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The Starswab Multitrans Collection and Transport System (Cat. No. S160) is intended for the collection and transportation of Chlamydia, Mycoplasmas and viruses obtained from clinical specimens.

Starswab Multitrans Collection and Transport System provides a safe and convenient way to collect and transport clinical specimens without leakage under optimum storage conditions. The osmotically balanced buffered medium will maintain the viability of viral, chlamydia and mycoplasma specimens during transportation to the laboratory. Antibiotics are incorporated into the medium to inhibit growth of competing bacteria and yeast. The addition of serum albumin provides a stabilizing effect. The high concentration of sucrose aids in the preservation of viruses and chlamydia if the specimens are frozen (-70℃) for prolonged storage.

The provided text describes a 510(k) premarket notification for the Starswab Multitrans Collection and Transport System, focusing on a change in the recommended storage condition. It does not contain information about a study proving the device meets specific performance criteria with detailed metrics like sensitivity, specificity, or reader performance.

However, based on the information provided, we can infer some details related to the "study" mentioned for the change in storage conditions.

Here's a breakdown of what can be extracted and what is not available in the given text:

1. Table of Acceptance Criteria and Reported Device Performance

Explanation: The document does not provide specific quantitative acceptance criteria (e.g., "X% viability of viral load"). Instead, the "acceptance criterion" is implicitly that the device's performance under the new storage conditions (2-25°C) should be equivalent to its performance under the old conditions (2-8°C). The reported performance is a qualitative statement that this was met.

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

• Sample Size: Not specified.
• Data Provenance: The "Clinical evaluation has been carried out by the Ontario Provincial Public Health Laboratory." This suggests the data is likely from Canada. The document does not explicitly state if it was retrospective or prospective, but clinical evaluation often implies prospective testing.

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 Ontario Provincial Public Health Laboratory would imply trained laboratory professionals, but specific qualifications (e.g., virologists, microbiologists, years of experience) are not detailed.

4. Adjudication Method for the Test Set

• Not specified.

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

• No, an MRMC comparative effectiveness study is not indicated or described. The evaluation focuses on the device's performance rather than human reader improvement with or without AI assistance.

6. Standalone (Algorithm Only) Performance Study

• No, a standalone algorithm performance study is not indicated. This device is a physical transport system, not an AI algorithm.

7. Type of Ground Truth Used

• Type of Ground Truth: The context suggests that the ground truth would have been based on established laboratory methods for detecting and quantifying viable viruses, chlamydia, and mycoplasmas in clinical specimens. This would likely involve viability assays, culture methods, and potentially molecular diagnostics to confirm the presence and viability of the target organisms after transport and storage.

8. Sample Size for the Training Set

• Not applicable. This device is a physical transport system, not an AI algorithm requiring a training set.

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

• Not applicable, as there is no training set for an AI algorithm.

Summary of Device Performance Study (as described for the storage condition change):

• Study Goal: To ensure the performance characteristics of the Starswab Multitrans Collection and Transport System are not compromised when the recommended storage condition prior to use is changed from 2-8°C to 2-25°C.
• Study Conducted By: Ontario Provincial Public Health Laboratory.
• Outcome: "Clinical evaluation has been carried out... to ensure performance characteristics of the product held under new storage conditions is not compromised." This is a qualitative statement indicating that the device met its implied performance criteria under the extended storage temperature range. Specific quantitative data, sample sizes, and detailed methodology are not provided in this 510(k) summary.

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"STARTOX" Drugs of Abuse Screening Test is a one-step lateral flow immunoassay intended for the simultaneous detection of multiple drug analytes in urine. "STARTOX" is intended for use in the qualitative detection of drugs of abuse at the following Substance Abuse Mental Health Services Administration (SAMHSA) recommended levels:

STARTOX™ Drugs of Abuse Screening Test provide only a preliminary qualitative test result. Use a more specific alternate quantitative analytical method to obtain a confirmed analytical result. Gas chromatography/mass spectrometry (GC/MS) is the preferred confirmatory method. Apply clinical and professional judgment to any drug of abuse test result, particularly when preliminary positive results are obtained.

For professional use only.

A lateral flow immunoassay for the detection of drugs of abuse.

