(50 days)
MSwab is a Collection, Transport and Preservation System intended for the collection and transport of clinical specimens containing Gram positive aerobic and facultative anaerobic bacteria, HSV 1 and HSV 2 from the collection site to the testing laboratory. In the laboratory, MSwab specimens are processed using standard clinical laboratory operating procedures for culture.
Copan MSwab Collection, Transport and Preservation System is supplied in two different formats: a collection kit format and a tube only format. Each collection kit consists of a package containing a plastic screw-cap tube with conical shaped bottom filled with 1 ml or 1.6 ml of MSwab transport and preservation medium and a small sterile peel pouch containing one specimen collection swab that has a tip flocked with soft nylon fiber. The tube only format consists of a plastic screw-cap tube with conical shaped bottom filled with 1 ml or 1.6 ml of MSwab transport and preservation medium. The MSwab is intended for single use. MSwab transport and preservation medium is a maintenance medium comprising TRIS HCl. EDTA. TRIS Base, Dimethyl Sulfoxide (DMSO) and Bovine Serum Albumin. The medium is designed to maintain the viability of Gram positive aerobic and facultative anaerobic bacteria. HSV 1 and HSV 2 during transit to the testing laboratory. The nylon flocked specimen collection swab provided in each collection kit of the Copan MSwab Collection. Transport and Preservation System has a solid plastic shaft with a molded breakpoint site.
Here's a breakdown of the acceptance criteria and study details for the Copan MSwab Collection, Transport and Preservation System, as extracted from the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Bacterial Recovery (Swab Elution): | No more than a 3 log₁₀ (1 x 10 +/- 10%) decline in Colony Forming Units (CFU) between the CFU count at 0 hours and the CFU count at 48 hours. | All tested Gram-positive aerobic and facultative anaerobic bacteria (12 strains) showed an acceptable log₁₀ decline within the 3 log₁₀ limit at both 4-8°C and 20-25°C for 48 hours. (Refer to Tables 1 and 2 for specific figures, all "Interpretation" rows are "Acceptable Recovery".) |
| Bacterial Recovery (Roll-Plate): | >5 CFU at 48 hours from the specific dilution that yielded 0 hour counts closest to 300 CFU. | All tested Gram-positive aerobic and facultative anaerobic bacteria (12 strains) showed acceptable recovery (>5 CFU at 48 hours) at both 4-8°C and 20-25°C for 48 hours. (Refer to Tables 3 and 4 for specific figures, demonstrating counts well above 5 CFU). |
| Viral Recovery (4-8°C & 20-25°C): | Any viral recovery at 48 hours (determined by fluorescing foci counts). | All tested HSV-1 and HSV-2 strains showed acceptable recovery (detectable fluorescing foci) at 48 hours at both 4-8°C and 20-25°C. (Refer to Table 5 for 4-8°C results and Table 6 for 20-25°C results, all "Interpretation" rows are "Acceptable Recovery" and non-zero foci counts are reported). |
| Viral Recovery (-70°C): | Any viral recovery at 14 days. | The results demonstrated acceptable recovery for all samples tested (specifically HSV-1 and HSV-2) at -70°C for 14 days. (No specific table for this data in the provided text, but the conclusion states it). |
| Recovery Stability: | Ability to maintain viability of specific bacterial (Streptococcus pyogenes, Streptococcus pneumoniae, Staphylococcus aureus (MRSA)) and viral (HSV 1, HSV 2) strains for at least 48 hours at 4-8°C and 20-25°C, when using aged MSwab System devices (up to 13 months following manufacture). | The results from three representative lots demonstrated the ability of the MSwab System to maintain the viability of the bacterial and viral strains evaluated for at least 13 months following the date of manufacture. |
| pH Stability: | Maintain pH within the target range at all time intervals tested (up to 13 months). | The results from three representative lots demonstrated the ability to maintain pH within the target range at all time intervals tested. |
| Sterilization: | Tubes and caps: Gamma irradiation in accordance with UNI EN ISO 11137:2006. Swabs: ETO treatment in accordance with UNI EN ISO 11135:2007. Aseptic filling process for medium. | Compliant, stated that "Representative samples were tested to validate the medium filling process with respect to risk of microbial contamination." and that components were sterilized according to the specified ISO standards. |
| Biocompatibility: | Swab component is non-cytotoxic, non-irritating, and non-sensitizing in accordance with ISO 10993. | The results demonstrated that the swab component is non-cytotoxic, non-irritating and non-sensitizing. |
| Cytotoxicity: | No alteration of MRC5 cell monolayers compared to a negative control, using MSwab System devices aged 1, 7, and 13 months. | The results from three representative lots aged 1 month, 7 months and 13 months showed no alteration of the cell monolayers compared to the negative control. |
2. Sample Size Used for the Test Set and Data Provenance
- Bacterial Recovery Studies:
- For each of the 12 bacterial strains, the test set involved inoculating swabs in triplicate for measurement at 0, 24, and 48 hours. This was done for the MSwab device and relevant predicate devices, across two temperature ranges (4-8°C and 20-25°C). The text also mentions "three representative lots" for stability and pH studies, implying that the recovery studies were conducted across these lots as well, but the specific number of test samples (swabs) per organism per lot for the primary recovery study is explicitly stated as triplicate.
