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Curian Campy, for use with the Curian Analyzer, is a rapid, qualitative fluorescent immunoassay for the detection of a Campylobacter-specific antigen in human fecal specimens. Curian Campy is intended to detect C. jejuni, C. coli, C. upsaliensis, and C. lari in human stool from patients with signs and symptoms of gastroenteritis. The test is intended for use with unpreserved fecal specimens or preserved fecal specimens in transport media. Test results are to be used in conjunction with information available from the patient clinical evaluation and other diagnostic procedures. Curian Campy is intended to aid in the diagnosis of Campylobacter infection.

The Curian® Campy assay is a qualitative in vitro diagnostic test for the detection of Campylobacter-specific antigens in human stool samples collected from individuals with signs and symptoms of gastroenteritis. Curian Campy is intended to detect C. jejuni, C. coli, C. upsaliensis, and C. lari in unpreserved or preserved stool in Cary-Blair or C&S transport media. The Curian® Campy assay utilizes fluorescence technology with the cleared Curian® Analyzer (K192817) to detect Campylobacter-specific antigens in human stool.

Here's a breakdown of the acceptance criteria and study details for the Curian Campy device, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document doesn't explicitly state "acceptance criteria" as a separate section with predefined thresholds. However, based on the presentation of clinical performance data, the implicit acceptance criteria for sensitivity and specificity are demonstrated by the confidence intervals achieved in the clinical studies. For analytical performance, 100% agreement for certain categories and no observed interference/cross-reactivity are the implicit acceptance criteria.

2. Sample Sizes Used for the Test Set and Data Provenance

• Prospective Clinical Study:
  • Sample Size: 1,474 specimens
  • Data Provenance: Prospective, collected from July 2020 to December 2020 at five clinical study sites across geographically distinct regions throughout the United States.
• Archived Clinical Study:
  • Sample Size: 290 archived samples
  • Data Provenance: Retrospective. The samples had prior culture and speciation results and were retrospectively tested.
• Contrived Study:
  • Sample Size: 210 specimens (150 positive, 60 negative).
  • Data Provenance: Contrived samples (spiked with Campylobacter species).
• Reproducibility Study:
  • Sample Size: 320 samples (160 unpreserved stool, 160 preserved stool in C&S media).
  • Data Provenance: Contrived samples, tested across three sites (one internal, two external).
• Prozone / Hook Effect Study:
  • Sample Size: 14 dilutions (n=7 for preserved, n=7 for unpreserved) tested in replicates of 5.
  • Data Provenance: Contrived samples.
• Cross-Reactivity/Microbial Interference Study:
  • Sample Size: Not explicitly stated as a number, but involves testing various bacteria, fungi, and viral strains (spiked into stool, some clinical Norovirus samples).
  • Data Provenance: Primarily contrived samples, with 5 clinical Norovirus stool specimens.
• Interfering Substances Study:
  • Sample Size: Not explicitly stated, but involves testing C. jejuni low positive contrived samples in the presence of 27 different chemical and biological substances.
  • Data Provenance: Contrived samples.
• Assay Reactivity/Inclusivity Study:
  • Sample Size: Not explicitly stated, but involves testing multiple strains of C. jejuni, C. coli, C. upsaliensis, and C. lari.
  • Data Provenance: Laboratory strains.
• Brush Bridging Study:
  • Sample Size: 53 non-pipettable clinical stool specimens (5 positive, 48 negative) from the prospective and archived clinical studies, plus a panel of contrived samples (25 at 3x LoD, 25 at 5x LoD, 25 negative).
  • Data Provenance: Clinical (from prior studies) and contrived.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications

• Ground Truth for Clinical Studies (Prospective and Archived): The ground truth was established by "standard of care Campylobacter culture and speciation" which is a laboratory method. There is no mention of human experts directly establishing the ground truth for classification of individual samples.
• Ground Truth for Contrived Studies (Reproducibility, Analytical Sensitivity, Prozone, Cross-Reactivity, Interfering Substances, Assay Reactivity): The ground truth was established by creating samples with known concentrations of organisms or by confirming the absence of organisms. This suggests laboratory verification rather than expert clinical assessment.

4. Adjudication Method for the Test Set

• Prospective Clinical Study: For specimens with discordant results between the Curian Campy assay and the reference method (culture and speciation), further evaluation was done using "FDA-cleared commercial nucleic acid amplification test (NAAT)". This acts as a form of adjudication for discordant results, though it's not a human consensus process.
• Archived Study, Contrived Studies, Analytical Performance Studies: No adjudication method is explicitly described for these studies other than the initial ground truth determination.

