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Retic-Chex for Cell-Dyn is an assayed control for evaluating the accuracy and precision of automated, semi-automated and manual methods of reticulocyte counting.

Retic-Chex for Cell-Dyn is a suspension of stabilized human red blood cells and simulated human reticulocytes packaged in plastic vials containing 1.0ml volumes. The device consists of two levels of reticulocyte percentage range. Control I reticulocyte percent range will be 1.5 - 2.0. Control II reticulocyte percent range will be 3.9 - 5.8. Closures are injection molded polypropylene screw-top caps. The vials are packaged in vacuum molded clam-shell box.

The provided text is a 510(k) summary for Retic-Chex for Cell-Dyn, a hematology control device. It describes the device, its intended use, and states that three studies were conducted to demonstrate its performance. However, the document does not explicitly state acceptance criteria in a quantitative manner, nor does it provide detailed quantitative results that would typically be reported as "reported device performance." Instead, it broadly concludes that the device is "consistently reproducible and stable."

Therefore, I cannot populate a table of acceptance criteria and reported device performance with specific numerical values as this information is not present in the provided text.

Based on the available information, here's what can be extracted:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample size for the test set: Not explicitly stated. The document mentions "Three studies... were conducted," but does not provide details on the number of samples or measurements within each study.
• Data provenance: Not explicitly stated. The studies were conducted by Streck Laboratories, Inc., presumably at their facilities. No information about the country of origin of the data or whether it was retrospective or prospective is provided.

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

• Not applicable. This device is a quality control material for automated reticulocyte counting. Its "ground truth" (or target values) would be established through a rigorous assay process using reference methods and potentially multiple instruments/operators, rather than expert interpretation of images or clinical cases. The document does not describe the specific method used to establish the "ground truth" for the control levels, other than stating it is an "assayed control."

4. Adjudication method for the test set:

• Not applicable. Given the nature of the device as a quality control material, rather than a diagnostic tool requiring interpretation of complex data (e.g., images), an adjudication method as typically understood for expert consensus is not relevant or described.

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 control material for laboratory instruments, not an AI-powered diagnostic system that assists human readers in interpreting clinical cases. Therefore, an MRMC study related to human reader improvement with AI assistance is not relevant.

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

• Not applicable. This device is a reagent/control material; it is not an algorithm or a standalone diagnostic system.

7. The type of ground truth used:

• The device is described as an "assayed control". This implies that the "ground truth" (the target reticulocyte percentage ranges for Control I and Control II) would have been established through analytical testing and validation using reference methods and/or the intended automated reticulocyte counters. The document specifies reticulocyte percentage ranges for Control I (1.5 - 2.0%) and Control II (3.9 - 5.8%), which serve as the "ground truth" or expected values for the control material.

8. The sample size for the training set:

• Not applicable. As this is a quality control material and not a machine learning algorithm, there is no "training set" in the context of AI/ML development. The studies performed ("Closed Vial Stability," "Open Vial Stability," and "Manual Count Closed Vial Stability") are for product validation, not algorithm training.

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

• Not applicable. See point 8.

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Cyto-Chex® BCT is intended for the collection and storage of blood specimens for immunophenotyping of WBC by flow-cytometry. Recovery of lymphocyte subset cell markers of the HIV panel can be accomplished over a 7 day period following collection.

Cyto-Chex BCT consists of a standard 13 x 75mm glass blood collection tube containing 57ul of sterile K,EDTA anti-coagulant and WBC preservative. It is manufactured with a vacuum to draw 5ml of blood by venipuncture.

The provided text is a 510(k) Summary for the Cyto-Chex® BCT device, which is a blood specimen collection device. It describes the device, its intended use, comparison with a predicate device, and the testing performed to demonstrate substantial equivalence. However, it does not explicitly state acceptance criteria in a quantitative manner or present a table of acceptance criteria versus reported device performance.

Instead, the submission focuses on demonstrating that the Cyto-Chex BCT performs comparably to fresh samples collected in K.EDTA tubes for immunophenotyping of WBCs by flow cytometry, specifically for lymphocyte subset cell markers of the HIV panel over a 7-day period. The conclusions drawn are qualitative or based on statistical analysis methods like Bland-Altman plots and correlation coefficients without providing specific thresholds.

