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Premier Toxins A&B is a qualitative enzyme immunoassay for the detection of Clostridium difficile toxin A and toxin B in stool from patients with antibiotic associated diarrhea. Premier Toxins A&B is intended for use as an aid in diagnosis of C. difficile associated disease.

Premier Toxins A&B is an enzyme immunoassay for the direct detection of Clostridium difficile toxin A and toxin B in stool samples. Breakaway microwells are coated with toxin specific monoclonal and polyclonal antibodies. Diluted patient specimens and HRP-conjugated anti-toxin A and B polyclonal antibodies are added to microwells. If either toxin is present in the diluted patient samples, HRP-conjugated toxin polyclonal antibodies (specific for both toxins) complexes are formed which remain in the microwells after washing. After a final washing step, a substrate / chromagen (urea peroxide and tetramethylbenzidine) is added to the wells. Any bound conjugate converts the substrate / chromagen to a blue color. Addition of acid (Stop Solution) converts the blue to a vellow color.

Here's an analysis of the provided text regarding the acceptance criteria and study for the Premier Toxins A&B device:

The document does not explicitly state pre-defined "acceptance criteria" in terms of specific performance thresholds that the device needed to meet. Instead, it presents the results of a clinical study, implying that these results were considered acceptable for 510(k) clearance by demonstrating substantial equivalence to a predicate device.

1. Table of Acceptance Criteria and Reported Device Performance

As noted, explicit "acceptance criteria" were not listed. However, we can construct a table showing the reported performance statistics from the clinical study. These reported values served as the evidence for substantial equivalence.

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

• Sample Size (Test Set):
  • Cytotoxin Positive: 90 (Site 1: 55, Site 2: 35)
  • Cytotoxin Negative: 465 (Site 1: 257, Site 2: 208)
  • Total Samples (All Sites): 90 + 465 = 555
• Data Provenance:
  • Country of Origin: United States (stated as "performed at two sites in the United States").
  • Retrospective or Prospective: Not explicitly stated, but typically for clinical studies supporting 510(k) in vitro diagnostics, especially for comparison to standard methods, samples might be collected prospectively, or a mix of archived and prospective samples. The document does not provide enough detail to definitively classify it.

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

• Ground Truth Method: The ground truth was established by comparison to the "cellular cytotoxicity assay." This is a laboratory-based method, not an expert review of images or clinical data in the human-reader sense.
• Number of Experts: Not applicable, as the ground truth was determined by a laboratory assay, not human experts.
• Qualifications of Experts: Not applicable.

4. Adjudication Method for the Test Set

• Adjudication Method: Not applicable. The "ground truth" was a laboratory reference method (cellular cytotoxicity assay), which has its own established interpretation criteria, not subject to human adjudication in the typical sense of reconciling multiple human readers.

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

• MRMC Study: No, an MRMC comparative effectiveness study was not conducted. This study compares the device directly to a laboratory reference method (cellular cytotoxicity assay) using stool samples, not a comparison of human readers with and without AI assistance.

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

• Standalone Performance: Yes, this study effectively represents standalone performance. The Premier Toxins A&B device (an enzyme immunoassay) is an automated algorithm-only system in the sense that the test results (color change, absorbance readings) are interpreted by the device's inherent mechanisms to produce a positive or negative result, without direct human intervention in the interpretation of the test itself. The performance statistics (sensitivity, specificity, etc.) are for the device's output compared to the reference standard.

7. The Type of Ground Truth Used

• Type of Ground Truth: The ground truth used was a laboratory reference standard: the cellular cytotoxicity assay. This is a well-established method for detecting Clostridium difficile toxins.

8. The Sample Size for the Training Set

• The document does not provide any information regarding a "training set" or its sample size. This is common for older 510(k) submissions for in vitro diagnostic devices like ELISAs, which are developed and validated using traditional laboratory methods. The concept of a distinct "training set" and "test set" in the machine learning sense is not explicitly applied here. The clinical study described served as the validation (test) set.

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

• Not applicable, as no information on a distinct "training set" is provided.

In summary: The Premier Toxins A&B device demonstrated strong performance (high sensitivity, specificity, and negative predictive value) when compared against the cellular cytotoxicity assay, which served as the gold standard. While explicit numerical acceptance criteria were not stated, the reported performance statistics were deemed sufficient by the FDA for clearance, supporting the device's intended use as an aid in diagnosing C. difficile-associated disease. The study was a standalone validation of the device against a laboratory reference method, not an AI-assisted human reader study.

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The Immunocard STAT! STEC O157 is a rapid test for the detection of antigens from shiga toxin producing E. coli O157 as an aid in the diagnosis of E. coli O157:H7 infection. The test can be used to directly test stool specimens, or confirmatory stool cultures grown in MacConkey broth or sorbitol MacConkey (SMAC) plates.

Stool or culture material are prepared / diluted and added to the sample port of the device. The sample mobilizes gold particles, coated with monoclonal antibody specific for the O157 lipopolysacchride, and migrates along the membrane through the Test and Control zones. The test zone contains immobilized monoclodal antibody specific for an epitope common to shiga toxin producing E. coli. After ten minutes the Test and Control zones are observed for the presence of red/purple lines across the membrane surface. If a shiga toxin producing E. coli O157 is present in the sample, a complex is formed between the capture antibody, the shiga toxin producing E. coli O157, and the monoclonal antibody-gold conjugate which can be seen visually as a red/purple line in the Test zone. No red/purple line in the Test zone indicates a negative result. The Control line serves as a procedural control, to assure that the sample has migrated the appropriate distance along the membrane.

