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The TECHLAB® TRI-COMBO PARASITE SCREEN test is an enzyme immunoassay for the simultaneous qualitative detection of Giardia spp., Cryptosporidium spp. and/or E. histolytica antigen in human fecal specimens. The test is indicated as an aid in the diagnosis of gastrointestinal infection when giardiasis, cryptosporidiosis and amebiasis is suspected. The test does not differentiate between the three parasites and follow-up testing is required for all positive results to confirm the specific diagnosis.

The TRI-COMBO PARASITE SCREEN test is an enzyme immunoassay for the simultaneous qualitative detection of Giardia spp., Cryptosporidium spp. and/or E. histolytica antigen in human fecal specimens. The test uses monoclonal and polyclonal antibodies to cell-surface antigens of Giardia, Cryptosporidium and E. histolytica. The microassay plate in the kit contains immobilized monoclonal antibodies against the antigens, and the Conjugate consists of polyclonal antibodies against the antigens. In the assay, an aliquot of a diluted fecal specimen is transferred to a microassay well. The immobilized monoclonal antibodies bind the Giardia, Cryptosporidium and/or E. histolytica antigens if they are present. Upon addition, Conjugate then binds to the antigen/ antibody complex. Any unbound materials are 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 antigens and conjugate.

Here's an analysis of the provided text regarding the TECHLAB® TRI-COMBO PARASITE SCREEN test, structured according to your requested points:

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

The document does not explicitly state pre-defined acceptance criteria (e.g., "The device must achieve sensitivity of X% and specificity of Y%"). Instead, it presents performance data which implicitly serves as the basis for the FDA's substantial equivalence decision. Therefore, I will present the reported performance data from the prospective clinical study as the proxy for "acceptance criteria met." For the retrospective study, while providing higher values, the prospective study is generally weighted more heavily for regulatory approval as it reflects real-world conditions more closely. The document also provides "95% Confidence Limits" for sensitivity and specificity.

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

• Prospective Study:
  • Sample Size: 754 (740 negative, 14 microscopy positive - 13 Giardia, 1 E. histolytica)
  • Data Provenance: Conducted at 3 independent clinical sites. Specific country of origin is not explicitly stated, but the submission is to the U.S. FDA by a U.S. company, suggesting U.S. clinical sites. The data is prospective.
• Retrospective Study:
  • Sample Size: 96 archived specimens (previously collected and frozen)
  • Data Provenance: From one clinical site in an E. histolytica endemic area (not specified by country). The data is retrospective.

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 primarily refers to "microscopy" and "molecular testing."

• Microscopy: It states that "accuracy of O&P results depends upon the skill of the technician." This implies trained laboratory technicians or medical technologists are performing microscopy. However, the exact number of experts or their specific qualifications (e.g., board certification, years of experience) are not provided in the document.
• Molecular Testing: The document mentions "molecular testing of a commercial FDA cleared device and PCR with sequencing." It does not specify the number or qualifications of experts involved in interpreting or performing these molecular tests.

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

The document does not describe a formal adjudication method (e.g., 2+1, 3+1) involving multiple human readers for discrepancies. Instead, discrepancies between the device and microscopy were resolved via further testing:

• For the prospective study, the 14 TRI-COMBO PARASITE SCREEN positives that were microscopy negative were "confirmed to be positive for Giardia with an alternate FDA cleared antigen test or by PCR with sequencing." This constitutes a form of resolution by a more definitive method rather than human adjudication.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

This is not an AI-assisted device for human readers. The device is an in vitro diagnostic (IVD) immunoassay for detecting antigens in fecal specimens. Therefore, an MRMC comparative effectiveness study involving human readers improving with AI assistance is not applicable to this device. The comparison is between the immunoassay and traditional methods (microscopy and molecular testing).

