a calibrator, not an algorithm or AI.

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

• Not available. Since no specific study details are provided for the calibrators, the type of ground truth for performance assessment is not mentioned. For the assay itself, typically, established reference methods or primary standards would serve as ground truth for accuracy and precision studies, but such studies are not detailed here for the calibrator.

8. The sample size for the training set:

• Not available. The document does not describe a training set for the calibrator.

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

• Not available.

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A urinary protein or albumin (nonquantitative) test system is a device intended to identify proteins or albumin in urine. Idetnification of urinary protein or albumin (nonquantitative) is used in the diagnosis and treatment of disease conditions such as renal or heart diseases or thyroid disorders, which are characterized by proteinuria or albuminuria.

When a sample is mixed with Buffer and Antibody, albumin in the sample combines specificaaly with anti-human albumin antibody (goat) in the Antibody to yeild an insoluble aggregate that causes increases turbidity in the solution. The degree of the turbidity of solution can be measured optically and is proportional to the concentration of albumin in the patient's sample.

The provided text describes a 510(k) summary for the "Wako Autokit Micro Albumin" device, which is a urinary protein or albumin (nonquantitative) test system. Here's a breakdown of the acceptance criteria and study information:

1. Table of Acceptance Criteria and Reported Device Performance

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

The document states "In comparison studies against the predicate, Wako Micro Albumin B assay". However, it does not specify the sample size used for these comparison studies. It also does not specify the country of origin of the data or whether the studies were retrospective or prospective.

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

This information is not provided in the document. The comparison is made against a predicate device (Wako Micro Albumin B assay), implying the predicate device's results serve as the reference, but there's no mention of expert involvement in establishing ground truth for the test set.

4. Adjudication method for the test set

This information is not provided in the document.

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

A multi-reader multi-case (MRMC) comparative effectiveness study was not performed or described. This device is an in-vitro diagnostic test for albumin measurement, not an AI-assisted diagnostic tool that would involve human readers.

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

Yes, the performance reported (minimum detectable level, correlation, regression) represents the standalone performance of the Wako Autokit Micro Albumin device when quantitatively measuring albumin, likely through its optical turbidity measurement method. There is no human-in-the-loop component for the direct measurement reported.

7. The type of ground truth used

The ground truth for the comparison studies was established using results from a legally marketed predicate device, the "Wako Micro Albumin B assay". This implies a comparison to an established, presumably accurate, laboratory method.

8. The sample size for the training set

This information is not provided in the document. The device is a laboratory assay, not a machine learning algorithm that typically undergoes a training phase with a dedicated training set.

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

This information is not applicable as the device is not a machine learning algorithm. If a "training set" were to refer to samples used during the development of the assay's reagents or method, the document does not elaborate on how ground truth for such samples would have been established.

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