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UA-Cellular® Complete is an assayed chemistry and cellular urine control for evaluating the accuracy and precision of automated procedures that measure urinary sediment and chemistry parameters on the following instruments and testing methods: Sysmex® UF-1000i™ Automated Urine Particle Analyzer: Siemens® Clinitek Atlas Automated Urine Chemistry Analyzer utilizing the Clinitek Atlas 10 Reagent Pak; the Arkray AUTION HYBRID™ AU-4050 fully-automated integrated urine analyzer: utilizing the Aution sticks 10EA Reagent strips: Siemens Clinitek Status® line of automated chemistry strip reader analyzers; Manual Reading of Urine Refractive Index; Manual Reading of the Siemens Multistix® 10SG Reagent Strips, and the Siemens Clinitest® hCG Pregnancy test.

The list of assayed parameters includes:

Sysmex® UF-1000i™: RBC(/uL), WBC(/uL), Epithelial (/uL), Cast (/uL), Bacteria (/uL), Crystals

Arkray AU-4050: RBC(/uL), WBC(/uL), Epithelial (/uL), Cast (/uL), Bacteria (/uL), Crystals

Arkray AU-4050 with Aution sticks 10EA Reagent strips : Glucose (mg/dL), Bilirubin (As Measured), Ketones (mg/dL), Specific Gravity (As Measured), pH (As Measured), pH (As Measured), Protein (mg/dL), Urobilinogen (EU/dL), Nitrite (As Measured), Leukocytes (As Measured), Color (As Measured), Turbidity (As Measured)

Siemens ® Clinitek Atlas with Atlas 10 Reagent Pak: Glucose (mg/dL), Bilirubin (As Measured), Ketones (mg/dL), Specific Gravity (As Measured), Blood (As Measured), pH (As Measured), Protein (mg/dL), Urobilinogen (EU/dL), Nitrite (As Measured), Leukocytes (As Measured), Color (As Measured), Clarity (As Measured)

Siemens Clinitek Status System line with Multistix 10SG Reagent Strips: Glucose (mg/d); Bilirubin (As Measured), Ketones (mg/dL), Specific Gravity (As Measured), Blood (As Mesured), pH (As Measured), Protein (me/dL), Urobilinogen (EU/dL), Nitrite (As Measured), Leukocytes (As Measured)

Siemens Multistix 10SG Reagent Strips: Glucose (mg/dL), Bilirubin (As Measured), Specific Gravity (As Measured), Blood (As Measured), pH (As Measured), Protein (mg/dL), Urobilinogen (EU/dL), Nitrite (As Measured), Leukocytes (As measured)

Siemens Clinitest hCG Pregnancy Test Cassette: Pregnancy hCG (As Measured)

Manual Confirmatory Testing: Refractive Index (nD)

UA-Cellular® Complete is a three-level, in-vitro diasis control that contains the following: stabilized mammalian red blood cells and white blood cells, stabilized bacteria, and simulative medium. Analyte levels are adjusted with appropriate chenicals. The product is packaged in a 4 oz. amber plastic bottle with a foil-lined flip-top cap. The product must be stored at 2-10°C.

The provided text describes the UA-Cellular® Complete device, a quality control material for urinalysis instruments, and studies performed to demonstrate its performance and stability.

Here's an analysis of the acceptance criteria and study information:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state numerical acceptance criteria in a table format for each specific parameter (e.g., RBC count, glucose level). Instead, it describes acceptance as:

• Cellular study: "acceptable if the mean of each run was within the acceptable range of control."
• Chemistry study: "considered acceptable if it was in agreement with the assigned range/concentration."

The reported device performance is broadly stated as:

• "All data collected fell within the acceptance criteria established for each instrument."
• "Study results show UA-Cellular Complete to be consistently equivalent to the predicate products, and stable for the entire product dating."
• "UA-Cellular Complete is a safe and effective product, which fulfills its intended use when used as instructed in the Instructions for Use."

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

The studies primarily focus on precision and stability testing of the quality control material itself, rather than a clinical trial with patient samples as a "test set" in the typical sense for a diagnostic device.