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

• No MRMC comparative effectiveness study was done.
• This device is an in-vitro diagnostic assay (Curian Campy) read by an automated analyzer (Curian Analyzer), not an AI assisting human readers. Therefore, the concept of "human readers improve with AI vs without AI assistance" does not apply.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done

• Yes, the performance data presented for the Curian Campy assay is standalone. The device (Curian Campy assay with the Curian Analyzer) provides a qualitative result (positive/negative) automatically. The interpretation of results is "automated by Curian Analyzer," and the clinical studies directly evaluate this automated output against a reference standard.

7. The Type of Ground Truth Used

• Clinical Studies (Prospective and Archived): The primary ground truth was culture and speciation for Campylobacter. For discordant results in the prospective study, an FDA-cleared commercial nucleic acid amplification test (NAAT) was used for further evaluation.
• Analytical Performance Studies (Reproducibility, Analytical Sensitivity, Prozone, Cross-Reactivity, Interfering Substances, Assay Reactivity, Contrived Study): The ground truth was based on known concentrations of spiked organisms or known negative samples, verified by laboratory methods.

8. The Sample Size for the Training Set

• The document does not describe algorithmic training. This device appears to be a fluorescence immunoassay interpreted by an analyzer, not a machine learning or AI algorithm that requires a separate training set. The descriptions of "analytical performance" and "clinical performance" are for evaluating the performance of the device itself, not for training an AI model.

9. How the Ground Truth for the Training Set was Established

• As there is no mention of an AI algorithm requiring a training set, this question is not applicable to the information provided.

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Sofia 2 Campylobacter FIA employs immunofluorescence for the rapid qualitative detection of a Campylobacter-specific antigen in human fecal specimens. Sofia 2 Campylobacter FIA is designed to detect C. jejuni, C. coli, C. lari and C. upsalients with signs and symptoms of gastroenteritis. The test is intended for use with preserved fecal specimens in transport media and unpreserved fecal specimens. Test results should be considered in conjunction with clinical findings and patient history.

The Sofia 2 Campylobacter FIA employs immunofluorescence technology that is used with Sofia 2 for the rapid qualitative detection of Campylobacter jejuni, Campylobacter lari, and Campylobacter upsaliensis specific antigens in fecal samples.

The patient's sample is placed in the Specimen Tube containing the Specimen Solution to dilute, making the antigenic components more accessible to the specific antibodies. An aliquot of the diluted sample is dispensed through a filter to remove particulates, making them more compatible for testing, into the Test Cassette sample well. From the sample well, the sample migrates through a test strip containing various unique chemical environments. If Campylobacter jejuni, Campylobacter coli, Campylobacter lari, or Campylobacter upsaliensis specific antigens are present, they will be bound by antibodies coupled to fluorescent microparticles that migrate through the test strip. The fluorescent microparticles containing bound proteins will be captured by antibodies at a defined location on the test strip where they are detected by Sofia 2. If Campylobacter jejuni, Campylobacter coli, Campylobacter lari, or Campylobacter upsaliensis specific antigens are not present, the fluorescent microparticles will not be trapped by the capture antibodies nor detected by Sofia 2.

The Test Cassette is placed inside of Sofia 2 for automatically timed development (WALK AWAY Mode), or pre-incubated on the bench top prior to loading into Sofia 2 (READ NOW Mode), where Sofia 2 will scan, measure, and interpret the immunofluorescent signal using method-specific algorithms. Sofia 2 will display the test results (Positive, Negative, or Invalid) on the screen.

The fluorescence signal obtained with this assay is invisible to the unaided eye. The test results can only be obtained with the proper use of Sofia 2.

The Sofia 2 Campylobacter FIA is a device for the rapid qualitative detection of Campylobacter-specific antigens. It is designed to detect C. jejuni, C. coli, C. lari, and C. upsaliensis from patients with signs and symptoms of gastroenteritis in human fecal specimens (preserved or unpreserved).

Here's an analysis of the acceptance criteria and the study data provided:

1. Table of Acceptance Criteria and Reported Device Performance

Based on the provided information, the key performance metrics are Sensitivity and Specificity from the Prospective Clinical Study.

