Search Results

Not Found

Not Found

I am sorry, but the provided text does not contain information about acceptance criteria, device performance, study design, or ground truth establishment. The document is an FDA 510(k) clearance letter for the BioSign Flu A+B device, which indicates that the device has been deemed substantially equivalent to a legally marketed predicate device. It discusses regulatory information, but not the technical data from performance studies.

Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them based on the given input.

Ask a specific question about this device

The Status DSTM OXY is an immunochromatograhic test for the qualitative detection of Oxycodone in urine samples. The decetion cut-off concentration of Oxycodone is 100 ng/ml. The test may be read visually or by using a DX press™ Reader. It is intended for clinical laboratory use only.

This assay provides only a preliminary analytical test result. A more specific alternate chemical must be used in order to obtain a confirmed analytical result. Gas chromatography/mass spectrometry (CCMS) is the preferred confirmatory method. Clinical consideration and professional judgment should be applied to the test result, particularly when preliminary positive results are obtained.

The Status DSTM OXY test device is a simple immuno-chromatographic test for the rapid, qualitative detection of oxycodone and/or their metabolites in human urine. The test may be read visually or by using a DXpress™ Reader. The DXpress reader captures an image of an inserted compatible test device and uses a software algorithm to calculate the intensity of the test line. The DXpress reader interprets test result automatically by comparing the intensity of the test line to the preset cutoff value. In addition, the software will use the presence of the control line to determine whether or not the test result is valid.

The Status DS™ OXY device is an immunochromatographic test for the rapid, qualitative detection of oxycodone and/or its metabolites in human urine. The test can be read visually or with a DXpress™ Reader which automatically interprets the results by comparing test line intensity to a preset cutoff.

1. Acceptance Criteria and Reported Device Performance

2. Sample Size and Data Provenance

• Test Set Sample Size: Not explicitly stated in the provided text. The text only mentions "In the performance study," without specifying the number of samples used.
• Data Provenance: Not explicitly stated. However, given that this is a 510(k) submission to the FDA, it is highly likely that the study was conducted within a clinical laboratory setting, potentially in the US, but the specific country of origin is not mentioned. The nature of the study (retrospective or prospective) is also not stated.

3. Number and Qualifications of Experts for Ground Truth

• Not applicable. The ground truth in this study was established using a legally marketed predicate device (MedTox Oxycodone, K060351) as the reference, not expert consensus.

4. Adjudication Method for the Test Set

• Not applicable. The study compares the performance of the Status DS™ OXY test directly against a predicate device. There is no mention of human readers or an adjudication process for discrepancy resolution in the context of establishing ground truth 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 performed. The study described is a direct comparison of the new device's performance against a predicate device, not an evaluation of human reader improvement with or without AI assistance.

6. Standalone Performance Study

• Yes, a standalone performance study was done in the sense that the Status DS™ OXY test performance was evaluated independently against a legally marketed predicate device. The DXpress™ Reader component itself includes a "software algorithm to calculate the intensity of the test line" and "interprets test result automatically," indicating a standalone algorithmic interpretation capability. The comparison of "98% agreement for positive samples and 96% for negative samples" directly reflects this standalone device performance.

7. Type of Ground Truth Used

• Ground Truth Type: A legally marketed predicate device (MedTox Oxycodone, K060351) served as the reference standard. The text states: "Status DS OXY test showed 98% agreement for positive samples and 96% for negative samples compared to the reference test, while MedTox Oxycodone showed 96% and 97% agreement, respectively, indicating the two test devices are substantially equivalent." While the predicate device itself is for "qualitative detection," the ultimate confirmatory method mentioned for clinical use is Gas chromatography/mass spectrometry (GC/MS). However, for the purpose of demonstrating substantial equivalence to the FDA, the predicate device served as the comparison standard.

8. Sample Size for the Training Set

• Not explicitly mentioned. The provided text describes a performance study for demonstrating substantial equivalence. It does not detail the development or training of any underlying algorithms, only the performance of the final device against a predicate.

