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Liquichek Urine Chemistry Control is intended for use as an assayed quality control urine to monitor the precision of laboratory testing procedures for the analytes listed in the package insert.

Liquichek Urine Chemistry Control is prepared from human urine with added constituents of human and animal origin, chemicals, preservatives and stabilizers. The control is provided in liquid form for convenience.

The provided document describes a 510(k) premarket notification for the Bio-Rad Laboratories Liquichek Urine Chemistry Control. This document is for a quality control material, not a diagnostic device with complex performance criteria or AI components. Therefore, many of the requested elements for a diagnostic device performance study (e.g., sample size for test sets, data provenance, ground truth establishment, MRMC studies, standalone algorithm performance, training set details) are not applicable to this type of submission.

Here is an analysis based on the information provided, highlighting the applicable criteria and findings for this specific type of device (a quality control material):

1. Table of Acceptance Criteria and Reported Device Performance

For this quality control material, the "acceptance criteria" are related to its stability and its comparability to a predicate device for its intended use. The "reported device performance" demonstrates it meets these criteria.

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

• Sample Size for Test Set: Not explicitly stated as a separate "test set" in the context of a diagnostic device. For quality control materials, "testing" involves stability studies and value assignment. The "value assignment" states it used "replicate analyses" and a "representative sampling of this lot of product." The exact number of replicates or product units sampled is not specified.
• Data Provenance: The studies were performed by "the manufacturer and/or independent laboratories." No specific country of origin is mentioned for the data, and it is assumed to be retrospective to the manufacturing process for the specific lot.

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

• Not Applicable. For a quality control material, "ground truth" is established through analytical methods and value assignments, not expert consensus on interpretations like in diagnostic imaging. The values are assigned based on "replicate analyses" using "manufacturer supported reagents."

4. Adjudication method for the test set

• Not Applicable. As there are no expert interpretations or subjective assessments involved in the performance evaluation of a quality control material, no adjudication method would be used. Value assignment is typically based on rigorous statistical analysis of quantitative measurements.

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 a diagnostic device that involves human readers or AI assistance.

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

• Not Applicable. This is a quality control material. There is no algorithm involved.

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

• For quality control materials, the "ground truth" (or accepted reference values) for the analytes within the control is established through analytical testing and quantitative measurement. The document states, "The mean values and the corresponding ±3SD ranges printed in the insert were derived from replicate analyses and are specific for this lot of product. The tests listed were performed by the manufacturer and/or independent laboratories using manufacturer supported reagents." This indicates a measurement-based analytical ground truth.

8. The sample size for the training set

• Not Applicable. This is a quality control product; there is no machine learning "training set."

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

• Not Applicable. As there is no training set.

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Liquid Assayed Multiqual is intended for use as an assayed quality control serum to monitor the precision of laboratory testing procedures for the analytes listed in this package insert.

Liquid Assayed Multiqual is prepared from human serum to which purified biochemical material (tissue extracts of human and animal origin), chemicals, drugs, preservatives, and stabilizers have been added.

Here's an analysis of the provided text regarding the acceptance criteria and supporting study for the "Liquid Assayed Multiqual" device:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present a "table of acceptance criteria" in the format of pass/fail thresholds for a device, as one might find for a diagnostic test's sensitivity or specificity. Instead, it describes product claims related to stability, which serve as performance characteristics that the device is intended to meet. The study's purpose is to demonstrate that the new device meets these claims, and establishes substantial equivalence to a predicate device.

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

• Sample Size for Test Set: The document states, "The assigned values were derived from replicate analyses and are specific for each lot of product. The tests listed were performed by the manufacturer and/or independent laboratories using manufacturer supported reagents and a representative sampling of the product lot."
  • This indicates that a "representative sampling of the product lot" was used for testing, but the exact number of samples or the sample size (n) for the stability studies is not specified in this summary.
• Data Provenance: The studies were performed by the manufacturer (Bio-Rad Laboratories) and/or independent laboratories. The country of origin for the data is not explicitly stated, but Bio-Rad Laboratories is based in Irvine, California, suggesting the studies were likely conducted in the USA or by labs commissioned from the USA. The studies appear to be prospective in nature, as they were conducted to determine the stability claims for a new product.

