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The DiaSpect Tm system is intended for the in vitro quantitative measurement of total hemoglobin in non-anticoagulated capillary whole blood and venous whole blood drawn in K2EDTA or lithium heparin tubes. The DiaSpect Tm system consists of the DiaSpect Tm analyzer and specifically designed disposable cuvettes, the DiaSpect Tm Cuvettes. The device is intended for use in point-of-care settings. The DiaSpect Tm analyzer is only to be used with DiaSpect Tm Cuvettes.

Device Description

The DiaSpect Tm system consists of an analyzer and cuvettes. The DiaSpect Tm analyzer is a spectrophotometric instrument for the total hemoglobin concentration in unaltered human blood. The DiaSpect Tm Cuvette is injection-molded of poly methyl methacrylate (PMMA) and contains a cavity of 10 uL volume. The cavity is empty.

AI/ML Overview

Here's a summary of the acceptance criteria and the study that proves the DiaSpect Tm system meets those criteria, based on the provided document:

Acceptance Criteria and Reported Device Performance

Criteria Category	Specific Acceptance Criteria	Reported Device Performance
Precision/Reproducibility	20-Day Precision: Total CV < 7% for external controls.	20-Day Precision Summary (Total %CV):- Level 1 (Mean 7.99 g/dL): 1.38%- Level 2 (Mean 12.58 g/dL): 1.09%- Level 3 (Mean 15.82 g/dL): 1.41%All met criteria.
	Single-Day Precision: Total CV < 7% for venous whole blood.	Single-Day Precision Summary (Total %CV):- Level 1 (Mean 4.87 g/dL): 2.57%- Level 2 (Mean 10.19 g/dL): 2.29%- Level 3 (Mean 13.75 g/dL): 3.19%- Level 4 (Mean 17.46 g/dL): 4.5%- Level 5 (Mean 22.93 g/dL): 6.47%All met criteria.
Linearity	Correlation coefficient > 0.95 and slope of linear equation within 1.0 ± 0.1 compared to reference method.	Linearity: Correlation coefficient > 0.95 and slope (0.9837) was within 1.0 ± 0.1.Met criteria.
Detection Limits	LoQ (Limit of Quantitation): To be determined based on specified Total Error.	LoB (Limit of Blank): 0.0 g/dLLoD (Limit of Detection): 0.3 g/dLLoQ (Limit of Quantitation): 1.2 g/dL
Analytical Specificity(Interference)	Bias < 7% for various potential interferents (pharmaceuticals, endogenous substances like bilirubin, and disease states).	All potential interferents (Bilirubin, Cholesterol, Creatinine, Protein, Triglyceride, Urea, Uric Acid, Acetaminophen, Ascorbic Acid, Dopamine, Ibuprofen, Tetracycline, Ferrous Sulfate, Ammonium Ferric Citrate, Ferrous Fumarate, Iron Dextran, Folic Acid, Vitamin B12, Lithium Carbonate, Immunoglobin, Methyldopa, Salicylic Acid, 5x EDTA, Hypochromia, High WBC Count, Polycythemia, Sickle Cell) were tested and passed the acceptance criterion of < 7%.
Method Comparison	Demonstrated substantial equivalence to predicate device (HemoPoint® H2 Hemoglobin Analyzer).	Overall Results Summary, Natural and Contrived, Samples All Sites:- EDTA Venous (N=349 clinical, 35 contrived): Slope: 0.9858 (95% CI: 0.969 - 1.002) Intercept: 0.2130 (95% CI: -0.029 - 0.455) R: 0.986- Capillary (N=363 clinical): Slope: 0.9903 (95% CI: 0.963 - 1.018) Intercept: 0.1164 (95% CI: -0.276 - 0.509) R: 0.963- Passing-Bablok Regression: Capillary: y = -0.1198 + 1.011x (R=0.965) EDTA Venous: Y = 0.4867 + 0.9637x (R=0.986)The data supports substantial equivalence.
Matrix Comparison	Agreement between different sample types (EDTA vs. Heparin, Venous vs. Capillary).	DiaSpect EDTA vs Heparin: Slope: 0.9981, Intercept: 0.0644, R: 0.9812DiaSpect, Venous vs Capillary: Slope: 0.9702, Intercept: 0.4634, R: 0.8839Agreement between capillary and EDTA samples was favorable, supporting interchangeability and substantial equivalence.
Stability	Cuvette shelf-life demonstrating consistent performance.	At least 2.5 years shelf life demonstrated with a mean Hb of 12.59 g/dL and total CV of 0.75% for control material across 12 lots over time.
Calibration	Device is factory calibrated and not user adjustable.	Device is factory calibrated and not user adjustable.
Quality Control	System includes control solutions for quality control.	The system includes 3 levels of control solutions (DiaSpect Control HBT) with known hemoglobin concentrations.