Multi-Site Precision Study (Test Set equivalent for evaluating the QC material's performance):

• Cellular Instrument Study (Arkray AU4050): Conducted across 3 instruments at three different sites. A single operator at each site ran each lot and level of control for 5 days, 2 runs per day, and 3 replicates per run.
• Chemistry Instrument Study: Not explicitly stated as a number of samples but implied by the different instruments/methods used. "Each site was instructed to run at minimum one 10-run."
• Data Provenance: Not explicitly stated as country of origin, but described as "Multi-Site," indicating data from multiple locations, likely within the US, given the FDA submission. The studies are prospective as they were conducted to substantiate the product performance.

Single-Site Precision Study:

• Cellular Instrument Study (UF-1000 and Arkray AU4050): Conducted with three separately manufactured lots of control. The "20x2x2 model" was followed: Two vials of control were used for each testing interval, and each vial of control was run in duplicate. This means 20 days x 2 vials x 2 replicates = 80 measurements per lot/level. Data was collected internally at Streck.
• Chemistry Instruments/Manual Methods Study: Conducted with three separately manufactured lots of control. The "20x2x2 model" was followed as above. Data was collected internally at Streck.
• Data Provenance: Internally collected at Streck. Prospective.

Open-Vial Stability Study:

• Cellular Instrument Study (UF-1000 and Arkray systems): Conducted with three separately manufactured lots of control. One vial of control per level from each lot was analyzed over 30 days plus one additional time point. Four replicates were taken during each testing event. Data was collected internally with one operator.
• Chemistry Instrument Study: Conducted with three separately manufactured lots of control for each representative instrument/method. One vial of control per level from each lot was analyzed over 30 days plus one additional time point. Four replicates were taken during each testing event.
• Data Provenance: Internally collected at Streck. Prospective.

Closed-Vial Stability Study:

• Cellular Instrument Study (UF-1000 and Arkray systems): Conducted with three separately manufactured lots of control. Two vials of control per level from each lot were analyzed in duplicate over 100 days plus one additional time point. Four data points were collected at each testing event. Data was collected internally with one operator.
• Chemistry Instrument Study: Conducted with three separately manufactured for each representative instrument/method. One vial of control per level from each lot was analyzed over 100 days plus an additional time point. Four replicates were taken during each testing event.
• Data Provenance: Internally collected at Streck. Prospective.

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

This device is a quality control material, not a diagnostic device that interprets patient data. Therefore, the concept of "ground truth" established by experts (like radiologists for image interpretation) for a "test set" of patient cases is not directly applicable.

Instead, the "ground truth" for this product is the assigned range/concentration of the analytes within the control material, determined by the manufacturer through rigorous characterization and validation processes not explicitly detailed in this summary (though typically involves reference methods and multiple testing events). The studies described here verify that the device performs within those pre-defined ranges.

4. Adjudication Method for the Test Set

Not applicable in the context of this type of device and study. The studies assess the control material's performance against its own established ranges/concentrations, not an interpretation of patient data requiring 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 where human readers (e.g., radiologists) interpret cases, and the study aims to show how AI assistance affects their diagnostic performance compared to reading without AI. UA-Cellular® Complete is a quality control material used to assess the performance of laboratory instruments, not for direct human interpretation of patient data or for AI-assisted diagnostic tasks.

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

Yes, the studies described are essentially "standalone" in the sense that they evaluate the performance of the UA-Cellular® Complete material on automated instruments without active human interpretive intervention for each "case." The human role is in performing the tests according to protocols and analyzing the resulting quantitative data.

7. The Type of Ground Truth Used

The ground truth for these studies is the assigned range/concentration for each analyte (e.g., RBC, glucose, pH) within the UA-Cellular® Complete material, established by the manufacturer. The studies then demonstrate that the device, when run on various instruments, consistently produces results that fall within these pre-defined acceptable ranges. This is an intrinsic property of the quality control material itself, rather than an external reference standard like pathology or outcomes data from patients.

8. The Sample Size for the Training Set

This document describes performance and stability studies for a quality control material. It does not mention a "training set" in the context of machine learning or AI models. The device itself (UA-Cellular® Complete) is a physical control material, not an algorithm that requires training data.

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 AUTION CHECK Plus is a quality control material intended for in vitro diagnostic use only, for performing quality control procedures with Arkray urine test strips and analyzers.

The AUTION CHECK Plus, is a two level liquid control prepared from human urine source material with added stabilizers and preservatives. Level 1 is positive for bilirubin and urobilinogen and Level 2 is positive for glucose, protein, blood, ketone, nitrite and leukocytes.

