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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).
• o 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 patients 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 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 unchanged. The Abutment extension accessory added to the Ponto bone anchored hearing system is a noninvasive component to be mounted on the abutment as point of attachment for the Ponto sound processor. The Abutment extension can be used with Ponto abutments and selected abutments from Cochlear BAS. When attached to the abutment it allows for connection of Ponto sound processors.

The provided text describes a 510(k) premarket notification for the Oticon Medical AB's Ponto bone anchored hearing system, specifically for the addition of an abutment extension accessory. This document focuses on demonstrating substantial equivalence to a predicate device rather than providing a detailed study of an AI/ML device's performance against specific acceptance criteria.

Therefore, many of the requested elements for an AI/ML device study are not directly applicable or available in this document.

However, I can extract the relevant information regarding performance testing that was conducted to support the substantial equivalence claim for the abutment extension.

Here's a breakdown of the available information structured to answer your request as closely as possible, with explicit notes about what is not applicable (N/A) or not provided in the document for an AI/ML device:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not specify quantitative acceptance criteria in a table format. Instead, it describes performance testing conducted to show the modified device is "as safe and effective as the previously cleared device." The performance data is summarized qualitatively.

2. Sample Size Used for the Test Set and Data Provenance

This document does not describe a clinical study with a "test set" in the context of an AI/ML device. The performance data mentioned refers to engineering and functional testing of the device and its accessory.

• Sample Size: Not specified for any of the performance tests (coupling force, sound transmission, lever effect, MRI testing).
• Data Provenance: Not specified (e.g., country of origin, retrospective/prospective). This would typically be laboratory or simulated testing rather than patient data.

3. Number of Experts and Qualifications for Ground Truth

• N/A: Ground truth based on human expert consensus is not applicable as this is not an AI/ML device for interpretation. The performance data is based on physical device measurements and engineering principles.

4. Adjudication Method for the Test Set

• N/A: Not applicable for device performance testing of this nature. Adjudication methods are typically relevant for human interpretation tasks or complex clinical endpoints.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

• No: This is not an AI/ML device, and no MRMC study is mentioned.

6. Standalone Performance Study

• Yes, in spirit (for device engineering): The performance data is for the "algorithm only" in the sense that it's for the device's physical performance, independent of human interaction for interpretation. The tests (coupling, sound transmission, lever effect, MRI) evaluate the physical characteristics of the device itself.
• The document states: "Performance data demonstrate that the modified device is as safe and effective as the previously cleared Ponto bone anchored hearing system and that the system will perform as intended during use." This implies standalone testing of the device's physical functions.

7. Type of Ground Truth Used

• Engineering/Physics-based Measurement: The "ground truth" for the performance data (coupling force, sound transmission, lever effect, MRI compatibility) would be established by established engineering standards, physical measurements, and comparison to the known performance of the predicate device. It's not clinical "ground truth" from pathology or outcomes data in the traditional sense for an AI/ML model.

8. Sample Size for the Training Set

• N/A: There is no "training set" as this is not an AI/ML device.

9. How the Ground Truth for the Training Set Was Established

• N/A: Not applicable as there is no training set mentioned for an AI/ML algorithm.

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