This document describes the ImmunoCard STAT! STEC O157 device, a rapid test for detecting E. coli O157 antigens.

Here's an analysis of its acceptance criteria and the study performance:

1. Table of Acceptance Criteria and Reported Device Performance:

The document doesn't explicitly state "acceptance criteria" for the ImmunoCard STAT! STEC O157. However, it presents the performance of the device in comparison to a predicate device (E. coli O157 Elisa Stool Assay), which implies these performance metrics are considered acceptable for market clearance. The key performance metrics are Sensitivity and Specificity for stool samples.

Note: The document also lists performance for the predicate device across various sample types including formalinized stool, MacConkey broth, and SMAC plates (100% Sensitivity, 99-100% Specificity), but these are for the predicate and not the ImmunoCard explicitly across all those sample types in the summary table.

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

• Sample Size: The document does not explicitly state the sample size used for the clinical test set evaluating the ImmunoCard STAT! STEC O157.
• Data Provenance: The document does not specify the country of origin of the data or whether the study was retrospective or prospective. It only mentions "patient stool" in the intended use and comparison tables.

3. Number of Experts Used to Establish Ground Truth and Qualifications:

The document does not provide information on the number of experts used or their qualifications for establishing the ground truth of the test set.

4. Adjudication Method for the Test Set:

The document does not describe any adjudication method (e.g., 2+1, 3+1, none) used for the test set.

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 a manual, visually read lateral flow immunoassay. Its interpretation is straightforward (presence or absence of a line). Therefore, a study focusing on inter-reader variability or the improvement of human readers with AI assistance would not be applicable.

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

Yes, the study primarily describes the standalone performance of the device. The ImmunoCard STAT! STEC O157 is a rapid test that provides a visual reading (red/purple line) after ten minutes, interpreted by a laboratory technician without any algorithmic or AI involvement. The reported sensitivity and specificity are for this standalone operation.

7. Type of Ground Truth Used:

The document doesn't explicitly state the exact "ground truth" method used for the clinical study. However, given that it's a diagnostic test for E. coli O157 and the comparison to "culture" is mentioned (in the statement "The safety and effectiveness of both assays are both substantially equivalent when compared to culture"), it is highly probable that bacteriological culture was used as the gold standard for confirming the presence or absence of E. coli O157 in patient stool samples.

8. Sample Size for the Training Set:

The document does not provide information on a "training set" sample size. This type of device (lateral flow immunoassay) typically does not involve machine learning algorithms that require a distinct training set. Its development involves optimizing chemical and biological components, not training a model on data in the conventional sense.

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

As there is no mention of a training set for a machine learning model, there is no information on how its ground truth was established. The development of such a diagnostic test relies on fundamental microbiology, immunology, and chemistry principles, not data-driven model training.

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The PREMIER™ TYPE SPECIFIC HSV-1 IgG ELISA TEST is to be used in the testing of human serum specimens from individuals for whom the qualitative presence of detectable IgG antibody to herpes simplex virus type 1 is warranted; specifically, when used in conjunction with the Premier™ Type Specific HSV-2 IgG ELISA Test in the screening of sexually active adults. This test is indicated for individuals at risk for a sexually transmitted HSV infection. For example, this test can clarify when an individual with symptoms suggestive of genital herpes has genital HSV-1 infection.

The PREMIER™ TYPE SPECIFIC HSV-1 IgG ELISA TEST is not recommended for use in a pediatric population. The performance characteristics of this device have not been established for testing patients with HSV-1 associated meningitis and encephalitis, prenatal and neonatal screening, the testing of immunosuppressed patients, or the detection of early stages of HSV seroconversion.

The Premier™ Type Specific HSV-1 IgG ELISA Test is an in vitro diagnostic medical device is intended for the qualitative detection of IgG antibody to herpes simplex virus type 1 in human serum by the enzyme-linked immunosorbent assay (ELISA) method.

The Premier™ Type Specific HSV-1 IgG ELISA Test is comprised of the following items:

• Antigen-Coated ELISA Plate: One 96-well plate comprised of twelve 8-well strips with breakaway wells, each well coated with affinity purified HSV-1 glycoprotein G (gG-1).
• IgG Specimen Diluent: One bottle containing 30 ml of a lavender colored dilution buffer with sodium azide.
• Conjugate: One bottle containing 15 ml of a pink colored solution of alkaline phosphatase-labeled antihuman IgG (Caprine) with sodium azide.
• Substrate Buffer: One bottle containing 30 ml of a blue colored buffer solution with sodium azide.
• p-NPP Tablets: One foil pack containing 6 tablets of p-nitrophenyl phosphate (p-NPP).
• Stopping Reagent: One bottle containing 30 ml of a colorless solution of 1.5 N sodium hydroxide (NaOH).
• Positive Control and Negative Control: One vial of each containing 200 ul of serum (human) with sodium azide.
• Reference Serum: One vial containing 400 ul of serum (human) with sodium azide.
• 20X Wash Solution: One bottle containing 60 ml of a green colored solution with detergent and sodium azide.
• ELISA Plate Sealer: One acetate sheet with contact adhesive.
• Resealable Storage Bag: One plastic sealable bag.
• ELISA Worksheet: One worksheet for recording data.

When the Premier™ Type Specific HSV-1 IgG ELISA Test is employed, diluted patient serum is incubated with purified herpes simplex virus type 1 glycoprotein (gG1) bound to the ELISA plate wells. If antibodies to the herpes simplex virus type 1 are present, they bind to the antigen and do not rinse off. Subsequently when enzyme-labeled antihuman IgG is added to the reaction site it binds to the immobilized IgG antibodies. After washing and the addition of a chromogenic substrate and stopping reagent, specimens containing antibodies to the herpes simplex virus type 1 produce a color endpoint reaction which can be read with a standard ELISA plate reader.

