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The Hp Detect™ Stool Antigen ELISA is an in vitro diagnostic qualitative enzyme immunoassay for the detection of Helicobacter pylori (H. pylori) antigens in human stool or feces. The Hp Detect™ Stool Antigen ELISA is intended to aid in the initial diagnosis and post-therapy diagnosis of H. pylori infection. Additionally, the test may be used to assess H. pylori infection status after treatment. Retesting at a minimum of 4 weeks after the completion of treatment may be done to assess H. pylori status. Test results should always be taken into consideration by the physician in conjunction with patient's clinical information (history and symptoms). For Prescription Use Only.

The Hp Detect Stool Antigen ELISA is an enzyme immunoassay which detects the H. pylori antigen in human fecal samples. The Hp Detect Stool Antigen ELISA comes in a kit that contains materials to assay a total of 92 samples. The device consists of a 96-well clear flat bottom polystyrene high bind microplate coated with affinity purified rabbit anti-human H. pvlori polyclonal antibody. The device is provided with detection antibody which is a purified mouse monoclonal antibody specific for H. pylori antigen and has been conjugated to horseradish peroxidase (HRP). The device kit is also provided with sample diluent buffer, wash buffer, substrate solution, stop solution along with negative and positive controls. Negative control is a phosphate buffered protein solution and positive control is composed of purified H. pylori antigen (ATCC strain 43504) from cell lysate. Polyclonal anti-H. pylori captures antibodies that are immobilized on microwells. Patient samples prepared in sample diluent are added to the microwells and incubated for one hour at 37 ± 2℃. If the H. pvlori antigen is present in the sample, it will bind to the immobilized antibody on the plate. Following this incubation, the plate is washed thoroughly. A peroxidase conjugated anti-H. pylori monoclonal antibody is then added to the microwells and incubated for 30 minutes at 37 ± 2℃. If H. pylori antigen is bound to the microwells in the first step, the detection antibody would now bind in this step to form a sandwich complex. Following this incubation, a thorough wash step is performed to remove non-specific and non-binding materials. Substrate is then added and incubated for 10 minutes at 37±2℃ to generate a color in the presence of the enzyme complex. Stop solution is then added to end the reaction. The results are read spectrophotometrically at the following wavelengths: 1. Single Wavelength Measurement at 450 nm 2. Dual Wavelength Measurement 450/620 nm or 450/630 nm

The provided document is an FDA 510(k) Pre-Market Notification for the Biomerica, Inc. Hp Detect Stool Antigen ELISA for the detection of Helicobacter pylori (H. pylori) antigens in human stool or feces. It is a qualitative immunoassay intended to aid in the initial diagnosis and post-therapy diagnosis of H. pylori infection.

Based on the provided text, the device itself has acceptance criteria for its analytical performance (e.g., reproducibility, LoD, specificity, inclusivity) and clinical performance (Positive Percent Agreement - PPA, Negative Percent Agreement - NPA). The study detailed in the document serves to prove that the device meets these internal acceptance criteria set by the manufacturer for FDA clearance.

Here's a breakdown of the requested information based on the document:

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

The document does not explicitly state pre-defined acceptance criteria values in a formal table for PPA and NPA. However, it presents the achieved performance and concludes that the results are "acceptable." We can infer the implicit acceptance criteria from these reported values. For analytical performance, criteria are implied by the "acceptable" statement for reproducibility, precision, LoD, cross-reactivity, interference, and inclusivity.

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

• Clinical Study - Frozen Specimen:
  • Sample Size: 433 frozen and de-identified fecal samples.
  • Provenance:
    • 355 specimens from Italy.
    • 78 specimens from three geographically different regions of the USA (west, southwest, and southeast).
  • Nature: Retrospective (frozen, de-identified samples). Patients were presenting with dyspepsia, undergoing endoscopy/biopsy, not on certain medications, and no H. pylori treatment within 6 months.
• Clinical Study - Fresh Stool Specimen:
  • Sample Size: 142 fresh, de-identified fecal specimens.
  • Provenance: Collected through multiple biospecimen vendors and clinical laboratories. Locations not specified beyond "collection centers" and "Biomerica (internal site)."
  • Nature: Likely prospective (freshly collected and then immediately tested/shipped). Patients had symptoms of H. pylori infection.
• Post-Therapy Diagnosis:
  • Sample Size: 14 paired (pre- and post-therapy) frozen retrospective specimens.
  • Provenance: Italy.
  • Nature: Retrospective (frozen, paired samples). All subjects initially positive by CRM and completed eradication therapy. Post-therapy samples collected minimum 4 weeks after treatment.

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)

The document states that the ground truth for the clinical studies (frozen and fresh specimens) was established by comparison with an "FDA cleared device" (predicate device). For the frozen specimen study, discrepant results were further analyzed by "chart review and determined to have a RUT or history result."

For the post-therapy study, the ground truth was a "composite reference method (CRM) consisting of histology and Rapid Urease Test."

The document does not specify the number of experts or their qualifications (e.g., pathologists, gastroenterologists) involved in establishing the ground truth via histology, RUT, or chart review. It implies laboratory testing capabilities for the predicate device.

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

The document describes adjudication for discrepant results in the frozen specimen clinical study:

• Discrepant results were "further analyzed by chart review and determined to have a RUT or history result."
  This suggests a form of adjudication after the initial comparison, using additional clinical information or laboratory results (RUT or histology) as a reference. This is not a multi-reader adjudication method but rather a method for determining the "true" status of discrepant samples.

There is no mention of multi-reader adjudication for the Hp Detect Stool Antigen ELISA results themselves. The device's results are read spectrophotometrically based on defined cut-offs.

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, a multi-reader multi-case (MRMC) comparative effectiveness study was not conducted. This device is an in-vitro diagnostic (ELISA), not an AI-powered diagnostic imaging tool that would typically involve human readers and MRMC studies. The device provides a quantitative or qualitative output (positive/negative) that is read spectrophotometrically, not interpreted by human readers in the same way as medical images.

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

This refers to the performance of the device itself (the "algorithm" in this context being the ELISA assay) without human interpretation variables beyond the initial lab procedure. Yes, the performance characteristics (analytical and clinical studies) directly report the standalone performance of the Hp Detect Stool Antigen ELISA device against comparator methods or reference standards. The results (PPA, NPA, sensitivity, specificity) represent the device's accuracy in detecting H. pylori antigens.

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

The ground truth for the test sets was primarily established through:

• Comparison to an FDA cleared predicate device for the frozen and fresh specimen clinical studies.
• Composite Reference Method (CRM) consisting of histology and Rapid Urease Test (RUT) for the initial H. pylori status and post-therapy evaluation.
• Chart review combined with RUT or histology results for resolving discrepant cases in the frozen specimen study.

