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The Simple 2 Test is intended for in vitro detection and identification of Chlamydia trachomatis (CT) and/or Neisseria gonorrhoeae (GC) in home-collected specimens which are shipped to a clinical laboratory for testing using the Aptima Combo 2 Assay on the Panther System. This product is available over-the-counter (OTC) to consumers 18 years of age and older.

The Simple 2 Test contains all the necessary components to collect urine from male patients (Simple 2 Urine Home Collection Kit (Penile)) or vaginal swabs from female patients (Simple 2 Swab Home Collection Kit (Vaginal)) in their home, or in similar environments, without supervision from a healthcare provider.

The Simple 2 Test Collection Kits may also be used to self-collect specimens in a clinic.

The testing is performed, as determined to be appropriate, based on the results of LetsGetChecked Suitability Questionnaire.

This test system is not a substitute for visits to a healthcare provider. The information provided by this product should not be used to start, stop, or change any course of treatment unless advised by your healthcare provider.

Testing is limited to the manufacturer, Priva Path laboratories (d.b.a. LetsGetChecked. Inc.).

The LetsGetChecked Simple 2 Test is composed of the Simple 2 Urine Home Collection Kit (Penile) and the Simple 2 Swab Home Collection Kit (Vaginal) and the samples are shipped to LetsGetChecked's Clinical Laboratory Improvement Amendments (CLIA)-certified laboratory for processing using the Aptima Combo 2 Assay on the Panther System. The Aptima Combo 2 Assay was previously cleared for the qualitative in vitro detection of Chlamydia trachomatis (CT) and/or Neisseria gonorrhoeae (GC) when used with male urine and self-collected vaginal swabs collected in clinical settings.

The home collection kits are intended to be distributed for purchase online without the need for prescription from a physician or healthcare professional (over-the-counter use). After purchase, the user activates the kit on LetsGetChecked's website and is requested to fill out the Suitability Questionnaire to determine whether this test is appropriate for this individual. The user follows detailed directions for self-collecting a urogenital specimen (male urine or female vaginal swab, as applicable), packaging and shipping it to the LetsGetChecked CLIA certified laboratory for testing (PrivaPath lab). The test results are delivered to the individual via LetsGetChecked online portal. Positive and invalid/inconclusive results are followed up with a call from the LetsGetChecked Care Team. If the patient received a positive chlamydia result, treatment options are discussed. Patients receiving a positive gonorrhea test result, will be advised to contact their healthcare provider to receive appropriate treatment. The LetsGetChecked Care Team will also contact all patients who test negative for chlamydia and gonorrhea, but do report symptoms, or concerns, or where further investigation is indicated. These patients are internally flagged for follow-up.

The provided text describes the evaluation of the Simple 2 Test, a device for the in vitro detection and identification of Chlamydia trachomatis (CT) and/or Neisseria gonorrhoeae (GC) in home-collected specimens. The device is intended for over-the-counter use by consumers 18 years of age and older.

The acceptance criteria for the device are focused on usability and comprehension by lay users and the analytical performance of the collection kits under various challenging conditions (flex studies, interfering substances, shipping stability), ensuring that the home collection process does not compromise the accuracy of the downstream testing performed by the Aptima Combo 2 Assay on the Panther System.

Here's a breakdown of the requested information based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present a single table outlining predefined "acceptance criteria" alongside specific performance metrics the device must meet. Instead, it describes various studies and their outcomes, implicitly demonstrating the device's acceptable performance. The "Success Rate" shown in Tables 3, 4, 7, and 8 for usability/comprehension, and the "Agreement with expected result" in Tables 9, 10, 11, 12, 13, 14, 16, 18, 19, and 20 for analytical performance, serve as the evidence of meeting the unstated acceptance goals.

Based on the summaries of the studies, the implicit acceptance criterion for usability and comprehension appears to be a high success rate (generally aiming for 100% in critical steps or demonstrating that modifications resolve issues) for proper specimen collection, packaging, and comprehension of instructions and results. For analytical performance, the criterion is largely 100% agreement with expected results under various challenging conditions, or demonstration that the test robustly performs within acceptable limits despite certain challenging conditions, with any identified limitations clearly called out in labeling.

Implicit Acceptance Criteria and Reported Performance (Selected examples from the document):

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

The test sets are primarily derived from usability and analytical performance studies.

• Usability Studies (Test Set):

  • Simple 2 Urine Home Collection Kit (Penile):
    • Initial study: 89 male participants.
    • Final usability study: 32 male participants.
  • Simple 2 Swab Home Collection Kit (Vaginal):
    • Initial study: 85 female participants.
    • Final usability study: 34 participants (33 female, 1 transgender male).
  • Data Provenance: The studies were conducted remotely from lay users' homes via online video conferencing. No specific country of origin is mentioned beyond being a US FDA submission, implying the studies were conducted in the US or for the US market. The studies appear to be prospective in nature, as they involve participants actively performing tasks following instructions and providing feedback/data.

