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The HemoChek Sample Collection Kit is indicated for use in the measurement of HbA1c on blood specimens which can be collected at the patient's home or at a physician's office on a filter paper and delivered to the laboratory by mail. The HbA1c test is used in the assessment of the average blood glucose over an 8-12 week period. The results are to be evaluated by the patient's physician. The product is not indicted for the diagnosis of diabetes mellitus.

The HemoChek Sample Collection Kit is a kit which is sent to the patient's home after the patient has been enrolled in the HemoChek program by the patient's physician. The kit consists of the following:

• A Sample Card containing the proprietary filter paper that the blood sample is deposited on. the patient's name and address, instructions on how to obtain the sample and send it to Osborn Laboratories and a place to make changes to any of the patient's information.
• A pamphlet containing a description of the HemoChek program and detailed instructions about how to obtain a blood sample and mail it to Osborn Laboratories.
• A self-adhesive envelope in which the card is inserted and then mailed to the preprinted address on the envelope.
• The mailing envelope which is used to mail the above three items to the patient.

After receiving the HemoChek Sample Collection Kit in the mail from Osborn Laboratories, the patient then collects a blood sample, using a lancet. The blood sample is placed on all three circles on the right hand side of the sample collection card, as described in the instructions. Then the card is placed in the mailing envelope provided in the kit and mailed to Osborn Laboratories. When the blood sample is received by Osborn Laboratories the patient's HbA1c level is measured using existing assay methods.

The provided text describes the Osborn Laboratories HemoChek Sample Collection Kit, a device intended for collecting blood samples for HbA1c measurement. It outlines the device description, intended use, comparison with a predicate device, and a summary of performance testing.

Here's the breakdown of the acceptance criteria and study information, as much as can be gleaned from the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

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

The document mentions several tests but does not provide specific sample sizes for each:

• Initial Validation (Accuracy & Repeatability): "whole blood specimens were selected to obtain a range of HbA1c levels." Additional "samples were obtained from each specimen using HemoChek Sample Cards."
• High HbA1c Specimens Validation: "blood specimens were taken at a local hospital from a number of persons with high levels of HbA1c."
• Environmental Testing: The number of kits subjected to environmental testing is not specified.

Data Provenance:

• Whole Blood Specimens (Initial Validation): Not explicitly stated, but likely from a laboratory or clinical setting where a range of HbA1c levels could be sampled.
• High HbA1c Specimens: "a local hospital."

The studies appear to be prospective in nature, as they involve collecting and analyzing samples specifically for the validation of the HemoChek Sample Cards.

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

The document does not specify the number of experts or their qualifications for establishing ground truth. The "ground truth" appears to be established by the "existing assay methods" used for analyzing whole blood specimens. These are implied to be standard, validated laboratory methods, but specific details about the personnel performing these assays are not provided.

4. Adjudication Method for the Test Set

No explicit adjudication method is mentioned. The comparison is made between values obtained from whole blood samples (serving as the reference/ground truth) and values obtained from samples collected with the HemoChek Sample Kit, both analyzed using the "same assay method." The "acceptable accuracy limits" imply a pre-defined range of difference that was considered acceptable.

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 device is a sample collection kit, not an imaging or diagnostic algorithm that would typically involve multiple human readers. The performance evaluation focuses on the accuracy and stability of the collected sample relative to a direct whole blood sample.

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

This question is not applicable in the context of the HemoChek Sample Collection Kit. The device itself is a collection kit and does not involve an algorithm. Its performance is evaluated based on the integrity and accuracy of the collected blood sample, which is then analyzed by existing laboratory assay methods (human-in-the-loop in the lab). There is no "algorithm only" component.

7. The Type of Ground Truth Used

The ground truth used was measurement from existing assay methods on whole blood specimens. This means direct laboratory analysis of unconcentrated blood samples provided the reference values against which the HemoChek collected samples were compared.