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

Yes, the device is a standalone diagnostic test (an immunoassay). Its performance is evaluated directly against comparator methods (microscopy, PCR, other FDA-cleared antigen tests) without human interpretation of the device's generated data being a variable. The test results are "spectrophotometric" or "visual" interpretations of a color change, but the core performance data reflects the device's ability to detect the analytes by itself.

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

The ground truth for the test sets was established using a combination of:

• Microscopy: Primarily light microscopy for identification of Giardia, Cryptosporidium, and E. histolytica.
• Molecular Testing:
  • For the prospective study, "composite results from multiple tests that consisted of light microscopy, molecular testing of a commercial FDA cleared device and PCR with sequencing for the identification of Giardia spp., Cryptosporidium spp., in addition to identification and subspeciation of E. histolytica." This "composite" is considered the ground truth.
  • For discrepancies, "alternate FDA cleared antigen test or by PCR with sequencing" was used.
• Archived Specimen Characterization: For the retrospective study, specimens were characterized as "microscopy and PCR positive."

8. The sample size for the training set

The document describes performance studies for the device but does not mention a training set because this is an in vitro diagnostic (IVD) immunoassay, not a machine learning or AI-based device that requires a training set. The design of the assay (antibodies, reagents) is based on scientific principles and previous research, not on learning from a specific dataset.

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

As there is no training set for this type of device, this question is not applicable.

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Trinity Biotech Uni-Gold™ Cryptosporidium is a single use rapid immunoassay for the qualitative detection of Cryptosporidium parvum (C. parvum) antigens in human stool specimens. This test is intended for use with patients with gastrointestinal symptoms as an aid in the diagnosis of suspected Cryptosporidium gastrointestinal infections. As with other Cryptosporidium tests, results should be considered in conjunction with the clinical evaluation and medical history. For In-Vitro Diagnostic use.

The Trinity Biotech Uni-Gold™ Cryptosporidium Test was designed as a single use, rapid, lateral flow immunoassay to detect the presence of Cryptosporidium parvum antigen in unpreserved (fresh & frozen), preserved, and media containing human stool specimens. The Trinity Biotech Uni-Gold™ Cryptosporidium test strip (5mm x 60mm) combines a nitrocellulose membrane with designated fiber pads (conjugate, sample and absorbant). The test strip is then placed into a plastic housing and is sealed constituting the Test Device.

Here's an analysis of the acceptance criteria and study details for the Uni-Gold™ Cryptosporidium device, based on the provided 510(k) summary:

1. Table of Acceptance Criteria and Reported Device Performance

The 510(k) summary does not explicitly state pre-defined "acceptance criteria" in terms of numerical thresholds for sensitivity and specificity. Instead, it presents the results of studies and aims to demonstrate substantial equivalence to a predicate device. For the purpose of this request, I will infer the implicit acceptance is achieving high sensitivity and specificity in comparison to gold standard methods and predicate devices.

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

• Comparator Device Study (Side-by-side with Remel Xpect®): 299 retrospective samples. Data provenance: United States (multiple external sites). Sample matrices included unpreserved frozen, Cary Blair, SAF, and formalin.
• Sensitivity/Specificity Study (vs. DFA Microscopy): 234 retrospective samples (77 positive, 157 negative). Data provenance: United States (2 external laboratories). Sample matrices included formalin, SAF, unpreserved frozen, Cary Blair, and C&S.
• Additional Retrospective Studies (vs. Non-fluorescent Microscopy):
  • Site 2: 47 retrospective samples (26 positive, 21 negative) vs. Modified Acid-Fast Stain.
  • Site 3: 281 retrospective SAF samples (60 positive, 221 negative) vs. Modified Kinyoun Stain.
• Prospective Study (vs. DFA Microscopy): 378 samples (all negative). Data provenance: one external laboratory in the US. Sample matrices included unpreserved fresh, unpreserved frozen, formalin, SAF, C&S, and Cary Blair.
• Overall Combined Test Set: 940 (prospective and retrospective) samples. Data provenance: Collected from Hospitals throughout the US and Canada.

