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The SmartLyte® Plus is an automated, microprocessor-controlled analyzer which utilizes ion-selective electrodes for the measurement of sodium, potassium, chloride, calcium and lithium in Serum, Sodium Heparin Plasma, and Venous Whole Blood, as well as measurement of sodium, potassium and chloride in pre-diluted Urine samples.

The SmartLyte® Plus Sodium Assay is intended to measure sodium in Venous Whole Blood, Serum, Sodium Heparin Plasma, and Urine on the SmartLyte® Plus Electrolyte Analyzer. Measurements obtained by this device are used to monitor electrolyte balance in the diagnosis and treatment of aldosteronism (excessive secretion of the hormone aldosterone), diabetes insipidus (chronic excretion of large amounts of dilute Urine, accompanied by extreme thirst), adrenal hypertension, Addison's disease (caused by destruction of the adrenal glands), dehydration, inappropriate antidiuretic hormone secretion, or other diseases involving electrolyte imbalance.

The SmartLyte® Plus Potassum Assay is intended to measure potassium in Venous Whole Blood, Serum, Sodium Heparin Plasma, and Urine on the SmartLyte® Plus Electrolyte Analyzer. Measurements obtained by this device are used to monitor electrolyte balance in the diagnosis and treatment of diseases conditions characterized by low or high blood potassium levels.

The SmartLyte® Plus Chloride Assay is intended to measure the level of chloride in Venous Whole Blood, Serum, Sodium Heparin Plasma, and Urine on the SmartLyte® Plus Electrolyte Analyzer. Chloride measurements are used in the diagnosis and treatment of electrolyte and metabolic disorders such as cystic fibrosis and diabetic acidosis.

The SmartLyte® Plus Calcium Assay is intended to measure ionized calcium levels in Venous Whole Blood, Sodium Heparin Plasma, and Serum on the SmartLyte® Plus Electrolyte Analyzer. Calcium measurements are used in the diagnosis and treatment of parathyroid disease, a variety of bone diseases, chronic renal disease and tetany (intermittent muscular contractions or spasms).

The SmartLyte® Plus Lithium Assay is intended to measure lithium carbonate) in Venous Whole Blood, Sodium Heparin Plasma, and Serum on the SmartLyte® Plus Electrolyte Analyzer. Measurements of ithium are used to assure that the proper drug dosage is administered in the treatment with mental disturbances, such as manic-depressive illness (bipolar disorder).

For in-vitro diagnostic use only.

The SmartLyte® Plus Na+, K+, Cl-, Ca++, Li+ Electrolyte Analyzer which can test Serum, Sodium Heparin Plasma, Venous Whole Blood, pre-diluted Urine samples, and QC materials is substantially equivalent to it's predicate SmartLyte® Na+, K+, Cl-, Ca++, Li+ Electrolyte Analyzer which tests Serum, Sodium Heparin Plasma, Venous Whole Blood, pre-diluted Urine samples, and QC materials. Both are microprocessor-controlled analyzers which utilize ion-selective electrodes for the measurement of Sodium, Potassium, Chloride, Calcium and Lithium in Serum, Sodium Heparin Plasma, Venous Whole Blood, pre-diluted Urine samples, and QC materials. The analyzer self-calibrates using Diamond Diagnostics Fluid Pack (510(k) 013850) every 4 hours throughout the day or on request. Sodium. Potassium. Chloride and Calcium are commonly measured for use in the diagnosis and management of patients with a broad range of renal, metabolic and cardiovascular disorders. Lithium is a drug used to treat mental illness. Mission controls (510 (k) 033063) are the recommended quality control material to be used daily.

The SmartLyte® Plus is intended to be a direct replacement for the SmartLyte® Electrolyte Analyzer (K082462).

The SmartLyte® Plus Electrolyte Analyzer is designed for clinical laboratory professionals to assess the levels of Sodium, Potassium, Chloride, Calcium and Lithium found in Venous Whole Blood, Sodium Heparin Plasma, Serum, and Urine of patients. The analysis is performed in-vitro, and neither the analyzer nor any of its components come in contact with the patient.

The document describes the performance of the SmartLyte® Plus Electrolyte Analyzer. This device is an in-vitro diagnostic instrument, and the provided information details its analytical performance characteristics rather than the performance of an AI algorithm with human readers or a medical imaging device. Therefore, many of the requested points related to AI, MRMC studies, human experts, and ground truth establishment for complex data like images are not directly applicable or available in this document.

However, I can extract and present the acceptance criteria and reported device performance for the SmartLyte® Plus Electrolyte Analyzer as it relates to its analytical accuracy and precision.

Here's an analysis based on the provided document:

Acceptance Criteria and Reported Device Performance

The document presents performance data for Precision and Linearity for each analyte (Na+, K+, Cl-, Ca++, Li+) across different sample types (Serum, Plasma, Whole Blood, Urine). The acceptance criteria are implicitly quantitative, as the 'Status' for each test is reported as "Pass" against numerical criteria.

1. Table of Acceptance Criteria and Reported Device Performance (Summary)

Since the document provides extensive tables for precision (within-run and run-to-run) and linearity for each analyte and matrix, I will summarize the general acceptance criteria and indicate that the device passed all these criteria as reported in the document. Presenting every single data point for all analytes and matrices would be too large for this format.

Precision (for Serum/Blood/Plasma)

Precision (for Urine)

Linearity (General Acceptance Criterion)

Detection Limit

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Diamond Diagnostics ISE Serum Standards are intended for in-vitro diagnostics to provide calibration points for the sodium, potassium, and chloride electrodes on ADVIA Chemistry systems in Human Serum mode.

Diamond Diagnostics ISE Urine Standards are intended for in-vitro diagnostics to provide calibration points for the sodium, potassium, and chloride electrodes on ADVIA Chemistry systems in Human Urine mode.

Diamond Diagnostics ISE Serum Standards and ISE Urine Standards are intended to serve as a direct replacement to Siemens (Bayer) Advia ISE Serum Standards and ISE Urine Standards.
Diamond Diagnostics ISE Serum Standards consists of an aqueous buffered solution of electrolytes, and preservative in Deionized water. It contains NO human or animal products It is a liquid packaged in a 100mL high density polyethylene (HDPE) dropper bottle. It consists of one Serum Low Standard and one Serum High Standard sold as a set in a box.
Diamond ISE Urine Standards consists of an aqueous buffered solution of electrolytes, and preservative in Deionized water. It contains NO human or animal products. It is a liquid packaged in a 100mL HDPE dropper bottle. It consists of one Urine Low Standard and one Urine High Standard sold as a set in a box.

This document describes the Diamond Diagnostics ISE Serum Standards and ISE Urine Standards, which are calibrators for medical devices. The document highlights the product's characteristics, intended use, and a comparison with a predicate device to demonstrate substantial equivalence.

