(51 days)
The Copan Venturi Transystem Amies Medium With Charcoal products are sterile, singleuse specimen collection chambers intended to preserve the viability of microorganisms after their collection and during their transport from the collecting area to the laboratory. These devices are intended for the collection, transport, and preservation of clinical specimens for bacteriological examination. Copan Venturi Transystem Amies Medium With Charcoal is designed to support the viability of a wide variety of clinically important aerobic and anaerobic bacteria.
The Copan Venturi Transystem Amies Medium With Charcoal products are comprised of a sterile peel pouch containing a swab applicator and a tube containing the Amies Transport Medium With Charcoal and are offered in six models. The only difference in the six models is the type of applicator used for the collection of the bacteriological sample. The applicator shafts vary for facilitation of the collection of the specimen from various sites of the patient. The six types of Copan Venturi Transystem Amies Medium With Charcoal products are:
- Product Code 114C with plastic applicator .
- Product Code 136C with two plastic applicators .
- Product Code 116C with regular aluminum applicator .
- Product Code 125C with soft aluminum applicator .
- Product Code 129C with slim paper applicator .
- Product Code 192C with flexible twisted wire applicator .
The provided document is a 510(k) summary for the Copan Venturi Transystem Amies Medium With Charcoal, a specimen collection and transport system. It is a premarket notification for a Class I medical device, which generally means it's considered low-risk and doesn't require extensive clinical trials like higher-risk devices.
Based on the document, here's a breakdown of the requested information:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state quantitative acceptance criteria or provide specific numerical performance metrics. Instead, it refers to "acceptable performance." This is common for Class I devices and 510(k) submissions where the focus is on substantial equivalence to predicate devices rather than proving specific performance against predefined thresholds.
| Acceptance Criteria (Implicit) | Reported Device Performance (Implicit) |
|---|---|
| Maintain viability of anaerobic bacteria during storage and use | "The results of this testing demonstrated acceptable performance of the proposed device under the intended conditions of use." |
| Ability of packaging to retard oxygen penetration | "The results of this testing demonstrated acceptable performance of the proposed device under the intended conditions of use." |
| Substantially equivalent to predicate devices in design and function | "The Copan Venturi Transystem Amies Medium With Charcoal products and the substantially equivalent products are all sterile, single-use devices intended for use in collection, transport and preservation of clinical specimens for bacteriological examination. The proposed and predicate devices are equivalent in design and function..." |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: The document does not specify exact sample sizes for the "recovery studies" or "additional studies" performed. It only mentions "Studies were conducted to evaluate the performance characteristics."
- Data Provenance: The document does not explicitly state the country of origin of the data or whether the studies were retrospective or prospective. Given it's a 510(k) submission from a US-based company (Copan Diagnostics Inc., Corona, CA), it's highly probable the studies were conducted in the US. The timeframe suggests they would have been prospective studies specifically designed for regulatory submission, rather than retrospective analysis of existing data.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This type of information is not applicable to this device and the context of its 510(k) submission. Ground truth established by medical experts (e.g., radiologists) is typically relevant for interpretative diagnostic devices (e.g., AI for medical imaging), not for specimen collection and transport systems where a definitive microbiological culture or molecular diagnostic result would serve as the "truth." The studies would have focused on the viability of microbial samples, not on expert interpretation.
4. Adjudication Method for the Test Set
This information is not applicable for the same reasons as point 3. Adjudication methods like 2+1 or 3+1 are used for expert consensus in interpretive tasks, which is not the nature of the performance testing described for this device.
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
An MRMC comparative effectiveness study is not applicable to this device. These studies are conducted for devices, particularly AI-driven ones, that assist human readers in making diagnoses (e.g., medical imaging interpretation). The Copan Venturi Transystem is a physical device for specimen collection and transport, not an interpretive aid. Therefore, there is no "human reader improvement with AI vs without AI assistance" to measure.
6. If a Standalone (i.e. algorithm only without human-in-the loop performance) was done
This information is not applicable as the device is a physical specimen collection system and not an algorithm.
7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)
The document implies that the ground truth for performance evaluation would be based on microbiological viability (e.g., culture growth) outcomes. For example, "Recovery studies were performed... to determine the ability of the products to maintain viability of anaerobic bacteria." The "truth" would be whether the bacteria remained viable to allow for subsequent laboratory examination and identification.
8. The Sample Size for the Training Set
This information is not applicable. The device is a physical collection and transport system, not an AI/ML algorithm that requires a training set.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable for the same reason as 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).