This is a form of "laboratory reference standard" and "clinical/pathology confirmation."

8. The sample size for the training set

The document describes the analytical and clinical performance studies, which are validation studies or test sets. It does not provide information on the sample size used for the training set of the Hp Detect Stool Antigen ELISA device. As an ELISA assay, it is a biochemical test, not a machine learning model that typically undergoes data-driven training. The "training" for such a device involves assay development, optimization, and establishment of reagents and procedures, rather than a machine learning training set of data.

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

As the Hp Detect Stool Antigen ELISA is a biochemical immunoassay (not an AI/ML device), the concept of a "training set" and establishing ground truth for it in the machine learning sense is not applicable. The "ground truth" for developing and optimizing such a device would implicitly rely on well-characterized H. pylori positive and negative samples, purified antigens, and potentially clinical samples with known infection status (established through methods like culture, PCR, histology, RUT) to guide the reagent selection, assay design, and cut-off determination. The document details the methodology for setting assay cut-off based on a panel of 227 specimens (83 positive, 144 negative by predicate device), which could be considered part of the "development" or "optimization" phase for establishing the device's operational parameters, but not a "training set" in the context of deep learning.

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The Premier HpSA Flex enzyme immunoasay (EIA) is an in vitro qualitative procedure for the detection of Helicobacter pylori antigens in human stool. The test is intended for use with unpreserved stool specimens or preserved stool specimens in transport media. Test results are intended to aid in the diagnosis of H. pylori infection and to monitor response during and post- therapy in patients. Accepted medical practice recommends that testing by any current method, to confirm eradication, be done at least four weeks following completion of therapy.

Meridian Bioscience has modified its FDA-cleared PREMIER Platinum HpSA® PLUS assay (K182559), a qualitative, in vitro diagnostic test for the detection of Helicobacter pylori antigens present in unpreserved human stool specimens. This modification, to be marketed under new device trade name Premier HpSA® Flex upon FDA clearance, is the addition of a new specimen type claim to the intended use of the previously cleared device (K182559) whereby specimens may be preserved in Cary-Blair or Culture and Sensitivity (C&S) transport media.

The Premier HpSA Flex test is a microwell-based enzyme immunoassay that detects H. pylori antigens present in human stool specimens, either unpreserved in transport media. The test uilizes a plurality (mixture) of monoclonal anti-H. pylori capture antibodies adsorbed to microwells. Diluted patient samples and an enzyme conjugate reagent are added to the microwells and incubated for one hour at room temperature. A wash is performed to remove unbound material. Substrate is added and incubated for 10 minutes at room temperature. Color develops in the presence of bound enzyme. Stop solution is added and the results are interpreted visually or spectrophotometrically.

Here's a breakdown of the acceptance criteria and study that proves the device meets them, based on the provided text.

Acceptance Criteria and Device Performance

The core of this submission is about adding a new specimen type claim (preserved stool in Cary-Blair or C&S transport media) to an already FDA-cleared device. Therefore, the "acceptance criteria" revolve around demonstrating that the device performs equivalently with these new specimen types as it did with the original unpreserved stool and that the performance remains robust.

Here's a summary of the performance characteristics presented as implicit acceptance criteria and the reported device performance:

Study Details

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

   • Analytical Sensitivity (LoD): Not explicitly stated how many samples per lot were used in the LoD study, but it mentions "Three lots" and "positive results >= 95% of the time."
   • Precision/Reproducibility: 360 samples (10 panels x 12 blinded samples x 3 laboratories). The samples were "contrived stool samples" with H. pylori antigen spiked in. Data provenance is implied to be domestic (USA) due to the submission context, and it's a prospective study looking at controlled, contrived samples.
   • Preserved Specimen Storage Stability: Not explicitly stated how many samples were used, but the study was designed to validate stability claims.
   • Freeze/Thaw Stability: Not explicitly stated how many samples were used.
   • Analytical Specificity/Interference: Not explicitly stated how many samples were used, but testing was performed in the presence of various substances.
   • Analytical Specificity/Cross-reactivity: Not explicitly stated how many samples were used, but each organism was tested with a true negative and a contrived low positive sample at specified concentrations.
   • Method Comparison (Clinical Performance): 200 archived stool specimens were enrolled, of which 182 were evaluable and used for the comparison. Data provenance is of archived specimens from patients, suggesting retrospective data. The specific country of origin is not mentioned.

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

   • This device is an in-vitro diagnostic (IVD) for detecting antigens, not an imaging device requiring expert interpretation for ground truth.
   • For the Precision/Reproducibility study, "expected assay result" was used as ground truth for contrived samples. This implies the ground truth was based on the known concentration of spiked antigen.
   • For the Method Comparison study, the comparison was against an "FDA-cleared comparator device" and "Standard of Care (SoC) testing using an FDA-cleared commercial assay." The "ground truth" for clinical performance appears to be established by the results of these existing FDA-cleared methods. No human expert consensus was used to define the ground truth for individual samples.

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

   • No human adjudication method was mentioned or implied, as the device is an IVD detecting antigens, and ground truth was established either by known concentrations in contrived samples or by results from existing FDA-cleared assays.

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 MRMC comparative effectiveness study was conducted. This type of study is typically performed for AI-assisted diagnostic imaging devices where human interpretation directly impacts results. This device is an immunoassay (IVD).

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

   • Yes, the performance data provided (LoD, Reproducibility, Interference, Cross-reactivity, Method Comparison) represent the standalone performance of the Premier HpSA Flex assay. It's an automated or semi-automated EIA, not an algorithm requiring human interaction for its direct output.

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

   • For analytical performance studies (LoD, Precision, Interference, Cross-Reactivity), the ground truth was known concentrations of H. pylori antigen in contrived samples or known presence/absence of interfering/cross-reacting substances/organisms.
   • For the method comparison (clinical performance), the ground truth was established by results from an FDA-cleared comparator device and Standard of Care (SoC) testing using an FDA-cleared commercial assay.

7. The sample size for the training set:

   • This is a traditional in-vitro diagnostic device (immunoassay), not a machine learning/AI algorithm that requires a "training set" in the conventional sense. The device's components and parameters are developed through standard chemistry and assay development processes, not through iterative training on a dataset.

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

   • As stated above, there is no "training set" for an immunoassay in the context of AI/ML. The "ground truth" for the development of the assay itself would align with standard analytical validation methods, ensuring the assay accurately detects the target analyte (H. pylori antigens) at various concentrations and in the presence of relevant interferents, against known standards.

