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510(k) Data Aggregation
(57 days)
Not Found
Micro Hematocrit Centrifuge
Operations Manual
Battery Charger
100 Micro Capillary/Micro Capillary Holders (heparinized)
General Laboratory Device
Methodology: Centrifugal
Measures Hematocrit
Battery Operated
Portable, Hand-Held
Safety Features: (1) Cover Lock (2) Low Battery Charge Indicator (3) Motor failure indicator
Optically read (digital readout)
Uses plastic disposable
Range 14% to 57%
Operates at 10,000 RPM
RCF= 4260
Rotor Radius= 1.5 inches
Here's a breakdown of the acceptance criteria and study information for the Spuncrit™ device, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The document doesn't explicitly state formal "acceptance criteria" in a numerical or pass/fail format for specific performance metrics. Instead, it presents performance data in comparison to a predicate device (Compur M1100 Minicentrifuge) and demonstrates precision. The "conclusion" section suggests that the device's performance is deemed "substantially equivalent" to the predicate, implying that its performance within the tested ranges is acceptable.
Assuming "substantial equivalence" is the overarching acceptance criterion, we can infer performance targets from the predicate device specifications and the presented data.
| Performance Metric | Acceptance Criteria (Inferred from Predicate/Substantial Equivalence) | Reported Device Performance (Spuncrit™) |
|---|---|---|
| Measurement Range (Hematocrit) | 10% to 80% (Predicate's range) | 14% to 57% (Device's calibrated range) |
| Measurement Range (Estimated Hemoglobin) | Not explicitly stated for predicate but likely similar clinical utility as hematocrit. | 12.2 g/dL to 18.2 g/dL (Normal range only) |
| Methodology | Centrifugal | Centrifugal |
| Readout Type | Manual, visual read (Predicate) | Optically read (digital readout) |
| Speed (RPM) | 11,500 RPM (Predicate) | 10,000 RPM |
| Relative Centrifugal Force (RCF) | 5396 (Predicate) | 4260 |
| Rotor Radius | 1.5 inches (Predicate) | 1.5 inches |
| Precision (Within-Run) - Hematocrit | Not explicitly defined as acceptance criteria, but predicate performs acceptably. | Physician Office #1 (Day 1): Level 1 SD 0.26, Cv 0.01; Level 2 SD 0.94, Cv 0.03; Level 3 SD 1.03, Cv 0.02Physician Office #1 (Day 7): Level 1 SD 0.77, Cv 0.04; Level 2 SD 0.63, Cv 0.02; Level 3 SD 0.63, Cv 0.02Physician Office #2 (Day 1): Level 1 SD 0.70, Cv 0.04; Level 2 SD 0.52, Cv 0.02; Level 3 SD 0.74, Cv 0.02Physician Office #2 (Day 7): Level 1 SD 0.64, Cv 0.04; Level 2 SD 0.59, Cv 0.02; Level 3 SD 0.59, Cv 0.01Alternate Site #3 (Day 1): Level 1 SD 0.51, Cv 0.03; Level 2 SD 0.88, Cv 0.02; Level 3 SD 1.11, Cv 0.02Alternate Site #3 (Day 7): Level 1 SD 0.68, Cv 0.04; Level 2 SD 0.51, Cv 0.02; Level 3 SD 0.52, Cv 0.01Laboratory (Day 1): Level A SD 0.32, Cv 0.02; Level B SD 0.48, Cv 0.02; Level C SD 0.48, Cv 0.02; Level D SD 0.58, Cv 0.01; Level E SD 0.68, Cv 0.01Laboratory (Day 13): Level A SD 0.52, Cv 0.04; Level B SD 0.67, Cv 0.02; Level C SD 0.92, Cv 0.02; Level D SD 1.51, Cv 0.02; Level E SD 0.52, Cv 0.01 |
| Precision (Between-Run) - Hematocrit | Not explicitly defined as acceptance criteria. | Physician Office #1: Level 1 SD 0.92, Cv 0.05; Level 2 SD 1.13, Cv 0.04; Level 3 SD 0.07, Cv < 0.01Physician Office #2: Level 1 SD 0.35, Cv 0.02; Level 2 SD 0.56, Cv 0.02; Level 3 SD 1.13, Cv 0.02Alternate Site Blood Bank #3: Level 1 SD 0.14, Cv 0.01; Level 2 SD 0.21, Cv 0.01; Level 3 SD 0.14, Cv < 0.01 |
| Correlation with Predicate (R) | High correlation (implied by substantial equivalence). | R = 0.99 for all comparative studies |
2. Sample Size Used for the Test Set and Data Provenance
- Comparative Studies (Performance/Effectiveness Information):
- Sample Size: A total of 45 whole blood samples were used for each of the four comparative study locations (Laboratory, Physician Office #1, Physician Office #2, Alternate Site/Blood Bank). Each location ran 15 samples at each of three levels (below normal, normal, upper normal). This means 180 total samples were run for comparative analysis (4 locations * 45 samples/location).