2. Sample size used for the test set and the data provenance

• Test Set Sample Size for Clinical Study: 811 total specimens.
  • 191 fresh, neat specimens
  • 620 fresh specimens in transport media
• Data Provenance: Prospective Clinical Study (likely multi-center, though specific countries are not mentioned). All specimens were "fresh".
• Test Set Sample Size for Archived Study: 70 frozen, characterized specimens.
  • 35 culture-negative specimens preserved in transport media.
  • 35 positive specimens (11 in transport media, 24 neat fecal specimens).
• Data Provenance for Archived Study: Archived, frozen specimens, characterized at a central laboratory.

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

The document does not specify the number of experts or their qualifications for establishing the ground truth.

4. Adjudication method for the test set

• For the Prospective Clinical Study: The primary comparison was against culture and identification. For discordant specimens (Sofia Positive/Culture Negative), species-specific RT-PCR and bi-directional sequence analysis were used for confirmation. In this case, 6 discordant specimens were identified as positive for Campylobacter (3 C. jejuni, 2 C. upsaliensis, and 1 C. coli) by this additional molecular testing. This suggests a form of discordant analysis/adjudication.
• For the Archived Clinical Study: Ground truth was established by culture and further characterized by RT-PCR and bi-directional sequencing. All 35 positive specimens were confirmed by all methods, and all 35 negative specimens yielded 100% correlation with all test methods.

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

This is not applicable as the Sofia 2 Campylobacter FIA is an automated IVD device. It does not involve human readers interpreting results with or without AI assistance in the context of diagnostic imaging, for example. The Sofia 2 instrument scans, measures, and interprets the immunofluorescent signal using method-specific algorithms and displays the result.

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

Yes, the device operates in a standalone manner. The Sofia 2 instrument itself provides the final "Positive, Negative, or Invalid" result after processing the test cassette. This performance directly reflects the algorithm's output. The performance data (Sensitivity, Specificity) from the clinical studies represents this standalone performance.

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

• Prospective Clinical Study: Culture and identification was the primary reference method. For discordant results (Sofia Positive/Culture Negative), species-specific RT-PCR and bi-directional sequence analysis were used as a confirmatory ground truth.
• Archived Clinical Study: Culture for initial characterization, and further confirmed by RT-PCR and bi-directional sequencing.

8. The sample size for the training set

The document does not explicitly state the sample size used for the training set of the device's algorithms. The provided data focuses on the validation of the finalized device.

9. How the ground truth for the training set was established

The document does not provide details on how the ground truth for the training set was established. It focuses on the analytical and clinical validation of the device.

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The provided text is a 510(k) clearance letter from the FDA for a device called "CAMPYLOBACTER CHEK." This letter primarily addresses the regulatory status and marketing approval of the device, rather than the detailed technical performance data or a description of the study that proves the device meets acceptance criteria.

The information requested in the prompt, specifically regarding acceptance criteria, device performance, sample sizes for training and test sets, expert ground truth establishment, adjudication methods, MRMC studies, and detailed ground truth types, are typically found in the device's 510(k) summary or the pivotal study report, which are not included in the provided document.

Therefore,Based on the provided document, I cannot answer the questions regarding the acceptance criteria and the study that proves the device meets those criteria. The document is an FDA 510(k) clearance letter, which confirms regulatory approval but does not contain the detailed performance study information required to answer your questions. This type of information would typically be found in the 510(k) summary document or the underlying scientific study report submitted to the FDA, which is not part of this letter.

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This FDA letter is a 510(k) clearance for a device called "CAMPYLOBACTER QUIK CHEK". It confirms that the device is substantially equivalent to a legally marketed predicate device. This type of letter does not contain the detailed study information required to answer your questions.

To describe the acceptance criteria and the study that proves the device meets them, I would need access to the actual 510(k) summary, clinical study reports, or performance data submitted by Techlab, Inc. and reviewed by the FDA. The information you're asking for would typically be found in those documents, not in the clearance letter itself.

Therefore, I cannot provide the requested information based solely on the provided text.

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The CAMPYLOBACTER QUIK CHEK™ test is a rapid membrane enzyme-linked immunosorbent assay for the qualitative detection of a Campylobacter-specific antigen in human fecal specimens. The CAMPYLOBACTER QUIK CHEK™ test is designed to detect C. jejuni and C. coli from patients with signs and symptoms of gastroenteritis. The test is intended for use with preserved fecal specimens in transport media and unpreserved fecal specimens. Test results should be considered in conjunction with clinical findings and patient history.

