Search Results

For In Vitro Diagnostic Use

Intelligent Medical Imaging, Inc.'s MICRO21® with Urine Sediment Analysis is a laboratory instrument for locating, digitally storing and displaying microscopic fields of view from urine sediments in a urine slide for examination by a qualified individual for use in reporting a urine microscopic result.

The MICRO21 with Urine Sediment Analysis, is an automated microscopic system that locates formed elements of wine sediment, digital stores images of the constituents and displays the images in an organized manner to aid technologists in performing an Urine Sediment Analysis procedure. The MICRO21 process is substantially equivalent to the manual microscopic process.

Here's a breakdown of the acceptance criteria and study details for the MICRO21® with Urine Sediment Analysis device, based on the provided text:

Acceptance Criteria and Device Performance

The provided document describes categories of testing rather than explicit numerical acceptance criteria. The "Conclusion" section summarizes that the device met the implicit acceptance criteria for each test.

Study Details

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

• Sample Size (Test Set): 182 stained samples. An additional 31 stained samples were created using serial dilution and enrichment to generate a wider range of urinary constituents.
• Data Provenance: Not explicitly stated regarding country of origin. The study appears to be retrospective in that existing samples were processed and then compared to manual methods. The generation of additional samples via serial dilution and enrichment suggests a controlled laboratory setting.

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

• Number of Experts: Three.
• Qualifications of Experts: Certified Medical Technologists.

4. Adjudication Method for the Test Set

The text states, "Using blinded experimental methods, the stained samples were reviewed manually, and processed by the MCRO21 and resultant images reviewed by the technologists." It doesn't explicitly describe an adjudication method (like 2+1 or 3+1) for resolving disagreements among the three technologists when establishing the manual ground truth. It implies their manual review was the ground truth.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

The study describes a comparison between the MICRO21 system and the "manual urine microscopic reference method using standard correlation statistics." This is a comparative study, and it involved multiple readers (three certified medical technologists) reviewing both the manual slides and the MICRO21 images.

• Effect Size of Human Readers with AI vs. Without AI Assistance: The document does not provide a specific "effect size" or quantitative measure of how much human readers improve with AI assistance. Instead, it aims to demonstrate that the MICRO21 system's results correlate well with the manual method, suggesting the device is "safe and effective for its intended use of locating, digitally storing and displaying microscopic fields of view from urine sediments in a urine slide for examination by a qualified individual for use in reporting a urine microscopic result." The phrasing "the MICRO21 process is substantially equivalent to the manual microscopic process" and the conclusion of correlation across various elements implies that performance with the device is comparable to human-only assessment.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

The MICRO21 is described as an "automated microscopic system that locates formed elements...digital stores images...and displays the images...to aid technologists in performing an Urine Sediment Analysis procedure." Crucially, item 8 of the process workflow states, "The technologist reviews the images and quantifies the results." This clearly indicates that the device is designed for human-in-the-loop operation, not standalone algorithmic interpretation. Therefore, a standalone performance study of the algorithm without human review was not performed or intended according to this document.

7. The Type of Ground Truth Used

Expert Consensus (Manual Method): The ground truth was established by three certified medical technologists performing the "manual urine microscopic reference method." This serves as the benchmark against which the MICRO21 results were compared.

8. The Sample Size for the Training Set

The document does not explicitly mention a separate "training set" or its sample size. The description of testing focuses on "performance testing" to assess precision, accuracy, linearity, and correlation, which typically refers to evaluation on a test set.

9. How the Ground Truth for the Training Set Was Established

Since a separate training set is not described, the method for establishing its ground truth is not provided.

Ask a specific question about this device

For In Vitro Diagnostic Use

Intelligent Medical Imaging, Inc.'s MICRO21 with WBC Estimate is a laboratory instrument for locating, digitally storing and displaying white blood cells to aid the technologist in performing the WBC Estimate. Examination and determination of the results must be performed by qualified individuals.

