FDA 510(k) Search - By Innolitics (SaMD and AI Experts)

The Osia System is intended for the following patients and indications:
· Patients 12 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 intended for patients 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., single-sided deafness or "SSD"). The pure tone average air conduction hearing thresholds of the 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 airconduction 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.

Device Description

The Osia 2 System, also known as 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 2 System is made up of several components. The Osia implant (OSI200) consists of a receiver/coil and an actuator/stimulator (vibrator) which is surgically implanted on the skull bone. The external component of the Osia 2 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 2 System is configured to meet an individual's hearing needs, using dedicated fitting software.
In normal operation, the Osia System functions as follows:

1. The external sound processor captures and digitally processes sound.
1. The sound processor transmits power and digital information to the implant coil/receiver.
1. The implant stimulator/actuator converts the digital information into an electric analogue signal that is converted to vibrations by the implant piezoelectric actuator.
This implant is fixed to the bone by the BI300 implant (K100360). 4.
The actuator converts the electrical signal into an amplified mechanical stimulation, bypassing the impaired middle ear (origin of the conductive part of the hearing loss) and providing some level of mechanical amplification in order to compensate for the damaged inner ear (sensorineural part of the hearing loss, in case of mixed hearing loss).
The updated Osia 2 System consists of modifications to the cleared OSI200 Implant, Osia 2 Sound Processor and Osia Fitting Software 2. All other components of the system remain unchanged from the cleared predicate.
The Cochlear MRI Kit is being introduced for use by Osia recipients. The MRI Kit is an accessory that enables an MR scan at 1.5T without the need to surgically remove a compatible Osia implant's magnet.

AI/ML Overview

The provided document is a 510(k) Summary for the Cochlear Osia 2 System. It describes the device, its intended use, indications for use, and a comparison to a predicate device. The primary purpose of this submission is seeking clearance for an updated Osia 2 System, which includes modifications to existing components (OSI200 Implant, Osia 2 Sound Processor, Osia Fitting Software 2) and the introduction of a new accessory, the Cochlear MRI Kit.

The core of the "acceptance criteria" and "proof" in a 510(k) submission like this is demonstrating substantial equivalence to a legally marketed predicate device, rather than proving a device meets specific quantitative performance metrics against a defined standard (which would be more typical for a PMA or de novo submission). Therefore, the "acceptance criteria" here largely refers to the criteria for demonstrating substantial equivalence, and the "study" is the collection of non-clinical (bench) testing performed to support this claim.

Here's an attempt to extract and describe the information requested based on the provided text, recognizing that a 510(k) summary primarily focuses on substantial equivalence rather than explicit performance criteria against a predefined threshold:

1. A table of acceptance criteria and the reported device performance

Since this is a 510(k) for an updated device, the primary "acceptance criterion" is functional equivalence and maintaining safety and effectiveness compared to the predicate device. The "reported device performance" is the conclusion that this equivalence was achieved through testing.

Acceptance Criterion (Implicit for 510(k))	Reported Device Performance
OSI200 Implant Modifications (PCA, Power Switch, Restart Time):
No adverse effect on the safety and effectiveness of the device.	"Verification related to the OSI200 Implant was completed based on changes to the printed circuit assembly (PCA) and concluded that the PCA does not affect the safety and effectiveness of the device."
Performance testing was re-executed for Functional, Safety and Reliability (Accelerated Life, Maximum Surface Temperature, Diagnostic Ultrasound, Therapeutic Ionizing Radiation, ESD, High Power Electric Fields), and Environmental Testing.
Validation activities for Intended Implant Lifetime were re-executed.
Osia Fitting Software 2 Modifications:
New functionalities (detect updated OSI200, activate gain) do not affect safety and effectiveness.	"Verification related to the Osia Fitting Software 2 was performed on a series of software builds which confirmed that the new functionalities added to the fitting software to allow it to detect the updated OSI200 implant and activate the gain setting do not affect safety and effectiveness of the device."
Osia 2 Sound Processor Firmware Modifications:
New functionalities (detect updated OSI200, activate gain, sleep mode) do not affect safety and effectiveness.	"Verification results related to the sound processor's firmware confirm that the new functionalities added to the sound processor firmware to allow it to detect the updated OSI200 implant and activate the gain setting do not affect safety and effectiveness of the device."
Cochlear MRI Kit Performance:
Safe and effective operation at 1.5T MRI with implant magnet in place.	"The Cochlear MRI Kit underwent verification testing of the MRI Kit when used at 1.5T with Osia implants..."
"The Osia System remains MR Conditional; however, MR Conditions have changed to allow MR scans at 1.5T with the implant magnet in place with the use of a Cochlear MRI Kit." (This fulfills the purpose of the MRI Kit accessory).
Usability of the MRI Kit and accompanying documentation.	"...and underwent summative usability testing to evaluate the usability of the MRI Kit and accompanying documentation by specialized healthcare professionals." (Results implicitly positive to support clearance).
Overall System Performance:
Functionally equivalent to the cleared Osia 2 System.	"The results demonstrate the updated Osia 2 System, including the modified OSI200 Implant, Osia 2 Sound Processor, and Osia Fitting Software 2 and new Cochlear MRI Kit, are functionally equivalent to the cleared Osia 2 System."
As safe and effective as the predicate device for its intended use.	"Based on the indications for use, technological characteristics, and substantial equivalence comparison to the predicate device, supported by non-clinical data, the updated Cochlear Osia 2 System has been shown to be as safe and as effective for its intended use as the predicate device."

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document primarily discusses bench testing and verification/validation activities for hardware, software, and accessories. It does not mention clinical trials with human subjects. Therefore, the concept of "sample size" in the context of a "test set" for clinical data or "data provenance" (country/retrospective/prospective) is not directly applicable here. The testing is non-clinical.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This section is not applicable as the document describes non-clinical (bench) testing, software verification, and usability testing for an accessory, not a diagnostic AI system requiring expert-established ground truth on medical images or patient data. The "summative usability testing" for the MRI Kit involved "specialized healthcare professionals," but their specific number, qualifications, or their role in establishing a "ground truth" (rather than evaluating usability) are not detailed.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This is not applicable as the device is not software for diagnostic image interpretation or a similar application that would require expert adjudication for ground truth.

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

This is not applicable. The device is an active implantable bone conduction hearing system and an associated MRI kit, not an AI-assisted diagnostic tool. No MRMC study or AI assistance to human readers is mentioned.

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

This is not applicable. The device is a physical hearing implant system and an MRI accessory, not an algorithm. The testing described is performance testing of the device components and system.

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

This is not applicable. For this type of device (hearing implant, MRI accessory), "ground truth" typically relates to engineering specifications, functional performance requirements, regulatory standards (e.g., for MRI compatibility), and safety profiles, which are assessed through bench testing and verification activities. It does not involve "ground truth" from medical images or patient outcomes in the sense of diagnostic accuracy.

8. The sample size for the training set

This is not applicable. The document describes a medical device (hardware and firmware/software) and its accessory, not a machine learning or AI model that requires a "training set."

9. How the ground truth for the training set was established

This is not applicable for the same reason as point 8.

Summary

Regulation Number and Section

§ 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.