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The Athelas Home is indicated for the quantitative determination of white blood cells (WBC) and Neutrophil percentages (NEUT%) in capillary whole blood. The Athelas Home system is for In Vitro Diagnostic use and for prescription use only. The Athelas Home is only to be used with Athelas Home Test Strips. The Athelas Home is indicated for use by patients and caregivers within home settings with results viewable by health care professionals. The Athelas Home is intended for patients at risk of neutropenia. For patients with psychiatric conditions, clinical judgement should be exercised when deciding the end-user, based on the instructions for use (IFU) of Athelas Home, the treating physician should determine which patients are competent to perform the test by themselves. The Athelas Home is indicated for adult populations only (aged 21 and older).

Results obtained with the Athelas Home should not be the sole basis for patient diagnosis, treatment or management of leukopenia and neutropenia. All results should be evaluated by a healthcare provider.

The Athelas Home is intended to be used by a single person and should not be shared.

Prescription Use Only.

Device Description

The Athelas Home is identical to the Athelas One K181288 in its technology, all software, the analytes measured, all components, and usage process. The Athelas Home has additional software and quality control safeguards to enable at-home usage of the device. Additionally, results generated from the Athelas Home are not shown to end-patients, rather are transmitted via the software directly to their healthcare provider. The Athelas Home also has Remote Lockout capabilities, such that a healthcare provider or manufacturer can remotely lock-out a device for safety in usage.

Athelas Home is indicated for the quantitative determination of white blood cells (WBC) and Neutrophil percentages (NEUT%) in capillary whole blood. The Athelas Home system is for In Vitro Diagnostic use and for prescription use only. The Athelas Home is only to be used with Athelas Home Test Strips. The Athelas Home is indicated for use by patients and clinicians within home and point-of-care settings, with results viewable by health care professionals only. The Athelas Home is indicated for operation by adult populations only (aged 21 and older).

The Athelas Home is not indicated to completely replace a patient's monitoring regimen on reference lab systems. Prescribers should continue monitoring patients using traditional lab-based means as deemed necessary and possible.

The Athelas Home is not indicated to return results directly to patients. The Athelas Home directly transfers results to a health-care professional for interpretation and analysis. The Athelas Home is not indicated to directly diagnose or assist in disease management. Rather, the Athelas Home should be used to quantify WBC and Neut% only, with all decision making owned by the physician as per standard of care.

The Athelas Home uses image processing and microfluidics in order to measure WBC and NEUT% values from whole blood in point-of-care and home settings. For further technological details refer to Athelas One K181288 application.

AI/ML Overview

The Athelas Home device is an automated differential cell counter designed for at-home quantitative determination of white blood cells (WBC) and Neutrophil percentages (NEUT%) in capillary whole blood. The following details describe the acceptance criteria and the studies performed to demonstrate the device meets these criteria.

