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The OSOM® Strep A Test is a color immunochromatographic assay intended for the qualitative detection of Group A streptococcal antigen directly from throat swab specimens.

The OSOM® Strep A Test is a color immunochromatographic assay.

This document is a 510(k) clearance letter from the FDA for the OSOM® Ultra Strep A Test. It indicates that the device is substantially equivalent to legally marketed predicate devices. However, this letter does not contain the acceptance criteria, details of a study proving the device meets acceptance criteria, or any of the specific information requested in your prompt.

The letter is primarily focused on confirming the regulatory clearance for the device and outlining the manufacturer's ongoing responsibilities. It mentions the "indications for use" as an enclosure, but this enclosure (Attachment #1) only describes what the device is for (qualitative detection of Group A streptococcal antigen from throat swab specimens) and not the performance criteria or study results.

Therefore, based solely on the provided document, I cannot answer your questions regarding:

1. A table of acceptance criteria and reported device performance.
2. Sample sizes or data provenance for a test set.
3. Number or qualifications of experts for ground truth.
4. Adjudication method for the test set.
5. MRMC comparative effectiveness study results or effect size.
6. Standalone performance.
7. Type of ground truth used.
8. Sample size for the training set.
9. How ground truth for the training set was established.

This information would typically be found in the 510(k) submission itself or in a summary document within that submission, not in the clearance letter.

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The OSOM® Card Pregnancy Test is intended for the qualitative determination of human chorionic gonadotropin, hCG, in urine for early detection of pregnancy for home use.

OSOM® Card Pregnancy Test uses color immunochromatographic technology with antibodies coated on the membrane. If hCG is present in urine, a blue test line will appear to indicate a positive result.

Here's an analysis of the provided text to extract information about the acceptance criteria and the study that proves the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance:

The document doesn't explicitly state "acceptance criteria" as a separate section with pass/fail thresholds. However, it presents precision data which implies the expected performance. The key performance metrics are sensitivity and specificity.

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

• Sample Size:
  • For comparison to a professional hCG test: 217 urine specimens.
  • For consumer testing: 74 participants.
• Data Provenance: The document does not specify the country of origin. It does not explicitly state if the data was retrospective or prospective, but "consumer testing" and comparison with a "professional hCG test" imply prospective collection for evaluation.

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

The document broadly mentions "professional hCG test" and "clinical status" without detailing the number or specific qualifications of experts involved in establishing the ground truth for the 217 specimens or the 74 participants.

4. Adjudication Method for the Test Set:

The document does not describe any specific adjudication method (e.g., 2+1, 3+1). It states that the OSOM® Card Pregnancy Test was "compared to a professional hCG test, OSOM® Classic hCG Urine Test" and "consumer testing was conducted... evaluated against their clinical status." This implies a direct comparison rather than an adjudication process involving multiple human readers for discrepancies.

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

No, an MRMC comparative effectiveness study was not explicitly done. The study compares the device's performance to a professional test and consumer clinical status, not human readers with or without AI assistance. The device itself is a diagnostic test, not an AI-assisted interpretation tool for human readers.

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

Yes, a standalone performance evaluation was done. The precision data (sensitivity and specificity) of the OSOM® Card Pregnancy Test was determined by comparing its results directly to a "professional hCG test" and the "clinical status" of consumers. The OSOM® Card Pregnancy Test is a non-AI diagnostic kit, so its performance is inherently standalone.

7. The Type of Ground Truth Used:

• For sensitivity and specificity: Comparison to a "professional hCG test (OSOM® Classic hCG Urine Test)". This serves as a reference standard, implying it's a higher-tier or validated test used to establish the true presence or absence of hCG.
• For overall agreement (consumer testing): "Clinical status" of the 74 participants. This likely refers to a confirmed pregnancy status obtained through other clinical means (e.g., physician diagnosis, repeat lab tests).

8. The Sample Size for the Training Set:

The document does not mention any training set size. This device is described as an immunochromatographic test, not a machine learning model, so the concept of a "training set" in the context of AI is not applicable here.

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

As there is no mention of a training set for an AI/machine learning model, this question is not applicable. The device's design and manufacturing process would be based on established chemical and biological principles for immunochromatography rather than a data-driven training process.

