Search Results

The ARX Liquid Amies Collection & Transport System (ARX) is intended for use in the collection of clinical specimens (i.e., nasal secretion/wash; lachrymal secretion/tears; auricular secretion/cerumen; urethral, rectal, or vaginal swab; wound/abscess material) potentially containing aerobic, and fastidious bacteria and their transport at 2-8°C or 25-30°C from the patient to the laboratory for bacteriological examination and culture. In the laboratory, the collected and transported clinical specimens of nasal, lachrymal, ceruminous, vaginal, urethral, rectal, and wound/abscess origin are processed using standard clinical laboratory operating procedures for bacterial culture.

The ARX Liquid Amies Collection & Transport System consists of a polypropylene screw-cap vial containing Liquid Amies transport medium and three (3) sterile peel-open pouches containing a pre-scored Microbrush nylon flocked swab for collecting specimens. The three (3) nylon flocked swabs are provided with various score points, tip sizes, and configurations to facilitate specimen collection from various sites on patients' bodies. Nylon flocked swabs facilitate quick absorption and release of clinical specimens. Proper specimen collection from the patient is critical for successful isolation and identification of infectious organisms.

Amies liquid medium is a non-nutritive balanced salt solution containing inorganic phosphates to provide buffering capability, sodium chloride, potassium chloride, and magnesium chloride to provide essential ions that help maintain osmotic balance and control permeability of bacterial cells. It also contains sodium thioglycolate to provide a reduced environment. ARX Liquid Amies transport medium is capable of maintaining the viability of aerobic, anaerobic, and fastidious bacteria (such as Neisseria gonorrhoeae) during specimen transport to the laboratory for bacteriological testing and culture.

All raw materials used in the manufacture of ARX Liquid Amies Collection & Transport System are qualified before use. Every batch of ARX Liquid Amies Collection & Transport System is tested prior to release for sterility, pH, and background count using microscopic examination. Representative samples of each batch are further evaluated for their ability to maintain the viability of selected bacterial agents over predefined time periods.

The provided text describes the performance characteristics of the ARX Liquid Amies Collection & Transport System for bacterial recovery. This information is relevant to the acceptance criteria and the study proving the device meets these criteria.

Here's an analysis of the provided information to address your request:

Device: ARX Liquid Amies Collection & Transport System

Purpose of Study: To demonstrate the ability of the device to maintain the viability of aerobic, anaerobic, and fastidious bacteria during specimen transport, and to establish shelf-life stability.

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for bacterial recovery are stated as:

• Roll-Plate studies: Minimum acceptable viability of at least 2% CFU relative to time 0.
• Swab Elution studies: Maximum 3 log10 decline in CFU acceptable relative to time 0.

For shelf-life stability:

• pH within specified range (7.30 ± 0.2).
• Visual inspection (no turbidity).
• Viscosity within specified range (1.075 ± 0.015 milliPascal.Second).

Table: Acceptance Criteria and Reported Device Performance (Summary)

Conclusion from non-clinical Performance Studies: "the ARX Liquid Amies Collection & Transport System showed recovery of bacteria within the acceptance criteria comparable to the predicate device for all holding temperatures tested. This demonstrates the acceptability claim of up to 48 hours for all organisms (except 24 hours for Neisseria gonorrhoeae) in clinical samples during storage and/or transport in this transport system. Additional studies conducted with the ARX Liquid Amies Collection & Transport System support the shelf-life stability claim of 18 months."

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

The "test set" in this context refers to the bacterial strains and conditions used for the performance studies, not a patient-derived dataset.

• Sample Size (Test Set):

  • Bacterial Strains: A total of 17 bacterial strains were used:
    • 3 aerobic bacteria
    • 6 facultative anaerobic bacteria (including 1 fastidious organism, Neisseria gonorrhoeae)
    • 8 obligate anaerobic bacteria (listed in Table 2)
  • Device Samples: For each study (Roll-Plate and Swab Elution, with NCM and Saline at different temperatures):
    • 3 independent lots of ARX Liquid Amies (Old, Middle-aged, New) were tested.
    • For each combination of organism, lot, and temperature/matrix, the swabs were inoculated in triplicate.
    • Measurements were taken at 0, 24, and 48 hours (except N. gonorrhoeae only at 24 hours).
  • Shelf-life Stability: 4 manufactured lots were evaluated.

• Data Provenance: The data appears to be from controlled laboratory studies (prospective experimental data) conducted to validate the device's performance. The document does not specify a country of origin for the data, but given it's an FDA submission, it's typically either conducted in the US or in adherence to international standards acceptable to the FDA. The matrices used were "Negative Clinical Matrix (NCM) or sterile saline," simulating clinical conditions.

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

This type of device (microbiological specimen collection and transport system) relies on established microbiological laboratory standards and quantitative measurements (CFU counts) rather than subjective expert interpretation of medical images or pathologies. Therefore, there is no mention of "experts" in the traditional sense (e.g., radiologists) establishing ground truth. The "ground truth" here is determined by the live cultures and their measured viability, following universally accepted laboratory protocols.

• Number of Experts: Not applicable in the context of expert consensus for ground truth on images or clinical outcomes.
• Qualifications of Experts: Not applicable. The "ground truth" (bacterial viability) is established by direct laboratory measurements following CLSI M40-A2 standards.

4. Adjudication Method for the Test Set

Adjudication methods (like 2+1, 3+1) are typically used in clinical studies where multiple human readers or algorithms provide interpretations, and a consensus or higher-level review is needed to establish a definitive ground truth.

For this device, the "ground truth" is based on direct quantitative laboratory measurements (colony forming unit counts) of bacterial viability. These are objective measures, not subjective interpretations. Therefore:

• Adjudication Method: Not applicable. Ground truth is derived from direct quantitative microbiological assays.