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

The document does not specify the number of individual experts or their exact qualifications (e.g., number of years of experience, specific medical specialty) used to establish the ground truth for the test sets.

Instead, it refers to "DFA microscopy," "Modified Kinyoun Stain light microscopy," and "Modified Acid-Fast Stain" as the reference methods (ground truth). It is implied that these microscopy methods are performed and interpreted by trained laboratory professionals, but specific expert details are not provided.

4. Adjudication Method for the Test Set

The document does not describe an explicit adjudication method (e.g., 2+1 reader consensus) for resolving discrepancies in the reference methods (DFA microscopy, Modified Kinyoun Stain, Modified Acid-Fast Stain).

In cases of discrepancy between the Uni-Gold™ device and the comparator/reference method within the studies, some retesting or re-evaluation against a "higher" ground truth was performed:

• Site 3 (Comparator Device Study): For the 51 samples positive by Uni-Gold™ but negative by comparator, 30 were positive by Modified Kinyoun Stain light microscopy and 3 by DFA microscopy (agreeing with Uni-Gold™). The one sample negative by Uni-Gold™ and positive by comparator was negative by Modified Kinyoun Stain microscopy (agreeing with Uni-Gold™). This indicates that microscopy was used as an adjudicator for samples where the test device and the comparator device disagreed.
• Site 3 (Non-fluorescent Microscopy Study): For the 23 negative samples (by Modified Kinyoun Stain) that tested positive on Uni-Gold™, three subsequently tested positive by DFA microscopy (agreeing with Uni-Gold™). This implies DFA microscopy acted as a higher-level adjudicator for certain discrepancies.

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 question is not applicable to the Uni-Gold™ Cryptosporidium device. The device is a rapid in vitro diagnostic immunoassay, not an AI-assisted diagnostic tool that involves human readers interpreting images. Therefore, an MRMC comparative effectiveness study involving human readers and AI assistance was not performed and is not relevant to this type of device.

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

This question is also not applicable. The Uni-Gold™ Cryptosporidium device is a standalone lateral flow immunoassay. Its performance is the "algorithm only" performance (the chemical reaction and visual readout) without human intervention in the detection process itself, beyond the initial sample preparation and result interpretation. There is no separate "algorithm without human-in-the-loop" performance as it is the test.

7. The Type of Ground Truth Used

The primary types of ground truth used for the test sets were:

• DFA Microscopy: Direct Fluorescent Antibody microscopy, considered a gold standard for Cryptosporidium detection.
• Modified Kinyoun Stain Light Microscopy: A non-fluorescent microscopy staining method.
• Modified Acid-Fast Stain: Another non-fluorescent microscopy staining method.
• Comparator Device Results: In some comparative studies, the results of the legally marketed predicate device (Remel Xpect® Cryptosporidium) were used for comparison. However, when discrepancies arose in these studies, microscopy methods (DFA or Modified Kinyoun) were often used to adjudicate.
• Clinical Evaluation and Medical History: The intended use statement notes that "results should be considered in conjunction with the clinical evaluation and medical history," implying that clinical context is part of the broader diagnostic process, but the technical ground truth for device performance was microscopy.

8. The Sample Size for the Training Set

The document does not explicitly mention a "training set" in the context of device development or any machine learning algorithm. This device is a biochemical immunoassay, not an AI or machine learning model that requires a discrete training set. The development of the assay's reagents and parameters would have involved internal validation and optimization, but not in the sense of a machine learning training set.

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

Since there is no "training set" for an AI/ML algorithm in this context, this question is not applicable. The ground truth for developing and optimizing the immunoassay would have been established through standard laboratory practices using known positive and negative controls, and possibly characterized clinical samples, during the assay development process, prior to the formal validation studies presented here.

