(20 days)
Ponto 5 SuperPower sound processors are intended for the following patients and indications:
· Patients 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 65 dB HL for use with the Ponto 5 SuperPower 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 either the Ponto implant system or with specific compatible Baha abutments/implants 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. The sound processor can be connected and disconnected by the user by the snap coupling.
The sound processors are individually adjusted to the patient audiogram and needs via the Genie Medical BAHS fitting software by the Hearing Care Professional (HCP). The HCP connects the sound processors to the computer running the Genie Medical BAHS fitting software through either a wireless connection or a cable.
Ponto 5 SuperPower sound processor is a further development of and substantially equivalent to the primary predicate Ponto 3 SuperPower (K161671) and predicate Ponto 5 Mini (K211640).
As for both predicates, the Ponto 5 SuperPower sound processor is intended for improvement of hearing for patients with conductive or mixed hearing losses, whether unilaterally or bilaterally fitted, or for those with single-sided deafness.
Ponto 5 SuperPower sound processor is indicated for hearing losses up to and including 65 dB HL (BC), same as the primary predicate Ponto 3 SuperPower sound processor.
Ponto 5 SuperPower sound processor includes the same sound processing platform and wireless technology as the predicate Ponto 5 Mini sound processor, enabling the same sound processing features and compatibility options as Ponto 5 Mini.
A minor updated hardware design (electronic and mechanic) is implemented in Ponto 5 SuperPower sound processor as compared to Ponto 3 SuperPower (K161671), to allow for a side neutral design that carries the same design and look as Ponto 5 Mini (K211640).
The functionality and features of the firmware in Ponto 5 SuperPower are the same as for predicate device Ponto 5 Mini, however updated in a new revision. No functionality or features of the firmware are changed, added or removed by this update.
Other than the minor updates in hardware design and the very minor change to the firmware, the technological characteristics of the Ponto 5 sound processors remain unchanged from the original design (as latest cleared in K161671 for Ponto 3 SuperPower and K211640 for Ponto 5 Mini).
Additional purposes of this 510(k) notice is to include a minor modification to the accessory Genie Medical BAHS fitting software and to include the addition of Softband 5 to the Ponto Bone Anchored Hearing System:
- The fitting software is, as part of this 510(k), updated to include compatibility with Ponto 5 SuperPower in addition to Ponto 5 Mini and Ponto 4. No feature or functionality is changed, added or deleted in Genie Medical BAHS 2022.1, when compared to the current version Genie Medical BAHS 2021.2 (cleared together with Ponto 5 Mini in K211640).
- -The Softband, previously cleared through K082108 and latest in K161671. consists of a band placed around the wearers head with a connector plate to which the sound processor is attached. The Softband can be used by patients in the pre-operative evaluation phase or as a long-term solution to benefit from the sound processor without having an implant (primarily children). The Softband can be used also bilaterally. The band and the connector plate have been modified for optimal comfort and use.
The provided text describes the regulatory clearance for the Ponto 5 SuperPower sound processor. It clarifies that this device is a modification of previously cleared sound processors, the Ponto 3 SuperPower (K161671) and Ponto 5 Mini (K211640), and asserts substantial equivalence to these predicates. The document focuses on demonstrating that the new device does not raise new safety or effectiveness concerns.
Here's an analysis of the acceptance criteria and the study information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance:
Based on the document, the primary "acceptance criterion" is proving substantial equivalence to predicate devices, particularly in terms of performance characteristics relevant to hearing aids. The key performance aspect explicitly mentioned and compared is "Maximum Force Output."
| Acceptance Criteria (Implied) | Reported Device Performance for Ponto 5 SuperPower |
|---|---|
| Equivalence of Maximum Force Output | "Maximum Force Output is measured and found comparable for Ponto 5 SuperPower and primary predicate Ponto 3 SuperPower (K161671)." |
| Software Verification | Performance data includes software verification. |
| Electroacoustic Verification | Performance data includes electroacoustic verification. |
| Electrical and Mechanical Safety Evaluation | Performance data includes electrical and mechanical safety evaluation. |
| Electromagnetic Compatibility (EMC) Evaluation | Performance data includes electromagnetic compatibility (EMC) evaluation. |
| Documentation of Radio Properties and Performance | Performance data includes documentation of radio properties and performance. |
| Functional Equivalence of Sound Processing Features | "No functionality or feature is changed, added or removed" compared to Ponto 5 Mini. |
| Functional Equivalence of Firmware | "No functionality or features of the firmware are changed, added or removed by this update." |
| Substantial Equivalence (Overall Safety & Effectiveness) | "The performance data confirm that the Ponto 5 SuperPower sound processors are substantially equivalent compared to the primary predicate Ponto 3 SuperPower (K161671) and predicate Ponto 5 Mini (K211640)." "The minor technological differences... raise no new issues of safety or effectiveness." |
2. Sample Size Used for the Test Set and Data Provenance:
The document does not specify a "test set" in the context of human subjects or a defined dataset with a particular sample size for performance evaluation. Instead, it refers to "performance data" derived from standard engineering and regulatory tests. The provenance of this data (country of origin, retrospective/prospective) is not explicitly stated, but it is implied to be internal testing conducted by the manufacturer for regulatory compliance.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:
This information is not applicable in the context of this document. The device is a medical device (hearing aid), not an AI/ML algorithm that requires expert consensus for ground truth on a test set. The performance evaluation relies on established engineering standards and comparative analysis with predicate devices.
4. Adjudication Method for the Test Set:
This information is not applicable. See point 3.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
This information is not applicable. The document does not describe an MRMC study comparing human readers with and without AI assistance. The device is a hearing aid, not an AI diagnostic tool that assists human readers in interpreting medical images or data.
6. Standalone (Algorithm Only) Performance:
This information is not applicable. The Ponto 5 SuperPower is a physical hearing aid device with embedded software and hardware for sound processing. Its performance is evaluated as a complete system, not as a standalone algorithm without human interaction.
7. Type of Ground Truth Used:
The "ground truth" here is based on established engineering standards and measurements for hearing aid performance (e.g., IEC 60118-9:2019 for Maximum Force Output) and the performance characteristics of the legally marketed predicate devices. The comparison relies on demonstrating that the new device meets or is comparable to these established standards and predicate performances.
8. Sample Size for the Training Set:
This information is not applicable. The Ponto 5 SuperPower is not an AI/ML device that requires a "training set" in the conventional sense for machine learning model development. Its development and verification involve engineering design, testing, and comparison to existing products and standards.
9. How the Ground Truth for the Training Set Was Established:
This information is not applicable. See 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.