The CAMPYLOBACTER QUIK CHEK™ test uses antibodies that recognize a Campylobacter-specific antigen in human fecal samples. The device contains a Reaction Window with two vertical lines of immobilized antibodies. The test line ("T") contains antibodies against a Campylobacter-specific antigen. The control line ("C"), contains anti-IgG antibodies. The Conjugate consists of antibodies to a Campylobacter-specific antigen coupled to horseradish peroxidase. To perform the test, a fecal specimen is added to a tube containing a mixture of Diluent and Conjugate. The diluted sample-conjugate mixture is added to the Sample Well and the device is allowed to incubate at room temperature for 15 minutes. During the incubation, the Campylobacter-specific antigens in the sample bind to the antibody-peroxidase conjugate. The antigen-antibody complexes migrate through a filter pad to a membrane where they are captured by the immobilized anti-Campylobacter antibodies in the line. The Reaction Window is subsequently washed with Wash Buffer, followed by the addition of Substrate. After a 10-minute incubation, the "T" reaction is examined visually for the appearance of a vertical blue line. A blue line indicates a positive "C" reaction, indicated by a vertical blue line, monitors/confirms that the sample and reagents were added correctly, the reagents were active at the time of performing the assay, and that the sample migrated properly through the Membrane Device. It also confirms the reactivity of the other reagents associated with the assay and that the results are valid.

The document describes the performance of the CAMPYLOBACTER QUIK CHEK™ test, a rapid membrane enzyme-linked immunosorbent assay for the qualitative detection of a Campylobacter-specific antigen in human fecal specimens.

Here's a breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for this device are implied by the reported performance relative to a "gold standard" (culture followed by further confirmation for discrepant results). While explicit numerical acceptance criteria are not stated for sensitivity and specificity in the provided text, the reported performance is presented as the device meeting the equivalency with the predicate and performing as well or better than standard culture.

Additional performance aspects that were evaluated include:

• Analytical Sensitivity (LoD): Established at various CFU/mL and CFU/test for C. jejuni and C. coli in raw fecal samples and different transport media.
• Analytical Specificity (Cross-Reactivity): No interference found with a broad panel of common intestinal organisms and viruses.
• Inclusivity: Found to be reactive with several tested strains of C. coli and C. jejuni (including C. jejuni sub-species doylei).
• Reproducibility: 100% correlation in results across different labs, technicians, and kit lots, with expected results 100% of the time.
• Prozone Effect: No prozone effect observed at high antigen concentrations.

2. Sample Size Used for the Test Set and Data Provenance

• Sample Size (Prospective Study): 1552 patients.
• Data Provenance (Prospective Study): The study was conducted at 4 independent sites. The country of origin is not explicitly stated, but the submission is to the U.S. FDA, and U.S. formulation information is mentioned for interfering substances, implying a U.S. context. The study was prospective, as it involved "Prospective incoming fecal specimens collected and tested."
• Sample Size (Retrospective Study): 30 specimens.
• Data Provenance (Retrospective Study): The data provenance (country) for the retrospective specimens is not specified. The study was retrospective.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

The ground truth for the primary clinical performance comparison (prospective study) was established by culture. While culture is a standard method, the text does not mention the number or qualifications of experts involved in performing or interpreting the initial culture results.

For the discrepant specimens (14 from the prospective study and 30 from the retrospective study), further characterization was performed using:

• An FDA-cleared commercial Microassay well EIA
• An FDA-cleared commercial molecular test
• In-house PCR (detecting the 16s rRNA gene of Campylobacter specific identification, and species-specific identification for the retrospective study)
• Bidirectional sequencing

The number of experts involved in interpreting these additional confirmatory tests or establishing a final consensus ground truth for discrepants is not specified in the document, nor are their qualifications.

4. Adjudication Method for the Test Set

For the initial 1552 prospective specimens, the comparison was directly between the CAMPYLOBACTER QUIK CHEK™ test and culture.

For the 14 discrepant specimens (culture negative/device positive, or culture positive/device negative) from the prospective study, an adjudication method was used by referring them for additional testing with multiple methods (commercial EIA, commercial molecular test, in-house PCR, bidirectional sequencing) at TECHLAB. The results of these additional tests were used to "confirm" the status of the discrepant samples. For example, 9 out of 13 culture negative/device positive samples were confirmed positive by all additional test methods. This suggests a form of consensus or comprehensive secondary testing was used to re-evaluate the true status of these discrepant cases. The specific consensus rule (e.g., majority vote, all methods agree) is not explicitly detailed.