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The GIARDIA/CRYPTOSPORIDIUM CHEK™ test is an enzyme immunoassay for the qualitative detection of Giardia cyst and Cryptosporidium oocyst antigen in human fecal specimens. It is indicated for use as an aid in the diagnosis of patients with diarrhea suspected of Giardia and/or Cryptosporidium gastrointestinal infections.

The GIARDIA/CRYPTOSPORIDIUM CHEK™ test uses monoclonal and polyclonal antibodies to cell-surface antigens of Giardia and an oocyst antigen of Cryptosporidium. The Microassay Plate in the kit contains immobilized monoclonal antibodies against the antigens and the Conjugate consists of polyclonal antibodies against the antigens. In the assay, an aliquot of a diluted fecal specimen is transferred to a microassay well. The immobilized monoclonal antibodies bind the Giardia and Cryptosporidium antigens if the antigens are present. Upon addition, Conjugate then binds to the antigen/antibody complex. Any unbound materials are 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 Giardia or Cryptosporidium antigens and Conjugate.

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

Acceptance Criteria and Device Performance

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state pre-defined acceptance criteria in terms of clinical performance thresholds. Instead, it presents the device's performance in comparison to predicate devices (ELISA) and microscopy. The implication is that the performance must be demonstrably comparable or superior to these established methods.

Here's the reported device performance:

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

• Sample Size (Clinical Evaluation compared to ELISA): n = 590 fecal specimens.
• Sample Size (Clinical Evaluation compared to Microscopy): n = 217 fecal specimens.
• Data Provenance: The samples were collected from "three clinical study sites" (Table 1) and specifically "Site 1" for the microscopy comparison (Table 2). The country of origin is not explicitly stated, but the submission is to the U.S. FDA, suggesting the studies were likely conducted in the U.S. The data appears to be prospective clinical evaluation data, as it describes "clinical evaluations" and samples "used in the clinical evaluation of the test."

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

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

• For the comparison to the commercially available ELISA (ProSpecT® Giardia/Cryptosporidium Microplate Assay), the ELISA itself served as a reference.
• For the comparison to microscopy, the ground truth was established by "IFA-confirmed microscopy results." The individuals performing or confirming these IFA microscopy results are not described.

4. Adjudication Method for the Test Set

The document does not describe an explicit adjudication method. The comparisons are made directly against the results of the reference methods (commercial ELISA or IFA-confirmed microscopy).

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

This device is an enzyme immunoassay (ELISA), not an AI-powered image analysis or diagnostic tool that involves human readers interpreting results with or without AI assistance. Therefore, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study of human readers with AI assistance is not applicable and was not performed.

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

Yes, the studies presented are for the device (GIARDIA/CRYPTOSPORIDIUM CHEK™) in a standalone capacity. The device itself performs the qualitative detection of antigens. The performance metrics (sensitivity, specificity, agreement) are for the assay's ability to detect the target antigens directly, without explicit human-in-the-loop interpretation that would significantly alter its performance.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)

The ground truth for the clinical evaluations was established by:

• Predicate Device Performance: Comparison to a "commercially available ELISA" (ProSpecT® Giardia/Cryptosporidium Microplate Assay) which itself is an established diagnostic method.
• IFA-Confirmed Microscopy: This is a laboratory diagnostic method where trained personnel visualize parasites in samples, and the "IFA-confirmed" implies an additional, highly specific immunological staining technique to confirm the identity of Giardia cysts and Cryptosporidium oocysts. This can be considered a form of expert-driven laboratory confirmation.

8. The Sample Size for the Training Set

This document describes a diagnostic test kit (ELISA), not a machine learning or AI algorithm. Therefore, the concept of a "training set" in the context of AI development is not applicable. The device's components (antibodies, reagents) are developed and optimized through laboratory research, but not via training on a data set in the same manner as an AI model.

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

As noted above, the concept of a "training set" is not applicable for this type of device. The ground truth for the analytical studies (sensitivity, specificity, cross-reactivity) was established using known positive and negative controls, spiked samples with quantified antigen levels, and samples positive for other specific pathogens.