Acceptance Criteria and Reported Device Performance

Parameter	Acceptance Criteria	Reported Performance (Athelas Home)
WBC Precision	7.5% CV above 2 K/µL WBC	At-Home Precision Study: 5.4% CV (combined patient and QC material self-test)
	0.25 K/µL SD below 2 K/µL WBC
WBC Bias/Error	±7.5% error above 2 K/µL WBC	At-Home Method Comparison: Mean Bias 0.0 K/µL (0.0% bias)
	±0.25 K/µL error below 2 K/µL WBC
Neutrophil % Precision	5% SD OR 15% CV	At-Home Precision Study: 1.2% SD (combined patient and QC material self-test)
Neutrophil % Bias	±10% bias or ±5% Neut% total error (whichever larger)	At-Home Method Comparison: Mean Bias -0.5 (1.3% bias)
Linearity (WBC)	R² > 0.99 (Implicit)	R²=0.997, Slope=1.013, Intercept=0.0449
LoD (WBC)	Below LoQ	0.079 K/µL
LoQ (WBC)	Below 1.0 K WBC/µL	0.44 K WBC/µL
Interfering Substances	No interference with measurements	Tested substances found not to interfere; all spiked samples performed within evaluation criteria.
Specimen Stability	24-hour stability met criteria	Overall, all samples tested within 24 hours of collection time met pre-set acceptance criteria.
Test Strip Stability	15-week expiration	16-week study showed no statistically significant degradation/drift over 105 days (justifies 15 weeks).
Flagging Accuracy	≥ 90% (for morphological flags)	% Positive Agreement (Sensitivity) = 90.91%, % Negative Agreement (Specificity) = 96.71%, % Overall Agreement = 94.87%
At-Home Usage Error Rate	Not explicitly stated but implied low	Over 94% of tests run successfully with no errors.
Environmental Robustness (Fill-Volume)	Error if too little/much blood, or accurate results if within acceptable variability	Fill-volume study found device robust; errors for 0 µL, accurate results otherwise meeting bias criteria.
Environmental Robustness (Tilt)	Error if tilted, or accurate results	No significant bias in both parameters across tilt orientations and samples.
Environmental Robustness (Drop)	Continue to function or return appropriate error codes	All devices continued to pass functional tests after drop and vibration.
Environmental Robustness (Temperature)	Retain performance characteristics after extreme temperatures	Both device and test-strip met performance specifications after exposure to extreme temperatures.
Environmental Robustness (Humidity)	Test-strips function within specifications	All eight test-strips found to be within specifications for both fill time and color.

Study Details

2. Sample Size and Data Provenance

At-Home Precision Study:
- Patient In-home Whole Blood Studies Self-Test: 24 patients, 2 replicates per sample. Data provenance: US, prospective (at-home settings).
- Patient In-home QC Material Repeatability Self-Test: 10 patients, 3 replicates per sample. Data provenance: US, prospective (at-home settings).
Linearity (WBC): 10 samples (pooled patient blood), 4 replicates across 4 devices.
LoD (WBC): 5 low-level samples, 2 replicates per sample across 2 test strip lots (60 strips each) and 2 instruments, over 3 days. Total of 60 measurements per lot.
LoQ (WBC): 4 independent low-level whole blood samples, 3 replicates per sample, 1 instrument, 2 test-strip lots, over 3 days.
Specimen Stability: 9 different venous blood samples (low, normal, high WBC levels).
Test Strip Stability: Not explicitly stated but likely from the Athelas One predicate device data.
Method Comparison (Athelas One vs. Sysmex XE-5000): 312 patient samples. Data provenance: US, 3 point-of-care sites.
Flagging Comparison (Athelas One vs. Sysmex XE-5000): Used data from the 312 patient samples from the method comparison study.
Matrix Comparison (Capillary vs. Venous blood on Athelas One): 59 patients.
At-Home Method Comparison (Athelas Home vs. Athelas One): 165 samples. Data provenance: US, at-home settings.
At-Home Usability Analysis: 32 users.
Fill-Volume Testing: 3 samples (low, medium, high WBC), each tested at 0, 1.4, 3.4, and 5.4 µL fill volumes.
Device Tilt Testing: 3 samples, each tested in 4 tilt conditions (Condition 1, 2, 3, 4).
Device Drop Testing: 12 devices.
Device and Test-Strip Temperature Testing: 3 devices and 3 test-strip lots, each tested in 3 environment conditions, with 9 replicates per condition.
Humidity Flex Testing: 8 test-strips, each subjected to specific humidity conditions.

3. Number of Experts Used to Establish Ground Truth and Qualifications

The document does not explicitly state the number or qualifications of experts used to establish ground truth for the test sets.
For the Method Comparison studies, the Sysmex XE-5000 analyzer was used as the predicate/reference method. This is a legally marketed device and its results implicitly serve as a clinical reference for ground truth.
For the 'Target Evaluation Criteria' which defines the device's precision/bias goals, these were "chosen based on CLSI clinical precision/bias recommendations for WBC and Neut%." This refers to standardized clinical laboratory guidelines, which are developed by expert consensus.

