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510(k) Data Aggregation
(39 days)
CONE-TROL Liquid Chemistry Control is a human liquid control serum to monitor the precision of laboratory testing procedures for the analytes listed in the package insert.
CONE-TROL Liquid Chemistry Control is prepared from human serum to which purified biochemical material (human and animal origin), chemicals, drugs, preservatives, and stabilizers have been added. The control is provided in liquid form for user convenience.
Here's an analysis of the acceptance criteria and study information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The provided document primarily focuses on demonstrating substantial equivalence to a predicate device rather than explicitly stating pre-defined acceptance criteria for performance metrics. However, we can infer the implicit "acceptance criteria" and how the device's performance aligns with them based on the stability testing described. The primary "performance" being evaluated here is the stability of the control material over time under various storage conditions.
| Acceptance Criteria (Inferred) | Reported Device Performance (CONE-TROL Liquid Chemistry Control) |
|---|---|
| Closed Vial Stability (2-8°C): Control material remains stable for at least 30 days at 2-8°C (matching predicate). | Acceptable stability through 33 days at 2-8°C (real-time testing). |
| Open Vial Stability (2-8°C): Control material remains stable for at least 14 days at 2-8°C after opening (matching predicate). | Acceptable stability through 15 days at 2-8°C after opening and simulating handling (real-time testing). |
| Shelf Life (Frozen <-20°C): Control material remains stable until expiration date at <-20°C (matching predicate). | Acceptable stability through 254 days at <-20°C (real-time testing). Real-time studies are ongoing to support the shelf life. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set:
- Value Assignment: 6 randomly selected vials from each manufacturing lot were assayed in duplicate across 2 or more instruments for each Abaxis Xpress panel. "Endogenous analytes" were value assigned using Kamiya and Sekisui reagents, but the specific number of vials/measurements for this is not explicitly stated, although it implies a similar process.
- Performance (Stability) Testing: The document does not specify the exact number of vials or lots used for the real-time stability studies. It mentions "CONE-TROL Liquid Chemistry Control was stored..." (singular phrasing), which could imply a limited number of samples, but it doesn't give a concrete count.
- Data Provenance: The studies were conducted by Cone Bioproducts, so the data is likely generated within the United States. The studies are described as "real-time stability testing," indicating they are prospective in nature, as the control material was monitored over time under specified conditions.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This type of device (liquid chemistry control) does not typically involve expert review for "ground truth" in the same way an imaging or diagnostic AI device would. The "ground truth" for a chemistry control is established through:
- Assigned Values: These are determined by assaying the control material on validated instruments (Abaxis Piccolo Express Analyzer, Roche Cobas Mira Plus, Mindray BS-200) using established methods and reagents.
- Stability: This is determined by comparing measured values at different time points to initial values, adhering to established analytical chemistry principles.
Therefore, there were no "experts" in the traditional sense involved in establishing a ground truth for interpretation based on subjective judgment. The "truth" is derived from analytical measurements performed by trained technicians or laboratory personnel.
4. Adjudication Method for the Test Set
Not applicable. As explained above, the "ground truth" for this type of device is based on quantifiable analytical measurements and stability parameters, not on subjective interpretations requiring adjudication among experts.
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
Not applicable. This is a medical device for quality control in chemistry testing, not an AI-assisted diagnostic tool for human readers. Therefore, an MRMC study is not relevant.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Not applicable. This device is a chemical quality control material, not an algorithm or AI system.
7. The Type of Ground Truth Used
The "ground truth" used for this device is based on analytical measurements and stability data against predetermined ranges or expectations for various analytes as measured by laboratory equipment. It ensures that the control material maintains its integrity and assigned values over time under specified conditions.
8. The Sample Size for the Training Set
The concept of a "training set" is not applicable to this device. This is a manufactured product (chemistry control) whose performance is evaluated against established analytical methods and specifications, not an algorithm that learns from data.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no training set for this type of device.
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