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Cyto-Chex® BCT™ is intended for collection and storage of blood specimens for immunophenotyping of WBC by flowcytometry. Recovery of lymphocyte subset cell markers of the HIV panel can be accomplished over a 14-day period following collection.

Cyto-Chex BCT consists of a standard 13 x 75mm glass blood collection tube containing 75.8ul of sterile KJEDTA anti-coagulant and WBC preservative. It is manufactured with a vacuum to draw 5ml of blood by venipuncture.

Here's a breakdown of the acceptance criteria and the study that demonstrates the device meets these criteria, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

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

• Sample Size: The text states "multiple healthy donors" and "samples from HIV positive patients." Specific numerical sample sizes for either group are not provided.
• Data Provenance: Not explicitly stated, but it implies a prospective clinical study where fresh blood samples were collected and then split into different tubes and analyzed over time. The mention of "resource-poor countries" in the conclusion suggests a global relevance, but doesn't specifically state the origin of the study participants. The study tested both healthy and HIV-positive individuals.

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

• Number of Experts: Not mentioned.
• Qualifications of Experts: Not mentioned. The ground truth was established by laboratory analysis using flow cytometry, a standardized method. The expertise would lie in the technicians performing and interpreting these tests, but their specific qualifications are not detailed.

4. Adjudication Method for the Test Set:

• Adjudication Method: Not applicable. This device is a blood collection tube for sample preservation, not an AI diagnostic tool requiring expert adjudication of image interpretations or similar subjective assessments. The "ground truth" was derived from direct laboratory measurements (flow cytometry results of fresh samples).

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done:

• MRMC Study: No. This is not an imaging or diagnostic device that involves human interpretation of results. Therefore, an MRMC study is not relevant.

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

• Standalone Performance: No. This is a medical device (blood collection tube) that is designed to preserve biological samples. Its performance is assessed by how well it maintains the integrity of the sample, not as an algorithm performing a task autonomously.

7. The Type of Ground Truth Used:

• Type of Ground Truth: The ground truth was established by direct laboratory measurement from fresh samples (specifically, flow cytometric data for lymphocyte subset cell-surface markers from K2EDTA blood collection tubes analyzed within 6 hours of draw). This serves as the "reference value" against which the Cyto-Chex BCT preserved samples were compared.

8. The Sample Size for the Training Set:

• Sample Size for Training Set: Not applicable. This is not an AI/ML device that requires training. The device's performance is based on its physical properties and chemical composition to preserve blood samples.

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

• Ground Truth for Training Set: Not applicable, as there is no training set for this type of device.

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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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