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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.

Study 2: Enteric Organism Recovery (with fecal matrix - Roll-Plate Method)
For Salmonella enterica, Vibrio parahaemolyticus, and Escherichia Coli, the log changes at 120 hours were within the ±2 log10 range at both 2-8°C and 20-25°C. For organisms that were "Too numerous to count" (N/A in the table), it indicates growth, which would still meet the non-reduction criterion given the initial inoculum.

Study 3: Enteric Organism Recovery (with fecal matrix - Swab Elution Method)
For Salmonella enterica, Vibrio parahaemolyticus, and Escherichia Coli, the log changes at 120 hours were within the ±2 log10 range at both 2-8°C and 20-25°C. For organisms that were "Too numerous to count" (N/A in the table), it indicates growth, which would still meet the non-reduction criterion given the initial inoculum.

Stability Testing:
Bacterial counts after 96 hours were within ±2 log10 for both newly manufactured vials and vials exceeding the 18-month expiration dating. |

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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