1. Acceptance Criteria and Reported Device Performance

The acceptance criteria are implied by the target values for each analyte in the standards, with a defined tolerance range. The "reported device performance" refers to the target values that the manufactured calibrators are designed to meet and are verified against.

Diamond Diagnostics ISE Serum Standard Low:

Diamond Diagnostics ISE Serum Standard High:

Diamond Diagnostics ISE Urine Standard Low:

Diamond Diagnostics ISE Urine Standard High:

The study demonstrates that the manufactured standards are tested to assure they meet these target values within the predetermined acceptance criteria.

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

• Test Set Description: The document refers to testing "reagents analytically prior to bottling" and "analytically during the bottling process and prior to release to stock for distribution." Additionally, "Six replicates of each sample are tested analytically for the electrolytes."
• Sample Size: Six replicates of each standard (ISE Serum Standard Low, ISE Serum Standard High, ISE Urine Standard Low, ISE Urine Standard High) were tested.
• Data Provenance: The data appears to be prospective, generated during the manufacturing and quality control process of the Diamond Diagnostics ISE Standards. The country of origin is not explicitly stated but implied to be the US given the FDA submission.

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

This section is not applicable. The device is a calibrator, and its performance is evaluated against chemical reference standards and methods, not expert human interpretation.

4. Adjudication method for the test set

This section is not applicable. The evaluation relies on objective analytical measurements rather than subjective human assessment 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

This section is not applicable. The device is a chemical calibrator, not an AI-assisted diagnostic tool.

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

This section is not applicable as the device is a chemical calibrator. However, the performance of the calibrator itself is assessed in a "standalone" manner through analytical testing of its constituent analytes using specified reference methods.

7. The type of ground truth used

The ground truth for the test set is established by:

• Reference Standard Materials: NIST (National Institute of Standards and Technology) salts (NIST 919b for Na and Cl, NIST 918b for K) which are gravimetrically prepared.
• Reference Methods:
  • IL 943 Flame Photometry for Na+ and K+.
  • SAT-500 Salt Analyzer (Titrimetric method) for Cl-.

8. The sample size for the training set

This section is not applicable. The device is a calibrator, and its formulation and target values are based on established chemical principles and comparison to predicate devices, not a 'training set' in the machine learning sense. The "training" for such a device would be the formulation and manufacturing process designed to consistently achieve the specified concentrations.

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

This section is not applicable. As explained in point 8, there isn't a "training set" in the traditional sense for this type of device. The "ground truth" for the calibrator's target values is established by:

• Gravimetric Preparation from NIST Standards: Analytes are derived from NIST certified reference materials.
• Analytical Verification using Reference Methods: The final concentrations are verified using established and accurate analytical methods (Flame Photometry and Titrimetry).
• Matching Predicate Device Values: The target values were chosen to match those of the predicate ADVIA ISE Serum Standards and ISE Urine Standards.

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Mission CliniCheck Controls is intended for use as an assayed quality control serum to monitor the precision of laboratory testing procedures for the following analytes: Acetaminophen, Acid Phosphatase (Total), Alanine Aminotransferase (ALT/GPT), Albumin, Alkaline Phosphatase (ALP), Alpha-1 Anti-Trypsin, Alpha Fetoprotein, Alpha Hydroxybutyrate Dehydrogenase (α-HBDH), Amylase, Apolipoprotein A-1 (APO-A1), Aspartate Aminotransferase (AST/GOT), Bilirubin (Direct), Bilirubin (Total), C3 Complement, C4 Complement, Calcium, Carbon Dioxide (CO2), Carcinoembryonic Antigen (CEA), Ceruloplasmin, Chloride, Cholesterol (Total), HDL- Cholesterol, LDL-Cholesterol, Cholinesterase, Creatine Kinase (CK), Creatinine, Digoxin, Gamma Glutamyltransferase (GGT), Glucose, Haptoglobin, Immunoglobulin A (IgA), Immunoglobulin G (IgG), Immunoglobulin M (IgM), Iron, Iron-Binding Capacity, Total (TIBC), Iron-Binding Capacity, Unsaturated (UIBC), Lactate (Lactic acid), Lactate Dehydrogenase (LDH), Lipase, Lithium, Magnesium, Phosphorus, Potassium, Protein-Total, Salicylate, Sodium, T3 Free, T3 Total, T4 Free, T4 Total, Thyroid Stimulating Hormone (TSH), Transferrin, Triglycerides, Urea Nitrogen, and Uric Acid on instruments listed in the expected values chart.

Mission CliniCheck Assayed Chemistry Control is a human serum based product containing constituents of purified biochemicals (tissue extracts of human and animal origin), chemicals, therapeutic drugs, preservatives and stabilizers. Two levels of Control are provided in a lyophilized form. Each level is packaged into a glass amber bottle containing 5mL of product. The product is packaged in single level boxes (12 x 5mL) or multiple level boxes (6 x 2 x 5mL) and stored at 2 - 8°C.

Here's an analysis of the provided text regarding the acceptance criteria and study for the Mission CliniCheck Assayed Chemistry Control device:

Important Note: The provided document is a 510(k) summary for an Assayed Quality Control Material. This type of device is used to monitor the performance of laboratory tests, not to perform diagnostic tests directly on patients. Therefore, the "acceptance criteria" and "study" described are centered around the performance of the control material (its stability and value assignment) and its equivalence to a predicate control device, rather than the diagnostic accuracy or clinical utility of a medical device that generates results on patient samples. Many of the requested categories in your prompt (e.g., number of experts, adjudication, MRMC studies, standalone performance, training set) are typically relevant for AI/imaging diagnostic devices and are not applicable to the type of device described here.

Acceptance Criteria and Reported Device Performance

1. Table of Acceptance Criteria and Reported Device Performance:

Study Description:

The study proving the device meets the acceptance criteria is primarily an internal validation study and comparative analysis against a predicate device and known standards.

The key aspects of the study include:

• Value Assignment Study: This involves preparing a new lot of the control material and characterizing its analyte concentrations.
  • Methodology: 16 replicates (4 replicates each over 4 days) are tested. The mean of these 16 data points establishes the target mean value. A range of ±20% of the mean defines the acceptable limits for control performance.
  • Comparative Element: Testing is performed alongside OEM material to verify values. Lot-to-lot variation is determined by comparing the new lot to a previous lot, normalized to a serum standard (NIST or OEM).
• Stability Studies: These evaluate how the control material performs under different storage conditions and over time.
  • Shelf Life: An accelerated (high temperature) stress test was conducted to project and support the 2-year shelf life.
  • Reconstituted Stability: Testing determined stability for 20 days when frozen at -20°C.
  • In-use Stability: Testing determined stability for 7 days when refrigerated at 2-8°C, with specific shorter stabilities noted for certain analytes.
• Safety Testing: All human source material was tested for infectious agents (HBsAg, HCV, HIV-1/2) using FDA-approved methods.
• Comparison to Predicate Device: A detailed comparison was made between the new device and the predicate device (K103364) across various attributes like name, 510(k) number, intended use, matrix, form, levels, storage, reconstituted stability, shelf life, and packaging. The key difference was the expanded list of analytes the new device is assayed for, indicating the device meets the performance for these additional analytes.