9. How Ground Truth for the Training Set Was Established

• Not applicable, as details about a training set are not provided. The information focuses on the performance of the final product in comparison to a predicate device. If there was an internal training process for the DXpress™ Reader's algorithm, the method for establishing ground truth for that training is not described in this document.

Ask a specific question about this device

The BioSign Flu A+B test is an in vitro rapid qualitative test that detects influenza type A and type B nucleoprotein antigens directly from nasal swab, nasopharyngeal swab, and nasopharyngeal aspirate/wash specimens obtained from patients with signs and symptoms of respiratory infection. It is intended to aid in the rapid differential diagnosis of influenza A and B viral infections. Negative test results are presumptive and it is recommended these results be confirmed by viral culture. Negative results do not preclude influenza virus infection and should not be used as the sole basis for treatment or other patient management decisions. The test is intended for professional and laboratory use. Performance characteristics for influenza were established during the 2007-2009 influenza seasons when influenza A viruses A/New Caledonia/20/99 (H1N1), A/Solomon Islands/3/2006 (H1N1), A/Brisbane/59/2007 (H1N1), A/California/07/2009 (H1N1), A/Wisconsin/67/2005 (H3N2), A/Brisbane/10/2007 (H3N2), and influenza B viruses B/Ohio/01/2005, B/Florida/4/2006, B/Brisbane/60/2008 were the predominant influenza viruses in circulation according to the Flu Activity & Surveillance report by CDC. Performance characteristics may vary against other emerging influenza viruses. If infection with a novel influenza virus is suspected based on current clinical and epidemiological screening criteria recommended by public health authorities, specimens should be collected with appropriate infection control precautions for novel virulent Influenza viruses and sent to state or local health department for testing. Viral culture should not be attempted in these cases unless a BSL+3 facility is available to receive and culture specimens.

The modification presented in this 510(k) is the addition of influenza A/Vietnam/1194/2004 (H5N1) and influenza A/Anhui/01/2005 (H5N1) along with their respective analytical sensitivity concentrations, to the Analytical Inclusivity section of the package insert. The avian influenza A (H5N1) viruses, A/Vietnam/1194/2004 (H5N1) and A/Anhui/01/2005 (H5N1) were obtained from CDC as a non-infectious form with known titer. Analytical sensitivity is reported as the lowest dilution/concentration of the virus that the BioSign Flu A+B Test is able to detect.

The provided text describes a 510(k) summary for a modification to an existing influenza test device, the BioSign Flu A+B. The modification involves adding two specific avian influenza A (H5N1) strains and their analytical sensitivity concentrations to the package insert.

Here's an analysis based on your request:

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

The document does not explicitly state acceptance criteria in the typical sense of numerical thresholds (e.g., sensitivity > X%, specificity > Y%). Instead, the acceptance criteria for this specific modification are implicit: the device must be able to detect the new H5N1 strains at a certain analytical sensitivity, and this information needs to be added to the product labeling.

The reported device performance for the new H5N1 strains is their "analytical sensitivity concentrations," which are reported as "the lowest dilution/concentration of the virus that the BioSign Flu A+B Test is able to detect." However, the exact numerical concentrations for A/Vietnam/1194/2004 (H5N1) and A/Anhui/01/2005 (H5N1) are not provided in this specific 510(k) summary, only that they were determined.

Since explicit acceptance criteria are not given, and only the type of performance metric is mentioned for the modification, a direct table comparing explicit acceptance criteria to reported performance for the modification cannot be fully generated from this text. The underlying assumption is that demonstrating any detectable analytical sensitivity for the new strains is sufficient for their inclusion in the labeling, given this is primarily an information update rather than a redesign or a change to the core diagnostic performance for general influenza A/B.