The MICRO21 with WBC Estimate is a new intended use that follows the same process as the currently approved MICRO21 with White Blood Cell (WBC) Differential (Diff). The MICRO21 with WBC Diff, Ref. No. K925670/A, is an automated microscopic system that locates WBCs, stores digital images of the cells and displays the images in an organized manner to aid technologists in performing the WBC Diff procedure. The MICRO21 process is substantially equivalent to the manual microscopic process.

The MICRO21 with WBC Estimate is an automated microscopic procedure that calculates an estimate of WBCs/uL using the information collected during the MICRO2/ with WBC Differential. Upon completion of the review process by a technologist, an algorithm calculates the WBC Estimate by using the number of classified WBCs and the number for low-power (200x magnification) fields visited. An estimated range for the WBCs/uL is calculated and reported.

Here's an analysis of the provided text regarding the acceptance criteria and study for the MICRO21 with WBC Estimate device:

Acceptance Criteria and Study Analysis for MICRO21 with WBC Estimate

The primary objective of the studies was to demonstrate the substantial equivalence of the MICRO21 with WBC Estimate to a Manual WBC Estimate and to automated cell counter results for total WBC count.

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state pre-defined acceptance criteria with specific thresholds (e.g., "accuracy must be >X%"). Instead, it describes a correlation study where the MICRO21's performance is compared against established methods. The "acceptance" is implied by demonstrating substantial equivalence, meaning the results are comparable and within clinically acceptable ranges.

2. Sample Size and Data Provenance

• Test Set Sample Size: 86 blood smear samples.
• Data Provenance: Not explicitly stated, but given the nature of a 510(k) submission for commercialization, it is highly likely a prospective study using clinical samples. The document mentions "various sites" for automated cell counters, suggesting a multi-center data collection effort, but specific countries are not mentioned.

3. Number of Experts and Qualifications for Ground Truth

• Number of Experts:
  • For Manual WBC Estimate (Accuracy Study): Three technologists.
  • For MICRO21 WBC Estimate (Precision and Classification Review): One technologist for the precision study, and three technologists for the "WBC Classification Review" section, which contributed to confirming "real cells" used in the MICRO21 calculation.
• Qualifications of Experts: Described as "technologists." Specific experience levels (e.g., years of experience, certification) are not provided in the document. The conclusion states "Examination and determination of the results must be performed by qualified individuals," but doesn't detail the qualifications of those who performed the study.

4. Adjudication Method for the Test Set

The document does not describe a formal adjudication method (like 2+1 or 3+1).

• For the Manual WBC Estimate, it states "Three technologists performed the manual reviews," implying they each performed their own estimate, but it doesn't specify how their results were consolidated or if consensus was required.
• For the MICRO21 Classification Review, "Three technologists performed the MICRO21 reviews" to verify image classification. Again, it doesn't mention an adjudication process if there were disagreements among them.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

An MRMC study, specifically comparing human readers with AI assistance versus without AI assistance, was not explicitly done or reported in this document. The MICRO21 is described as an "automated microscopic system that locates WBCs, stores digital images of the cells and displays the images in an organized manner to aid technologists." The "aid" here is the display and organization of images, and then the automated calculation based on the technologist's reviewed classifications. The study focuses on the accuracy and precision of the device's estimate compared to manual/automated methods, not on the improvement in human performance due to the aid.

Therefore, no effect size of how much human readers improve with AI vs without AI assistance is provided.

6. Standalone (Algorithm Only) Performance

A standalone performance study was performed for the core calculation of the WBC Estimate. The algorithm automatically calculates the WBC Estimate based on:

• The number of classified WBCs (which are verified by a technologist, but the calculation itself is algorithmic).
• The number of low-power fields visited.
• A Correction Factor.

The "Test Method 1, Accuracy" and "Test Method 2, Precision" evaluate the output of this algorithmic estimate against established methods. While human input (technologist review) confirms the "Real Cells" used in the formula, the final calculation and the resulting "MICRO21 WBC Estimate" range are generated by the device's algorithm.

