Search Results

FOR IN VITRO DIAGNOSTIC USE. The SPQ TM Antibody Reagent Set for Lp(a) is designed for the quantitative determination of human lipoprotein(a) in mg/dL in human serum by immunoprecipitin analysis using a turbidimetric clinical analyzer. The measurement of Lp(a) is indicated for use in conjunction with clinical evaluation, patient risk assessment and other lipoprotein tests to evaluate disorders of lipid metabolism and to assess coronary heart disease (CHD) in male Caucasian populations.

Lipoprotein(a) Immunological Test Kit

The provided text describes a Special 510(k) for a device modification: Lp(a) SPQ™ III Antibody Reagent Set. The purpose of the submission is to demonstrate that the modified device, which includes an additional instrument application for the Hitachi 911 analyzer, is substantially equivalent to the predicate device.

Here's an analysis of the acceptance criteria and study information provided:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state numerical acceptance criteria in a table format. However, the overall acceptance criterion for this 510(k) submission is "Substantial Equivalence" to the predicate device. The performance is reported qualitatively.

2. Sample Size Used for the Test Set and Data Provenance

• Sample Size for Test Set: The document states that "Bench testing with clinical samples" was performed. However, it does not specify the number of clinical samples used in this testing.
• Data Provenance: The document does not specify the country of origin of the data. Given the "FOR IN VITRO DIAGNOSTIC USE" and "human serum" description, it can be inferred that the data is from human subjects, likely in a clinical setting. It is a retrospective or prospective study is not explicitly stated, but "bench testing with clinical samples" suggests a study where samples were analyzed.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications

The document does not provide information on the number of experts used or their qualifications for establishing ground truth. For this type of in vitro diagnostic device, the ground truth would typically be established by a reference method or a clinically accepted laboratory standard, not by expert consensus in the traditional sense of image interpretation.

4. Adjudication Method for the Test Set

The document does not describe any adjudication method for the test set. For an in vitro diagnostic assay, adjudication usually refers to resolving discrepancies in expert interpretations (e.g., in imaging studies). For a quantitative assay, the performance is typically compared against a reference method or established statistical measures.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

A Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not performed or described. This type of study is typically relevant for interpretative devices (e.g., medical imaging AI) where human readers are involved. This device is an in vitro diagnostic (IVD) reagent set for quantitative measurement, which falls into a different category of performance assessment. The comparison is between the modified device and the predicate device's performance, not human readers with and without AI assistance.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

The device described is an in vitro diagnostic (IVD) reagent set, not an algorithm or AI. It is designed for "immunoprecipitin analysis using a turbidimetric clinical analyzer." Therefore, the concept of "standalone (algorithm only)" performance does not directly apply as it would for a software-based AI device. The performance evaluated is the measurement capability of the reagent set on an analyzer, which is inherently a "standalone" measurement in terms clinical context but not in the AI context.

7. The Type of Ground Truth Used

The type of ground truth used is implied to be quantitative measurements of human lipoprotein(a). For IVD devices, "ground truth" is typically established by:

• Comparison to a reference method (e.g., a more sensitive, specific, or established laboratory test).
• Correlation with clinically established standards or diagnostic criteria.
• In this case, the comparison is made against the predicate device's performance, implying the predicate device's results serve as a benchmark for substantial equivalence.

8. The Sample Size for the Training Set

The document does not mention a training set or any machine learning/AI components. This device is a chemical reagent set for a laboratory assay.

9. How the Ground Truth for the Training Set Was Established

As no training set is mentioned (because the device is an IVD reagent set, not an AI/ML device), this question is not applicable.

Ask a specific question about this device

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

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)

Ask a specific question about this device