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510(k) Data Aggregation
(329 days)
SAL
The X100 with the Full Field Bone Marrow Aspirate (BMA) Application is an automated cell locating device, intended for in vitro use only. The Full Field BMA application automatically locates and presents images of hematopoietic cells to trained operators for visual evaluation of Romanowsky stained bone marrow aspirate (BMA) smears. The Full Field BMA application assists trained operators to perform bone marrow smear quality assessment, blast cell, plasma cell, and M:E ratio estimation. A qualified operator must review, confirm or modify classification of each cell according to type, and verify results before finalizing and releasing the report.
The X100 with the Full Field Bone Marrow Aspirate (BMA) application presents images of Prussian Blue stained BMA smear.
X100HT with Full Field BMA Application:
The X100HT with the Full Field Bone Marrow Aspirate (Full Field BMA) Application is an automated cell locating device. intended for in vitro use only. The Full Field BMA application automatically locates and presents images of hematopoietic cells to trained operators for visual evaluation of Romanowsky stained bone marrow aspirate (BMA) smears. The Full Field BMA application assists trained operators to perform bone marrow smear quality assessment, blast cell, plasma cell, and M:E ratio estimation. A qualified operator must review, confirm or modify classification of each cell according to type, and verify results before finalizing and releasing the report.
The X100HT with the Full Field Bone Marrow Aspirate (BMA) application presents images of Prussian Blue stained BMA smear.
The X100 and X100HT instruments include a digital scanner and processing unit (computer) capable of acquiring high-resolution digital images from Romanowsky or Prussian Blue stained BMA slides with software application (Full Field Bone Marrow Aspirate (BMA) Application) for evaluation of acquired images. The X100 allows for three slides while X100HT comes with an additional component, a slide loader, a mechanical loading mechanism that holds up to 30 slides in three 10-slide cassettes and performs cover slipping and slide loading into the X100 scanner. The Full Field BMA application contains two scan modes - Romanowsky stain and Prussian Blue stain.
The X100 and X100HT devices with the Full Field Bone Marrow Aspirate (BMA) Application are automated cell-locating devices intended to assist trained operators in evaluating Romanowsky or Prussian Blue stained bone marrow aspirate smears. The application specifically aids in bone marrow smear quality assessment, blast cell estimation, plasma cell estimation, and Myeloid:Erythroid (M:E) ratio estimation. A qualified operator must review, confirm, or modify classifications and verify results before finalizing reports.
1. Table of Acceptance Criteria & Reported Device Performance
The acceptance criteria for the device performance are indicated by the successful completion of the studies and the reported sensitivities, specificities, and agreements, particularly for the key parameters of specimen quality, blast cells, plasma cells, and M:E ratio. The tables show the performance results from the clinical study comparing the device to manual microscopy and to de-identified medical data.
Clinical Study: Comparison of Candidate Device to Manual Microscopy
| Parameter (Clinical Application) | Acceptance Criteria (Implicit: Passed Study) | Reported Performance (Sensitivity, Specificity, Accuracy/Agreement 95% CI) |
|---|---|---|
| Specimen Quality Assessment | ||
| Sample Quality (Adequate/Inadequate) | Passed Study | Sensitivity: 88.72% (82.22%, 93.05%) |
| Specificity: 99.36% (98.69%, 99.69%) | ||
| Accuracy: 98.21% (97.31%, 98.82%) | ||
| Stripped Cells (Normal/Increased) | Passed Study | Sensitivity: 66.67% (54.06%, 77.27%) |
| Specificity: 95.45% (94.07%, 96.52%) | ||
| Accuracy: 93.99% (92.48%, 95.21%) | ||
| Sample Quality (Particulate/Pauciparticulate/Aparticulate) | Passed Study | Sensitivity: 90.86% (86.02%, 94.14%) |
| Specificity: 99.42% (98.74%, 99.73%) | ||
| Agreement: 97.64% (96.63%, 98.35%) | ||
| Sample Quality (Bloody tap/Diluted/Adequate BMA) | Passed Study | Sensitivity: 91.88% (86.60%, 95.19%) |
| Specificity: 99.06% (98.29%, 99.49%) | ||
| Agreement: 96.25% (95.04%, 97.18%) | ||
| Count Estimation | ||
| Blast Estimation (Normal (20%) | Passed Study | Sensitivity: 91.67% (87.21%, 94.66%) |
| Specificity: 96.34% (94.88%, 97.39%) | ||
| Accuracy: 95.41% (94.00%, 96.50%) | ||
| Plasma Cell Estimation ( |
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