(137 days)
Puritan OptiTranz Liquid Stuart Collection and Transport System is intended for use in the collection and transport of clinical specimen containing aerobic and fastidious bacteria from patient to the laboratory for bacteriological examination and culture.
Puritan OptiTranz Collection and Transport System is comprised of a sterile peel pouch containing a rayon or flock tipped swab applicator for collecting specimen and a polypropylene vial containing 1 ml of Stuart liquid medium.
Puritan OptiTranz Liquid Stuart Medium is a nonnutritive balanced salt solution containing phosphates to provide buffering capability and calcium chloride to provide essential ions that help maintain osmotic balance. Mercaptoacetic acid provides a reduced environment. It is recommended for maintaining the viability of aerobic and fastidious bacteria during the transport to the laboratory.
The provided document describes the Puritan OptiTranz™ Liquid Stuart Collection and Transport System, a device for collecting and transporting clinical specimens containing aerobic and fastidious bacteria. The study conducted to demonstrate its effectiveness is primarily a recovery testing study, comparing its performance to a predicate device.
Here's an breakdown of the requested information:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (What was measured) | Reported Device Performance |
|---|---|
| Ability to maintain viability of aerobic and fastidious bacteria | No significant differences in recovery were detected between Puritan OptiTranz and the predicate device. |
| Stability over time (shelf life) | Products maintained microbial recovery up to the expiry date (18 months). |
| pH stability | All samples tested maintained pH within the specified range ($7.3 \pm 0.2$). |
| Cytotoxicity | No evidence of cytotoxicity was detected (for glue, shaft, and swab tips). |
| Sterilization | Sterilized by gamma irradiation, validated following ANSI/AAMI/ISO 11137:2006. |
2. Sample size used for the test set and the data provenance:
- Sample Size: The document mentions "known inoculum of ATCC type culture and clinically significant microorganisms" but does not specify the exact number of samples or isolates used in the recovery testing.
- Data Provenance: The study was conducted by the manufacturer, Puritan Medical Products LLC, as part of their 510(k) submission. It appears to be a prospective study designed to evaluate the new device against an established predicate within a laboratory setting. The country of origin of the data is not explicitly stated but would likely be the USA, where the manufacturer is located.
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 in the document. The recovery testing relies on direct measurement of microbial viability after transport, not on expert interpretation of results.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
This information is not applicable as the study did not involve human interpretation or adjudication of outcomes in the traditional sense of medical imaging or diagnostic tests. The performance was measured directly through microbiological viability assays.
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 specimen collection and transport system, not an AI-powered diagnostic tool. Therefore, an MRMC study related to human readers and AI assistance would not be relevant.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
Not applicable. This device is a physical product for specimen collection and transport, not a standalone algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
The ground truth for the recovery testing was established by comparing the viability of known inoculum of ATCC type culture and clinically significant microorganisms after transport in the Puritan OptiTranz system versus the predicate device. This is a microbiological ground truth based on controlled inoculation and subsequent quantitative recovery.
8. The sample size for the training set:
Not applicable. This device is not an AI/ML model, and therefore, there is no "training set" in the context of machine learning. The studies described are performance evaluations of a physical product.
9. How the ground truth for the training set was established:
Not applicable. See point 8.
§ 866.2390 Transport culture medium.
(a)
Identification. A transport culture medium is a device that consists of a semisolid, usually non-nutrient, medium that maintains the viability of suspected pathogens contained in patient specimens while in transit from the specimen collection area to the laboratory. The device aids in the diagnosis of disease caused by pathogenic microorganisms and also provides epidemiological information on these diseases.(b)
Classification. Class I (general controls).