Here's a breakdown of the acceptance criteria and study information for the Premier™ Type Specific HSV-1 IgG ELISA Test, based on the provided text:

Acceptance Criteria and Device Performance

The acceptance criteria are not explicitly stated as distinct numerical targets. Instead, the document frames "substantial equivalence" as the primary criterion, supported by acceptable agreement, relative sensitivity, and relative specificity when compared to a Western Blot Method (which is considered the reference standard in these studies) and the predicate device. For the "substantial equivalence performance data," the overall agreement, sensitivity, and specificity are reported.

Note: The document presents results from several studies. The table above focuses on the largest prospective study for the "Reported Device Performance."

Study Information:

2. Sample Size and Data Provenance:

• Initial Clinical Laboratory Study:
  • Sample Size: 193 frozen sequential sera from patients.
  • Data Provenance: Clinical laboratory in the Pacific Northwest Region of the US. Retrospective.
• CDC Serum Panel Study:
  • Sample Size: 100 clinical specimens (50 paired sera).
  • Data Provenance: Centers for Disease Control (CDC) (characterized previously by CDC EIA and Western Blot testing). The origin country is likely the US. Retrospective.
• Archived HSV-1 Culture-Documented Samples:
  • Sample Size: 49 archived serum samples from patients with culture-documented HSV-1 infection.
  • Data Provenance: Not explicitly stated, but implies a retrospective collection from culture-positive patients.
• Prospective STD Clinics Study:
  • Sample Size: 756 serum samples from unduplicated individuals.
  • Data Provenance: Prospectively collected from two STD Clinics in the Pacific Northwest Region of the US. Prospective.
• Low Prevalence Populations Studies:
  • Pediatric Patients: 199 serum samples. Northeast Region of the US.
  • University Student Health Clinic: 209 serum samples. Pacific Northwest Region of the US.
  • Blood Bank Donors: 100 serum samples. Northeast Region of the US.
  • Data Provenance: All three are from the US. Implied retrospective but collected from specific low prevalence populations. (The method for their initial selection is not detailed beyond "low prevalence.")

3. Number of Experts and Qualifications:

• No information provided. The document describes comparisons to "Western Blot Method" and "CDC results" or "CDC EIA and Western Blot testing" as the ground truth, but does not specify the number or qualifications of experts involved in establishing these reference standards.

4. Adjudication Method:

• For the Main Prospective Study (STD Clinics): Western Blot results were based on initial testing. Specimens with initial atypical results were reanalyzed by Western Blot, and these repeat results were used for patients returning for repeat analysis. Patients not returning were presumed negative. Premier™ ELISA equivocal specimens were retested, and the second test result was used. This implies a form of retesting and a decision rule for ambiguous cases.
• For Low Prevalence Studies: Similar adjudication for Western Blot (reanalysis of atypical results) and ELISA (retesting equivocal samples) was applied.
• No explicit "2+1" or "3+1" expert adjudication is mentioned. The Western Blot itself, when performed and interpreted, serves as the comparison method, and its interpretation would encompass an "adjudication" (e.g., whether it's positive, negative, or atypical/equivocal requiring reanalysis).

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

• No, an MRMC study was not done. The studies described compare the device's performance to a laboratory reference method (Western Blot or CDC characterized panels), not directly measuring the improvement of human readers with or without AI assistance. This is an in vitro diagnostic device, not an AI-assisted diagnostic tool for human interpretation.

6. Standalone Performance:

• Yes, a standalone performance was done. All the reported studies assess the performance of the Premier™ Type Specific HSV-1 IgG ELISA Test as a standalone diagnostic tool, comparing its results (qualitative detection of IgG antibody) directly against the established reference methods (Western Blot or CDC characterized results). There is no "human-in-the-loop" component described for the device's operation.

7. Type of Ground Truth Used:

• Expert Consensus/Reference Method: The primary ground truth for comparison across most key studies is the Western Blot Method for detection of HSV type specific antibody. For the CDC serum panel, the ground truth was "characterized previously by CDC EIA and Western Blot testing." For a smaller study, clinical culture-documented HSV-1 infection was used.

8. Sample Size for the Training Set:

• Not applicable / Not specified. As an ELISA test, this device is a laboratory assay with reagents; it's not a machine learning or AI model that requires a "training set" in the conventional sense. The "training" in the manufacturing process would be related to quality control and standardization of the assay components.

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

• Not applicable / Not specified. (See point 8.) The performance characteristics are established via clinical validation studies against recognized reference methods.

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The PREMIER™ TYPE SPECIFIC HSV-2 IgG ELISA TEST is to be used in the testing of human serum specimens from individuals for whom the qualitative presence of detectable IgG antibody to herpes simplex virus type 2 is warranted; specifically, when used in conjunction with the Premier™ Type Specific HSV-1 IgG ELISA in the screening of sexually active adults. This test is indicated for individuals at risk for a sexually transmitted HSV infection or disease (STD), For example, this test is to be used to screen samples from patients with or without clinical history of herpes and can clarify when an individual with symptoms suggestive of genital herpes has genital HSV-2 infection.

The PREMIER™ TYPE SPECIFIC HSV-2 IgG ELISA TEST is not recommended for use in a pediatric population. The performance characteristics of this device have not been established for prenatal and neonatal screening, the testing of patients with other HSV associated diseases and immunosuppressed patients, or the detection of early stages of HSV seroconversion.

