Search Results

Coproset Salmonella: In vitro Disposable diagnostic device with Selenite Broth intended for the collection and transport, from the collection site to the testing laboratory, of stool samples and for the enrichment of Salmonella spp.

Coproset Shigella: In vitro Disposable diagnostic device with GN Broth intended for the collection and transport from the collection site to the testing laboratory of stool samples and for the enrichment of Shigella spp

Uriset preservative tubes: Disposable in vitro diagnostic device for the collection and transport of urine samples from the collection site to the testing laboratory.

Swab set General Use: Disposable in vitro diagnostic device with Eugon Broth, intended for the collection and transport of pathogenic agents collected by swabs from the collection site to the testing laboratory and for enrichment of Streptococcus pyogenes, Staphylococcus aureus, Candida spp., Streptococcus agalactiae.

Coproset: disposable in vitro diagnostic device for the collection and transportation of stool samples and the enrichment of pathogenic organisms present in the sample.

Coproset Salmonella: In vitro Disposable diagnostic device with Selenite Broth intended for the collection and transport, from the collection site to the testing laboratory, of stool samples and for the enrichment of Salmonella spp.

Coproset Shigella: In vitro Disposable diagnostic device with GN Broth intended for the collection and transport from the collection site to the testing laboratory of stool samples and for the enrichment of Shigella spp.

Uriset Preservative tubes with holder: Disposable in vitro diagnostic device for the collection and transport of urine samples from the collection site to the testing laboratory.

Swab set General use: Disposable in vitro diagnostic device with Eugon Broth, intended for the collection and transport of pathogenic agents collected by swabs from the collection site to the testing laboratory and for enrichment of Streptococcus pyogenes, Staphylococcus aureus, Candida spp., Streptococcus agalactiae.

The provided text describes a 510(k) summary for several microbiological specimen collection and transport devices, namely Coproset Salmonella, Coproset Shigella, Uriset Preservative tubes, and Swab set General Use. The document details the device descriptions and general information but does not contain detailed information regarding acceptance criteria, specific study designs, or performance data in the format requested.

Therefore, I cannot provide a table of acceptance criteria and reported device performance or information about sample sizes for test/training sets, ground truth establishment, expert involvement, adjudication methods, or MRMC studies.

The document states: "Performance evaluation, further demonstrate the substantial equivalence and the safety and effectiveness of Diesse Devices when compared with the respective Predicate Device: in the case of Coproset devices and Swab set device viability of pathogen is maintained and the results obtained are comparable with those obtained for predicate device; Uriset preservative tubes with holder have the same intended use, Indication for use, material and design than its predicate device and thus it possible to conclude that they are substantially equivalent. The results obtained in the comparison between Uriset preservative tube and Vacutainer demonstrate that DIESSE Uriset give a good performance in terms of sample preservation and data are comparable with those obtained for the predicate device."

This statement indicates that performance evaluations were conducted, and the results were found to be "comparable" with predicate devices, suggesting the device does meet certain performance expectations. However, the specific metrics, criteria, and detailed study results demonstrating this comparison are not included in this summary.

In summary, the input text lacks the specific details required to answer your questions about acceptance criteria, study design, and performance metrics.

Ask a specific question about this device

ENZY-WELL SYPHILIS IgG is an immunoenzymatic method for the qualitative detection of IgG antibodies to Treponema pallidum in human serum by a manual technique. The test may be used in conjunction with non-treponemal testing to provide serological evidence of infection with T. pallidum. For in vitro diagnostic use only.

ENZY-WELL SYPHILIS IgG is an immunoenzymatic method for the qualitative detection of IgG antibodies to Treponema pallidum in human serum/ plasma. The test may be used in conjunction with non-treponemal testing to provide serological evidence of infection with T. pallidum. The ENZY-WELL SYPHILIS IgG test is based on the ELISA technique (Enzyme-linked immunosorbent assay). Diluted patient sample is incubated in microplate wells coated with T. pallidum. During this incubation specific immunoglobulins, if present, bind to the antigen on the well. After washing, to eliminate unbound proteins, a second incubation is performed with the conjugate, composed of human IgG monoclonal antibodies labeled with peroxidase. After washing to remove unbound conjugate from the wells, the substrate is added, which will react to produce color in the presence of the peroxidase. An acidic solution is added to stop the reaction and the absorbance of the developed color is read at 450 nm