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

For the specific modification concerning the H5N1 strains:

• Sample size: Not explicitly stated. The text mentions that the viruses were obtained in a non-infectious form with a known titer, and "analytical sensitivity is reported as the lowest dilution/concentration of the virus that the BioSign Flu A+B Test is able to detect." This implies a series of dilutions were tested, but the number of replicates or different samples tested at each dilution is not specified.
• Data provenance:
  • Country of origin: The H5N1 viruses were obtained from the CDC (Centers for Disease Control and Prevention), which is a US-based agency. The viruses themselves are A/Vietnam/1194/2004 and A/Anhui/01/2005.
  • Retrospective or prospective: This study is best described as an analytical study or in-vitro technical validation using prepared samples, rather than a clinical study with retrospective or prospective patient data. The viruses were obtained and then tested in a controlled laboratory setting.

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

Not applicable for this type of analytical validation study. The "ground truth" for the H5N1 strains was their known presence and concentration (titer) as determined by the CDC. This is a technical standard rather than an expert interpretation.

4. Adjudication method for the test set

Not applicable. This was an analytical sensitivity study, not a clinical study involving human interpretation or adjudication of diagnostic results. The "result" (detection or non-detection) at various dilutions would be objectively observed, not adjudicated by a panel.

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 not an AI/CAD device. It is an in vitro diagnostic (IVD) rapid test for influenza. There are no human readers in the context of an MRMC study and no AI assistance involved.

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

Not applicable. This is not an algorithm or AI device. The device itself performs the detection. The analytical sensitivity study evaluates the device's inherent ability to detect the target analytes.

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

The ground truth for the H5N1 strains was defined by the known titer/concentration of the non-infectious viral material provided by the CDC. This is essentially a "reference standard" or "analytical standard" rather than a clinical ground truth like pathology or expert consensus.

8. The sample size for the training set

Not applicable. This device is an IVD rapid test. There is no machine learning or AI model involved that would require a "training set." The device's performance is based on its biochemical reactions.

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

Not applicable, as there is no training set for this type of device.

Ask a specific question about this device

The BioSign Flu A+B test is an in vitro rapid qualitative test that detects influenza type A and type B nucleoprotein antigens directly from nasal swab, nasopharyngeal swab, and nasopharyngeal aspirate/wash specimens obtained from patients with signs and symptoms of respiratory infection. It is intended to aid in the rapid differential diagnosis of influenza A and B viral infections. Negative test results are presumptive and it is recommended these results be confirmed by viral culture. Negative results do not preclude influenza virus infection and should not be used as the sole basis for treatment or other patient management decisions. The test is intended for professional and laboratory use. Performance characteristics for influenza were established during the 2007-2009 influenza seasons when influenza A viruses A/New Caledonia/20/99 (H1N1), A/Solomon Islands/3/2006 (H1N1), A/Brisbane/59/2007 (H1N1), A/California/07/2009 (H1N1), A/Wisconsin/67/2005 (H3N2), A/Brisbane/10/2007 (H3N2), and influenza B viruses B/Ohio/01/2005, B/Florida/4/2006, B/Brisbane/60/2008 were the predominant influenza viruses in circulation according to the Flu Activity & Surveillance report by CDC. Performance characteristics may vary against other emerging influenza viruses. If infection with a novel Influenza virus is suspected based on current clinical and epidemiological screening criteria recommended by public health authorities, specimens should be collected with appropriate infection control precautions for novel virulent Influenza viruses and sent to state or local health department for testing. Viral culture should not be attempted in these cases unless a BSL+3 facility is available to receive and culture specimens.

Not Found

This document is a 510(k) clearance letter for the BioSign® Flu A+B immediate from the FDA to Princeton Biomeditech Corporation. It confirms the device's substantial equivalence to legally marketed predicate devices. The document also includes the device's intended use. However, it does not contain the detailed information about acceptance criteria, study design, or performance metrics requested in the prompt.

Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets the acceptance criteria from the provided text. The document is primarily a regulatory approval notice, not a performance study report.

Ask a specific question about this device

The BioSign® Flu A+B test is an in vitro rapid qualitative test that detects influenza type A and type B antigens directly from nasal swab, nasopharyngeal swab, and nasopharyngcal aspirate/wash specimens obtained from patient with signs and symptoms of respiratory infection. It is intended to aid in the rapid differential diagnosis of influenza A and B viral infections. A negative test result is presumptive and it is recommended these results be confirmed by viral culture. Negative results do not preclude influenza virus infection and should not be used as the sole basis for treatment or other management decisions. The test is intended for professional and laboratory use.

