(302 days)
The EasyCell is intended to locate and display images of white cells, red cells, and platelets acquired from fixed and stained peripheral blood smears and assists a qualified technologist in conducting a WBC differential, RBC morphology evaluation, and platelet estimate using those images. For in vitro diagnostic use only. For professional use only.
The EasyCell automatically locates and presents images of blood cells on peripheral smears. The operator reviews the suggested classification of each white cell according to type and may manually change the suggested classification of any cell. The operator can characterize red cell morphology and estimate platelets based on observed images. The EasyCell is intended to be used by skilled operators, trained in the use of the device and in the identification of blood cells.
This document describes the performance characteristics and acceptance criteria for the EasyCell Automated Cell-Locating Device (K092116).
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are implicitly derived from the "Correlation between Reference Method and Test Method" and "Sensitivity and Specificity" tables provided in the submission. The device is deemed acceptable if its performance is "good" or "equivalent" to the reference method. Specific quantitative targets for correlation coefficients, sensitivity, and specificity should have been defined as acceptance criteria but are not explicitly stated as such. Based on the provided data, the device meets these implicit criteria.
| Metric | Acceptance Criteria (Implied) | Reported Device Performance (Full Sample) | Reported Device Performance (100 vs. 200 cells) |
|---|---|---|---|
| WBC Differential (Correlation Coefficient r) | ≥ 0.90 for Neutrophils, Lymphocytes, Eosinophils; ≥ 0.80 for Monocytes | Neutrophil: 0.99Lymphocyte: 0.98Monocyte: 0.93Eosinophil: 0.97 | Neutrophil: 0.96Lymphocyte: 0.95Monocyte: 0.83Eosinophil: 0.93 |
| WBC Differential (Slope) | Close to 1.00 | Neutrophil: 1.00Lymphocyte: 1.00Monocyte: 0.85Eosinophil: 0.95 | Neutrophil: 0.99Lymphocyte: 1.00Monocyte: 0.83Eosinophil: 0.99 |
| WBC Differential (Intercept) | Close to 0.00 | Neutrophil: 0.39Lymphocyte: 0.88Monocyte: 0.59Eosinophil: 0.066 | Neutrophil: -0.15Lymphocyte: 0.73Monocyte: 0.72Eosinophil: -0.01 |
| Efficiency (% agreement) | Not explicitly specified, assumed to be high | Overall: 84% | 200 cells: 84%100 cells: 83% |
| Sensitivity | Not explicitly specified, assumed to be high | Overall: 91% | 200 cells: 91%100 cells: 90% |
| Specificity | Not explicitly specified, assumed to be high | Overall: 72% | 200 cells: 72%100 cells: 70% |
| Platelet Estimate Accuracy | "Good agreement" (Cohen's kappa) | "Good agreement" between methods (Cohen's kappa statistic calculated, but value not provided) | N/A |
| Red Blood Cell Morphology Accuracy | "Good agreement" (e.g., >90%) | >90% agreement between methods | N/A |
| Between Run Precision | Equivalent to Reference Method | "Test Method has equivalent precision to the Reference Method." | N/A |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: A total of 304 specimens were collected and analyzed. This sample included:
- 155 specimens from normal (healthy) subjects.
- 149 specimens from subjects with specific disease conditions.
- Data Provenance: The data was collected and analyzed at three sites. The country of origin is not explicitly stated, but the submission is to the US FDA, implying clinical sites within the US or compliant with US standards. The study design is prospective, as specimens were collected and analyzed for this method comparison.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
- Number of Experts: The ground truth (Reference Method) for the test set was established by two trained technologists at each of the three sites. This totals 6 experts for the initial reading, though the independent analysis by two technologists per site suggests independent assessments that were likely compared or adjudicated.
- Qualifications of Experts: The experts are described as "trained technologist" or "skilled operators, trained in the use of the device and in the identification of blood cells." Specific experience levels (e.g., years of experience or board certification) are not provided.
4. Adjudication Method for the Test Set
The document states that slides were "randomly selected, blinded and read by two technologists at each site." It does not explicitly mention an adjudication method (e.g., 2+1 or 3+1). It is implied that the readings from the two technologists at each site formed the "Reference Method" for comparison, but how discrepancies between these two readers were resolved (if at all) is not detailed.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
An MRMC study, comparing human readers with AI assistance versus without AI assistance, was not explicitly detailed in the provided text. The study design focuses on comparing the EasyCell (with human operator review) to a manual reference method. The "Test Method" described involves an operator reviewing and potentially reclassifying the suggested classifications from the EasyCell. Therefore, the reported performance is already that of the human-in-the-loop system, not "without AI assistance." As such, an effect size of how much human readers improve with AI vs. without AI assistance is not presented.