Therefore, many of the requested sections about acceptance criteria and quantitative performance metrics cannot be directly extracted from the provided text. I will fill in the available information and explicitly state when information is not present.

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

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

Information Not Explicitly Stated: The document does not provide a table with specific, quantitative acceptance criteria (e.g., "recovery of X% of cell markers" or "correlation coefficient > Y") and then list the device's performance against those criteria. The conclusions are generally qualitative or indicate a comparison to fresh samples.

Summary of Reported Performance (Qualitative based on text):

• Stability of Reagent: Unused Cyto-Chex BCT tubes can be stored for at least one year at room temperature.
• Immunophenotyping Performance: Bland Altman Plots, Light Scatter Dot Plots, and Correlation Coefficient results demonstrate that Cyto-Chex BCT tubes can be effectively used to collect and store clinical specimens for flow-cytometry analysis of Lymphocyte subsets. This performance is implied to be comparable to fresh samples (6 hours after draw in K.EDTA) over a 7-day period.
• Underfilling Impact: Testing verified that underfilling the tube would not compromise results (no specific details provided on the extent of underfilling tested or the results).

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

• Test Set Sample Size:
  • Healthy Donors: "multiple healthy donors" (exact number not specified).
  • HIV Positive Patients: "samples from HIV positive patients" (exact number not specified).
• Data Provenance: The country of origin is not specified. The study involved collecting peripheral blood samples, which implies a prospective collection for the study purpose.

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

Information Not Stated: The document does not mention the use of experts to establish ground truth for the test set. The ground truth appears to be based on flow cytometric analysis of fresh samples collected in K.EDTA tubes as the comparative 'gold standard'.

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

Information Not Stated: Adjudication methods are not described.

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/Information Not Stated: This device is a blood specimen collection tube, not an AI-powered diagnostic imaging or analysis tool that would involve "human readers" in the context of MRMC studies. Therefore, an MRMC comparative effectiveness study regarding human readers improving with/without AI assistance is not relevant or described.

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

Not Applicable: This device is a physical specimen collection tube, not an algorithm or AI system.

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

• Type of Ground Truth: The ground truth or reference standard for comparison was "fresh samples (6 hours after draw in K.EDTA)". This indicates a comparison to the established method for immediate processing of blood samples for flow cytometry.

8. The sample size for the training set

Not Applicable: This device is a physical medical device (blood collection tube) and does not involve a "training set" in the context of machine learning.

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

Not Applicable: As above, there is no training set for this type of device.

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A1c-Chex is a bi-level whole blood based, assayed control for monitoring performance of analysis procedures for HbA1c.

A1c-Chex is bi-level, whole blood based, assayed control for monitoring performance of tastal A IC-Chex is blevel, whole blood, acouryed of he same as a patient specimen and tested procedures for ribATC. ATT offex brith the instrument, kit or reagent being used. A1c-Chex following the instructions included with the including in oversion of analysis procedures, including lysing of the RBC.

The provided document is a 510(k) Summary for the A1c-Chex device, a quality control material for monitoring the performance of HbA1c analysis procedures. The document focuses on demonstrating substantial equivalence to a predicate device and does not include a detailed study proving specific acceptance criteria for a new AI-powered medical device.

Therefore, many of the requested details about acceptance criteria, efficacy studies with AI, and detailed ground truth methodologies are not present in this type of regulatory submission. The information below is extracted from the provided text, and where information is not available, it is noted as "Not applicable" or "Not provided".

Here's an analysis based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly list specific numerical acceptance criteria (e.g., a target precision value or stability range). Instead, it states general conclusions about performance in relation to the predicate device.

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

• Sample Size for Test Set: Not explicitly stated. The document mentions "Studies were conducted" for stability, precision, and the proposed assay sheet, but does not provide details on the number of samples or tests performed.
• Data Provenance: Not provided. The document does not specify the country of origin of the data or whether the studies were retrospective or prospective.