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

• Sample Size for Value Assignment (Test Set): 16 replicates were used for each analyte to establish the mean and range for value assignment.
• Data Provenance: The data is generated internally by Diamond Diagnostics, Inc., as part of their manufacturing and quality control processes. The document does not specify the country of origin for the data, but the company is located in Holliston, MA, USA, and the submission is to the FDA, implying studies conform to US regulatory standards. The studies conducted are prospective for the specific lot being validated.

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

This question is not applicable to this type of device. The "ground truth" for a quality control material is established through precise analytical measurements using calibrated instruments and reference materials (like NIST standards) or comparison to existing validated OEM materials. It does not involve human expert interpretation in the way that, for example, a diagnostic imaging device would.

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

Not applicable. As described above, the "truth" for this control material is based on analytical measurements, not subjective human judgment 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 a quality control material, not an AI-powered diagnostic device involving human readers or interpretation of clinical cases.

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

Not applicable. This is not an algorithm or AI-based device. Its "performance" is its intrinsic analytical characteristics and stability, which are measured directly.

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

The "ground truth" for the control material's analyte concentrations is established by:

• Analytical Measurement: Precise quantitative measurement of analytes using laboratory instrumentation.
• Reference Materials: Normalization to NIST (National Institute of Standards and Technology) comparable standards or Original Equipment Manufacturer (OEM) materials.
• Comparison to Predicate/Previous Lots: Ensuring consistency and comparability with previously validated lots and the predicate device.

8. The sample size for the training set:

Not applicable. This device is not an AI/machine learning model and therefore does not have a "training set" in that context. The "value assignment" process involves establishing the characteristics of each new lot, which is analogous to a validation step for that specific lot, rather than training a model.

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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Diamond Diagnostics ATAC 8000/Envoy 500 ISE calibrators are intended to provide calibration points for the Na+, K+, Cl-, and CO2 electrodes on the ATAC 8000 and Envoy 500 instruments.

Diamond Diagnostics ATAC 8000/Envoy 500 ISE Calibrators are intended to serve as a direct replacement to ATAC 8000/Envoy 500 ISE Calibrators. Diamond Calibrator Low consists of an aqueous buffered solution of electrolytes and preservative in De-ionized water. It contains NO human or animal products. It is a liquid packaged in a 22ml screw top amber vial. Each vial contains 20 ml of solution. Diamond Calibrator High consists of an aqueous buffered solution of electrolytes and preservative in De-ionized water. It contains NO human or animal products. It is a liquid packaged in a 22ml screw top amber vial. Each vial contains 20 ml of solution.

The provided text describes a 510(k) summary for a medical device (calibrators) and does not contain information about studies proving the device meets acceptance criteria in the manner expected for diagnostic algorithms or imaging devices. The acceptance criteria and "device performance" in this context refer to the established concentration ranges for the analytes within the calibrator solutions. The "study" here is a stability test and analytical testing to verify the stated concentrations and demonstrate substantial equivalence, rather than a clinical performance study with patient data.

Here's the information extracted and formatted, with explanations for where certain requested details are not applicable to this type of device submission:

Acceptance Criteria and Reported Device Performance

Note on "Reported Device Performance": For calibrators, "performance" is typically defined by the accuracy and stability of the analyte concentrations within the specified ranges. The 510(k) summary states that "Target values, (or specifications) were obtained by testing reagents analytically prior to bottling, adjusting if necessary to meet specifications, testing analytically during the bottling process and prior to release to stock for distribution." This implies that the device meets these target values as part of its manufacturing and quality control process. The stability study further supports that these values are maintained over time.

Study Details

1. 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 explicitly state a "test set" sample size in terms of clinical subjects or a specific number of calibrator units tested.
   • The "test" here involves analytical testing of the calibrator solutions themselves.
   • Data provenance: Not specified in terms of country, but it's an in-vitro diagnostic device manufactured by Diamond Diagnostics Inc. in Holliston, MA. The testing is analytical, not clinical, so retrospective/prospective does not apply in the typical sense.

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. For a calibrator device, the "ground truth" for the analyte concentrations is established through analytical methods using NIST standards, not through expert human interpretation.

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

   • Not applicable. "Adjudication" typically refers to resolving disagreements among human readers in a clinical study. Here, the "truth" is determined by reference analytical methods.

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 device is a calibrator, not an AI-powered diagnostic algorithm. Therefore, no MRMC study or assessment of human reader improvement with AI assistance was performed.

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

   • The device itself is a standalone calibrator solution. Its "performance" is its ability to accurately provide known concentrations for instrument calibration.
   • The "study" supporting this involved:
     • Stability testing: "Accelerated (high temperature) stress test was conducted to support stability claim. Heat stressed reagents showed that calibrator parameters remained within specification thereby demonstrating stability equivalent to ATAC 8000 calibrators." This is a standalone performance test of the calibrator's chemical integrity over time.
     • Traceability and Analytical Testing: Analytes were determined using NIST standards (NIST 919a, 918a, 351). Instruments used for verification included IL 943 (Flame Photometry for Na, K), Corning 925, SAT-500 Salt Analyzer (Titrimetric for Cl), and Hitachi 912, Olympus-Beckman CX-7 (for CO2). This constitutes the direct analytical performance demonstration.

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

   • Reference Standards / Analytical Methods: The ground truth for the analyte concentrations (Na+, K+, Cl-, CO2) was established using certified National Institute of Standards and Technology (NIST) reference materials and validated reference analytical methods (Flame Photometry, Titrimetry).

7. The sample size for the training set:

   • Not applicable. This device is not an AI algorithm that requires a "training set."

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

   • Not applicable. This device is not an AI algorithm. The ground truth for the calibrator's analyte concentrations is established during its manufacturing and quality control process using NIST-traceable standards and analytical methods, as described in point 6.

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The SMARTLYTE is an automated, microprocessor-controlled analyzer which utilizes ion-selective electrodes for the measurement of sodium, potassium, chloride, calcium and lithium in serum, plasma, whole blood, pre-diluted urine samples. In addition, the analyzer can also measure sodium, chloride and calcium in dialysate samples.

The SMARTLYTE Sodium Assay is intended to measure sodium in whole blood, serum, plasma, pre-diluted urine and dialysate on the SMARTLYTE Electrolyte Analyzer. Measurements obtained by this device are used to monitor electrolyte balance in the diagnosis and treatment of aldosteronism (excessive secretion of the hormone aldosterone), diabetes insipidus (chronic excretion of large amounts of dilute urine, accompanied by extreme thirst), adrenal hypertension, Addison's disease (caused by destruction of the adrenal glands), dehydration, inappropriate antidiuretic hormone secretion, or other diseases involving electrolyte imbalance.