6. Standalone (i.e., algorithm only without human-in-the-loop performance) Study
A standalone performance study of the algorithm without human-in-the-loop review was not conducted or reported. The device description explicitly states: "The operator reviews the suggested classification... and may manually change the suggested classification of any cell." The "Test Method" in the performance study is defined as "EasyCell using Examiner Review." This indicates that all reported performance metrics include the human element of review and potential reclassification, making it a human-in-the-loop system, not a standalone algorithm.
7. Type of Ground Truth Used
The ground truth used for comparison was expert consensus / manual microscopic examination. Specifically, it is referred to as the "Reference Method," which is described as "a manual differential microscopic examination of the peripheral blood slides by a trained technologist."
8. Sample Size for the Training Set
The sample size for the training set is not provided in the given excerpts. The document describes the "ANN's trained to distinguish between classes of white blood cells" but does not give details about the data used for this training.
9. How the Ground Truth for the Training Set was Established
The method for establishing the ground truth for the training set is not explicitly stated in the provided excerpts. It can be inferred that it would involve expert classification of blood cells, similar to the reference method for the test set, but specific details are absent.
{0}------------------------------------------------
Medica Corporation 510(k) Submission K092116
510(k) Summary
Device Name and Classification 1. Trade or Proprietary Name: EasyCell Automated Cell-Locating Device Common or Usual Name: JOY Product Code: Product Classification: Class 2 Hematology Review Panel; Regulation Number: 21CFR864.5260
MAY 1 2 2010
.. •
2. Description of the Device
The EasyCell automatically locates and presents images of blood cells on peripheral smears. The operator reviews the suggested classification of each white cell according to type and may manually change the suggested classification of any cell. The operator can characterize red cell morphology and estimate platelets based on observed images. The EasyCell is intended to be used by skilled operators, trained in the use of the device and in the identification of blood cells.
3. Substantial Equivalency
The EasyCell is substantially equivalent to the CellaVision DM96 Automatic Hematology Analyzer.
Predicate Device Information
| Manufacturer: | CellaVision AB, Lund, Sweden |
|---|---|
| Product: | CellaVision DM96 Automatic Hematology Analyzer |
| 510(k) number: | K033840 |
4. Intended Use
The EasyCell is intended to locate and display images of white cells, red cells, and platelets acquired from fixed and stained peripheral blood smears and assists a qualified technologist in conducting a WBC differential, RBC morphology evaluation, and platelet estimate using those images. For in vitro diagnostic use only. For professional use only.
{1}------------------------------------------------
Medica Corporation
510(k) Submission K092116
4
.
・ .
| Characteristic | Predicate Device | EasyCell | Equivalent |
|---|---|---|---|
| Intended use | Automated cell-locating device for cell-location, and identification, for in-vitrouse. Verification of results by humanoperator. | The EasyCell is intended to locate and displayimages of white cells, red cells, and plateletsacquired from fixed and stained peripheral bloodsmears and assists a qualified technologist inconducting a WBC differential, RBC morphologyevaluation, and platelet estimate using thoseimages. For in vitro diagnostic use only. Forprofessional use only. | ✓ |
| Sample type | Stained blood film on glass slides ofperipheral whole blood. | Stained blood film on glass slides of peripheralwhole blood. | ✓ |
| Samplepreparation | Romanowsky stain | Romanowsky stain | ✓ |
| $f$/sis1...nique:White BloodCells | Cells are located/counted by movingaccording to the battlement track pattern.Cell images are analyzed using standardmathematical methods, includingdeterministic artificial neural networks(ANN's) trained to distinguish betweenclasses of white blood cells.The cell images are pre-classified and theoperator verifies the suggestedclassification by accepting or reclassifying | Cells are located/counted by moving according tothe battlement track pattern. Cell images areanalyzed using standard mathematical methods,including deterministic artificial neural networks(ANN's) trained to distinguish between classes ofwhite blood cells.The cell images are pre-classified and theoperator reviews the suggestedclassification, and accepts or reclassifies theimages. | ✓ |
| Red BloodCells | The device presents an overview image.The reviewer characterizes red blood cellmorphology from the image. | The device presents a series of images.The reviewer characterizes red blood cellmorphology from the images. | ✓ |
| Platelets | The device presents an overview image.The reviewers manually count and estimatethe platelet concentration from theoverview image according to astandardized procedure. | The device presents a series of images.The reviewers manually count and estimate theplatelet concentration from the images accordingto a procedure in the Operator's Manual. | ✓ |
{2}------------------------------------------------
Medica Corporation 510(k) Submission K092116
5. Performance Characteristics
Method Comparison
A Method Comparison was conducted to compare the EasyCell using Examiner Review (the Test Method) to the Reference Method. The Reference Method is a manual differential microscopic examination of the peripheral blood slides by a trained technologist. A total of 304 specimens were collected and analyzed at three sites. 155 specimens were from normal (healthy) subjects and 149 were from subjects with specific disease conditions (see Table 3). Slides were prepared from each specimen. The slides were randomly selected, blinded and read by two technologists at each site.