7. Type of Ground Truth Used

The ground truth used was a combination of:

• Established device measurements: Total White Blood Cell Count generated by automated cell counters (e.g., TOA Sysmex NE 9000, Coulter STKS, Technicon H2). These automated counters are considered a gold standard or a highly reliable reference for total WBC count.
• Expert Consensus/Reference Standard: Manual WBC Estimate performed by three technologists. This serves as a clinical reference method for comparison.

8. Sample Size for the Training Set

The document does not explicitly state the sample size for a training set. The 86 specimens mentioned are for the "Accuracy" test method, which appears to be the primary validation set.
There is a "Correction Factor" (CF) that was "defined as the mean value of the 86 specimens tested." This suggests that the 86 specimens were used to determine or fine-tune this factor, which could be considered a form of calibration or training data for that specific parameter. However, it's not a typical "training set" in the context of modern machine learning where a completely separate hold-out or test set would be used.

9. How the Ground Truth for the Training Set Was Established

As noted above, a distinct "training set" is not described. However, the Correction Factor was derived from the mean value of the 86 specimens tested. For these 86 specimens, the ground truth involved:

• Total WBC Counts from automated cell counters (controlled and calibrated according to manufacturer's specifications).
• Manual WBC Estimates performed by three technologists.

These established ground truths for the 86 specimens were then used to define the Correction Factor, making it essentially a calibrated parameter for the algorithm.

Ask a specific question about this device

Intelligent Medical Imaging, Inc.'s MICRO21™ with Cerebrospinal Fluid (CSF) is a laboratory instrument used to perform cytological analysis by locating, digitally storing and displaying nucleated cells in human cerebrospinal fluid preparations. Examination of cellular morphology and classification must be performed by qualified individuals.

The MICRO21™ with Cerebrospinal Fluid is a new procedure for the MICRUZ/ with the tollowing in vitro diagnostic intended use: Intelligent Medical Imaging, Inc.'s MICRO21™ with Cerebrospinal Fluid (CSF) is a laboratory instrument used to perform cytological analysis by locating, digitally storing and displaying nucleated cells in human cerebrospinal fluid preparations. Examination of cellular morphology and classification must be performed by qualified individuals.

A summary of the MICRO21 with Cerebrospinal Fluid process is as follows:

• Patient CSF samples are prepared using the cytocentrifugation method for specimen concentration 1. using the Cytospin® centrifuge. . .
• Each slide has a black mask over the non-frosted portion with a hole in the mask for specimen 2. placement.
• 3. The slide is stained using Wright's stain.
• The slides are barcoded and placed into a frame holder, and the frame is placed on the MICRO21 for 4. processing.
• ડ. The MICRO21 locates nucleated cells.
• The nucleated cell images are stored by the instrument and displayed on a color monitor for review by 6. a technologist.
• The technologist reviews the images and confirms each cell type. 7.
• 8. A report of the CSF result for each patient is printed.

The provided text describes information relevant to the regulatory submission for the MICRO21™ with Cerebrospinal Fluid, an automated cell locating device. Based on the document, here's a structured breakdown of the acceptance criteria and the study conducted:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present a table of quantitative acceptance criteria with corresponding performance metrics. Instead, it describes various test methods and concludes that these tests "confirm the safety and effectiveness" for the intended use. Therefore, the "acceptance criteria" are implied by the successful completion and correlation reported in the "Conclusion" section for the specified tests.

2. Sample Size and Data Provenance for the Test Set

• Test Method 1 (Method Verification and Sensitivity):

  • Sample Size: "Ten slides" were processed.
  • Data Provenance: Not explicitly stated, but implied to be human CSF preparations for testing the device's main function. Retrospective or prospective is not specified.

• Test Method 2 (Precision):

  • Sample Size: "Three CSF specimen slides" were processed.
  • Data Provenance: Not explicitly stated. Retrospective or prospective is not specified.