BioSign® Flu A+B is an immuno-chromatographic test for the rapid, qualitative detection of influenza A and B. The test device has two test lines, thereby allowing the separate identification of type A and/or type B viral antigens from the same specimen.

In the test procedure, a specimen is collected and placed into the Extraction Well of the test device containing extraction solution for one minute, during which time antigen is extracted from disrupted virus particles. The test device is then raised, tapped and laid back down onto a level surface to allow the solution in the Extraction Well to migrate through the pads containing lyophilized detector antibodies conjugated to gold dye and then through the test membrane. If influenza antigens are present in the specimen, they will react with anti-influenza antibody coupled to gold dye particles, migrate through the membrane as antigen-antibody-dye complexes, bind to the immobilized anti-influenza antibody on the membrane, and generate a colored line in the Test line position (A and/or B). The rest of the sample and unbound/bound dye complexes continue to migrate to the Control line position, where antibody to the antiinfluenza antibody is immobilized, and anti-influenza antibody-unbound/bound dye complexes form the Control line (internal procedural control).

Here's an analysis of the provided 510(k) summary, extracting the requested information:

The device under review is the BioSign® Flu A+B / Status™ Flu A & B, an immuno-chromatographic test for the rapid, qualitative detection of influenza A and B antigens.

1. Acceptance Criteria and Reported Device Performance

The acceptance criteria for this device are implicitly set by the reported performance (sensitivity and specificity) when compared against viral culture as the reference method. The document presents performance for different sample types (nasopharyngeal aspirate, nasopharyngeal swab, nasal swab).

Table of Acceptance Criteria and Reported Device Performance:

Note: The document does not explicitly state numerical "acceptance criteria" thresholds, but rather reports the observed performance and implies these values were sufficient for regulatory clearance. The wide confidence intervals in some cases suggest that the performance might vary.

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

• Sample Size for Test Set:
  • Total Patients: 862
  • Nasopharyngeal Aspirate: 253 cases
  • Nasopharyngeal Sample: 251 cases
  • Nasal Swab Sample: 358 cases
    (Note: The sum of individual sample types is 862, matching the total number of patients, indicating these might be overlapping or distinct subsets of samples from the same patient pool, or simply different sample types evaluated from the overall patient population.)
  • Archived Samples: 80 samples for both Flu A and Flu B verification (Columbia NY Presbyterian Hospital).
• Data Provenance:
  • Country of Origin: USA (samples collected at 5 sites in the USA).
  • Retrospective or Prospective: Prospective clinical study, with additional testing on "Archived Samples" which would be considered retrospective.

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

The document does not specify the number of experts used to establish the ground truth or their qualifications. The ground truth method was viral culture, and it's common for laboratory professionals to perform and interpret viral cultures, but no details on their expertise are provided.

4. Adjudication Method for the Test Set

The primary reference method for initial comparison was viral culture. For samples that produced discrepant results between the BioSign® Flu A+B test and viral culture, a third, more definitive method was used for resolution: proFLU plus by Prodesse (real-time RT-PCR, or PCR). This constitutes an adjudication method, where ambiguous cases are resolved by a higher-tier test. The document refers to the results from the PCR as "further analyzed" or used to identify cases that were "positive by both BioSign and PCR" or "negative by both BioSign and PCR".

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

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not conducted. This study design is typically used for image-based diagnostic aids where human readers interpret results with and without AI assistance to assess the impact of AI on reader performance. The BioSign® Flu A+B is a rapid diagnostic test, not an AI-powered diagnostic imaging device.

6. Standalone (Algorithm Only) Performance Study

Yes, a standalone performance study was done for the device. The reported sensitivity and specificity values directly reflect the performance of the BioSign® Flu A+B device itself, without any human interpretation adjustments beyond standard operation and reading of a rapid diagnostic test. The entire clinical study section, including the performance tables, represents the standalone performance of the device against the ground truth.