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The OSOM® Card II hCG-Urine Test is intended for the qualitative determination of human chorionic gonadotropin (hCG) in urine for early detection of pregnancy. FOR LABORATORY AND PROFESSIONAL IN VITRO USE ONLY.

OSOM® Card II hCG-Urine Test uses color immunochromatographic technology with antibodies coated on the membrane. If hCG is present in urine, a blue test line in Result Window will appear to indicate a positive result.

Here's an analysis of the acceptance criteria and study details for the OSOM® Card II hCG-Urine Test, based on the provided text:

1. Acceptance Criteria and Reported Device Performance

The document doesn't explicitly state quantitative acceptance criteria in a dedicated section. However, based on the "Substantial Equivalence" claim and the "Precision" study, the implied acceptance criteria are achieving high sensitivity and specificity comparable to the predicate devices.

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

• Sample Size for Test Set:
  • For the comparison study with OSOM® Classic hCG Urine Test: 217 urine specimens.
  • For the physician's office evaluation: The exact number of samples in the "randomly coded panel consisting of negative, low positive and moderate positive samples" is not specified, but it was tested over three days at three different offices.
• Data Provenance: Not explicitly stated (e.g., country of origin). The studies appear to be prospective, as the specimens were tested with the new device.

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

• Number of Experts: Not specified.
• Qualifications of Experts: Not specified. The comparison study uses the "OSOM® Classic hCG Urine Test" as a comparator, which would imply the ground truth was established by that test or by an independent method against which both tests were compared. For the physician's office evaluation, "expected results" implies a pre-determined ground truth, likely established by laboratory reference methods or expert consensus, though the specific method and experts are not detailed.

4. Adjudication Method for the Test Set

• No explicit adjudication method (e.g., 2+1, 3+1) is described for either study. For the comparison study, it's assumed the results of the OSOM® Classic hCG Urine Test served as the reference. For the physician's office evaluation, the "expected results" served as the reference.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, If So, What Was the Effect Size of How Much Human Readers Improve with AI vs Without AI Assistance

• No MRMC study was done. This device is an in-vitro diagnostic (IVD) test, not an AI-assisted diagnostic tool. Therefore, questions regarding human reader improvement with AI assistance are not applicable.

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

• A standalone performance evaluation was done. The "Precision" study, which reports sensitivity and specificity and the physician's office evaluation, assess the performance of the device itself (the OSOM® Card II hCG-Urine Test) in detecting hCG, without describing a human interpretation step that is separated from the device's inherent result output. The device itself produces a visual result (a blue test line).

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

• For the comparison study: The ground truth was established by comparison to a legally marketed predicate device, the "OSOM® Classic hCG Urine Test." This implies the predicate device's results were considered the reference truth.
• For the physician's office evaluation: The ground truth was based on "expected results" for a "randomly coded panel consisting of negative, low positive and moderate positive samples." This suggests that the panel samples had their hCG status confirmed by a highly reliable reference method (e.g., quantitative hCG assay, expert-verified reference standard), ensuring known negative and positive concentrations.

8. The Sample Size for the Training Set

• The document describes performance studies (test sets) but does not mention a separate training set. This is typical for IVD devices where the "training" (if any, in the context of analytical performance) is done during development and validation, not explicitly detailed as a separate data set for an algorithm.

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

• Not applicable, as no separate training set is described in the provided text.

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The OSOM™ hCG-Urine Test is intended for the qualitative determination of human chorionic gonadotropin (hCG) in urine for early detection of pregnancy. FOR LABORATORY AND PROFESSIONAL IN VITRO USE ONLY.

Wyntek's OSOM hCG- Urine Test uses color immunochromatographic stick technology with antibodies coated on the membrane. If hCG is present in urine, a blue test line will appear to indicate a positive result.

Here's an analysis of the OSOM hCG-Urine Test's acceptance criteria and the study that proves its performance, based on the provided documents:

Acceptance Criteria and Device Performance for OSOM™ hCG-Urine Test

1. Table of Acceptance Criteria and Reported Device Performance

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

• Comparison Study: "limited sample size" - The exact number of samples is not specified.
• Physician Office Evaluation: A "randomly coded panel consisting of negative, low positive and moderate positive samples" was used. The total number of samples in this panel is not specified, nor is how many times they were tested over the three days.
• Data Provenance: The document does not explicitly state the country of origin for the data or whether it was retrospective or prospective. Given the context of a 510(k) submission for a diagnostic device prior to marketing, it is highly likely that these were prospective studies conducted specifically for regulatory submission, probably in the United States (where the company is based and the FDA operates).