For the 30 retrospective specimens, all were initially Campylobacter spp. culture positive and were "further characterized as Campylobacter spp. positive by an FDA-cleared commercial Microassay well EIA, an FDA-cleared commercial molecular test, in-house PCR... and bidirectional sequencing." This indicates a multi-method confirmation process for the ground truth of these samples before being tested retrospectively by the device.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done, and Effect Size

No, an MRMC comparative effectiveness study involving human readers with and without AI assistance was not done. This device is an in vitro diagnostic (IVD) assay for antigen detection, not an AI-powered image analysis or diagnostic aid for human readers. Therefore, the concept of human readers improving with AI assistance is not applicable here.

6. If a Standalone Study Was Done

Yes, a standalone study was performed ("algorithm only without human-in-the-loop performance"). The entire performance evaluation, including the prospective and retrospective studies, analytical sensitivity, specificity, inclusivity, and prozone, evaluates the performance of the CAMPYLOBACTER QUIK CHEK™ test device itself. The primary clinical performance (sensitivity and specificity) is presented for the device's ability to detect the target antigen compared to culture.

7. The Type of Ground Truth Used

The primary ground truth used for the clinical performance evaluation (prospective study) was bacterial culture.

For discrepant samples, the ground truth was further refined and confirmed by multiple orthogonal laboratory methods, including an FDA-cleared commercial Microassay well EIA, an FDA-cleared commercial molecular test, in-house PCR, and bidirectional sequencing. This can be considered a form of expert consensus derived from multiple confirmatory tests.

8. The Sample Size for the Training Set

The document does not provide information on a training set sample size. This is likely because the CAMPYLOBACTER QUIK CHEK™ test is a traditional immunoassay device, not an AI/machine learning model that typically requires a large training dataset. The studies described are for validation and performance evaluation of the manufactured device.

9. How the Ground Truth for the Training Set Was Established

As no training set is mentioned for an AI/machine learning model, this question is not applicable.

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The CAMPYLOBACTER CHEK™ test is an enzyme immunoassay for the qualitative detection of a Campylobacter-specific antigen in human fecal specimens. The CAMPYLOBACTER CHEK™ test is designed to detect C. jejuni and C. coli from patients with signs and symptoms of gastroenteritis. The test is intended for use with preserved fecal specimens in transport media and unpreserved fecal specimens. Test results should be considered in conjunction with clinical findings and patient history.

The CAMPYLOBACTER CHEK™ test uses antibodies that recognize a Campylobacter-specific antigen. The Microassay Plate in the kit contains immobilized capture monoclonal antibodies against a Campylobacter-specific antigen. The Conjugate consists of polyclonal antibodies to a Campylobacter-specific antigen conjugated to horseradish peroxidase. In the assay, an aliquot of a diluted fecal specimen is transferred to a microassay well containing the Conjugate. If the antigen is present in the specimen, it will bind to the Conjugate and to the immobilized capture antibody during the incubation phase. Any unbound material is removed during the washing steps. Following the addition of Substrate, a color is detected due to the enzyme-antibody-antigen complexes that formed in the presence of antigen.

The document describes the CAMPYLOBACTER CHEK™ test, an enzyme immunoassay for the qualitative detection of a Campylobacter-specific antigen in human fecal specimens. It is designed to detect C. jejuni and C. coli from patients with signs and symptoms of gastroenteritis.

Here's a breakdown of the acceptance criteria and study information:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state pre-defined acceptance criteria in terms of specific sensitivity and specificity thresholds. However, it presents the reported performance from a prospective clinical study, which implicitly serves as the successful demonstration of performance for clearance. The predicate device's performance is not provided in a comparative table within the document, so a direct comparison of acceptance criteria to predicate performance isn't possible from the given text.

2. Sample Size Used for the Test Set and Data Provenance

• Sample Size (Prospective Study): N = 1552 patients.
• Data Provenance: The prospective study was conducted at "4 independent sites." The country of origin is not explicitly stated, but the document refers to the "U.S. Formulation" for interfering substances testing, suggesting a U.S. context for the clinical studies. The data is prospective, meaning specimens were collected and tested over time.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

The ground truth for the prospective study was primarily established by bacterial culture.

• Number of Experts: Not specified.
• Qualifications: Since traditional bacterial culture is the method, it would implicitly involve trained laboratory technologists or microbiologists. Specific qualifications (e.g., radiologist with X years of experience) are not applicable or provided in this context as it's not an imaging device.