4. Adjudication Method

The document does not describe a formal adjudication method (e.g., 2+1, 3+1) for establishing ground truth in the context of expert review.
Instead, the ground truth for performance studies (precision, linearity, method comparison, etc.) was generally established by comparison to a predicate device (Sysmex XE-5000) or by following CLSI guidelines for analytical performance evaluation. This implies a reference standard rather than multi-expert consensus.

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

No MRMC comparative effectiveness study was specifically described where human readers' performance with and without AI assistance was evaluated. The device is an "Automated Differential Cell Counter," meaning it is intended to perform the cell counting automatically, and human involvement is primarily in interpreting the results provided by the device, not in assisting in the primary cell counting task. The usability studies focus on ease of use by patients/caregivers and remote result viewing by healthcare professionals, not on human-in-the-loop performance improvement in cell counting.

6. Standalone Performance

Yes, extensive standalone performance was done. The precision, linearity, LoB, LoD, LoQ, interfering substances, specimen stability, and test strip stability studies were all conducted to evaluate the performance of the Athelas Home device itself, independent of immediate human intervention beyond operating the device as intended. The "Method Comparison" studies (both clinical and at-home) compare the device's measurements directly against a predicate device, representing its core analytical performance.

7. Type of Ground Truth Used

Reference Instrument/Predicate Device: For quantitative measurements (WBC, NEUT%), the Sysmex XE-5000 automated hematology analyzer was used as the reference/predicate device. This represents an established clinical standard.
CLSI Guidelines: Performance metrics and study designs (e.g., precision, linearity, stability) were based on CLSI (Clinical and Laboratory Standards Institute) recommendations. These are widely accepted standards in laboratory medicine.
Known Concentrations: For studies like LoD, LoQ, and linearity, samples with known or precisely diluted concentrations were used.
Functional Criteria: For flex testing (fill-volume, tilt, drop, temperature, humidity), the ground truth was whether the device continued to function within specified performance criteria (e.g., meeting bias/precision goals or returning appropriate error codes).

8. Sample Size for the Training Set

The document refers to the Athelas Home as "identical to the Athelas One K181288 in its technology, all software, the analytes measured, all components, and usage process." It also states, "As per Agency guidance in presubmission (Q190305), studies from the Athelas One were used to support the Athelas Home because the devices are identical."
This implies that the training data for the underlying algorithm (computer vision-based image analysis for cell counting and classification) would have been used for the Athelas One, and subsequently transferred to the Athelas Home.
However, the specific sample size for the training set (e.g., number of images, number of cases, specific data augmentation applied) is not provided in this document. It mentions the "software" is identical, suggesting the trained model is the same.

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

Given that the Athelas Home utilizes "computer vision based image analysis" to count and classify cells, the ground truth for training such an algorithm typically involves manual expert annotation of cell types (e.g., white blood cells, neutrophils) on images of blood smears.
However, similar to the training set size, the document does not explicitly detail how the ground truth for the training set's image analysis algorithm was established (e.g., number of expert annotators, their qualifications, consensus method for disagreements). This information would likely be found in the original Athelas One 510(k) submission (K181288) or internal company documentation. The reference to "A microfluidic test strip channel creates a stained monolayer of white blood cells. Multiple images are taken of the monolayer and the cells are counted and classified by computer vision based image analysis" describes the overall process but not the ground truth generation for the training of that computer vision system.

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K Number

K181288

Device Name

Athelas One

Manufacturer

Athelas Inc.

Date Cleared

2018-11-05

(173 days)

Product Code

Regulation Number

Type

Panel

Reference & Predicate Devices

K112605,K071967

Predicate For

K200828

Intended Use

Athelas One is indicated for use for quantitative determination of white blood cells (WBC) and Neutrophil percentages (NEUT%) in capillary or K2EDTA venous whole blood. The Athelas One system is for In Vitro Diagnostic use only. The Athelas One is only to be used with Athelas One Test Strips. The Athelas One is indicated for use in clinical laboratories and for point of care settings. The Athelas One is only indicated for use in adult populations (aged 21 and older).