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

• The document does not specify the number of experts used to establish the ground truth.
• The qualifications of those experts are also not mentioned. The physician office evaluation implies healthcare professionals (physicians or their staff) were involved in generating the results, but their role in establishing the "expected results" (ground truth) for the coded panel is unclear.

4. Adjudication Method for the Test Set

• The document does not describe any specific adjudication method (e.g., 2+1, 3+1).
• For the physician office evaluation, it states "The results obtained had 100% agreement with the expected results," implying a direct comparison against a pre-established ground truth without a complex adjudication process between multiple readers of the new device.

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

• No, a multi-reader, multi-case (MRMC) comparative effectiveness study was not done. This device is a rapid diagnostic test, not an imaging or complex interpretation system where MRMC studies are typically employed to assess human reader performance with and without AI assistance. The precision study involved multiple sites (physician offices) but not multiple readers for comparative effectiveness.

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

• Yes, the studies described primarily assess the standalone performance of the device itself (the OSOM hCG-Urine Test). Although human interpretation of the color lines is inherent to the use of such a test, the "100% agreement with expected results" suggests the test's intrinsic ability to correctly indicate positive or negative. The "algorithm" here is the immunochromatographic stick technology, and its performance is reported. There isn't an "AI" component mentioned that would typically distinguish between an algorithm-only and human-in-the-loop performance in the modern sense.

7. The Type of Ground Truth Used

• For the comparison study with the Abbott TestPack Plus hCG Urine Test, the predicate device's results likely served as a form of ground truth or reference standard.
• For the physician office evaluation, the ground truth was established as "expected results" for the randomly coded panel of negative, low positive, and moderate positive samples. This implies that the hCG concentration in these samples was independently confirmed (likely through a highly accurate laboratory method, though not specified) to determine their true positive/negative/concentration status. This would typically be a form of analytical reference standard based on known sample characteristics.

8. The Sample Size for the Training Set

• The document does not mention a "training set" in the context of machine learning or AI. This device is a chemical immunoassay, not an AI or algorithm that requires a separate training phase with labeled data. All mentioned samples are for performance evaluation (test/validation).

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

• As there is no "training set" in the AI/machine learning sense for this device, this question is not applicable. The device's underlying chemistry and design are based on established biological principles, not trained on data.

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The OSOM™ Card hCG-Urine Test is intended for the qualitative determination of human chorionic gonadotropin (hCG) in urine for early detection of pregnancy. FOR LABORATORY AND PROFESSIONAL IN VITRO USE ONLY.

OSOM Card hCG-Urine Test uses color immunochromatographic technology with antibodies coated on the membrane. If hCG is present in urine, a red test line in Result Window will appear to indicate a positive result.

Here's a breakdown of the acceptance criteria and study information for the OSOM™ Card hCG-Urine Test, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Comparative Study (Sensitivity & Specificity):
  • Sample Size: 227 urine specimens
  • Data Provenance: Not explicitly stated (e.g., country of origin). The study seems retrospective as it compared the OSOM Card hCG-Urine Test to the Abbott TestPack Plus hCG Urine Test using these specimens.
• Evaluation at Physician Offices:
  • Sample Size: A "randomly coded panel consisting of negative, low positive and moderate positive samples." The exact number of samples in this panel is not specified, but it was tested over three days.
  • Data Provenance: Not explicitly stated, but implies prospective testing in a clinical setting ("three physicians offices").

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

This information is not provided in the document. The "expected results" for the physician office evaluation and the reference values for the 227 urine specimens are not attributed to specific experts or their qualifications.

4. Adjudication Method for the Test Set

This information is not provided in the document.

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

• No, an MRMC study was not explicitly mentioned or described. The studies focused on device performance against a predicate device and known panels, not on comparing human readers with and without AI assistance.
• Effect size of human readers improving with AI vs. without AI assistance: Not applicable, as this was not an AI-assisted device study.

