(44 days)
Copan Liquid Amies Elution Swab (ESwab) Collection and Transport System is intended for the collection and transport of clinical specimens containing aerobes, anaerobes and fastidious bacteria from the collection site to the testing laboratory. In the laboratory, ESwab specimens are processed using standard clinical laboratory operating procedures for bacterial culture.
Copan Liquid Amies Elution Swab (ESwab) Collection and Transport System is supplied in a collection kit format. Each collection kit consists of a sterile package containing a plastic screw-cap tube with conical shaped bottom filled with 1 ml of Liquid Amies transport medium and a small sterile peel pouch containing one of two sizes of a specimen collection swab that has a tip flocked with soft nylon fiber.
The Liquid Amies transport medium is a maintenance medium comprising inorganic phosphate buffer, calcium and magnesium salts and sodium chloride with a reduced environment due to the presence of sodium thioglycollate. The medium is designed to maintain the viability of aerobic bacteria, anaerobic bacteria and fastidious bacteria such as Neisseria gonorrhoeae during transit to the testing laboratory.
The nylon flocked specimen collection swabs provided with the Copan ESwab Collection and Transport System have a solid plastic shaft with a molded breakpoint site. Copan ESwab Collection and Transport System kits are available with two different size nylon flocked swab options to facilitate the collection of specimens from various sites on a patient.
The provided text describes the 510(k) summary for the Copan Liquid Amies Elution Swab (ESwab) Collection and Transport System. This document focuses on demonstrating substantial equivalence to predicate devices and does not detail specific acceptance criteria or a comprehensive study report in the way typically expected for a medical device with quantifiable performance metrics like accuracy, sensitivity, or specificity.
Instead, the performance testing described is focused on the ability of the product to maintain the viability of bacterial strains. As such, the information you've requested regarding specific acceptance criteria, sample sizes for test/training sets, ground truth establishment, expert involvement, and MRMC studies is not explicitly present in the provided text.
However, I can extract the information that is available and indicate where details are missing based on your request.
Summary of Device Performance and Study (Based on Provided Text):
The Copan Liquid Amies Elution Swab (ESwab) Collection and Transport System underwent performance testing to evaluate its ability to maintain the viability of various aerobic, anaerobic, and fastidious bacteria during storage and use, in comparison to predicate devices. Stability testing was also performed to support its 15-month expiration date.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Inferred from text) | Reported Device Performance (Summary) |
|---|---|
| Maintain viability of aerobic bacteria during storage and use. | Studies were conducted to determine the ability of the ESwab to maintain viability of various strains of aerobic bacteria. (Specific quantitative results not provided). |
| Maintain viability of anaerobic bacteria during storage and use. | Studies were conducted to determine the ability of the ESwab to maintain viability of various strains of anaerobic bacteria. (Specific quantitative results not provided). |
| Maintain viability of fastidious bacteria (e.g., Neisseria gonorrhoeae) during storage and use. | Studies were conducted to determine the ability of the ESwab to maintain viability of various strains of fastidious bacteria, specifying Neisseria gonorrhoeae. (Specific quantitative results not provided). |
| Support a 15-month expiration date. | Stability testing was performed on aged Copan ESwab products to support the 15-month expiration date. (Specific results not provided). |
2. Sample size used for the test set and the data provenance
- Sample Size: Not specified in the provided text. The text mentions "various strains of aerobic, anaerobic and fastidious bacteria" but does not give a number of strains, replicates, or overall sample size for the viability studies.
- Data Provenance: Not specified. It can be inferred that the testing was conducted by Copan Diagnostics Inc., as they are the sponsor. The country of origin of the data (e.g., in-house lab, external lab, specific geographic location) and whether it was retrospective or prospective is not mentioned.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Number of Experts: Not applicable/Not specified. For this type of device (collection and transport system for bacterial viability), "ground truth" is typically established through laboratory culture and viability assessment, not through expert consensus on medical images or diagnoses.
- Qualifications of Experts: Not applicable/Not specified, as expert consensus is not the stated method for ground truth. The studies relied on laboratory methods for assessing bacterial viability.
4. Adjudication method for the test set
- Adjudication Method: Not applicable/Not specified. Adjudication methods (like 2+1, 3+1) are typically used when subjective assessments by multiple experts are being reconciled, such as in image interpretation. For bacterial viability studies, objective laboratory measurements are generally used.
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
- MRMC Study: No, an MRMC comparative effectiveness study was not done. This type of study is relevant for AI-powered diagnostic aids that assist human readers (e.g., radiologists interpreting images). The Copan ESwab system is a physical medical device for specimen collection and transport, not an AI diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Standalone Performance: No, this is not an algorithm, so a standalone algorithm performance study is not applicable. The device's performance is tested on its ability to maintain bacterial viability as a physical system.
7. The type of ground truth used
- Type of Ground Truth: The ground truth for the performance studies would be the documented presence and viability (e.g., colony-forming units or other microbiological growth metrics) of specific strains of aerobic, anaerobic, and fastidious bacteria at different time points, as determined by standard laboratory culture techniques.
8. The sample size for the training set
- Sample Size for Training Set: Not applicable/Not specified. This device is not an AI algorithm that requires a "training set." The performance studies described are for validation, not training.
9. How the ground truth for the training set was established
- How Ground Truth for Training Set was Established: Not applicable, as there is no training set for this type of 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.