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The AiBiomed Parathyroid Detection System (PTeye) is an adjunctive tool intended to aid in the identification of parathyroid tissue by confirming parathyroid tissue already visually located by the surgeon.

The Parathyroid Detection (PTeye) System aids surgeons in differentiating parathyroid tissue during common surgical procedures. The handheld probe assembly includes one glass fiber-optic element that emits non-ionizing radiation at 785 nm in the near IR range (NIR) and one fiber optic detector element that collects and transmits the fluorescence emitted by the tissue to a photo detector. The Parathyroid Detection (PTeye) System consists of the following components: 1. A console that includes: An LED display that indicates if the laser is on. A display for visual feedback. A speaker for auditory feedback. 2. A handheld fiber-optic probe assembly that interfaces into the console unit using two unique connectors. One connector plugs into the laser output and the other plugs into the photo detector input (fluorescent signal). 3. A foot pedal attached by a cable to the rear of the unit, used to control power to the laser and initiate data collection. 4. An external power supply and power cord that plugs into the power supply. Tissue detection is based on the ratio of the fluorescent response of parathyroid to thyroid tissue; with the assumption that the fluorescence of thyroid tissue is much lower than parathyroid. During surgery, five thyroid data points are collected by touching thyroid tissue with the probe assembly. The system calculates a baseline median for the thyroid tissue based on those points. The baseline value establishes a reference point for distinguishing parathyroid tissue, which produces a higher level of fluorescence. Once the baseline thyroid value has been calculated, a new operational screen will display to support continuous parathyroid search mode. To operate in this mode, the foot switch must be pressed in order to activate the laser. When laser emission is taking place, the LASER ON LED at the front of the system will illuminate. Responses indicating parathyroid tissue are communicated to the user through a bar graph, a detection percentage, a detection ratio, and audio feedback.

Here's a breakdown of the acceptance criteria and study details for the Parathyroid Detection (Model PTeye) System, based on the provided text:

Acceptance Criteria and Device Performance for PTeye System

Study Details:

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

   • Test Set (Effectiveness Data): 81 patients (40 from Site A (Vanderbilt), 41 from Site B (Ohio State University Medical Center)).
   • Additional exclusion: 2 patients with secondary hyperparathyroidism (r-SHPT) were excluded from the final effectiveness analysis due to known limitations of the device in these cases, resulting in data from 79 patients for core effectiveness analysis.
   • Total tissues measured: 181 PGs and 546 non-PG tissues (194 thyroid, 116 fat, 119 neck muscle, and 117 trachea).
   • Data Provenance: Prospective, multi-center clinical study conducted in the USA (Vanderbilt University Medical Center, Nashville, TN; Ohio State University Medical Center).

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

   • Experts: 4 surgeons (high-volume endocrine surgeons).
   • Qualifications: Perform >25 thyroid surgeries per year and >15 parathyroid surgeries per year.
     • Surgeon #1: 16 years of experience as a practicing endocrine surgeon.
     • Surgeon #2: 4 years of experience as a practicing endocrine surgeon.
     • Surgeon #3: 16 years of experience as a practicing endocrine surgeon.
     • Surgeon #4: 4 years of experience as a practicing endocrine surgeon.

3. Adjudication method for the test set:

   • Ground truth was established by a combination of:
     • Histological examination: For excised tissues (frozen section or Hematoxylin-Eosin stained). 68 PGs (37.6% of all PG measurements) were confirmed with histology.
     • Expert surgeon's visual assessment: For in-situ tissues not excised, the surgeon's visual identification was used, but only those with "high" or "moderate" confidence were included. "Low confidence" assessments were excluded unless histological validation was obtained. The study was single-blinded, meaning surgeons were blinded to the PTeye device output during their initial visual assessment.

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:

   • Yes, a comparative effectiveness study was done comparing the PTeye's performance to human visual assessment. However, it was not an MRMC study designed to show how much human readers improve with AI assistance (human-in-the-loop). Instead, it compared the PTeye's standalone performance to the surgeons' standalone visual assessment.
   • Comparison of PTeye vs. Surgeon's Visual Determination (validated by histology for excised PGs, excluding r-SHPT patients):
     • Overall PG detection rate (validated by histology):
       • Surgeons: 93.3% (56/60)
       • PTeye: 93.3% (56/60)
     • Overall non-PG tissue identification (excised, assumed as PG, validated by histology):
       • Surgeons: 0.0% (0/5) correctly identified as non-PG.
       • PTeye: 80.0% (4/5) correctly identified as non-PG.
   • (Effect size of human improvement with AI vs. without AI assistance): This specific "human-in-the-loop" effect size (synergy or improvement) was not reported or evaluated in this study, as the surgeons were blinded to the PTeye's output for their initial assessment. The study focused on the PTeye's standalone accuracy compared to visual assessment.

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

   • Yes, the primary effectiveness endpoint measures the standalone performance of the PTeye system in identifying parathyroid glands. The overall accuracy, sensitivity, specificity, PPV, and NPV figures (e.g., 96.3% accuracy) represent the PTeye's performance independently of the surgeon's real-time interpretation of its output (as the surgeon was blinded). The study also directly compared this standalone PTeye performance against the surgeons' standalone visual assessment.

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

   • A combined ground truth was used:
     • Histopathology/Pathology: For excised tissues (frozen section or Hematoxylin-Eosin stained tissue section analysis by pathologists). This was considered the "gold standard" when available.
     • Expert Surgeon Consensus/Opinion: For in-situ tissues not excised, the visual assessment of expert surgeons, expressed with "high" or "moderate" confidence, served as the ground truth.

7. The sample size for the training set:

   • The document does not explicitly state the sample size for a training set. The study described is a clinical study to support the safety and effectiveness of the device, likely using a pre-trained model. If the device's internal model was developed using a training set, that information is not provided in this regulatory document.

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

   • As the training set sample size is not explicitly provided, the method for establishing its ground truth is also not described in this document.

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