- Viral Recovery Studies:
- For each of the 2 viral strains, the test set involved inoculating swabs in triplicate for measurement at 0, 24, and 48 hours. This was done for the MSwab device and relevant predicate devices, across two temperature ranges (4-8°C and 20-25°C).
- Recovery Stability, pH Stability, Cytotoxicity: Mention "three representative lots."
- Data Provenance: The document does not specify the country of origin of the data. The studies are described as prospective laboratory recovery studies, where organisms were purposefully inoculated onto the collection systems and then tested for viability over time.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
- The ground truth in this context is the viability of microorganisms (CFU counts for bacteria, fluorescing foci counts for viruses) after storage in the transport medium.
- The document does not report the number of experts or their qualifications used to establish this ground truth. This is a standard laboratory study where the measurement of CFU or foci counts is a direct, quantifiable outcome, typically performed by trained laboratory personnel following established protocols (like CLSI M40-A). It is not a subjective assessment requiring expert consensus in the same way an imaging study might.
4. Adjudication Method for the Test Set
- No adjudication method is explicitly described. The determination of "acceptable recovery" is based on quantitative thresholds applied to the CFU counts (for bacteria) or the presence of viral recovery (for viruses), as defined in the acceptance criteria. These are objective measures rather than subjective interpretations requiring 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
- No, an MRMC comparative effectiveness study was not done. This device is a specimen collection, transport, and preservation system, not an AI-powered diagnostic imaging or interpretation system that would involve human "readers" or AI assistance. The study focuses on the device's ability to maintain microorganism viability, not on improving human diagnostic accuracy.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
- Yes, in concept, this is a standalone performance study for the device. The "algorithm" here isn't a software algorithm but rather the physical and chemical properties of the MSwab system (medium, swab material, etc.) in preserving organisms. The studies directly measure the performance of the device itself (its ability to maintain viability) without human intervention in the preservation process or interpretation stage beyond the initial inoculation and final enumeration.
7. The Type of Ground Truth Used
- The ground truth used is direct microbial enumeration:
- Colony Forming Units (CFU) counts for bacteria.
- Fluorescing foci counts for viruses.
- For viral recovery at -70°C, the ground truth was simply "any viral recovery" (implying detectability).
- This is a form of direct measurement of biological viability rather than expert consensus, pathology, or outcomes data.
8. The Sample Size for the Training Set
- This information is not applicable to this type of study. The device is a physical collection and transport system, not a machine learning or AI algorithm that requires a "training set" in the computational sense. The reported studies are performance validation studies.
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.
§ 866.2900 Microbiological specimen collection and transport device.
(a)
Identification. A microbiological specimen collection and transport device is a specimen collecting chamber intended for medical purposes to preserve the viability or integrity of microorganisms in specimens during storage of specimens after their collection and during their transport from the collecting area to the laboratory. The device may be labeled or otherwise represented as sterile. The device aids in the diagnosis of disease caused by pathogenic microorganisms.(b)
Classification. Class I (general controls). The device, when solely intended for use in the collection of concentrated parasites from specimens and transport, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 866.9.