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

• This information is not provided. The testing relates to the performance of a quality control material, not a diagnostic device requiring expert interpretation of results to establish ground truth.

4. Adjudication method for the test set

• Not applicable. Adjudication methods (like 2+1, 3+1) are typically used for diagnostic interpretation where there's a need to resolve discrepancies between readers. This device is a quality control material.

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

• No. This is a quality control material for laboratory tests, not a diagnostic device involving human readers or AI assistance. An MRMC study is not relevant here.

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 regulatory submission.

7. The type of ground truth used

• For a quality control material, the "ground truth" is typically established by the manufacturer through a rigorous process of characterizing the material's properties (e.g., target analyte concentration, stability over time). This is done through internal analytical testing rather than external expert consensus, pathology, or outcomes data in the way it's understood for diagnostic devices. The document implies that the studies conducted (stability, precision, assay sheet) directly characterize the material itself.

8. The sample size for the training set

• Not applicable. This device is a quality control material, not an AI algorithm requiring a training set.

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

• Not applicable. This device is a quality control material, not an AI algorithm requiring a training set.

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Sickle-Chex Solubility Kit is a qualitative solubility test kit for tasting the presence of sickling hemoglobins in human blood or sickle cell control materlal.

Sickle-Chex Solubility Kit consists of:

• Sickle-Chex Solubility Buffer; two LDPE bottles, each illied ville 100mL of a A. 2.3M potassium phosphate buffer solution containing Saponin.
• Sickle-Chex Reagent Powder; two glass vials, each filled with 4 grams of B. Sodium Hydrosulfite.
  The testing principles of the kit is based on NCCLS, H10-F.

Here's an analysis of the provided text regarding the Sickle-Chex Solubility Kit, with an emphasis on the acceptance criteria and supporting study details.

Important Note: The provided document is a 510(k) summary, which is a regulatory document filed to demonstrate substantial equivalence to a predicate device. It typically summarizes studies and conclusions without going into granular detail on study designs, statistical methodologies, or all acceptance criteria. Therefore, some specific details requested (like exact sample sizes for test/training sets, blinding protocols, or multi-reader studies) are not explicitly stated in this document.

1. Table of Acceptance Criteria and Reported Device Performance

The 510(k) summary for the Sickle-Chex Solubility Kit primarily focuses on demonstrating equivalence to a predicate device (Dade® Sickle-Sol™ Test) and confirming the product's stability and reliability. The acceptance criteria, while not explicitly listed as quantitative metrics in a table, can be inferred from the "Conclusions Drawn from the Tests."

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

• Sample Size for Test Set: Not explicitly stated in the 510(k) summary. The document mentions "Off-site studies" and "in house studies," but does not provide the number of samples or cases used in these evaluations.
• Data Provenance:
  • Country of Origin: Not explicitly stated. Given that Streck Laboratories is located in La Vista, NE (USA) and the regulatory body is the FDA (USA), it is highly probable the data was collected within the USA.
  • Retrospective or Prospective: Not explicitly stated. "Off-site studies" could be either, but often includes prospective testing in a laboratory setting. "In house studies" would also typically be prospective testing conducted by the manufacturer.

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

• Number of Experts: Not mentioned. This type of qualitative solubility test typically relies on direct chemical reaction observation, and the "ground truth" for evaluating the kit's performance would likely be established by comparing its qualitative results against established laboratory methods or reference materials.
• Qualifications of Experts: Not mentioned.

4. Adjudication Method for the Test Set

• Adjudication Method: Not applicable or not mentioned. For a chemical solubility test, the "adjudication method" involving human experts reading results is usually not relevant in the same way it would be for image-based diagnostics. The ground truth for such a test is typically based on the chemical principle itself, or comparison to established reference methods/materials.

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

• MRMC Study: No, an MRMC comparative effectiveness study was not performed. This type of study is primarily relevant for diagnostic imaging devices where human readers interpret results, and the AI's impact on their performance is being evaluated. This device is a qualitative chemical test kit.
• Effect Size of AI Improvement: Not applicable, as no MRMC study was conducted and this is not an AI-assisted device.

