(16 days)
FOR IN VITRO DIAGNOSTIC USE.
The SPQTM Antibody Reagent Set for Lp(a) is designed for the quantitative determinatior of human lipoprotein(a) in mg/dL in human serum by immunoprecipitin analysis using દ turbidimetric clinical analyzer. The measurement of Lp(a) is indicated for use ir conjunction with clinical evaluation, patient risk assessment and other lipoprotein tests tc evaluate disorders of lipid metabolism and to assess coronary heart disease (CHD) ir male Caucasian populations.
Lipoprotein(a) Immunological Test Kit
The provided text describes a Special 510(k) for a device modification: the Lp(a) SPQ™ III Antibody Reagent Set. This submission is for a modification to an existing device, and the primary goal is to demonstrate "substantial equivalence" to a predicate device, rather than proving novel clinical efficacy. Therefore, the information typically found in a study proving acceptance criteria for a new device might be limited or presented differently.
Based on the provided text, here's an analysis of the acceptance criteria and the study:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Implicit) | Reported Device Performance |
|---|---|
| Substantial equivalence to predicate device (SPQ™ II Antibody Reagent Set for Lipoprotein(a)) in performance characteristics. | "Bench testing with clinical samples demonstrated that the performance characteristics of the modified device were substantially equivalent to those of the predicate device." |
| Continued intended use for quantitative determination of human lipoprotein(a) in human serum by immunoprecipitin analysis using a turbidimetric clinical analyzer to evaluate disorders of lipid metabolism and assess coronary heart disease (CHD) in male Caucasian populations. | The intended use remains the same as the predicate device. |
| Technological basis remains the same. | "The modified device has the same technological basis as the predicate device." |
| Labeling changes directly reflect device modification (additional antibody and reduced reaction time) and are substantially equivalent. | "The labeling of the modified device is substantially equivalent to that of the predicate device. Changes in labeling directly reflect the device modification (additional antibody and reduced reaction time)." |
Note on Acceptance Criteria: For a 510(k) modification aiming for substantial equivalence, the "acceptance criteria" are not typically quantitative performance metrics like sensitivity and specificity for a diagnostic claim (unless a new diagnostic claim is being made). Instead, the primary acceptance criterion is whether the modified device performs comparably to the predicate device, demonstrating that the changes do not introduce new questions of safety or effectiveness. The text explicitly states that the device's performance was "substantially equivalent."
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: Not explicitly stated. The text mentions "bench testing with clinical samples," but the number of samples is not provided.
- Data Provenance: "Clinical samples" are mentioned, implying human samples. The country of origin and whether the data was retrospective or prospective are not specified.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts
- Number of Experts: Not applicable/not specified. The study focuses on comparing the modified device to a predicate device, not on establishing a new ground truth or diagnostic accuracy against a gold standard that would typically involve expert consensus. The "ground truth" here would be the results obtained by the predicate device.
- Qualifications of Experts: Not applicable/not specified.
4. Adjudication Method for the Test Set
- Adjudication Method: Not applicable/not specified. As the study is a comparison to a predicate device rather than an evaluation against a clinical ground truth requiring interpretation, an adjudication method for expert consensus is not relevant or described.
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
- MRMC Study: No, an MRMC study was not done. This device is an in vitro diagnostic (IVD) reagent set for quantitative determination, not an imaging or interpretive device that would involve human readers. Therefore, the concept of human readers improving with or without AI assistance is not relevant to this device type.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
- Standalone Performance: Yes, implicitly. The device itself is a reagent set for an automated turbidimetric clinical analyzer. Its performance is inherent to the reagent-analyzer combination, and it operates autonomously without human interpretation playing a direct role in the measurement of Lp(a) levels. Humans operate the analyzer, but the 'performance' refers to the analytical accuracy of the test itself. The clinical samples were tested against the predicate device's results.
7. The Type of Ground Truth Used
- Type of Ground Truth: The "ground truth" in this context is the results obtained from the predicate device, the SPQ™ II Antibody Reagent Set for Lipoprotein(a). The study's aim was to demonstrate analytical substantial equivalence, meaning the modified device should yield comparable results to the established predicate device on the same "clinical samples."
8. The Sample Size for the Training Set
- Sample Size for Training Set: Not applicable/not specified. This device is a reagent set, not an AI algorithm that requires a training set in the conventional sense. The "bench testing" mentioned refers to analytical validation.
9. How the Ground Truth for the Training Set Was Established
- How Ground Truth for Training Set Established: Not applicable/not specified. (See point 8)
§ 866.5600 Low-density lipoprotein immunological test system.
(a)
Identification. A low-density lipoprotein immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the low-density lipoprotein in serum and other body fluids. Measurement of low-density lipoprotein in serum may aid in the diagnosis of disorders of lipid (fat) metabolism and help to identify young persons at risk from cardiovascular diseases.(b)
Classification. Class II (performance standards).