Here's a breakdown of the acceptance criteria and study information for the AUTION CHECK Plus device, based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Test Set Sample Size: For value assignment, the testing involves three operators and three analyzers, with each performing four tests on the control product. This means 3 operators * 3 analyzers * 4 tests = 36 individual tests per lot for value assignment.
• Data Provenance: The data is prospective, generated by Quantimetrix Corporation's Quality Control group in their laboratories. The document doesn't specify the country of origin, but given the FDA submission, it's presumably US-based.

3. Number of Experts and Qualifications for Ground Truth

• Number of Experts: Three different operators were used for the value assignment process.
• Qualifications of Experts: The document does not explicitly state the qualifications of the operators beyond them being "operators" in the Quality Control group.

4. Adjudication Method for the Test Set

• Adjudication Method: The value assignment process uses a consensus approach where "The means from all three operators and analyzers must fall within the specification range for the lot to be released." This implies a form of consensus-based adjudication, where all operators/analyzers must agree within a specified range for the lot to be accepted.

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

• No, an MRMC comparative effectiveness study was not done. This device is a quality control material, not a diagnostic device intended for human interpretation or a device designed to assist human readers.

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

• This device is a quality control material; therefore, the concept of an "algorithm" or "human-in-the-loop" performance doesn't directly apply in the same way it would for an AI diagnostic tool. The performance evaluation is based on the chemical properties and stability of the control material, and its ability to produce expected results on Arkray analyzing equipment. The "standalone" performance here refers to the intrinsic characteristics of the control material.

7. Type of Ground Truth Used

• For the value assignment (which serves as the "ground truth" for the control material's expected performance), the ground truth is established by internal laboratory analysis, comparing the control material's results against a pre-defined "specification range for the lot." This effectively establishes a known, expected range for the control.
• For the stability studies, the "ground truth" is the performance of the device over time compared to its initial established values, under various storage conditions.

8. Sample Size for the Training Set

• This product is a quality control material, not an AI or machine learning model that requires a "training set." Therefore, this question is not applicable.

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

• Since there is no training set for this device, this question is not applicable.

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UA-Cellular® Complete is an assayed chemistry and cellular urine control for evaluating the accuracy and precision of automated procedures that measure urinary sediment and chemistry parameters on the Sysmex® UF-1000i™ Automated Urine Particle Analyzer and the Siemens® Clinitek Atlas Automated Urine Chemistry Analyzer utilizing the Clinitek Atlas 10 Reagent Pak.

The list of assayed parameters includes:

Sysmex UF-1000i:RBC(/μL), WBC//μL), Epithelial (/uL), Cast, Bacteria (/uL), Crystals, Conductivity (mS/cm)

Siemens Clinitek Atlas with Atlas 10 Reagent Pak: Glucose (mg/dL), Bilirubin (As Measured), Ketones (mg/dL), Specific Gravity (As Measured), Blood (As Measured), pH (As Measured), Protein (mg/dL), Urobilinogen (EU/dL), Nitrite (As Measured), Leukocytes (As Measured), Color (As Measured), Clarity (As Measured)

UA-Cellular Complete is an in vitro diagnostic control prepared from stabilized mammalian red blood cells and white blood cells, stabilized bacteria, and simulated urine sediments in a preservative medium. Analyte levels are adjusted with appropriate chemicals.

Here's an analysis of the provided text regarding the acceptance criteria and study for the UA-Cellular® Complete device:

The provided text describes UA-Cellular® Complete, a quality control material, and its performance studies. It is important to note that this device is a control material for other diagnostic devices, not a diagnostic device itself that processes patient data. Therefore, the "acceptance criteria" and "study" described are focused on substantiating the control material's stability, accuracy (value assignment), and precision when used with the specified automated urine analyzers. The typical metrics for AI systems (like sensitivity, specificity, AUC) are not applicable here.

Here's the breakdown of the information requested, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for this control material are implicitly derived from its intended use to evaluate the accuracy and precision of automated procedures. The "reported device performance" refers to the successful demonstration of these criteria.

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

The concept of a "test set" as typically understood for an AI algorithm (a distinct dataset for final performance evaluation) doesn't directly apply here, as this is a control material. Instead, the studies involved collecting data on the performance of the control material.