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Curian HpSA, for use with the Curian Analyzer, is a rapid, qualitative, fluorescent immunoassay for the detection of Helicobacter pylori antigen in human stool. Test results are intended to aid in the diagnosis of H, pylori infection and to demonstrate loss of H. pyloriantigen following treatment. Accepted medical practice recommends that testing by any current method, to confirm eradication, be done at least following completion of therapy. Test results should be taken into consideration by the physician in conjunction with the patient history and symptoms.

The Curian™ HpSA® assay is a qualitative in vitro diagnostic test for the detection of Helicobacter pylori in human stool. The Curian™ HpSA® assay utilizes fluorescence technology with the newly developed Curian™ Analyzer to detect H. pylori antigen. The Curian™ Analyzer has been designed to disposition sample results from lateral flow immunoassays.

Here's a breakdown of the acceptance criteria and study information for the Curian™ HpSA® and Curian™ Analyzer, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are implied by the clinical performance study aiming for substantial equivalence to an FDA-cleared predicate device. The predicate device had a demonstrated sensitivity and specificity ≥ 95%, with a lower bound of the two-sided 95% confidence interval (CI) greater than 89% against a composite reference method. Therefore, the new device's agreement with this predicate is the key performance metric assessed.

2. Sample Sizes and Data Provenance

• Test Set Sample Size: 542 evaluable specimens.
• Data Provenance: The specimens were from the intended use population, collected in a multi-center method comparison study conducted at three sites in the USA. The study appears to be prospective in nature, as it "evaluated" the device for detecting H. pylori stool antigen in human stool.

3. Number of Experts and Qualifications for Ground Truth (Test Set)

This information is not explicitly provided in the document for the test set. The clinical study compares the new device to an "FDA-cleared H. pylori stool antigen EIA" which was itself previously evaluated against a composite reference method. The document does not describe the establishment of the ground truth for this specific study's test set, nor the number or qualifications of experts involved in that.

4. Adjudication Method (Test Set)

The primary comparison is between the new device and an FDA-cleared comparator EIA. However, in cases of discordance, PCR was used for adjudication:

• "2/3 Curian HpSA false negatives were dispositioned as negative by PCR"
• "8/14 Curian HpSA false positives were dispositioned as positive by PCR"

This suggests a form of supplementary adjudication using a molecular method for discordant results between the new device and the comparator EIA.

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

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This document describes the performance of a diagnostic assay (Curian™ HpSA®) in a standalone clinical comparison against another assay, not the improvement of human readers with AI assistance.

6. Standalone Performance

Yes, a standalone performance study was done. The document explicitly describes the "Comparison of Curian™ HpSA® assay to an FDA-cleared H. pylori Stool Antigen EIA" focusing on the device's accuracy in detecting H. pylori antigen in human stool samples. The device itself (the Curian™ Analyzer) interprets the results from the lateral flow immunoassay.

7. Type of Ground Truth Used (Test Set)

The "ground truth" for the current study is effectively the results from an FDA-cleared H. pylori stool antigen EIA. This predicate EIA was, in turn, previously established against a "composite reference method (i.e., culture, histology, and RUT) for initial H. pylori diagnosis." So, indirectly, the ultimate ground truth is a composite reference method.

8. Sample Size for Training Set

The document does not provide information on the sample size used for the training set. This is an in vitro diagnostic device, and details about its internal algorithm training (if any is applicable beyond general assay development) are not disclosed in this 510(k) summary.

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

The document does not provide information on how the ground truth for the training set was established, as details about training sets are not included in this summary.

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Vstrip® H.pylori Antigen Rapid Test is a single use immunochromatographic assay for the qualitative detection of H. pylori antigen in unpreserved human stool specimens. Test results are intended to aid in the initial diagnosis and treatment of H. pylori infection. Test results should be taken into consideration by the physician in conjunction with the patient history and symptoms.

The Vstrip® H.pylori Antigen Rapid Test (Vstrip®) is a Helicobacter pylori (H. pylori) antigen rapid test. It is a lateral flow immunochromatographic assay which employs antibody-coated latex beads to detect H. pylori antigens in stool specimens from patients suspected of H. pylori infection. This test is an in vitro diagnostic device to be used for the qualitative detection of H. pylori antigen in human stool samples, and test results are intended to aid in the diagnosis and treatment of H. pylori infection. This test utilizes a pair of H. pylori-specific monoclonal antibodies that are capable of detecting H.pylori antigens in human stool. The assay kit includes a foil pouch containing test cassette which houses a strip incorporated with a pair of H. pylori-specific monoclonal antibodies, sample preparation tubes that contain sample diluent buffer for dilution of stool sampler tool attached to the underside of the tube cap and a dispenser tool attached to the top of the tube, positive control reagent containing inactivated H.pylori, and the package insert and instructions. Each diagnostic strip is enclosed in a plastic frame with a window to display the results. To perform the test, a diluted stool sample which is first prepared by a sample preparation tube is added to the Test Cassette. If the sample contains H.pylori antigen, a pink-red test to the letter T) along with a blue control line (next to the letter C) will be visible in the rectangle "Result Window", as depicted in Figure 1. A blue control line is a line to show that adequate flow of the sample has occurred and active components have been employed during a test run. The presence of the blue line at the control position on the device confirms that the device is working properly. If H. pylori antigen is absent or below the level of detection, no pink-red line will appear in the rectangle "Result Window" of the cassette next to the letter T, but a distinct blue line shows next to the letter C, as depicted in Figure 1. For invalid result, no visible blue line in the rectangle "Result Window" of the cassette next to the letter C, with or without a visually detectable pink-red line, as depicted in Figure 1. It may occur with the deteriorated materials, but an excess of stool sample and incorrect procedure is mostly the main reason for control line failure. When an invalid result appears, review the test procedure and re- test same specimen. If the test fails again, repeat the test with different specimens. If the problem persists, the use of concerned test kit lot should be discontinued.

Here's a breakdown of the acceptance criteria and the study proving the device meets them, based on the provided text:

Device: Vstrip® H.pylori Antigen Rapid Test
Indication for Use: Single use immunochromatographic assay for the qualitative detection of H. pylori antigen in unpreserved human stool specimens. Test results are intended to aid in the initial diagnosis and treatment of H. pylori infection.

1. Table of Acceptance Criteria and Reported Device Performance

The core performance evaluation for the device relies on a "Comparison Study" against an FDA-cleared H. pylori stool antigen ELISA. The acceptance criteria for this study are specified in the last paragraph of the "Comparison Study" section: "The study acceptance criteria were met." While the specific numerical targets for the acceptance criteria aren't explicitly stated in a standalone table, they are implied by the performance of the comparator ELISA, which was previously evaluated with "a demonstrated sensitivity and specificity greater than or equal to 95% and a lower bound of the two-sided 95% confidence interval (CI) greater than 89%." The Vstrip device's performance is then reported against these implied criteria.

