(80 days)
The ABX PENTRA 60™ Hematology Analyzer is a fully automated (microprocessor controlled) hematology analyzer used for the in vitro diagnostic testing of whole blood specimens. The ABX PENTRA 60™ is able to operate either in complete blood count (CBC) mode or in CBC + 5 differential leucocyte count (5DIFF) mode.
The ABX PENTRA 60™ Hematology Analyzer is a benchtop, clinical laboratory instrument which analyzes in-vitro samples of whole blood to provide complete blood count and leucocyte differential count using principles of cytochemistry, focused flow impedance and light transmission using a halogen light source. The instrument is microprocessor driven.
The document describes the ABX PENTRA 60™ Hematology Analyzer and its comparison to a predicate device, the VEGA Hematology Analyzer (K962633), to establish substantial equivalence.
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1. Table of Acceptance Criteria and Reported Device Performance:
The document doesn't explicitly define "acceptance criteria" in a quantitative table format with specific thresholds (e.g., "accuracy > 95%"). Instead, it describes performance studies demonstrating comparability to the predicate device. The primary "acceptance criterion" appears to be substantial equivalence to the predicate device, demonstrated through various performance evaluations.
| Performance Metric | Reported Device Performance | Notes |
|---|---|---|
| Clinical Performance (Comparison to Predicate Device) | Performance data on various hematological indices using human blood samples processed in both the ABX PENTRA 60™ and the VEGA Hematology Analyzer. The overall effect of modifications (hardware, reagents, dilution ratios) on safety and efficacy was evaluated in a clinical study. | The document states "Performance data on various hematological parameters comparing the ABX PENTRA 60™ Hematology Analyzer and the VEGA Hematology Analyzer... indicate that the ABX PENTRA 60™ is substantially equivalent to the predicate device." Specific numerical results (e.g., correlation coefficients, mean differences) are not provided in this summary. |
| Assay Linearity/Sensitivity | Evaluated using commercially available low-range and high (full) range specimens. | Studies were performed; specific quantitative results are not detailed. |
| Carry-over | Evaluated using commercially available low-range and high (full) range specimens. | Studies were performed; specific quantitative results are not detailed. |
| Precision (Within-run) | Evaluated using three commercially available control specimens having leukocytes, erythrocytes, platelets, and hemoglobin in the low, normal, and high range. | Studies were performed; specific quantitative results (e.g., CV%) are not detailed. |
| Precision (Between-run) | Evaluated using three commercially available control specimens having leukocytes, erythrocytes, platelets, and hemoglobin in the low, normal, and high range. | Studies were performed; specific quantitative results are not detailed. |
| Precision (Between-day) | Evaluated using three commercially available control specimens having leukocytes, erythrocytes, platelets, and hemoglobin in the low, normal, and high range. | Studies were performed; specific quantitative results are not detailed. |
| Sample Stability | Evaluated using clinical samples. | Studies were performed; specific details on the stability parameters are not detailed. |
| Software Validation | New software has been validated to address modifications. | The nature and extent of validation are not detailed. |
2. Sample Sizes used for the Test Set and Data Provenance:
- Sample Size for Clinical Comparison:
- 105 clinical specimens from patients with normal complete blood count.
- 104 clinical specimens from patients with at least one parameter outside the normal range.
- Total:* 209 human blood samples for predicate device comparison.
- Sample Size for Linearity/Sensitivity and Carry-over: "Commercially available low range and high (full) range specimens." (Number not specified)
- Sample Size for Precision: "Three commercially available control specimens having leukocytes, erythrocytes, platelets, and hemoglobin the low, normal and high range." (Number of runs/days not specified)
- Data Provenance: "Human blood samples" and "clinical specimens." The country of origin is not explicitly stated, but the company is based in Irvine, CA, suggesting the samples were likely from the US, though this is not confirmed. The study appears to be retrospective in the sense that the samples were already collected and then analyzed on both devices, or prospective in analyzing new samples on both. Given the phrasing, it's more likely a direct comparison study on a set of clinical samples.
3. Number of Experts used to establish the ground truth for the test set and their qualifications:
The document does not mention the use of experts to establish ground truth for the test set in the traditional sense of diagnostic image interpretation. The "ground truth" for hematology analyzers is typically considered the reference method or the predicate device's results, which are themselves subject to established clinical laboratory standards. There is no mention of radiologists, pathologists, or other human experts manually reviewing the blood samples to establish a "ground truth" against which the device's performance was compared beyond the predicate device.
4. Adjudication Method for the test set:
Not applicable in the context of this device. Adjudication methods (like 2+1, 3+1) are typically used for interpreting subjective findings like medical images where human consensus is needed to establish ground truth for an AI system. For a hematology analyzer, the comparison is against the predicate device's quantitative results or established control values.
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 is a standalone diagnostic laboratory instrument, not an AI-assisted interpretation tool for human readers. Therefore, an MRMC study examining reader improvement with AI assistance was not performed.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Yes, this entire study describes the standalone performance of the ABX PENTRA 60™ Hematology Analyzer. It is an automated instrument that provides complete blood count and leukocyte differential count without direct human interpretation of individual cellular images or raw data. The "algorithm" here refers to the device's inherent cytochemistry, flow impedance, and light transmission principles, and its microprocessor-driven analysis.
7. The type of ground truth used:
The primary "ground truth" used for establishing substantial equivalence was:
- Predicate Device Performance: The results from the CE-cleared VEGA Hematology Analyzer (K962633). The ABX PENTRA 60™'s performance was compared directly to this device for various hematological indices.
- Commercially Available Controls/Specimens: Used for evaluating linearity, carry-over, and precision. These controls have known or expected values.
8. The sample size for the training set:
The document does not specify a separate training set or details about how the internal algorithms of the ABX PENTRA 60™ were trained. This is typical for a 510(k) summary for a traditional laboratory instrument, where the focus is on the validation of the final product's performance against a predicate and established methods rather than detailing the internal development/training of the proprietary analytical methods.
9. How the ground truth for the training set was established:
Since a training set is not explicitly mentioned or detailed, the method for establishing its "ground truth" is also not described. The instrument's underlying principles (cytochemistry, flow impedance, light transmission) are well-established analytical techniques in hematology, rather than a machine learning model that requires explicit "ground truth" labeling during a training phase in the AI sense.
§ 864.5220 Automated differential cell counter.
(a)
Identification. An automated differential cell counter is a device used to identify one or more of the formed elements of the blood. The device may also have the capability to flag, count, or classify immature or abnormal hematopoietic cells of the blood, bone marrow, or other body fluids. These devices may combine an electronic particle counting method, optical method, or a flow cytometric method utilizing monoclonal CD (cluster designation) markers. The device includes accessory CD markers.(b)
Classification. Class II (special controls). The special control for this device is the FDA document entitled “Class II Special Controls Guidance Document: Premarket Notifications for Automated Differential Cell Counters for Immature or Abnormal Blood Cells; Final Guidance for Industry and FDA.”