• Value Assignment and Precision Performance:

  • Sample Size: Each of the three external sites and the internal Streck site performed a "10-run reproducibility study for the tri-level control on each lot (n=40 per level)". Given three lots and four sites, this would be: 3 lots * 4 sites * 40 runs/level = 480 data points per level for value assignment and precision. Since it's a tri-level control, the total number of individual runs would be 3 (levels) * 480 = 1440 runs.
  • Data Provenance: Data was collected "across three external sites and data collected internally at Streck." The text does not specify the country of origin for the external sites, nor does it explicitly state if the data was retrospective or prospective, though "real-time" is mentioned for stability testing, suggesting prospective collection.

• Open-Vial Stability and Closed-Vial Stability:

  • Sample Size: Not explicitly stated as "n=X" in the same way as value assignment. However, data was collected "real time across three separately manufactured lots." and over "the last 30-days of product dating" for open-vial stability. For closed-vial, it was verified "utilizing three-separately manufactured lots." The sample size here refers to the number of measurements taken over time for each lot, but precise numbers are not given.
  • Data Provenance: "All data was collected internally at Streck." This suggests the US. The "real-time" aspect indicates prospective data collection.

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

• Ground truth concept for a control material: For a control material, the "ground truth" is not established by expert consensus on clinical findings, but rather by the assigned value range for each parameter, which is determined through a rigorous value assignment study.
• Number of 'experts' / operators: The Value Assignment and Precision Performance studies each utilized "Four operators." While their specific qualifications (e.g., medical technologist, lab technician) are not stated, they are implied to be qualified laboratory personnel capable of operating the analyzers and performing reproducibility studies.

4. Adjudication Method for the Test Set

The concept of an "adjudication method" (like 2+1 or 3+1) is typically used when multiple human readers interpret an image or clinical finding to establish a consensus ground truth, especially for diagnostic AI applications. This is not applicable here as:

• The device is a control material.
• The "ground truth" (assigned values) are established through a statistical process (meeting ±3 Standard Deviation requirements) using instrumental measurements, not human interpretation requiring adjudication.

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

No, an MRMC comparative effectiveness study was not done. This type of study assesses how AI assistance impacts human reader performance, which is not applicable to a quality control material.

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

The device itself is a control material that works with automated analyzers. Its "performance" is inherently its interaction with the automated systems.

The studies described (Value Assignment, Stability, Precision) are effectively evaluating the standalone performance of the control material when run by the automated analyzers (without manual data adjustment or human decision-making influencing the measurement itself, beyond typical operational procedures). The "operators" are running the instruments, not interpreting the control material results to make a diagnosis or similar complex decision.

7. Type of Ground Truth Used

For the UA-Cellular® Complete control material, the "ground truth" for its performance is defined by:

• Assigned Assay Range/Values: This is essentially a statistically determined target range or value for each parameter, established through robust multi-site, multi-lot studies (Value Assignment study) meeting specific statistical criteria (e.g., ±3 Standard Deviation requirements). This is a form of quantifiable reference value based on instrument measurement and statistical analysis.

8. Sample Size for the Training Set

The concept of a "training set" is not applicable here. This device is a physical control material, not an AI algorithm that is trained on data. The studies described are for validation and characterization of the control material's properties (stability, assigned values, precision) with specific predicate devices, not for training an algorithm.

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

As there is no "training set" for this control material, this question is not applicable.

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The Randox Urinalysis Controls (URNAL Control 1 and URNAL Control 2) are urine controls containing Bilirubin, Blood, Creatinine, Crystals, Galactose, Glucose, hCG, Ketones, Leukocytes, Microalbumin, Nitrite, pH, Protein, Red Blood Cells, Specific Gravity, Urobilinogen and White Blood Cells. The Randox Urinalysis controls (URNAL Control 1 and URNAL Control 2) are intended for in vitro diagnostic use in the quality control of urine test strips for the analytes; Bilirubin, Blood, Creatinine, Glucose, Ketones, Leukocytes, Microalbumin, Nitrite, pH. Protein, Specific Gravity and Urobilinogen. This control is also intended for the evaluation of microscopic test procedures for Crystals, Red Blood Cells and White Blood Cells and also for the confirmatory tests hCG and Galactose. This in vitro diagnostic device is intended for prescription use only

The Randox Urinalysis Controls (URNAL Control 1 and URNAL Control 2) are urine controls containing Bilirubin, Blood, Creatinine, Crystals, Galactose, Glucose, hCG, Ketones, Leukocytes, Microalbumin, Nitrite, pH, Protein, Red Blood Cells, Specific Gravity, Urobilinogen and White Blood Cells.

