(137 days)
The Ponto bone anchored hearing system is intended for improvement of hearing for patients with conductive and mixed hearing losses, bilateral fitting and single sided deafness.
The Ponto bone anchored hearing system (sound processors Ponto, Ponto Pro and Ponto Pro Power 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 and Ponto Pro sound processors, 55 dB HL for use with the Ponto Pro 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 sound processors are intended to be used with the Ponto implant system (all models) or the Baha abutment snap coupling from Cochlear Bone Anchored Solutions (BAS) according to the below;
The Ponto implant system can be used for connection of the Ponto sound processors (all models) or the Baha sound processors with snap coupling from Cochlear BAS according to the below;
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.
Here's a breakdown of the acceptance criteria and study information for the Oticon Medical's Ponto Bone Anchored Hearing System, based on the provided text:
Acceptance Criteria and Device Performance
The document doesn't explicitly state "acceptance criteria" in a quantitative, pass/fail format with specific thresholds. Instead, it describes equivalency to predicate devices through design, functional testing, and intended use matching. The core "acceptance" is based on demonstrating that the Ponto system performs as intended and is as safe and effective as its predicate devices, especially regarding cross-compatibility.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Ponto sound processor compatibility with Ponto abutment/implant: The Ponto sound processor should function as intended when connected to the Ponto implant system. | Verified through testing: "The Ponto sound processor... has been tested... Maximum release force, minimum retention force and vibration has been tested both initially on new couplings and after wear. In all instances the Ponto sound processor functioned as intended and the coupling forces and vibration transmission was as expected." |
| Ponto sound processor compatibility with compatible Cochlear Baha abutment snap: The Ponto sound processor should function as intended when connected to specified compatible Baha abutments. | Verified through testing: "The Ponto sound processor... has been tested in cross combination with the Baha sound processor with snap coupling and Baha abutment snap... The testing verifies the performance of the Ponto sound processor both when used on the Ponto abutment and the Baha abutment snap. In all instances the Ponto sound processor functioned as intended and the coupling forces and vibration transmission was as expected." |
| Cochlear Baha sound processor compatibility with Ponto abutment/implant: Specified Baha sound processors should function as intended when connected to the Ponto implant system. | Verified through testing: "Testing also verifies equivalent performance of the Baha sound processor when connected to either the Ponto abutment or the Baha abutment snap." |
| Physical (dimensional) compatibility for cross-usage: Essential dimensions of Ponto abutments should match those of compatible Baha abutments to allow cross-system use. | Described in the "Technological Characteristics" and "Performance Data" sections: "Pertinent dimensions of the Ponto abutment were designed to match the respective dimensions of compatible Cochlear Baha abutments in order to permit compatibility between the Cochlear Baha sound processors and Ponto abutments/implants, and also between Ponto processors and the above specified compatible abutments from Cochlear Bone Anchored Solutions." This is not a direct "performance" metric but a design criterion that facilitates the intended performance. |
| Safety and Effectiveness: The Ponto system must be as safe and effective as the predicate devices. | "The Ponto bone anchored hearing system is as safe and effective as the Baha system and previously cleared versions of the Ponto system. The Ponto system has the same intended uses and similar indications, technological characteristics, and principles of operation as its predicate device. The minor differences between the Ponto system and its predicate devices raise no new issues of safety or effectiveness. Thus, the Ponto system is substantially equivalent." This is the overarching conclusion of the 510(k) submission based on all provided data and comparisons. |
Study Details
The provided document describes bench testing to demonstrate physical and functional compatibility, rather than a clinical study involving human subjects or a "test set" in the sense of patient data for an AI algorithm.
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Sample size used for the test set and the data provenance:
- Sample Size: Not specified for the bench tests. The testing was done on "new couplings" and "after wear," implying multiple units were tested.
- Data Provenance: Not explicitly stated as "country of origin." The testing was conducted by Oticon Medical AB (Sweden), implying the data originated from their internal testing. The nature of the data is retrospective in the sense that it describes tests performed on the physical devices.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable as this was bench testing of physical device performance, not an expert-driven assessment of ground truth on patient data. The "ground truth" was derived from predefined engineering specifications for force and vibration, and the expectation of "functioning as intended."
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Adjudication method for the test set:
- Not applicable. This was mechanical/vibrational testing, not a subjective assessment requiring adjudication.
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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:
- Not applicable. This device is a bone-anchored hearing system, not an AI-based diagnostic tool that assists human readers.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is a physical hearing device, not an algorithm. The "standalone" performance here refers to the device's functional characteristics (force, vibration) independent of a human's subjective experience in the context of the testing performed.
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The type of ground truth used:
- The "ground truth" for the bench testing was based on engineering specifications and expected functional performance. This includes "maximum release force," "minimum retention force," and "vibration" measurements, compared against predefined acceptable ranges. The "intended function" also serves as a ground truth baseline.
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The sample size for the training set:
- Not applicable. This device does not involve a "training set" in the context of machine learning or AI. The design and development of the device would have involved internal R&D, but not a formally characterized "training set" for an algorithm.
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How the ground truth for the training set was established:
- Not applicable, as there is no training set for an AI algorithm.
§ 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.