8. The Sample Size for the Training Set

No information is provided about a "training set." This type of device (a sample collection kit) typically undergoes validation, not a machine learning training process.

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

As there is no mention of a training set, this question is not applicable.

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The Oral-Eze Oral Fluid Collection System is a prescription device, intended for use by a person under the supervision of a trained health care professional to collect oral fluid specimens, contain these specimens, and preserve the specimens after collection and during transport from the collection area to the laboratory.

The Oral-Eze Oral Fluid Collection System is a device used by a person under the supervision of a trained health care professional to obtain an oral fluid specimen and have the specimen contained for transport to a laboratory. The device consists of the following:

• A collector pad holder/handle with a collector pad, contained in a sealed "peel-apart" plastic envelope. . The collector pad holder/ handle itself consists of two parts, a collector pad holder and a collector pad slider. The collector pad is held in the holder/handle by a pin in the slider that fits into a hole in the collector pad, and by the holder, which keeps the pad from falling off the pin. The slider has a round indicator port in it. A blue color appears in this indicator port when a predetermined amount of oral fluid has been collected.
• An Oral Fluid Collection Tube with a screw-on lid, containing preservative fluid. ..
• A clear plastic sealed envelope that contains all three of the above items. .

The provided text describes the "Osborn Laboratories Oral-Eze™ Oral Fluid Collection System." Since this is a collection device and not a diagnostic or AI-powered system, the typical acceptance criteria and study designs (like MRMC studies) for such devices are not applicable in the same way they would be for an AI algorithm interpreting medical images.

Instead, the performance evaluation focuses on direct comparison to predicate devices and ensuring the practical utility and stability of the collected specimens.

Here's an analysis based on the provided text, adapted for a medical device that collects biological samples:

1. Table of Acceptance Criteria and Reported Device Performance:

Note: The text explicitly states "The test results demonstrated that the Oral-Eze device is substantially equivalent to the Saliva-Sampler predicate device" for characteristics like collection time and volume. For environmental stability, it states "The test results were considered to be within acceptable accuracy limits." The specific quantitative thresholds for these metrics are not provided in the summary.

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

• Sample Size: Not explicitly stated. The text only mentions "To assess the suitability... both the Oral-Eze device and the Saliva · Sampler predicate device were tested for a number of characteristics." For environmental testing, it notes "Oral-Eze collection tubes with collector pads containing oral fluid specimens were subjected to environmental testing."
• Data Provenance: Not explicitly stated. The testing seems to be internal to Osborn Laboratories. Given it's a pre-market submission, it would typically be conducted under controlled laboratory conditions, possibly drawing from a pool of healthy volunteers for initial collection tests.

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

This level of detail is not provided. For a device like this, "ground truth" would likely involve objective measurements (e.g., volume collected, chemical analysis of preservative efficacy, stability of drugs/analytes in collected samples, if relevant, although not detailed here). The "suitability" and "acceptable accuracy limits" would be determined by laboratory professionals or engineers with expertise in medical device testing and quality control.

4. Adjudication Method for the Test Set:

Not applicable or provided. This is typically for subjective assessments (e.g., image interpretation). Performance for this device would rely on objective measurement against pre-defined engineering or performance specifications.

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 fluid collection system, not an AI diagnostic or assistance tool, so MRMC studies are not relevant.

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

Not applicable. This device does not involve an algorithm.

7. The Type of Ground Truth Used:

For the performance testing mentioned:

• Comparison to Predicate Performance: The "ground truth" for collection time and volume was likely the observed performance of the predicate device (Saliva-Sampler).
• Defined Acceptable Limits: For environmental stability, the "ground truth" would be pre-defined "acceptable accuracy limits" for the integrity and chemical stability of the oral fluid specimens after exposure to extreme temperatures. This would usually be based on established laboratory standards or regulatory guidance for specimen transport.

8. The Sample Size for the Training Set:

Not applicable. This device does not use machine learning or AI, so there is no "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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