(118 days)
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 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 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 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.
Cochlear's Osia System mechanically vibrates the skull bone and subsequently the cochlea to compensate for conductive hearing loss, mixed hearing loss, or single-sided deafness (SSD).
The Osia System is made up of several components. The Osia Implant (OSI100) consists of a receiver/stimulator and an actuator (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.
In normal operation, the Osia System functions as follows:
- The external sound processor captures and digitally processes sound.
- The sound processor transmits power and digital information to the implant.
- The implant receiver-stimulator converts the digital information into an electric analogue signal.
- This electric signal is converted to vibrations by the implant piezoelectric actuator.
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 provided document (K190589) describes the Cochlear™ Osia™ System, an active implantable bone conduction hearing system. However, it does not include specific acceptance criteria or a study designed to explicitly prove that the device meets those criteria with numerical performance targets (e.g., a specific sensitivity, specificity, or improvement in a metric).
Instead, the document details a substantial equivalence (SE) submission to the FDA. The purpose of this submission is to demonstrate that the new device (Cochlear™ Osia™ System) is as safe and effective as a legally marketed predicate device (Bonebridge™ System). The document describes the system and presents performance data in the context of supporting this claim of substantial equivalence, rather than hitting pre-defined acceptance criteria for a novel device.
The "performance data" section (Section K) broadly states that clinical performance data was gathered and showed significant improvements, similar to the predicate device. It doesn't present specific acceptance criteria in a table format with corresponding performance metrics.
Therefore, I cannot generate the table as requested because the specific acceptance criteria and their corresponding numerical outcomes are not explicitly stated in the provided text.
However, I can extract the information related to the clinical study and its findings to give you the context of the device's performance as described:
1. Table of Acceptance Criteria and Reported Device Performance:
- Acceptance Criteria: Not explicitly stated as pass/fail numeric targets in the document. The general acceptance criterion for a 510(k) is demonstrating "substantial equivalence" to a predicate device, meaning the new device is as safe and effective.
- Reported Device Performance:
- Audiometric thresholds: Significant improvements reported when compared to the pre-implant condition.
- Speech in noise: Significant improvements reported when compared to the pre-implant condition.
- Speech in quiet: Significant improvements reported when compared to the pre-implant condition.
- Patient reported outcomes: Significant benefits demonstrated.
- Hearing Loss Accommodation: The Osia System can accommodate greater degrees of hearing loss (45 dB vs. 55 dB for the predicate, though the document states "greater degrees of hearing loss (45 versus 55 dB)" which seems to be a typo and likely means 55dB for Osia which is higher).
- Force output measurements: Higher for the Osia System at the same frequencies compared to the predicate device, enabling an expanded fitting range.
2. Sample Size Used for the Test Set and Data Provenance:
- Sample Size: Not explicitly stated. The document mentions "data gathered in a multi-center trial."
- Data Provenance:
- Country of Origin: One site was in the United States; other sites not specified.
- Retrospective or Prospective: Prospective clinical investigation.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications:
- This information is not provided in the document. The study was a clinical trial on human patients, and the "ground truth" would be the patient's actual hearing ability and perceived benefit, measured through audiometric tests and patient-reported outcomes, rather than expert interpretation of data for ground truth establishment.
4. Adjudication Method for the Test Set:
- This information is not provided in the document. The study was an "open, two-armed" clinical investigation. It was not blinded.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
- No, an MRMC study was not described. The study focused on the effectiveness of the device itself by comparing pre-implant conditions to post-implant conditions with the Osia device, and implied similar performance to a predicate device. It did not involve comparing human readers with and without AI assistance, as this is a medical device for hearing, not an AI diagnostic imaging tool.
6. Standalone (Algorithm Only) Performance:
- Not applicable in the typical sense of AI standalone performance. The "algorithm" here is the signal processing within the sound processor. The clinical study did evaluate the performance of the device system (implant + sound processor) in a "standalone" fashion (i.e., its performance in patients), but not in the context of an AI algorithm making a diagnosis without human interaction.
7. Type of Ground Truth Used:
- Clinical Outcomes and Audiometric Data: The "ground truth" was established by objective audiometric measures (pure tone average bone conduction thresholds, air conduction hearing thresholds) and subjective patient-reported outcomes regarding hearing ability and benefit.
8. Sample Size for the Training Set:
- Not applicable. This device is a hearing aid system, not a machine learning model that requires a training set in the conventional sense. The "training" in this context would be the device development and engineering process to optimize its acoustic and mechanical properties, not a machine learning training phase on data.
9. How the Ground Truth for the Training Set Was Established:
- Not applicable. As above, there isn't a machine learning training set with established ground truth described in this submission.
§ 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.