7. Type of Ground Truth Used

The type of ground truth used was primarily viral culture, which is a laboratory-based method for identifying and growing viruses. For discrepant results, real-time RT-PCR (proFLU plus by Prodesse) was used as a confirmatory or adjudicating ground truth.

8. Sample Size for the Training Set

The document does not explicitly mention a "training set" or its sample size. This type of device (rapid diagnostic test) is typically developed and optimized during its R&D phase using various sample sets, but the clinical study described is primarily for validation/testing of the finalized device.

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

As no explicit training set is described, the method for establishing ground truth for a training set (if one existed in the R&D phase) is not provided. The ground truth for the clinical test set was established by viral culture (and PCR for discrepants), as described in point 7.

Ask a specific question about this device

Ask a specific question about this device

SpermCheck® Fertility is a qualitative test that detects sperm concentration at or above 20,000,000 sperm/mL. The test is intended for use as an aid in the determination of a man's fertility status. For in vitro, over the counter home use.

SpermCheck® Fertility is an immunochromatographic test for the rapid, qualitative detection of sperm concentration.

The provided text describes the 510(k) summary for the SpermCheck® Fertility device. Here's a breakdown of the requested information based on the text:

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

The document does not explicitly state "acceptance criteria" with specific numerical thresholds that the device had to meet and then report its performance against them. Instead, it focuses on substantial equivalence to existing devices. The key performance characteristic mentioned is its ability to detect sperm concentration at or above 20,000,000 sperm/mL.

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

The document does not provide details on the sample size used for the test set or the data provenance (country of origin, retrospective/prospective).

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 does not provide details on the number of experts or their qualifications used to establish ground truth for a test set. It mentions "standard microscopic analysis (counting by Hemacytometer) based on WHO guidelines" as a comparator, which implies expert analysis, but specifics are missing.

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

The document does not provide details on any adjudication method used for 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

This section is not applicable as the device described is a qualitative home-use immunochromatographic test, not an AI-based system assisting human readers. It's a standalone diagnostic.

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

Yes, a standalone performance was done. The SpermCheck® Fertility is an "immunochromatographic test for the rapid, qualitative detection of sperm concentration" intended for "over the counter home use." This inherently means it operates as a standalone device without a human-in-the-loop performance aspect beyond the user interpreting the visual result of the test. The primary comparative study mentioned is against "standard microscopic analysis (counting by Hemacytometer)."

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

The ground truth for comparison appears to be the "standard microscopic analysis (counting by Hemacytometer) based on WHO guidelines." This implicitly relies on expert interpretation and established laboratory procedures, which can be considered a form of "expert consensus" or established "diagnostic standard."

8. The sample size for the training set

The document does not provide details on the sample size for a training set. As an immunochromatographic test, it's unlikely to have a "training set" in the machine learning sense. The development would involve analytical validation and clinical testing, but not a separate training phase for an algorithm.

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

The document does not provide details on a training set or how its ground truth was established, as it's not an AI/machine learning device.

Ask a specific question about this device

The StatusFirst™ Strep A is intended for use as an in vitro diagnostic product for the qualitative detection of group A streptococcal antigen directly from throat swab specimens. The test is intended for use in the physician's offices, hospitals, and clinical laboratories as an aid in the clinical diagnosis of group A streptococcal infection.

Not Found

This document is a 510(k) clearance letter for three different Strep A rapid diagnostic tests: StatusFirst™ Strep A, BioStrep® A, and BioSign® Strep A / Status AccuStrepA™. However, it does not contain the detailed study information regarding acceptance criteria and performance data. The letter only states that the devices are substantially equivalent to legally marketed predicate devices.

Therefore, I cannot provide the requested information from this document. The document primarily focuses on the regulatory clearance for the device, not the technical performance study details.

