(90 days)
The Osia System is intended for the following patients and indications:
· Patients 5 years of age or older.
• Patients who have a conductive or mixed hearing loss and still can benefit from sound amplification. The pure tone average (PTA) bone conduction (BC) threshold (measured at 0.5, 1, 2, and 3 kHz) should be better than or equal to 55 dB HL.
· Bilateral fitting of the Osia System is intents having a symmetrically conductive or mixed hearing loss. 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 profound sensorineural hearing loss in one ear and normal hearing in the opposite ear (i.e., singlesided deafness or "SSD"). The pure tone average air conduction hearing ear should be better than or equal to 20 dB HL (measured at 0.5, 1, 2, and 3 kHz).
• The Osia System for SSD is also indicated for any patient who is 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 have experience with appropriately fitted air conduction or bone conduction hearing aids.
The Osia System mechanically vibrates the skull bone and subsequently the cochlea to compensate for conductive hearing loss, mixed hearing loss, or single-sided sensorineural deafness (SSD).
The Osia System is made up of several components. The Osia Implant consists of a receiver/coil and an actuator/stimulator (vibrator) which is surgically implanted on the skull bone. The external component of the Osia System is a sound processor, worn off-the-ear, which picks up the sound from the environment, and sends, after processing, the information to the implant via a transcutaneous inductive link. This link is also referred to as radiofrequency (RF) link. Each Osia System is configured to meet an individual's hearing needs, using dedicated fitting software.
Here's a breakdown of the acceptance criteria and the study details for the Cochlear Osia System, based on the provided FDA 510(k) summary:
1. Table of Acceptance Criteria and Reported Device Performance
The document doesn't explicitly define "acceptance criteria" in a quantitative, pass/fail format for this specific submission, as this submission is for an expanded pediatric indication, not a new device. However, the study aims to demonstrate safety and effectiveness in the expanded population in comparison to the existing predicate. The "acceptance criteria" can be inferred from the study's objectives and the conclusion of substantial equivalence.
| Acceptance Criteria (Inferred from Study Objectives) | Reported Device Performance |
|---|---|
| Safety: Adverse events and safety considerations for children ages 5-11 are consistent with those experienced by individuals 12 and older (the predicate population). | Results demonstrated that adverse events and safety considerations for the expanded indication remained consistent with adverse events for individuals ages 12 and older. |
| Effectiveness (Quality of Life): Significant improvement in quality of life for children ages 5-11. | Children ages 5-11 implanted with the Osia System demonstrated significant improvement in quality of life as evidenced in parental questionnaires. |
| Effectiveness (Speech Perception - Quiet): Improved speech perception performance in quiet postoperatively. | Children ages 5-11 implanted with the Osia System demonstrated significant improvement in speech perception as evidenced in testing in quiet. |
| Effectiveness (Speech Perception - Adaptive Noise): Improved adaptive speech in noise performance postoperatively. | Children ages 5-11 implanted with the Osia System demonstrated significant improvement in speech perception as evidenced in testing in adaptive noise. |
| Substantial Equivalence: The expanded pediatric indication is as safe and effective as the cleared indications for the predicate Osia System. | Based on technological characteristics, substantial equivalence comparison to the predicate device, and the indications for use supported by clinical data, the change to expand the pediatric indications for use of Cochlear Osia System has been shown to be as safe and effective for its intended use as the cleared indications for the predicate Osia System. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: Not explicitly stated for the "test set" in a traditional sense. The document refers to a "pivotal, prospective, multi-center study... to determine the safety and effectiveness of the Osia system in children ages 5-11." The number of participants in this study is not numericaly provided.
- Data Provenance: The study was a "pivotal, prospective, multi-center study." The country of origin of the data is not specified.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
This submission is for a medical device (hearing system), not an AI/software device requiring "ground truth" derived from expert consensus on images or similar data. The "ground truth" is based on clinical outcomes relevant to hearing devices:
- Adverse Events: Clinical reporting by medical professionals during the study.
