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510(k) Data Aggregation
(32 days)
SPINALSCOPICS
The Quantimetrix Spinalscopics Control is intended for monitoring cell counts performed manually using a hemocytometer to validate quantitation of red and white blood cells in patient CSF samples. The Spinalscopics Control is intended for use as Quality Control materials having known component concentrations. Daily monitoring of the control values establishes intralaboratory parameters for accuracy and precision of the manual cell counting methods.
Spinalscopics Spinal Fluid Cell Count Control is supplied in two levels, 3 mL per bottle. It is a ready-to-use liquid requiring no reconstitution or dilution. It is prepared in a human protein matrix fortified to target levels with purified chemicals and stabilized human red blood cells and human white blood cells. Preservatives, including sodium azide, have been added to inhibit microbial growth.
Here's a breakdown of the acceptance criteria and study details for the Quantimetrix Spinalscopics Spinal Fluid Cell Count Control, based on the provided 510(k) summary:
Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Acceptance Criteria (Failure Criteria) | Reported Device Performance |
|---|---|---|
| Closed Vial Stability | A decrease of greater than 15% of the mean cell recovery compared to the initial cell count OR a greater than 10% decrease in the range of cells counted in 10 duplicate hemocytometer chambers. | Passed accelerated stability with >85% mean cell recovery or equal recovery of the range of cells. 75% mean cell recovery at 32 days/room temp. |
| Open Vial Stability (Refrigerated) | Not explicitly stated as a failure criteria here, but implied by "passed real time open vial refrigerated stability for 6.5 months with >90% recovery." | >90% recovery of RBC and WBC cell counts for 6.5 months. |
| Open Vial Stability (Room Temperature) | Not explicitly stated as a failure criteria here, but implied by "passed real time open vial room temperature storage stability for 30 days with >90% recovery." | >90% recovery of RBC and WBC cell counts for 30 days. |
Study Details
1. Sample Size Used for the Test Set and Data Provenance:
- Closed Vial Stability (Accelerated): 10 samples (control samples) were counted in duplicate for each storage condition (5C, 25C) at day 0, 32 days, and 48 days.
- Closed Vial Stability (Real-time): Not explicitly stated, but "vials were held at refrigerated temperature for 6.5 months" and "vials of a second lot which had been stored refrigerated unopened for four months." The number of vials is not specified.
- Open Vial Stability (Refrigerated): One product lot of each level of control.
- Open Vial Stability (Room Temperature): Three lots of product for each level of control.
- Data Provenance: Not explicitly stated, but given the nature of a control product for laboratory testing, it's safe to assume the data was collected prospectively under controlled laboratory conditions during product development and testing. The location (US-based company) would suggest US data.
2. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications:
- N/A. This device is a quality control material intended to validate manual cell counts. The "ground truth" for the test set is established by the known, manufactured concentrations of red and white blood cells within the control product itself, rather than by expert consensus on clinical samples. The performance evaluation focuses on the stability of these known concentrations over time under various storage conditions.
3. Adjudication Method for the Test Set:
- N/A. As the "ground truth" is the manufactured concentration within the control, there is no need for expert adjudication of results from the control material itself. The assessment involves comparing cell counts obtained by standard hemocytometer methods to a baseline.
4. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
- No. This is not a diagnostic device that interprets clinical images or data requiring human input. It is a control material for validating manual cell counting methods. Therefore, an MRMC study comparing human readers with and without AI assistance is not applicable.
5. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study:
- Yes (in essence, the control's inherent characteristics). The product itself is designed to have known, stable concentrations of cells (the "algorithm's" output, if you will, in terms of its manufacturing specification). The stability studies evaluate if the control maintains these inherent characteristics over time without human intervention in its composition. The human element comes in when using the control to validate other tests, but its performance as a control is standalone.
6. Type of Ground Truth Used:
- Manufactured, known concentrations of red and white blood cells. The control is formulated to contain specific, target concentrations of cells. The "ground truth" for its performance evaluation is whether it maintains these known concentrations over time.
7. Sample Size for the Training Set:
- N/A. This product is a physical chemical control, not a machine learning model. Therefore, there is no "training set" in the context of AI/ML. Its formulation and stability characteristics are based on established chemical and biological principles, and empirical testing.
8. How the Ground Truth for the Training Set Was Established:
- N/A. See above.
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