This document is a 510(k) clearance letter from the FDA for a medical device called "Randox Urinalysis Controls URNAL Control 1 and URNAL Control 2." This type of document is an approval for marketing based on substantial equivalence to a predicate device, not a detailed study report. Therefore, it does not contain the specific information requested in your prompt regarding acceptance criteria and detailed study data.

The letter explicitly states: "We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices..."

Here's why the requested information cannot be extracted from this document:

• Acceptance Criteria and Device Performance: The letter confirms substantial equivalence, meaning the new device performs similarly to an existing, legally marketed device. It does not provide specific acceptance criteria or an analytical study comparing the performance of the new device against those criteria.
• Sample Size and Data Provenance: This information would be found in the detailed study report submitted as part of the 510(k) application, which is not provided here.
• Experts and Adjudication Method: These details are relevant for studies establishing ground truth, which are typically part of the scientific evidence supporting the 510(k) application, not the clearance letter itself.
• MRMC Comparative Effectiveness Study: This letter does not describe any MRMC studies or human-in-the-loop performance.
• Standalone Performance: The letter does not detail standalone algorithm performance.
• Type of Ground Truth: The letter doesn't specify how ground truth was established for any studies, as it's not a study report.
• Training Set Sample Size and Ground Truth Establishment (Training Set): These are details of the development and validation of the device, which would be in the technical documentation of the 510(k) submission, not the FDA's clearance letter.

In summary, this document is an FDA clearance letter for a device based on substantial equivalence, not a scientific study report. Therefore, it does not contain the detailed study results and acceptance criteria information you are seeking.

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The Mission Liquid Urine Control, Mission Liquid Diptube Urine Control and Mission Dry Strip Urine Control are assayed urine controls intended for use in validating the precision of visual and analyzer reading of urinalysis for one or more of the following analytes: Ascorbic acid, Glucose, Bilirubin, Ketone (Acetoacetic acid), Specific Gravity, Blood, pH, Protein, Urobilinogen, Nitrite and Leukocytes. It is intended for professional in vitro diagnostic use only.

The Mission Liquid Urine Control and Mission Liquid Diptube Urine Control are prepared from simulated human urine with purified chemicals, constituents of animal origin, preservatives and stabilizers. The controls are available in two levels, ready to use liquid format packaged in dropper bottles under the brand name Mission Liquid Urine Control and in diptube containers under the brand name Mission Liquid Diptube Urine Control. The results of the Mission Liquid Urine Control and Mission Liquid Diptube Urine Control are compared to the lot-specific expected values listed in the package insert to ensure the consistent performance of Mission Urinalysis Reagent Strips and Mission Urine Analyzers.

The Mission Dry Strip Urine Control are firm plastic strips onto which reagent areas are affixed. The negative level strips have five reagent areas containing one or more synthetic ingredients. When placed in a measured quantity of distilled or deionized water, the ingredients dissolve out of the reagent areas to produce a Level 1 Control Solution. The Level 2 strips have six reagent areas affixed. The ingredients on the positive level strips dissolve out to produce a Level 2 Control Solution. The results of the Mission Dry Strip Urine Control are compared to the lot-specific expected values listed in the package insert to ensure the consistent performance of Mission Urinalysis Reagent Strips and Mission Urine Analyzers

The provided 510(k) summary (K103387) describes the "Mission Liquid Urine Control, Mission Liquid Diptube Urine Control, and Mission Dry Strip Urine Control" devices. However, it does not explicitly state specific, quantifiable acceptance criteria or provide a detailed study that proves the device meets such criteria.

Instead, the document focuses on demonstrating substantial equivalence to predicate devices. The "Discussion of Non-Clinical Tests Performed" section broadly lists types of evaluations conducted (matrix effects, control value assignment, temperature flexibility, humidity effect, lighting effect, number of dip times, incubation time, and shelf life and stability), but it does not present the results of these tests in a way that allows for the extraction of acceptance criteria or performance metrics directly from this document.

