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The binx health io CT/NG Assay, when tested using the binx health io Instrument, is a fully automated, rapid, qualitative test intended for use in point-of-care or clinical laboratory settings for the detection of Chlamydia trachomatis and Neisseria gonorrhoeae DNA in female vaginal swab specimens collected either by a clinician or self-collected by a patient in a clinical setting, to aid in the diagnosis of symptomatic or asymptomatic infection in female patients with Chlamydia trachomatis and/or Neisseria gonorrhoeae.

The binx health io CT/NG Assay System (the "binx io System", "binx io CT/NG Assay" or the "System") is a rapid qualitative in vitro diagnostic system consisting of the following:

1. The binx io Instrument for running the Cartridge (the "Instrument")
2. The binx io CT/NG Cartridge (the "CT/NG Cartridge", "Cartridge" or "Cartridges"), which contains all the necessary reagents to perform the binx io CT/NG Assay (the "Assay") on the binx io Instrument
3. A single-use, fixed-volume transfer pipet (packaged with the Cartridge) for transferring the sample to the Cartridge
4. A female Vaginal Swab Specimen Collection Kit consisting of a swab and a sample Collection tube containing preservation medium (the "Vaginal Swab Specimen Collection Kit")

The binx io CT/NG Cartridge is a single-use assay-specific cartridge for use on a single patient. All reagents are contained in the Cartridge as a combination of liquid reagents in blister packs and dried reagents. The Instrument is a small, bench top, fully integrated Instrument that uses air pressure to open and close valves on the CT/NG Cartridge which, in turn, controls the movement of solutions within the Cartridge; the Instrument takes full control of the Cartridges once they are inserted. The operation of the Instrument requires a minimal number of steps that a user follows via a graphical user interface (GUI) screen to load the Cartridge onto the Instrument. Once the Cartridge is loaded, no further interaction by the user is required as no sample preparation is needed. Turnaround time from adding a raw patient sample to a result on the Instrument takes about 30 minutes.

The Vaginal Swab Collection Kit consists of a sterile flocked swab and a tube of preservative medium. The Cartridge has a visual sample loading indicator window which turns from light to dark to confirm to the user that a sample has been added to the Cartridge.

The Cartridge has three fully automated assay steps, (i) sample preparation to isolate and purify target DNA, (ii) ultra-rapid polymerase chain reaction (PCR), which amplifies specific regions of DNA from the target organisms, and (iii) a proprietary electrochemical detection to identify the presence of amplified DNA.

When the specimen is added to the Cartridge, it is automatically mixed with a lysis solution to disrupt the cells present and release DNA which also rehydrates the Internal Process Control (IPC) sample. DNA extraction takes place and the eluted DNA is transferred to a homogenization chamber.

Ultra-rapid PCR is carried out using sequence-specific primers for CT, NG (two separate genomic targets) and the IPC.

Amplified target DNA is detected by hybridization to electrochemically labeled probes and cleavage of the label using a double-strand specific exonuclease. The free label diffuses to the electrode surface and generates an electrical current measured at a distinct voltage in nano Amps (nA) for each electrochemical label used.

The presence of a measurable peak to a fixed cut-off parameter for each target returns a qualitative result with no requirement for interpretation or calculations.

Here's a breakdown of the acceptance criteria and the study that proves the device meets them, based on the provided text.

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are not explicitly stated as numerical targets before the results are presented. However, the study aims to demonstrate substantial equivalence to predicate devices and acceptable clinical performance. We can infer the performance targets from the reported results and the fact that the device received clearance. The performance is reported as sensitivity, specificity, and predictive values against a Composite Infected Status (CIS).

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

• Sample Size (Clinical Performance Study):
  • Total participants enrolled: 1,634
  • Participants after exclusions: 1,524 (for whom CIS could be determined)
  • Fully evaluable vaginal swab specimens: 1,523
  • Self-collected vaginal swabs (SCVS): 736
  • Clinician-collected vaginal swabs (CCVS): 787
• Data Provenance: Prospective, multi-center study conducted at nine investigational sites throughout the U.S.

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

The ground truth (Composite Infected Status - CIS) was established using three reference NAAT (Nucleic Acid Amplification Test) comparator systems:

1. Hologic Aptima Combo 2 (AC2) Chlamydia/Gonorrhea Assay run on Panther
2. BD ProbeTec Chlamydia trachomatis (CT) Qx and BD ProbeTec Neisseria gonorrhoeae (GC) Qx assays run on the Viper XTR™
3. Roche cobas CT/NG v2.0 test run on the cobas 4800 System.

The document does not specify the number or qualifications of human experts who interpreted these comparator test results to establish the CIS. The CIS itself is defined by a concordance rule of at least two out of the three reference tests being positive or negative. The personnel who carried out testing using the binx io CT/NG Assay were "point-of-care personnel trained in the use of the binx io CT/NG System, but not trained or experienced in general laboratory testing procedures" (96% overall). This indicates the binx io test was operated by non-experts in laboratory medicine, which is relevant to its point-of-care intended use, but the establishment of the ground truth relies on the established performance of the comparator NAATs.

4. Adjudication Method for the Test Set

The adjudication method used to establish the Composite Infected Status (CIS) was a 2 out of 3 concordance rule. A patient was considered:

• Infected: If at least two out of the three reference NAAT tests were positive.
• Not Infected: If at least two out of the three reference NAAT tests were negative.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done in the context of human readers improving with or without AI assistance, as this is a diagnostic device for direct detection of pathogens and not an AI-assisted diagnostic imaging or interpretation system. The device itself performs the detection.

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

Yes, the study presents standalone performance of the binx health io CT/NG Assay. This device is a fully automated, qualitative test designed to be run without complex human interpretation. The reported sensitivity, specificity, PPV, and NPV are measures of its standalone diagnostic accuracy against the established ground truth.

7. The Type of Ground Truth Used

The type of ground truth used was a Composite Infected Status (CIS), defined by a 2 out of 3 concordance rule of three legally marketed and established reference NAATs (Nucleic Acid Amplification Tests). This is a robust method for establishing ground truth in diagnostic studies for infectious diseases when a single "gold standard" may not always be definitive or available for all samples.

8. The Sample Size for the Training Set

The document does not explicitly mention a "training set" in the context of a machine learning algorithm. This is a molecular diagnostic assay, not an AI/ML-based diagnostic. Therefore, there isn't a "training set" in the typical sense for algorithm development.

Instead, the device's design and analytical performance were established through various analytical studies (e.g., Limit of Detection, Analytical Reactivity, Analytical Specificity, Interference, Reproducibility). These analytical studies would involve testing known concentrations of target organisms and interfering substances, following established laboratory practices for assay development and validation.

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

As noted above, there is no typical "training set" for an AI/ML algorithm. For the analytical studies, the ground truth was inherently known based on the controlled spiking of specific organisms at known concentrations (e.g., GE/mL, CFU/mL, PFU/mL) and known interfering substances into negative matrices.

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