The SMARTLYTE Potassium Assay is intended to measure potassium in whole blood, serum, plasma, urine and dialysate. Measurements obtained by this device are used to monitor electrolyte balance in the diagnosis and treatment of diseases conditions characterized by low or high blood potassium levels.

The SMARTLYTE Chloride Assay is intended to measure the level of chloride in whole blood, serum, plasma, urine and dialysate. Chloride measurements are used in the diagnosis and treatment of electrolyte and metabolic disorders such as cystic fibrosis and diabetic acidosis.

The SMARTLYTE Calcium Assay is intended to measure ionized calcium levels in whole blood, plasma, serum, and dialysate. Calcium measurements are used in the diagnosis and treatment of parathyroid disease, a variety of bone diseases, chronic renal disease and tetany (intermittent muscular contractions or spasms).

The SMARTLYTE Lithium Assay is intended to measure lithium (from the drug lithium carbonate) in whole blood, plasma, and serum. Measurements of lithium are used to assure that the proper drug dosage is administered in the treatment of patients with mental disturbances, such as manic-depressive illness (bipolar disorder).

The SMARTLYTE Nat, K", CT, Ca*, Li Electrolyte Analyzer which can test serum, plasma, whole blood, pre-diluted urine samples, dialysate solutions and QC materials is identical to GEMLYTE Electrolyte Analyzer ( cleared under K082462) which tests serum, plasma, whole blood, pre-diluted urine samples, and QC materials. Both are microprocessor-controlled analyzers which utilize ion-selective electrodes for the measurement of sodium, potassium, chloride, calcium and lithium in serum, plasma, whole blood, pre-diluted urine samples, dialysate solutions and QC materials. The analyzer self-calibrates using Diamond Diagnostics Fluid Pack (510(k) 013850) every 4 hours through out the day or on request. Sodium, potassium, chloride and calcium are commonly measured for use in the diagnosis and management of patients with a broad range of renal, metabolic and cardiovascular disorders. Lithium is a drug used to treat mental illness. Mission controls (510 (k) 033063) are the recommended . quality control material to be used daily.

Here's an analysis of the provided text, outlining the acceptance criteria and the study that proves the device meets them, based on your requested format:

Acceptance Criteria and Device Performance Study for SMARTLYTE Electrolyte Analyzer

The SMARTLYTE Electrolyte Analyzer is an automated, microprocessor-controlled device using ion-selective electrodes to measure sodium, potassium, chloride, calcium, and lithium in various sample types, including dialysate. The study aimed to demonstrate the substantial equivalence of the SMARTLYTE to its predicate device, the AVL 9180 (K961458), particularly for dialysate measurements, which represent a modification from previously cleared uses.

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are generally implied by the predicate device's performance characteristics or defined in the "Reproducibility" section as maximum allowable CVs or SDs. The reported device performance is from the "Precision Dialysate" and "Dialysate Comparison" sections.

Note on Acceptance Criteria: The document primarily compares the SMARTLYTE's performance to the predicate device's expected values and establishes its own internal precision targets. For the method comparison, "good correlation to predicate with correlation coefficients typically greater than 0.99 and slope values between 0.96 and 1.04" serves as a key acceptance criterion for the clinical claims (correlation with a predicate device). For precision, specific CV/SD targets are given.

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

• Precision (Dialysate):
  • Within-run: 30 replicates for each of three dialysate samples (low, mid, high concentrations) per measurand.
  • Between-run (Total precision): 40 replicates (4 groups of 10 replicates over 10 days) for each of three dialysate samples per measurand.
• Linearity (Dialysate):
  • Sodium: 34 samples
  • Potassium: 36 samples
  • Chloride: 34 samples
  • Calcium: 48 samples
• Method Comparison (Dialysate):
  • Sodium: 43 samples
  • Potassium: 56 samples
  • Chloride: 51 samples
  • Calcium: 43 samples

Data Provenance: The document implies these were prospective studies conducted to support the 510(k) submission for the specific device modifications. No explicit country of origin is stated for data collection, but given it's a US FDA submission, it's typically assumed to be North American or adhering to international standards accepted by the FDA. The samples were "dialysates collected" and some were "spiked or diluted" to span the measurement ranges, suggesting a mix of clinical and artificially prepared samples. Prior data for whole blood, serum, plasma, and urine were "previously cleared (K082462)".

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

Not applicable. This is an in-vitro diagnostic device measuring analytes. The "ground truth" for the test set is established by the reference methods or the predicate device that the SMARTLYTE is compared against, not by human expert assessment of images or clinical cases. The reference for comparison would be the AVL 9180 predicate device.

4. Adjudication Method for the Test Set

Not applicable. Adjudication methods (like 2+1, 3+1 for consensus among experts) are used in studies involving human interpretation or subjective assessments. This study evaluates the analytical performance of an IVD device against a predicate or defined analytical targets.

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 involves multiple human readers evaluating cases with and without AI assistance to measure a change in human performance (e.g., diagnostic accuracy, reading time). The SMARTLYTE is an automated IVD device; it does not involve human readers interpreting output in the same way an imaging AI would.

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

Yes, the studies described (precision, linearity, method comparison) represent standalone performance of the SMARTLYTE device. The device operates automatically to measure analyte concentrations. The "human-in-the-loop" aspect is limited to operating the device and collecting samples, not interpreting an AI's output to make a diagnosis.

7. The Type of Ground Truth Used

The "ground truth" for the performance studies can be defined as:

• Reference Intervals/Expected Values: For linearity studies, expected values based on known dilutions of stock solutions serve as the ground truth.
• Predicate Device Measurements: For the method comparison study, the measurements from the predicate device (AVL 9180) on the same dialysate samples served as the comparative ground truth.
• Internal Precision Targets: For the precision studies, the acceptance criteria (max CV/SD) are internal performance targets, and the reported values are measured against these.

8. The Sample Size for the Training Set

Not applicable. The SMARTLYTE Electrolyte Analyzer is an IVD device based on ion-selective electrode technology, not a machine learning or AI algorithm that requires a "training set" in the conventional sense. Its performance is based on its hardware, chemistry, and pre-programmed algorithms, which are calibrated and verified through analytical studies.

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

Not applicable, as there is no "training set" in the context of this device's technology. The device uses established physical and chemical principles (ion-selective electrodes). Calibrations are performed using certified calibration fluids.

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The PROLYTE Electrolyte Analyzer Na*/K*/Cli/Li is designed for clinical laboratory use by laboratory professionals to assess the levels of Sodium, Potassium, Chloride and Lithium found in whole blood, serum, plasma, and urine of patients. The analysis is performed in-vitro, and neither the analyzer nor any of its components come in contact with the patient.

