(124 days)
The Ponto bone anchored hearing system (Ponto sound processors and implant system) is intended for the following patients and indications:
- . Patient with conductive or mixed hearing losses, who can still benefit from amplification of the sound. The pure tone average (PTA) bone conduction (BC) threshold (measured at 0.5, 1, 2 and 3 kHz) of the indicated ear should be better than or equal to 45 dB HL for use with the Ponto, Ponto Pro and Ponto Plus sound processors, 55 dB HL for use with Ponto Pro Power and Ponto Plus Power sound processors.
- Bilateral fitting is applicable for most 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 4 kHz, or less than 15 db at individual frequencies.
- Patients who have a 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 (PTA) air conduction (AC) threshold of the hearing ear should then be better than or equal to 20 dB HL (measured at 0.5, 1, 2 and 3 kHz).
- 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.
The placement of a bone anchored implant is contraindicated for patient below the age of 5.
The Ponto sound processors are intended to be used with either the Ponto implant system or with specific compatible Baha abutments/implants from Cochlear Bone Anchored Solutions (BAS) (refer to the Ponto labeling for specific compatible Cochlear models). In addition, selected Cochlear Baha sound processors can be used with the Ponto implant/abutment system (refer to the Ponto labeling for compatible Baha sound processor models).
The Ponto bone anchored hearing system consists of an external sound processor unit and an implant with a skin penetrating abutment. The implant is placed in or around the mastoid region of the skull on either one or both sides. The implant is then used as anchorage for the skin penetrating abutment that connects to the external sound processor. Vibrations generated by the sound processor are transmitted directly through the skull bone to the cochlea as bone conduction sound. The sound processor has a coupling so that it can easily be connected to and disconnected from the abutment by the user. This submission concerns the abutment component.
The provided text is a 510(k) summary for the Oticon Medical AB's Ponto Bone Anchored Hearing System. It describes a modification to an existing device rather than a new AI-powered device. Therefore, it does not contain the specific information requested about acceptance criteria, device performance, and study details typically associated with AI/ML medical devices.
The 510(k) summary focuses on demonstrating substantial equivalence to a predicate device for regulatory clearance, primarily through engineering and bench testing rather than clinical performance studies with human subjects that measure metrics like sensitivity, specificity, or reader improvement.
Here's why the requested information cannot be extracted from the document:
- AI/ML Device: The Ponto Bone Anchored Hearing System is a physical medical device (hearing aid/implant system), not an AI/ML algorithm. Therefore, the concepts of "acceptance criteria" and "device performance" in your prompt (e.g., sensitivity, specificity, F1 score) do not apply in the same way.
- Study Type: The document states, "Performance data, including bench testing of mechanical forces, show that the modified device is as safe and effective as the previously cleared device." This refers to non-clinical (bench) testing, not clinical studies with human readers, ground truth establishment, or multi-reader multi-case studies.
- Ground Truth/Experts: Since it's a physical device and the "performance data" is bench testing, there's no mention of experts establishing ground truth for a test set, adjudication methods, or training sets as these are concepts relevant to diagnostic AI algorithms.
Based on the provided document, I can extract the following relevant information regarding the device and its testing:
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Safety and effectiveness comparable to previously cleared device | Performance data (including bench testing of mechanical forces) shows the modified device is as safe and effective as the previously cleared device. |
| Functions as intended during use | Will perform as intended during use. |
2. Sample size used for the test set and data provenance:
- Sample size: Not specified. The performance data refers to "bench testing of mechanical forces," which typically involves testing a sample lot of manufactured devices rather than a patient test set.
- Data Provenance: Bench testing, not patient data (retrospective or prospective).
3. Number of experts used to establish the ground truth for the test set and qualifications:
- Not applicable/Not mentioned. Ground truth in the context of AI/ML diagnostic devices and expert review is not relevant for this physical device's bench testing.
4. Adjudication method for the test set:
- Not applicable/Not mentioned. Adjudication is relevant for expert review of clinical cases.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, and effect size:
- No, an MRMC comparative effectiveness study was not done, as this is a physical device regulatory submission, not an AI/ML diagnostic algorithm.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- Not applicable, as this is a physical device, not an algorithm.
7. The type of ground truth used:
- Not applicable/Not mentioned in the context of clinical ground truth. For bench testing, "ground truth" would be established engineering specifications and measurement standards.
8. The sample size for the training set:
- Not applicable. This is a physical device, not an AI/ML algorithm that requires a training set.
9. How the ground truth for the training set was established:
- Not applicable.
In summary: The provided document is a 510(k) premarket notification for a physical medical device (a new abutment size for a bone-anchored hearing system) and focuses on demonstrating substantial equivalence through bench testing. It does not provide the kind of information requested for AI/ML diagnostic devices, such as clinical performance metrics, expert review details, or training/test set characteristics.
§ 874.3302 Bone-conduction hearing aid.
(a)
Identification. A bone-conduction hearing aid is a wearable sound-amplifying device intended to compensate for impaired hearing and that conducts sound to the inner ear through the skull. The non-implantable components of a bone-conduction hearing aid, such as the external sound processor, are subject to the requirements in § 801.422 of this chapter.(b)
Classification. Class II.