(199 days)
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Here's an analysis of the provided text, focusing on the acceptance criteria and study details:
1. Table of Acceptance Criteria and Reported Device Performance
| Metric | Acceptance Criteria | Reported Device Performance (Upgraded Assay) |
|---|---|---|
| Specificity | Not explicitly stated | 99% (95% CI = 93 to 100%) |
| Sensitivity | Not explicitly stated | 94% (95% CI = 85 to 99%) |
Note: The document does not explicitly state pre-defined acceptance criteria. The "reported device performance" reflects the outcomes of the study for the upgraded assay.
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: n = 130
- CME negative: 76
- CME positive: 54
- Data Provenance:
- Country of Origin: Implied to be the USA, as the samples were obtained from the Mayo Clinic.
- Retrospective or Prospective: Retrospective. The samples were "actual specimens submitted to Mayo Clinic Reference Laboratory for O&P examination," suggesting they were collected prior to the study for routine clinical purposes.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
- Number of Experts: Not specified.
- Qualifications of Experts: Not specified.
- The "Conventional Microscopic Exam (CME)" is stated as the ground truth, but the details of who performed this exam (e.g., number of microscopists, their experience, their specific qualifications for identifying Cryptosporidium) are not provided.
4. Adjudication Method for the Test Set
- Adjudication Method: Not specified. It's unclear if multiple Conventional Microscopic Exams were performed for each sample and how discrepancies were resolved. The results are presented as definitive CME positive/negative.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done
- No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. The study compares two different assays (Upgraded vs. Original) against a conventional method, but not the improvement of human readers with AI assistance.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was Done
- Yes, this study represents a standalone performance evaluation of the upgraded Cryptosporidium Antigen Detection Assay. The assay itself is the "device," and its performance is evaluated against a ground truth without human interpretation of the assay's direct output.
7. The Type of Ground Truth Used
- Ground Truth Type: Expert consensus (implicitly, through the Conventional Microscopic Exam). The CME is presented as the definitive determination of positive or negative for Cryptosporidium.
8. The Sample Size for the Training Set
- Not Applicable / Not Provided. This study describes a diagnostic assay, not a machine learning algorithm that would typically have a separate training set. The "Upgraded version" implies development work, but there's no mention of a distinct training set.
9. How the Ground Truth for the Training Set Was Established
- Not Applicable / Not Provided. As there's no mention of a training set, the establishment of its ground truth is not discussed.
§ 866.3220
Entamoeba histolytica serological reagents.(a)
Identification. Entamoeba histolytica serological reagents are devices that consist of antigens and antisera used in serological tests to identify antibodies toEntamoeba histolytica in serum. Additionally, some of these reagents consist of antisera conjugated with a fluorescent dye (immunofluorescent reagents) used to identifyEntamoeba histolytica directly from clinical specimens. The identification aids in the diagnosis of amebiasis caused by the microscopic protozoan parasiteEntamoeba histolytica and provides epidemiological information on diseases caused by this parasite. The parasite may invade the skin, liver, intestines, lungs, and diaphragm, causing disease conditions such as indolent ulcers, an amebic hepatitis, amebic dysentery, and pulmonary lesions.(b)
Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 866.9.