The Premier™ Type Specific HSV-2 IgG ELISA Test is an in vitro diagnostic medical device is intended for the qualitative detection of IgG antibody to the herpes simplex virus type 2 in human serum by the enzyme-linked immunosorbent assay (ELISA) method.

The Premier™ Type Specific HSV-2 IgG ELISA Test is comprised of the following items:

1. Antigen-Coated ELISA Plate: One 96-well plate comprised of twelve 8-well strips with breakaway wells, each well coated with affinity purified HSV-2 glycoprotein G (gG-2).
2. IgG Specimen Diluent: One bottle containing 30 ml of a lavender colored dilution buffer with sodium azide.
3. Conjugate: One bottle containing 15 ml of a pink colored solution of alkaline phosphatase-labeled antihuman IgG (Caprine) with sodium azide.
4. Substrate Buffer: One bottle containing 30 ml of a blue colored buffer solution with sodium azide.
5. p-NPP Tablets: One foil pack containing 6 tablets of p-nitrophenyl phosphate (p-NPP).
6. Stopping Reagent: One bottle containing 30 ml of a colorless solution of 1.5 N sodium hydroxide (NaOH).
7. Positive Control and Negative Control: One vial of each containing 200 ul of serum (human) with sodium azide.
8. Reference Serum: One vial containing 400 ul of serum (human) with sodium azide.
9. 20X Wash Solution: One bottle containing 60 ml of a green colored solution with detergent and sodium azide.
10. ELISA Plate Sealer: One acetate sheet with contact adhesive.
11. Resealable Storage Bag: One plastic sealable bag.
12. ELISA Worksheet: One worksheet for recording data.

When the Premier™ Type Specific HSV-2 IgG ELISA Test is employed, diluted patient serum is incubated with purified herpes simplex virus type 2 glycoprotein (gG2) bound to the ELISA plate wells. If antibodies to the herpes simplex virus type 2 are present, they bind to the antigen and do not rinse off. Subsequently when enzyme-labeled antihuman IgG is added to the reaction site it binds to the immobilized IgG antibodies. After washing and the addition of a chromogenic substrate and stopping reagent, specimens containing antibodies to the herpes simplex virus type 2 produce a color endpoint reaction which can be read with a standard ELISA plate reader.

The Premier™ Type Specific HSV-2 IgG ELISA Test is an in vitro diagnostic medical device intended for the qualitative detection of IgG antibody to the herpes simplex virus type 2 in human serum.

Here's an analysis of the provided text regarding the acceptance criteria and supporting study:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state pre-defined acceptance criteria (e.g., "The device must achieve a sensitivity of X% and specificity of Y%"). Instead, it presents performance metrics from various studies and implies that these "acceptable agreement" and "relative sensitivity and relative specificity" values demonstrate substantial equivalence to a predicate device, particularly noting "improved specificity" over the predicate.

Given the lack of explicit acceptance criteria, the table below reports the performance metrics achieved in the primary clinical studies.

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

• Study 1 (STD Clinics):
  • Sample Size: 756 serum samples.
  • Data Provenance: Prospectively collected from unduplicated individuals attending two STD Clinics in the Pacific Northwest Region of the US.
• Study 2 (Clinical Laboratory):
  • Sample Size: 193 patients (sequential sera), with 179 included in calculations after exclusions.
  • Data Provenance: Frozen samples from patients submitted to a clinical laboratory in the Pacific Northwest Region of the US.
• Study 3 (CDC Panel):
  • Sample Size: 100 clinical specimens (50 paired sera).
  • Data Provenance: Serum panel obtained from the Centers for Disease Control (CDC).
• Study 4 (Culture Documented HSV-2 Infection):
  • Sample Size: 335 archived serum samples.
  • Data Provenance: Archived serum samples from patients with culture documented HSV-2 infection (retrospective, pre-selected).
• Study 5 (Low Prevalence Populations for Specificity):
  • Sample Size:
    • 199 pediatric patients (Northeast Region, US).
    • 209 individuals (University Student Health Clinic, Pacific Northwest Region, US).
    • 100 Blood Bank donors (Northeast Region, US).
  • Data Provenance: Prospectively collected (implied by "pediatric patients," "individuals attending," "Blood Bank donors" in specific regions of the US).

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

The ground truth for most studies was established using the Western Blot Method for type specific IgG antibody to HSV-2.

• For Study 1 (STD Clinics), it states, "Western Blot results were based on initial testing with the exception of specimens with initial atypical results which were reanalyzed."
• For Study 2 (Clinical Laboratory), it states, "Tested for IgG antibodies to HSV-2 using... a Western Blot Method."
• For Study 3 (CDC Panel), the specimens were "characterized previously by CDC EIA and Western Blot testing."
• For Study 5 (Low Prevalence Populations), the ground truth was also "a Western Blot Method for type specific IgG antibody to HSV-2."

The document does not specify the number of experts or their qualifications who interpreted these Western Blot results. However, Western Blot is typically considered a highly reliable, gold-standard method for HSV-2 serology.

For Study 4 (Culture Documented HSV-2 Infection), the ground truth was prior culture documentation of HSV-2 infection. This does not require expert interpretation of a secondary diagnostic test.

