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the INDICATION/INTENDED USE of the modified device as described in its labeling HAS NOT CHANGED

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This 510(k) submission describes modifications to the HemoCue® HbA1c 501 Glycosylated Hemoglobin Monitoring System (K121366). The provided text indicates this is a "SPECIAL 510(k): Device Modification OIR Review Memorandum" and focuses on verifying that the modifications do not change the fundamental scientific technology or intended use of the device.

Crucially, the provided document does NOT contain a study with acceptance criteria and device performance results as typically requested for demonstrating clinical effectiveness or accuracy. Instead, it focuses on design control and regulatory compliance for minor device changes.

Therefore, many of the requested sections (sample size, experts, adjudication, MRMC, standalone performance, ground truth details, training set details) cannot be answered from this document as it does not contain information about a clinical performance study. The document explicitly states that the "INDICATION/INTENDED USE of the modified device as described in its labeling HAS NOT CHANGED." This type of 510(k) often relies on demonstrating that the changes do not negatively impact the previously established performance.

However, based on the provided text, we can infer some information about acceptance criteria in a general design control context:

Acceptance Criteria and Reported Device Performance

The document states: "Based on the Risk Analysis, an identification of the verification and/or validation activities required, including methods or tests used and acceptance criteria to be applied." And further: "a statement signed by the individual responsible, that, as required by the risk analysis, all i) verification and validation activities were performed by the designated individual(s) and the results demonstrated that the predetermined acceptance criteria were met".

This indicates that internal verification and validation activities were performed with predetermined acceptance criteria. However, the specific acceptance criteria and the quantitative or qualitative results of these activities (i.e., the "reported device performance") are not detailed in this review memorandum. The modifications are related to usability, appearance, and internal checks of the device, not its core HbA1c measurement performance.

Study Details (Based on what can be inferred/is absent from the document):

1. Sample size used for the test set and the data provenance: Not applicable or not provided. This document does not describe a clinical performance study with a test set of patient samples. The "test set" here refers to internal verification and validation tests for the modifications.
2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable or not provided. No clinical "ground truth" establishment is described for these device modifications.
3. Adjudication method: Not applicable or not provided.
4. If a multi-reader multi-case (MRMC) comparative effectiveness study was done: No. This document describes a Special 510(k) for device modifications, not a comparative effectiveness study of the device's diagnostic performance.
5. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable. This is a point-of-care analytical device, not an AI algorithm requiring standalone performance evaluation in the typical sense.
6. The type of ground truth used: Not applicable for a clinical performance evaluation. For the modifications, the "ground truth" would be the successful functioning of the new features as per design specifications (e.g., correct light intensity check, accurate shelf-life display, proper initialization sequence).
7. The sample size for the training set: Not applicable or not provided. This is not an AI/machine learning device with a "training set."
8. How the ground truth for the training set was established: Not applicable or not provided.

In summary, the provided document is a regulatory review memorandum for a Special 510(k) focusing on design control and confirming that minor modifications do not alter the fundamental scientific technology or intended use of a previously cleared device. It does not contain the details of a clinical performance study with specific acceptance criteria, reported performance, or ground truth establishment as would be typically found for an initial clearance or a significant change requiring new performance data.

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The Hemocue® Hbalc 501 assay is an in vitro diagnostic test that quantitatively measures the percent concentration glycosylated hemoglobin in capillary or venous whole blood samples for clinical laboratory and point of care use. Measurement of percent HbAlc is used to monitor long-term glucose control in individuals with diabetes mellitus. Hemocue® Hbalc 501 is for in vitro diagnostic use and is not to be used for the diagnosis or screening of diabetes or for neonatal use.

The test is for prescription use as an aid in the management of diabetes.