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

• Yes, a standalone performance study was implicitly done. The OSOM Card hCG-Urine Test is a qualitative immunoassay. The reported sensitivity and specificity of 100% and the 100% agreement with expected results in physician offices represent the performance of the device itself (the "algorithm" in a broad sense, though it's a chemical reaction and visual interpretation) without explicitly factoring in trained human readers as a separate variable in these performance metrics. The device's output (presence/absence of a red line) is a direct result.

7. The Type of Ground Truth Used

• Comparative Study: The "ground truth" for the 227 urine specimens appears to be established by the Abbott TestPack Plus hCG Urine Test. The OSOM test's results were compared against this predicate device. This is a form of agreement with a recognized standard.
• Evaluation at Physician Offices: The ground truth for the "randomly coded panel" was based on "expected results." This suggests a known panel with confirmed concentrations of hCG (or absence thereof), likely derived from quantitative assays or spiking experiments, implying a form of reference standard/laboratory-confirmed truth.

8. The Sample Size for the Training Set

This information is not applicable/not provided as this device is a qualitative immunochromatographic test, not an AI/machine learning algorithm that requires a "training set" in the conventional sense.

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

This information is not applicable/not provided for the reasons stated above.

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The OSOM™ Mono Test is intended for the qualitative determination of infectious mononucleosis heterophile antibodies in serum, plasma or whole blood as an aids in the diagnosis of infectious mononucleosis .

OSOM Mono Test uses color immunochromatographic technology with bovine erythrocyte extract coated on the membrane. If the specific IM heterophile antibody is present in the sample, a visible blue test line will appear to indicate a positive result.

The provided text is a 510(k) summary for the OSOM™ Mono Test, an in vitro diagnostic device. It does not contain the detailed study information or acceptance criteria requested in the prompt.

Specifically, the document focuses on:

• Device Identification: Proprietary name, common name, classification.
• Intended Use: Qualitative determination of infectious mononucleosis heterophile antibodies.
• Description: Color immunochromatographic technology.
• Substantial Equivalence Claim: Comparing it to two predicate devices (Meridian's MonoSpot Latex Test and Pacific Biotech's CARDS OS Mono Test) based on similar intended use and technology.
• Regulatory Communication: An FDA letter granting substantial equivalence.

Therefore, I cannot provide a table of acceptance criteria, reported device performance, sample sizes, ground truth information, or details about MRMC or standalone studies because this information is not present in the provided text.

The document implies that the device meets criteria for substantial equivalence to predicates, but it does not specify what those criteria are or present the data from a study to demonstrate performance against such criteria. The letter from the FDA confirms that the device is substantially equivalent to legally marketed predicate devices, which means its performance is considered comparable enough, but the specific data supporting that comparison is not in this extract.

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Perfecta Pregnancy Test is a pregnancy test intended for home use.

Perfecta Pregnancy Test uses color immunochromatographic technology with antibodies coated on the membrane. If hCG is present in urine, a blue test line will appear to indicate a positive result.

The provided text describes a 510(k) summary for the "Perfecta™ Pregnancy Test" by Wyntek Diagnostics Inc. While it outlines the product's intended use, description, and claims of substantial equivalence, it does not contain specific information about acceptance criteria or a study proving that the device meets those criteria.

Therefore, I cannot fulfill your request for the detailed table and study information based on the input provided. The text lacks:

• A table of acceptance criteria and reported device performance.
• Details about sample sizes for test sets, data provenance, number or qualifications of experts, or adjudication methods for ground truth.
• Information on MRMC comparative effectiveness studies or standalone algorithm performance.
• The type of ground truth used for test or training sets.
• Training set sample size or how its ground truth was established.

The document primarily focuses on regulatory submission details like contact information, product name, intended use, and substantial equivalence claims, without delving into the specifics of performance validation studies.

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The OSOM™ Classic hCG-Urine Test is intended for the qualitative determination of human chorionic gonadotropin (hCG) in urine for early detection of pregnancy.

OSOM Classic hCG-Urine Test uses color immunochromatographic technology with antibodies coated on the membrane. If hCG is present in urine, a blue test line will appear to indicate a positive result.

The provided document is a 510(k) summary for the OSOM™ Classic hCG-Urine Test. It describes the product, its intended use, and its substantial equivalence to other devices. However, this document does not contain the detailed information necessary to answer the questions about acceptance criteria and a study proving the device meets those criteria.

