(113 days)
The Cochlear Osia System uses bone conduction to transmit sounds to the cochlea (inner ear) with the purpose of enhancing hearing. Osia Implants are single use devices intended for long term implantation under the skin in the mastoid region of either side of the head. They are for professional use only.
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 (OSI300) 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.
The provided text describes a 510(k) premarket notification for the Cochlear™ Osia® System, an active implantable bone conduction hearing system. This submission primarily focuses on demonstrating substantial equivalence to a predicate device (Cochlear™ Osia® 2 System) for an updated version of the system.
The core of the submission involves bench testing to compare the updated system with the predicate. There is no evidence of a clinical study or performance study with patients designed to establish specific acceptance criteria directly tied to the device's clinical efficacy or diagnostic accuracy (e.g., sensitivity, specificity, AUC). The acceptance criteria, therefore, appear to be based on functional equivalency, safety, and performance compared to the predicate device through non-clinical means.
Here's a breakdown of the information based on your request, with an emphasis on what is not present in the provided text regarding specific performance criteria as typically understood in a clinical study for diagnostic or AI-based devices:
1. Table of Acceptance Criteria and Reported Device Performance
Since this is a 510(k) submission and the provided text focuses on demonstrating substantial equivalence through non-clinical testing (bench testing), explicit quantitative clinical acceptance criteria like sensitivity, specificity, or AUC are not stated, nor are their corresponding reported device performance values from a clinical study. Instead, the "acceptance criteria" are implied by successful completion of various verification activities ensuring the updated device functions as intended and is as safe and effective as the predicate.
| Acceptance Criterion (Implied by Verification Activities) | Reported Device Performance (Summary from Bench Testing) |
|---|---|
| Functional verification successful | Device functions as intended. |
| Fixation Screw verification successful | Fixation screw performs as intended. |
| Safety & Reliability verification related to MRI Safety successful | OSI300 allows MRI at 1.5T and 3T without magnet removal or MRI kit. |
| Safety & Reliability verification related to Maximum Surface Temperature successful | Maximum surface temperature within acceptable limits. |
| Safety & Reliability verification related to Coil Tensile and Flexural Robustness successful | Coil tensile and flexural robustness maintained. |
| Safety & Reliability verification related to Magnet Retention successful | Magnet retention maintained. |
| Safety & Reliability verification related to Fluid Ingress successful | Fluid ingress protection maintained. |
| Safety & Reliability verification related to Implant Impact successful | Implant impact resistance maintained. |
| Safety & Reliability verification related to Coil Impact successful | Coil impact resistance maintained. |
| Safety & Reliability verification related to Release of Particulate Matter successful | Release of particulate matter within acceptable limits. |
| Safety & Reliability verification related to ESD successful | ESD resistance maintained. |
| Environmental Testing verification successful | Device performs under specified environmental conditions. |
| Compatibility verification (Sound Processor to Implant) successful | Osia 2(I) Sound Processor is compatible and optimized for the OSI300 implant. |
| Software updates (Osia Fitting Software 2, Osia Smart App) function as intended | Software identifies new components and provides updated functionalities. |
| Biocompatibility of Implant verified | Evaluated as biologically safe per ISO 10993-1:2018, ISO 14708-7:2013, and FDA guidance. |
| Sterilization of Implant verified | In compliance with ISO 11135:2014. |
| Shelf Life and Packaging - Implant verified | Shelf-life, sterility, and integrity maintained. |
| Biocompatibility of Sound Processor verified | Demonstrated biocompatibility per ISO/EN ISO 10993-1. |
2. Sample size used for the test set and the data provenance
The document explicitly states that bench testing was conducted. This implies that the "test set" consisted of physical devices, prototypes, or simulated scenarios in a lab environment. There is no mention of human subjects, patient data, or a clinical test set. Therefore, information regarding human sample size, country of origin, or retrospective/prospective nature is not applicable to the described study.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Since the study described is non-clinical bench testing, the concept of "ground truth established by experts" in a clinical context (e.g., radiologist opinions) is not applicable. The "ground truth" for bench testing is derived from engineering specifications, established standards (e.g., ISO, FDA guidance), and physical measurements by engineers and technicians.
4. Adjudication method for the test set
As the evaluation was non-clinical bench testing, an adjudication method like 2+1 or 3+1 for clinical interpretation is not applicable. Test results are typically evaluated against pre-defined engineering criteria and specifications.
5. 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
There is no mention of an MRMC study or any study involving human readers with or without AI assistance. The device is a hearing system, not an AI-assisted diagnostic tool for human interpretation.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
The device itself is a hearing system that directly assists the patient, not a diagnostic algorithm. Therefore, the concept of "standalone algorithm performance" (in the typical AI/diagnostic sense) is not applicable. The device's performance is inherently "human-in-the-loop" as it's worn by a person to enhance hearing. However, its individual components' functional performance was evaluated independently through bench testing.
7. The type of ground truth used
For the non-clinical bench testing and verification activities, the "ground truth" used was based on:
- Engineering specifications and design requirements of the device.
- Established industry standards (e.g., ISO 10993-1:2018, ISO 14708-7:2013, ISO 11135:2014, EN 45502-1, EN ISO 11607-2009 +A1:2014).
- FDA guidance documents.
- Comparative data against the performance of the predicate device (Cochlear™ Osia® 2 System).
8. The sample size for the training set
This is not applicable as the document does not describe the development of an AI algorithm or model that requires a training set. The descriptions are about hardware revisions, firmware updates, and software modifications for a medical device.
9. How the ground truth for the training set was established
This is not applicable as no training set for an AI algorithm or model is described.
§ 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.