The "Conclusion" states: "The laboratory testing demonstrates that the Mission Liquid Urine Control, Mission Liquid Diptube Urine Control and Mission Dry Strip Urine Control are safe, accurate and easy-to-use. It also demonstrates that the Mission Liquid Urine Control, Mission Liquid Diptube Urine Control and Mission Dry Strip Urine Control are substantially equivalent to the Bio-Rad Laboratories Liquicheck Urinalysis Control and Siemens Healthcare Diagnostics Inc. Chek-Stix Positive and Negative Control Strips for Urine Chemistry, currently sold on the U.S. market."

Based on the provided text, the specific information requested cannot be fully extracted in the format desired for acceptance criteria and a performance study. Here's a breakdown of what can be inferred or directly stated from the document, and what is missing:

1. Table of Acceptance Criteria and Reported Device Performance

Cannot be fully provided as specific, quantifiable acceptance criteria and performance data are not detailed in the provided 510(k) summary. The document focuses on demonstrating substantial equivalence through a comparison of technological characteristics and general statements about testing.

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

• Sample Size: Not specified in the provided document. The text only refers to "Laboratory Testing" and "studies" without detailing the number of units or measurements included in these evaluations.
• Data Provenance: Not specified. The document does not mention 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 Qualifications of Those Experts

Not applicable based on the provided document. The device is a quality control material intended for validating the precision of urinalysis instruments and visual reading. The "ground truth" for such controls typically involves precisely manufactured solutions with known concentrations of analytes, not expert interpretation of results. The document states "control value assignment" was evaluated through laboratory testing, implying these values are determined analytically rather than by expert consensus.

4. Adjudication Method for the Test Set

Not applicable. As noted above, the "ground truth" for this type of device is likely based on precise chemical formulation and analytical validation, not expert adjudication of subjective assessments.

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 quality control material for urinalysis, not an AI-powered diagnostic tool. No MRMC study or AI assistance is mentioned or relevant to this device type.

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

Not applicable. This device is a quality control material, not an algorithm, and does not involve AI or human-in-the-loop performance in the context of its function.

7. The Type of Ground Truth Used

The ground truth for this type of device (urinalysis control) would be based on known, precisely manufactured concentrations of analytes within the control solutions. The document mentions "control value assignment" was evaluated, which supports this. It is a "manufacturer-assigned value" (also often referred to as an "assayed control").

8. The Sample Size for the Training Set

Not applicable. This device is a quality control material, not an AI model or 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 type of device.

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CLINIQA® Liquid QC™ DipScopics Urinalysis Control is intended for use as an assayed quality control material for various urinalysis reagent strips, qualitative hCG methods as well as confirmatory tests such as Acetest®, Clinitest", and Ictotest This control is also intended to evaluate microscopic examination test procedures

Not Found

I am sorry, but based on the provided text, I cannot provide the requested information. The document is a 510(k) clearance letter from the FDA for CLINIQA Liquid QC Urinalysis Controls, Levels 1 and 2. It confirms that the device has been found substantially equivalent to a predicate device but does not contain any details about acceptance criteria, study design, reported device performance, sample sizes, expert qualifications, adjudication methods, or ground truth establishment. This type of information is typically found in the 510(k) submission itself, not in the clearance letter.

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IRISpec™ CA/CB/CC is an assayed QC material for monitoring of urine chemistry analytes and devices as listed on the package insert. For in vitro diagnostic (IVD) use only.

IRISpec™ CA/CB/CC controls are based on a synthetic matrix simulating human urine, with preservatives and bovine-sourced biological material for serum albumin, hemoglobin, bilirubin. No human sourced materials.

Here's a breakdown of the acceptance criteria and the study details for the IRISpec™ CA/CB/CC device, based on the provided 510(k) summary:

1. Table of Acceptance Criteria and Reported Device Performance

Device: IRISpec™ CA/CB/CC

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

• Test Set Sample Size:
  • Matrix Effects: 3 lots of proposed CC control.
  • Closed Vial Stability: 3 lots of proposed CC controls, plus IRISpec™CA and IRISpec™CB as negative controls.
  • Accelerated Temperature Stability: 3 lots of IRISpec™CC controls, plus IRISpec™CA and IRISpec™CB for the 6-month 25°C study.
• Data Provenance: The data is generated internally by the manufacturer (Iris Diagnostics, a Division of IRIS International Inc). The country of origin is implicitly the USA, where the company is located. The studies are prospective in nature, as they involve testing the performance and stability of newly manufactured lots of the device over time and under various conditions.