4. Adjudication Method for the Test Set

The document details the following adjudication methods:

• Study 1 (STD Clinics) and Study 5 (Low Prevalence Populations):
  • Western Blot: Initial atypical results were reanalyzed. Patients not returning for repeat testing were presumed negative.
  • Premier™ Type Specific HSV-2 IgG ELISA Test: Specimens initially reported as equivocal were retested, and the second test result was used.
• Study 2 (Clinical Laboratory): "There were ten specimens which demonstrated either equivocal ELISA results or atypical Western Blot results and four specimens that could not be typed by Western Blot which were not included in the above calculations." This implies exclusion rather than a specific re-adjudication protocol for these excluded cases.
• Study 4 (Culture Documented HSV-2 Infection): "Based on repeat testing of equivocal samples."

No explicit "2+1" or "3+1" expert adjudication scheme is mentioned, but rather a protocol for handling equivocal or atypical results with repeat testing or re-analysis.

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 an in vitro diagnostic (IVD) device, specifically an ELISA test, which is read by an automated ELISA plate reader to produce a color endpoint reaction that is then quantitatively measured. It is not an AI-assisted diagnostic imaging or interpretation device that would involve human readers or AI assistance in the way typically discussed in MRMC studies. Therefore, an MRMC comparative effectiveness study involving human readers and AI assistance was not applicable and not performed.

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

Yes, the studies presented are standalone performance studies for the Premier™ Type Specific HSV-2 IgG ELISA Test. The device provides a quantitative result (color endpoint) which is then interpreted qualitatively (positive/negative/equivocal) based on pre-defined cut-offs without human interpretive "readings" in the sense of image analysis. The performance metrics (sensitivity, specificity, agreement) directly reflect the algorithm's (the ELISA test's) ability to correctly classify samples against the ground truth.

7. The Type of Ground Truth Used

The primary type of ground truth used across most studies was:

• Expertly Interpreted Gold Standard Test: The Western Blot Method for type specific IgG antibody to HSV-2. This is considered the reference standard for HSV type-specific serology.
• Outcomes Data/Validated Diagnosis: For one study (Study 4), culture documented HSV-2 infection was used as the ground truth.

8. The Sample Size for the Training Set

The document does not explicitly mention a separate "training set" for the Premier™ Type Specific HSV-2 IgG ELISA Test. The studies described are performance evaluations of the completed device. For IVDs like ELISA tests, the "training" analogous to machine learning often involves optimizing reagent concentrations, incubation times, and optical density cut-offs during product development, typically using characterized clinical samples (development panels), but this is not typically referred to as a "training set" in the same way as for AI/ML models. No sample size for such a set is provided.

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

Since no explicit training set is mentioned, this information is not provided. If the question implies how the inherent parameters (like cut-offs) of the ELISA test were established during development, it would have been based on characterized samples, likely against a gold standard like Western Blot or culture results, but the document does not detail this process or the ground truth establishment for such a developmental phase.

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The Premier Platinum HpSA 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 adult 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 test utilizes polyclonal anti-H. pvlori capture antibody adsorbed to microwells. Diluted patient samples and a peroxidase conjugated polyclonal antibody are added to the wells and incubated for one hour at room temperature. A wash is performed to remove unbound material. Substrate is added and incubated for ten 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 an analysis of the provided text, focusing on the acceptance criteria and study details for the Premier Platinum HpSA device:

1. Table of Acceptance Criteria and Reported Device Performance

The document doesn't explicitly state "acceptance criteria" in a numerical target format for the Premier Platinum HpSA device itself. Instead, it justifies substantial equivalence by comparing its performance against a predicate device (Meretek UBT). The acceptance is implied by the comparable or superior performance relative to the predicate.

Here's a table comparing the Premier Platinum HpSA's performance to its predicate:

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

The document does not explicitly state the sample size used for the test set during the performance validation. It provides confidence intervals for Sensitivity, Specificity, and Correlation for both the Premier Platinum HpSA and the predicate device, which implies a certain sample size was used to achieve those intervals, but the exact number is not given.

The data provenance (country of origin, retrospective/prospective) is also not specified in the provided text.

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

The document does not specify the number of experts used or their qualifications to establish the ground truth for the test set.

4. Adjudication Method for the Test Set

The document does not specify the adjudication method used for the test set.

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

A Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This device is an in-vitro diagnostic test for detecting H. pylori antigens in stool, interpreted visually or spectrophotometrically, not an imaging device requiring human reader interpretation in the same way an MRMC study would apply. The comparison is between two diagnostic assays, not between human readers with and without AI assistance.

6. Standalone Performance Study

Yes, a standalone performance study was done. The reported Sensitivity, Specificity, and Correlation for the Premier Platinum HpSA (94.7%, 96.1%, and 95.8% respectively) represent the standalone performance of the algorithm/assay itself.

7. Type of Ground Truth Used

The document states "Performance vs. Reference Methods" when presenting the sensitivity, specificity, and correlation. While not explicitly defined, "Reference Methods" in the context of diagnostic tests typically refer to established, highly accurate diagnostic tests or a combination of clinical outcomes and other diagnostic modalities (e.g., histology/pathology, culture, or a consensus of multiple established clinical tests). Given this is a diagnostic test for H. pylori, common reference methods include histology, culture, or other validated breath tests/serology in combination with clinical presentation.

8. Sample Size for the Training Set

The document does not provide any information about a "training set" or its sample size. This is typical for traditional in-vitro diagnostic (IVD) assays developed without machine learning or AI components in the modern sense. The "training" and optimization of such assays usually refer to laboratory development and optimization steps, not a distinct "training set" for an algorithm.

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

As no training set is mentioned (see point 8), there is no information on how its ground truth was established.

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The Premier Cryptosporidium enzyme immunoassay (EIA) is an in vitro qualitative procedure for the detection of Cryptosporidium antigens in stool. Test results are intended to aid in the diagnosis of Cryptosporidium infection.