The Hemocue® HbA1c 501 M Glycosylated Hemoglobin test system measures Hemoglobin A 1c in venous and capillary whole blood. The Hemocue® HbA1c 501 ™ Glycosylated Hemoglobin test system includes Analyzer. Test cartridge, Check cartridges(Monthly and Daily), Thermal printer, Barcode scanner, PC cable and fan filter. The Hemocue® HbA1c 501 ™ Glycosylated Hemoglobin test system is a fully automated boronate affinity assay for the determination of the percentage of hemoglobin A1c(HbA1c, %) in human whole blood.

The Test Cartridge consists of a cartridge and a reagent pack containing the reagents necessary for the determination of hemoglobin Alc, with a sampling area for blood collection.

The reagent pack is pre-filled with reagent solution and rinsing solution. The reagent solution contains agents that hemolyse erythrocytes and bind hemoglobin specifically as well as a boronate resin that binds to the cis-diols of glycated hemoglobin.

The blood sample (4uL) is collected at the sampling area of the reagent pack, which is then inserted into the cartridge, where the blood is instantly lysed releasing the hemoglobin and the boronate resin binding the glycated hemoglobin.

The reagent pack containing the blood sample is inserted in Hemocue® HbA1c 501 Analyzer (in which the cartridge has been placed). The cartridge is automatically rotated, placing the blood sample in the measuring zone. The total hemoglobin is photometrically measured by the diffused reflectance of the optical sensor composed of both a LED (Light Emitting Diode) and a PD (Photo Diode). The assembled cartridge is rotated and the rinsing solution washes out non-glycated hemoglobin from the blood sample, enabling photomectical measurement of glycated hemoglobin.

The provided text describes a Special 510(k) submission for the Infopia Co.,Ltd. Glycosylated Hemoglobin (HbA1c) Monitoring System. While it states that "Test results showed substantial equivalence" for clinical performance, it does not provide specific acceptance criteria or detailed results of a study proving the device meets those criteria.

Instead, the submission focuses on demonstrating substantial equivalence to a predicate device (CLOVER A1c The Glycosylated Hemoglobin Monitoring System, K082275) based on similarities in intended use, operating principle, materials, use environment, shelf life, and calibration method, along with a statement that verification, validation, and testing activities were conducted and passed.

Therefore, many of the requested details cannot be extracted from the provided text.

Here is what can be inferred and what is explicitly stated:

1. Table of Acceptance Criteria and Reported Device Performance:

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

• Sample Size (Test Set): Not specified. The text mentions "clinical performance evaluation" but does not give a sample size.
• Data Provenance: Not specified (e.g., country of origin, retrospective/prospective).

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

• Number of Experts: Not specified.
• Qualifications of Experts: Not specified.
• Method of establishing ground truth: Not specified.

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

• Adjudication Method: Not specified.

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:

• MRMC Study: No, this device is a stand-alone analytical instrument for measuring HbA1c, not an AI-assisted diagnostic imaging or interpretation tool. Therefore, an MRMC study related to human readers improving with AI is not applicable.

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

• This device is an in vitro diagnostic device that quantitatively measures HbA1c. Its performance is its standalone performance. The "clinical performance evaluation" assessed how accurately the device measures HbA1c in blood samples.

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

• Type of Ground Truth: Not explicitly stated. For HbA1c measurements, the "ground truth" would typically be established by a reference method of HbA1c measurement (e.g., HPLC) recognized as highly accurate, against which the new device's measurements are compared.

8. The sample size for the training set:

• Sample Size (Training Set): Not applicable for this type of medical device which is an in vitro diagnostic instrument for directly measuring a biomarker. The device relies on a chemical/optical detection system, not a machine learning algorithm that requires a training set.

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

• Training Set Ground Truth: Not applicable, as there is no training set for a machine learning model.

In summary: The provided text is a high-level 510(k) summary focusing on substantial equivalence to a predicate device for an HbA1c monitoring system. It does not contain the detailed study results, specific acceptance criteria, or methodological specifics typically found in a full efficacy study report. The key information provided is that a clinical performance evaluation was conducted and deemed "substantially equivalent," and non-clinical tests passed predetermined criteria.

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