Device Description

The Athelas One is an automated diagnostic device intended to perform tests on whole blood samples collected in K2EDTA or capillary finger stick samples collected directly into the Athelas One test strip. The system is intended to be placed within the Point of Care, and Clinical Laboratory sites. Athelas One returns WBC and Neut% metrics from the blood sample. A clinician places a sample on the Athelas One test strip either directly from finger or via pipette from K2EDTA whole blood tube. The Athelas One test strip stains and creates a monolayer of the blood sample within the chamber. The strip is inserted into the test strip slot of the Athelas One device and the device returns results by conducting image analysis of cells present. Result-viewing and device control are conducted through a companion tablet/mobile application.

AI/ML Overview

Here's a breakdown of the acceptance criteria and study details for the Athelas One device based on the provided document:

Acceptance Criteria and Reported Device Performance

Parameter	Acceptance Criteria (Target Evaluation)	Reported Device Performance	Study Section
WBC Precision	7.5% CV above 2K/µL WBC. 0.25 K/µL SD below 2K/µL WBC.	Within-run Precision: All samples met the 7.5% CV target. For example, a mean value of 2.20 K/µL had a total CV of 5.87%, and a mean value of 23.33 K/µL had a total CV of 5.81%.
Between-run Precision (Reproducibility): Total CV for WBC Low (2.746 K/µL) was 5.583%. Total CV for WBC Medium (7.546 K/µL) was 5.726%. Total CV for WBC High (15.246 K/µL) was 6.305%. All met the acceptance criteria.	Bench: Within-run Precision/Reproducibility, Precision Reproducibility (between run)
WBC Bias/Error	±7.5% error above 2K/µL WBC. ±0.25 K/µL error below 2K/µL WBC.	Method Comparison: Mean Bias for WBC (1.1 - 23 K/µL) was -0.151 K/µL (-2.31%).
Specimen Stability: Met ± 7.5% Bias for WBC for samples tested within 24 hours.	Clinical: Method Comparison, Specimen Stability Studies
Neutrophil % Precision	5% SD OR 15% CV (updated based on Sysmex XW-100 Neut% CV criteria).	Within-run Precision: Not explicitly stated in the WBC Summarized table for Neutrophils.
Between-run Precision (Reproducibility): Total CV for NEUT % Low (50.781%) was 6.780%. Total CV for NEUT % Medium (49.990%) was 6.689%. Total CV for NEUT % High (50.823%) was 6.525%. All met the acceptance criteria (which allows for 15% CV if 5% SD is not met).	Bench: Precision Reproducibility (between run)
Neutrophil % Bias	±10% bias or ±5% Neut% total error (whichever larger).	Method Comparison: Mean Bias for Neutrophil % (8 - 92.89%) was 0.636% (1.18%).
Specimen Stability: Met ± 10% Bias for Neutrophils for samples tested within 24 hours.	Clinical: Method Comparison, Specimen Stability Studies
Linearity (WBC)	Not a single target, but demonstrated to be linear with acceptable max % diff for each interval.	R² = 0.997, Slope = 1.013, Intercept = 0.0449, CVr = 5.08%. Demonstrated to be linear from lower limit to upper limit and within measured allowable max % diff.	Bench: Linearity
Flagging Accuracy (Morphological Flags)	≥ 90% accuracy	Positive Agreement (Sensitivity) = 90.91%. Negative Agreement (Specificity) = 96.71%. Overall Agreement = 94.87%. Met the specification.	Clinical: Flagging Comparison
Matrix Comparability (Venous vs. Capillary)	No statistical difference and met evaluation criteria for regression parameters and 95% CI of bias.	WBC: Slope 1.026 (CI: 1.000, 1.055), Intercept -0.145 (CI: -0.319, 0.018), Mean Bias 0.056 K/µL (-0.588%). R = 0.996.
Neutrophil %: Slope 0.999 (CI: 0.938, 1.058), Intercept 0.457 (CI: -2.502, 3.614), Mean Bias 0.162 Percentage Points (-0.333%). R = 0.969. Concluded no statistical difference.	Clinical: Matrix Comparison