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The CRYPTOSPORIDIUM II test is an enzyme immunoassay for the qualitative detection of Cryptosporidium oocyst antigen in human fecal specimens. It is indicated for use as an aid in the diagnosis of patients with diarrhea suspected of Cryptosporidium gastrointestinal infection. FOR IN VITRO DIAGNOSTIC USE.

Not Found

The provided text is a 510(k) premarket notification letter from the FDA, granting market clearance for the "CRYPTOSPORIDIUM II" device. It outlines the device's indications for use and states that it has been deemed substantially equivalent to a legally marketed predicate device.

However, the provided text does not contain the detailed study information required to answer your specific questions regarding acceptance criteria, reported device performance, sample sizes, ground truth establishment, expert qualifications, or MRMC comparative effectiveness studies. This type of information is typically found in the 510(k) summary or the actual study reports submitted to the FDA, not in the clearance letter itself.

The letter explicitly states: "We have reviewed your Section 510(k) premarket notification of intent to market the device we have and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (the Act) that do not require approval of a premarket approval application (PMA)." This indicates that the device was cleared based on substantial equivalence, not necessarily on a de novo study proving it meets specific acceptance criteria with detailed performance metrics in the way you've outlined for an AI/imaging device.

Therefore, I cannot populate the table or answer the subsequent questions based solely on the provided text. To get this information, you would need to access the full 510(k) submission for K052932, which might be publicly available through FDA databases or by request.

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REMEL's Xpect™ Cryptosporidium kit is an in vitro qualitative immunoassay for the detection of Cryptosporidium antigens in preserved and unpreserved fecal specimens. This test is intended as an aid in the laboratory diagnosis of suspected Cryptosporidium infections.

The Xpect™ Cryptosporidium Lateral Flow Assay is a chromatographic immunoassay that detects the presence of Cryptosporidium antigen. The test utilizes sample wicking to capture Cryptosporidium antigen on a test line containing antigen-specific antibody. A specimen is added to a dilution tube containing a buffered solution. A conjugate containing colored micro-particles linked to murine monoclonal antibody specific for Cryptosporidium is added. The mixture is dispensed into the sample well of the device and wicks along a membrane containing capture antibody stripes. The Cryptosporidium immune complex, if present, reacts with anti-Cryptosporidium antibody at the test line. Conjugate not bound at the test line is later captured at the control line containing anti-mouse antibody. A red line of any intensity will appear at the Cryptosporidium test position if Cryptosporidium antigen is present. A line in the Control position indicates that the test is working properly.

Here's a summary of the acceptance criteria and study details for the Xpect™ Cryptosporidium Lateral Flow Assay, based on the provided 510(k) notification:

Acceptance Criteria and Device Performance

Study Details

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

   • Sensitivity/Specificity Study:
     • Total Samples: 578 (112 positive for Cryptosporidium by microscopy, 466 negative by microscopy).
     • Provenance: Not explicitly stated regarding country of origin; the study was conducted at "six geographically diverse laboratories" (implying multiple sites within a country or potentially internationally), and data was retrospective (compared to microscopy, which would have been performed on collected samples).
   • Percent Agreement Study (Comparison with Predicate):
     • Total Samples: 146 (30 positive for Cryptosporidium by microscopy, 116 negative by microscopy).
     • Provenance: Not explicitly stated regarding country of origin or retrospective/prospective nature.

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

   • The ground truth for the test set was established by microscopy. The document does not specify the number of experts (e.g., microscopists) involved in reading these slides or their qualifications. It's common in diagnostic studies for the comparator method (like microscopy) to be performed by qualified laboratory personnel, but this detail is not provided.

3. Adjudication method for the test set:

   • The document does not specify any formal adjudication method for the microscopy results that served as the ground truth. It simply states the comparison was "to microscopy."

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, an MRMC comparative effectiveness study was not done. This device is a standalone in vitro diagnostic (IVD) lateral flow assay, not an AI or imaging device designed to assist human readers.