Here's an analysis of the acceptance criteria and study detailed in the provided document:

Acceptance Criteria and Device Performance

The document states that the STARTOX™ Drugs of Abuse Screening Test is substantially equivalent to a legally marketed predicate device. The performance is assessed by comparison to other approved devices (Medtox Profile II and RDS 9) and subsequently confirmed to be substantially equivalent.

Table of Acceptance Criteria and Reported Device Performance:

Note: The acceptance criteria for the STARTOX™ device are implicitly its ability to detect the specified compounds at the listed SAMHSA recommended levels with comparable performance to the predicate devices. The study concludes that the device performed substantially equivalent to the legally marketed predicate devices, thereby meeting the acceptance criteria of being comparable in performance.

Study Details:

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

   • Sample Size: 90 samples were tested against each drug (4 drugs), consisting of 50 negative and 40 positive specimens. This means a total of 90 samples per drug, so 90 x 4 = 360 individual tests were performed across the four drugs.
   • Data Provenance: Not explicitly stated, but typically for in vitro diagnostic device studies, samples would be collected from a relevant population (e.g., clinical samples, drug screening samples). It is retrospective as the "drug status of these samples was tested by EMIT and quantified by GC/MS," indicating these were pre-existing samples with established ground truth. The country of origin is not specified.

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

   • Number of Experts: Not applicable, as expert consensus was not the primary method for establishing ground truth.
   • Qualifications of Experts: Not applicable.

3. Adjudication method for the test set:

   • Adjudication Method: Not applicable. The ground truth was established by quantitative analytical methods rather than expert adjudication.

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:

   • MRMC Study: No, this was not a MRMC study. This device is a lateral flow immunoassay for in vitro diagnostic use, not an AI-assisted diagnostic tool requiring human reader interpretation in the context of an MRMC study.

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

   • Standalone Performance: Yes, the study evaluates the performance of the STARTOX™ device directly, comparing its results to established analytical methods and predicate devices. This represents its standalone performance. The device provides a "preliminary qualitative test result" which is then confirmed by other methods, implying its standalone role as a screening tool.

6. The type of ground truth used:

   • Ground Truth Type:
     • EMIT (Enzyme Multiplied Immunoassay Technique): A commonly used immunoassay for drug screening, often considered a good initial positive/negative indicator.
     • GC/MS (Gas Chromatography/Mass Spectrometry): Stated as the "preferred confirmatory method" and used for quantification. GC/MS is widely considered the gold standard for drug confirmation due to its high specificity and sensitivity.
     • Therefore, the ground truth was established using a combination of a commonly accepted screening method (EMIT) and the gold standard analytical method (GC/MS) for quantification and definitive drug status.

7. The sample size for the training set:

   • Training Set Sample Size: Not applicable. This document describes a performance validation study for an immunoassay, not a machine learning model that requires a distinct training set.

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

   • Ground Truth for Training Set: Not applicable, as there was no training set in the context of a machine learning model.

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STARTOX™ Drugs of Abuse Screening Test is a one-step lateral flow immunoassay intended for the simultaneous detection of multiple drug analytes in urine. STARTOX™ is intended for use in the qualitative detection of drugs of abuse at the following Substance Abuse Mental Health Services Administration (SAMHSA) recommended levels:

STARTOX™ Drugs of Abuse Screening Test provide only a preliminary qualitative test result. Use a more specific alternate quantitative analytical method to obtain a confirmed analytical result. Gas chromatography/mass spectrometry (GC/MS) is the preferred confirmatory method. Apply clinical and professional judgment to any drug of abuse test result, particularly when preliminary positive results are obtained.

For professional use only.

A lateral flow immunoassay for the detection of drugs of abuse.

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

1. Table of Acceptance Criteria and Reported Device Performance

Notes on the table:

• The acceptance criteria are the "Substance Abuse Mental Health Services Administration (SAMHSA) recommended levels" at which the device is intended to detect the drugs.
• The reported device performance is a single aggregated metric ("greater than 99% accuracy") stated against a legally marketed device (Medtox Profile II). The document does not provide separate accuracy figures for each compound, nor does it specify the accuracy relative to the SAMHSA cut-off levels in this particular section (though the study involved testing above and below cut-offs for reproducibility). The "greater than 99% accuracy" is essentially the device meeting its substantial equivalence claim against a predicate, implying it performs at least as well.