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

MRMC studies are typically performed for diagnostic devices (e.g., AI-powered imaging systems) where human interpretation plays a role, and the goal is to assess how a new technology impacts diagnostic performance.

This device is a specimen collection and transport system, not a diagnostic imaging or AI-driven interpretive tool. The study focuses on the physical and biological performance of the transport medium and swabs in maintaining bacterial viability.

• MRMC Study: No, an MRMC study was not done as it is not relevant for this type of device.
• Effect Size of Human Readers: Not applicable.

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

The concept of "standalone performance" typically refers to the performance of an AI algorithm independent of human intervention. This device is not an AI algorithm. Its performance is inherent to its physical and biological properties.

• Standalone Performance: Not applicable. This is not an AI device. The studies conducted evaluate the intrinsic performance of the device itself (transport medium and swabs) in preserving bacterial samples.

7. The Type of Ground Truth Used

• Type of Ground Truth: The ground truth for the performance studies was bacterial viability/colony counts (CFU) established through controlled laboratory experiments. This is a direct, quantitative measure of the device's ability to preserve the bacteria. The studies followed FDA-recognized sections of Clinical Laboratory Standards Institute (CLSI) M40-A2:2014 Quality Control of Microbiological Transport Systems.

8. The Sample Size for the Training Set

This device is not an AI/ML device, and therefore does not have a "training set" in the computational sense. The studies described are validation and performance testing, not model training.

• Sample Size for Training Set: Not applicable, as this is not an AI/ML device.

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

As there is no training set for this device in the context of AI/ML, this question is not applicable. The device's performance is based on its material properties and chemical composition, validated through standard microbiology testing.

• How Ground Truth for Training Set Was Established: Not applicable.

Ask a specific question about this device

ARX Viral Transport Media Collection & Transport System (ARX-VTM) is intended for the collection and transport of clinical specimens containing viruses from the collection site to the testing laboratory. The ARX-VTM is a culture-based media that is intended to be used in the laboratory to perform viral culture or diagnostic assays for viruses including, Influenza A, Parainfluenza type 3, Coronavirus OC43, Respiratory Syncytial Virus (RSV) A, Herpes Simplex virus 1 & 2, Echovirus, and Cytomegalovirus.

ARX Viral Transport Media Collection and Transport System (ARX-VTM) is a specialized systems for collecting and transporting viruses at 2-8 ºC or 20-25 ºC. The ARX-VTM is for use in laboratories to aid in the diagnosis of infections, especially when there is a delay between specimen collection and processing for up to 72 hrs. ARX Viral Transport Media Collection & Transport System (ARX-VTM) is intended for the collection and transport of clinical specimens containing viruses from the collection site to the testing laboratory. The ARX-VTM is a culturebased media that is intended to be used in the laboratory to perform viral culture or diagnostic assays for viruses including, Influenza A, Parainfluenza type 3, Coronavirus OC43, Respiratory Syncytial Virus (RSV) A, Herpes Simplex virus 1 & 2, Echovirus, and Cytomegalovirus.

Device Specifications: The ARX-VTM contains a non-propagating media supplied in a polypropylene (PP) tube individually with 1 or 3 mL of transport medium and as a kit. The kit contains a PP tube with 1 or 3 mL of transport medium and a sterile peel pouch containing a nylon flocked swab applicator for collecting specimens. Nylon flocked swabs are available in various score points and configurations to facilitate specimen collection from various anatomical sites.

The provided document describes the ARX Viral Transport Media Collection and Transport System (ARX-VTM) and its performance characteristics for viral recovery.

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

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

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

• Sample Size for Viral Recovery: For each virus and each temperature condition (2-8°C and 25-30°C), tests were conducted with swabs in triplicate at time points 0, 24, 48, and 72 hours. While the exact number of swabs per time point isn't explicitly stated beyond "in triplicate," this would mean at least 3 swabs per virus per time point per temperature. The total 'n' would be 8 viruses * 2 temperatures * 4 time points * 3 replicates = 192 samples (excluding additional replicates for baseline).
• Sample Size for Shelf-Life: Three lots of ARX-VTM samples were tested, with duplicate samples from each lot for visual inspection, pH, and osmolarity.
• Data Provenance: The document does not specify the country of origin of the data. The study appears to be a prospective laboratory study, where the performance of the ARX-VTM was measured under controlled conditions.

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

The ground truth for viral recovery was established via visual enumeration of fluorescent foci units (FFU) by researchers. The document does not specify the number or qualifications of experts involved in this enumeration. It appears to be a standard laboratory method rather than expert consensus on clinical cases.

4. Adjudication method for the test set

The document does not describe an adjudication method for the test set, as the ground truth was established through quantitative laboratory measurements (FFU counts). Adjudication methods like "2+1" typically apply to subjective assessments requiring multiple readers, which is not the case here.

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

No, an MRMC comparative effectiveness study was not done. The device is a viral transport medium, not an AI-assisted diagnostic tool. Therefore, the concept of human readers improving with or without AI assistance is not applicable to this submission.

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

This is not applicable as the device is a viral transport medium, not an algorithm or software. The performance assessment focused on the medium's ability to maintain viral viability.

7. The type of ground truth used

The type of ground truth used for viral recovery studies was quantitative laboratory measurement of viral viability, specifically the visual enumeration of fluorescent foci units (FFU) after inoculation into monolayer cells and immunostaining. For shelf-life, the ground truth involved quantitative measurements of pH and osmolarity, and qualitative visual inspection.

8. The sample size for the training set

This is not applicable. The ARX-VTM is a physical medical device (transport medium) and not an AI/ML algorithm that requires a training set.

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

This is not applicable for the same reason as above; there is no training set for this type of device.

Ask a specific question about this device