Other performance studies with implied acceptance criteria:

• Moderate positive: 97.8% (88/90)
• Low positive: 97.8% (88/90)
• High negative: 98.9% (89/90)
• True negative: 100% (90/90) |
  | Analytical Sensitivity (LOD) | A defined Limit of Detection (LOD) for the strains tested. | LOD for ATCC 43504: 8.5 x 10^5 CFU/mL
  LOD for ATCC 51653: 1.9 x 10^5 CFU/mL |
  | Inclusivity | Positive results for additional H. pylori strains. | ATCC700392: 3.8 x 10^5 CFU/mL (positive at least 95% of the time)
  ATCC 51110: 1.9 x 10^5 CFU/mL (positive at least 95% of the time)
  BCRC 17132: 3.8 x 10^6 CFU/mL (positive at least 95% of the time) |
  | Analytical Specificity (Cross-reactivity) | No false positive or false negative results with non-target microorganisms. | None of the microorganisms tested produced false positive or false negative results. (Tested 37 bacteria, 7 virus types) |
  | Interfering Substances | No interference with assay results from common medications or endogenous substances. | None of the substances with the indicated concentrations interfered with the performance. (Tested 15 potentially interfering substances) |
  | Sample Stability | Established stability parameters for storage and freeze/thaw cycles. | Stool samples can be stored:
• Up to 7 days refrigerated at 2-8°C
• Up to 20 days frozen at -20°C
  Samples can undergo up to three freeze/thaw cycles. |
  | Dose-Hook Effect (Prozone) | No negative affects on performance at high antigen concentrations. | No dose hook effect was observed at the tested concentrations (10^5 - 10^8 CFU/mL, 10-100X LoD for 5 H. pylori strains). |

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

• Sample Size for Comparison Study (Test Set): A total of 333 fresh fecal specimens.

  • Provenanc_e: 150 fresh fecal samples collected in the USA and 183 fresh fecal samples collected in Taiwan. The study was prospective as samples were collected for the study from the intended use population.

• Sample Size for Reproducibility Study: 5 panels of 12 frozen fecal samples each, analyzed over 5 days by multiple operators at multiple laboratories. This means 5 panels * 12 samples/panel * 5 days = 300 samples per operator for the agreement calculation, and 90 replicates per panel member (5 panels * 18 replicates/panel, with 3 sites * 2 operators * 3 replicates). The specific breakdown for 90 replicates is 3 sites * 2 operators * 5 days * 3 replicates, suggesting a total of 90 replicates per panel member.

• Sample Size for Analytical Sensitivity (LOD): Each dilution was tested 10 times by four operators (a total of 40 replicates).

• Sample Size for Inclusivity: Not explicitly stated, but implies sufficient testing to achieve 95% positive results.

• Sample Size for Analytical Specificity: Each condition was run in triplicate. (37 bacteria and 7 virus types).

• Sample Size for Interfering Substances: Both positive and negative samples tested in triplicate for each of the 15 substances.

• Sample Size for Dose-Hook Effect Study: Five H. pylori strains were tested in triplicate at various concentrations.

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

The ground truth for the comparison study was established by an FDA cleared H. pylori stool antigen ELISA that had been previously evaluated relative to an endoscopy biopsy composite reference method. Therefore, no human experts were involved in establishing the ground truth for this device's test set directly. The ground truth for the comparator ELISA itself was established via a composite reference method (culture, histology, and RUT), which would typically involve expert interpretation (e.g., pathologists for histology, microbiologists for culture/RUT), but the focus of this 510(k) is the Vstrip device's performance against the cleared ELISA, not the ELISA's performance against the composite reference.

4. Adjudication Method for the Test Set

Since the ground truth for the comparison study was established by a single, previously validated ELISA, there was no adjudication method described for the Vstrip device's test set. The Vstrip results were simply compared to the ELISA results.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and 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 a rapid diagnostic test (qualitative immunoassay) and is not intended to be "read" by human readers in the same way an imaging AI study is. The result (presence/absence of line) is a direct output of the device, not an interpretation of a complex image. Therefore, there's no concept of human readers improving with AI assistance in this context.

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

This device is essentially a standalone test in its performance evaluation. The "reading" of the test (presence of lines) is visual and straightforward, not involving a complex "human-in-the-loop" interpretation process like an imaging algorithm. The "reported device performance" directly reflects the algorithm's (immunoassay's) output. The comparison study evaluates the device's agreement with a reference method, which is a standalone performance assessment.

7. The Type of Ground Truth Used

The primary ground truth for the device's performance evaluation was an FDA cleared H. pylori stool antigen ELISA. This ELISA, in turn, had its ground truth established previously by a composite reference method (culture, histology, and RUT). So, indirectly, the ground truth traces back to a combination of laboratory and pathology results.

8. The Sample Size for the Training Set

The provided text does not mention a training set or machine learning model. The Vstrip H.pylori Antigen Rapid Test is an immunochromatographic assay, a biochemistry-based diagnostic test, not an AI or machine learning algorithm. Therefore, the concept of a "training set" in the context of machine learning doesn't apply. The development of such a device involves biochemical optimization rather than data-driven model training.

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

As there is no training set for this type of device (immunoassay), this question is not applicable. The development of the device likely involved extensive research and development to select appropriate antibodies and optimize the assay chemistry to achieve specificity and sensitivity to H. pylori antigens.

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The PREMIER Platinum HpSA PLUS enzyme immunoassay (EIA) is an in vitro qualitative procedure for the detection of Helicobacter pylori antigens in human stool. Test results are intended to aid in the diagnosis of H. pylori infection and to monitor response during and post-therapy in patients. Accepted medical practice recommends that testing by any current method, to confirm eradication, be done at least four weeks following completion of therapy.

The PREMIER Platinum HpSA® PLUS test is a microwell-based enzyme immunoassay that detects H. pylori antigens present in human stool. The test utilizes a plurality (mixture) of monoclonal antibodies adsorbed to microwells. Diluted patient samples and an enzyme conjugate reagent are added to the microwells and incubated for one hour at room temperature. A wash is performed to remove unbound material. Substrate is added and incubated for 10 minutes at room temperature. Color develops in the presence of bound enzyme. Stop solution is added and the results are interpreted visually or spectrophotometrically. No calculations are required and the visual color change makes the interpretation of results objective and simple.

In addition, the HpSA test permits assessment of established or novel anti-H. pylori treatment during and posttherapy to monitor for treatment effectiveness, relapse or eradication.