• Analytical Performance Studies (Flex, Interfering Substances, Shipping Stability - Test Set):

  • These studies involved specific numbers of replicates for each condition (e.g., [b-4] positive and [b-4] negative replicates for flex studies on urine volume). The exact total sample sizes for these analytical tests are scattered across tables with redacted information (e.g., "[b-4] positives/[b-4] tested").
  • Data Provenance: These are laboratory-based analytical studies, not human clinical trials. The data provenance is internal to the manufacturer's testing or a clinical laboratory. No specific country of origin is stated, but given the FDA submission, the data is expected to be relevant to US regulatory standards. These are experimental evaluations, likely prospective in nature within a controlled lab setting, designed to mimic real-world conditions.

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

• Usability Studies: Ground truth for these studies was generally based on the objective observation of successful completion of tasks (e.g., transferring correct urine volume, proper packaging) and comprehension of instructions/information as assessed by study staff questions. The document does not specify the number or qualifications of experts involved in observing or assessing these lay user interactions directly. However, the design of the modifications and the evaluation criteria would have been informed by regulatory requirements and potentially human factors experts.
• Analytical Performance Studies: For these studies, the ground truth is the expected presence or absence of CT/GC in the spiked or unspiked samples. This is a scientific, laboratory-defined ground truth, established by the precise spiking of organisms at known concentrations into negative matrices or using truly negative samples. The "experts" in this context are the laboratory scientists and technicians conducting the assays and preparing the samples, presumed to be qualified in molecular diagnostics. No specific number or external qualifications are mentioned for establishing this analytical ground truth, as it's inherent to the experimental design (e.g., "spiked with CT or GC organisms at the target concentration of LoD").

4. Adjudication Method for the Test Set

• Usability Studies: The success/failure of user actions and comprehension was likely determined by the study staff observing and questioning participants. The document doesn't detail a formal "adjudication" process akin to expert reader consensus, but rather a direct assessment of task completion and questionnaire responses. Issues identified (e.g., difficulty transferring urine) led to design modifications, implying an iterative evaluation process rather than a strict adjudication of initial failures.
• Analytical Performance Studies: The results (e.g., #positives/#tested, agreement with expected result) are quantitative outcomes of the biochemical assay. There is no mention of an "adjudication method" in the sense of multiple human experts reviewing results. The expectation is that the laboratory results directly represent the device's performance under the tested conditions.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

There is no mention (and no indication) of a Multi-Reader Multi-Case (MRMC) comparative effectiveness study involving human readers with and without AI assistance. This device is not an AI-assisted diagnostic. It is a home collection kit for a laboratory test, wherein the "device" is the collection system and the final analysis is done by an established IVD system (Aptima Combo 2 Assay on the Panther System). The studies focus on the usability and analytical integrity of the home-collected samples, not on AI-assisted interpretation of diagnostic images or data.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

This question is Not Applicable in the context of this device. The Simple 2 Test is a collection kit, not a standalone algorithm. The "algorithm" (nucleic acid amplification assay) is the Aptima Combo 2 Assay on the Panther System, which is a pre-existing cleared/approved device. The performance data presented relates to the integrity and suitability of the home-collected samples for use with that established assay, not a novel standalone algorithm.

7. Type of Ground Truth Used

• Usability Studies: The ground truth for these studies was the observed proper execution of instructed tasks and comprehension of information by lay users, assessed against predefined criteria for successful use of the collection kit and understanding of the accompanying materials.
• Analytical Performance Studies: The ground truth was analytically established through precise spiking of known concentrations of CT and GC organisms into negative matrices, or the use of confirmed negative samples. This constitutes a laboratory-defined ground truth (e.g., "spiked with GC or CT at 3x LoD").

8. Sample Size for the Training Set

The document describes two phases of usability/comprehension studies (initial and final) for both the urine and vaginal swab kits. The initial studies for both kits served a similar function to a training set or preliminary evaluation, leading to modifications in the kit and instructions.

• Simple 2 Urine Home Collection Kit (Penile): 89 male participants in the initial study.
• Simple 2 Swab Home Collection Kit (Vaginal): 85 female participants in the initial study.
  These initial studies acted as "training" or optimization phases by identifying deficiencies that informed product improvements.

For the analytical "flex studies, interfering substances, and shipping stability" tests, the concept of a "training set" is not applicable in the typical machine learning sense. These are experimental validations. The initial LoD (Limit of Detection) establishment, mentioned briefly, might involve some preliminary testing that could be seen as "training" for setting analytical parameters, but no specific sample size for such an activity is provided.

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

For the usability studies, the ground truth for the initial "training" phase was based on direct observation of user performance and comprehension assessments, identifying areas where users struggled or misunderstood. For example, the 9% of users having difficulty transferring urine volume in the initial penile kit usability study highlighted a deficiency that needed to be addressed. This identified "ground truth" (i.e., areas of user error) then informed the modifications.

For the analytical studies, as noted in point 7, ground truth is laboratory-defined by precise manipulation of samples (e.g., spiking with known concentrations, ensuring negative samples are truly negative). This analytical ground truth would be established through standard laboratory and molecular biology techniques.

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