4. Adjudication Method for the Test Set

The primary comparison was between the CAMPYLOBACTER CHEK™ test and culture. For discrepant specimens (14 culture-negative/device-positive and 3 culture-positive/device-negative), additional testing was performed at TECHLAB.

• Adjudication Method: "The 17 discrepant specimens were further characterized by additional testing at TECHLAB. This testing included an FDA-cleared commercial Microassay well EIA, an FDA-cleared commercial molecular test, in-house PCR (detecting the 16s rRNA gene of Campylobacter specific identification), and bidirectional sequencing." This indicates a multi-method adjudication process.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

No, an MRMC comparative effectiveness study was not done. This device is an in-vitro diagnostic (IVD) assay that produces a qualitative result, not an imaging device requiring human reader interpretation in the context of improving diagnostic accuracy with AI assistance.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done

Yes, the performance reported (Sensitivity 91.4%, Specificity 99.1%) is for the CAMPYLOBACTER CHEK™ test operating as a standalone diagnostic assay. The results are read by either visual inspection or spectrophotometric means, but the performance metrics reflect the direct output of the assay compared to the reference method (culture).

7. The Type of Ground Truth Used

• Primary Ground Truth: Bacterial Culture (for the prospective study).
• Adjudication Ground Truth: For discrepant results, a combination of "FDA-cleared commercial Microassay well EIA, an FDA-cleared commercial molecular test, in-house PCR (detecting the 16s rRNA gene of Campylobacter specific identification), and bidirectional sequencing." This represents a form of expert consensus or multi-method confirmation based on established diagnostic techniques.

8. The Sample Size for the Training Set

The document describes performance studies, but it does not mention a training set in the context of an algorithm or machine learning model. This device is an enzyme immunoassay (EIA) kit, which is a laboratory test, not an AI/ML software device. Therefore, the concept of a "training set" for an algorithm is not applicable here. The development of the assay itself would have involved extensive R&D and optimization, but not in the sense of a machine learning training set.

9. How the Ground Truth for the Training Set Was Established

As noted above, the concept of a "training set" for an algorithm is not applicable to this device. Therefore, no ground truth for a training set was established in the context of AI/ML development.

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ImmunoCard STAT! CAMPY is an immunochromatographic rapid test for the qualitative detection of specific Campylobacter antigens in human stool. ImmunoCard STAT! CAMPY detects C. jejuni and C. coli in human stool, where stool may be either unpreserved or preserved in Cary-Blair-based transport media. Test results are to be used in conjunction with information available from the patient's clinical evaluation and other diagnostic procedures.

ImmunoCard STAT! CAMPY is not intended for point-of-care use. The device is intended for use in hospital, reference, regional, private or state laboratory settings.

ImmunoCard STAT! CAMPY is an immunochromatographic, rapid test for the detection of specific Campylobacter antigens in stool samples from patients with signs and symptoms of Campylobacteriosis. The assay is intended to be used by hospital and reference laboratories to test for bacterial colonization. It is used in conjunction with information obtained from the patient's clinical symptoms and with other tests to diagnose Campylobacter infection. The assay consists of ImmunoCard STAT! Test Devices (containing specific capture antibodies and colloidal gold-antibody conjugate detector antibodies), ImmunoCard STAT! CAMPY Sample Diluent/Negative Control and ImmunoCard STAT! CAMPY Positive Control.

No calibrators are used with this device.

The ImmunoCard STAT! CAMPY device is an immunochromatographic rapid test for the qualitative detection of specific Campylobacter antigens (specifically C. jejuni and C. coli) in human stool samples. Test results are intended to be used in conjunction with a patient's clinical evaluation and other diagnostic procedures within hospital, reference, regional, private, or state laboratory settings, not for point-of-care use.

1. Table of Acceptance Criteria and Reported Device Performance:

The provided document does not explicitly list predefined "acceptance criteria" for sensitivity and specificity. However, based on the clinical study results, the collective performance demonstrates acceptable diagnostic accuracy for the intended use. The table below presents the overall combined site performance:

2. Sample size used for the test set and the data provenance:

• Sample Size: A total of 421 qualified patient samples were used in the clinical trials.
• Data Provenance: The data was collected from three independent test sites located in the Midwestern and Southeastern regions of the United States. 189 of these samples were retrospective frozen samples, while the remaining were likely prospective as they were tested in an unpreserved state. Forty-nine percent of samples were collected in Cary-Blair-based transport and preservative media, and the rest were unpreserved.