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

This device is a quality control material, not a diagnostic imaging or interpretive device that requires expert human interpretation for ground truth. The "ground truth" for this type of device is established by its formulation and verified chemical properties. The expected values (e.g., 40 mg/dL ascorbic acid) are determined by the precise manufacturing and spiking process.

Therefore, no external experts in the sense of clinicians or radiologists were used to establish ground truth for this device. The "expertise" involved would be the internal R&D and quality control personnel who formulated the control and verified its chemical composition.

4. Adjudication Method for the Test Set

Not applicable. As described above, the ground truth is established by the chemical formulation and direct analytical measurements, not by expert consensus or subjective interpretation requiring 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 where human readers interpret patient data (e.g., medical images) and the AI's impact on their performance is being evaluated. This device is a quality control material and does not involve human readers interpreting diagnostic cases.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study was done

Yes, in a way, this entire submission represents a "standalone" performance study of the quality control material itself. The device (IRISpec™ CA/CB/CC) is designed to have specific chemical properties and stability. The studies evaluate whether the device itself (the "algorithm" in this context refers to the intrinsic properties of the QC material) consistently meets these specifications when tested by an analytical instrument (like the iChem 100 Urine Chemistry Analyzer). There is no "human-in-the-loop" performance being measured for the QC material directly, only its inherent performance as a standard.

7. The Type of Ground Truth Used

The ground truth used is based on chemical formulation and direct analytical measurement (laboratory analysis). The device is formulated to contain a specific concentration of ascorbic acid (40 mg/dL). Its performance is then verified by measuring this concentration using a standardized analytical instrument (iChem 100 Urine Chemistry Analyzer) and comparing it to the expected, formulated value. For negative controls, the ground truth is the absence of the analyte (NEG).

8. The Sample Size for the Training Set

Not applicable. This device is a chemical quality control material, not a machine learning or AI algorithm that requires a "training set" in the conventional sense. Its "knowledge" comes from its chemical formulation and manufacturing process, not from learning from a dataset.

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

Not applicable, as there is no training set for this type of device.

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Liquichek Urinalysis Control is intended for use as an assayed quality control urine to monitor the precision of urinalysis test procedures for the analytes listed in the package insert.

Liquichek Urinalysis Control is prepared from human urine with added human erythrocytes, simulated leukocytes, constituents of animal origin, pure chemicals, preservatives and stabilizers. The control is provided in liquid form for convenience.

The provided text is related to the submission of a medical device for FDA approval (510(k) premarket notification) and does not describe acceptance criteria, performance studies, or efficacy data in the typical sense for a diagnostic algorithm or advanced medical device.

The "device" in question is the "Liquichek™ Urinalysis Control," which is a quality control solution for laboratory urinalysis tests. The purpose of this submission is to demonstrate substantial equivalence to a previously approved control solution, with the only addition being claims for "color and clarity."

Therefore, many of the requested elements (like sample size for test sets, number of experts, adjudication methods, MRMC studies, standalone performance, ground truth types for training, etc.) are not applicable in this context. The study described is a stability study for the control solution itself, not a study evaluating the performance of a diagnostic device against a clinical outcome or expert consensus.

Here's an attempt to answer the questions based on the provided text, noting where information is not applicable:

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

Since this is a quality control material and not a diagnostic device, the "performance" relates to its stability. The acceptance criteria essentially define the stability required for its intended shelf life and open-vial use.

Note: The document states "All supporting data is retained on file at Bio-Rad Laboratories" and "Real time studies will be ongoing to support the shelf life of this product." This implies the "reported device performance" in terms of stability is based on conducted studies, but the specific raw data or detailed performance metrics (e.g., drift, acceptable range of variation) are not provided in this summary.

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

Not applicable in the context of an algorithm or diagnostic device. For the stability studies of the control solution, the "sample size" would refer to the number of lots or vials tested over time. This information is not provided in the summary. The studies are prospective in nature, as they involve monitoring the product over time. The country of origin of the data is Bio-Rad Laboratories (Irvine, California, 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)

Not applicable. The "ground truth" for a quality control solution would be its known chemical and physical properties at different time points, measured by laboratory instrumentation, not expert human evaluation.

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

Not applicable. Adjudication is used for interpreting ambiguous clinical data, which is not relevant here.

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 quality control solution, not an AI-powered diagnostic tool, and involves no human readers or AI assistance in its function.

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 device. The "performance" is the inherent stability of the chemical control solution over time.

