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Puritan Liquid Amies Collection and Transport System is intended for use in the collection and transport of clinical specimens containing aerobic and fastidious bacteria from the patient to the laboratory for bacteriological examination and culture.

Puritan Liquid Amies Collection and Transport System is comprised of a sterile peel pouch containing a polyester flock swab applicator for collecting specimen and a polypropylene vial containing 1 ml of modified Amies liquid transport medium. The polyester flock swab applicators are provided in two different tip sizes to accommodate various specimen types. Amies liquid medium is a nonnutritive balanced salt solution containing inorganic phosphates to provide buffering capability, sodium chloride, potassium chloride, calcium chloride and magnesium chloride to provide essential ions that help maintain osmotic balance. Sodium thioglycollate provides a reduced environment. It is recommended for maintaining the viability of aerobic, anaerobic and fastidious bacteria during the transport to the laboratory.

The Puritan Liquid Amies Collection and Transport System is intended for the collection and transport of clinical specimens containing aerobic, anaerobic, and fastidious bacteria. The pivotal study demonstrating its performance is the "Recovery Testing" described in section 5.8 of the 510(k) summary. This study compared the Puritan system to a predicate device (BD (Copan) Liquid Amies Collection and Transport System, K061301) to demonstrate substantial equivalence.

Here's a breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance:

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

• Sample Size: The document mentions "known inocula of ATCC type culture and clinically significant microorganisms" were inoculated. It also states "random samples from three different lots of Puritan Liquid Amies Collection and Transport System" were used for pH stability. However, the exact number of microorganisms tested, replicates per microorganism, or total sample size for the core bacterial recovery study is not explicitly stated in the provided text.
• Data Provenance: The origin of the data is from laboratory testing (in vitro) comparing the Puritan device to a predicate device. It is not patient or country-specific data, but rather controlled experimental data. The study is prospective in the sense that the experiments were conducted specifically to evaluate the device.

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

This information is not applicable and not provided for this type of device (microbiological transport system). The ground truth for bacterial viability is established through quantitative laboratory methods (e.g., colony counting) and comparison to established standards (CLSI M40-A), not by expert consensus or interpretation of images/clinical data.

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

This information is not applicable and not provided. Adjudication methods are typically used in studies involving human interpretation (e.g., radiology for diagnostic devices) where multiple readers disagree. For this in vitro microbiological test, the results are quantitative and objective, eliminating the need for adjudication.

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 information is not applicable. The Puritan Liquid Amies Collection and Transport System is a medical device for specimen collection and transport, not an AI-powered diagnostic tool involving human readers. Therefore, an MRMC study or AI assistance is irrelevant to its evaluation.

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

This information is not applicable. This device is not an algorithm. Its performance is evaluated independently (standalone in a laboratory setting) by assessing its ability to maintain bacterial viability, followed by subsequent testing by laboratory personnel. There is no human-in-the-loop aspect for the function of the transport medium itself.

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

The ground truth used for the bacterial recovery test is based on quantitative microbiological methods, specifically the known initial inoculum of ATCC type cultures and clinically significant microorganisms, and their subsequent viability over time. The Clinical and Laboratory Standards Institute (CLSI) M40-A guidelines likely define the acceptable range of recovery, acting as the reference standard.

8. The sample size for the training set:

There is no training set in the context of this device. This is a laboratory-tested medical device, not a machine learning model.

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

This information is not applicable as there is no training set for this device.

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Puritan UTM – RT Collection and Transport System is intended for the collection and transport of clinical samples containing viruses, chlamydiae, mycoplasmas and ureaplasmas from the collection site to the testing laboratory. The specimen transported in the Puritan UTM - RT can be used in the laboratory to perform viral, chlamydial, mycoplasmal and ureaplasmal culture.

Puritan UTM-RT is an enclosed system recommended for the collection and transport of viruses, chlamydiae, mycoplasmas and ureaplasma. The osmotically balanced and buffered culture medium contains Hank's balanced salt solution with a pH indicator, sucrose as a preservative, protein and gelatin as stabilizers. Antimicrobial agents are incorporated to minimize commensal bacterial and fungus contamination.

