(152 days)
M. pneumoniae is the simplest self-replicating microorganism known. It is primarily a respiratory tract pathogen, and is one of the most common causes of pneumonia and upper-respiratory tract infections. Symptomatic infections attributable to this organism most commonly occur in children and young adults; however, the elderly may also be at risk.
Clinical signs of the onset of illness are gradual and characterized by headache, malaise, and fever, cough is prominent, and sore throat is frequent. For patients presenting such clinical symptoms, this test system may aid in the determination of the patient's serological status, and therefore, may aid in the diagnosis of disease associated with M. pneumoniae. The test system provides a means for the qualitative detection of IgG-class antibody to M. pneumoniae in human serum. The test system is for in vitro diagnostic use.
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This document is a 510(k) clearance letter for an in vitro diagnostic device, the Mycoplasma IgG ELISA Test System. It does not contain the detailed study information required to fill out the table of acceptance criteria and device performance as it's a regulatory approval document, not a clinical study report. Therefore, most of the requested information is not available in the provided text.
Here's a breakdown of what can and cannot be answered based on the provided text:
1. A table of acceptance criteria and the reported device performance
- Cannot be answered from the provided text. This document is a clearance letter, not a performance study report. It states that the device is "substantially equivalent" to a predicate device, implying its performance is acceptable, but does not specify the acceptance criteria or reported performance metrics (e.g., sensitivity, specificity, accuracy).
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Cannot be answered from the provided text. The document does not discuss the specifics of any test sets or data provenance.
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 answered from the provided text. This information would typically be found in a study report, not a clearance letter.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Cannot be answered from the provided text. Study design details like adjudication methods are not included in this regulatory letter.
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 answered from the provided text. This device is an ELISA test system, an in vitro diagnostic for antibody detection, not an AI-assisted imaging device. Therefore, an MRMC study or AI-related metrics are irrelevant and not present.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- Cannot be answered from the provided text. This question is formulated for AI/algorithm-based devices. An ELISA test system inherently has a "standalone" performance, as it's a laboratory test, but the question's premise doesn't directly apply. The document does not describe the specific laboratory validation.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Cannot be answered from the provided text. While the test aims to "aid in the diagnosis of disease associated with M. pneumoniae" by detecting IgG-class antibody, the specific ground truth used for validating the test (e.g., culture, PCR, a reference serological method) is not mentioned.
8. The sample size for the training set
- Cannot be answered from the provided text. The concept of a "training set" as understood for machine learning models is not directly applicable to an ELISA test system in the same way. The document does not provide details on sample sizes used for internal assay development or calibration.
9. How the ground truth for the training set was established
- Cannot be answered from the provided text. Similar to point 8, this question is not directly applicable to the type of device and the information provided.
Summary of available information from the document:
- Device Name: Mycoplasma IgG ELISA Test System
- 510(k) Number: K970150
- Regulatory Class: I
- Product Code: LJZ
- Intended Use: Qualitative detection of IgG-class antibody to M. pneumoniae in human serum to aid in the diagnosis of disease associated with M. pneumoniae. For in vitro diagnostic use.
- Type of device: ELISA (Enzyme-Linked Immunosorbent Assay) for serological testing.
- Approval Type: Substantial Equivalence to a predicate device.
To obtain the requested information, one would need to review the actual 510(k) submission document or any peer-reviewed publications detailing the device's validation studies, which are not included in this regulatory clearance letter.
§ 866.3375
Mycoplasma spp. serological reagents.(a)
Identification. Mycoplasma spp. serological reagents are devices that consist of antigens and antisera used in serological tests to identify antibodies toMycoplasma spp. in serum. Additionally, some of these reagents consist ofMycoplasma spp. antisera conjugated with a fluorescent dye (immunofluorescent reagents) used to identifyMycoplasma spp. directly from clinical specimens. The identification aids in the diagnosis of disease caused by bacteria belonging to the genusMycoplasma and provides epidemiological information on diseases caused by these microorganisms.Mycoplasma spp. are associated with inflammatory conditions of the urinary and respiratory tracts, the genitals, and the mouth. The effects in humans of infection withMycoplasma pneumoniae range from inapparent infection to mild or severe upper respiratory disease, ear infection, and bronchial pneumonia.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 866.9.