(268 days)
Audit® MicroLQ™ Spinal Fluid Control is a quality control material intended for monitoring the precision of laboratory testing procedures.
When used for quality control purposes, it is recommended that each laboratory establish its own means and acceptable ranges and use the values provided only as guides. The Audit® MicroLQ™ Spinal Fluid is for In Vitro Diagnostic use only.
The Audit® MicroLQ™ Spinal Fluid is a human based, liquid set of QC material. Each level of the set contains Chloride, Glucose, Immunoglobulin A (IgA), Immunoglobulin G (IgG), Immunoglobulin M (IgM), Lactate, Lactate Dehydogenase (LD), Microalbumin, Microprotein, and Sodium analytes. It is used to confirm the proper calibration of Chloride, Glucose, Immunoglobulin A (IgA), Immunoglobulin G (IgG), Immunoglobulin M (IgM), Lactate, Lactate Dehydogenase (LD), Microalbumin, Microprotein, and Sodium
The provided document is a 510(k) premarket notification for a medical device called "Audit® MicroLQ™ Spinal Fluid." This document describes the device, its intended use, and its substantial equivalence to a predicate device. However, it does not contain the kind of detailed study information (acceptance criteria, sample sizes, expert qualifications, adjudication methods, multi-reader multi-case studies, standalone performance, or ground truth establishment for AI/algorithm-based devices) that your request outlines.
The "studies" mentioned in the document are limited to stability studies performed to determine the shelf life of the quality control material. This is a very different type of study from those typically conducted for AI/algorithm-based diagnostic devices.
Therefore, I cannot fulfill your request for the specific details about acceptance criteria and study design as laid out in your prompt because this information is not present in the provided text. The document is for a quality control material for laboratory testing, not an AI or algorithm-based diagnostic device.
Here's a breakdown of why the information is missing based on the provided text:
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Acceptance Criteria and Reported Device Performance (Table): Not applicable in the context of stability studies for a QC material. The "device performance" here is its stability, detailed below.
- Acceptance Criteria (Implicit - based on product claims):
- Shelf Life: Two years, when stored unopened at 2 – 8º C.
- Open Vial: 30 days, when stored at 2 – 8º C.
- Reported Device Performance:
- The document states "Stability studies have been performed to determine the shelf life for the Audit® MicroLQ™ Spinal Fluid Set. All supporting data is retained on file at Aalto Scientific. Ltd. Product claims are as follows:
- Shelf Life: Two years, when stored unopened at 2 - 8º C.
- Open Vial: 30 days, when stored at 2 - 8º C."
- It also notes: "Real time studies are ongoing to support the shelf life of this product."
- The document states "Stability studies have been performed to determine the shelf life for the Audit® MicroLQ™ Spinal Fluid Set. All supporting data is retained on file at Aalto Scientific. Ltd. Product claims are as follows:
- Acceptance Criteria (Implicit - based on product claims):
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Sample Size used for the test set and data provenance: Not relevant for a stability study of a QC material. There is no "test set" in the context of evaluating an algorithm's performance on patient data.
- The document states that "All supporting data is retained on file at Aalto Scientific. Ltd." but doesn't detail the sample size or specific methodology of the stability studies.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Stability studies do not involve expert interpretation for ground truth.
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Adjudication method for the test set: Not applicable.
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If a multi reader multi case (MRMC) comparative effectiveness study was done: No, this type of study is for evaluating human performance with and without AI assistance, which is not relevant for a quality control material.
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If a standalone (i.e. algorithm only without human-in-the loop performance) was done: No, this device is a quality control material, not an algorithm.
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The type of ground truth used: For stability studies, the "ground truth" would be the known concentration of analytes in the QC material over time, measured by analytical methods, not expert consensus, pathology, or outcomes data. The document does not specify how this ground truth was measured or established in detail.
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The sample size for the training set: Not applicable. This device is not an AI/algorithm that requires a training set.
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How the ground truth for the training set was established: Not applicable.
In summary, the provided document describes a quality control material used to monitor the precision of laboratory tests, not an AI-powered diagnostic device. Therefore, the specific types of studies, acceptance criteria, and ground truth methodologies requested are not relevant or present in this context.
§ 862.1660 Quality control material (assayed and unassayed).
(a)
Identification. A quality control material (assayed and unassayed) for clinical chemistry is a device intended for medical purposes for use in a test system to estimate test precision and to detect systematic analytical deviations that may arise from reagent or analytical instrument variation. A quality control material (assayed and unassayed) may be used for proficiency testing in interlaboratory surveys. This generic type of device includes controls (assayed and unassayed) for blood gases, electrolytes, enzymes, multianalytes (all kinds), single (specified) analytes, or urinalysis controls.(b)
Classification. Class I (general controls). Except when intended for use in donor screening tests, quality control materials (assayed and unassayed) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9.