(27 days)
Retic-Chex for Cell-Dyn is an assayed control for evaluating the accuracy and precision of automated, semi-automated and manual methods of reticulocyte counting.
Retic-Chex for Cell-Dyn is a suspension of stabilized human red blood cells and simulated human reticulocytes packaged in plastic vials containing 1.0ml volumes. The device consists of two levels of reticulocyte percentage range. Control I reticulocyte percent range will be 1.5 - 2.0. Control II reticulocyte percent range will be 3.9 - 5.8. Closures are injection molded polypropylene screw-top caps. The vials are packaged in vacuum molded clam-shell box.
The provided text is a 510(k) summary for Retic-Chex for Cell-Dyn, a hematology control device. It describes the device, its intended use, and states that three studies were conducted to demonstrate its performance. However, the document does not explicitly state acceptance criteria in a quantitative manner, nor does it provide detailed quantitative results that would typically be reported as "reported device performance." Instead, it broadly concludes that the device is "consistently reproducible and stable."
Therefore, I cannot populate a table of acceptance criteria and reported device performance with specific numerical values as this information is not present in the provided text.
Based on the available information, here's what can be extracted:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Not explicitly stated quantitatively in the document) | Reported Device Performance (Summary from document) |
|---|---|
| Device to be consistently reproducible | Study results showed Retic-Chex for Cell-Dyn to be consistently reproducible. |
| Device to be stable for the entire product dating | Study results showed Retic-Chex for Cell-Dyn to be stable for the entire product dating. |
| Substantially equivalent to predicate product | Study results show Retic-Chex for Cell-Dyn to be substantially equivalent to the predicate product (Retic-Chex Linearity, K000115). |
| Fulfills intended use when used as instructed | Retic-Chex for Cell-Dyn is a safe and effective product, which fulfills its intended use when used as instructed in the product package insert. |
2. Sample size used for the test set and the data provenance:
- Sample size for the test set: Not explicitly stated. The document mentions "Three studies... were conducted," but does not provide details on the number of samples or measurements within each study.
- Data provenance: Not explicitly stated. The studies were conducted by Streck Laboratories, Inc., presumably at their facilities. No information about the country of origin of the data or whether it was retrospective or prospective is provided.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. This device is a quality control material for automated reticulocyte counting. Its "ground truth" (or target values) would be established through a rigorous assay process using reference methods and potentially multiple instruments/operators, rather than expert interpretation of images or clinical cases. The document does not describe the specific method used to establish the "ground truth" for the control levels, other than stating it is an "assayed control."
4. Adjudication method for the test set:
- Not applicable. Given the nature of the device as a quality control material, rather than a diagnostic tool requiring interpretation of complex data (e.g., images), an adjudication method as typically understood for expert consensus is not relevant or 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. This device is a control material for laboratory instruments, not an AI-powered diagnostic system that assists human readers in interpreting clinical cases. Therefore, an MRMC study related to human reader improvement with AI assistance is not relevant.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Not applicable. This device is a reagent/control material; it is not an algorithm or a standalone diagnostic system.
7. The type of ground truth used:
- The device is described as an "assayed control". This implies that the "ground truth" (the target reticulocyte percentage ranges for Control I and Control II) would have been established through analytical testing and validation using reference methods and/or the intended automated reticulocyte counters. The document specifies reticulocyte percentage ranges for Control I (1.5 - 2.0%) and Control II (3.9 - 5.8%), which serve as the "ground truth" or expected values for the control material.
8. The sample size for the training set:
- Not applicable. As this is a quality control material and not a machine learning algorithm, there is no "training set" in the context of AI/ML development. The studies performed ("Closed Vial Stability," "Open Vial Stability," and "Manual Count Closed Vial Stability") are for product validation, not algorithm training.
9. How the ground truth for the training set was established:
- Not applicable. See point 8.
§ 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.