Search Results

The Sight OLO is a quantitative multi-parameter automated hematology analyzer intended for in vitro diagnostic use in screening capillary or venous whole blood samples collected in KyEDTA blood collection tubes, or fingertip samples collected using the Sight OLO test kit micro-capillary tubes.

When used with the Sight OLO cartridge, the Sight OLO enumerates the following CBC parameters in whole blood: WBC, RBC, HGB, HCT, MCV, MCH, RDW, PLT, NEUT%#, LYMPH %#, MONO %#, EOS%#, and BASO%/#.

The Sight OLO is indicated for use in clinical laboratories to identify and classify one or more of the formed elements of blood in children 3 months and above, adolescents and adults.

The Sight OLO device is a computer vision based platform for blood analysis. The platform combines computer-vision algorithms for image processing to identify and quantify blood components (e.g., red blood cells) and their characteristics (e.g., cell volume) in an automated fashion. Using dedicated staining, the proposed platform provides complete blood count analysis. The Sight OLO is a compact device, designed to be automated and simple to operate, to enable rapid testing and analysis. The Sight OLO consists of a scanning and analyzing device and a CBC test kit, including disposable cartridges and sample preparation tools. The disposable cartridge containing the blood sample is loaded into the device through the loading slot. The device is operated through the touch screen interface.

The Sight OLO provides complete blood count information with 5-part differentials for white blood cell types. Specifically, the CBC parameters measured by the Sight OLO are listed below and include: WBC, RBC, HGB, HCT, MCV, MCH, MCHC, RDW, PLT, NEUT%#, LYMPH %#, MONO %/#, EOS%# and BASO%#. In addition, the Sight OLO signals specific WBC abnormal cases by flagging the sample.

Here's a breakdown of the acceptance criteria and the study that proves the device meets them, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

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

• Method Comparison Study: 679 residual clinical K₂EDTA whole blood samples.
  • Provenance: Collected from both adults (≥22 years old) and pediatric patients (3 months to 21 years old) at three (3) US sites. The majority were venous samples; a few pediatric samples were capillary whole blood. The study included normal and pathological samples, covering an age range of 3 months to 94 years old. 32% were pediatric samples. Consisted of 355 males (52%) and 324 females (48%). This was a retrospective study using residual clinical samples.
• Repeatability Study: Minimum of 11 samples per site, covering the laboratory reference range and medical decision levels for HGB, PLT, WBC, and upper range for RBC, HGB, WBC, and PLT.
  • Provenance: Residual K₂EDTA whole blood samples. Performed at 3 US sites.
• Reproducibility Study: 3 lots of commercial control material (low, normal, high concentrations). For a total of 240 measurements per level of control material (presumably 4 replicates x 2 runs/day x 5 days x 2 instruments/site x 3 sites, though the exact breakdown to reach 240/level is not fully detailed).
  • Provenance: Commercial control material. Conducted at 3 sites, including 2 US sites.
• Detection Limits (LoB, LoD, LoQ):
  • LoB: Preserved RBC samples (WBC and PLT), diluent (HGB). Two Sight OLO instruments, two reagent lots, 60 measurements per instrument.
  • LoD and LoQ: Six low concentration samples (manipulated concentrated and diluted venous blood samples), each measured 10 times, for a total of 60 repeated measurements per test. This was repeated for a different test reagent lot (another 60 measurements).
  • Provenance: Manipulated venous blood samples for LoD/LoQ.
• Linearity Studies: Ten (10) venous whole blood samples manipulated to create linearity panels. Seven concentrations for WBC and PLT, ten for RBC and HGB. Each concentration scanned in duplicate. Repeated on three OLO devices.
• Analytical Specificity/Interference Study: Not explicitly stated as a sample size of patient samples, but implied various samples manipulated with interferents.
• Sample Stability Study: 10 freshly collected venous whole blood samples (7 normal, 3 around medical decision levels).
• Test Kit Shelf-Life: Three lots of test kits.
• Transportation Studies: Not specified in terms of sample size, but indicates testing of the physical device and test kits.
• Flagging Study: 208 samples.
  • Provenance: Collected at 3 clinical study sites.
• Adult Reference Intervals Study: 240 (120 male and 120 female) apparently healthy adults.
  • Provenance: K₂EDTA venous whole blood samples collected from apparently healthy adults (≥22 years) at a single US site. This was a prospective study.
• Pediatric Reference Intervals Study: 80 apparently healthy pediatric subjects (20 per subpopulation: baby (3-23 months), child (2-<12 years), adolescent (12-<18 years), transitional adolescent (18-<22 years)).
  • Provenance: Residual blood samples collected from apparently healthy pediatric subjects. This was a retrospective study.
• Capillary vs. Venous Matrix Comparison: 67 normal and pathological paired capillary and venous whole blood specimens.
  • Provenance: Paired specimens collected from the same individuals.
• Capillary Microtube vs. Sight OLO Test Kit Micro-capillaries Matrix Comparison: 40 paired K₂EDTA anticoagulated capillary microtube samples and 2-drop finger prick samples.
  • Provenance: Collected from healthy volunteer subjects at the company's internal laboratory.

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

• Flagging Study:
  • Number of Experts: Two qualified morphology examiners (initially). A third qualified morphology examiner was used for adjudication.
  • Qualifications: "Qualified morphology examiners" (specific experience level not provided in the summary).

4. Adjudication Method for the Test Set:

• Flagging Study: A 2+1 adjudication method was used. Two qualified morphology examiners evaluated one of the three blood films for each sample. In case of disagreement between the first two readers (who performed a 200-cell count each, totaling 400 cells), a third qualified morphology examiner reviewed the third blood film.

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

• No MRMC comparative effectiveness study was done. The studies compared the Sight OLO device's performance against a predicate device (Sysmex XN-Series) or manual microscopy (for flagging), but not a direct comparison of human readers with and without AI assistance. The study focuses on the performance of the device itself.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study:

• Yes, the performance studies described (Method Comparison, Repeatability, Reproducibility, Detection Limits, Linearity, Analytical Specificity, Stability) are all standalone performance evaluations of the Sight OLO device. It tests the accuracy and precision of the automated hematology analyzer without human intervention in the CBC parameter enumeration process.
• The Flagging Study involves a comparison to manual light microscopy, which is a human-read method, to establish agreement in flagging abnormal samples. While this involves human input for comparison, the Sight OLO's flagging itself is an automated algorithm-only output being evaluated.

7. Type of Ground Truth Used:

• Method Comparison: Predicate device (Sysmex XN-Series) results.
• Repeatability/Reproducibility/Detection Limits/Linearity/Analytical Specificity/Stability: Internal reference methods, commercial control materials, or manipulated samples (e.g., concentrated/diluted blood samples), and comparison to expected analytical results.
• Flagging Study: Manual light microscopy by qualified morphology examiners.
• Adult and Pediatric Reference Intervals: Literature reference limits (for verification in pediatric study), and statistical calculation from healthy population samples.
• Matrix Comparison: Paired samples compared to each other on the OLO device.

8. Sample Size for the Training Set:

• This information is not provided in the given 510(k) summary. The document focuses on performance testing (validation) datasets.

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

• This information is not provided in the given 510(k) summary, as it does not detail the development or training of the device's algorithms.

Ask a specific question about this device