This analyzer is used by trained laboratory technicians in clinical laboratories to aid in the diagnosis and treatment of paiients with electrolyte imbalance as well as monitoring the lithium levels for those patients taking lithium. These locations routinely conform to CLA regulations, and conduct daily quality control programs.

The PROLYTE is an automated, microprocessor-controlled analyzer which utilizes ion-selective electrodes for the measurement of sodium, potassium, chloride and lithium in whole blood, plasma, serum, and urine samples.

The PROLYTE Sodium Assay is intended to measure sodium in whole blood, plasma, serum, and urine on the PROLYTE Electrolyte Analyzer Na 7K 7CI/Li. Measurements obtained by this device are used to monitor electrolyte balance in the diagnosis and treatment of aldosteronism (excessive secretion of the hormone aldosterone), diabetes insipidus (chronic excretion of dilute urine, accompanied by extreme thirst), adrenal hypertension, Addison's disease (caused by destruction of the adrenal glands), dehydration, inappropriate antidiuretic hormone secretion, or other diseases involving electrolyte imbalance.

The PROLYTE Potassium Assay is intended to measure potassium in whole blood, plasma, serum, and urine on the PROLYTE Electrolyte Analyzer Na */K */C//Li. Measurements obtained by this device are used to monitor electrolyte balance in the diagnosis and treatment of diseases conditions characterized by low or high blood potassium levels.

The PROLYTE Chloride Assay is intended to measure the level of chloride in whole blood, plasma, serum, and urine on the PROLYTE Electrolyte Analyzer Na*/K*/Cli/Li. Chloride measurements are used in the diagnosis and treatment of electrolyte and metabolic disorders such as cystic fibrosis and diabetic acidosis.

The PROLYTE Lithium test system is intended to measure lithium (from the drug lithium carbonate) in whole blood, plasma, or serum on the PROLYTE Electrolyte Analyzer Na*/K*/Cl'/Li. Measurements of lithium are used to assure that the proper drug dosage is administered in the treatment of patients with mental disturbances, such as manic-depressive illness (bipolar disorder).

It is For In Vitro Diagnostic Use.

The PROLYTE Electrolyte Analyzer Na*/K'/Cl/Li* is intended to be a direct replacement for the PROLYTE Electrolyte Analyzer Na K * (K102959). The PROLYTE Na * , K , CI / Li * Electrolyte Analyzer has all the Elookofyo Khayzerman Proyte Electrolyte Analyzer Na/K'/Cl (K102959), with the added feature that the CI ISE sensor may be replaced by a Li* ISE sensor by the end-user.

The PROLYTE Electrolyte Analyzer Na*/K*/Cli/Lif is designed for clinical laboratory professionals to assess the levels of Sodium, Potassium, Chloride and Lithium found in whole blood, plasma, and serum of patients. Sodium, Potassium, and Chloride are also assessed in urine of patients. The analysis and scrum of pairons. Ocularly be analyzer nor any of its components come in contact with the patient.

This bench top analyzer is used by trained laboratory technicians in clinical laboratories to aid in the ring bonen top and freatment of patients with electrolyte imbalance as well for the monitoring drug levels in those patents taking Lithium. These locations routinely conform to CLIA regulations, and conduct daily control programs.

It uses the Diamond Diagnostics Fluid Pack (K031159) which contains in a sealed package the two calibrants required for calibration along with a flush solution and a waste container. The analyzer can be programmed to self-calibrate at set intervals or on request. The analyzer establishes a slope for the electrode by means of the two calibrants. A value for a sample is determined by direct comparison to the calibrants. Mission Controls (K033063) are the recommended quality control material to be used daily.

The provided text describes the PROLYTE Electrolyte Analyzer Na+/K+/Cl-/Li+ and its performance based on non-clinical and clinical testing, primarily for the Lithium (Li+) assay as other analytes were previously cleared.

Here's an analysis of the acceptance criteria and study details based on the provided input:

Acceptance Criteria and Device Performance for PROLYTE Electrolyte Analyzer (K121140)

1. Table of Acceptance Criteria and Reported Device Performance (Lithium only)

The acceptance criteria are implied by the "Spec, BLD" (Specification for Blood) rows in the precision tables and the comparison against predicate device performance.

Precision (for Lithium: Blood, Plasma, Serum)

Linearity (Lithium)

Method Comparison (Lithium vs. Predicate GEMLYTE K082462)

Note on Precision "F" (Fail) for Plasma and Serum within-run precision at V High:
The tables show "F" for Plasma and Serum at the "V High" concentration for within-run precision (Spec, BLD = 0.03). However, the narrative states, "Lithium demonstrated precision within the limits defined below in the reference range, 0.3 to 2.0 mEq/L." The "V High" concentrations (4.41513 and 4.30820 mEq/L) are outside this stated reference range. The "Spec, BLD" of ≤ 0.03 appears to be the acceptance criterion for the reference range (0.3 - 2.0 mEq/L). The reported standard deviations for these V High values, while exceeding 0.03, may be acceptable for concentrations outside the strict clinical reference range or may indicate a different specification applied to the extreme high end which is not explicitly stated. Given the overall conclusion of safety and effectiveness, it's implied these were deemed acceptable.

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

• Precision Test Set (Lithium):

  • Within Run: 30 replicates for each of 5 concentration levels (V Low, Low, Mid, High, V High) for whole blood, plasma, and serum matrices. (Total of 30 samples/level * 5 levels = 150 measurements per matrix).
  • Run to Run (Total Precision):
    • Plasma/Serum: 40 replicates (measured twice each morning and twice each afternoon for 10 days) for most concentration levels. Some levels had 41 or 44 replicates.
    • Whole Blood: 4 groups of 10 replicates, separated by calibration (total of 40 measurements).
  • Data Provenance: Not explicitly stated, but the context of an FDA 510(k) submission for IVD devices typically implies data collected in a controlled laboratory setting, often in the US, following GLP/GCP guidelines for clinical studies. It is prospective data collection specifically for these tests.

• Linearity Test Set (Lithium):

  • Whole Blood: 100 samples
  • Plasma: 38 samples
  • Serum: 44 samples
  • Data Provenance: Not explicitly stated, but derived from serially diluted stock solutions. Prospective data.

• Method Comparison Test Set (Lithium):

  • Whole Blood: 94 patient samples
  • Plasma: 100 patient samples
  • Serum: 91 patient samples
  • Data Provenance: "patient samples" implies retrospective or prospective collection from clinical pathology/laboratory settings. The country of origin is not specified, but typically for US regulatory submissions, the data is often generated in-country or by international labs adhering to recognized standards. It's not explicitly stated if it's retrospective or prospective collection, but method comparison studies often use prospectively collected "real-world" patient samples or archived samples.

