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Copan Liquid Amies Elution Swab (ESwab) Collection and Transport System is intended for the collection and transport of clinical specimens containing aerobes, anaerobes and fastidious bacteria from the collection site to the testing laboratory. In the laboratory, ESwab specimens are processed using standard clinical laboratory operating procedures for bacterial culture.

Copan Liquid Amies Elution Swab (ESwab) Collection and Transport System is supplied in a collection kit format. Each collection kit consists of a sterile package containing a plastic screw-cap tube with conical shaped bottom filled with 1 ml of Liquid Amies transport medium and a small sterile peel pouch containing one of two sizes of a specimen collection swab that has a tip flocked with soft nylon fiber.

The Liquid Amies transport medium is a maintenance medium comprising inorganic phosphate buffer, calcium and magnesium salts and sodium chloride with a reduced environment due to the presence of sodium thioglycollate. The medium is designed to maintain the viability of aerobic bacteria, anaerobic bacteria and fastidious bacteria such as Neisseria gonorrhoeae during transit to the testing laboratory.

The nylon flocked specimen collection swabs provided with the Copan ESwab Collection and Transport System have a solid plastic shaft with a molded breakpoint site. Copan ESwab Collection and Transport System kits are available with two different size nylon flocked swab options to facilitate the collection of specimens from various sites on a patient.

The provided text describes the 510(k) summary for the Copan Liquid Amies Elution Swab (ESwab) Collection and Transport System. This document focuses on demonstrating substantial equivalence to predicate devices and does not detail specific acceptance criteria or a comprehensive study report in the way typically expected for a medical device with quantifiable performance metrics like accuracy, sensitivity, or specificity.

Instead, the performance testing described is focused on the ability of the product to maintain the viability of bacterial strains. As such, the information you've requested regarding specific acceptance criteria, sample sizes for test/training sets, ground truth establishment, expert involvement, and MRMC studies is not explicitly present in the provided text.

However, I can extract the information that is available and indicate where details are missing based on your request.

Summary of Device Performance and Study (Based on Provided Text):

The Copan Liquid Amies Elution Swab (ESwab) Collection and Transport System underwent performance testing to evaluate its ability to maintain the viability of various aerobic, anaerobic, and fastidious bacteria during storage and use, in comparison to predicate devices. Stability testing was also performed to support its 15-month expiration date.

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size: Not specified in the provided text. The text mentions "various strains of aerobic, anaerobic and fastidious bacteria" but does not give a number of strains, replicates, or overall sample size for the viability studies.
• Data Provenance: Not specified. It can be inferred that the testing was conducted by Copan Diagnostics Inc., as they are the sponsor. The country of origin of the data (e.g., in-house lab, external lab, specific geographic location) and whether it was retrospective or prospective is not mentioned.

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

• Number of Experts: Not applicable/Not specified. For this type of device (collection and transport system for bacterial viability), "ground truth" is typically established through laboratory culture and viability assessment, not through expert consensus on medical images or diagnoses.
• Qualifications of Experts: Not applicable/Not specified, as expert consensus is not the stated method for ground truth. The studies relied on laboratory methods for assessing bacterial viability.

4. Adjudication method for the test set

• Adjudication Method: Not applicable/Not specified. Adjudication methods (like 2+1, 3+1) are typically used when subjective assessments by multiple experts are being reconciled, such as in image interpretation. For bacterial viability studies, objective laboratory measurements are generally used.

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

• MRMC Study: No, an MRMC comparative effectiveness study was not done. This type of study is relevant for AI-powered diagnostic aids that assist human readers (e.g., radiologists interpreting images). The Copan ESwab system is a physical medical device for specimen collection and transport, not an AI diagnostic tool.

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

• Standalone Performance: No, this is not an algorithm, so a standalone algorithm performance study is not applicable. The device's performance is tested on its ability to maintain bacterial viability as a physical system.

7. The type of ground truth used

• Type of Ground Truth: The ground truth for the performance studies would be the documented presence and viability (e.g., colony-forming units or other microbiological growth metrics) of specific strains of aerobic, anaerobic, and fastidious bacteria at different time points, as determined by standard laboratory culture techniques.