Specifically, the document lacks:

• A table of acceptance criteria and reported device performance.
• Information on sample size for test sets, data provenance, number/qualifications of experts, or adjudication methods.
• Details regarding multi-reader multi-case (MRMC) comparative effectiveness studies.
• Results from standalone algorithm performance tests.
• The type of ground truth used (e.g., pathology, outcomes data).
• Sample size for training sets or how their ground truth was established.

This document is a regulatory submission summary, focusing on demonstrating substantial equivalence to predicate devices rather than providing a detailed clinical study report or performance validation.

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OSOM™ Strep A Test is an immunochromatographic assay for the qualitative detection of Group A Streptococcal antigen from throat swabs or confirmation of presumptive Group A Streptococcal colonies from culture.

OSOM Strep A Test uses color immunochromatographic dip stick technology with antibodies coated on the membrane. If group A Streptococcus is present in the swab sample, a blue test line will appear to indicate a positive result.

Here's an analysis of the provided text regarding the OSOM™ Strep A Test, focusing on the requested information about acceptance criteria and the study:

The provided document does not contain detailed information about specific acceptance criteria (e.g., sensitivity, specificity thresholds) or a formal clinical study with a specified test set sample size, ground truth establishment, or expert adjudication as typically found in comprehensive medical device submissions.

Instead, it focuses on demonstrating substantial equivalence to an existing method (isolation of Group A Streptococcus colonies on sheep blood agar medium followed by serological grouping). The "performance" described is in the context of this substantial equivalence claim.

However, based only on the provided text, here's what can be extracted and inferred against your questions:

1. Table of Acceptance Criteria and Reported Device Performance

As specific numerical acceptance criteria (e.g., "Sensitivity must be >90%") are not explicitly stated in the provided text, I will delineate the basis of acceptance implied by the substantial equivalence claim and the performance characteristics mentioned.

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

• Sample Size for Test Set: Not specified in the provided document.
• Data Provenance: Not specified. The document does not indicate the country of origin of any data or whether it was retrospective or prospective.

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

• Number of Experts: Not specified.
• Qualifications of Experts: Not specified. The document mentions "serological grouping" but does not detail who performs this or their qualifications.

4. Adjudication Method for the Test Set

• Adjudication Method: Not specified.

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

• MRMC Study: No, not indicated. The document describes a comparison for substantial equivalence, but not a MRMC comparative effectiveness study involving human readers.
• Effect Size of Human Readers with vs. without AI Assistance: Not applicable as no MRMC study or AI assistance is mentioned.

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

• Standalone Performance: Yes, implicitly. The OSOM™ Strep A Test is described as an "immunochromatographic assay" that produces a result (blue test line) without human interpretation of complex images or data beyond reading the presence/absence of the line. This is a standalone diagnostic test where the device itself provides the qualitative result. The "performance" being compared to existing methods would be its standalone diagnostic capability.

7. The Type of Ground Truth Used

• Ground Truth Type: Established by comparative method. The "ground truth" against which the OSOM Strep A Test is being "substantially equivalent" to is "results obtained through isolation of Group A Streptococcus colonies on sheep blood agar medium followed by a serological grouping of presumptive Group A Streptococcus." Serotyping is used to confirm identity. This is a laboratory-based, culture-confirmed method.

8. Sample Size for the Training Set

• Sample Size for Training Set: Not specified. The document does not mention a "training set" in the context of machine learning or algorithm development. The device is an immunoassay, not an AI/ML-based system.

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

• Ground Truth Establishment for Training Set: Not applicable. As there is no mention of a training set or an AI/ML algorithm requiring one, this point is not relevant based on the provided text.

Summary of Limitations Based on Provided Text:

The provided 510(k) Summary focuses heavily on the "Substantial Equivalence" claim, explicitly comparing the OSOM Strep A Test to established laboratory methods. It highlights differences in speed and detection of non-viable organisms as advantages of the new device. However, it lacks the detailed quantitative performance data (e.g., sensitivity, specificity, PPV, NPV with confidence intervals) and the specifics of a rigorous clinical study that would answer many of your detailed questions about sample sizes, expert involvement, and adjudication methods. This kind of detail is typically found in the full submission, not necessarily in the brief 510(k) Summary.

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