PREMIER Platinum HpSA PLUS (K053335), as the predicate device for this submission, was a modification of PREMIER Platinum HpSA (K983255, K980076) that provided increased signal strengths with positive test results and better discrimination between low positive and negative tests. This submission is for modifications to the antibodies used in the microwells and conjugate reagent.

The PREMIER Platinum HpSA PLUS assay is an in vitro qualitative procedure for the detection of Helicobacter pylori antigens in human stool, intended to aid in the diagnosis of H. pylori infection and to monitor response during and post-therapy.

Here's the breakdown of the acceptance criteria and study proving the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance

The modification being assessed is to the antibodies used in the microwells and conjugate reagent of the PREMIER Platinum HpSA® PLUS. The relevant performance characteristics for comparison are based on the predicate device.

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

• Sample Size for Clinical Study: 159 archived, unpreserved stool samples.
• Data Provenance: The samples were from symptomatic patients but no country of origin is specified. The samples were "archived," indicating a retrospective study.

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

The documentation does not provide details on the number or qualifications of experts used to establish the ground truth for this specific clinical study comparing the modified device to the predicate. The "ground truth" for this comparison was the result obtained from the predicate device itself.

4. Adjudication Method for the Test Set

Not applicable. The study involved a direct comparison of the modified device's results against the predicate device's results. There was no independent adjudication of individual cases against an external ground truth in the traditional sense, as the predicate served as the reference.

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

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not performed. This device is an in-vitro diagnostic (EIA) test for detecting antigens, not an imaging or diagnostic aid that involves human readers interpreting results in a variable manner. The interpretation of results is visual or spectrophotometric, implying a more objective, less reader-dependent outcome.

6. Standalone Performance Study

Yes, a standalone performance of the modified device was effectively demonstrated by comparing its results against the predicate device on the same set of samples. The performance metrics (sensitivity, specificity, reproducibility, analytical sensitivity, cross-reactivity, interfering substances) are all measures of the algorithm's (or device's) standalone performance under specified conditions.

7. Type of Ground Truth Used

For the clinical study, the ground truth was established by the predicate device (PREMIER Platinum HpSA® PLUS K053335). The study aimed to demonstrate substantial equivalence by showing agreement between the modified device and the predicate. For analytical studies, the ground truth was based on controlled experimental conditions (e.g., known concentrations of H. pylori protein for LoD, known presence/absence of microorganisms for cross-reactivity, known interfering substances).

8. Sample Size for the Training Set

The document does not specify a separate "training set" sample size. The PREMIER Platinum HpSA PLUS is an enzyme immunoassay, implying a deterministic chemical reaction, not a machine learning algorithm that requires a separate training phase. The development of the device would involve optimization and internal testing, which might be analogous to model training, but these details are not provided in terms of sample size or methodology.

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

As noted above, there's no mention of a traditional "training set" in the context of an EIA device. The "ground truth" during initial development and optimization would have been established through controlled experiments using known concentrations of H. pylori antigens and various other substances (cross-reactants, interferents) to characterize the assay's performance and specificity. This would involve laboratory standards and analytical methods to confirm the composition of samples.

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The LIAISON® Helicobacter Antigen assay is a chemiluminescent immunoassay (CLIA) intended for the qualitative determination of Helicobacter pylori (H. pylori) antigen in human stool. The test is an aid in the diagnosis of patients suspected of H. pylori infection and to measure post therapy response from patients who have discontinued therapy for at least 4 weeks. Assay results should be used in conjunction with other clinical and laboratory data to assist the clinician in making individual patient management decisions.

The test must be performed on the LIAISON® XL Analyzer.

The LIAISON® Helicobacter Antigen Control Set is intended for use as assayed quality control samples to monitor the performance of the LIAISON® Helicobacter Antigen assay.

The performance characteristics of the LIAISON® Helicobacter Antigen Control Set have not been established for any other assay or instrument platforms different from the LIAISON® XL.

The LIAISON® Helicobacter Antigen assay is a delayed one-step sandwich assay for detection of H. pylori stool antigen. H. pylori antigen is first extracted from human stool samples with sample diluent using the LIAISON® Stool Extraction Device.

The assay uses a monoclonal antibody for detection of H. pylori stool antigen. The assay uses 200 µL of sample consisting of a mixture of extraction buffer and stool extracted H. pylori stool antigen which is incubated with paramagnetic particles coated with a capture antibody for H. pylori stool antigen. Following incubation, an isoluminol conjugated antibody for H. pylori stool antigen is added to the reaction and incubated. After the second incubation, the unbound material is removed with a wash cycle. The starter reagents are then added and a flash chemiluminescent reaction is initiated. The light signal is measured by a photomultiplier as relative light units (RLU) and is proportional to the concentration of H. pylori stool antigen present in the calibrators, controls or samples.

All assay steps and incubations are performed by the LIAISON® XL Analyzer.

Here's an analysis of the provided text, focusing on the acceptance criteria and the study details:

Device Name: LIAISON® Helicobacter Antigen

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state pre-defined acceptance criteria in terms of numerical thresholds for sensitivity and specificity. Instead, it presents the achieved performance in clinical studies. We can infer the "accepted performance" to be the results obtained in these studies, which are then deemed sufficient for substantial equivalence.

Further Performance Data (Precision/Reproducibility):

The precision studies (12-Day and 5-Day) show low percent coefficients of variation (%CV) for various samples and controls, indicating good reproducibility. This data supports the reliability of the device but doesn't have a direct "acceptance criteria" table in the manner of specificity/sensitivity.

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

• Pre-Therapy Population Test Set: 277 subjects (specimens)
• Post-Therapy Population Test Set: 8 subjects (specimens)
• Data Provenance:
  • Country of Origin: Both within the US and outside the US (OUS). The specific countries OUS are not detailed.
  • Retrospective or Prospective: Prospective study. Samples were collected from subjects undergoing evaluation for H. pylori infection.

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

The ground truth was established using a "Composite Reference Method (CRM)" which comprised at least two of the three methods:

• Histological Evaluation
• Culture of the Organism
• Urease Detection Test

The document does not specify:

• The number of experts involved in performing or interpreting these CRM methods.
• The qualifications of those experts (e.g., specific medical specialization, years of experience).

4. Adjudication Method for the Test Set

The document describes the ground truth as a "Composite Reference Method (CRM)" using at least two of three methods. It does not explicitly detail an adjudication method (e.g., 2+1, 3+1 consensus) if there were discrepancies between the CRM components. It implies that the CRM itself served as the definitive diagnosis.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size of AI Improvement

No, an MRMC comparative effectiveness study involving human readers and AI assistance was not performed. This device is an in-vitro diagnostic (IVD) assay designed for standalone performance, not for aiding human interpretation of complex images or data in an MRMC setting.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study Was Done

Yes, the clinical performance study directly assesses the standalone performance of the LIAISON® Helicobacter Antigen assay. The results (sensitivity and specificity) are for the device itself, against the Composite Reference Method, without human interpretation as a variable or as an aid to the device. The device is a "chemiluminescent immunoassay (CLIA)" performed on an automated analyzer (LIAISON® XL Analyzer).