Puritan UTM-RT is comprised of a conical polypropylene vial filled with three 3-mm glass beads and 1.5ml or 3 ml of the transport medium, affixed with a high density polyethylene cap. Each unit of Puritan UTM-RT is provided in a peel pouch containing one of the following swab combinations:

1ml UTM with ultrafine tip HydraFlock® Swab .
3ml UTM with one elongated tip HydraFlock® and one ultrafine tip swab
3ml UTM with elongated tip HydraFlock®® swab .
. 3ml UTM with mini-tip HydraFlock® swab, scored shaft
3ml UTM with ultrafine HydraFlock® tip swab
. 3ml UTM vial with 2 reg polyester tip swabs, scored shaft
3ml UTM vial with regular polyester tip and one wire/plastic shaft with polyester tip

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

Device: Puritan UTM-RT Collection and Transport System (UTM-RT)

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size for Microbial Recovery:
  • Microorganisms: Adenovirus, Cytomegalovirus, Echovirus Type 30, Herpes Simplex Virus Type II, Influenza A, Respiratory Syncytial Virus, Parainfluenza Type 3, Varicella Zoster Virus, Herpes Simplex Virus Type I (9 viruses), Chlamydia pneumonia Strain CM-1, Chlamydia trachomatis Type 1 Strain UW-12/UR (2 chlamydiae), Mycoplasma hominis, Mycoplasma pneumonia, Ureaplasma urealyticum (3 mycoplasmas/ureaplasmas). A total of 14 specific strains/organisms.
  • Replicates: For each organism, "100 µl were directly inoculated onto swabs in triplicate." This means 3 swabs per organism per dilution.
  • Dilutions: "Two different dilutions of neat stock suspensions were prepared."
  • Storage Conditions: "held at both 4° C and room temperature (20-25° C)."
  • Time Points: "At key time points following inoculation (0, 24, and 48 h)."
  • Total for Microbial Recovery (excluding initial stock prep variations): 14 organisms * 3 replicates * 2 dilutions * 2 storage temperatures * 3 time points = 1008 test samples.
• Sample Size for Shelf Life Stability:
  • Lots: "Three lots of the test device beyond the expiration point and one newly prepared lot" = 4 lots.
  • Microorganisms: Cytomegalovirus, Herpes Simplex Virus Type II, Respiratory Syncytial Virus, Chlamydia pneumonia, Mycoplasma pneumonia (5 specific strains).
  • Swabs: "spiking swabs that accompanied each transport system with the chosen test dilution."
  • Storage Temperatures: "stored at different temperatures (refrigerated and room temperature)."
  • Time Points: "held at 0, 24 and 48 hours."
  • Total (excluding replicates which are not explicitly stated for stability but would typically be used): 4 lots * 5 organisms * 2 storage temperatures * 3 time points = 120 test conditions.
• Sample Size for pH Stability: "random samples from three different lots of Puritan UTM-RT." (Number of samples not specified, but multiple samples per lot).
• Sample Size for Antibiotics Stability Test: "3 expired lots and a new lot of test device" = 4 lots.
• Sample Size for Cytotoxicity: "three lots of test devices."
• Data Provenance: The study appears to be a prospective bench study conducted by Puritan Medical Products LLC, an American company. The country of origin of the data is therefore USA (Guilford, ME).

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

• The document does not specify the number of experts or their qualifications used to establish the ground truth for the test set.
• The ground truth in this context (viability/recovery of microorganisms) is established through laboratory-based culture methods and microscopic examination (immunostaining and enumeration of fluorescent foci or colony forming units). While these methods require trained personnel, the document refers to "standard laboratory techniques" and does not imply a consensus panel of clinical experts for interpretation.

4. Adjudication Method for the Test Set

• The document describes laboratory-based assays, such as shell vial assay followed by immunostaining and enumeration of fluorescent foci, or direct culture methods followed by enumeration of colony-forming units.
• There is no mention of an adjudication method involving multiple human readers/experts for the interpretation of results. The assessment appears to be based on objective lab measurements.

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

• No, a MRMC comparative effectiveness study was not done.
• This type of study is typically used for diagnostic devices that involve human interpretation of images or other data to assess the impact of AI on reader performance. The Puritan UTM-RT is a specimen collection and transport system, and its performance is evaluated through direct microbial recovery, not by assessing human reader accuracy.

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

• This question is not applicable to the Puritan UTM-RT device.
• The device itself is a collection and transport medium, not an algorithm. The performance tests are for the ability of the physical medium and swabs to preserve biological samples.

7. The Type of Ground Truth Used

• The ground truth used is primarily direct microbial viability/culturability.
  • For viruses and chlamydiae: Viability determined by shell vial assay followed by immunostaining and enumeration of fluorescent foci.
  • For mycoplasmas and ureaplasmas: Viability determined using direct culture methods onto appropriate growth media followed by enumeration of colony forming units (CFU).
  • For pH: Direct measurement using a calibrated pH meter.
  • For cytotoxicity: Sulforhodamine B assay for cellular toxicity.

8. The Sample Size for the Training Set

• The Puritan UTM-RT is a physical collection and transport system, not an AI/ML algorithm. Therefore, there is no "training set" in the context of machine learning. The studies described are performance validation studies for the physical product.

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

• As there is no AI/ML component, the concept of a "training set" and its associated ground truth establishment is not applicable.

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