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

This is a medical device for measuring analytes (Sodium, Potassium, Chloride, Lithium) in patient samples. The "ground truth" (or reference method) for such devices is typically established through:

• Reference laboratory methods: For quantitative measurements, this refers to established, highly accurate, and precise analytical methods.
• Comparison to a legally marketed predicate device: The method comparison study directly uses the predicate device's measurements as the reference for comparison, implying the predicate itself is the "ground truth" for regulatory purposes in this context.

No 'experts' in the sense of clinicians or radiologists are typically used to establish ground truth for this type of quantitative IVD assay. The accuracy is determined by analytical methods and comparison to a proven device, not expert consensus on qualitative interpretation.

4. Adjudication Method for the Test Set

Not applicable. Adjudication typically applies to qualitative or semi-quantitative assessments where multiple human interpreters might disagree (e.g., image interpretation). For a quantitative analyzer measuring discrete chemical levels, the output is a numerical value, and the ground truth relies on established analytical methods or comparison to a predicate device, not human subjective assessment needing adjudication.

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

Not applicable. This is an In Vitro Diagnostic (IVD) device for quantitative chemical analysis, not an imaging device or AI-assisted diagnostic tool that involves human readers interpreting cases. Therefore, a multi-reader multi-case (MRMC) comparative effectiveness study or analysis of human reader improvement with AI assistance is not relevant to this device type.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

Yes, the studies presented (precision, linearity, method comparison) are inherently standalone performance studies for the device (the "algorithm" in a broader sense of the instrument's measurement principle and processing) without direct human intervention in the measurement process itself once initiated. The device provides a direct numerical output.

7. Type of Ground Truth Used

• Precision: Internal consistency of the device, measured against statistical definitions (standard deviation, coefficient of variation). The "truth" is the mean of multiple measurements.
• Linearity: Expected values based on serial dilution of known stock solutions. The "truth" is the theoretical concentration.
• Method Comparison: Measurements from a legally marketed predicate device (GEMLYTE K082462). This is the primary "ground truth" for demonstrating substantial equivalence. For the analytes (Na, K, Cl, Li) this is a direct quantitative comparison.

8. Sample Size for the Training Set

The document does not explicitly mention a "training set" in the context of machine learning or AI development. This device uses ion-selective electrode technology, which is a well-established analytical principle based on electrochemical measurements, not a machine learning model that requires a discrete training phase. The "training" of the device is analogous to calibration, which uses known calibrant solutions.

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

As noted above, a "training set" for an AI model is not applicable here. However, for the operational aspect of the device (calibration), the "ground truth" is established by:

• The use of "Fluid Pack (K031159) which contains in a sealed package the two calibrants required for calibration." These calibrants would have precisely known concentrations of the target analytes.
• The analyzer "establishes a slope for the electrode by means of the two calibrants." This process essentially "trains" the electrodes to accurately translate electrochemical signals into analyte concentrations.

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Diamond Calibrators for Tokyo Boeki ISE Modules are intended for in-vitro diagnostics use to provide calibration points for the Na', K', and Cl electrodes on the Tokyo Boeki Prestige 24i, Biolis 24i, MGC 240, and Sirrus instruments in both Human Serum and Human Urine modes.

Diamond Tokyo Boeki Calibrators are intended to serve as a direct replacement to Tokyo Boeki ISE Calibrators. Diamond Tokyo Boeki ISE Module calibrators are intended to provide calibration points for the Na*, K*, and Cl electrodes on the Tokyo Boeki Prestige 24i, Biolis 24i, MGC 240, Sapphire 400, Sirrus, TMS-1024i, TRX-7010 and Labmax 240 instruments in both Human Serum and Human Urine modes.

Diamond Calibrator 1 consists of a buffered solution of electrolytes and preservative. It contains no human or biological materials. It is packaged in a foil bag with a draw tube and covered in a corrugated box. Each foil bag contains 420 ml of solution.

Diamond Calibrator 2 consists of a buffered solution of electrolytes and preservative. It contains no human or biological materials. It is packaged in a plastic bottle with a cap. Each plastic bottle contains 20 ml of solution.

Diamond Urine Calibrator is comprised of Urine Calibrator 1 and 2 which are not sold separately. Each box contains 10 ampules of Calibrator 1 in a tray and 10 ampules of Calibrator 2 in a separate tray.

Diamond Urine Calibrator 1 consists of a buffered solution of electrolytes and preservative. It contains no human or biological materials. It is packaged in glass ampule. The ampule is placed into a tray containing 10 ampules which is then placed into a card stock box. Each ampule contains 1.8 ml of solution.

Diamond Urine Calibrator 2 consists of a buffered solution of electrolytes and preservative. It contains no human or biological materials. It is packaged in glass ampule. The ampule is placed into a tray containing 10 ampules which is then placed into a card stock box. Each ampule contains 1.8 ml of solution.

The provided submission, K120591, describes the Diamond Calibrators for Tokyo Boeki ISE Module Calibrators. This is a medical device for in-vitro diagnostics. The information provided is detailed but does not align with the typical structure of an AI/ML device study. It focuses on the analytical performance of the calibrator itself, rather than the performance of an AI algorithm.

Therefore, many of the requested sections about AI/ML device studies (e.g., sample size for test set, number of experts, adjudication method, MRMC study, standalone performance, training set details) are not applicable to this submission.

However, I can extract the acceptance criteria and reported device performance from the provided text for the analytical performance of the calibrators.

Acceptance Criteria and Reported Device Performance

Device: Diamond Calibrators for Tokyo Boeki ISE Module Calibrators

Intended Use: To provide calibration points for Na+, K+, and Cl- electrodes on specific Tokyo Boeki instruments in both Human Serum and Human Urine modes.

Type of Study: Analytical performance studies (Precision, Linearity, Comparison, Stability, Traceability) were conducted to demonstrate that the Diamond Calibrators are substantially equivalent to the predicate Tokyo Boeki ISE Module Calibrators.

Ground Truth Used: The ground truth for the analytical studies was established through reference methods and NIST (National Institute of Standards and Technology) salts for traceability. For comparison studies, the predicate device's performance served as a reference.

Training Set: Not applicable, as this is a calibrator device, not an AI/ML algorithm that requires a training set.

Summary of Acceptance Criteria and Reported Device Performance:

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Mission CliniCheck Controls is intended for use as an assayed quality control serum to monitor the precision of laboratory testing procedures for the following analytes Acid Phosphatase (Total), Alanine Aminotransferase (ALT/GPT), Albumin, Alkaline Phosphatase (ALP), Alpha Hydroxybutyrate Dehydrogenase (a-HBDH), Amylase, Apolipoprotein A-1, Aspartate Aminotransferase (AST/GOT), Bilirubin (Direct), Bilirubin (Total), C3 Complement C4 Complement, Calcium, Carbon Dioxide (CO2), Chloride, Cholesterol (Total), HDL- Cholesterol, LDL-Cholesterol, Cholinesterase, Creatine Kinase (CK), Creatinine, Gamma Glutamyltransferase (GGT), Glucose, Immunoglobulin A (IgA), Immunoglobulin G (IgG), Immunoglobulin M (IgM), Iron, Iron Binding Capacity, Total (TIBC), Iron Binding Capacity, Unsaturated (UIBC), Lactate (Lactic acid), Lactate Dehydrogenase (LDH), Lipase, Lithium, Magnesium, Phosphorus, Potassium, Protein-Total, Salicylate, Sodium, T3 Free, T3 Total, T Free, T4 Total, Thyroid Stimulating Hormone (TSH), Transferrin, Triglycerides, Urea, Urea Nitrogen, and Uric Acid on instruments listed in the expected values chart.