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

   • Yes, this was a standalone performance study. The Xpect™ Cryptosporidium Lateral Flow Assay is an "algorithm-only" in the sense that it provides a direct qualitative result (presence/absence of a line) without human interpretation beyond reading the line. The presented sensitivity and specificity values represent the performance of the device itself.

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

   • The primary ground truth used was microscopy (specifically, for detection of Cryptosporidium).

7. The sample size for the training set:

   • The document does not provide information regarding a separate training set for algorithm development. As this is a lateral flow immunoassay, not an AI or machine learning model, a distinct "training set" in the context of data-driven algorithm development is typically not applicable. The assay's performance characteristics are inherent to its design and manufacturing.

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

   • As there's no explicit mention of a training set in the context of algorithm development, this information is not applicable to this device. Early development and optimization of the assay would involve various characterized positive and negative samples, but these are not typically referred to as a "training set" in the same way as for AI.

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This microwell enzyme linked immunoabsorbant assay (ELISA) detection kit is an in vitro diagnostic (IVD) immunoassay for the detection of Cryptosporidium antigen in human feces using peroxidase as the enzyme. The assay may be read visually or with an ELISA reader. This IVD assay is intended to be used with stools that are fresh, frozen or preserved in 10% formalin, SAF or Medical Chemical Corporation's (MCC) Universal fixative. Concentrated samples cannot be used with this IVD.

This microwell enzyme-linked immunoabsorbant assay (ELISA) detection kit (Cryptosporidium ELISA Kit) is an in vitro diagnostic (IVD) immunoassay for the detection of antigen to Cryptosporidium species in human feces using peroxidase as the indicator enzyme. The assay may be read visually or with an ELISA reader. Concentrated fecal samples cannot be used with this immunoassay. Rather, this IVD Cryptosporidium ELISA Kit is intended to be used with human stools that are fresh, frozen or preserved in 10% formalin, SAF or Medical Chemical Corporation's (MCC's) Universal fixative in a clinical laboratory use setting.

This ELISA is an in vitro immunoassay for the qualitative determination of Cryptosporidium species antigen in feces. The ELISA uses a rabbit anti-Cryptosporidium antibody to capture the antigen from the stool supernatant. A second goat anti-Cryptosporidium antibody is then added which sandwiches the captured antigen. This reaction is visualized by the addition of an anti-second antibody conjugated to peroxidase and the chromogen tetramethylbenzidine (TMB). The resulting blue color development indicates the presence of Cryptosporidium species antigens being bound by the anti-Cryptosporidium antibodies.

Here's an analysis of the acceptance criteria and study details for the IVD Research Inc.'s Cryptosporidium Human Fecal Antigen Detection Microwell ELISA Kit, based on the provided text:

Acceptance Criteria and Device Performance

The acceptance criteria are implied by the performance metrics reported for comparison to the gold standard and the predicate device. For diagnostic tests, this generally includes high sensitivity, specificity, and agreement rates.

Study Details

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

   • Study #1 (Outside Lab): 174 human fecal specimens (formalin, SAF, fresh/frozen and Universal Fixative preserved stools). Data provenance is from "clinical laboratories or in-house collections," making it retrospective. The country of origin is not explicitly stated but is implied to be the US, given the FDA submission.
   • Study #2 (Manufacturer Performed): 44 fresh or fresh/frozen human fecal specimens. Data provenance is from "clinical laboratories or in-house collections," making it retrospective. The country of origin is implied to be the US.

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

   • The document does not specify the number of experts or their qualifications for establishing the ground truth (O&P microscopy results or other commercial ELISA results). It only refers to "O&P microscopy" as the "gold standard for parasitology" and "another commercial ELISA."

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

   • The document does not describe any specific adjudication method for the ground truth. It simply states that the results were interpreted against O&P microscopy or another commercial ELISA.

