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Apo-Tek Lp(a)™ is an Apo(a) isoform independent enzyme-linked immunosorbent assay (ELISA) for the quantitative determination of lipoprotein(a) [Lp(a)] in human serum and plasma. The measurement of Lp(a), in conjunction with other lipoprotein tests, is of diagnostic significance when assessing atherosclerotic cardiovascular disease in specific populations.

Apo-Tek Lp(a)™ is an apolipoprotein(a) [Apo(a)] isoform independent in vitro diagnostic enzyme-linked immunosorbent assay (ELISA) intended for the quantitiative assessment of lipoprotein(a) [Lp(a)] in human serum or plasma. This test utilizes a sandwich ELISA format in which the Lp(a) particle is captured with a specific anti-Apo(a) monoclonal antibody and, after washing away nonbound serum or plasma components, is detected with a peroxidase conjugated anti-apolipoprotein B [Apo B] polyclonal antibody.

This prompt is asking to extract information about the acceptance criteria and the study that proves the device meets the acceptance criteria from a 510(k) summary document. However, the provided document is a 510(k) summary for a diagnostic test (Apo-Tek Lp(a)™ ELISA) and does not describe acceptance criteria in the typical sense of a medical device study (e.g., sensitivity, specificity, AUC targets). Instead, it discusses the performance characteristics and clinical utility of the assay. Because the document does not contain the requested information in a clearly defined manner, the following is a best effort to interpret and extract relevant details based on the provided text.

Here's an analysis based on the supplied text:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state "acceptance criteria" for the device in a tabular format with predefined thresholds. Instead, it describes various performance characteristics and clinical correlations. Here's a table attempting to capture these:

Note: The "acceptance criteria" column is an interpretation of the performance specifications for which data is provided, as explicit thresholds are not stated in the document.

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

The document does not explicitly define a "test set" in the context of an algorithm or imaging study. Instead, it refers to "two clinical evaluations" and a "cross-sectional cohort study of a well-characterized U.S. population" for clinical utility.

• Sample Size for Clinical Evaluations: Not specified.
• Sample Size for Cross-sectional Cohort Study (U.S. population): Not specified.
• Data Provenance:
  • "Two clinical evaluations" - geographic origin not specified.
  • "Cross-sectional cohort study of a well characterized U.S. population" - United States, retrospective (implied by "have had").
  • The reproducibility study (NCCLS document EP5-T2) uses "samples ranging from 8.8 to 34.8 mg/dL", but the number of samples is not specified.

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

This information is not applicable and not provided in the document. The Apo-Tek Lp(a)™ is an in vitro diagnostic ELISA kit, not an imaging or AI-driven diagnostic device that relies on expert ground truth for interpretation. The clinical utility is established through correlation with clinically determined diseases (e.g., myocardial infarction, stenosis), likely based on standard diagnostic procedures and outcomes, not expert consensus on image interpretation.

4. Adjudication Method for the Test Set

This information is not applicable and not provided. As explained above, the device is an ELISA kit, and its performance is assessed against clinical outcomes, not expert adjudication of classifications.

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

No, a MRMC comparative effectiveness study was not done. This type of study is relevant for imaging devices or AI tools where human readers interpret cases with and without AI assistance. The Apo-Tek Lp(a)™ is a laboratory assay.

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

Yes, the performance described is a standalone performance. The Apo-Tek Lp(a)™ is an automated laboratory assay. Its "performance" refers to its analytical characteristics (e.g., cross-reactivity, reproducibility) and its correlation with clinical outcomes when used as a diagnostic test. There is no "human-in-the-loop" component for its basic operation or interpretation in this context, other than the clinician interpreting the numerical result in conjunction with other clinical information.

7. The Type of Ground Truth Used

The "ground truth" for evaluating the clinical utility of Apo-Tek Lp(a)™ appears to be based on clinical disease diagnoses or outcomes data. For example:

• Myocardial infarction
• Coronary artery stenosis (>50%)
• Cerebrovascular disease
• Carotid artery stenosis (≥20% or ≥50%)

The accuracy of these diagnoses would be established through standard medical practice (e.g., angiograms for stenosis, clinical criteria for MI).

8. The Sample Size for the Training Set

This information is not applicable and not provided. The Apo-Tek Lp(a)™ is an ELISA assay, not a machine learning algorithm that requires a "training set" to develop its logic or parameters. Its operating characteristics are inherent to its chemical and biological design.

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

This information is not applicable and not provided. As mentioned, there is no "training set" in the context of this diagnostic kit.

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AuraTek FDP is a rapid one-step gold dye particle lateral flow immunoassay indicated for the in vitro qualitative measurement of fibringen and fibrinogen degradation products (FDP) in human urine, to be used with standard cystoscopic examination to aid in the management of patients with a history of bladder cancer.

