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CONE-TROL Liquid Chemistry Control is a human liquid control serum to monitor the precision of laboratory testing procedures for the analytes listed in the package insert.

CONE-TROL Liquid Chemistry Control is prepared from human serum to which purified biochemical material (human and animal origin), chemicals, drugs, preservatives, and stabilizers have been added. The control is provided in liquid form for user convenience.

Here's an analysis of the acceptance criteria and study information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The provided document primarily focuses on demonstrating substantial equivalence to a predicate device rather than explicitly stating pre-defined acceptance criteria for performance metrics. However, we can infer the implicit "acceptance criteria" and how the device's performance aligns with them based on the stability testing described. The primary "performance" being evaluated here is the stability of the control material over time under various storage conditions.

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CONE-TROL Hemoglobin A1c Control Set is intended for use as quality control material to monitor the performance and precision of Hemoglobin A 1 c determination methods.

The CONE-TROL Hemoglobin A 1c Control Set is prepared from human blood to which chemicals, preservatives, and stabilizers are added. The control is provided in liquid form for user convenience.

The provided documentation describes the acceptance criteria and study for the CONE-TROL Hemoglobin A1c Control Set, a quality control material, primarily focusing on its stability. It is not an AI/ML device, so many of the requested fields (e.g., MRMC studies, human reader improvement, multi-reader consensus) are not applicable.

Here's the breakdown of the available information:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criterion for the CONE-TROL Hemoglobin A1c Control Set is that the analyte activity (concentration) must fall within ±10% of the initial value at various storage conditions and time points.

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

• Sample Size:
  • For stability studies, the "sample" typically refers to the number of vials or batches tested. The document mentions two vials were assayed in triplicate for value assignment, and data points were collected over several days (minimum 6 data points per level for value assignment). For stability, specific numbers of individual vials tested at each time point are not explicitly stated, but it follows a standard protocol of testing representative aliquots from the prepared control sets.
• Data Provenance: Not explicitly stated (e.g., country of origin, retrospective/prospective). However, the studies were conducted by the manufacturer, Cone Bioproducts, located in Seguin, TX, USA, for regulatory submission to the FDA. The stability studies are prospective, as they track the product over time.

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

Not applicable. This device is a quality control material whose "truth" is its chemical concentration, determined by analytical instrumentation. It does not involve human interpretation or expert opinions to establish ground truth in the way an AI diagnostic device would.

4. Adjudication Method for the Test Set

Not applicable. Ground truth for this chemical control is established through objective analytical measurements, not through adjudication of expert opinions.

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 not an AI/ML device.

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

Yes, in a sense, the performance of the control material is assessed in a "standalone" manner. Its stability and value assignment are determined purely through analytical measurements on laboratory instruments (Tosoh G7 HPLC Analyzer). There is no "human-in-the-loop" component in determining the performance of the control material itself; it's an objective measurement of its chemical properties over time.

7. The Type of Ground Truth Used

The ground truth used is the measured concentration of HbA1c in the control material, determined by objective analytical methods using the Tosoh G7 HPLC Analyzer. This is a form of measurement data/analytical truth.

8. The Sample Size for the Training Set

Not applicable. This is not an AI/ML device, so there is no "training set."

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. The "ground truth" for the control material's initial value (value assignment) is established by assaying Levels 1 and 2 in triplicate on the applicable instrument system, with a minimum of 6 data points for each level. The mean, standard deviation, and coefficient of variance are then determined.

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Hemoglobin Alc Linearity is intended for use as quality control material to demonstrate linearity throughout the reportable range of Hemoglobin A1c (HbA1c%) for Immunoassay and HPLC test methods using protocols established in individual laboratories.

The HbAIc Linearity Set is prepared from human blood to which stabilizers are added. The control is provided in liquid form for user convenience.

This submission describes a medical device, the Cone Bioproducts' HbA1c Linearity Set, which is a quality control material. As such, the concept of "acceptance criteria" and "device performance" in the context of clinical efficacy (as with an AI diagnostic tool) does not directly apply. The submission focuses on demonstrating substantial equivalence to a predicate device for its intended use as a quality control material to verify linearity for HbA1c testing.

Therefore, many of the requested items (e.g., sample size for test set, ground truth experts, MRMC study, standalone performance) are not relevant to this type of device and its regulatory submission.

Instead, the "acceptance criteria" here are implicitly defined by the demonstration of substantial equivalence to the predicate device, LiniCAL Enzyme Calibration Verifiers (K040535), based on comparison of intended use and physical properties.

Here's an analysis based on the provided document:

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

As this is a quality control material seeking substantial equivalence, the "acceptance criteria" are not based on diagnostic performance metrics but rather on characteristics that establish its equivalence to a predicate. The "reported device performance" is essentially the detailed description of the subject device's characteristics compared to the predicate.

Notes on the table: The "acceptance criteria" column is derived from the characteristics of the predicate device. The submission argues that even with differences (e.g., single vs. multiple analytes, specific methodologies), the subject device is substantially equivalent for its stated intended use (HbA1c linearity) as a quality control material.

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

This information is not applicable and not provided in the submission. The submission is for a quality control material, not a diagnostic or screening device that would typically involve a "test set" of patient data. The demonstration of equivalence relies on comparing product characteristics and intended use, not on a clinical performance study using patient samples.

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 information is not applicable and not provided in the submission. There is no "test set" or "ground truth" establishment in the context of clinical interpretation by experts for this type of device.

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

This information is not applicable and not provided in the submission. There is no "test set" requiring expert adjudication.

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

This information is not applicable and not provided in the submission. This is a quality control material, not an AI-assisted diagnostic tool.

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

This information is not applicable and not provided in the submission. This is a quality control material, not an algorithm or AI system.

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

This information is not applicable and not provided in the submission. For a quality control material, the "truth" is established by the known concentration or characteristic of the control material itself, and its ability to demonstrate linearity is assessed through its performance on a laboratory analyzer, not by comparison to external clinical ground truth.

8. The sample size for the training set

This information is not applicable and not provided in the submission. The device is a manufactured product (quality control material), not a machine learning 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 in the submission. As above, there is no "training set" for this type of device.

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