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

This document describes a quality control material used to monitor the precision of laboratory testing procedures. The concept of "ground truth" established by experts, as required for diagnostic devices (e.g., radiologists interpreting images), is not applicable here.

Instead, the "ground truth" for this type of device (Assayed Quality Control Material) is the assigned values for the analytes within the control. These are established through:

• Method: "replicate analyses"
• Personnel: Tests were "performed by the manufacturer and/or independent laboratories"
• Qualifications: While not explicitly detailed, these laboratories would employ trained personnel (e.g., clinical chemists, laboratory scientists) proficient in the analytical methods for each analyte.

4. Adjudication Method for the Test Set

Again, the concept of "adjudication" in the sense of resolving discrepancies among expert readers (e.g., 2+1, 3+1) is not applicable to this type of device. The "ground truth" (assigned values) is established through rigorous laboratory testing using replicate analyses, not through human interpretation of complex data that might require adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size of AI

No, an MRMC comparative effectiveness study was not done. This device is a quality control material, not a diagnostic imaging or screening tool that would involve AI assistance for human readers. Therefore, the effect size of AI improvement is not relevant or reported.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

No, a standalone (algorithm only) performance study was not done. This device is a biochemical control material, not an algorithm or AI system. Its performance is evaluated based on its stability and the accuracy of its assigned values when measured by laboratory instruments, not as a standalone algorithmic output.

7. The Type of Ground Truth Used

The ground truth used for this type of quality control device is the assigned values for the various analytes it contains. These values are established through:

• Expert Consensus / Reference Methods: While not explicitly stated as "expert consensus," the "replicate analyses" performed by the manufacturer and independent laboratories using "manufacturer supported reagents" are indicative of adherence to established, scientifically sound analytical methodologies that are considered the reference or "true" values for the analytes. The ±3SD ranges reported are statistical measures around this empirically determined true value.

8. The Sample Size for the Training Set

This document describes a quality control material, not a machine learning model. Therefore, the concept of a "training set" for an algorithm is not applicable. The device itself is the "product," and its stability and assigned values are characterized through direct experimentation.

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

As explained above, there is no "training set" or "ground truth for a training set" in the context of this device. The "assigned values" for the control material are established through "replicate analyses" by the manufacturer and/or independent laboratories.

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Lyphochek Whole Blood Immunosuppressant Controls is intended for use as an assayed quality control material to monitor the precision of laboratory testing procedures for the analytes listed in the package insert. The following analytes are listed in the package insert: Sirolimus, Tacrolimus, Cyclosporine. Abbott Immunosuppressant MCC is intended for use as an assayed quality control material to monitor the precision of laboratory testing procedures for the analytes listed in the package insert. The following analytes are listed in the package insert: Sirolimus, Tacrolimus.

Lyphochek Whole Blood Immunosuppressant Controls and Abbott Immunosuppressant MCC are both prepared from human whole blood, with added chemicals, and stabilizers.

This appears to be a 510(k) premarket notification for in-vitro diagnostic control materials, not a device that involves AI or requires the detailed study information you've requested. The provided text describes the product, its intended use, a comparison to a predicate device, and stability studies. It does not mention any AI algorithms, deep learning, imaging analysis, or human-in-the-loop performance studies that would necessitate the fields you've outlined.

Therefore, many of the requested fields cannot be filled from the provided document. I can, however, provide the acceptance criteria and the type of study mentioned for this specific device.