• Test Method 3 (Correlation Study Performance):

  • Sample Size: "Fifty CSF specimens" were used.
  • Data Provenance: "obtained from various geographic sites." This suggests a multi-site data collection, which could be a mix of retrospective or prospective data. The document does not specify.

3. Number of Experts and Qualifications for Ground Truth (Test Set)

• Test Method 1 (Method Verification and Sensitivity): The manual confirmation was done by an unspecified number of individuals, but implies medical professionals capable of identifying cells and precipitates. No specific qualifications are given.
• Test Method 2 (Precision): "The resulting images were presented to a technologist for review." Implies one technologist. Qualifications are "technologist," with no further detail.
• Test Method 3 (Correlation Study Performance):
  • Manual Method Ground Truth: "two technologists processed and examined each slide by bright-field microscopy." Qualifications: "qualified technologists." (No specific experience level or certifications provided beyond "qualified").
  • MICRO21 Image Review: "two technologists independently reviewed the stored images for each specimen and classified all nucleated cells accordingly." Qualifications: "technologists."

4. Adjudication Method (Test Set)

• Test Method 1 (Method Verification and Sensitivity): "manually confirming the location of real cells or the location of non-cells". The adjudication method is not specified (e.g., if there were disagreements, how they were resolved).
• Test Method 2 (Precision): Not applicable for explicit adjudication as it focuses on instrument reproducibility, with a single technologist reviewing results.
• Test Method 3 (Correlation Study Performance):
  • Manual Method: "two technologists processed and examined each slide". It's not explicitly stated if there was an adjudication process if their classifications differed. It is possible they performed their counts and classifications independently, and the aggregated results were used for correlation.
  • MICRO21 Image Review: "two technologists independently reviewed the stored images... and classified all nucleated cells accordingly." Similar to the manual method, it's not specified if there was an adjudication process for discrepancies between the two technologists' independent reviews.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No, a multi-reader multi-case (MRMC) comparative effectiveness study as typically understood (comparing human readers with AI assistance vs. without AI assistance to measure an effect size) was not explicitly described.

The "Correlation Study Performance" compared the device's output (images reviewed by technologists) with the manual method performed by technologists. While it involves multiple readers (technologists) and multiple cases (50 CSF specimens), it's more of a standalone performance evaluation of the device in a clinical workflow context, aiming to show agreement with current standard practice, rather than an MRMC study designed to quantify the improvement of human readers through AI assistance. The device's role is to locate, store, and display cells, with technologists performing the final classification.

6. Standalone Performance Study

Yes, a standalone (algorithm only without human-in-the-loop performance) study was performed for the locating component of the device.

• Test Method 1 (Method Verification and Sensitivity): This test determined "the ability of the instrument to locate cells at low and high power." While manual confirmation was used to verify the accuracy of the locations, the initial "locating" was an algorithm-only step.
• Test Method 2 (Precision): This test assessed the instrument's intra-instrument precision, focusing on the reproducibility of the locating and imaging process, which is largely an algorithmic function.

Even for the "Correlation Study Performance," the MICRO21 "located" and "captured" the images. The subsequent human technologists reviewed these captured images. Thus, the locating capability itself is a standalone function of the algorithm, which was then presented to human readers for final classification.

7. Type of Ground Truth Used

The ground truth for the test set was:

• Expert Consensus/Expert Review: For all test methods, the ultimate "ground truth" or reference standard involved human experts (technologists) making classifications or confirming locations.
  • For Test Method 1 and 2, it involved technologists manually confirming cell locations or reviewing images.
  • For Test Method 3 (Correlation Study), the "manual method" performed by two qualified technologists served as the reference standard against which the device's performance (images reviewed by other technologists) was compared. While "consensus" isn't explicitly stated for the manual method, it's implied that their independent processing and examination established the manual CCDs.