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

• Sample Size: 90 samples were tested for each drug. This means:
  • 90 samples for Amphetamine.
  • 90 samples for Opiates.
  • 90 samples for Phencyclidine.
  • 90 samples for Cocaine.
  • 90 samples for Cannabinoids.
    Each set of 90 samples consisted of 50 negative specimens and 40 positive specimens.
• Data Provenance: Not explicitly stated regarding country of origin. The study appears to be retrospective, using previously collected samples that were confirmed as drug-free or screened positive and confirmed by GC/MS.

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

• This information is not provided. The ground truth (confirmation of drug presence/absence and quantification) was established by analytical methods (GC/MS and Emit screening), not by human experts.

4. Adjudication Method for the Test Set

• Not applicable as the ground truth was established by analytical methods (Emit screening and GC/MS), not human interpretation.

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 device is a lateral flow immunoassay (a point-of-care type test), not an AI-assisted diagnostic device requiring human interpretation in an MRMC study.

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

• This is effectively a standalone study. The device is a diagnostic assay that provides a direct result (positive/negative) without human interpretation as part of the core test mechanism. Its performance was evaluated against analytical gold standards.

7. The Type of Ground Truth Used

• The ground truth was established using analytical methods:
  • Negative samples were "confirmed to be drug free" (method not specified for this confirmation, but implied to be robust).
  • Positive specimens were "screened as positive by Emit, confirmed and quantified by GC/MS." GC/MS (Gas Chromatography/Mass Spectrometry) is explicitly stated as the preferred confirmatory method and the method used for quantification.

8. The Sample Size for the Training Set

• This information is not explicitly provided. As a lateral flow immunoassay, it is a hardware-based diagnostic device, not a machine learning algorithm that typically undergoes a "training phase" with a labeled dataset in the same way. Its development would involve calibrating the assay components and reagents, which isn't typically referred to as a "training set" in this context.

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

• Not applicable for the reasons mentioned in point 8. The "training" or development of such an assay involves chemical and biological engineering to ensure the reagents perform as expected, rather than "ground truth" derived from a specific dataset for algorithmic learning.

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The Starswab Culture Collection and Transport System is selfcontained, sterile and intended for maintaining the viability of clinical specimens during transportation to the laboratory.

The Starswab Culture Collection and Transport System is selfcontained, sterile and intended for maintaining the viability of clinical specimens during transportation to the laboratory. The medium contains sodium thioglycollate as a reducing agent and the moisture and media depth provide an ideal environment for the survival of both aerobic and anaerobic microorganisms.

Here's an analysis of the provided text regarding acceptance criteria and the study that proves the device meets them:

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

Note: The document does not explicitly state quantitative acceptance criteria (e.g., "recovery rate must be >X%"). The acceptance criterion is implied by the comparison to the predicate device and the judgment of "equivalence."

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

• Sample Size for Test Set: The document simply states "Known inocula of ATCC type cultures and clinically significant microorganisms." It does not specify the number of different ATCC strains or clinically significant microorganisms used. It also doesn't specify how many replicates were performed for each microorganism.
• Data Provenance: The study appears to be prospective (controlled laboratory experiment) and performed by the manufacturer, or a facility working on their behalf. The country of origin of the data is not explicitly stated beyond the contact address for the manufacturer (Canada) and the predicate device manufacturer (USA).

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

This information is not provided. The "ground truth" here is the growth characteristics of the microorganisms. While someone would have interpreted these results, their number and qualifications are not mentioned.

4. Adjudication method for the test set

This information is not provided. It's unclear how agreement was reached on "no significant differences" or "results were judged to be equivalent" if multiple individuals were involved in assessing growth characteristics. It's possible a single individual made these judgments.

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

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This study is a microbiological performance study comparing two transport media, not an AI-assisted diagnostic device evaluated by human readers.

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

This question is not applicable as the device is a microbiological specimen collection and transport system, not an algorithm or AI. The performance tested was the ability of the medium to maintain microbial viability, which is a standalone performance of the device itself.

7. The type of ground truth used

The ground truth used was microbial growth characteristics (i.e., whether the inoculated microorganisms grew successfully after transport in the Starswab vs. the predicate device). This is a direct measure of the device's intended function.

8. The sample size for the training set

Not applicable/Not mentioned. This device is not an AI/ML algorithm that requires a training set. The study describes the performance evaluation of the physical medical device.

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

Not applicable/Not mentioned. As above, this device does not use a training set in the context of AI/ML.

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