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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

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.

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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

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.

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The GEN-PROBE® APTIMA® Adapter Kit is to be used to test male urethral specimens collected with the GEN-PROBE® PACE® Specimen Collection Kit for Urethral or Conjunctival Specimens or female endocervical specimens collected with the GEN-PROBE PACE Specimen Collection Kit for Endocervical Specimens in the APTIMA Assays.

The APTIMA Adapter Kit is specifically formulated to allow testing of specimens collected with the GEN-PROBE PACE collection devices in the APTIMA Combo 2 Assay. The APTIMA Adapter Kit provides a diluent for PACE specimens. The diluent is identical to the transport media provided in both the PACE and APTIMA collection kits. The APTIMA Adapter Kit can only be used in conjunction with the GEN-PROBE PACE Specimen Collection Kits for testing in the APTIMA Combo 2 Assay. The description provided pertains to the test application (the APTIMA Combo 2 Assay).

Here's a breakdown of the acceptance criteria and study details for the GEN-PROBE® APTIMA® Adapter Kit, based on the provided document:

Acceptance Criteria and Device Performance

The study aimed to establish the equivalence of the APTIMA Adapter Kit with the APTIMA Combo 2 Unisex Swab Collection Kit. While explicit "acceptance criteria" in terms of specific percentages were not stated before the results, the implication is that high levels of agreement between the two methods would demonstrate equivalence.

The study concluded that the results demonstrate that using the APTIMA Adapter Kit with specimens collected in the PACE Specimen Collection Kits yield equivalent APTIMA Combo 2 Assay results when compared to specimens collected with the APTIMA Combo 2 Assay, Unisex Swab Specimen Collection Kits. This statement confirms the device met the implicit acceptance criteria of demonstrating equivalence.

Study Details

1. Sample sizes used for the test set and data provenance:

• Male subjects: 154
• Female subjects: 232
• Total test results analyzed: 772 (for Chlamydia trachomatis (CT) and Neisseria gonorrhoeae (GC))
• Data Provenance: The specimens were collected from subjects attending STD and Family Planning clinics. The document does not explicitly state the country of origin, but given the submission is to the FDA (USA), it is highly probable the data is from the USA. The study design comparing two collection methods for the same patients suggests a prospective collection for this specific study, although the underlying APTIMA Combo 2 Assay itself would have been validated with clinical data (which could be retrospective). This specific study focuses on the adapter kit's performance in a comparative manner.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

• The document does not mention the number of experts or their qualifications used to establish ground truth. This is a study comparing two specimen collection methods with the same assay, rather than comparing an assay to a gold standard. The "ground truth" implicitly relies on the established accuracy of the APTIMA Combo 2 Assay itself.

3. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

• The document does not describe any adjudication method. The study design compares results from paired swab specimens using two different collection kits with the same assay.

4. 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. This is not an AI or imaging device, nor is it a multi-reader study. The device is an adapter kit for a diagnostic assay.

5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

• Yes, in essence. The APTIMA Combo 2 Assay itself, with the adapter kit, operates as a standalone diagnostic test for detecting C. trachomatis and N. gonorrhoeae rRNA. The "algorithm" here refers to the assay's biochemical processes and detection methods (TMA and DKA), which yield qualitative results (positive/negative) without human interpretation of raw data beyond reading the instrument's output. The study here validates the specimen collection component in conjunction with this standalone assay.

6. The type of ground truth used (expert consensus, pathology, outcome data, etc):

• The "ground truth" in this comparative study is the results obtained from specimens collected with the APTIMA Combo 2 Unisex Swab Collection Kit. The study aims to show that using the PACE kit with the adapter yields equivalent results to this existing, presumably validated, collection method. The underlying ground truth for the APTIMA Combo 2 Assay itself would likely be a combination of culture results (historically considered the gold standard for N. gonorrhoeae), and molecular methods, as culture is no longer the gold standard for C. trachomatis. The document mentions amplification methods (like APTIMA Combo 2) are more sensitive than culture for C. trachomatis.

7. The sample size for the training set:

• The document does not provide information about a separate training set. This kit adapts an existing, validated assay. The study cited is a clinical validation study for the adapter kit's use with the existing assay.

8. How the ground truth for the training set was established:

• As no training set is mentioned for this specific adapter kit validation, this information is not available in the document.

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The Sierra Diagnostics L.L.C. Urine Collection, Preservation and Transport System is intended for use in the collection, preservation, and transportation of urine specimens at temperatures not exceeding 60°C for testing with the Abbott LCx® Neisseria qonorrhoeae and Chlamydia trachomatis assays.