7. The Type of Ground Truth Used

The ground truth used was a Composite Reference Method (CRM), consisting of at least two of the following:

• Histological Evaluation
• Culture of the Organism
• Urease Detection Test

This is a robust method often used in IVD studies to establish infection status. It directly assesses the presence of the pathogen by different laboratory techniques.

8. The Sample Size for the Training Set

The document does not mention a specific training set size or methodology. Given that this is an IVD assay, the development process would involve internal optimization and validation, but the reported performance data focuses on a distinct test set (prospective clinical study) to demonstrate performance against a reference standard. There isn't an "algorithm training set" in the sense of AI/machine learning models that typically require large, curated training datasets for model development.

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

As no specific "training set" with separate ground truth establishment is described for an algorithm, this question is not directly applicable in the context of this device's submission. The development and internal validation of the assay (e.g., establishing optimal antibody concentrations, reaction times, cutoff values) would have occurred prior to the clinical performance studies, likely using characterized samples, but details of this are not part of the regulatory submission description for a training set.

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The TECHLAB H. PYLORI CHEK™ test is an enzyme immunoassay for the qualitative detection of Helicobacter pylori specific antigen. It is intended for use with human fecal specimens to aid in the diagnosis of H. pylori infection and to demonstrate loss of H. pylori antigen following treatment. The test can be used with unpreserved fecal specimens and fecal specimens preserved in transport media from patients suspected of H. pylori infection. Testing of patients to demonstrate loss of H. pylori antigen following treatment should be performed no sooner than 4 weeks after completion of the treatment regimen. Test results should be taken into consician in conjunction with the patient history and symptoms.

The H. PYLORI CHEK™ test uses antibodies specific to H. pylori antigen. The Microassay Plate in the kit contains immobilized capture antibodies aqainst H. pylori antigen. The Conjugate consists of antibodies specific to H, pylori antigen conjucated 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 Coniugate 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.

Acceptance Criteria and Study for H. PYLORI CHEK™ Test

This document describes the acceptance criteria for the H. PYLORI CHEK™ test, an enzyme immunoassay for the qualitative detection of Helicobacter pylori specific antigen in human fecal specimens, and the studies performed to demonstrate that the device meets these criteria.

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size and Data Provenance for Test Sets

• Initial Diagnosis: 109 patients. The data was collected prospectively from patients undergoing endoscopy as part of routine care at 6 independent sites. The country of origin is not explicitly stated but is implicitly within the US given the FDA submission.
• Post-Therapy: 9 samples from patients being tested post-therapy. Data provenance is similar to the initial diagnosis group (prospectively collected, unclear country of origin but likely US).
• Retrospective Sample Study: 196 samples (75 positive, 121 negative by comparison ELISA). The provenance is "retrospective," and the country of origin is not specified but commonly implies US labs for FDA submissions unless otherwise noted.

3. Number of Experts and Qualifications for Ground Truth in Test Set

The document does not explicitly state the number of experts or their specific qualifications (e.g., years of experience as a radiologist) for establishing the ground truth.

For the Initial Diagnosis and Post-Therapy studies, the ground truth was established by a Composite Reference Method (CRM). This CRM consisted of:
* Rapid urease testing of biopsy samples.
* Histology of biopsy samples.

For the Retrospective Sample Study, the ground truth was an FDA cleared commercial ELISA.

4. Adjudication Method for the Test Set

The adjudication method for establishing the ground truth based on the Composite Reference Method (CRM) (rapid urease and histology) is not explicitly described. It is implied that a consensus or predefined rule was used to combine these two methods to determine the CRM positive or negative status. No adjudication by human readers for the device under evaluation is mentioned for this standalone performance study.

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

No Multi-Reader Multi-Case (MRMC) comparative effectiveness study was mentioned or performed. This study focuses on the standalone performance of the diagnostic test.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

Yes, a standalone performance study was conducted. The performance data for the H. PYLORI CHEK™ test (e.g., sensitivity, specificity, agreement) are reported as the performance of the device without human interpretation (other than reading the device output). While visual reading of plates was also mentioned (achieving 99% agreement with spectrophotometric results), the primary reported performance metrics are based on the more objective dual wavelength spectrophotometric analysis.

7. Type of Ground Truth Used

The type of ground truth used was:

• Composite Reference Method (CRM): For the initial diagnosis and post-therapy studies, which combined rapid urease and histology from biopsy samples. This is considered a high-standard clinical ground truth.
• FDA cleared commercial ELISA: For the retrospective sample study, representing a comparative method ground truth.

8. Sample Size for the Training Set

The document does not provide information about a separate training set or its sample size. This type of device (enzyme immunoassay) typically does not involve a "training set" in the same way machine learning algorithms do. Instead, it relies on extensive analytical validation and clinical performance studies to establish its effectiveness.

9. How Ground Truth for the Training Set Was Established

As no explicit training set for an AI/ML algorithm is mentioned, there is no information provided on how ground truth for a training set would have been established. The development of this immunoassay would involve internal R&D and validation, but these stages are distinct from the "training set" concept in AI/ML.

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The TECHLAB® H. PYLORI QUIK CHEK™ test is a rapid membrane enzyme immunoassay for the qualitative detection of Helicobacter pylori specific antigen in a single use cassette. It is intended for use with human fecal specimens to aid in the diagnosis of H. pylori infection and to demonstrate loss of H. pylori antigen following treatment. The test can be used with unpreserved fecal specimens and fecal specimens preserved in transport media from patients suspected of H. pylori infection. Testing of patients to demonstrate loss of H. pylori antigen following treatment should be performed no sooner than 4 weeks after completion of the treatment regimen. Test results should be taken into consideration by the physician in conjunction with the patient history and symptoms.

The H. PYLORI QUIK CHEK™ test utilizes antibodies specific for H. pylori antigen. The Membrane Device contains a Reaction Window with two vertical lines of immobilized antibodies. The test line ("T") contains antibodies specific for H, pylori antigen. The ("C") contains antibodies to horseradish peroxidase (HRP). The Conjugate consists of antibodies to H. pylori antigen coupled to horseradish peroxidase. To perform the test, the sample 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, any H. pylori antigen in the sample binds to the antibody-peroxidase conjugate. The antigen-antibody-peroxidase complexes migrate through a filter pad to a membrane where they are captured by the immobilized anti-H. pylori antigen antibodies in the test line. The Reaction Window is subsequently washed with Wash Buffer, followed by the addition of Substrate. After a 10-minute incubation period, the Reaction Window is examined visually for the appearance of vertical blue lines on the "C" and "T" sides of the Reaction Window. A blue line on the "T" side of the Reaction Window indicates a positive result. A positive "C" reaction, indicated by a vertical blue line on the "C" side of the Reaction Window, 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.

