(120 days)
The Osia 2 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 2 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 2 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 2 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 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 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.
Here's an analysis of the provided information regarding the acceptance criteria and the study conducted for the Cochlear™ Osia™ 2 System:
1. Table of Acceptance Criteria and Reported Device Performance
The provided document, a 510(k) summary, focuses on demonstrating substantial equivalence to a predicate device rather than explicitly stating acceptance criteria and detailed device performance metrics in a table. However, it does highlight key comparisons and generally indicates that the Osia 2 System either performs "Same" as the predicate or has "improved" features. The clinical study's conclusion also states "did not reveal significant differences in hearing performance."
Below is a reconstructed table based on the information provided, inferring acceptance criteria by the demonstrated equivalence to the predicate. Specific numerical performance values beyond those for hearing loss thresholds are not provided in this summary.
| Acceptance Criteria (Inferred from Predicate Equivalence) | Reported Device Performance (Osia 2 System) |
|---|---|
| Audiological Performance: Equivalent hearing performance in adaptive speech recognition to the predicate Osia System. The device should allow patients with specified hearing loss (conductive, mixed, profound sensorineural in one ear) to benefit from sound amplification / overcome hearing loss. | Clinical Performance: "The clinical evaluation did not reveal significant differences in hearing performance between either system [Osia 2 and predicate Osia System] in regard to adaptive speech recognition (p-value > 0.05)." Indications for Use: Meets specified hearing loss criteria (e.g., PTA bone conduction threshold better than or equal to 55 dB HL, PTA air conduction hearing thresholds better than or equal to 20 dB HL for SSD). |
| Implant Lifetime: Minimum of 6 years (based on predicate). | Implant Lifetime: Minimum of 10 years (Improved from predicate OSI100). |
| Magnetic Resonance (MR) Conditional: Equivalent or improved MR compatibility compared to the predicate device. | MR Conditional: OSI200 Implant is MR Conditional with magnet removed at 1.5 T and 3.0 T (explicitly stated). |
| Safety - Biocompatibility: Materials are biocompatible as per ISO 10993 standards for permanent implant device contacting tissue and bone (implant) and permanent surface device contacting intact skin (sound processor). | Biocompatibility: "Biocompatibility of the device system has been evaluated and tested. All tests were passed and confirm that the system is biocompatible." Refers to ISO 10993-1, -3, -5, -6, -10, -11, -18 and EN45502-1:2015. Direct contact materials are largely the same as the predicate (Titanium, Silicone), with the exception of the platinum plate electrode (Osia 2 does not have it). |
| Safety - Mechanical Reliability: Implant and system robustness under various conditions (e.g., environmental, acoustic, impact, cyclic load, fluid ingress, fixation, particulate matter). | Implant Reliability Testing & Performance Data: "Same" as predicate (underwent performance testing for Environmental Conditioning, Acoustic, Link Integrity, Maximum Surface Temperature, Coil Robustness, Coil Impact, Static Load, Cyclic Load, Fluid Ingress, Fixation, and Particulate Matter Testing). System Performance: "Same" as predicate (underwent functional testing, intra-operability, compatibility, system performance, safety and measurement functions). |
| Safety - Electromagnetic Compatibility (EMC): Meets relevant EMC standards. | Osia System EMC Testing: "Same" as predicate, "Including additional EMC testing to AIM Standard 7351731". (Radiated Emission, Conducted Emission, Immunity to Radiated RF Field (RRFF), Immunity to Proximity Fields from RF Wireless Communications Equipment, EN 45502-2-3 Clauses 27.3 and 27.4, Conducted RF disturbance, Exposure to RFID, Static Magnetic Field Immunity). |
| Other Functional Characteristics: Maintains core functional characteristics (e.g., receiver coil, actuator, inductive link, power source). Enhancements (e.g. wireless capabilities, fitting software features) should not negatively impact core function. | Implant Components: Receiver Coil "Same", Implant Actuator "Same", Osseointegrated component "Same", Inductive Link "Same", Implant Power Source "Same". Actuator Dampening Pads: Design "improved by adding a damping system... to improve shock performance. The addition... does not raise new issue of safety nor effectiveness." Link between Received Coil and Actuator: Smaller design does not require a lead; stimulator-electrical assembly and actuator housed together. Sound Processor Wireless Capabilities: Has additional ability to connect wirelessly to fitting software and accessories. Fitting Software Features: Osia Fitting Software 2.0 has additional features allowing wireless connection, accessory pairing, more settings, and factory reset. |
2. Sample Size Used for the Test Set and the Data Provenance
The document states: "Clinical performance data was gathered through a simulation study that allowed audiological testing of the Osia 2 Systems and Osia Systems without having to surgically implant the OSI200 Implant and OSI100 Implant, respectively."
- Sample Size: The exact sample size for the "simulation study" is not specified in the provided text.
- Data Provenance: The document does not explicitly state the country of origin. It indicates the study was a prospective simulation designed to assess audiological performance without physical implantation of the investigational device.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
This information is not provided in the document. The study described is a "simulation study" for audiological testing. If human subjects were involved, the "ground truth" would likely be their measured hearing thresholds and subjective speech recognition scores. There is no mention of experts establishing ground truth in the context of diagnostic performance or image interpretation.
4. Adjudication Method for the Test Set
This information is not applicable and therefore not provided. The study described is an audiological performance simulation, not a diagnostic study requiring adjudication of interpretations.
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, not an AI-powered diagnostic tool requiring human reader interpretation of images or other data. Therefore, an MRMC comparative effectiveness study involving human readers and AI assistance was not performed or described.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This is not applicable. The device is a hearing system, not a standalone algorithm. The "clinical performance data" discussed refers to the audiological efficacy of the device (or its simulated function), not the performance of an independent algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
For the audiological performance assessment, the "ground truth" would have been the measured audiological outcomes (e.g., adaptive speech recognition scores) of the participants in the simulation study. This is directly related to hearing function.
8. The sample size for the training set
This information is not applicable and therefore not provided. The device is a physical hearing aid system, not a machine learning algorithm that requires a training set in the conventional sense. The "simulation study" would involve testing against human participants or a defined audiological standard, not training a model.
9. How the ground truth for the training set was established
This information is not applicable as there is no training set for a machine learning algorithm.
§ 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.