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, a multi-reader multi-case (MRMC) comparative effectiveness study was not performed. This is an ELISA kit, not an AI-assisted diagnostic tool for human readers.

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

   • Yes, this is effectively a standalone diagnostic device. The ELISA kit itself provides the qualitative determination. While a human reads the results (visually or with an ELISA reader), the performance metrics reported are for the kit's ability to detect the antigen, independent of human interpretive variability beyond simply reading a color change or optical density.

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

   • For Study #1, the ground truth was O&P (Ova and Parasite) microscopy, considered the "gold standard for parasitology."
   • For Study #2, the ground truth was O&P microscopy and/or another commercial ELISA.

7. The sample size for the training set:

   • The document does not explicitly mention a "training set" in the context of machine learning or algorithm development. This refers to an ELISA kit, not an AI model. The studies described are validation (test) sets.

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

   • Given that this is an immunoassay kit and not an AI/machine learning device, there isn't a "training set" in the conventional sense. The "ground truth" for the test sets was established by O&P microscopy or a commercial ELISA, as described above.

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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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ProSpecT® Cryptosporidium Microplate Assay uses monoclonal antibodies for the qualitative detection of Cryptosporidium Specific Antigen (CSA) in aqueous extracts of fecal specimens.

ProSpecT® Cryptosporidium Microplate Assay

The provided document is a 510(k) clearance letter from the FDA for a device called "ProSpecT® Cryptosporidium Microplate Assay." It does not contain detailed information about the acceptance criteria or a study proving the device meets those criteria. The letter primarily states the FDA's finding of substantial equivalence to a predicate device.

Therefore, I cannot extract the requested information about acceptance criteria and study details from this document. The document confirms the device's classification and allows it to be marketed but does not delve into the specifics of performance studies.

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The Cryptosporidium TEST is an enzyme immunoassay for the qualitative detection of Cryptosporidium oocyst antigen in fecal specimens. It is indicated for use with fecal specimens from patients with diarrhea to determine the presence of Cryptosporidium gastrointestinal infection. This test can be used for fecal specimens submitted for routine clinical testing from adults or children. FOR IN VITRO DIAGNOSTIC USE.

The kit, which includes ready-to-use reagents, contains microtiter wells coated with monoclonal antibody, positive control reagent, detecting antibody (polyclonal antibody), conjugate (anti-rabbit IgG-peroxidase), substrates, wash solution, and stop solution. The microtiter wells coated with monoclonal antibody "capture" the antigen and the polyclonal antibody serves as the "detecting" antibody. The polyclonal antibody used as the detecting antibody is prepared from hyperimmune antiserum developed in rabbits. The monoclonal antibody used to coat microtiter wells is prepared from mouse ascites fluid.

1. Acceptance Criteria and Reported Device Performance:

2. Sample Size and Data Provenance:

The document does not specify the exact sample size used for the test set. It only mentions "clinical evaluations" and comparison with other methods. The data provenance is not explicitly stated in terms of country of origin or whether it was retrospective or prospective.

3. Number of Experts and Qualifications for Ground Truth:

The document does not specify the number of experts or their qualifications used to establish the ground truth. It refers to "microscopy with conventional staining and immunofluorescence" as methods for detection, implying expert interpretation, but offers no details about the experts themselves.

4. Adjudication Method:

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

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

No MRMC comparative effectiveness study is mentioned. The study focuses on the standalone performance of the device compared to other detection methods.

6. Standalone Performance Study:

Yes, a standalone performance study was conducted. The Cryptosporidium TEST was directly compared against established methods (microscopy with conventional staining, immunofluorescence, and the Alexon ProSpecT Cryptosporidium Microplate Assay) to evaluate its effectiveness in detecting Cryptosporidium in fecal specimens.

7. Type of Ground Truth Used:

The ground truth used was based on established laboratory diagnostic methods:

• Detection of the organism in fecal specimens by microscopy with conventional staining.
• Detection of the organism in fecal specimens by immunofluorescence.
• Detection of Cryptosporidium antigen in fecal specimens using the Alexon ProSpecT Cryptosporidium Microplate Assay (a predicate device).

