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Para-Fix™ C&S Medium provides a method for collecting and preserving fecal specimens for the culture of intestinal enteric bacteria. Because the medium is capable of maintaining the bacteria for 96 hours, immediate transportation and processing of the specimen is not necessary.

Para-Fix C&S Medium is a non-nutritive, buffered, isotonic solution with a pH indicator added. The medium also contains agar and sodium thioglycolate to maintain a low oxygen tension for the preservation of anaerobic species. The phenol red indicator will turn yellow when the solution is acidic and the conditions are not optimal for recovery of the intended organisms. Each 30 mL vial contains 15 ml of solution and a built in sample collection spoon. The kit is available with or without a multilingual instruction sheet and re-sealable bag.

Here's a breakdown of the acceptance criteria and the studies performed for the MCC Para-Fix C&S Medium, based on the provided document:

Acceptance Criteria and Reported Device Performance

Study Information

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

   • Test Set (without fecal matrix): The specific number of replicates per organism and temperature condition is not explicitly stated, but the tables provide "Average CFU's Recovered," implying multiple measurements. There were 10 different enteric organisms tested at two temperature conditions (2-8°C and 20-25°C).
   • Test Set (with fecal matrix): For the "Representative Enteric organism recovery results for Para-Fix™ C&S Medium using Roll-Plate Method" and "Swab Elution Method", three organisms were tested (Salmonella enterica, Vibrio parahaemolyticus, Escherichia coli) at two temperature conditions, with measurements at 0, 72, 96, and 120 hours. Again, "Average CFU's Recovered" implies multiple runs.
   • Data Provenance: The study used "clinically negative human fecal matrix." No specific country of origin is mentioned, but it is a laboratory study, likely prospective, evaluating the performance of the device under controlled conditions.

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

   • Not applicable for this type of performance study. The ground truth (initial bacterial counts and subsequent counts after storage) was established through quantitative microbiological methods (plate counts, CFU determination) performed in a laboratory, rather than expert interpretation of a diagnostic outcome.

3. Adjudication method for the test set:

   • Not applicable. This is a quantitative laboratory performance study, not a clinical study involving human interpretation or consensus.

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 device is a transport medium for laboratory samples, not an AI-assisted diagnostic tool requiring human reader studies.

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

   • Yes, this was a standalone performance study of the physical device (transport medium). There is no "algorithm" or "human-in-the-loop" component. The device's ability to preserve organisms was tested directly.

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

   • Quantitative Microbiological Analysis: The ground truth was based on quantitative culture results (Colony Forming Units - CFUs) obtained through standard laboratory techniques (plate counts, swab elution, roll-plate methods) for specific bacterial organisms under controlled conditions. This is a direct measurement of the device's functional performance.

7. The sample size for the training set:

   • Not applicable. This is not a machine learning or AI-based device, so there is no training set in that context. The "training" of the medium itself is its chemical formulation and manufacturing process.

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

   • Not applicable, as there is no training set in the context of an algorithmic or AI device. The "ground truth" for the device's design and formulation would have been established through traditional microbiology and chemistry research and development, aiming to meet established standards like CLSI M40-A2 for transport media.

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Para-FixTM Cary Blair Medium provides a method for collecting and preserving fecal specimens for the culture of intestinal enteric bacteria. Because the medium is capable of maintaining the bacteria for 96 hours, immediate transportation and processing of the specimen is not necessary.

Para-Fix Cary Blair Medium is a non-nutritive, buffered, isotonic solution with a pH indicator added. The medium also contains agar and sodium thioglycolate to maintain a low oxygen tension for the preservation of anaerobic species. The phenol red indicator will turn yellow when the solution is acidic and the conditions are not optimal for recovery of the intended organisms. Each 30 mL vial contains 15 ml of solution and a built in sample collection spoon. The kit is available with or without a multilingual instruction sheet and re-sealable bag.

The provided text describes the acceptance criteria and a study demonstrating the performance of the MCC Para-Fix™ Cary Blair Medium device. Here's a breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance

The performance criterion as specified by Clinical and Laboratory Standards Institute (CLSI), M40-A2, is that the number of viable organisms remains within ±2 log10 of the original inoculum.

2. Sample Size Used for the Test Set and the Data Provenance

• Sample Size (Test Set): The document reports results for 10 distinct enteric organisms tested in various conditions (temperature, presence/absence of fecal matrix, and over different time points). For each condition, the "Average CFU's" are reported, implying multiple experimental replicates were performed, but the exact number of replicates for each organism and condition is not explicitly stated.
  • Study 1 (without fecal matrix): 10 organisms, 2 temperatures (20 total conditions).
  • Study 2 (with fecal matrix, Roll-Plate): 3 organisms, 2 temperatures (6 total conditions), sampled at 0, 72, 96, 120 hours.
  • Study 3 (with fecal matrix, Swab Elution): 3 organisms, 2 temperatures (6 total conditions), sampled at 0, 72, 96, 120 hours.
• Data Provenance: The document does not specify the country of origin of the data. It appears to be a laboratory-based study conducted by Medical Chemical Corporation to support their 510(k) submission. It is a prospective study designed to assess the device's performance under specified conditions.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts

This information is not applicable as the ground truth for this device (a transport medium) is based on quantitative microbiological assays (colony-forming unit - CFU counts), not expert interpretation of clinical data or images.

4. Adjudication Method for the Test Set

This is not applicable as the ground truth is established objectively through laboratory assays and statistical analysis of CFU counts, not through expert consensus or arbitration.

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 is not applicable. The device is a "Transport Culture Medium" and does not involve AI, human readers, or image interpretation. Its effectiveness is measured by its ability to preserve bacterial viability, not by improving human diagnostic performance.

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

This is not applicable. The device is a physical medium for specimen transport, not a software algorithm.

7. The Type of Ground Truth Used

The ground truth used for this study is quantitative microbiological data (CFU counts). This data directly measures the viability and growth/reduction of specific bacterial species under controlled experimental conditions, which is the direct performance metric for a transport medium. The criteria are based on CLSI standard M40-A2.

8. The Sample Size for the Training Set

This is not applicable. There is no "training set" in the context of a physical medical device like a transport medium. The studies described are performance validation studies.

9. How the Ground Truth for the Training Set Was Established

This is not applicable as there is no training set for this device.

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