Ask a specific question about this device

SpermCheck® Vasectomy is a rapid qualitative test that detects low concentrations of sperm at or above 250,000 sperm/mL in human semen as an aid for vasectomized men. For in vitro OTC home use.

SpermCheck® Vasectomy is an immunochromatographic test for the rapid, qualitative detection of sperm concentration.

The provided text describes the 510(k) summary for the SpermCheck® Vasectomy device. However, it does not include detailed information regarding acceptance criteria, specific study designs, sample sizes for test sets, ground truth establishment, or multi-reader multi-case studies. The document primarily focuses on establishing substantial equivalence to predicate devices and defining the intended use.

Therefore, many of the requested details cannot be extracted directly from the provided text. I will provide the information that is available and highlight what is missing.

Here's an analysis based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document defines the device's capability but does not explicitly state acceptance criteria in terms of sensitivity, specificity, accuracy, or agreement percentages against a gold standard. It states the device "detects low concentrations of sperm at or above 250,000 sperm/mL".

The document mentions "SpermCheck® Vasectomy is substantially equivalent to standard microscopic analysis (counting by Hemacytometer) based on WHO guidelines in its performance". This implies that its performance is comparable to the hemacytometer, but specific metrics of this comparison are not provided.

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

This information is not provided in the given 510(k) summary. The document does not detail any specific clinical study data, sample size, or the origin (country, retrospective/prospective) of the data used for performance claims.

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

This information is not provided in the given 510(k) summary. Given the nature of the device (sperm concentration), the "ground truth" would typically involve laboratory analysis by trained personnel, but details are not included.

4. Adjudication Method for the Test Set

This information is not provided in the given 510(k) summary.

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

This information is not provided in the given 510(k) summary. The device is described as an "in vitro OTC home use" test, which suggests it is designed for direct user interpretation rather than being integrated into a workflow involving expert readers.

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

Yes, the device is inherently a standalone test. It is a "rapid qualitative test" intended for "in vitro OTC home use." It operates as an immunochromatographic test, meaning the result is directly interpreted from the test strip by the user, without an algorithm or human-in-the-loop requiring additional interpretation beyond reading the visual result.

7. The Type of Ground Truth Used

The primary ground truth referenced for substantial equivalence is "standard microscopic analysis (counting by Hemacytometer) based on WHO guidelines." This implies a laboratory-based, expert-performed quantitative measurement that serves as the gold standard for sperm concentration.

8. The Sample Size for the Training Set

This information is not provided in the given 510(k) summary. As an immunochromatographic test, it likely doesn't have a "training set" in the sense of a machine learning algorithm. Its development would involve analytical studies and clinical performance validation, but the sample sizes for these are not detailed.

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

This information is not provided in the given 510(k) summary. If referring to the development and validation of the immunoassay, the ground truth would have been established through methods like "standard microscopic analysis (counting by Hemacytometer) based on WHO guidelines" for semen analysis samples, but the specifics of how this was applied for the device's development are not outlined.

Ask a specific question about this device

Immunoassay for the qualitative detection of methamphetamine, opiates, cocaine metabolite, THC metabolite, phencyclidine, benzodiazepines, barbiturates, tricyclic antidepressants, methadone, and amphetamine in human urine to assist in screening of abuse samples. The detecting cut-off concentrations are as follows:

This assay provides only a preliminary analytical test result. A more specific alternate chemical method m ust be used in order to obtain a confirmed analytical result. Gas chromatography/mass spectrometry (GC/ MS)/High performance liquid chromatography (HPLC, for TCA) are the preferred confirmatory methods. Cl inical consideration and professional judgment should be applied to any drug of abuse test result, particula rly when preliminary positive results are obtained.

The AccuSign® RCDOA 10 test device is a simple immuno-chromatographic test for the rapid, qualitative detection of methamphetamine, opiates, cocaine, THC, phencyclidine, benzodiazepines, barbiturates, tricyclic antidepressants, methadone, amphetamine and/or their metabolites in human urine. The test result can be read visually or with DXpress reader (K050955).

Here's an analysis of the provided 510(k) summary, detailing the acceptance criteria and the study information.