Acceptance Criteria and Device Performance (Based on provided text)

Information that Cannot Be Extracted from the Provided Document (and why):

This document describes a quality control material used to monitor the precision of laboratory tests, not a diagnostic device that analyzes data or images and thus would not involve the following:

1. Sample size used for the test set and the data provenance: Not applicable. The "test set" here refers to samples used in stability studies, not patient data for algorithm evaluation. The document states "All supporting data is retained on file at Bio-Rad Laboratories" but does not provide specific sample sizes or provenance.
2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for an AI/imaging device would refer to clinical diagnoses or expert annotations. For a control material, "ground truth" would be the known concentration of analytes, established through analytical methods, not expert consensus.
3. Adjudication method for the test set: Not applicable.
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 control material, not an AI-powered diagnostic tool for human readers.
5. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable. There is no algorithm.
6. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): For a control material, the "ground truth" would be the certified values/concentrations of the analytes within the control, established by chemical analysis and reference methods, not expert consensus or pathology on patient data.
7. The sample size for the training set: Not applicable. There is no AI model or training set.
8. How the ground truth for the training set was established: Not applicable.

Summary of the Study that Proves the Device Meets Acceptance Criteria:

The device's performance against its acceptance criteria is demonstrated through stability studies. These studies aim to prove that the control material maintains its integrity and expected analyte concentrations over time under specified storage conditions (shelf-life and open-vial stability). The document states:

• "Stability studies have been performed to determine the open vial stability and shelf life for this control."
• "Product claims are as follows: After reconstituting, all analytes will be stable for 14 days at 2 to 8°C or 30 days at -20 to -70°C."
• "Shelf Life: 3 Years at 2 to 8°C"
• "All supporting data is retained on file at Bio-Rad Laboratories."

The FDA's acceptance of the 510(k) (K072721) indicates that these stability studies and the comparison to the predicate device (K022041) were deemed sufficient to prove substantial equivalence and meet regulatory requirements for a Class I clinical toxicology control material.

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Liquichek Microalbumin Control is intended for use as an assayed quality control urine to monitor the precision of laboratory procedures listed in the package insert.
Liquichek Microalbumin Control is intended for use as an assayed quality control material to monitor the precision of laboratory testing procedures for the analytes listed in the package insert.

Liquichek Microalbumin Control is prepared from human urine with added constituents of human, pure chemicals, preservatives and stabilizers. The contral is provided in Iliginal form for convenience.

Here's an analysis of the provided text regarding the acceptance criteria and supporting study for the "Liquichek Microalbumin Control":

This document is a 510(k) Premarket Notification for a medical device, which typically focuses on demonstrating substantial equivalence to a predicate device rather than presenting a performance study against predefined acceptance criteria in the same way a novel device might. The "acceptance criteria" here are implicitly tied to the performance of the predicate device and the stability of the new control material itself.

1. Table of Acceptance Criteria and Reported Device Performance

Given the nature of this submission (a control material seeking substantial equivalence), the "acceptance criteria" are primarily related to the stability claims, which are demonstrated to be within acceptable limits for a quality control material.

Note: The document emphasizes that the new device (Liquichek Microalbumin Control) is substantially equivalent to the predicate device (Liquichek Urine Chemistry Control) in many key characteristics (intended use, form, matrix, storage claims) and simply has a more focused analyte panel. The core "performance data" presented directly relates to the stability of the control material, ensuring it reliably functions as intended during its shelf life and open-vial period.

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

The document does not specify a "test set" in the traditional sense of a clinical study with patient samples. The performance data presented refers to stability studies conducted on the control material itself.

• Sample Size: Not explicitly stated as a number of samples in the context of a clinical study, but rather implied through the successful completion of stability experiments on the control material.
• Data Provenance: The stability studies were conducted by Bio-Rad Laboratories. The country of origin for the data is implicitly the United States, where Bio-Rad Laboratories is located. The studies are prospective as they track the performance of the control material over time for open-vial and shelf-life stability.

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

Not applicable to this type of submission. This device is a quality control material, not a diagnostic device that interprets clinical data or images requiring expert judgment for ground truth. The "ground truth" for a control material is its chemical composition and stability characteristics, measured through analytical methods.

4. Adjudication Method for the Test Set

Not applicable. There is no "adjudication" for stability testing of a quality control material. The assessment is based on objective chemical analysis and predefined statistical criteria for stability.