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

The ground truth for the clinical test set was established using bacterial culture as the reference comparator method. The document does not specify the number of experts or their qualifications for performing and interpreting these bacterial cultures. However, bacterial culture is a standard microbiological reference method.

4. Adjudication method for the test set:

The document does not describe an explicit adjudication method (e.g., 2+1, 3+1) for the clinical test set results. The comparison was primarily made between the ImmunoCard STAT! CAMPY result and the bacterial culture result.

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:

This device is an in vitro diagnostic test (a lateral flow immunoassay) and not an AI-powered diagnostic imaging or interpretation tool. Therefore, a multi-reader multi-case (MRMC) comparative effectiveness study focusing on human reader performance improvement with or without AI assistance is not applicable to this device. The reading method is visual, indicating a positive result by a visible pink-red line and a negative result by no line.

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

The ImmunoCard STAT! CAMPY is a standalone in vitro diagnostic test that provides a visual reading (presence or absence of a line). Its performance is inherently "standalone" in the sense that the test device itself produces the result, which is then interpreted visually by a human operator. There is no algorithm involved in the interpretation process described.

7. The type of ground truth used:

The ground truth used for the clinical performance evaluation was bacterial culture.

8. The sample size for the training set:

The document does not explicitly specify a "training set" in the context of machine learning or algorithm development. For this type of in vitro diagnostic device, the development typically involves analytical studies (like analytical sensitivity, specificity, interference, cross-reactivity) and then clinical validation. The samples used for design and development (which could be considered analogous to a training set in some contexts) are not quantified here.

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

As there is no explicitly defined "training set" in the context of an algorithm, the method for establishing its ground truth is not detailed. However, for the analytical studies (e.g., analytical sensitivity), known quantities of C. jejuni or C. coli were used to spike samples, establishing a controlled and known "ground truth" for those specific tests. For cross-reactivity and interference studies, known organisms and substances were introduced to assess their impact on the device's accuracy.

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Premier™ CAMPY enzyme immunoassay (EIA) is an in vitro qualitative procedure for the detection of specific Campylobacter antigens in stool samples from patients with signs and symptoms of gastroenteritis. Premier CAMPY detects C. jejuni and C. coli in human stool that may be either unpreserved or preserved in Cary Blair-based transport media. Test results are to be used in conjunction with information obtained from the patient's clinical evaluation and other diagnostic procedures.

Premier CAMPY is intended for use in hospital, reference or state laboratory settings. The device is not intended for point-of-care use.

Premier CAMPY is an in vitro diagnostic, microwell-based enzyme-linked immunoassay for the detection of common antigens found on Campylobacter jejuni and C. coli in stool samples from patients with signs and symptoms of Campylobacteriosis. The assay is intended to be used by hospital and reference laboratories to test for bacterial colonization. It is used in conjunction with information obtained from the patient's clinical symptoms and with other tests to diagnose Campylobacter infection. The assay consists of Premier CAMPY microwells coated with specific antibodies (capture antibodies). Premier CAMPY Enzyme Conjugate, Premier CAMPY Sample Diluent/Negative Control, Premier 20X Wash Buffer III, Premier Substrate Solution I, Premier Stop Solution I and Premier CAMPY Positive Control.

No calibrators are used with this device.

Acceptance Criteria and Device Performance for Premier CAMPY

1. Table of Acceptance Criteria and Reported Device Performance

Study Proving Device Meets Acceptance Criteria:

The device's performance was established through a series of non-clinical (analytical) tests and clinical trials.

2. Sample Size Used for the Test Set and Data Provenance:

• Clinical Test Set:

  • Total Sample Size: 2073 qualified patient samples.
  • Data Provenance: Four independent test sites located in the Western, Midwestern, and Southeastern regions of the United States.
  • Retrospective/Prospective: Majority (1862/2073) were collected in a Cary Blair-based transport and preservative medium and tested prospectively (implied by "collected in a Cary Blair-based transport and preservative medium" and "The remaining 211 samples were tested in the unpreserved state"). 166 samples were explicitly stated as retrospective frozen samples.