6. Standalone Performance Study

• Standalone Performance Study: Yes, a standalone performance evaluation was implicitly done. The "Off-site studies" that verified the performance against competitor kits, and the "in house" stability studies, represent the device's performance characteristics independent of human interpretation beyond recording the qualitative reaction. The device itself is the "algorithm" in this context, producing a qualitative result.

7. Type of Ground Truth Used

• Type of Ground Truth: The ground truth for this type of device would typically be:
  • Reference Method Comparison: Comparing the results of the Sickle-Chex kit to a gold-standard or well-established method for detecting sickling hemoglobins (e.g., electrophoresis, or another validated solubility test).
  • Known Samples: Testing with control materials or patient samples with known sickle cell status (e.g., confirmed by genetic testing or other definitive methods).
  • Clinical Outcomes Data: Unlikely to be the primary ground truth for a qualitative screening test.
  • Expert Consensus: Unlikely to be the primary ground truth for a chemical reaction test.

The summary mentions "sickle cell control material" and "human blood," suggesting a combination of known samples and potentially clinical samples verified by other means.

8. Sample Size for the Training Set

• Sample Size for Training Set: Not applicable / not mentioned. This device is a chemical reagent kit, not an AI/ML algorithm that requires a distinct "training set" in the computational sense. Its performance is based on its chemical formulation and reaction properties.

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

• Ground Truth for Training Set: Not applicable. As this is not an AI/ML device, there is no "training set" or establishment of ground truth for such a set in the context of machine learning. The chemical properties and formulation are developed and refined through R&D and quality control, not via a machine learning training process.

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Para 5X is intended for use as a multi-parameter quality control material for ABX Pentra 60 C+ and Beckman Coulter™ AcT™ hematology analyzers. It includes assay values for CBC/Diff parameters.

Para® 5X is a tri-level multi-parameter hematology control consisting of stabilized human red blood cells, human white blood cells and simulated platelets. The product is packaged in glass vials containing 3 ml. The closures are polypropylene screw caps with pierceable liners.

The provided text describes the Para® 5X hematology control device, but it lacks specific acceptance criteria (numerical thresholds for performance) and detailed study results that would allow for a comprehensive table of acceptance criteria vs. device performance. The document generally states that "All testing showed that Para 5X is consistently reproducible and performs within the claims."

However, based on the available information, here is an attempt to address the request as best as possible, with significant limitations due to the lack of explicit numerical data in the provided text.

Acceptance Criteria and Study Details for Para® 5X

1. Table of Acceptance Criteria and Reported Device Performance

As specific numerical acceptance criteria (e.g., CV% thresholds, bias limits) are not explicitly stated in the provided text, the table below uses descriptive terms based on the general conclusions presented. The reported performance is also described in general terms for the same reason.

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

• Sample Size: The document does not specify the sample sizes used for the "Open Vial Stability," "Long-Term Stability (Shelf Life)," or "Alternate/Off-Site Testing" studies. It generally refers to "Studies" being conducted.
• Data Provenance: The document does not specify the country of origin of the data. It also does not explicitly state whether the data was retrospective or prospective. Given the nature of stability and performance testing for a control product, it is most likely a prospective study conducted by the manufacturer.

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

This section is not applicable to this type of device (hematology quality control material). Ground truth for control materials is typically established through extensive characterization and validation using reference methods and statistical analysis within the manufacturer's own quality control processes, rather than by human expert consensus or pathology reports on patient samples.

4. Adjudication Method for the Test Set

This section is not applicable. Since the device is a quality control material whose performance is measured against internal specifications and established reference instrument values, an adjudication method for reconciling expert opinions is not relevant.

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 relevant for diagnostic devices where human readers (e.g., radiologists, pathologists) interpret cases with and without AI assistance. Para® 5X is a quality control material, not an AI-based diagnostic tool for human interpretation.

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

Yes, in a sense, the testing described for Para® 5X represents a "standalone" assessment of the control material's performance. The device itself (the control material) is evaluated for its inherent stability and reproducibility on the specified hematology analyzers, independent of human interpretation of patient results. The studies focused on the performance of the control material when processed by the automated analyzers.