8. Sample Size for the Training Set

The document does not provide information about the sample size used for the training set of the MICRO21™ device. This information is typically found in development documentation and is often distinct from the regulatory submission's test set.

9. How Ground Truth for the Training Set Was Established

The document does not provide information on how the ground truth for the training set was established. Given the device's function (locating cells and displaying images for human review), it's highly probable that the training data would have involved slides prepared with known cellular content, manually annotated or classified by expert cytotechnologists or pathologists to teach the system to identify and locate target cells. However, this is an inference and not explicitly stated in the provided text.

Ask a specific question about this device

The MICRO21 with nDNA is a new MICRO21 intended use that follows the same process as the MICRO21 with WBC Diff, but instead locates, digitally stores and displays nDNA Images to aid the technologist in performing a nDNA Screen for Positive or Negative results. A nDNA Screen is a microscopic exam of a patient serum sample that has been set-up using an indirect enzyme antibody test for the semi-quantitative detection of nDNA which is an aid in the detection of systemic rheumatic disease.

The MICRO21 with nDNA is a new MICRO21 intended use that follows the same process as the MICRO21 with WBC Diff, but instead locates, digitally stores and displays nDNA Images to aid the technologist in performing a nDNA Screen for Positive or Negative results. A nDNA Screen is a microscopic exam of a patient serum sample that has been set-up using an indirect enzyme antibody test for the semi-quantitative detection of nDNA which is an aid in the detection of systemic rheumatic disease. The nDNA Test System used on the MICRO21 is Immuno Concepts® Colorzyme® nDNA Test System. A summary of the MICRO21 with nDNA process is as follow:

1. Patient serum samples are prepared following the Color zyme Test Procedure and then placed in designated wells on the nDNA slide.
2. Each slide has three control wells and nine patient wells.
3. Barcode the slides, place the slides into a frame holder, and insert the slides on the MICRO21 for processing.
4. The MICRO21 locates the central area of each well on the slide and captures four images from each well.
5. The nDNA images are stored by the instrument and displayed on a color monitor for review by a technologist.
6. The technologist reviews the images and confirms a positive determination by selecting the appropriate result.
7. A report of the nDNA screening result for each patient well is printed.

This document describes the validation study for the MICRO21™ with nDNA automated cell locating device.

Here's an analysis of the provided information:

1. Table of Acceptance Criteria and Reported Device Performance:

2. Sample size used for the test set and the data provenance:

• Sample Size: 205 patient nDNA images.
• Data Provenance: Retrospective, as the images were pre-identified as Positive or Negative by a technologist at Immuno Concepts manually reading the tests. The country of origin is not explicitly stated.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

• Number of Experts: One technologist.
• Qualifications of Experts: A technologist at Immuno Concepts who manually read the 205 nDNA patient tests using a bright light microscope. No further details on experience or specific certifications are provided.

4. Adjudication method for the test set:

• The document implies a single-reader manual interpretation for establishing ground truth, followed by a comparison of the MICRO21 displayed images to this ground truth. There is no mention of multiple expert agreement or an adjudication process (e.g., 2+1, 3+1).

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:

• No, a multi-reader multi-case (MRMC) comparative effectiveness study was not explicitly done in this context. The study focuses on the equivalence of image presentation and not on human reader performance improvement with AI assistance. The MICRO21 is presented as a tool to aid the technologist by locating, storing, and displaying images, effectively streamlining the manual review process rather than replacing it or directly enhancing diagnostic accuracy through AI interpretation.

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

• No, a standalone (algorithm-only) performance was not done. The device's function is to "aid the technologist," and the final determination of Positive or Negative results is made by a human technologist reviewing the displayed images. The device itself does not provide a diagnostic output.

7. The type of ground truth used:

• Expert Consensus: The ground truth for the 205 patient nDNA images was established by a single technologist at Immuno Concepts who manually reviewed the slides using a bright light microscope. While it's expert opinion, it's explicitly a single expert's determination, not a consensus among multiple experts.