• Non-clinical (Interference and Cross-reactivity) Test Set:

  • Interference Testing: Not specified as a patient sample size, but involved "three positive and three negative samples" inoculated with C. jejuni, tested in triplicate.
  • Cross-reactivity Study: Not specified as a patient sample size, but involved "Microorganisms that were present as normal intestinal flora or associated with gastroenteritis" tested at specific concentrations in human stool. The number of unique organisms tested was over 30.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:

The document does not explicitly state the number or qualifications of experts used to establish the ground truth for the clinical test set. The ground truth method, bacterial culture, is typically performed by trained laboratory personnel, but no specifics on expert involvement in interpreting these cultures for ground truth are provided.

4. Adjudication Method for the Test Set:

The document does not describe an adjudication method for the clinical test set. It states that "bacterial culture" was used as the "reference comparator method." This implies that the bacterial culture results were directly used as the ground truth without further expert adjudication or consensus with the Premier CAMPY results.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This device is an in vitro diagnostic (IVD) assay designed for laboratory use, not an interpretation aid for human readers. Therefore, there is no discussion of human reader improvement with or without AI assistance.

6. Standalone Performance Study:

Yes, a standalone performance study was done. The clinical performance data presented (Sensitivity and Specificity against bacterial culture) reflects the performance of the Premier CAMPY assay as an algorithm-only device, without human intervention in the result interpretation beyond what is inherent in standard laboratory EIA testing procedures (e.g., reading spectrophotometric values).

7. Type of Ground Truth Used:

For the clinical performance evaluation, the ground truth used was bacterial culture.

8. Sample Size for the Training Set:

The document does not specify a training set sample size. As an in vitro diagnostic (EIA) intended for detection of specific antigens, it's unlikely to involve machine learning models that require a distinct "training set" in the conventional sense. The "training" of such assays is defined by their manufacturing process, reagent formulation, and quality control, rather than algorithmic training on patient data.

9. How the Ground Truth for the Training Set was Established:

Since there is no explicit "training set" in the context of a machine learning algorithm, the concept of establishing ground truth for a training set does not directly apply here. The device's performance relies on its biochemical properties and how well its antibodies bind to the target antigens. The development process would involve extensive analytical validation against known positive and negative samples, but these are part of the assay's development and analytical characterization, not typically labeled as a "training set" with ground truth for algorithm learning.

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The ProSpecT® Campylobacter Microplate Assay is an in vitro microplate EIA for the qualitative detection of Campylobacter Specific Antigen in fecal specimens and broth enriched fecal cultures. ProSpecT Campylobacter Microplate Assay is intended for use as an aid in the diagnosis of Campylobacter infections.

in vitro microplate EIA for the qualitative detection of Campylobacter Specific Antigen

Based on the provided text, the document is a 510(k) clearance letter for the ProSpecT® Campylobacter Microplate Assay. It does not contain the detailed study information required to answer all aspects of your request. The letter only confirms that the device is substantially equivalent to a legally marketed predicate device.

Therefore, many of the requested details about acceptance criteria and study design are not present in this document.

However, I can extract the following:

1. A table of acceptance criteria and the reported device performance

• Acceptance Criteria: Not explicitly stated in this document. The focus of this letter is substantial equivalence to a predicate device, not a performance report against specific criteria.
• Reported Device Performance: Not detailed in this document. The letter indicates the device is cleared for "qualitative detection of Campylobacter Specific Antigen" but does not provide sensitivity, specificity, or other performance metrics.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• This information is not available in the provided document.

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)

• This information is not available in the provided document.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

• This information is not available in the provided document.

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

• This type of study is not applicable as the device is an in vitro diagnostic assay, not an AI-powered image analysis tool for human readers. This information is not available in the provided document.

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

• The device is described as a "microplate EIA," which is a lab-based assay, implying it functions in a "standalone" manner (i.e., the device itself performs the detection) rather than requiring continuous human-in-the-loop performance for each test result interpretation beyond standard laboratory procedures. However, the specific details of a "standalone performance study" in the context of your question are not provided.

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

• This information is not available in the provided document. For an in vitro diagnostic for infectious disease, typical ground truth would involve culture methods, PCR, or other established diagnostic tests.

8. The sample size for the training set

• This information is not available in the provided document. For an in-vitro diagnostic assay, the concept of a "training set" in the machine learning sense is generally not applicable in the same way. The development and validation involve different types of sample sets.

9. How the ground truth for the training set was established

• This information is not available in the provided document.

In summary, the provided FDA 510(k) clearance letter confirms the regulatory approval of the ProSpecT® Campylobacter Microplate Assay for its stated indications for use but does not delve into the detailed performance study data, acceptance criteria, or ground truth establishment methodologies that would be found in a more comprehensive clinical study report.

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