(22 days)
The PROG CAL is an in vitro diagnostic product for the calibration of the Progesterone (PROG) assay on the Dimension Vista® System.
PROG CAL is a single analyte, liquid, frozen, product containing progesterone and preservatives in a human serum base, for in vitro diagnostic use. Contains human source material. Each donor unit used in the preparation of this product was tested by FDA-approved methods for the presence of antibodies to Human Immunodeficiency Virus Type 1 (HIV-1) and Type 2 (HIV-2), as well as for Hepatitis B surface Antigen and antibody to Hepatitis C Virus (HCV), and found to be negative (not repeatedly reactive). Because no testing can offer complete assurance that these or other infectious agents are absent, this material should be handled using good laboratory practice to avoid skin contact and ingestion. The kit consists of ten vials, two each of five levels containing 1 mL per vial.
The provided text describes a 510(k) submission for a medical device (Siemens Healthcare Diagnostics Dimension Vista® Progesterone Calibrator) and focuses on demonstrating substantial equivalence to a predicate device. It does not contain information about the acceptance criteria or a study proving the device meets those criteria, as typically found in clinical performance studies. The document primarily details the device's technical specifications, intended use, and a comparison to a similar, already-marketed device for the purpose of regulatory clearance.
Therefore, many of the requested details, such as sample size, data provenance, expert qualifications, adjudication methods, MRMC studies, standalone performance, and ground truth for training sets, are not applicable or not mentioned in this regulatory submission for a calibrator.
However, I can extract the information that is present:
1. Table of Acceptance Criteria and Reported Device Performance:
The document doesn't explicitly state quantitative acceptance criteria in a table format for device performance in the way a clinical study would. The primary "performance" discussed relates to stability and value assignment, which are confirmed to meet "defined acceptance criteria" without specifying the exact criteria or the numerical results of those criteria in detail.
| Acceptance Criteria Category | Reported Device Performance |
|---|---|
| Stability (Frozen: -15C to -25C) | Real-time calibrator shelf life determined by comparing results of calibrator levels stored at -15C and -25C with control calibrators stored at -70C. Recovery versus time monitored, and percent change over time determined. "Defined acceptance criteria were met at all conditions." |
| Stability (Opened/Thawed: 2-8°C) | Real-time testing after thawing at 2-8°C for 15 days. "Defined acceptance criteria were met at all conditions." Assigned values are stable for 15 days when recapped immediately and stored at 2-8°C. Assigned values are stable for 15 days when stored on board the Dimension Vista System after vial puncture. |
| Value Assignment | Values for each level of calibrator assigned using multiple Dimension Vista instruments and multiple reagent lots. Traceable to the Progesterone reference method (ID/GC/MS). The bottle value for each level is the mean of 45 replicates. "Defined acceptance criteria were met at all conditions." |
2. Sample Size for Test Set and Data Provenance:
- Sample Size for Test Set: Not explicitly stated as a separate "test set" in the context of clinical performance. For value assignment, "45 replicates" were used for each calibrator level to determine the mean bottle value. For stability, multiple calibrator levels were tested over time.
- Data Provenance: Not specified. Likely internal laboratory data from Siemens Healthcare Diagnostics. Given it's a calibrator, the "data" would be analytical measurements rather than patient data.
- Retrospective/Prospective: Not explicitly stated. Stability studies generally imply a prospective monitoring over time.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:
- Not applicable in the context of calibrator performance. Ground truth for progesterone concentration is established through a reference method (ID/GC/MS), not expert consensus.
4. Adjudication Method for the Test Set:
- Not applicable. The ground truth is based on an analytical reference method (ID/GC/MS) rather than subjective interpretation requiring adjudication.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
- No. This is a calibrator, not an AI-assisted diagnostic device that would involve human readers interpreting images or results. Therefore, an MRMC study is not relevant.
6. Standalone Performance Study:
- Yes, indirectly. The stability testing and value assignment studies describe the performance of the calibrator itself (algorithm/device only in this context) to ensure it performs as expected over time and accurately assigns progesterone values. These studies confirm its analytical performance in a standalone capacity.
7. Type of Ground Truth Used:
- Reference Method Traceability: The "ground truth" for the progesterone concentrations in the calibrator levels is established through traceability to the Isotope Dilution Gas Chromatography Mass Spectrometry (ID/GC/MS) reference measurement procedure.
8. Sample Size for the Training Set:
- Not applicable. This is a calibrator, not a machine learning algorithm that requires a "training set" in the conventional sense. Its values are assigned based on measurements, not learning from data.
9. How the Ground Truth for the Training Set Was Established:
- Not applicable, as there is no "training set" for a calibrator. The accuracy of the calibrator's assigned values is rooted in its traceability to the ID/GC/MS reference method.
§ 862.1150 Calibrator.
(a)
Identification. A calibrator is a device intended for medical purposes for use in a test system to establish points of reference that are used in the determination of values in the measurement of substances in human specimens. (See also § 862.2 in this part.)(b)
Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9.