The device is comprised of a urine collection cup containing of a nucleic acid chemical preservative. The device allows urine specimens for LCx® gonococcal or chlamydial testing to be preserved for up to 6 days at temperatures not to exceed 60°C. Inert indicator beads are included in the urine cup as an indicator that a preservative is present in the sample.

Here's an analysis of the acceptance criteria and study detailed in the provided 510(k) summary:

Given the nature of the device (urine collection, preservation, and transport system) and the provided text, the acceptance criteria are not explicitly stated in numerical terms typical for diagnostic accuracy (e.g., sensitivity, specificity). Instead, the criteria relate to the effectiveness of preservation and correlation of results compared to a predicate method.

1. A table of acceptance criteria and the reported device performance

2. Sample size used for the test set and the data provenance

• Sample Size:
  • Comparative Testing (Spiked Samples): Not explicitly stated how many samples were used for the gonococcal and chlamydial DNA spiking experiment.
  • Multi-Site Clinical Study: Not explicitly stated.
  • Preservative Concentration Study: Not explicitly stated, but mentioned "urine specimens spiked with less than 10 cfu of 10 different gonococcal serovars." This implies at least 10 specimens, likely more for various concentrations.
• Data Provenance: Not specified (e.g., country of origin). The studies appear to be prospective as they involved controlled experiments (spiking, controlled temperature/time, multi-site clinical study testing the device).

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable. The ground truth for this device is based on laboratory assays (LCx® testing for Neisseria gonorrhoeae and Chlamydia trachomatis nucleic acid detection), not expert consensus on images or clinical findings. The "experts" would be the laboratory technicians performing and interpreting the LCx® assays.

4. Adjudication method for the test set

Not applicable. Ground truth is established by a quantitative laboratory assay (LCx®), not by human interpretation 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

Not applicable. This device is a pre-analytic collection, preservation, and transport system, not an AI-assisted diagnostic tool. No human "readers" are involved in interpreting its direct output.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Yes, in essence, the performance shown is standalone for the device's function. The device's ability to preserve nucleic acids is tested directly, and the output (presence/absence of nucleic acid via LCx®) is objective. While the downstream LCx® assay itself is a laboratory test, the performance data presented here focuses solely on the preservation capability of the Sierra device when used with that assay.

7. The type of ground truth used

The ground truth used is primarily laboratory assay results (Abbott LCx® Neisseria gonorrhoeae and Chlamydia trachomatis assays) on fresh or spiked specimens.

• For the comparative testing, the ground truth was the LCx® result of refrigerated fresh samples.
• For the spiking studies, the ground truth was the known presence/absence and concentration of spiked nucleic acid, detected by LCx®.
• For the multi-site clinical study, the ground truth would have been the LCx® results from the freshly collected specimens from symptomatic and asymptomatic individuals, against which the preserved specimens were compared.

8. The sample size for the training set

Not mentioned. This is a medical device for specimen handling, not a machine learning model, so "training set" is not a standard concept here in the sense of model development. The studies described are performance evaluation studies.

9. How the ground truth for the training set was established

Not applicable, as there's no "training set" in the context of machine learning. The studies described are for evaluating the device's performance.

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The Copan Easy-Swab Collection and Transport System products are sterile, single-use specimen collection chambers intended to preserve the viability of aerobic 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 aerobic clinical specimens for bacteriological examination. The Copan Easy-Swab Collection and Transport System products are designed to support the viability of a wide variety of clinically important aerobic bacteria.

The Copan Easy-Swab is offered in two configurations. The Copan Easy-Swab I is offered with a single swab applicator and the Copan Easy-Swab II is offered with two swab applicators. The Copan Easy-Swab is composed of a sterile peel pouch containing one or two swab applicators inside the transport tube. The swab applicator incorporates a polyurethane foam tip on a plastic shaft secured to a cap. The tube is manufactured from polypropylene.

To use the Copan Easy-Swab Collection and Transport System, the sterile peel pouch is opened and discarded. The applicator swab is removed from the tube and used to collect the clinical specimen. During specimen collection, the applicator tip should only touch the area where the infection is suspected. The applicator swab is returned to the transport tube, the cap firmly closed, and the specimen sent to the laboratory for analysis. After use, the tubes and swabs must be disposed of according to hospital or laboratory procedures for infectious waste.

Here's an analysis of the provided text regarding the Copan Easy-Swab Collection and Transport System, focusing on the acceptance criteria and the study that proves the device meets them:

Overall Assessment:

The provided document (K993161) is a 510(k) summary for a medical device. It focuses on demonstrating substantial equivalence to a predicate device rather than presenting a detailed clinical study with strict acceptance criteria for novel performance claims. Therefore, many of the requested elements (like specific effect sizes for human readers in MRMC studies, details on ground truth for training sets, etc.) are not applicable or not explicitly provided in this type of regulatory submission. The "study" here refers to performance testing to show viability and stability.

