(122 days)
The Ponto bone anchored hearing system intended use is for improvement of hearing for patients with conductive and mixed hearing losses, bilateral fitting and single-sided deafness.
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/implant 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 with the abutment is surgically anchored in the bone behind the ear. Vibrations generated by the sound processor are transmitted directly through the skull bone to the cochlea as bone conduction sound processor has a coupling so that it can be easily connected to and disconnected from the abutment by the user.
The technological characteristics of the Ponto bone anchored hearing system remain substantially unchanged from the original design. A modification has been made to the 4.5 mm diameter implant, introducing Ponto BHX implants with a rougher surface topography on parts of the implant. The purpose of the modification is to enhance osseointegration properties of the implant.
In addition, minor modifications have been made to surgical instruments for a less invasive surgical approach, Minimally Invasive Ponto Surgery (MIPS), for installation of Ponto implants. Instead of a linear incision, a single circular incision is created by means of a biopsy punch equivalent in size to the implant/abutment, enabling access for placement of the implant in the bone.
Here's an analysis of the provided text regarding acceptance criteria and supporting studies for the Ponto Bone Anchored Hearing System (K152067).
Acceptance Criteria and Study Analysis for Ponto Bone Anchored Hearing System (K152067)
This document describes a 510(k) submission for a modification to an existing device, the Ponto Bone Anchored Hearing System. The modification involves a change in the implant's surface topography to enhance osseointegration and minor modifications to surgical instruments for a less invasive surgical approach. The submission aims to demonstrate substantial equivalence to previously cleared predicate devices.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria & Performance Goals (as inferred) | Reported Device Performance |
|---|---|
| Safety: | |
| - Biocompatibility of new implant surface | Verified (implied by "tested in comparison to previously cleared device to verify the performance to support safety") |
| - Mechanical integrity/stability of implant | Verified (implied by "tested in comparison to previously cleared device to verify the performance to support safety") |
| - Surgical instrument functionality (cutting ability) | Verified (reported: "drill performance and cutting ability") |
| Effectiveness: | |
| - Osseointegration properties of the implant | Enhanced (reported: "enhance osseointegration properties of the implant") |
| - Bone anchorage of the implant | Verified (reported: "bone anchorage of the implant show that the modified device is as safe and effective") |
| - Equivalent clinical benefit (hearing improvement) | Implied by substantial equivalence and no change in intended use/indications |
| Substantial Equivalence: | |
| - Same Intended Use and Indications | Confirmed (explicitly stated in "Substantial Equivalence" section) |
| - Same Principles of Operation | Confirmed (explicitly stated in "Substantial Equivalence" section) |
| - Same Technological Characteristics (except changes) | Confirmed (explicitly stated in "Substantial Equivalence" section, with noted differences for the modification) |
| - Performance as intended during use | Verified (reported: "Performance data demonstrates that the modified device is as safe and effective... and that the system will perform as intended during use.") |
Key takeaway for this section: The document does not provide specific quantitative acceptance criteria or numerical performance data. Instead, it relies on a qualitative statement of verification and enhancement for the modified components and an overall claim of substantial equivalence to the predicate device.
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify the sample size used for any of the tests conducted (e.g., surface characterization, drill performance, cutting ability, bone anchorage). It also does not mention the data provenance (e.g., country of origin, retrospective or prospective nature). The Performance Data section only states that the modified device has been "tested in comparison to the previously cleared device."
3. Number of Experts Used to Establish Ground Truth and Qualifications
The document does not mention the involvement of experts to establish a ground truth for any test set. The performance data appears to be derived from engineering and physical tests rather than clinical evaluation with human interpretation.
4. Adjudication Method for the Test Set
Since no human experts are mentioned in establishing ground truth for a test set, there is no adjudication method described.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
A Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not performed or described in this document. The device is a hearing system, and the changes described are physical modifications (implant surface, surgical instruments) aimed at improving osseointegration and surgical technique, not at altering diagnostic accuracy requiring human reader interpretation.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
This is not applicable as the device is a medical implant and associated surgical tools, not an algorithm or AI system. The "performance data" refers to the physical and biological performance of the implant and instruments, which are inherently "standalone" in the sense of not involving a human-in-the-loop for their direct function (though a human surgeon installs them and a human user benefits from them).
7. Type of Ground Truth Used
The ground truth for the performance data appears to be based on:
- Engineering measurements and material science properties for surface characterization.
- Mechanical and operational testing for drill performance, cutting ability, and bone anchorage.
The document implies that these tests are compared against established benchmarks or the performance of the predicate device, which serves as a de facto "ground truth" for substantial equivalence.
8. Sample Size for the Training Set
This information is not applicable/not provided. There is no mention of a "training set" as this is a physical device modification, not a machine learning model.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable/not provided for the same reason as point 8.
§ 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.