Here's an analysis of the acceptance criteria and study data for the H. PYLORI QUIK CHEK™ device:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are not explicitly stated as distinct numerical targets (e.g., "sensitivity must be >90%"). Instead, the document presents the performance data and implies these values are acceptable for demonstrating substantial equivalence. The key performance metrics are Sensitivity and Specificity compared to a Composite Reference Method (CRM) for initial diagnosis, and Sensitivity for post-therapy. Also included are agreement rates from a retrospective study against an FDA-cleared ELISA, and analytical sensitivity (Limit of Detection).

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

• Initial Diagnosis & Post-Therapy Study:

  • Sample Size: 122 patients for initial diagnosis, 9 samples for post-therapy.
  • Data Provenance: The study was conducted at 6 independent sites. It involved patients "undergoing endoscopy as part of routine care," suggesting prospective enrollment of clinical samples. The country of origin is not explicitly stated, but given the FDA submission, it is likely the US.

• Retrospective Sample Study:

  • Sample Size: 200 samples (94 positive and 106 negative by the commercial ELISA).
  • Data Provenance: Retrospective study. Country of origin not specified.

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

• Initial Diagnosis & Post-Therapy Study:

  • Number of Experts: Not specified.
  • Qualifications of Experts: Not specified. The ground truth was a Composite Reference Method (CRM) consisting of "rapid urease and histology of the biopsy samples." These methods are typically performed and interpreted by pathologists and gastroenterologists/endoscopists, but the specific number or qualifications of individuals involved in the CRM determination are not detailed.

• Retrospective Sample Study:

  • Number of Experts: Not applicable, as ground truth was established by an "FDA cleared commercial ELISA."
  • Qualifications of Experts: Not applicable.

4. Adjudication Method for the Test Set

• Initial Diagnosis & Post-Therapy Study: The document states "A composite reference method (CRM) comparison was used in the evaluation consisting of rapid urease and histology of the biopsy samples." This implies a combined clinical assessment, but the specific adjudication method (e.g., how discrepancies between rapid urease and histology were resolved, or if multiple readings were combined) is not detailed.
• Retrospective Sample Study: Adjudication was not involved as the comparison was against a single FDA-cleared commercial ELISA. PCR was used to further investigate discordant results, but this was for understanding discrepancies, not for establishing initial ground truth.

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

• No, an MRMC comparative effectiveness study was not done. This study focuses on the standalone performance of the device compared to a reference method, not on how human readers' performance improves with or without the device. The H. PYLORI QUIK CHEK™ is a laboratory test, not an AI-assisted diagnostic tool for human interpretation.

6. Standalone Performance Study

• Yes, a standalone performance study was done. The entire clinical performance section (Initial Diagnosis, Post-Therapy) and the retrospective sample study describe the performance of the H. PYLORI QUIK CHEK™ test on its own, producing a qualitative (positive/negative) result, against an established ground truth or cleared predicate device. This is the standalone performance of the algorithm/device.

7. Type of Ground Truth Used

• Initial Diagnosis & Post-Therapy Study: Composite Reference Method (CRM) consisting of rapid urease and histology of biopsy samples.
• Retrospective Sample Study: An FDA cleared commercial ELISA. Discordant results were further investigated using H. pylori DNA amplification with PCR.

8. Sample Size for the Training Set

• The document does not explicitly mention a training set or details about its size. This is a diagnostic device (an enzyme immunoassay), not a software or AI algorithm that typically requires a distinct training phase on a dataset. The development of such a device involves optimizing reagents and protocols, which is a different process than machine learning algorithm training.

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

• As a distinct "training set" for an algorithm is not described, the method for establishing ground truth for such a set is not applicable/not provided in this document. The device's components (antibodies, reagents) would have been developed and validated through internal R&D processes, likely using characterized H. pylori samples and controls, but this isn't presented as a formal "training set" in the context of this 510(k) summary.

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The LIAISON® H. pylori IgG assay uses chemiluminescent immunoassay (CLIA) technology for the qualitative determination of IgG antibodies to Helicobacter pylori in human serum from symptomatic adults as an aid in the diagnosis of Helicobacter pylori infection. Assay results should be used in conjunction with other clinical or laboratory data to assist the clinician in making individual patient management decisions. The test has to be performed on the LIAISON® XL Analyzer.

The LIAISON® H. pylori IgG Control Set is intended for use as assayed quality control samples to monitor the performance of the LIAISON® H. pylori IgG assay.

The method for qualitative determination of IgG antibodies to Helicobacter pylori (H.pv/ori IgG) is a two-step, indirect chemiluminescence immunoassay (CLIA). The principal components of the test are magnetic particles (solid phase) coated with Helicobacter pylori antigen and a conjugate of anti-human IgG monoclonal antibodies to linked to an isoluminol derivative (isoluminol-antibody conjugate). During the first incubation, H. pylori antibodies present in calibrators, samples or controls bind to the solid phase. During the second incubation, the monoclonal antibody conjugate reacts with H. pylori lgG that is already bound to the solid phase. After each incubation, unbound material is removed with a wash cycle.

Subsequently, the starter reagents are added and a flash chemiluminescence reaction is thus induced. The light signal, and therefore, the amount of isoluminol-antibody conjugate, is measured by a photomultiplier as relative light units (RLU) and is indicative of the presence of H. pylori IgG in calibrators, samples or controls.

All assay steps and incubations are performed by the LIAISON® XL Analyzer.

The provided text describes a 510(k) premarket notification for the "LIAISON® H. pylori IgG" assay, an in vitro diagnostic device. This document focuses on demonstrating the substantial equivalence of the new device to a legally marketed predicate device (Siemens IMMULITE 2000 H. pylori IgG Assay).

Here's an analysis of the acceptance criteria and study data based on the provided text, using the requested framework:

Acceptance Criteria and Device Performance

The document doesn't explicitly state "acceptance criteria" in a table format with specific numerical targets. Instead, it presents performance data for comparison against a predicate device. The implied acceptance criteria are that the new device's performance (specifically, accuracy as measured by percent agreement) is comparable to that of the predicate device within acceptable statistical variation.