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

For the stability studies, the "ground truth" is likely the quantitative measurements of the analytes (e.g., concentration, pH, specific gravity) and qualitative observations (color, clarity) performed using standardized laboratory methods at defined time points. This is analogous to analytical accuracy or reference method values.

8. The sample size for the training set

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

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

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

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The ADVIA Chemistry Microalbumin Control is intended for in vitro diagnostic use in the control of the ADVIA® Chemistry systems for the Microalbumin method.

The ADVIA® Chemistry Microalbumin Controls is a human urine based solution containing various constituents.

Here's the analysis of the provided text regarding the ADVIA® Chemistry Microalbumin Controls:

Acceptance Criteria and Study for ADVIA® Chemistry Microalbumin Controls

This device is a Quality Control Material, and the "acceptance criteria" and "study" are focused on its stability and performance as a control, establishing substantial equivalence to a predicate device rather than a clinical efficacy study typically seen for diagnostic devices.

1. Table of Acceptance Criteria and Reported Device Performance

For this type of device (quality control material), the "acceptance criteria" revolve around its stability and intended function, demonstrating it performs as expected for quality control. The provided information focuses on aspects related to its stability and composition compared to a predicate.

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

• Test Set Sample Size: The document does not specify a "test set" in the traditional sense of a patient cohort. For this quality control material, the "test" primarily refers to stability studies. The actual number of control vials or batches tested for stability is not provided.
• Data Provenance: The stability validation was performed at the manufacturing site: Randox Laboratories, Inc. 55 Diamond Road Crumlin, Antrim Country, UK. The data is retrospective in the sense that the studies were completed before the 510(k) submission.

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

This information is not applicable and not provided. For a quality control material, "ground truth" is established by laboratory analytical methods to determine its stated values and stability characteristics, not by expert consensus on clinical images or diagnoses.

4. Adjudication Method for the Test Set

This information is not applicable and not provided. Adjudication methods (like 2+1, 3+1) are used in studies where human readers interpret data (e.g., images) and their interpretations need to be reconciled for ground truth. This is not relevant for a quality control material.

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

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study is used for diagnostic algorithms or imaging devices to assess how AI impacts human reader performance, which is not relevant for a quality control material.

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

No, a standalone (algorithm-only) study was not performed. The device itself is a physical quality control material, not a software algorithm. Its "performance" is its inherent stability and stated values, validated through laboratory procedures.

7. The Type of Ground Truth Used

The "ground truth" for the ADVIA® Chemistry Microalbumin Controls is established through laboratory analytical testing (e.g., using a reference method or validated assays) to determine the concentration of microalbumin and to confirm the stability of these concentrations over time and under various storage conditions. This is considered a form of analytical truth.

8. The Sample Size for the Training Set

This information is not applicable and not provided. The device is a physical control material, not an AI/ML algorithm that requires a "training set."

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

This information is not applicable and not provided for the same reason as point 8.

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The Randox Laboratories Ltd. Urine Controls are based on lyophilised human urine and have been developed for the control of both accuracy and precision in clinical chemistry applications particularly urine analysis. These control materials are available at two constituent concentrations.

The Randox Assayed and Unassayed Urine Controls should only be used by suitably qualified laboratory personnel under appropriate laboratory conditions.

Assayed and Unassayed Urine Controls based on lyophilised human urine.

This document is a 510(k) clearance letter from the FDA for "Randox Urine Controls," which are classified as a Class I quality control material. It confirms that the device is substantially equivalent to a legally marketed predicate device.

Based on the provided text, the document does not contain information related to acceptance criteria, specific device performance data, study designs (sample sizes, provenance, ground truth, expert qualifications, adjudication methods), multi-reader multi-case studies, or standalone algorithm performance. This is typical for a 510(k) clearance letter for a Class I device like a quality control material, which generally relies on demonstrating substantial equivalence to a predicate rather than extensive clinical efficacy studies.

Therefore, I cannot provide the requested table and details because the information is not present in the document.

The document focuses on:

• Device Name: Randox Urine Controls (Assayed and Unassayed)
• Regulation Number/Name: 21 CFR 862.1660, Quality control material (assayed and unassayed)
• Regulatory Class: Class I
• Product Code: JJW
• Indication for Use: For the control of both accuracy and precision in clinical chemistry applications, particularly urine analysis. Available at two constituent concentrations and to be used by suitably qualified laboratory personnel.

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