The intended use Certain® Hct is as a bi-level quality control material and CVM™ is a calibration verification material both for use with hematocrit analyzers.

Device Description

The Chiron Certain Hct is a bi-level quality control material uniquely formulated to provide quality control values for hematocrit analyzers. There are two levels of Certain Hct each provided in 2.5 mL ampules. The product allows verfication of analyzer hematocrit performance within established ranges.

Chiron Calibration Vefication Material (CVM™) is formulated to verify the calibration of hematocrit analyzers. The product contains four levels of 2.5 mL ampules and is intended to assist laboratories in compliance with the requirements of calibration verification under CLIA.

AI/ML Overview

This looks like a 510(k) premarket notification for a hematocrit quality control and calibration verification material, not a medical device in the typical sense of a diagnostic or therapeutic tool that relies on complex algorithms or human interpretation of images/data.

Therefore, many of the requested categories in your prompt (such as "number of experts," "adjudication method," "MRMC study," "standalone performance," "training set size") are not applicable to this type of product. The focus for this submission would be on the analytical performance of the control material itself, often demonstrated through precision, linearity, and stability studies.

Here's how I can address the applicable parts of your request based on the provided text:

Description of the Acceptance Criteria and Study:

The provided text K961807 is a "Summary of Safety and Effectiveness" for a quality control and calibration verification material for hematocrit analyzers. It describes the product (Certain® Hct and CVM™ Hct) and its intended use. However, the provided excerpt does not contain the specific acceptance criteria or the study details that demonstrate the device meets those criteria.

A typical 510(k) submission for a quality control material would include:

Acceptance Criteria for Analytical Performance: This would likely involve specifications for parameters like:
- Precision/Reproducibility: How consistently the material yields the same Hct value over repeated measurements. (e.g., %CV < X%)
- Accuracy/Target Value Assignment: How close the assayed value of the control material is to a reference method or assigned target. (e.g., reported value within Y% of target value)
- Stability: How long the material maintains its assigned value under specified storage conditions.
- Linearity (for CVM Hct): For calibration verification, the material should demonstrate a linear response across the range of Hct values it represents.
Study Design: This would typically involve:
- Testing the material on multiple hematocrit analyzers from different manufacturers.
- Performing multiple replicates over several days to assess precision.
- Comparing the material's performance to an established reference method or predicate device.
- Conducting accelerated and real-time stability studies.

Since this information is not in the provided summary, I cannot fill in the table or answer all your questions specifically.

Here's what I can extract or infer from the provided text, and where I must state "Not Provided" or "Not Applicable":

1. Table of Acceptance Criteria and Reported Device Performance

Category	Acceptance Criteria (As defined in original submission, not provided in excerpt)	Reported Device Performance (As defined in original submission, not provided in excerpt)
Precision	Not Provided in excerpt	Not Provided in excerpt
Accuracy	Not Provided in excerpt	Not Provided in excerpt
Stability	Not Provided in excerpt	Not Provided in excerpt
Linearity (for CVM)	Not Provided in excerpt	Not Provided in excerpt

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 Provided in excerpt. (This would refer to the number of vials/lots tested, number of replicates, number of instruments used in validation studies for the control material itself).
Data Provenance: Not Provided in excerpt. (Likely collected in the USA given the submitter's address, and would be prospective analytical studies).

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 typically established by certified reference methods, inter-laboratory comparisons, or highly precise assays performed by qualified laboratory personnel, rather than interpretation by a panel of clinical experts (like radiologists for imaging). The "ground truth" for Hct values would be based on primary measurement methods.

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

Not Applicable. Adjudication methods like 2+1/3+1 are used for expert consensus on clinical diagnoses (e.g., reviewing medical images). For an analytical quality control material, measurements are quantitative and compared to pre-defined statistical criteria, not subjective expert opinion.

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

Not Applicable. This is a quality control material, not an AI-powered diagnostic or assistive device where human readers are involved in clinical interpretation.

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

Not Applicable. This device is a consumable reagent used to verify the performance of an analyzer, not an algorithm itself. Its "performance" is inherent to its stated values and stability, not a computational output.

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

Analytical Measurement Reference: The "ground truth" would be the assigned hematocrit values for each level of the control material, established through rigorous analytical testing using reference methods and/or comparison to internationally recognized standards or highly characterized primary measurement systems. It would not be expert consensus, pathology, or outcomes data.

8. The sample size for the training set

Not Applicable. This product is not an AI/ML algorithm that requires a "training set."

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

Not Applicable. As above, no training set is involved.

Summary

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K961807

JUL 26 1996

Summary of Safety and Effectiveness

As required by 21 CFR 807.92, the following 510(k) Summary is provided:

1. Submitters Information

Contact person:	William J. Pignato
	Director of Regulatory Affairs

Address: Chiron Diagnostics Corp. 63 North Street Medfield, MA 02052

508 359-3825 Phone:

April 25, 1996 Date Summary Prepared:

2. Device Information

Proprietary Name:	Certain® Hct and CVM™ Hct
Common Name:	Hematocrit quality control and calibrationverification materials
Classification Name:	Quality Control Material (assayed & unassayed)Calibration Verification Material
Classification Number:	21 CFR 862.1660

3. Predicate Device Information

Name:	GEM critCheck
Manufacturer:	Mallinckrodt
510(k) Number:

4. Device Description

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5. Statement of Intended Use

The intended use Certain® Hct is as a bi-level quality control material and CVM™ is a calibration verification material both for use with hematocrit analyzers.

6. Summary of Technological Characteristics

Certain® Hct and CVM™ Hct are assayed aqueous based bicarbonate solution and other salts.

Regulation Number and Section

§ 864.8625 Hematology quality control mixture.

(a)
Identification. A hematology quality control mixture is a device used to ascertain the accuracy and precision of manual, semiautomated, and automated determinations of cell parameters such as white cell count (WBC), red cell count (RBC), platelet count (PLT), hemoglobin, hematocrit (HCT), mean corpuscular volume (MCV), mean corpuscular hemoglobin (MCH), and mean corpuscular hemoglobin concentration (MCHC).(b)
Classification. Class II (special controls). Except when intended for use in blood components, the device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 864.9.