AuraTek FDP is a one-step gold dye particle immunoassay on a porous carrier. Mobile purple-red dye particles labeled with anti-FDP and fibrinogen antibody and immobile capture anti-FDP and fibringgen antibodies are coated as discrete zones on the porous carrier. In addition a test control zone with antimurine IgG (Reaction Control 2) is coated on the carrier. A sample placed on the device is absorbed by the porous carrier. The rehydrated colored sol particles move through the porous carrier to the capture anti-FDP and then to the anti-murine IgG. If the sample contains FDP and/or fibrinogen, the antibodylabeled sol particles will bind in a sandwich-type reaction to the capture anti-FDP and fibrinogen antibody producing a purple-red dot in the test result window. With a negative sample, the white test result window remains unchanged at the time of reading. AuraTek FDP has the unique feature that the test run validity is double-checked with the appearance and disappearance of color in the Reaction Control 1 window and development of a purple-red dot in the Reaction Control 2 window.

Here's a breakdown of the acceptance criteria and the study details for the AuraTek FDP device, based on the provided document:

Acceptance Criteria and Device Performance

The acceptance criteria are not explicitly stated as distinct thresholds in the document. Instead, the device's performance is presented in comparison to existing methods (cytology and hemoglobin dipstick) and against general clinical expectations for accuracy in bladder cancer monitoring. The key performance metrics are Sensitivity and Specificity.

Here's a table summarizing the reported device performance and implicitly, the targets it aims to meet or exceed:

Study Details

2. Sample Size and Data Provenance

• Test Set Sample Size:
  • Clinical Sensitivity Study: 192 patients with a history of bladder cancer undergoing cystoscopic examination.
    • 79 patients with confirmed bladder tumors (positive cystoscopy with confirmatory biopsy).
    • 113 patients with negative cystoscopy results (used for specificity analysis).
  • Specificity Study (Healthy Subjects): 73 healthy subjects.
  • Specificity Study (Non-Bladder Cancer Urological Disease): 232 subjects with various non-bladder cancer urological diseases.
• Data Provenance: The study was a "multi-center study" involving "a general urology practice." While specific countries are not mentioned, the context of a 510(k) submission to the FDA suggests the data would be primarily from the United States. The study is prospective as it involved patients "undergoing cystoscopic examination," implying data collection at the time of follow-up.

3. Number of Experts and Qualifications for Ground Truth

• Number of Experts: Not explicitly stated.
• Qualifications of Experts: The ground truth for bladder cancer confirmation was established by positive cystoscopy results with confirmatory biopsy. This implies a pathologist would be involved in interpreting the biopsy and a urologist in performing the cystoscopy. Specific years of experience are not mentioned, but these are standard clinical practices performed by qualified medical professionals.

4. Adjudication Method

• The document implies that the ground truth for cancer diagnosis was established by confirmatory biopsy following cystoscopy. This is a definitive diagnostic method, not typically requiring additional adjudication among experts in the same way imaging interpretations might. The mention of "positive cystoscopy results with confirmatory biopsy" suggests a definitive, pathological diagnosis. Therefore, a specific adjudication method (like 2+1 or 3+1) among multiple readers of the same data type isn't detailed, as the biopsy serves as the ultimate diagnostic confirmation.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

• No, a MRMC comparative effectiveness study was not done in the context of human readers improving with AI vs. without AI assistance.
• The study compares the performance of the AuraTek FDP device to standard clinical methods (cytology and hemoglobin dipstick) directly, not as an AI-assisted tool for human readers. It's a standalone device performance study.

6. Standalone Performance Study

• Yes, a standalone (algorithm only without human-in-the-loop performance) study was done. The entire "Summary of Studies" section (1.7) details the performance of the AuraTek FDP device in isolation, evaluating its sensitivity, specificity, reproducibility, high dose hook effect, and interference from various substances. The reported sensitivity and specificity values are for the device itself.

7. Type of Ground Truth Used

• The primary ground truth for the presence of bladder cancer in the clinical sensitivity study was Pathology (confirmatory biopsy following positive cystoscopy).
• For the specificity analyses, ground truth was derived from "healthy subjects," "cystoscopy negative patients with a history of bladder cancer," and patients diagnosed with "non-bladder cancer urological disease" (presumably confirmed by standard clinical diagnostic procedures relevant to their conditions).

8. Sample Size for the Training Set

• Not applicable / Not explicitly stated. This device is a rapid immunoassay (lateral flow immunoassay), not an AI/machine learning device that typically requires a large 'training set' in the conventional sense. The "training" of such a device involves optimization of its chemical and physical components (e.g., antibody concentrations, membrane properties) during its development, rather than a data-driven algorithmic training process. The document describes analytical validation and clinical performance studies, not an AI model's training phase.

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

• Not applicable. As explained in point 8, this is not an AI/machine learning device. Therefore, there isn't a "training set" with ground truth in the context of an algorithm learning from data. The device's performance is driven by its biological and chemical design (monoclonal antibodies, gold dye particles, etc.).

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