7. The Type of Ground Truth Used

The "ground truth" for Para® 5X (a hematology control) would be based on:

• Reference Instrument Measurements: Expected values for CBC/Diff parameters are established by running the control material on validated reference analyzers.
• Methodology-Specific Characterization: Extensive characterization on the target analyzers (ABX Pentra 60 C+ and Beckman Coulter™ AcT™) to establish assay values and acceptable ranges.
• Statistical Analysis: Rigorous statistical methods are used to determine limits for stability, precision, and accuracy, ensuring the material meets its intended quality control function.
• Manufacturing Specifications: The product's formulation and stabilization processes are designed to achieve specific biological properties, which serve as the intrinsic "truth" the control is designed to maintain.

8. The Sample Size for the Training Set

This section is not applicable. Para® 5X is a physical quality control material and not a machine learning or AI algorithm that requires a "training set" in the conventional sense. Its development involves chemical and biological formulation, stability studies, and performance characterization, not data-driven model training.

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

This section is not applicable for the reasons stated in point 8.

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Cal-Chex CD Plus is intended to be used as a calibrator for the calibration of WBC, RBC, Hgb, MCV, PLT and MPV (MPV on CD4000 only) on the Abbott Cell-Dyn 3200 and 4000 hematology instruments.

Cal-Chex CD Plus is a suspension of stabilized human red blood cells, human white blood cells, and human platelets packaged in glass vials containing 3.0 mL volumes. Closures are injection molded polypropylene screw-top caps. The vials are packaged in a PVC clamshell.

The provided text describes the Cal-Chex CD Plus device, an in-vitro diagnostic calibrator for hematology instruments. Let's break down the acceptance criteria and study details based on the information provided.

1. Table of Acceptance Criteria and Reported Device Performance

The submission does not explicitly list quantitative acceptance criteria with specific thresholds (e.g., "accuracy > 95%"). Instead, the acceptance criteria are framed around performance characteristics observed in the studies, demonstrating the device's suitability as a calibrator.

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

The document does not explicitly state the sample size used for the test set in terms of the number of samples or runs. It mentions "Three studies of Cal-Chex CD Plus were conducted," but details on the number of units or measurements within these studies are not provided.

• Sample Size: Not specified quantitatively.
• Data Provenance: Not specified (e.g., country of origin). The studies were conducted by Streck Laboratories, Inc., the manufacturer. It is a retrospective analysis of internal studies.

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

This information is not provided. For a calibrator, "ground truth" would typically refer to established reference values or methods for calibration. The document states the device was compared to "whole blood calibration methods," implying these methods served as a reference, but does not detail the process or expert involvement in establishing these reference values.

4. Adjudication Method for the Test Set

This information is not applicable and therefore not provided. Adjudication methods (like 2+1, 3+1) are typically used for subjective assessments where multiple experts might disagree on an interpretation, often in imaging or clinical diagnosis. For a quantitative calibrator, the assessment is based on measurements against a reference.

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 information is not applicable and therefore not provided. MRMC studies and the concept of "human readers improve with AI" are relevant for devices involving human interpretation of data, often in the context of AI-assisted diagnostics. Cal-Chex CD Plus is a calibrator for automated hematology instruments, not a device that assists human readers in interpreting data.

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

This concept is not directly applicable in the same way it would be for an AI algorithm. Cal-Chex CD Plus is the device (a physical calibrator), and its performance is its "standalone" performance when used with the specified hematology instruments. The studies evaluate the performance of the calibrator itself.

7. The Type of Ground Truth Used

The ground truth used for comparison was "whole blood calibration methods." This implies using fresh patient samples calibrated through established and presumably validated laboratory procedures as the reference standard against which the performance of Cal-Chex CD Plus was assessed.

8. The Sample Size for the Training Set

This information is not provided. For a physical calibrator, the concept of a "training set" as understood in machine learning is not directly applicable. The formulation and initial testing of the product would involve extensive internal R&D, but this is not typically framed as a distinct "training set" in the context of device validation for regulatory submission.

