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;

Device Description

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.

AI/ML Overview

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.

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.
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."
Adjudication method for the test set:
- Not applicable. This was mechanical/vibrational testing, not a subjective assessment requiring adjudication.
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.
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.
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.
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.
How the ground truth for the training set was established:
- Not applicable, as there is no training set for an AI algorithm.

Summary

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510(k) SUMMARY

Oticon Medical's Ponto Bone Anchored Hearing System

Submitter name: Oticon Medical AB Address: Ekonomiv. 2 SE-436 33 Askim Sweden Establishment Registration #: 3007367732 Contact person: Karolin Isberg Jernby Telephone number: +46 31 748 6153 Fax number: +46 31 687 756 kai@oticonmedical.se E-mail: Date of submission: 2012-04-19 Device trade name: Ponto Bone Anchored Hearing System Common name: Bone anchored hearing aid Classification name: Hearing aid, bone conduction, implanted Classification regulation: 21 C.F.R. 874.3300 Product Code: MAH

Predicate Devices

Trade name	Manufacturer
Ponto bone anchored hearing system (K112053).	Oticon Medical AB
Cochlear Baha BP100 (K090720)	Cochlear BAS

Intended Use

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.

Indications for Use

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

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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;

Ponto and Ponto Pro sound processors	Compatible implant/abutments from Cochlear
(130-00-212-00, 130-00-222-00, 130-00-112-00, 130-00-122-00, 130-00-211-00, 130-00-221-00, 130-00-111-00,130-00-121-00, 130-00-210-00, 130-00-220-00, 130-00-110-00, 130-00-120-00, 130-00-911-00, 130-00-921-00,130-00-910-00, 130-00-920-00, 130-00-113-00, 130-00-123-00, 130-00-213-00, 130-00-223-00)	BAS
Ponto Pro Power sound processors(M50676, M50677, M50872, M50873, M50874, M70875,M50881, M50883, M50884, M50902, M50903, M50882)	Baha abutment snap coupling 5.5mm (90305)Baha abutment snap coupling 8.5mm (90410)Flange fixture ST 4 mm with Baha abutment(90434)Flange fixture ST 3 mm with Baha abutment(90480)
	Not compatible implant/abutments fromCochlear BASBA300 Series abutments (92126, 92127, 92130,92131, 92346)BA210 Series abutments (92132, 92133, 92134,92135)

In addition, 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;

Ponto implant system	Compatible sound processors from Cochlear
3mm implants with pre mounted 6mm abutment (M50784)	BAS
4mm Implants with pre mounted abutment 6mm (M50358)	Baha sound processors with snap coupling:
4mm Implants with pre mounted abutment 9mm (M50785)	Baha Classic 300 snap (HCB-410-0, HCB-411-0,
Wide implant, 4mm, with abutment 6mm (M51136)	HCB-412-0)
Wide implant, 4mm, with abutment 9mm (M51137)	Baha Compact (90140, 90141, 90142)
Wide implant, 4mm, with abutment 12mm (M51138)	Baha Divino (90500, 90510, 90501, 90511,
Wide implant, 3mm, with abutment 6mm (M51140)	90502, 90512, 90503, 90513)
Wide implant, 3mm, with abutment 9mm (M51141)	Baha Intenso™ (90730, 90731, 90732, 90733)
Abutments 6mm (M50349)	Baha Cordelle (HCB 400-0, HCB 401-0, HCB 402-
Abutment 9mm (M50318)	0)
Abutment 12mm (M51149)	Baha BP100 (91300, 91301, 91302, 91303,
Angled abutment (M50362)	91304, 91305)
	Baha 3 Power BP110 (92840, 92841, 92842,
	92843, 92844, 92845)

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Technological Characteristics

Performance Data

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. The Ponto sound processor and Ponto abutment have been tested in cross combination with the Baha sound processor with snap coupling and Baha abutment snap. Maximum release force, minimum retention force and vibration has been tested both initially on new couplings and after wear. 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. Testing also verifies equivalent performance of the Baha sound processor when connected to either the Ponto abutment or the Baha abutment snap.

Substantial Equivalence

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.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 description: The image is a black and white logo for the Department of Health & Human Services - USA. The logo features a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the top half of the circle. Inside the circle is a stylized eagle or bird-like symbol with three curved lines representing the wings or body.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

Oticon Medical AB c/o Ms. Karolin Isberg Jernby Quality Assurance & Regulatory Affairs Manager Ekonomiv 2 SE-436 33 Askim Sweden

Re: K121228

Trade/Device Name: Ponto Bone Anchored Hearing System Regulation Number: 21 CFR 874.3300 Regulation Name: Hearing aid, bone conduction, implanted Regulatory Class: Class II Product Code: MAH Dated: July 06, 2012 Received: July 11, 2012

Dear Ms. Jernby:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your becamed the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the encreations of the enactment date of the Medical Device Amendments, or to conimered prior to 1125 20, 2017 11:57 accordance with the provisions of the Federal Food, Drug, devices that have been rocksonied in quire approval of a premarket approval application (PMA). and Costience Act (110) that to neview subject to the general controls provisions of the Act. The I ou may, merciolo, market afte as act include requirements for annual registration, listing of general controls provisions of the free labeling, and prohibitions against misbranding and devices, good manufacturing practices and evaluate information related to contract liability additeration. Trease note: CDICT acce not ovaluate must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it If your device is classified (500 a00 ve) into major regulations affecting your device can be fifay be subject to additional controls. "Bitle 21, Parts 800 to 898. In addition, FDA may rouad in the Code of Peachants concerning your device in the Federal Register.

SEP 7 2012

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Page 2 - Ms. Karolin Isberg Jernby

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 53.1-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely vours.

Kesia Alexander

Malvina B. Eydelman, M.D. Director Division of Ophthalmic, Neurological, and Ear, Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for use

510(k) Number:

Device Name: Ponto Bone Anchored Hearing System

Indications for Use:

The Ponto bone anchored hearing system (sound processors Ponto, 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 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).

Prescription Use _ X (Part 21 CFR 801.109) OR

Over-The-Counter Use

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Zaisk Dake

Division Sign-Off) vision of Ophthalmic, Neurological and

K121228

510(k) Number

Regulation Number and Section

§ 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.