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The Sentio Ti implant, in combination with Sentio 1 Mini, is indicated for the following patients:

· Patients with conductive or mixed hearing losses, who can still benefit from amplification of the sound. The pure tone average (PTA) bone conduction (BC) threshold (measured at 0.5, 1, 2 and 3 kHz) of the indicated ear should be better than or equal to 45 dB HL.

• Patients having a symmetrically conductive or mixed hearing loss are candidates for a bilateral fitting. The difference between the left and right sides' BC thresholds should be less than 10 dB on average measured at 0.5, 1, 2 and 3 kHz, or less than 15 dB at individual frequencies.

· Patients who have a profound sensorineural hearing loss in one ear and normal hearing in the opposite ear (i.e., single sided deafness or "SSD"). The pure tone average (PTA) air conduction (AC) threshold of the hearing ear should then be better than or equal to 20 dB HL (measured at 0.5, 1, 2 and 3 kHz).

· Patients who are indicated for an air-conduction contralateral routing of signals (AC CROS) hearing aid, but who for some reason cannot or will not use an AC CROS.

· Prior to receiving the device, it is recommended that an individual has experience with appropriately fitted air conduction or bone conduction hearing aids.

· Patients 12 years of age or older.

The Sentio system is an osseointegrating, transcutaneous active bone conduction hearing system that uses the body's natural ability to transfer sound through bone conduction, thus offering improvement of hearing for patients with conductive or mixed hearing loss whether unilaterally or bilaterally fitted, or for those with single sided deafness. A bone conduction system transmits sound directly to the cochlea independently of the function of the ear canal and middle ear.

The Sentio system primarily consists of a sound processor (Sentio 1 Mini) and an implant (Sentio Ti Implant). The two components are kept in relation to each other by means of a magnetic retention system. The sound is picked up by the microphones in the external sound processor, processed and transmitted by a transmission coil using a radio frequency (RF) link through the intact skin to an implant placed in the temporal and mastoid bone area. The receiver coil of the implant receives the signal that is converted into mechanical energy (vibrations) by the transducer. The vibrations are conveyed from the bottom of the transducer to the skull and thereafter by means of bone conduction to the cochlea. In the cochlea the vibrations are converted to signals that are transmitted to the brain through the auditory nerve.

The Sentio system is intended for improvement of hearing for patients with conductive or mixed hearing losses up to 45 dB BC. The implant has been tested and verified to allow for larger mixed hearing losses, up to an anticipated 65 dB BC.

Here's an analysis of the acceptance criteria and study detailed in the provided text:

The document describes the Sentio Active Implantable Bone Conduction Hearing System, including the Sentio Ti Implant Kit, Sentio 1 Mini, and Genie Medical BAHS. The primary study referenced for demonstrating safety and performance is Study BC101.

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present a formal "acceptance criteria" table with pre-defined thresholds for performance that the device must meet in a comparative format. Instead, it discusses performance results in context of showing meaningful improvement and equivalence to predicate devices. However, we can infer performance targets based on the documented results and comparisons to normal hearing/speech levels.

Note: PPS = Per Protocol Set, FAS = Full Analysis Set. The document clarifies that a calibration error impacted some early subjects, leading to the use of both sets for analysis.

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

• Sample Size (Study BC101): 51 adult patients (18 years or older) were included in the Full Analysis Set (FAS).
• Data Provenance (Study BC101):
  • Country of Origin: Multi-center study, including six clinics in three countries (specific countries are not named in the provided text).
  • Retrospective or Prospective: Prospective study.

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

The document does not specify the number or qualifications of experts used to establish ground truth for the test set. Clinical studies of this nature typically involve audiologists and ENT surgeons who administer tests and evaluate outcomes, but no explicit details are provided regarding their role in establishing a "ground truth" independent of the device's own performance measurements. The "normal hearing threshold for pure tones (20 dB HL)" and "normal speech level (65 dB SPL)" serve as general external benchmarks.

4. Adjudication Method for the Test Set

The document does not describe any specific adjudication method (e.g., 2+1, 3+1). For an audiology study focused on objective measurements (e.g., dB HL, speech recognition percentages) and patient-reported outcomes, a formal adjudication process akin to image interpretation may not be necessary in the same way. The results are primarily based on quantifiable audiometric tests and standardized questionnaires.

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

An MRMC study was not conducted in the traditional sense involving multiple human readers interpreting cases with and without AI assistance. This device is a hearing aid system, not an imaging AI diagnostic tool. The "assistance" it provides is direct auditory amplification and sound processing for the patient, not a clinical interpretation aid for a human expert.

The study does compare aided performance (with the device) against unaided performance (without the device), demonstrating the effectiveness directly. For example:

• "Speech recognition in quiet is significantly improved with the Sentio system compared to unaided for patients with conductive and mixed hearing losses as well as patients with single sided deafness."
• "The study concludes that the primary end-points (improved hearing and improved speech recognition on the implanted ear) were statistically significant in favor of the Sentio when compared to reference values."

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

The device's core function is as a "standalone" system in its operation for the patient. While it requires clinical fitting and programming (Genie Medical BAHS software, performed by a Hearing Care professional), the performance metrics presented (e.g., aided thresholds, speech recognition, functional gain) are reflective of the device's performance as used by the patient, meaning the algorithm's output directly impacts the patient's hearing perception. There's no separate human-in-the-loop task where the algorithm assists a human to perform a diagnostic task; rather, the device is the therapeutic intervention.

7. Type of Ground Truth Used

The ground truth for evaluating the device's performance is established through a combination of:

• Objective Audiometric Measurements: This includes bone conduction thresholds, air conduction thresholds, pure tone average (PTA), functional gain, and speech intelligibility percentages. These are standard, quantifiable audiological assessments.
• Patient-Reported Outcomes (PROs): Standardized questionnaires, specifically the Glasgow Benefit Inventory (GBI), were used to assess health-related quality of life and patient satisfaction.
• Safety Data: Adverse event reporting and MRI experience questionnaires.
• Comparison to Reference Values: Performance is compared to established "normal" hearing thresholds (20 dB HL) and speech levels (65 dB SPL), and also to unaided listening conditions.

8. Sample Size for the Training Set

The document does not explicitly describe a separate "training set" for the Sentio system in the context of an AI/machine learning model. The device is a medical device (active implantable bone conduction hearing system) with specific mechanical and electrical properties, and its "programming" or "fitting" (e.g., using Genie Medical BAHS software) is based on established audiological science and algorithms, not typically on a large-scale, iterative machine learning training process with a distinct training dataset.

The clinical studies (O1, C58, BC114, BC101) described are clinical trials to evaluate the device's safety and performance in humans, not "training sets" for an AI algorithm in the conventional sense. Previous design iterations or prototypes might have undergone internal development and testing, but the text doesn't detail this as a formal "training set."

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

As noted above, the concept of a "training set" and associated ground truth is not directly applicable in the typical AI/ML sense for this device based on the provided text. The device's design, functionality, and fitting parameters are developed and refined through engineering principles, audiological research, and validation against clinical needs and outcomes (as demonstrated in the clinical studies listed).

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