(268 days)
INTENDED USE: This is an indirect Fluorescent antibody test for the qualitative and semi-quantitative detection of IgG autoantibodies in human serum by manual fluorescent microscopy or with the Image Navigator® Fluorescence SemiAutomated Microscope. This test system is to be used as an aid in the detection of anti-mitochondrial (AMA), antiparietal cell (APCA), and anti-smooth muscle (ASMA) autoantibodies associated with Type 1 Autoimmune Hepatitis, Primary Biliary Cholangitis, and Pernicious Anemia/Autoimmune Gastritis in conjunction with other laboratory and clinical findings. A trained operator must confirm results generated with the Image Navigator® semi-automated device and software.
Not Found
This FDA 510(k) clearance letter for K180202, the HISTOFLUOR RODENT LKS FLUORESCENT ANTIBODY TEST SYSTEM Image Navigator by Immuno Concepts, provides information about its intended use but does not include a detailed description of the acceptance criteria or a study proving that the device meets those criteria, nor does it provide specifics about the test set, ground truth, or training set parameters.
The letter primarily confirms that the device is substantially equivalent to legally marketed predicate devices and outlines general regulatory obligations. The "Indications for Use" section describes what the device is intended for (qualitative and semi-quantitative detection of certain autoantibodies) and how it's to be used (manual fluorescent microscopy or with the Image Navigator® Fluorescence Semi-Automated Microscope, with a trained operator confirming results).
Therefore, based solely on the provided text, I cannot complete the requested table and detailed study information. The details about the performance study, acceptance criteria, sample sizes, expert qualifications, and ground truth methodologies would typically be found in the 510(k) submission document itself, which is a much larger and more technical document than this clearance letter.
Here's what can be inferred or stated from the provided text, along with the limitations:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Not explicitly stated in the document) | Reported Device Performance (Not explicitly stated in the document) |
|---|---|
| No specific performance metrics or acceptance criteria are provided in this FDA clearance letter. | No specific reported device performance data (e.g., sensitivity, specificity, agreement rates with predicate or gold standard) is provided in this FDA clearance letter. |
| (Typically, acceptance criteria for an IVD would involve demonstrating comparable diagnostic performance to a legally marketed predicate device, often through sensitivity, specificity, and agreement studies. However, these specific targets are absent here.) | (Usually, this section would present quantitative results from clinical or analytical studies comparing the device's output to a reference method or predicate.) |
Information that cannot be determined from the provided FDA clearance letter:
2. Sample sizes used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
- Cannot be determined from the provided text. The clearance letter does not include details on the study design, sample sizes, or data origin.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)
- Cannot be determined from the provided text. The letter states that a "trained operator must confirm results generated with the Image Navigator® semi-automated device and software," implying human oversight, but it does not specify the number or qualifications of experts for establishing ground truth during the validation studies.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
- Cannot be determined from the provided text. No information on adjudication methods is present.
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
- Cannot be determined from the provided text. The letter does not explicitly mention an MRMC study or quantify human performance improvement with AI assistance. It indicates the device can be used with a semi-automated microscope and software, but the impact on human readers is not detailed.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
- Implied not standalone by "A trained operator must confirm results." The text states, "A trained operator must confirm results generated with the Image Navigator® semi-automated device and software." This indicates that the device is intended for use with human-in-the-loop and not as a fully standalone diagnostic tool for final results. Whether a standalone performance evaluation was conducted internally for algorithm development is not stated.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Cannot be determined from the provided text. While the device aids in detecting autoantibodies associated with specific conditions (Type 1 Autoimmune Hepatitis, Primary Biliary Cholangitis, and Pernicious Anemia/Autoimmune Gastritis) "in conjunction with other laboratory and clinical findings," the specific method for establishing ground truth in the device's validation studies is not described.
8. The sample size for the training set
- Cannot be determined from the provided text. Information about the training set size is not included in this document.
9. How the ground truth for the training set was established
- Cannot be determined from the provided text. No details are provided regarding the establishment of ground truth for any training data used for the device's algorithm.
§ 866.5660 Multiple autoantibodies immunological test system.
(a)
Identification. A multiple autoantibodies immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the autoantibodies (antibodies produced against the body's own tissues) in serum and other body fluids. Measurement of multiple autoantibodies aids in the diagnosis of autoimmune disorders (disease produced when the body's own tissues are injured by autoantibodies).(b)
Classification. Class II (performance standards).