Mission CliniCheck Assayed Chemistry Control is a human serum based product containing constituents of purified biochemicals (tissue extracts of human and animal origin) chemicals, preservatives and stabilizers. Two levels of Control are provided in a lyophilized form. Each level is packaged into a glass amber bottle containing 5mL of product. The product is packaged in single level boxes (12 x 5mL) or multiple level boxes (6 x 2 x 5mL) and stored at 2 - 8°C. All human source material was tested and found negative by FDA approved methods for HBsAG, HCV, and HIV-1/2.

Here's a breakdown of the acceptance criteria and study information based on the provided text:

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

The provided text does not explicitly state quantitative acceptance criteria in terms of performance metrics (e.g., accuracy, precision limits) for the Mission CliniCheck Assayed Chemistry Control. Instead, the "performance" described relates to stability and shelf-life, demonstrating that the control material maintains its characteristics over time.

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 specify a "test set" in the context of typical AI algorithm validation. The tests conducted were related to stability studies for the control material itself. Therefore, the sample size would refer to the number of control units tested for stability, but this information is not provided.

The provenance of this data is internal to the manufacturer, Diamond Diagnostics, Inc., as they conducted these tests to support their product claims. The studies appear to be prospective in nature, as they involve testing the product over time under various conditions (accelerated, refrigerated, frozen) to determine its stability. No information regarding country of origin for the data is provided beyond the applicant's address in Holliston, MA, USA.

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 question is not applicable to the type of device being described. The Mission CliniCheck Assayed Chemistry Control is a quality control material, not a diagnostic device requiring expert interpretation of results to establish "ground truth." Its "truth" is its certified analyte concentrations.

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

Not applicable. This device does not involve human interpretation or adjudication in the way an AI diagnostic tool would.

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 a quality control material and not an AI-assisted diagnostic device 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 quality control material, not an algorithm.

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

The "ground truth" for this device would be the certified values of the analytes within the control material. These values are established through rigorous analytical testing using reference methods and/or expert laboratories to define the expected concentration ranges for each analyte. The document doesn't detail this process, but it is standard for assayed quality control materials.

8. The sample size for the training set

Not applicable. This device is a quality control material, not a machine learning model, so there is no 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 PROLYTE is intended to be a direct replacement for the PROLYTE Electrolyte Analyzer (K070104).

The PROLYTE Electrolyte Analyzer is designed for clinical laboratory use by laboratory professionals to assess the levels of Sodium, Potassium, and Chloride found in whole blood, serum, plasma, and urine of patients. The analysis is performed in-vitro, and neither the analyzer nor any of its components come in contact with the patient.

This analyzer is used by laboratory trained technicians in clinical laboratories to aid in the diagnosis and treatment of palients with electrolyte imbalance. These locations routinely conform to CLIA requlations, and conduct daily quality control programs.

The PROLYTE is an automated, microprocessor-controlled analyzer which utilizes ion-selective electrodes for the measurement of sodium, potassium, and chloride in whole blood, plasma, serum, and pre-diluted urine samples.

The PROLYTE Sodium Assay is intended to measure sodium in whole blood, plasma, serum, and urine on the PROLYTE Electrolyte Analyzer. Measurements obtained by this device are used to monitor electrolyte balance in the diagnosis and treatment of aldosteronism (excessive secretion of the hormone aldosterone), diabetes insipidus (chronic excretion of large amounts of dilute urine, accompanied by extreme thirst), adrenal hypertension, Addison's disease (caused by destruction of the adrenal glands), dehydration, inappropriate antidiuretic hormone secretion, or other diseases involving electrolyte imbalance.

The PROLYTE Potassium Assay is intended to measure potassium in whole blood, plasma, serum, and urine on the PROLYTE Electrolyte Analyzer. Measurements obtained by this device are used to monitor electrolyte balance in the diagnosis and treatment of diseases conditions characterized by low or high blood potassium levels.

The PROLYTE Chloride Assay is intended to measure the level of chloride in whole blood, plasma, serum, and urine. Chloride measurements are used in the diagnosis and treatment of electrolyte and metabolic disorders such as cystic fibrosis and diabetic acidosis.

For In Vitro Diagnostic Use

The PROLYTE is an automated, microprocessor-controlled analyzer which utilizes ion-selective electrodes for the measurement of sodium, potassium and chloride in serum, plasma, whole blood and pre-diluted urine samples. The PROLYTE analyzer is designed with the user in mind. It is fully automated with simple 'Yes' or 'No' commands for menu navigation. This simple interface ensures that the analyzer be easy to use for quick analysis, (one minute for most samples), but also that the testing of samples can be done by even non-skilled operators with relative ease. The analyzer can be programmed to selfcalibrate using Mission Diagnostics Fluid Pack Na/K/Cl (510(k) 031159) at set intervals or on request. Sodium, potassium and chloride are commonly measured for use in the diagnosis and management of patients with a broad range of renal, metabolic and cardiovascular disorders. Mission Controls (510(k) 033063) are the recommended quality control material to be used daily.

Here's an analysis of the acceptance criteria and study details for the PROLYTE Electrolyte Analyzer, based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for the PROLYTE Electrolyte Analyzer are primarily focused on precision (within-run and total imprecision) and linearity. Another critical criterion for this 510(k) submission is substantial equivalence to its predicate device throughout its claimed measuring range, demonstrated through method comparison studies.

Here's the table summarizing these criteria and the reported performance from the provided document:

2. Sample Size and Data Provenance for the Test Set

• Precision Test Set Sample Sizes:
  • Within-Run Imprecision: 30 replicates for each sample (low, mid, high concentrations) per analyte and matrix.
  • Total Imprecision: 40 replicates (2 measurements daily for 10 days for serum, plasma, urine; 40 replicates on 2 instruments for whole blood).
• Linearity Test Set Sample Sizes:
  • Whole Blood: 42 (Na+), 36 (K+), 42 (Cl-)
  • Plasma: 42 (Na+), 54 (K+), 42 (Cl-)
  • Serum: 33 (Na+), 33 (K+), 27 (Cl-)
  • Urine: 40 (Na+), 36 (K+), 34 (Cl-)
• Method Comparison Test Set Sample Sizes:
  • Whole Blood: 110 (Na+), 111 (K+), 108 (Cl-)
  • Plasma: 101 (Na+), 104 (K+), 101 (Cl-)
  • Serum: 103 (Na+), 100 (K+), 106 (Cl-)
  • Urine: 102 (Na+), 105 (K+), 101 (Cl-)
  • Data Provenance: The document does not specify the country of origin. It indicates that these are "non-clinical tests" and "clinical tests" referring to method comparisons with patient samples. The samples were either patient samples or spiked/diluted samples to cover the entire measuring range. This implies a prospective collection and testing approach for portions of the method comparison and possibly for precision and linearity.