- Data Provenance: The document does not explicitly state the country of origin. The studies were conducted in "a typical laboratory," "Physician Office #1," "Physician Office #2," and a "Blood Bank." Given the submission is to the US FDA, it's highly probable the data is from within the United States. The studies described are prospective in nature, as they involved actively running samples to test the new device against the predicate.
- Precision Studies:
- Within-Run Precision:
- Physician Offices & Blood Bank: For each of the three sites, data was collected on Day 1 and Day 7. On each day, 15 samples were processed per each of three control levels, totaling 45 samples per day per site. So, 270 samples were analyzed for this part of precision (3 sites * 2 days * 3 levels * 15 samples/level).
- Laboratory: 10 whole blood samples were run at each of five levels on Day 1 and Day 13. This totals 100 samples (2 days * 5 levels * 10 samples/level).
- Between-Run Precision: This uses the data from the "within-run" studies across the two days of testing.
- Data Provenance: Similar to the comparative studies, likely United States and prospective.
- Within-Run Precision:
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
The document does not explicitly mention "experts" in the context of establishing ground truth for the test set.
- For the comparative studies, the predicate device (Compur M1100 Minicentrifuge) served as the reference standard. The results from the Compur M1100 were used to compare against the Spuncrit™.
- For the precision studies, assayed whole blood controls (from Streck Laboratories, Lot Numbers 61410065, 61410066, and 61410067) were used. The hematocrit values for these controls (e.g., 16 +/- 3) effectively served as the "ground truth" or target values. These controls are manufactured with established values.
The personnel operating the devices included a "technician running the Spuncrit" in the laboratory setting, "nurse running Spuncrit" in physician offices, and a "Phlebotomist running the Spuncrit" in the blood bank. Their qualifications are mentioned to indicate typical users but not as ground truth experts.
4. Adjudication Method for the Test Set
No explicit adjudication method is described. The comparison is made directly between the Spuncrit™ readings and the Compur M1100 readings (for comparative effectiveness) or against the established values of assayed controls (for precision). There's no mention of multiple human readers independently assessing results or an adjudication process for discrepancies.
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 done. The study focuses on comparing the device performance (Spuncrit™ vs. Compur M1100), not on how human readers (or their performance) are influenced by the Spuncrit™ technology. The Spuncrit™ has an optical/digital readout, which inherently reduces reader variability compared to the predicate's manual/visual read. However, this is a feature of the device, not an AI assistance for human readers as conceptualized in an MRMC study.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
Yes, the studies presented are essentially standalone performance evaluations of the Spuncrit™ device. While humans operate the device (technician, nurse, phlebotomist), the device itself (with its optical digital readout)
generates the result. The performance data (correlation with predicate, precision) reflects the device's capability directly, independent of subjective human interpretation after the device has processed the sample. The "optically read (digital readout)" feature strongly supports this as it automates the reading process that was manual on the predicate.
7. The Type of Ground Truth Used
- Comparative Studies: The ground truth was effectively established by the predicate device (Compur M1100 Minicentrifuge). The assumption is that the predicate device provides clinically acceptable hematocrit measurements.
- Precision Studies: The ground truth was established by assayed whole blood controls with known standard values (e.g., 16 +/- 3). This is a form of reference standard materials.
8. The Sample Size for the Training Set
The document describes studies for validation and substantial equivalence, not for training a specific algorithm or AI model. Therefore, there is no explicit "training set" mentioned in the context of device development or performance evaluation. The device being tested, the Spuncrit™ (Model DRC-40), is a hematocrit centrifuge with an optical digital readout, rather than an AI-powered diagnostic system that would require a separate training phase.
9. How the Ground Truth for the Training Set Was Established
Since no training set for an AI/algorithm is described, this question is not applicable to the provided document. The Spuncrit™ is a physical medical device for centrifuging blood and optically reading hematocrit, not an AI software.
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