8. The sample size for the training set

• Sample Size for Training Set: Not applicable/Not specified. This device is not an AI algorithm that requires a "training set." The performance studies described are for validation, not training.

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

• How Ground Truth for Training Set was Established: Not applicable, as there is no training set for this type of device.

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Copan Universal Transport Medium (UTM-RT) System is intended for the collection and transport of clinical specimens containing viruses, chlamydiae, mycoplasma or ureaplasma from the collection site to the testing laboratory. UTM-RT can be processed using standard clinical laboratory operating procedures for viral, chlamydial, mycoplasma and ureaplasma culture.

The Copan UTM-RT System includes a universal transport medium that is room temperature stable and that can sustain viability (and infectivity) of a plurality of organisms that include clinically important viruses, chlamydiae, mycoplasma and ureaplasma during transit to the testing laboratory. The formulation of UTM-RT medium includes protein for stabilization, antibiotics to minimize bacterial and fungal contamination, and a buffer to maintain a neutral pH.
Copan UTM-RT System medium is provided in screw-cap tubes designed for transport of the clinical sample. Copan UTM-RT System is also supplied as a sample collection kit that comprises a package which contains one screw-cap tube of UTM-RT medium and a peel pouch incorporating one or two sterile specimen collection swabs. A range of UTM-RT sample collection kits are available which incorporate different types of shaft swabs which facilitate the collection of specimens from different sites of the patient.

The provided text describes the Copan Universal Transport Medium (UTM-RT) System, a device intended for the collection and transport of clinical specimens containing viruses, chlamydiae, mycoplasma, or ureaplasma. The document is a 510(k) summary submitted to the FDA, detailing the device's description, intended use, and performance testing for substantial equivalence.

Based on the information provided, here's a description of the acceptance criteria and the study that proves the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance

The 510(k) summary does not explicitly state numerical or specific performance acceptance criteria for the Copan UTM-RT System. However, the objective of the performance testing was to demonstrate the device's ability to maintain the viability of various microorganisms, establishing substantial equivalence to predicate devices. The implicit acceptance criterion is that the Copan UTM-RT System performs comparably to or better than the predicate devices in maintaining viability and supporting culture.

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

• Sample Size for Test Set: The document states that "recovery studies were performed using the Copan UTM-RT System and a comparative product" to determine viability of "various strains of viruses, chlamydiae, mycoplasma and ureaplasma."
  • The exact number of strains or replicates used for each microorganism is not specified in the provided text.
• Data Provenance: The document does not specify the country of origin of the data or whether the studies were retrospective or prospective. Given the nature of a 510(k) submission, it is highly likely these were prospective laboratory studies conducted by or for Copan Diagnostics Inc.

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

• The document describes in vitro recovery and stability studies for microorganisms in transport media. For such studies, the "ground truth" is typically established by direct laboratory measurements of viable organism counts (e.g., plaque-forming units for viruses, colony-forming units for bacteria/mycoplasma) rather than expert interpretation of images or clinical cases.
• Therefore, the concept of "experts" establishing ground truth in the sense of clinical specialists is not applicable to this type of performance study for a transport medium. The expertise would lie in the microbiologists and laboratory personnel conducting the viability assays. Their qualifications are not detailed.

4. Adjudication Method for the Test Set

• The concept of an "adjudication method" (like 2+1, 3+1) is relevant for studies where human interpretation or diagnosis is involved, particularly in image analysis or clinical assessment.
• This is an in vitro diagnostic device for specimen transport, and the performance studies focused on microorganism viability and stability. Therefore, no adjudication method as typically understood in human-reader studies was employed or described. The results were based on quantitative laboratory assays.

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

• No, an MRMC comparative effectiveness study was not done. MRMC studies are typically used to evaluate the diagnostic performance of devices (often AI-based) and human readers in interpreting clinical cases.
• This device is a transport medium, not a diagnostic algorithm that interprets data. The performance studies focused on the physical and biological characteristics of the medium (viability, stability) in a laboratory setting.

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

• This question is not applicable as the Copan UTM-RT System is a physical transport medium, not an algorithm or AI-based device. Its performance is inherent to its biochemical composition and physical characteristics, not an algorithm's output.