3. Number of Experts and Qualifications for Ground Truth

• This device is an in vitro diagnostic (IVD) device (analyzing chemical analytes in body fluids) for which the "ground truth" is typically established by reference methods, calibrated standards, or a predicate device, not by human expert interpretation like in imaging.
• For the method comparison studies, the predicate device (original PROLYTE Electrolyte Analyzer K070104) served as the reference for ground truth. Therefore, the "experts" in this context would be the predicate device itself, which has been previously cleared by the FDA based on its own validation.

4. Adjudication Method for the Test Set

• No adjudication method (like 2+1 or 3+1 consensus) is applicable or mentioned. As an IVD device, measurements are quantitative and compared directly to either itself (for precision and linearity) or a predicate device (for method comparison), not to subjective expert interpretations requiring adjudication.

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

• No MRMC comparative effectiveness study was done or is applicable. This is an IVD device providing quantitative measurements, not an AI imaging or diagnostic algorithm that assists human readers.

6. Standalone Algorithm Performance

• Yes, the entire study focuses on standalone performance of the PROLYTE Electrolyte Analyzer. The "algorithm" here refers to the instrument's internal measurement and processing capabilities. The non-clinical (precision and linearity) and clinical (method comparison) tests assess the device's inherent performance characteristics directly.

7. Type of Ground Truth Used

• For precision and linearity, the ground truth is established by the known concentrations of the analytes in the control materials and diluted stock solutions. These are internal reference points.
• For method comparison, the ground truth is established by the measurements obtained from the predicate device (original PROLYTE Electrolyte Analyzer K070104). This approach aims to demonstrate substantial equivalence, meaning the new device performs comparably to a device already cleared for market.

8. Sample Size for the Training Set

• The document does not explicitly mention a "training set" in the context of machine learning. The device is an analyzer that uses ion-selective electrodes, and its "software" was rewritten, but its underlying measurement principles are the same as the predicate. The performance studies described are for validation/testing of the implemented system, not for training a model in the machine learning sense. The device is likely calibrated using standardized solutions, which could be considered an ongoing "training" or calibration process, but this is distinct from a one-time dataset for algorithm development.

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

• As noted above, the concept of a training set as typically understood in machine learning is not directly applicable here. The device functions based on established electrochemical principles. The "calibration" of the device likely uses certified reference materials with known concentrations, ensuring accuracy. This would be part of the device's operational procedure rather than a study-specific training set.

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Diamond Calibrators for Medica ISE Modules are intended for in-vitro diagnostics use to provide calibration points for the Na *, K , and Ci electrodes on the Poly-Chem and Randox Daytona instruments having the Medica ISE Module.

Diamond Calibrant A matrix consists of a buffered solution of electrolytes and preservative. It contains no human or biological materials. It is packaged in a foil bag with a draw tube and covered in a corrugated box. Each foil bag contains 500 ml of solution.

Diamond Calibrant B matrix consists of a buffered solution of electrolytes and preservative. It contains no human or biological materials. It is packaged in a plastic bottle with a cap. Each plastic bottle contains 125 ml of solution.

Here's a breakdown of the acceptance criteria and the study information for the Diamond Calibrators for Medica ISE Module, based on the provided text:

Acceptance Criteria and Reported Device Performance

The core acceptance criteria for these calibrators revolve around their ability to provide accurate calibration points for Na+, K+, and Cl- electrodes, effectively performing equivalently to the predicate device. The values for Calibrant A and B are explicitly stated:

Reported Device Performance:
The summary states: "Results show equivalent performance for Na+, K+, and Cl calibration and precision. The devices show good correlation." This indicates that the Diamond Calibrators met the objective of providing calibration points within acceptable limits and demonstrating similar precision to the predicate device. While specific measured values are not provided in this summary, the declaration of "equivalent performance" and "good correlation" implies that the new device's output falls within the expected ranges and performs comparably to the predicate.

Study Details:

Based on the provided text, the study conducted is focused on demonstrating substantial equivalence to an existing predicate device rather than an independent standalone performance study or a comparative effectiveness study with human readers.

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

   • Sample Size: Not explicitly stated. The text mentions "Calibrators for Medica ISE Module were tested side by side with the predicate device on the Poly-Chem Dallrona Galleralyzer and Randox Daytona instruments." This implies multiple test runs or samples, but the exact number is not quantified.
   • Data Provenance: Not explicitly stated. However, given it's a 510(k) submission from a US company (Holliston, MA), it's highly likely the testing was conducted in the US. The time frame (October 2009 submission) suggests prospective testing for this specific submission.

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

   • This information is not applicable and not provided as this is a chemical calibrator, not an imaging or diagnostic device requiring expert interpretation of results to establish ground truth. The "ground truth" for calibrators is their known chemical composition and the accuracy of the measurements they enable on an instrument.

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

   • This is not applicable and not provided. Adjudication methods are typically used in studies involving human interpretation or subjective assessments, which is not the case for a chemical calibrator. The performance here is objectively measured by the instrument.

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:

   • No, an MRMC comparative effectiveness study was not done. This type of study is completely irrelevant for a chemical calibrator. The device described is not an AI-assisted diagnostic tool that aids human readers.

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

   • No, a standalone (algorithm-only) performance study was not done in the context of AI. However, the study essentially functions as an instrument-based standalone performance study for the calibrators. The "algorithm" here is the chemical process and the instrument's measurement system. The calibrators themselves were tested "side by side with the predicate device on the Poly-Chem Dallrona Galleralyzer and Randox Daytona instruments." This represents the performance of the calibrators as measured by the instrument, without human intervention in the measurement process itself, beyond operating the analyzer.

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

   • The ground truth for the calibrators is their certified chemical concentrations (e.g., $140 \pm 2.0$ mmol/L for Na+ in Calibrant A). These are established through precise manufacturing and analytical chemistry methods. The "ground truth" during the comparison study would be the expected values on the instruments when calibrated correctly, as confirmed by the predicate device's performance.

7. The sample size for the training set:

   • This is not applicable and not provided. This device is a chemical calibrator, not a machine learning algorithm that requires a "training set."

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

   • This is not applicable as there is no "training set" for this type of device. The ground truth for the calibrators themselves is established through their precise formulation and analytical verification during manufacturing.

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