- Quality of Life: Patient-reported outcomes via parental questionnaires.
- Speech Perception: Objective audiological testing (unaided vs. aided performance).
- Bone Conduction Thresholds: Audiological measurements by qualified audiologists.
The document does not mention a specific number of experts or their qualifications in terms of establishing a "ground truth" for the test set in the same way an imaging AI algorithm might. The clinical data itself serves as the evidence.
4. Adjudication Method for the Test Set
Not applicable in the context of this device and study. The data collected (adverse events, questionnaire results, audiological test results) are direct clinical observations and measurements, not subjective evaluations requiring adjudication by multiple experts.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, an MRMC comparative effectiveness study was not done. This study focuses on the clinical performance of the device itself in a specific patient population, not on human readers' interpretation of data with and without AI assistance.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done
Yes, in a way. The device itself (Cochlear Osia System) is the "algorithm only" in the context of its function as an active implantable bone conduction hearing system. Its performance (improvements in hearing, quality of life, speech perception) is measured as a standalone effect of the device on the patient, without human intervention during the hearing process. The human element comes in during the fitting and programming of the device by audiologists. The study's effectiveness measures (parental questionnaires, speech perception tests) evaluate the device's functional outcome.
7. The Type of Ground Truth Used
The "ground truth" for this study is derived from various clinical measures and outcomes:
- Safety: Reports of adverse events during the prospective study.
- Effectiveness (Quality of Life): Patient-reported outcomes from parental questionnaires (SSQ - Speech, Spatial and Qualities of Hearing).
- Effectiveness (Hearing Thresholds): Audiological measurements of bone conduction thresholds.
- Effectiveness (Speech Perception): Audiological tests measuring speech perception in quiet and in adaptive noise.
8. The Sample Size for the Training Set
The document does not mention a "training set." This study is a clinical trial evaluating a medical device, not an AI algorithm that requires training data in the computational sense. The device itself (the Osia System) has undergone prior development and testing, but that is distinct from a "training set" for a machine learning model.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no "training set" in the context of this device and the provided document.
§ 874.3340 Active implantable bone conduction hearing system.
(a)
Identification. An active implantable bone conduction hearing system is a prescription device consisting of an implanted transducer, implanted electronics components, and an audio processor. The active implantable bone conduction hearing system is intended to compensate for conductive or mixed hearing losses by conveying amplified acoustic signals to the cochlea via mechanical vibrations on the skull bone.(b)
Classification. Class II (special controls). The special controls for this device are:(1) Clinical performance testing must characterize any adverse events observed during implantation and clinical use, and must also demonstrate that the device performs as intended under anticipated conditions of use.
(2) Non-clinical performance testing must demonstrate that the device performs as intended under anticipated conditions of use, including the following:
(i) Performance data must validate force output in a clinically relevant model.
(ii) Impact testing in a clinically relevant anatomic model must be performed.
(iii) Mechanical integrity testing must be performed.
(iv) Reliability testing consistent with expected device life must be performed.
(3) The patient-contacting components of the device must be demonstrated to be biocompatible.
(4) Performance data must demonstrate the sterility of the patient-contacting components of the device.
(5) Performance data must support the shelf life of the device by demonstrating continued sterility, package integrity, and device functionality over the identified shelf life.
(6) Performance data must demonstrate the wireless compatibility, electromagnetic compatibility, and electrical safety of the device.
(7) Software verification, validation, and hazard analysis must be performed.
(8) Labeling must include:
(i) A summary of clinical testing conducted with the device that includes a summary of device-related complications and adverse events;
(ii) Instructions for use;
(iii) A surgical guide for implantation, which includes instructions for imaging to assess bone dimensions;
(iv) A shelf life, for device components provided sterile;
(v) A patient identification card; and
(vi) A patient user manual.