Study Details

Sample sizes used for the test set and data provenance:
- Precision Studies:
  - 20-Day Precision: 240 measurements per level (3 levels), across 3 sites, with 6 operators, using 3 lots and 3 instruments.
  - Single-Day Precision: 54 measurements per level (5 levels), at a single site, using 3 instruments, 3 lots, and 3 self-trained operators.
- Linearity Study: 11 hemoglobin levels, tested in triplicate on one DiaSpect Tm analyzer.
- Detection Limit Studies:
  - LoB: Plasma samples from 5 individual whole blood donors, quadruplicate tests (x4) for 3 days on one meter using 2 cuvette lots.
  - LoD: 4 whole blood samples (K2EDTA), 60 tests each on one device using 2 cuvette lots for 3 days.
  - LoQ: 9 unique donor whole blood samples, at least 10 tests per lot for 3 days using 2 cuvette lots on one analyzer.
- Analytical Specificity (Interference) Studies: Whole venous blood (K2EDTA) at 3 hemoglobin concentrations (11.0, 14.0, 18.0 g/dL), spiked with potential interferent at specified concentrations. For disease conditions, K2EDTA venous blood specimens from up to five (5) donors with specific conditions were collected.
- Method Comparison Studies:
  - Total of 399 subjects across four point-of-care clinical sites.
  - Clinical Samples: 364 male and female subjects (9 months to 89 years of age) provided:
    - 363 capillary samples (ranges 8.5 to 20.1 g/dL)
    - 349 K2EDTA venous samples (ranges 6.5 to 19.9 g/dL)
    - 120 lithium heparin venous samples (ranges 10.4 to 20.0 g/dL)
  - Contrived Samples: An additional 35 contrived EDTA venous samples used to challenge the full measuring range.
  - Data Provenance: The studies were conducted at multiple clinical sites, suggesting a U.S. context (given FDA submission). The samples were described as "natural and manipulated K2EDTA venous blood" and "natural and contrived samples," implying a mix of retrospective (manipulated/contrived) and prospective (clinical site collections) data. IRB approval was obtained prior to initiating the clinical studies.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- For the Method Comparison study, the predicate device, HemoPoint® H2 Hemoglobin Analyzer (K081719), was used as the comparative method, effectively serving as the "ground truth" reference. The performance of the predicate device is established through its own FDA clearance.
- For the Analytical Specificity studies, the predicate device HemoPoint® H2 was also used as the reference method.
- For Linearity, a HemoPoint® H2 analyzer was also used as the reference method.
- The document does not explicitly state the qualifications of the individuals who performed the tests on the predicate device or established its performance. However, for the method comparison study, "untrained, intended use operators" (full-time employees of Certificate of Waiver test sites who normally perform phlebotomy and/or patient testing) operated the DiaSpect Tm system, and the HemoPoint H2 was used as the comparative method alongside these measurements.
Adjudication method for the test set:
- Not applicable in this context. The study compares the new device's measurements against a recognized predicate device and its own inherent precision and analytical performance, rather than requiring human expert adjudication of results.
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, this is not an MRMC study. This device is an automated hemoglobin measurement system, not an imaging device for which human readers would interpret results, nor does it incorporate AI assistance for human interpretation. The study is a comparison of a new device against a predicate device.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- The DiaSpect Tm system is an automated spectrophotometric instrument. Its performance is inherently "algorithm only" in terms of its ability to measure hemoglobin concentration. The precision, linearity, detection limits, and interference studies are all evaluations of this standalone performance. The method comparison study evaluates its standalone performance against another standalone device.
The type of ground truth used:
- Comparative method / Reference Standard: The predicate device, HemoPoint® H2 Hemoglobin Analyzer (K081719), served as the primary reference method for method comparison and some analytical specificity studies. Its results were considered the "ground truth" for comparison.
- Defined Samples: For precision and linearity, samples with pre-defined or manipulated hemoglobin levels were used. For detection limits, plasma "blank" and low-concentration whole blood samples were prepared.
- Clinical Samples: Natural patient samples (capillary, K2EDTA venous, lithium heparin venous) spanning a range of hemoglobin values were collected and tested.
The sample size for the training set:
- This document describes a pre-market notification (510(k)) for a medical device that measures hemoglobin. It does not refer to a machine learning or AI algorithm that requires a "training set" in the conventional sense. The device's underlying "algorithm" is spectrophometric measurement, calibrated at the factory. Therefore, there's no "training set" as one would discuss for, e.g., a deep learning model.
How the ground truth for the training set was established:
- As there is no "training set" in the AI/ML sense, this question is not applicable. The device relies on principles of spectrophotometry and is factory calibrated. Quality control materials and established reference methods are used to verify its accuracy and performance metrics.

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