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

No. An MRMC study is relevant for diagnostic imaging systems or clinical decision support tools where multiple human readers interpret cases. This document is for a laboratory quality control material.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

Not applicable. This device is a laboratory reagent (quality control material), not an algorithm or AI system.

7. The Type of Ground Truth Used

The "ground truth" for this device's performance is established through:

• Chemical Analysis and Reference Measurements: The actual concentrations of microalbumin and creatinine within the control material are determined using validated analytical methods.
• Stability Studies: These studies involve periodically measuring the analyte concentrations in the control material under specified storage conditions (e.g., 2-8 °C) over time to ensure they remain within predefined acceptable limits of variation. This demonstrates the material's consistency and reliability as a control.

8. The Sample Size for the Training Set

Not applicable. This device is not an AI/ML algorithm requiring a training set.

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

Not applicable. This device does not have a training set.

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i-STAT® Activated Clotting Time (ACT) Control is used to verify the integrity of newly received i-STAT® Activated Clotting Time cartridges.

This is a lyophilized product prepared from human plasma, with added purified I mo to a ly ophilizes. The control is provided in lyophilized form for increased stability.

The provided document describes the Bio-Rad Laboratories i-STAT Activated Clotting Time (ACT) Control Set, a device used to verify the integrity of newly received i-STAT ACT cartridges. This is a 510(k) premarket notification, which means the device claims substantial equivalence to a legally marketed predicate device (i-STAT Coagulation Control Set, K981752), rather than undergoing a de novo clinical trial to prove efficacy.

Therefore, the document does not contain information about acceptance criteria or a study that proves the device meets specific performance metrics in the way a new device would. Instead, the "study" referred to here is a comparison to a predicate device and stability studies.

Here's a breakdown of the requested information based on the provided text, with many points indicating that the information is "Not Applicable" or "Not Provided" due to the nature of a 510(k) submission for a control set:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria: The document implies that the primary acceptance criterion is that the new device performs similarly enough to the predicate device to be considered substantially equivalent for its intended use. For an IVD control, this typically means:

• Intended Use: Identical.
• Matrix: Identical.
• Form: Identical.
• Storage (Unopened): Similar (2 to 8°C vs. 2 to 10°C).
• Open Vial Stability: Identical ("Use immediately").
• Shelf Life: Established through stability testing.

Reported Device Performance:

2. Sample Size for Test Set and Data Provenance

• Sample Size: Not provided. The submission refers to "Stability studies" and "All supporting data is retained on file at Bio-Rad Laboratories." This implies internal testing rather than a large clinical test set.
• Data Provenance: Not provided, but given it's a Bio-Rad submission, the data is likely from internal testing by the manufacturer. The document does not specify country of origin or if it's retrospective or prospective.

3. Number of Experts Used to Establish Ground Truth and Qualifications

• Not Applicable. As a control set, its performance is determined by its chemical and biological properties, and its stability over time. It's not a diagnostic device that requires expert interpretation of results to establish a "ground truth" in the diagnostic sense. The ground truth for this device would be its validated chemical properties and stability, confirmed by laboratory testing.

4. Adjudication Method

• Not Applicable. See point 3.

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

• No. This device is a control set, not an AI or diagnostic tool that involves human readers or interpretation of complex cases. Therefore, an MRMC study is not relevant.

6. Standalone Performance Study (Algorithm Only)

• Not Applicable. This is a physical control product, not an algorithm. Its "performance" is its ability to remain stable and provide expected results for verifying other devices.

7. Type of Ground Truth Used

• The "ground truth" for this device would be established through laboratory testing and analytical methods to confirm the composition and stability of the human plasma and other components. Specifically, "Stability studies have been performed to determine shelf life for this control," indicating that these studies form the basis of the performance claims.

8. Sample Size for the Training Set

• Not Applicable. This is a physical control product, not a machine learning algorithm, so there is no "training set."

9. How Ground Truth for Training Set was Established

• Not Applicable. See point 8.

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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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