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Ponto 4 sound processors 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 4 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 4 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 4 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).

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 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).

Here's a breakdown of the acceptance criteria and study information for the Ponto 4 sound processor, based on the provided FDA 510(k) summary:

Acceptance Criteria and Device Performance

The provided document describes the Ponto 4 as a modification of a previously cleared device (Ponto 3) and relies on demonstrating similar safety and effectiveness. Therefore, the "acceptance criteria" presented are implicitly aligned with the performance and safety characteristics of the predicate device. The Ponto 4's reported performance is stated to be "as expected" and "as safe and effective" as the Ponto 3.

Table 1: Acceptance Criteria and Reported Device Performance

Study Information

The document describes the testing performed to demonstrate substantial equivalence, rather than a standalone clinical study to establish new performance metrics.

1. Sample size used for the test set and the data provenance:

   • The document does not specify a sample size for a "test set" in terms of patient data.
   • The testing described is primarily for device-centric performance verification (electroacoustic and EMC), not clinical data from patients.
   • Data provenance: Not applicable in the context of patient data for a test set, as the testing focuses on the device itself. The studies are described as internal verification tests by the manufacturer, Oticon Medical AB (Sweden).

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

   • Not applicable as the testing is device-centric, not based on expert-adjudicated clinical data to establish a ground truth for a diagnostic or screening algorithm. The "truth" for electroacoustic measurements comes from established physical principles and measurement standards.

3. Adjudication method (e.g., 2+1, 3+1, none) for the test set:

   • Not applicable for the type of device-centric testing described.

4. 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:

   • No, an MRMC comparative effectiveness study was not conducted. This device is a hearing aid, not an AI-powered diagnostic or screening tool that would involve human "readers" or AI assistance in interpretation.

5. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:

   • This is not an AI algorithm in the context of medical image analysis or diagnosis. The "standalone" performance refers to the device's inherent electroacoustic, EMC, and functional capabilities, which were indeed tested as described. The performance is assessed based on the device's output and specifications, without continuous human intervention during its operation.

6. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

   • For the device's performance testing (electroacoustic, EMC), the "ground truth" is based on engineering specifications, physical laws, and established measurement standards. For example, a nominal frequency response or maximum output level would be the "ground truth" against which the device's measured performance is compared.
   • For biocompatibility, the ground truth refers to established standards for medical-grade materials and their safety.

7. The sample size for the training set:

   • Not applicable. This is not a machine learning or AI algorithm in the sense of requiring a training set from clinical data. The "training" for such devices involves product development, engineering design, and iterative testing.

8. How the ground truth for the training set was established:

   • Not applicable, as there is no training set in the context of machine learning. The design and performance targets for the device are established through engineering design principles, previous device generations (Ponto 3), and relevant industry standards for hearing aids.

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