Table 1
Correlation between Reference Method and Test Method
| Cell Type | CorrelationCoefficient (r) | Slope | Intercept |
|---|---|---|---|
| Neutrophil | 0.99 | 1.00 | 0.39 |
| Lymphocyte | 0.98 | 1.00 | 0.88 |
| Monocyte | 0.93 | 0.85 | 0.59 |
| Eosinophil | 0.97 | 0.95 | 0.066 |
Sensitivity and Specificity
The number of normal and abnormal slides determined by each method was compared to determine the clinical sensitivity and specificity of the EasyCell.
Table 2
| Morphological | Distributional | Overall | |
|---|---|---|---|
| Efficiency (% agreement) | 82% | 89% | 84% |
| Sensitivity | 84% | 92% | 91% |
| Specificity | 82% | 87% | 72% |
Platelet Estimate Accuracy
Platelet counts were estimated by each method as decreased, normal, or increased; and a corresponding value of 1, 2, or 3 was entered in the database. A Cohen's kappa statistic was calculated to demonstrate the agreement between the Test Method and the Reference Method for each technologist. The data show a good agreement between platelet estimates using the Reference Method and using the Test Method.
Red Blood Cell Morphology Accuracy
For each slide, the technologists classified the red blood cells according to morphology. This was done for both methods. The results showed >90% agreement between methods.
{3}------------------------------------------------
Between Run Precision
20 slides were made from one normal patient sample at each site. Each slide was labeled. Each day for 20 days a slide was chosen at random and a 200-cell differential count was made using both the Reference Method and the Test Method. The results show the Test Method has equivalent precision to the Reference Method.
100 vs 200 Total Cell Count
In order to confirm the equivalence of total cell counts of 100 and 200 cells, data from three sites were compared. 304 slides were evaluated using a total count of 100 cells.
The 100 cell results were compared to the 200 cell count Reference Method results. The data showed good correlation between the Reference method and the 100-cell counts.
Table 3 Correlation between Reference Method and Test Method by Cell Type
| Cell Type | CorrelationCoefficient (r) | Slope | Intercept |
|---|---|---|---|
| Neutrophil | 0.96 | 0.99 | -0.15 |
| Lymphocyte | 0.95 | 1.00 | 0.73 |
| Monocyte | 0.83 | 0.83 | 0.72 |
| Eosinophil | 0.93 | 0.99 | -0.01 |
Table 4
Comparison of Test Method to Reference Method Results (200 vs 100 cells)
| Test method(200 cells) | Test Method(100 cells) | |
|---|---|---|
| Efficiency (% agreement) | 84% | 83% |
| Sensitivity | 91% | 90% |
| Specificity | 72% | 70% |
{4}------------------------------------------------
Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle with three stripes forming its wing, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circle around the eagle. The eagle is facing to the right. The logo is black and white.
Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-0609 Silver Spring, MD 20993-0002
Medica Corporation c/o Ms. Fran White Regulatory Consultant 163 Cabot Street Beverly, MA 01915
MAY 1 2 2010
Re: K092116
Trade/Device Name: EasyCell Cell Locator Regulation Number: 21 CFR §864.5260 Regulation Name: Automated Cell-Locating Device Regulatory Class: Class II Product Code: JOY Dated: March 24, 2010 Received: April 28, 2010
Dear Ms. White:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into class II (Special Controls), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. In addition, FDA may publish fruther announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements not he act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Parts 801 and 809); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820). This letter will allow you to begin marketing your device as described in your Section 510(b) premarket
{5}------------------------------------------------
Page 2 - Ms. Fran White
notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Parts 801 and 809), please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (301) 796-5450. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
ia m cham
Maria M. Chan, Ph.D Director Division of Immunology and Hematology Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
{6}------------------------------------------------
Indications for Use
Indications for Use
510(k) Number (if known): K092116
Device Name: EasyCell Cell Locator
Indications for Use: The EasyCell is intended to locate and display images of white cells, red cells, and platelets acquired from fixed and stained peripheral blood smears and assists a qualified technologist in conducting a WBC differential, RBC morphology evaluation, and platelet estimate using those images. For in vitro diagnostic use only. For professional use only.
Prescription Use X (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Device Evaluation and Safety (OIVD)
Sharrow man
Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) Kogall 6
1 of 1
CONFIDENTIAL
§ 864.5260 Automated cell-locating device.
(a)
Identification. An automated cell-locating device is a device used to locate blood cells on a peripheral blood smear, allowing the operator to identify and classify each cell according to type. (Peripheral blood is blood circulating in one of the body's extremities, such as the arm.)(b)
Classification. Class II (performance standards).