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for this device are implicitly tied to demonstrating substantial equivalence to its predicate device (K983501: AccuSign® DOA10). Since the new device (AccuSign® RC-DOA 10) is stated to be "identical and use the same formula and manufacturing processes with the same reagents" as the predicate, and the key difference is the addition of a reader-compatible option, the acceptance criteria are effectively that its performance should be commensurate with the established performance of the predicate device.

The document directly states the detection cut-off concentrations for each substance as both the intended use and the "Detection Cutoff" in the substantial equivalence comparison table. This indicates that the device must accurately detect these substances at or above these specified cut-off levels.

Note on Reported Device Performance: The provided 510(k) summary does not contain specific performance metrics (e.g., sensitivity, specificity, accuracy) from a separate clinical study for the new device. Instead, the claim of substantial equivalence relies on the new device being "identical" to the predicate in its core biochemical function, with the only change being an additional reading method. Therefore, the "reported device performance" is essentially that it achieves the same detection capabilities as the legally marketed predicate device at the specified cut-off concentrations.

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

The provided 510(k) summary does not explicitly detail a separate test set size or its data provenance (e.g., country of origin, retrospective/prospective). The submission relies heavily on the claim that the new device is "identical" to the predicate device in terms of its chemical components and manufacturing process. Therefore, the performance data from the predicate device's original clearance would be presumed to apply.

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

The 510(k) summary does not mention the use of experts for establishing ground truth for a test set for this specific submission. This is because the device is a diagnostic test kit for drugs of abuse, and the "ground truth" for such tests typically comes from validated analytical methods (like GC/MS). Expert consensus is usually more relevant for image-based diagnostic devices or complex clinical scenarios where subjective interpretation is involved.

4. Adjudication Method for the Test Set

No adjudication method is described, as no specific test set or study requiring adjudication is detailed in this 510(k) summary.

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

No MRMC comparative effectiveness study was mentioned or performed for this submission. MRMC studies are typically used for devices where human readers interpret diagnostic images or data, and the AI system is intended to assist or replace human interpretation. This device is a rapid immunoassay test where results are either visually read or read by a simple optical reader (DXpress). The 510(k) focuses on the "Reader reading compatible" aspect, implying it's an alternative to visual reading, not an AI assistance for human interpretive tasks.

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

Yes, in a sense, a standalone performance is implied. The device, whether read visually or by the DXpress reader, functions as a standalone diagnostic tool for detecting the presence of drugs of abuse. The performance is based on its ability to react to specific concentrations of analytes, independent of human interpretive faculties beyond simply observing a line or reading a digital output. The "algorithm" here is the chemical reaction and optical detection mechanism. However, no specific separate standalone clinical study with new data is presented in this summary.

7. The Type of Ground Truth Used

The ground truth for this type of immunoassay is based on analytical chemical methods, specifically the concentration of the target drug or metabolite in urine samples. The document explicitly states that the test provides "only a preliminary analytical result" and that "a more specific alternative chemical method must be used to obtain a confirmed analytical result. GC/MS is the preferred confirmatory method." This indicates that Gas Chromatography/Mass Spectrometry (GC/MS) (and for TCA, HPLC) is the gold standard used to establish definitive ground truth for drug presence and concentration.

8. The Sample Size for the Training Set

The 510(k) summary does not mention a training set size. This is because the device is an immunoassay kit built on established chemical principles and reagents. It does not involve machine learning algorithms that require a training set in the conventional sense. The "training" in this context would refer to the development and optimization of the chemical formulations and reaction conditions, which were already established for the predicate device.

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

As there is no conventional training set for a machine learning algorithm, the concept of establishing ground truth for it does not apply here. The fundamental "ground truth" for the device's design and operation, derived from the predicate, would have been established through a combination of:

• Analytical validation: Testing the device with known concentrations of drug standards and interferences.
• Clinical correlation: Comparing test results with confirmed results from definitive analytical methods (like GC/MS) on patient samples during the development and validation of the predicate device.

Ask a specific question about this device