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

This information is not applicable in the typical machine learning sense. The "ground truth" for developing the calibrator (its formulation, stability, etc.) would have been established through a combination of scientific principles, laboratory development, and comparison to existing validated calibration methods for hematology parameters.

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Sickle-Chex is intended to be used as a sickle cell control in testing for the presence of hemoglobin S in solubility tests and hemoglobin electrophoresis.

Sickle-Chex consists of Control materials for verifying performance of sickle cell hemoglobin testing systems. The controls contain human red blood cells and preservative suspension media packaged in a polyethylene dropper bottle with dispensing tip. Product fill is 2.5 ml per vial.

Here's an analysis of the provided text regarding the Sickle-Chex 510(k) notification, focusing on the acceptance criteria and the study that proves the device meets them:

Disclaimer: This device is a quality control material, not a diagnostic device for direct patient use. Therefore, the "acceptance criteria" and "study" described are about the performance of the control material itself in verifying diagnostic tests, rather than its diagnostic accuracy on patient samples. Many of the questions provided in the prompt are more applicable to diagnostic devices, and the information in the 510(k) for a control material will naturally be different.

1. Table of Acceptance Criteria and Reported Device Performance

Study Proving Acceptance Criteria:

The provided text does not contain a detailed study section with explicit methodology, results, or statistical analysis to "prove" the device meets acceptance criteria in the way a diagnostic device would.

Instead, for a quality control material like Sickle-Chex, the "proof" primarily relies on:

• Manufacturing and Characterization: The control material is manufactured to contain human red blood cells with specific hemoglobin characteristics (presence of Hb S in the positive control, absence in the negative control).
• Intended Use Statements: The submission defines the intended use, which inherently outlines the expected performance: "The Positive Control will produce a positive test..." and "The Negative Control contains normal human red blood cells that will produce a negative test...". This is a statement of what the product is designed to do and what has been verified during its development.
• Substantial Equivalence: The FDA's 510(k) clearance is based on a determination of substantial equivalence to a predicate device. This means that the FDA found the Sickle-Chex to be as safe and effective as a legally marketed predicate device, likely by demonstrating similar performance characteristics through internal testing and possibly comparison to the predicate. The document refers to "Predicate product package insert and assay sheet," suggesting that the performance of Sickle-Chex was benchmarked against an existing similar product.

Without access to the full 510(k) submission, specific details of laboratory characterization and comparison to the predicate device are not available in the provided text.

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

• Sample Size for Test Set: Not specified in the provided text. For a control material, the "test set" would likely refer to a series of internal characterization tests and comparisons to a predicate device.
• Data Provenance: Not specified. It can be inferred that any testing would have been conducted by Streck Laboratories, Inc. (USA) as part of their manufacturing and regulatory submission process.
• Retrospective or Prospective: Not specified.

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 concept of "experts establishing ground truth" is generally not applicable to the characterization of a quality control material. The "ground truth" for Sickle-Chex is inherent in its design and manufacturing:

• The Positive Control is designed to contain sickling hemoglobin (Hb S).
• The Negative Control is designed to contain normal hemoglobin.
  The presence or absence of Hb S would be determined through standard laboratory methods (e.g., electrophoresis, high-performance liquid chromatography, or other definitive assays) during the manufacturing and quality control process, not by expert consensus in the same way a diagnostic image might be interpreted.

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

Not applicable/not specified. Adjudication methods are typically used for interpreting subjective data (like imaging) from multiple human readers. For the characterization of a chemical/biological control, objective laboratory measurements are used, not human reader 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. Sickle-Chex is a quality control material, not an AI diagnostic device. An MRMC study would not be performed for this product.

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

Not applicable. Sickle-Chex is a physical control material, not an algorithm or AI.

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

The "ground truth" for the Sickle-Chex controls is their inherent biochemical composition.

• The Positive Control contains human red blood cells with hemoglobin S. This is confirmed through definitive laboratory assays during its production.
• The Negative Control contains human red blood cells with normal hemoglobin. This is also confirmed through definitive laboratory assays.

8. The sample size for the training set

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

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

Not applicable. As above, this is not an AI/machine learning device.

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