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Medical Packaging Corporation's CULTURE-PAK™ Collection and Transport System, with Modified Amies Transport Media, is intended for use as a disposable, sterile culture collection device for use in the collection, preservation, and transportation of microbiological specimens.

Medical Packaging Corporation's CULTURE-PAK™ Collection and Transport System. Modified Amies Transport Media, is substantially equivalent to Medical Packaging Corporation's Culture Collection and Transport Device (K881105), and CULTURE-PAK™ Collection and Transport System, Modified Stuart's Media (K936078) and ( K932337/S1). Listed devices are intended to collect, preserve, and transport clinical specimens to the laboratory for microbiological analysis. Devices are composed of two plastic parts:

• . The top plastic part holds 0.4 mL of clinical transport media and a plastic shaft, Rayon® tipped swab. Configuration of the CULTURE-PAK™ Collection and Transport System, Modified Amies Transport Media, will also provide two plastic shaft, Rayon® tipped swabs; an aluminum shaft, Rayon® Mini-Tip swab for collection of either male urethral or nasopharyngeal specimens; or a CytoSoft™ cytology brush.
• The bottom plastic part protects the swab(s) or brush ( hereafter referred to . as: collection device ) and fits tightly into the top plastic part. The CULTURE-PAK™ and the Culture Collection and Transport Device are packaged sterile. Sterilization is conducted at SteriGenics, International, Inc., and validated by North American Science Associates, Inc. for both devices.

The methods for use are similar for the CULTURE-PAK™ and the Culture Collection and Transport Device. The two plastic parts are pulled apart, exposing the swab(s) or brush. After the culture is collected, the bottom is refitted into the top. The media seal is broken and the fluid is forced into the bottom extrusion to keep the collection device moist for up to 48 hours at room temperature.

The primary differences between Medical Packaging Corporation's CULTURE-PAK™ Collection and Transport System and the Culture Collection and Transport Device are how the media is contained, how to free the media so it will flow down into the bottom plastic part, and the provision of additional specimen collection devices as configured. The CULTURE-PAK™ has a plastic plug that holds the media in the top part. The top is bent 45 ° to break the plug allowing the media to flow into the bottom. The Culture Collection and Transport Device has a glass ampule that holds the media in the top plastic part. The top is squeezed to crush the ampule allowing the media to flow into the bottom. The CULTURE-PAK™ Collection and Transport System, Modified Amies Transport Media will also be available with an aluminum shaft Rayon® Mini-Tip rayon swab and a CytoSoft™ cytology brush.

This submission describes a medical device, the CULTURE-PAK™ Collection and Transport System, with Modified Amies Transport Media, which is a sterile device for collecting and transporting microbiological specimens. This is not an AI/ML device and therefore no studies on acceptance criteria based on algorithm performance are included in the provided text.

Here's an analysis based on the provided text, specifically addressing the questions you've posed, but adapted to the nature of this non-AI device:

Analysis of Acceptance Criteria and Device Performance for CULTURE-PAK™ Collection and Transport System

1. Table of Acceptance Criteria and Reported Device Performance

For this device, the "acceptance criteria" are related to its functional equivalence to predicate devices and sterility validation. "Reported device performance" directly refers to the outcomes of these validation studies and comparisons.

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

The provided summary does not detail a "test set" in the context of an algorithm's performance evaluation or a clinical trial with patient samples. The studies mentioned are primarily related to sterilization validation and substantial equivalence claims based on design and functional similarity to predicate devices.

• Sample Size for Sterilization Validation: Not specified within this document. Sterilization validation typically involves specific sample sizes determined by validation protocols (e.g., AAMI standards).
• Data Provenance: Not specified, but given the nature of the device and the submission date (1996), any comparative or validation data would likely be from laboratory settings or internal testing. It is not clear if it's retrospective or prospective for a patient-level study as no such study is described.

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

This concept is not applicable here as there is no "test set" for an algorithm, nor a need for expert-established ground truth in the traditional sense. The "ground truth" for this device would be its ability to maintain specimen viability, which is typically assessed via microbiological culture studies, not expert consensus on images or diagnostic data.

4. Adjudication Method for the Test Set

Not applicable, as there is no "test set" (in the context of diagnostic performance) or expert review process described.

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 is a manual specimen collection and transport device, not an AI-powered diagnostic system.

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

Not applicable, as this is not an AI algorithm.

7. The Type of Ground Truth Used

The "ground truth" for this device's efficacy would broadly be microbiological viability/growth studies demonstrating that collected specimens remain viable for culture over the specified transport time (e.g., 48 hours at room temperature). This involves comparing the growth of microorganisms from specimens transported in the device versus a control or predicate device under controlled laboratory conditions. The document states its intended use for "collection, preservation, and transportation of microbiological specimens" and that it keeps the "collection device moist for up to 48 hours at room temperature," implying these types of studies were performed or referenced in establishing substantial equivalence. However, the specific study details are not provided in this summary.

8. The Sample Size for the Training Set

Not applicable, as this is not an AI/ML device and does not involve a "training set."

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

Not applicable.

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