8. Sample Size for the Training Set:

The document does not specify the sample size for the training set.

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

The document does not provide information on how the ground truth for any training set was established. The focus of this submission is on the clinical evaluation of the device's performance against existing methods for substantial equivalence. It's common for 510(k) submissions, especially older ones, not to detail training data if the device's development wasn't explicitly machine learning-driven in a way that requires extensive training set documentation.

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The TechLab Crypto-Cel IF Test can be used to detect Cryptosporidium oocysts in fecal specimens from persons suspected of having intestinal disease due to this pathogen.

The kit, which includes ready-to-use reagents, contains an antibody reagent consisting of FITC-labeled anti-Cryptosporidium monoclonal antibody. This antibody functions as the detecting antibodies. The monoclonal antibody is prepared from mouse ascites fluid.

This document describes a diagnostic test for detecting Cryptosporidium oocysts in fecal specimens. As such, concepts like "AI," "machine learning," "training sets," "test sets," "ground truth," "MRMC studies," and "adjudication methods" are not applicable in their typical sense. Instead, the study evaluates the performance of a new diagnostic device against existing, approved diagnostic methods.

Here's an interpretation of the provided text in the context of diagnostic device evaluation, addressing the requested categories where feasible:

1. Table of Acceptance Criteria and Reported Device Performance

The concept of specific "acceptance criteria" for performance metrics like sensitivity, specificity, or accuracy is not explicitly stated with numerical targets in the provided text. Instead, the primary acceptance criterion appears to be demonstrating substantial equivalence to an already approved immunofluorescent test.

The performance is reported as a correlation rather than traditional diagnostic accuracy metrics.

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

The exact sample sizes for the "two studies" are not provided in the text. The data provenance (country of origin, retrospective/prospective) is also not specified. The studies are clinical evaluations comparing the new test to existing ones, implying they involved fecal specimens from persons suspected of having intestinal disease.

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

The concept of "experts establishing ground truth" in the AI sense is not directly applicable here. The "ground truth" for the performance comparison is established by existing, approved diagnostic tests themselves. Therefore, human experts did not "establish" the ground truth for this specific study in the way they might annotate images for an AI. The experts involved would be the laboratory personnel performing and interpreting the reference immunofluorescent tests. Their qualifications are not specified.

4. Adjudication Method for the Test Set

Adjudication methods (like 2+1 or 3+1) are typically used to resolve discrepancies among multiple human readers or between human readers and an AI. Since the comparison is between two laboratory assays, no human adjudication method in this sense would be used. The "truth" is determined by the results of the reference assays.

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 was not done. This type of study is relevant for evaluating the impact of AI assistance on human performance. The provided text describes a direct comparison between two diagnostic assays, not an AI system.

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

Yes, in a sense, a "standalone" performance was evaluated. The Crypto-Cel IF Test is a laboratory assay that produces a result (detection of oocysts). Its performance was assessed independently by comparing its results to those of other established laboratory assays. There is no "human-in-the-loop" performance in the AI context; the test itself is the "algorithm" and its output is compared.

7. The Type of Ground Truth Used (Expert Consensus, Pathology, Outcomes Data, etc.)

The "ground truth" for evaluating the Crypto-Cel IF Test was established by the results of existing, approved immunofluorescent diagnostic tests (Merifluor Cryptosporidium/Giardia Direct Immunofluorescent Detection Procedure and Crypto/Giardia-Cel IF Test). These tests themselves are considered the standard for detecting Cryptosporidium oocysts in fecal specimens.

8. The Sample Size for the Training Set

There is no training set in this context. The Crypto-Cel IF Test is a traditional immunofluorescent assay, not an AI model that undergoes a training phase.

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

Since there is no training set, this question is not applicable.

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