Here's a table summarizing the reported device performance, which serves as evidence of meeting the implied acceptance criteria for equivalence:

Table 1: Device Performance (Comparative Clinical Study)

Note: The document also includes extensive precision/reproducibility data (Within-Laboratory Precision and Reproducibility at multiple sites), which are crucial for establishing the reliability and consistency of the assay. While not direct "acceptance criteria" in terms of accuracy against a true disease state, these data demonstrate the device's analytical performance meets expected standards for an in vitro diagnostic.

Study Details

Here's a breakdown of the specific information requested, based on the provided text:

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

• Sample Size: 504 samples
• Data Provenance:
  • Country of Origin: Multiple geographical locations in the U.S.
  • Retrospective or Prospective: Prospective study. Samples were collected from non-selected adult subjects sent to the laboratory for H. pylori IgG serological testing.

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

• Not Applicable / Not Provided: For this type of in vitro diagnostic device (immunoassay for antibodies), the "ground truth" for the comparative clinical study is established by the results of a legally marketed predicate device, not by expert interpretation of images or other clinical data. Hence, there is no mention of experts establishing a ground truth in the context of radiologists or similar clinical reviewers.

4. Adjudication Method for the Test Set:

• Not Applicable / Not Provided: Adjudication methods (e.g., 2+1, 3+1) are typically used in studies involving human interpretation (e.g., image reading) where there might be disagreement. In this comparative study with a predicate device, the comparison is directly between the new device's results and the predicate device's results, with no mention of human adjudication of results. The "ground truth" is effectively the predicate device's 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:

• No: An MRMC comparative effectiveness study is not applicable as this is an in vitro diagnostic assay, not an AI-assisted diagnostic tool for human readers. The device performs the test autonomously.

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

• Yes: This device (LIAISON® H. pylori IgG assay) is inherently a standalone diagnostic test. Its performance is evaluated based on its ability to detect antibodies independently. The clinical study compares its standalone performance against another standalone device (the predicate).

7. The Type of Ground Truth Used:

• Predicate Device Results: For the comparative clinical study, the "ground truth" against which the LIAISON® H. pylori IgG assay was evaluated was the results from the FDA-cleared predicate device (Siemens IMMULITE 2000 H. pylori IgG Assay).

8. The Sample Size for the Training Set:

• Not Applicable / Not Provided: This is an immunoassay, not an AI/machine learning algorithm that requires a "training set" in the conventional sense. The development of reagents and assay parameters is based on biochemical and analytical principles, not on training data in the way an AI model would be.

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

• Not Applicable / Not Provided: As noted above, there is no "training set" in this context. The assay's performance characteristics (e.g., cutoff values) are established through analytical validation and optimization, often against known positive and negative samples, but not through a "ground truth" establishment process for a training set as would be done for an AI algorithm.

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The ImmunoCard STAT! HpSA is a rapid in vitro qualitative procedure for the detection of Helicobacter pylori antigens in human stool. The stool antigen detection is intended to aid in the diagnosis of H. pylori infection and to demonstrate loss of H. pylori stool antigen following treatment. Conventional medical practice recommends that testing by any method to confirm loss of antigen be done at least four weeks following completion of therapy.

Not Found

The provided document is a 510(k) premarket notification letter for the ImmunoCard STAT! HpSA device. It primarily focuses on the FDA's determination of substantial equivalence and regulatory compliance information, rather than a detailed study report with acceptance criteria and performance data.

Therefore, I cannot provide a complete answer to your request based solely on the provided text. The document does not contain the specific details of a study, acceptance criteria, or performance metrics. It's a regulatory approval letter.

However, I can extract information related to the device and the type of data that would be relevant if a full study report were available.

Based on the provided document, here's what I can infer and what is missing:

The device, ImmunoCard STAT! HpSA, is a rapid in vitro qualitative procedure for the detection of Helicobacter pylori (H. pylori) antigens in human stool. It is intended to aid in the diagnosis of H. pylori infection and to demonstrate loss of H. pylori stool antigen following treatment.

To address your request, if a full study report were available, it would typically include the following information:

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

• Missing from the document. A study report would typically define performance metrics such as sensitivity, specificity, positive predictive value (PPV), and negative predictive value (NPV) or overall agreement, along with the pre-defined target values (acceptance criteria).

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

• Missing from the document. A study report would specify the number of patient samples included in the test set, whether the samples were collected prospectively or retrospectively, and details about the patient population and geographical 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)

• Missing from the document. For a diagnostic test like this, the "ground truth" would likely be established using a comparator method (e.g., culture, biopsy with histological examination, UBT, or another validated molecular test). The experts involved would typically be clinical microbiologists, gastroenterologists, or pathologists. The number and qualifications would depend on the complexity of the ground truth method.

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

• Not applicable in the context of this device. Adjudication methods like "2+1" (where two readers agree, or a third reader resolves discrepancies) are common in imaging studies. For a qualitative diagnostic test like the ImmunoCard STAT! HpSA, adjudication typically refers to the resolution of discrepancies between the device's result and the reference standard, rather than between multiple human readers interpreting the device's output.

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

• Not applicable. The ImmunoCard STAT! HpSA is a qualitative in vitro diagnostic device, not an AI-based imaging interpretation system. Therefore, MRMC studies involving human readers improving with AI assistance are not relevant to this device.

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

• Could be considered "standalone" in a different sense. The ImmunoCard STAT! HpSA provides a direct qualitative result (positive/negative) based on antigen detection. Its performance is evaluated as the device itself, without a "human-in-the-loop" in the same way an AI algorithm for image analysis would be. A standalone study for this device would assess its accuracy against a known truth.

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

• Inferred based on "H. pylori antigen detection": For H. pylori detection, the gold standard (ground truth) typically used in clinical studies includes:
  • Culture: Growing the bacteria from biopsy samples.
  • Histology: Microscopic examination of gastric biopsy tissues for H. pylori.
  • Urea Breath Test (UBT) or Stool Antigen Test (SAT) using a highly sensitive and specific comparator method: These are non-invasive methods, often used as reference for other non-invasive tests.
  • Rapid Urease Test (RUT): Performed on biopsy samples.
  • Overall Clinical Diagnosis: Based on a combination of invasive and non-invasive tests.
• The specific ground truth used for ImmunoCard STAT! HpSA would be detailed in a study report.

8. The sample size for the training set

• Not applicable in the context of this device. The ImmunoCard STAT! HpSA is a biochemical/immunological test kit, not an AI or machine learning algorithm that requires a "training set." Its design and optimization would involve R&D and validation, but not in the sense of AI model training.

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

• Not applicable. As above, training sets and their ground truth establishment are relevant for AI/ML models, not for this type of in vitro diagnostic kit.

In summary: The provided document is a regulatory communication of FDA clearance. To answer your detailed questions about acceptance criteria and study particulars, a separate clinical study report or performance evaluation data would be required.

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