(81 days)
Puritan Fecal Opti-Swab Collection and Transport System is intended for use in the collection and transport of clinical fecal and rectal swab specimens to preserve the viability of enteric bacteria during transport from the collection site to the testing laboratory for bacteriological examination and culture.
Puritan Fecal Opti-Swab Collection and Transport System is comprised of a sterile peel pouch containing a sterile polyester flock swab applicator for collecting clinical fecal and rectal specimens and a polypropylene vial containing 2 ml of Fecal Opti-Swab medium.
Fecal Opti-Swab medium is a nonnutritive balanced salt solution containing phosphates to provide buffering capability, chloride salts to provide essential ions that help maintain osmotic balance. Agar is a solidifying agent that increases the viscosity of the medium. Sodium thioglycolate and L-cysteine provides an oxygen-reduced environment. It is recommended for maintaining the viability of enteric bacteria during the transport to the laboratory.
The document describes the Puritan Fecal Opti-Swab Collection and Transport System, a device for collecting and transporting fecal and rectal swab specimens to preserve the viability of enteric bacteria. The study presented is a substantial equivalence comparison with a predicate device, not a comparative effectiveness study with human readers or a standalone algorithm performance study.
Here's an analysis of the provided information:
1. Table of Acceptance Criteria and Reported Device Performance:
The document doesn't explicitly list "acceptance criteria" in a typical quantitative sense (e.g., target sensitivity/specificity). Instead, it states that the Puritan Fecal Opti-Swab Collection and Transport System was compared to a predicate device, and "No notable differences in recovery were detected" and that the performance "is not adversely affected by fecal material." It also reports on pH stability, cytotoxicity, and sterilization.
| Feature/Test | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|
| Microbial Recovery (vs. Predicate Device) | No notable differences in recovery compared to predicate device. | "No notable differences in recovery were detected between the Puritan Fecal Opti-Swab Collection and Transport System and the predicate device." |
| Microbial Recovery (in Fecal Matrix) | Not adversely affected by fecal material. | "It was determined that clinical fecal material does not notably alter the recovery of the challenge organisms from the Puritan Fecal Opti-Swab Collection and Transport System." |
| pH Stability | pH of 6.90-7.50 up to expiry date. | "All samples tested were found to maintain pH within the specified range [6.90-7.50] for up to 15 months after manufacturing date." |
| Cytotoxicity | No evidence of cytotoxicity. | "No evidence of cytotoxicity was detected." |
| Sterilization | Sterilized according to ANSI/AAMI/ISO 11137:2006 guidelines. | "Puritan Fecal Opti-Swab Collection and Transport System is sterilized by gamma irradiation and validated following ANSI/AAMI/ISO 11137:2006, Sterilization of health care products Radiation guidelines." |
| Shelf Life | 15 months. | The device demonstrated pH stability and microbial recovery up to the expiry date (15 months). |
| Specimen Storage for C. difficile | Up to 48 hours at 2 – 8 °C and up to 24 hours at 20 – 25 °C. | Stated as the intended performance characteristic for both test and predicate device. Testing confirmed viability to meet this (implied by recovery testing). |
| Specimen Storage for Other Target Organisms | Up to 72 hours at 2 – 8 °C and up to 48 hours at 20 – 25 °C. | Stated as the intended performance characteristic for both test and predicate device. Testing confirmed viability to meet this (implied by recovery testing). |
2. Sample Size Used for the Test Set and Data Provenance:
- Sample Size: The document does not explicitly state the specific number of samples (e.g., number of swabs, fecal samples, or bacterial cultures) used for each recovery and stability test. It mentions "known inoculum of ATCC type culture and clinically significant microorganisms" and "three representative challenge organisms," but not specific quantities.
- Data Provenance: The study appears to be prospective in nature, as it involves preparing inocula and conducting experiments in a controlled lab setting to compare the Puritan device with a predicate. The specific country of origin for the data is not mentioned, but the sponsor is Puritan Medical Products LLC from Guilford, ME, USA.
The study compares the device to the predicate following CLSI M40-A2 guidelines, which are standard for microbiological transport systems.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:
- This information is not provided as the study focuses on the performance of a transport medium for microbial viability, not on diagnostic interpretation by human experts. The "ground truth" here is the known quantity and viability of bacterial cultures established through standard microbiology laboratory techniques.
4. Adjudication Method for the Test Set:
- An adjudication method is typically used when human interpretation is involved and discrepancies arise. As this study is a laboratory-based evaluation of microbial viability in a transport medium, an adjudication method for a test set is not applicable and therefore not described.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:
- No, an MRMC comparative effectiveness study was not done. This type of study assesses the effect of a device (like AI software) on human reader performance. The Puritan Fecal Opti-Swab is a physical collection and transport system, not an AI-powered diagnostic tool. Therefore, the concept of human readers improving with or without AI assistance is not relevant to this device or study.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- No, a standalone algorithm performance study was not done. This device is a manual collection and transport system, not an algorithm or software.
7. The Type of Ground Truth Used:
- The ground truth used was based on known bacterial ATCC type cultures and clinically significant microorganisms with known concentrations (inoculum). This is a laboratory-established ground truth, typically validated by quantitative plating methods to determine viable colony-forming units (CFUs). For the fecal matrix experiment, "clinical fecal material" was used, and presumably, spiked with known organisms to assess recovery.
8. The Sample Size for the Training Set:
- This device is a physical product (collection and transport system) and not an AI/ML algorithm. Therefore, there is no "training set" in the context of machine learning. The stability and recovery tests are analogous to validation or performance testing for a traditional device.
9. How the Ground Truth for the Training Set Was Established:
- As there is no training set for an algorithm, this question is not applicable.
§ 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).