Acceptance Criteria and Device Performance:

Study Details:

1. Sample sizes used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective):

   • Test Set Sample Size: Not explicitly stated in terms of a specific number of individual swabs or patient samples. The text mentions "a variety of aerobic organisms" were used for recovery studies.
   • Data Provenance: Not specified. It's likely an in-vitro laboratory study conducted by the manufacturer (Copan Diagnostics Inc. is based in Corona, CA, USA), but this is not explicitly stated. It is a prospective study as it involves active testing of the device.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience):

   • Not Applicable / Not Provided. For a device like a specimen collection and transport system, "ground truth" would typically be established by standard microbiological culture techniques performed by trained laboratory personnel. The document does not describe the use of "experts" in the sense of clinical specialists establishing a diagnosis. The viability assessment would be based on standard lab protocols.

3. Adjudication method (e.g., 2+1, 3+1, none) for the test set:

   • Not Applicable / None. Adjudication methods like 2+1 are typically used in studies involving subjective interpretation (e.g., imaging studies). For a device like this, performance is assessed by objective microbiological viability counts, not subjective interpretation.

4. 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 is not an AI-assisted diagnostic device, nor does it involve human "readers" interpreting results in the way an MRMC study would measure. It's a collection and transport system.

5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

   • Not Applicable. This is a physical device, not an algorithm. Performance is inherent to the device's ability to maintain organism viability.

6. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

   • Microbiological Culture Viability. The ground truth for the performance claim ("All organisms tested remained viable...") is established by standard microbiological culture methods, where the presence and growth of viable microorganisms are directly observed and quantified after the transport period. This is an objective, laboratory-based measurement.

7. The sample size for the training set:

   • Not Applicable. This device does not use machine learning or AI, and therefore does not have a "training set" in the computational sense.

8. How the ground truth for the training set was established:

   • Not Applicable. As there is no training set for a machine learning model, this element is not relevant.

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The Sensititre 18 hour MIC or Breakpoint Susceptibility system is an in vitro diagnostic product for clinical susceptibility testing of gram negative and gram positive organisms. This 510(k) is for the addition of Meropenem in the dilution range of 0.004 – 8 ug/ml to the Sensititre 18 – 24 hour MIC panel for testing gram negative isolates.

Not Found

The provided text is a 510(k) clearance letter from the FDA for a susceptibility testing device. It does not contain the detailed information necessary to answer your specific questions about acceptance criteria, study design, sample sizes, ground truth establishment, or expert qualifications. This document primarily confirms that the device, a Sensititre 18-24 Hour Susceptibility Plate with Meropenem, has been found substantially equivalent to a legally marketed predicate device.

Therefore, many of your questions cannot be answered from the provided text.

Here's what can be inferred or stated based on the text:

1. A table of acceptance criteria and the reported device performance: This information is not present in the provided document. The 510(k) clearance letter states that the device is "substantially equivalent" to predicate devices, but it does not detail the specific performance metrics or acceptance criteria used to make that determination.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): This information is not present in the provided document.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience): This information is not present in the provided document. For susceptibility testing, the "ground truth" would typically be established by a reference method (e.g., agar dilution or broth microdilution performed according to CLSI guidelines), not necessarily by human experts in the same way as imaging analysis.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: This information is not present in the provided document.

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: This information is not present in the provided document. MRMC studies are typically associated with diagnostic imaging AI, not susceptibility testing.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: The device is a "Susceptibility Test Panel" (in vitro diagnostic product) which determines the susceptibility of organisms to an antibiotic. It is inherently a standalone analytical test, not an AI algorithm requiring human-in-the-loop performance. Its performance would be evaluated on its ability to accurately determine susceptibility based on growth patterns in the presence of various antibiotic concentrations.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): While not explicitly stated, for an in vitro diagnostic susceptibility test, the ground truth would almost certainly be established by a reference method (e.g., standard broth microdilution or agar dilution) performed by a qualified laboratory, following recognized standards (like those from CLSI - Clinical and Laboratory Standards Institute). It would not be expert consensus, pathology, or outcomes data.

8. The sample size for the training set: This information is not present in the provided document. For an in vitro diagnostic device like this, there wouldn't typically be a "training set" in the machine learning sense. Instead, performance is evaluated against known bacterial isolates with established susceptibility profiles.

9. How the ground truth for the training set was established: As mentioned in point 8, a "training set" in the AI sense is not applicable here. The ground truth for the performance evaluation of such a device would be established using a gold standard reference method (e.g., CLSI-defined methods like broth microdilution) to determine the true Minimum Inhibitory Concentration (MIC) for tested organisms against the antibiotic Meropenem.

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