7. The Type of Ground Truth Used

• The ground truth for the performance studies was laboratory-measured viability (e.g., organism recovery/survival rates) and stability of specific strains of viruses, chlamydiae, mycoplasma, and ureaplasma. This implicitly serves as the "truth" against which the performance of the transport medium (Copan UTM-RT vs. comparator) was evaluated.

8. The Sample Size for the Training Set

• Not applicable. The Copan UTM-RT System is a biological transport medium, not an AI/machine learning model that requires a training set. The performance studies described are for validation of its intended function, not for training a computational model.

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

• Not applicable for the reasons stated in point 8.

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The Copan Easy-Swab Collection and Transport System products are sterile, single-use specimen collection chambers intended to preserve the viability of aerobic microorganisms after their collection and during their transport from the collecting area to the laboratory. These devices are intended for the collection, transport, and preservation of aerobic clinical specimens for bacteriological examination. The Copan Easy-Swab Collection and Transport System products are designed to support the viability of a wide variety of clinically important aerobic bacteria.

The Copan Easy-Swab is offered in two configurations. The Copan Easy-Swab I is offered with a single swab applicator and the Copan Easy-Swab II is offered with two swab applicators. The Copan Easy-Swab is composed of a sterile peel pouch containing one or two swab applicators inside the transport tube. The swab applicator incorporates a polyurethane foam tip on a plastic shaft secured to a cap. The tube is manufactured from polypropylene.

To use the Copan Easy-Swab Collection and Transport System, the sterile peel pouch is opened and discarded. The applicator swab is removed from the tube and used to collect the clinical specimen. During specimen collection, the applicator tip should only touch the area where the infection is suspected. The applicator swab is returned to the transport tube, the cap firmly closed, and the specimen sent to the laboratory for analysis. After use, the tubes and swabs must be disposed of according to hospital or laboratory procedures for infectious waste.

Here's an analysis of the provided text regarding the Copan Easy-Swab Collection and Transport System, focusing on the acceptance criteria and the study that proves the device meets them:

Overall Assessment:

The provided document (K993161) is a 510(k) summary for a medical device. It focuses on demonstrating substantial equivalence to a predicate device rather than presenting a detailed clinical study with strict acceptance criteria for novel performance claims. Therefore, many of the requested elements (like specific effect sizes for human readers in MRMC studies, details on ground truth for training sets, etc.) are not applicable or not explicitly provided in this type of regulatory submission. The "study" here refers to performance testing to show viability and stability.

Acceptance Criteria and Device Performance:

Study Details:

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

   • Test Set Sample Size: Not explicitly stated in terms of a specific number of individual swabs or patient samples. The text mentions "a variety of aerobic organisms" were used for recovery studies.
   • Data Provenance: Not specified. It's likely an in-vitro laboratory study conducted by the manufacturer (Copan Diagnostics Inc. is based in Corona, CA, USA), but this is not explicitly stated. It is a prospective study as it involves active testing of the device.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience):

   • Not Applicable / Not Provided. For a device like a specimen collection and transport system, "ground truth" would typically be established by standard microbiological culture techniques performed by trained laboratory personnel. The document does not describe the use of "experts" in the sense of clinical specialists establishing a diagnosis. The viability assessment would be based on standard lab protocols.

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

   • Not Applicable / None. Adjudication methods like 2+1 are typically used in studies involving subjective interpretation (e.g., imaging studies). For a device like this, performance is assessed by objective microbiological viability counts, not subjective interpretation.

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:

   • Not Applicable. This is not an AI-assisted diagnostic device, nor does it involve human "readers" interpreting results in the way an MRMC study would measure. It's a collection and transport system.

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

   • Not Applicable. This is a physical device, not an algorithm. Performance is inherent to the device's ability to maintain organism viability.

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

   • Microbiological Culture Viability. The ground truth for the performance claim ("All organisms tested remained viable...") is established by standard microbiological culture methods, where the presence and growth of viable microorganisms are directly observed and quantified after the transport period. This is an objective, laboratory-based measurement.

7. The sample size for the training set:

   • Not Applicable. This device does not use machine learning or AI, and therefore does not have a "training set" in the computational sense.

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

   • Not Applicable. As there is no training set for a machine learning model, this element is not relevant.

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