The assay is a conventional microwell sandwich enzyme immunoassay, utilizing polyclonal capture and monoclonal detection antibodies.

Here's a breakdown of the acceptance criteria and study information for the Premier Cryptosporidium 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, it provides performance metrics for the Premier Cryptosporidium and compares them to a predicate device. We can infer the "acceptance criteria" were implicitly met if the Premier Cryptosporidium's performance was considered substantially equivalent to or better than the predicate.

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

The document does not explicitly state the sample size used for the test set or the data provenance (e.g., country of origin, retrospective/prospective). It only provides the summarized performance metrics.

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

This information is not provided in the document.

4. Adjudication Method for the Test Set:

This information is not provided in the document.

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

This information is not provided in the document. This type of study is more common for diagnostic imaging devices where human interpretation is a primary component. For an immunoassay like this, the focus is typically on the standalone performance of the assay.

6. Standalone Performance Study:

Yes, a standalone performance study was done. The reported sensitivity of 100% and specificity of 99% for the Premier Cryptosporidium are results of its standalone performance. The document explicitly states "Performance vs. Reference Methods," indicating that the device was evaluated on its own against established reference methods (which serve as the ground truth).

7. Type of Ground Truth Used:

The document states "Performance vs. Reference Methods." While the specific reference methods are not detailed, in the context of diagnostic assays for infections, this typically implies:

• Culture: Growing the Cryptosporidium parasite in a laboratory setting.
• Microscopy: Direct observation of Cryptosporidium oocysts in stool samples by trained personnel using specific staining techniques (e.g., acid-fast stain).
• PCR (Polymerase Chain Reaction): Molecular detection of Cryptosporidium DNA.

Without more detail, it's most likely a combination of these, with microscopy and potentially culture being the gold standards at the time for direct detection of the parasite.

8. Sample Size for the Training Set:

This information is not provided in the document. Given that this is an immunoassay, the "training set" concept (as used in machine learning) may not directly apply in the same way. Immunoassays are typically developed and validated through a series of experiments to optimize reagents and conditions, rather than being "trained" on a data set.

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

This information is not provided in the document. As mentioned above, the concept of a "training set" with ground truth in the machine learning sense is unlikely to be directly applicable to this type of device. The development process would involve extensive analytical sensitivity and specificity testing, cross-reactivity studies, and optimization of assay components and protocols against known positive and negative samples.

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The Premier Giardia enzyme immunoassay (EIA) is an in vitro qualitative procedure for the detection of Giardia antigens in human stool. Test results are intended to aid in the diagnosis of Giardia infection (giardiasis).

The Premier Giardia test utilizes polyclonal anti-Giardia capture antibody adsorbed to microwells.

Here's a breakdown of the acceptance criteria and study information for the Premier Giardia device, based on the provided text:

Acceptance Criteria and Device Performance

The core acceptance criteria for the Premier Giardia device, as presented in comparison to its predicate device, are focused on its diagnostic performance metrics:

1. Acceptance Criteria and Reported Device Performance

Note: The document explicitly states that the Premier Giardia performed at 98% sensitivity and 98% specificity, directly matching the performance of the predicate device, the Alexon ProspecT Giardia Microplate Assay. This direct match implies that these performance metrics of the predicate device serve as the acceptance criteria for the new device.

2. Sample Size and Data Provenance for the Test Set

The provided 510(k) summary does not explicitly state the sample size used for the test set or the data provenance (e.g., country of origin, retrospective or prospective nature of the data).

3. Number and Qualifications of Experts for Ground Truth

The document does not specify the number of experts used to establish the ground truth for the test set or their qualifications. For an in vitro diagnostic device like this, ground truth would typically be established by culture, microscopy, or other established reference methods interpreted by qualified laboratory personnel.

4. Adjudication Method for the Test Set

The document does not describe an adjudication method for the test set.

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

A Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not performed or reported in this 510(k) summary. This type of study is more common for imaging devices where human interpretation is a critical component influencing diagnostic accuracy. The Premier Giardia is an in vitro diagnostic assay with a qualitative (positive/negative) output.

6. Standalone (Algorithm Only) Performance

The information provided describes the performance of the Premier Giardia as a standalone device. It's an enzyme immunoassay (EIA) that directly detects Giardia antigens. There is no indication of a human-in-the-loop component or an "algorithm only" performance separate from the assay itself. The "Level of Skill Required" is stated as a "Laboratory Technician," meaning technicians perform the assay according to the specified steps and interpret the results.

7. Type of Ground Truth Used

The document does not explicitly state the type of ground truth used for the performance evaluation (e.g., expert consensus, pathology, other reference methods, or outcomes data). However, for an in vitro diagnostic for infectious disease, the ground truth is typically established by:

• Microscopy: Direct observation of Giardia cysts or trophozoites in stool samples by a trained microbiologist.
• Culture: Growing the Giardia parasite in a laboratory setting (though this can be challenging for Giardia).
• Reference molecular tests: PCR or other nucleic acid-based tests could also be used as a gold standard.

Given the context of a 510(k) for an EIA, it is highly probable that the reference "Performance vs. Reference Methods" implies comparison against microscopy or another established laboratory method for Giardia detection.

8. Sample Size for the Training Set

The provided 510(k) summary does not mention a training set sample size. For an immunoassay like the Premier Giardia, there isn't typically a "training set" in the machine learning sense. The assay itself is developed and optimized, not "trained" on data. The figures for sensitivity and specificity reflect the performance after development and optimization, assessed against a "test set" (though its size is not specified).