Here's a summary of the acceptance criteria and the study details for the ENZY-WELL SYPHILIS IgG device, based on the provided document:

Acceptance Criteria and Device Performance

Study Details

1. Sample sizes used for the test set and data provenance:

   • Clinical Sample Correlation (Primary Study):
     • First group (syphilitic sera): 125 samples (pediatric and adult, male and female patients). Data provenance not explicitly stated (e.g., country), but implied to be clinical. Retrospective/prospective not specified.
     • Second group (negative sera): 300 samples (150 from clinical sources/blood donors, 150 from normal donors). Data provenance not explicitly stated, but implied to be clinical. Retrospective/prospective not specified.
     • Third group (different pathologies): 100 samples (no known history/serological evidence of syphilis, suspected for other infective/clinical pathology). Data provenance not explicitly stated. Retrospective/prospective not specified.
   • Clinical Studies (Independent Labs): 387 specimens across two independent clinical laboratories (Lab B and Lab C).
   • Cross-Reactivity & Interference Studies: 332 sera with known diseases collected from a "seroteque" (implying retrospective sourcing).
   • Precision Studies: Various control and serum samples (number not detailed for each type beyond "3 replicates" for specific samples in each run/day experiment).

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

   • The document primarily relies on "comparative testing methods" and "confirmatory tests" (FTA-ABS, TPHA, VDRL) rather than direct expert consensus on raw data.
   • For the 'First group' of 125 syphilitic sera, it states "no disagreement between two comparative testing methods." This suggests at least two methods or interpretations were used, but not necessarily by human experts on individual cases.
   • For discordant results in the negative and pathological groups, confirmatory tests like FTA-ABS, TPHA, and VDRL were used. The interpretation of these confirmatory tests would likely be performed by qualified laboratory personnel, but the number and specific qualifications of such "experts" are not detailed.

3. Adjudication method for the test set:

   • For the primary clinical sample correlation, disputes between the ENZY-WELL SYPHILIS IgG and the predicate device (CAPTIA Syphilis - G) were resolved using confirmatory tests like FTA-ABS, TPHA, and VDRL.
   • For the 10 discordant samples in the independent clinical study, a "third commercially available test" (referee test) was used, and it agreed with the Diesse test for 8 out of 10 samples.

4. 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:

   • No, this device is an immunoassay (laboratory test kit), not an AI-assisted diagnostic device. Therefore, an MRMC study related to human readers improving with AI assistance is not applicable and was not performed.

5. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:

   • Yes, the performance data presented is for the standalone performance of the ENZY-WELL SYPHILIS IgG immunoassay kit. It measures the qualitative detection of IgG antibodies directly from human serum/plasma. There is no "human-in-the-loop" component in the interpretive function of the device itself, although human laboratory technicians perform the assay.

6. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

   • Clinical Status: Ground truth was established based on clinical diagnosis of syphilis ("patients with syphilis") or confirmed negative status ("negative to Syphilis").
   • Confirmatory Tests: For validation and adjudication of discordant results, established laboratory confirmatory tests were used:
     • FTA-ABS (Fluorescent Treponemal Antibody Absorption)
     • TPHA (Treponema Pallidum Hemagglutination Assay)
     • VDRL (Venereal Disease Research Laboratory)

7. The sample size for the training set:

   • This is an immunoassay kit, not a machine learning or AI model. Therefore, there isn't a traditional "training set" in the computational sense. The "development" of the assay involves optimizing reagents and conditions using internal samples, but these are not typically referred to as a "training set" in the context of device validation. The provided data focuses on the validation of the finalized kit.

8. How the ground truth for the training set was established:

   • As noted above, there is no explicit "training set" for an AI or machine learning model. The ground truth for the performance evaluation (test set) samples was established based on clinical diagnosis, serological history, and confirmatory laboratory tests (FTA-ABS, TPHA, VDRL).

Ask a specific question about this device