8. The sample size for the training set:

• The document does not provide information about a training set. The study described is a performance comparison, implying the MICRO21 device was already developed.

9. How the ground truth for the training set was established:

• Since there's no mention of a training set, there's no information on how its ground truth was established.

Ask a specific question about this device

The MICRO21 with ANA is a new MICRO21 intended use that follows the same process as the MICRO21 with WBC Diff, but instead locates, digitally stores and displays ANA Images to aid the technologist in performing an ANA Screen for Positive or Negative results. An ANA Screen is a microscopic exam of a patient serum sample that has been set-up using an indirect enzyme antibody test for the semi-quantitative detection of antinuclear antibody (ANA) which is an aid in the detection of systemic thematic disease.

The MICRO21™ with WBC Diff (White Blood Cell Differential) Ref. No. K925670/A is an automated microscopic system that locates WBCs, stores digital images of the cells and displays the images in an organized manner to aid technologists in performing the WBC Diff procedure. The MICRO21 process is substantially equivalent to the manual microscopic process.

The MICRO21 with ANA is a new MICRO21 intended use that follows the same process as the MICRO21 with WBC Diff, but instead locates, digitally stores and displays ANA Images to aid the technologist in performing an ANA Screen for Positive or Negative results.

Here's an analysis of the provided text, focusing on the acceptance criteria and study details for the MICRO21 with ANA device:

1. Table of Acceptance Criteria and Reported Device Performance

Important Note: The provided text is a summary of the 510(k) submission. It focuses on the equivalence of image presentation rather than providing detailed performance metrics (e.g., sensitivity, specificity, accuracy) that would typically be expected from a device making a diagnostic determination. The device's role is described as an "aid" to the technologist, implying human-in-the-loop performance is the ultimate measure.

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

• Sample Size: 204 patient ANA images.
• Data Provenance:
  • Country of Origin: Not explicitly stated, but the mention of "Immuno Concepts®" suggests a US-based company, which (if it's the test site) implies US data. Could be from a clinical lab in any country where Immuno Concepts® operates.
  • Retrospective or Prospective: Appears to be retrospective in nature, as the 204 patient ANA images were "identified by a technologist at Immuno Concepts® who manually read the 204 ANA patient tests using a bright light microscope" before being loaded onto the MICRO21. This suggests existing patient samples were used.

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

• Number of Experts: One technologist.
• Qualifications: "a technologist at Immuno Concepts® who manually read the 204 ANA patient tests using a bright light microscope." No further detail (e.g., years of experience, certification) is provided.

4. Adjudication Method for the Test Set

• Adjudication Method: Not applicable/explicitly stated as a multi-reader adjudication process. The ground truth was established by a single technologist's manual reading. The MICRO21 then displayed images, and a technologist (not necessarily the same one, but possibly) reviewed them and made a determination. The wording suggests a comparison to this single technologist's ground truth, rather than an adjudication of multiple expert opinions to establish ground truth for the study.

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

• No, an MRMC comparative effectiveness study was not explicitly described. The study compares the image presentation of the device to the manual method, based on a single technologist's manual ground truth. While a technologist reviews the device's output, the design doesn't appear to be a formal MRMC study evaluating human reader performance with and without AI assistance with an effect size analysis. It's more of a usability/equivalence study for the displayed images.

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

• No, a standalone performance study was not the primary focus or conclusion. The device is described as an "aid" to the technologist. While the MICRO21 makes an initial "Positive/Negative determination," the process explicitly states: "The technologist reviews the images and confirms that the MICRO21's Positive/Negative determination is correct. If not correct, the technologist changes the determination." Therefore, the final reported result is a human-in-the-loop performance, with the technologist retaining ultimate decision-making authority. The study confirms the image presentation for their review.

7. The Type of Ground Truth Used

• Expert Consensus: Specifically, the single expert opinion/manual reading of a technologist at Immuno Concepts® using a bright light microscope.