Study Details

Sample size used for the test set and the data provenance:
- Within-run Precision: 9 whole blood samples, 90 tests per sample (total 810 tests). Provenance not explicitly stated beyond "K2EDTA whole blood samples" and "normal and abnormal samples."
- Precision/Reproducibility (between run): 3 levels of quality control material, 80 readings per level at each of 3 sites (total 720 readings for controls). Provenance not explicitly stated.
- Linearity: 10 samples run in 4 replicates across 4 devices (total 160 measurements + varying replicates/devices for different points in the linearity study, but "10 samples" is the core). Provenance of samples not explicitly stated, but "pooling together one low WBC concentration fresh whole blood sample one high WBC concentration sample."
- Interfering Substances: "Various substances... found naturally occurring in patient samples, or were spiked in whole blood." Specific sample size not provided.
- Reference Intervals: 120 healthy donors. Provenance not explicitly stated.
- Limit of Blank (LoB): 120 total repeated measurements of blank samples.
- Limit of Detection (LoD): 5 low-level samples, 2 replicates per sample over 3 days (total ~30 measurements per lot for low-level samples, plus 60 blank measurements per lot).
- Limit of Quantification (LoQ): 4 independent low-level whole blood samples, 3 replicates per sample.
- Specimen Stability: 9 different venous blood samples (low, normal, high WBC levels).
- Test Strip Stability: Not a patient sample study, but involved testing control fluid.
- Method Comparison: 312 patient samples. Provenance: "taken at 3 point of care sites in the US." The document implies prospective collection as they were "run ... on the XE-5000" and then analyzed by Athelas One.
- Flagging Comparison: The same 312 patient samples used in Method Comparison.
- Matrix Comparison: 59 patients who provided both capillary finger-prick and venous whole blood samples.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- The document does not explicitly state the number of experts or their qualifications used to establish ground truth.
- For the Method Comparison and Flagging Comparison, the "ground truth" was the Sysmex XE-5000 predicate analyzer. This is a legally marketed device and generally considered a gold standard in this context.
- For the Linearity study, "original concentrations were obtained from the predicate analyzer (Sysmex XE-5000)."
Adjudication method for the test set:
- Not applicable as the ground truth was primarily established by a predicate device (Sysmex XE-5000) or by CLSI-recommended methods for bench studies. There was no mention of human expert adjudication for discrepancies.
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 MRMC comparative effectiveness study was done. This document describes a standalone performance study of the Athelas One device against a predicate device, not a human-in-the-loop study comparing human performance with and without AI assistance.
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Yes, a standalone performance study was done. The Athelas One device, which uses "computer vision based image analysis" (i.e., its algorithm), was compared directly against a predicate automated hematology analyzer (Sysmex XE-5000) for WBC and Neutrophil % measurement.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The primary ground truth for clinical comparisons (Method Comparison, Flagging Comparison) was the Sysmex XE-5000 automated hematology analyzer, a legally marketed predicate device.
- For bench studies like Linearity and LoQ, concentrations were often referenced against the Sysmex XE-5000 as well.
- For precision studies, the device's own measurements were evaluated for consistency against predefined statistical targets (SD, CV).
- For interfering substances, the impact on bias and precision performance was evaluated, likely against expectations from predicate devices or known clinical impact.
The sample size for the training set:
- The document does not provide information on the training set size or how the algorithm was developed. This submission focuses on the validation of the finished device for regulatory approval, not its development process.
How the ground truth for the training set was established:
- Since information on the training set itself is not provided, how its ground truth was established is also not described in this document.

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