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The Ponto Plus sound processors are intended for improvement of hearing for patients with conductive and mixed hearing losses, bilateral fitting and single sided deafness.

The Ponto Plus and Ponto Plus Power are 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 Plus sound processor, 55 dB HL for use with the Ponto Plus Power sound processor.
• 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 Plus and Ponto Plus Power 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 Plus 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).

Ponto Plus and Ponto Plus Power are modifications of the previously cleared Ponto Pro (K090996) and Ponto Pro Power (K103594) and represent the two latest sound processor models in the Ponto bone anchored hearing system. A bone anchored hearing system consists of a sound processor connected to an implant with a skin penetrating abutment. The implant is surgically anchored in the skull bone behind the ear. Vibrations generated by the sound processor are transmitted via the implant 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. Alternatively, it can be connected to head band accessories, to function as a conventional bone conductor. Using a computer based fitting system the sound processor can be adjusted to the patient's individual hearing requirements. The Ponto Plus family utilizes wireless technology and can receive audio signals from external sources when used together with an optional accessory, Ponto Streamer, from Oticon A/S. Ponto Streamer can also be used as a remote control to adjust the volume of the sound processor, or to change the listening program. The Ponto Plus family is intended to be used with either the Ponto implant system or with specific compatible BAHA abutments/implants from Cochlear Bone Anchored Solutions (BAS). The Ponto Plus sound processors include the same sound processing features as the currently marketed models but they have also been complemented with an updated sound processing feature for feedback cancellation, the Inium feedback shield. Also the transducer design in Ponto Plus sound processors has been optimized resulting in higher maximum output in the mid to high frequency range.

Here's an analysis of the provided text regarding the acceptance criteria and study for the Ponto Plus and Ponto Plus Power devices:

Based on the provided document, the submission is a 510(k) premarket notification, which focuses on demonstrating substantial equivalence to predicate devices, rather than establishing de novo safety and effectiveness through extensive clinical trials. Therefore, the "study that proves the device meets the acceptance criteria" is primarily an equivalency assessment grounded in technical testing and comparison to existing, legally marketed devices.

1. Table of Acceptance Criteria and Reported Device Performance:

The document doesn't explicitly lay out a table of "acceptance criteria" in the sense of specific performance thresholds for a clinical study endpoint. Instead, the acceptance criteria are implicitly defined by the performance of the predicate devices and relevant standards. The "reported device performance" refers to the Ponto Plus family's ability to meet these established benchmarks.

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

The document describes functional testing and firmware validation rather than clinical studies with "test sets" in the typical sense of patient cohorts.

• Sample Size for Test Set: Not applicable in the context of clinical patient data. The "test set" here refers to the device itself undergoing various technical and performance tests. The testing focuses on the device's physical and electronic characteristics.
• Data Provenance: The testing was conducted by the manufacturer, Oticon Medical AB, in Sweden. It is retrospective in the sense that it evaluates the manufactured device against pre-established technical specifications and predicate device performance. There is no mention of prospective patient data collection for this 510(k) submission.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:

Not applicable. The ground truth for this type of submission is established by engineering and quality control specifications, compliance with recognized industry standards, and documented performance of the predicate devices. It does not involve expert clinical review of test data in the way a diagnostic AI product might.

4. Adjudication Method for the Test Set:

Not applicable. Technical testing is verified against specifications, not through a consensus of human adjudicators.

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

No, an MRMC comparative effectiveness study was not done. This submission is for a medical device (hearing aid) that directly treats a condition (hearing loss) by amplifying sound, rather than providing diagnostic information that human readers would interpret. Its effectiveness is assessed through its performance characteristics and equivalence to predicate devices, not through a comparative study of human reader performance with and without AI assistance.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study:

Not applicable. The device is a physical hearing aid that works in conjunction with the human user's auditory system. There is no "algorithm only" performance that stands alone from its mechanical and electronic function within a human use case. The "algorithms" mentioned (e.g., feedback cancellation) are integrated functionalities of the device. The technical tests conducted are essentially a "standalone" evaluation of the device's physical performance characteristics.

7. Type of Ground Truth Used:

The ground truth used for this submission is:

• Technical Specifications: Performance parameters (e.g., frequency range, output levels, power consumption) are measured against predefined engineering specifications.
• International Standards: Compliance with recognized electrical safety, EMC, and quality management standards (e.g., IEC 60601-1-2, ISO 13485).
• Predicate Device Performance: The established, legally marketed performance and safety profiles of the Ponto Pro/Pro Power and specific Oticon A/S air conduction hearing aids serve as benchmarks for demonstrating equivalence.

8. Sample Size for the Training Set:

Not applicable. This device is a hardware product with integrated signal processing, not a machine learning or AI model in the sense of requiring a "training set" of data to learn from. The design and optimization of its sound processing features (like the Inium feedback shield) would have involved extensive engineering development and testing, but not a "training set" in the context of computational learning.

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

Not applicable, as there is no "training set" for an AI model. The "ground truth" for the device's design and functionality comes from auditory science, psychoacoustics, electrical engineering principles, and clinical knowledge of hearing loss and its amplification.

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