8. The Sample Size for the Training Set

• Not explicitly stated/provided. The document discusses the test method and samples used for testing, but does not give any details about a separate training set used for developing the MICRO21's initial determination capabilities. Given the era (1996) and the device's function (locating, storing, displaying images, with the technologist making the final call), it's possible the "determination" logic was rule-based or trained on a much smaller, internal dataset not detailed here.

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

• Not explicitly stated/provided. Without information on a specific training set, the method for establishing its ground truth cannot be determined from this document.

Ask a specific question about this device

The MICRO21 with Retic is a new MICRO21 intended use that follows the same process as the MICRO21 with WBC Diff, but instead locates, digitally stores and displays reticulated red blood cells (retics) to aid the technologist in performing the Reticulocyte Count procedure.

The MICRO21 with Retic is an automated microscopic system that locates reticulated red blood cells (retics), stores digital images of the cells and displays the images in an organized manner to aid technologists in performing the Reticulocyte Count procedure. The process involves preparing a blood wedge smear stained with a supravital stain, affixing a bar code to each slide, placing the slides into a frame holder and inserting the frame into the MICRO21. The instrument locates 1000 RBCs. The reticulated RBCs are stored as high magnification color images (1000x magnification). The images of retics stored by the instrument are displayed on a color monitor for review by a technologist. The technologist confirms that each reticulated RBC image displayed contains retic markings. If the image does not contain retic markings, the image is eliminated by the technologist and consequently not included in the retic count. A report of the percent of retics per 1000 RBCs is printed.

Here's a breakdown of the acceptance criteria and study details for the MICRO21™ with Retic, based on the provided text:

1. Acceptance Criteria and Reported Device Performance

2. Sample Size and Data Provenance

• Test Set Sample Size: 40 patient samples, from which 80 slides were created (two slides per sample).
• Data Provenance: The document does not explicitly state the country of origin. The study appears to be retrospective as it involves prepared slides from patient samples.

3. Number and Qualifications of Experts for Ground Truth

• Number of Experts: Two certified technologists.
• Qualifications of Experts: Certified technologists. The document does not specify their years of experience or precise certifications beyond "certified technologists."

4. Adjudication Method

• For Test Method One (correlation with manual method): Two technologists independently performed manual retic counts. The text does not explicitly state an adjudication method (like 2+1 or 3+1) if there were discrepancies between the two technologists' manual counts. It seems their individual manual counts were used for comparison.
• For Test Method Two (sensitivity): Two certified technologists independently observed the MICRO21's ability to locate RBCs and reticulated RBCs. The "agreement with the technologist" for sensitivity suggests their observations were the reference, but no specific adjudication process for disagreement is described.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

• No, an MRMC comparative effectiveness study was not explicitly described in the provided text. The study focused on correlating the device's output with manual methods performed by technologists and assessing the device's ability to locate cells, rather than measuring the improvement in human reader performance with augmentation versus without augmentation.

6. Standalone (Algorithm Only) Performance

• A standalone performance evaluation was implicitly conducted for some aspects. Test Method Two focused on the MICRO21's "ability to locate RBCs and reticulated RBCs" independently, with its sensitivity measured against technologists' observations. The device's fundamental function of identifying and storing images of retics before technologist review demonstrates an algorithmic component. However, the overall "process" described always includes technologist review (step 5 and 6), meaning the final "count" isn't purely standalone.

7. Type of Ground Truth Used

• Expert Consensus / Technologist Observation:
  • For Test Method One (correlation): The ground truth for the reticulocyte count was established by manual retic counts performed independently by two technologists.
  • For Test Method Two (sensitivity): The ground truth for RBC and reticulated RBC location was the agreement with the technologist's observation.

8. Sample Size for the Training Set

• The document does not provide information on the sample size used for the training set. Only the test set details are given.

9. How Ground Truth for the Training Set was Established

• The document does not provide information on how the ground truth for the training set was established, as it does not discuss the training process or data.

Ask a specific question about this device