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Para Tech Plus Retics is intended to be used as a control for complete blood cell count (CBC), white cell five-part differential, and reticulocyte parameters on Bayer Advia 120 and Technicon H-Series hematology instruments.

Para Tech Plus Retics is a suspension of stabilized human red blood cells, human white cells, simulated human platelets, and simulated human reticulocytes packaged in glass vials containing 4.0 mL volumes. Closures are injection molded polypropylene screw-top caps. The vials are packaged in polystyrene jars.

The provided text describes a 510(k) summary for a medical device called "Para Tech Plus Retics," an assayed hematology control. This submission focuses on demonstrating substantial equivalence to a predicate device, rather than establishing de novo acceptance criteria with supporting studies as typically seen for novel devices.

Therefore, the information regarding specific acceptance criteria and detailed study results to prove device performance against those criteria is not explicitly present in the provided 510(k) summary. The document focuses on demonstrating that the new device is "substantially equivalent" to an existing one.

However, I can extract the information provided about the overall study and conclusions:

1. Table of Acceptance Criteria and Reported Device Performance:

As mentioned, explicit, quantified acceptance criteria (e.g., specific thresholds for a given metric) are not provided in this 510(k) summary. The "reported device performance" is described qualitatively as meeting the overall goals of the studies.

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

The document mentions "Four studies of Para Tech Plus Retics were conducted: I) Run to Run Reproducibility and Comparison to Whole Blood; II) Site to Site Reproducibility; III) Long Term Stability; and IV) Open Vial Stability." However, no specific sample sizes or data provenance (e.g., country of origin, retrospective/prospective) for these studies are provided.

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

Not applicable/Not provided. This is an in-vitro diagnostic control device, not an imaging or diagnostic algorithm that relies on expert interpretation of results to establish ground truth. Its "ground truth" would likely be laboratory measurements and comparisons to established reference methods or predicate devices.

4. Adjudication Method for the Test Set:

Not applicable/Not provided. As stated above, this is an in-vitro diagnostic control. Adjudication methods like 2+1 or 3+1 are typically used in clinical studies involving interpretation of results, not for the performance validation of a hematology control.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:

No, an MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic imaging or analytical devices where human interpretation plays a role. This device is a control for automated hematology instruments.

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

Not applicable (in the typical sense of an AI algorithm). The "device" is a physical control substance. The performance being evaluated is its interaction with and control over automated hematology analyzers, not an algorithm's standalone output. The studies aimed to prove the control's reproducible and stable performance on these instruments.

7. The Type of Ground Truth Used:

The ground truth for proving the device's performance is implicitly based on:

• Comparison to Whole Blood: For the "Run to Run Reproducibility and Comparison to Whole Blood" study.
• Comparison to Predicate Device (Para Tech): For establishing "substantial equivalence."
• Laboratory measurements and established methods: To assess reproducibility and stability over time.

8. The Sample Size for the Training Set:

Not applicable/Not provided. This device is a control, not an AI/ML algorithm that requires a training set. Its formulation would have been developed through R&D, but not in the sense of an algorithm's training data.

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

Not applicable/Not provided. (See point 8).

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