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

Since there is no "training set" in the context of this immunoassay, the question of how its ground truth was established is not applicable. The development of the assay likely involved internal validation and optimization against known positive and negative samples, but these are part of the assay's development, not a separate "training set" with ground truth in the way a machine learning algorithm would have.

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The Premier Platinum HpSA 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 in adult symptomatic patients.

The Premier Platinum HpSA test utilizes polyclonal anti-H. pylori capture antibody adsorbed to microwells. Diluted patient samples and a peroxidase conjugated polyclonal antibody are added to the wells and incubated for one hour at room temperature. A wash is performed to remove unbound material. Substrate is added and incubated for ten 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 details for the Premier Platinum HpSA device, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are implied by the comparison to the predicate device and the overall performance evaluation. They aim to demonstrate that the Premier Platinum HpSA test is "substantially equivalent" to existing methods for detecting H. pylori.

Note: The document explicitly states, "The differences in technology does not raise additional concerns regarding safety and effectiveness. Safety and effectiveness are demonstrated to be substantially equivalent." This indicates that the reported performance metrics for the Premier Platinum HpSA were considered sufficient to meet the acceptance criteria by demonstrating equivalence.

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

• Sample Size: 200 symptomatic adults were evaluated in the clinical study. Nine patients were considered unevaluable, meaning the effective sample size for performance calculations was 191 (99 infected, 90 not infected, plus 2 'Equ' and 1 'Equ' at site 3, 2 'Equ' at site 4, which were excluded from the main table's infected/not infected counts but are implicitly part of the overall 200 evaluated).
• Data Provenance: The data was collected prospectively from four sites:
  • One midwestern United States location
  • One site in Canada
  • Two sites in Italy

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

The document does not specify the number of experts or their qualifications directly. However, it states that the diagnosis of H. pylori infection (ground truth) was "judged by objective reference methods." These reference methods are:

• Culture
• Rapid Urease Test (RUT)
• Histology
• Urea Breath Test (UBT)

It's implied that these objective reference methods were interpreted by qualified personnel (e.g., microbiologists for culture, pathologists for histology, and trained technicians for RUT and UBT), but no specific number or detailed qualifications are provided.

4. Adjudication Method for the Test Set

Patients were considered H. pylori positive if:

• Culture was positive, OR
• Two or more of the other three tests (Rapid Urease, Histology, UBT) were positive.

Patients were considered unevaluable if:

• They had negative or no culture results, AND
• Only one other test (RUT, Histology, UBT) was positive.

This acts as a consensus-based adjudication method for establishing the ground truth.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, an MRMC comparative effectiveness study was not done. The study compares the Premier Platinum HpSA test (an in vitro diagnostic device) against established diagnostic reference methods for H. pylori infection (the ground truth), not against human readers with and without AI assistance. The device in question is a laboratory assay, not an AI-powered image analysis tool for human readers.

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

The Premier Platinum HpSA test is a standalone in vitro diagnostic device. Its performance metrics (Sensitivity, Specificity, Correlation) are reported for the device itself, functioning independently, with results interpreted visually or spectrophotometrically. There is no "human-in-the-loop" component in the direct processing of the sample by the device; rather, it's a lab test where technicians perform the procedure and interpret the final result based on established cutoffs.

7. The Type of Ground Truth Used

The ground truth used was a composite reference standard based on objective laboratory and pathological evidence. Specifically, it relied on a combination of:

• Culture
• Rapid Urease Test (RUT)
• Histology
• Urea Breath Test (UBT)

A patient was considered positive if culture was positive, or if two or more of the other three tests were positive. This is referred to as expert consensus (albeit on objective data) or composite clinical diagnosis.

8. The Sample Size for the Training Set

The document does not specify a separate training set or its sample size. This device is an immunoassay, not a machine learning model that typically requires a distinct training phase. Therefore, the concept of a "training set" in the context of AI models does not apply here. The performance evaluation is based on a clinical test set.

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

As noted in point 8, there is no mention of a "training set" for this immunoassay device. The ground truth for the test set was established using a composite reference standard (Culture, Rapid Urease, Histology, UBT) as detailed in point 7.

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Para-Pak SPINCON is for the concentration of eggs, larvae, and protozoa from preserved fecal specimens. Specimens preserved in 10% Formalin, Sodium Acetate Formalin (SAF), and ECOFIX may be used with the system.

Para-Pak SPINCON involves passing a surfactant treated, preserved stool specimen through a preliminary screen by gravity flow. The surfactant helps to break down fecal aggregates, thus freeing parasites. The specimen is then forced by centrifugation through a series of two screens with successively smaller mesh. The series of screens, not present in other devices, trap stool debris, yet allow even the larger parasites to pass through. This second filtration step eliminates the need for organic solvent extraction of the stool specimen. The resulting pellet may be examined for the presence of parasites by standard wet mount procedures.

SPINCON Devices: 200/500 SPINCON Caps: 200/500 SPINCON Preliminary Funnel Screens: 200/500 Para-Pak Surfactant: 33ml

The provided text describes a medical device called Para-Pak SPINCON used for concentrating parasites from fecal specimens. The acceptance criteria and the study proving the device meets these criteria are outlined as follows:

1. Table of Acceptance Criteria and Reported Device Performance:

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

The document does not explicitly state the sample size used for the test set or the data provenance (e.g., country of origin, retrospective or prospective). It simply refers to "Clinical studies."

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

The document does not provide information on the number of experts used or their qualifications to establish ground truth for the test set.

4. Adjudication Method for the Test Set:

The document does not describe any adjudication method used for the test set.

