(112 days)
The Ponto Pro is 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 for the indicated ear should be better than 45 dB HL (measured at 0.5, 1, 2 and 3 kHz).
- 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, who for some reason will not or cannot use an AC CROS. The pure tone average (PTA) air conduction (AC) threshold of the hearing ear should then be better than 20 dB HL (measured at 0.5. 1, 2 and 3 kHz).
The placement of a bone anchored implant is contraindicated for patients below the age of 5.
The Ponto Pro sound processor is intended to be connected to the Oticon Medical bone anchored implant system or to the Baha® Abutment snap coupling from Cochlear BAS. In addition, the Oticon Medical abutments can be used for connection of the Baha® sound processors with snap coupling from Cochlear BAS (Baha Divino®, Baha IntensoTM, Baha Cordelle II, Baha BP100),
The Ponto Pro is a bone conduction-type hearing aid. The Ponto Processor is connected to an implant with a skin penetrating abutment which as been 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 Ponto Pro sound processor has a coupling so that it can be easily connected to and disconnected from the abutment by the user. The Ponto Pro can alternatively be connected to head band accessories, to function as a conventional bone conductor. Using a computer based fitting system the Ponto Pro can be adjusted to the patient's individual hearing requirements. The sound processor is intended to work with the Oticon Medical bone anchored implant system or the Baha® Abutment snap coupling from Cochlear BAS (ref no. 90410, 90305, 90434, 90480). In addition, the Oticon Medical abutments can be used for connection of the Baha® sound processors with snap coupling from Cochlear BAS (Baha Divino®, Baha Intenso"" Baha Cordelle II, Baha BP100; ref no. 90500, 90510, 90511, 90502, 90512, 90503, 90513, 90730, 90731, 90732, 90733, HBC 400-0, HCB 401-0, HCB 402-0, 91301, 91302, 91303, 91304, 91305).
The provided document describes the Ponto Pro bone anchored sound processor, which falls under the classification of a Class II medical device (Hearing Aid, Bone Conduction, Product Code: LXB). The device is intended for improving hearing in patients with conductive and mixed hearing losses, bilateral fitting, and single-sided deafness.
The submission is a 510(k) summary, which typically demonstrates substantial equivalence to a predicate device rather than presenting full clinical study data for new acceptance criteria. Therefore, the information provided focuses on the comparison to predicate devices and functional testing, not a detailed study with specific acceptance criteria and detailed device performance outcomes in a traditional clinical trial sense.
Here's an analysis based on the provided text, addressing your points where information is available:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state "acceptance criteria" in the formal sense found in a clinical trial report or a performance goal. Instead, the submission relies on demonstrating substantial equivalence to predicate devices. The "reported device performance" is essentially that it functions equivalently to these established devices.
| Characteristic | Acceptance Criteria (Implied by Predicate Equivalence) | Reported Device Performance (Ponto Pro) |
|---|---|---|
| Design | Bone conduction sound processor connected to surgically placed implant | Bone conduction sound processor connected to surgically placed implant |
| Intended Use | Improve hearing for patients with conductive/mixed hearing loss, bilateral fitting, single-sided deafness | Same as predicate; specific audiometric thresholds are given for intended use |
| Material | Sound processor coupling: PEEK; Implant: Titanium | Sound processor coupling: PEEK; Implant: Titanium |
| Power Requirement | Zinc-air battery | Zinc-air battery |
| Max Gain | 33dB | 33dB |
| Frequency Response | 125 Hz - 8 kHz | 125 Hz - 8 kHz |
| Sound Processing | Digital | Digital |
| Patient Fitting | Individual adjustment via computer-based fitting system | Individual adjustment via computer-based fitting system |
| Accessories | Various accessories for direct audio input (DAI) | Various accessories for direct audio input (DAI) |
| Safety & Efficacy | No new concerns compared to predicate devices | Functional testing and software validation confirm equivalence, raising no new safety/efficacy concerns. |
2. Sample Size Used for the Test Set and Data Provenance
The document explicitly states: "Testing of the Ponto Pro include functional testing and software validation. These tests verify that the Ponto Pro is functionally equivalent to the OBC, why we have come to the conclusion that further testing will not raise new issues of safety and efficacy."
This indicates that the "test set" for performance evaluation was likely functional testing and software validation of the device itself, rather than a clinical study on a patient population.
- Sample Size: Not applicable in the context of a patient-based test set, as no patient study is detailed for proving functional equivalence in this section. The "testing" refers to internal device verification.
- Data Provenance: Not applicable for a patient-based test set. The functional and software testing would have been conducted by the manufacturer (Oticon Medical AB in Sweden).
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
This information is not provided. Since the submission relies on functional and software testing to demonstrate equivalence, and not on a clinical ground truth evaluation by experts for a patient test set, this detail is not relevant to the provided text.
4. Adjudication Method for the Test Set
Not applicable. There's no mention of a human-reviewed "test set" for which adjudication would be required. The "testing" described is functional and software-based.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done
No, a multi-reader multi-case (MRMC) comparative effectiveness study is not mentioned or indicated. The submission focuses on substantial equivalence based on technological characteristics and functional testing.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was Done
The device is a hearing aid, which by its nature requires human interaction (the patient wearing it and an audiologist fitting it). The concept of "standalone algorithm only" performance doesn't directly apply in the same way it would for an AI diagnostic imaging algorithm. The "functional testing and software validation" could be considered a form of standalone testing of the device's inherent functionality.
7. The Type of Ground Truth Used
For the purpose of this 510(k) submission, the "ground truth" for demonstrating safety and effectiveness relied on:
- Predicate Device Performance: The established safety and efficacy of the legally marketed predicate devices (OBC, Baha Divino, and air conduction hearing aids with digital sound processing). The Ponto Pro's performance is deemed acceptable because it is substantially equivalent to these devices.
- Functional Testing and Software Validation: Internal verification that the Ponto Pro performs according to its design specifications, ensuring it functions as intended and safely, similar to its predicates.
No external "expert consensus, pathology, or outcomes data" is described as being used to establish a ground truth for a novel performance claim beyond equivalence.
8. The Sample Size for the Training Set
Not applicable. As this is a medical device (a hearing aid), not an AI algorithm trained on a dataset of patient cases, there is no "training set" in the context of machine learning. The device's design and software are developed through engineering processes, and its functionality is validated through testing and comparison to predicate devices, not by training on a data set.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no "training set" in the context of this device. The "ground truth" for the device's development and validation is based on established audiological principles, engineering standards, and the performance of predicate devices.
§ 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.