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

The document does not mention a multi-reader multi-case (MRMC) comparative effectiveness study. It compares the device's performance to a predicate device, but not in the context of human reader improvement with or without AI assistance.

6. Standalone Performance Study:

A standalone performance study was conducted to demonstrate the device's ability to concentrate eggs, larvae, and protozoa from preserved fecal specimens. The "Performance" section explicitly states "Clinical studies demonstrate equivalent performance and recovery" in comparison to the predicate device. This implies the device was evaluated on its own merits for this purpose.

7. Type of Ground Truth Used:

The ground truth used appears to be the detection and recovery of parasites from fecal specimens, with the predicate device (Para-Pak CON-Trate) serving as the benchmark for "equivalent performance and recovery" in clinical studies. This suggests a benchmarking against an established and validated method.

8. Sample Size for the Training Set:

The document does not provide information on a training set sample size. This device is a concentration system, not an AI or machine learning algorithm that would typically have a "training set."

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

As this is a physical device for specimen concentration and not an AI algorithm, the concept of a "training set" and establishing "ground truth for the training set" as it relates to AI is not applicable. The device's performance is likely evaluated through laboratory and clinical studies demonstrating its ability to correctly concentrate parasites from known positive and negative samples, as well as samples from clinical cases.

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The ImmunoCard STAT! Rotavirus Immunoassay is a rapid in vitro qualitative procedure for the detection of rotavirus antigen in human stool. The test can be used to aid in the diagnosis of rotavirus associated gastroenteritis.
For use to detect the presence of rotavirus in stool specimens from patients with loose stools, diarrhea, gastroenteritis, or suspected to be infected with rotavirus.

The ImmunoCard STAT! Rotavirus assay system is a membrane based immunogold assay for rotavirus. Each kit contains the following components: ImmunoCard STAT! Rotavirus devices(30), Positive Control (1.8ml), Sample Diluent (10.5ml), Transfer Pipets (30). In brief, 1/15 diluted stool enters the sample application pad and migrates through the conjugate pad. Monoclonal antibody (conjugated to colloidal gold particles) contained in the pad is dissolved in the specimen and travels onto the nitrocellulose membrane. The nitrocellulose membrane contains two "capture" zones. The first holds polyclonal antibody to rotavirus, and the second has polyclonal anti-mouse IgG. The first zone serves as the test line, indicating the presence of rotavirus. The second zone acts as a procedural control and verifies that the sample has migrated sufficiently into the device to permit a valid test result to be read in the first (test) zone. The final absorbent pad acts as a reservoir and draws the sample through the test strip.

{
  "1. A table of acceptance criteria and the reported device performance": {
    "Performance vs Electron Microscopy": {
      "Acceptance Criteria": "Not explicitly stated as numerical criteria, but implied to be comparable to predicate devices.",
      "Sensitivity": "93.1%",
      "Specificity": "95.8%",
      "Correlation": "94.4%"
    },
    "Performance vs Premier Rotaclone (Predicate Device)": {
      "Acceptance Criteria": "Not explicitly stated as numerical criteria, but implied demonstration of substantial equivalence.",
      "Sensitivity": "97.7%",
      "Specificity": "100.0%",
      "Correlation": "98.8%"
    },
    "Sensitivity Limits": {
      "Acceptance Criteria": "Not explicitly stated as numerical criteria.",
      "Reported Performance": "Approximately 1.8-3.7 x 10^6 viral particles."
    },
    "Reproducibility": {
      "Acceptance Criteria": "Not explicitly stated as numerical criteria.",
      "Reported Performance": "100% on controls, negative and moderate positive stools, and 96% on low positive stools."
    },
    "Cross-Reactivity": {
      "Acceptance Criteria": "No false positive or false negative results with a panel of bacteria and viruses.",
      "Reported Performance": "Met the criteria: gave no false positive or false negative results."
    },
    "Interfering Substances": {
      "Acceptance Criteria": "Barium sulfate should not have an effect. High levels of blood may affect flow, potentially causing an occasional invalid result.",
      "Reported Performance": "No effect from barium sulfate. High levels (≥33%) of blood could affect flow, resulting in an occasional invalid test result (consistent with criteria)."
    }
  },
  "2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)": "The sample size for the clinical test set is not explicitly stated in the provided text. The data provenance (country of origin, retrospective or prospective) is also not specified.",
  "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)": "Not applicable/Not specified. The ground truth for the core performance evaluation was established using Electron Microscopy and a predicate device (Premier Rotaclone), not necessarily human expert consensus for individual case adjudication.",
  "4. Adjudication method (e.g. 2+1, 3+1, none) for the test set": "Not applicable/Not specified. The performance was referenced against Electron Microscopy and a predicate device, not human adjudication of a test set.",
  "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. This is an in vitro diagnostic device, not an AI-assisted diagnostic tool for human readers.",
  "6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done": "Yes, the device performance metrics (sensitivity, specificity, correlation) are presented as standalone performance evaluations against Electron Microscopy and a predicate device, indicating algorithm-only performance.",
  "7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)": "The primary ground truth used for performance comparison was **Electron Microscopy**. A second comparison was also made against the **Premier Rotaclone** predicate device.",
  "8. The sample size for the training set": "Not applicable. For this type of in vitro diagnostic device (immunoassay), there isn't typically a 'training set' in the machine learning sense. The device's capture and detection antibodies are developed and optimized through laboratory work, not by 'training' on a dataset.",
  "9. How the ground truth for the training set was established": "Not applicable, as there is no traditional 'training set' for this immunoassay device."
}

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