Patients who have a conductive or mixed hearing loss and can still benefit from sound amplification. The pure tone average bone conduction threshold should be better than or equal to 45 dB HL (measured at 0.5, 1, 2 and 3 kHz)
Bilateral fitting of the Divino is intended for patients who suffer from moderate to severe bilateral symmetric conductive and/or mixed hearing losses. Symmetric bone conductive thresholds are defined as less than 10 dB in average (measured at 0.5, 1, 2 and 4 kHz) or less than 15 dB at individual frequencies
The single sided deafness (SSD) indication for the Divino hearing aid is intended for patients who suffer from unilateral sensorineural deafness on one ear while the other ear has normal hearing. Normal hearing is defined as PTA AC threshold equal to or better than 20dB measured at 0.5, 1, 2 and 3 kHz

BAHA for SSD is also indicated for patients who are indicated for an AC CROS but who for some reason cannot or will not use an AC CROS.

Device Description

The BAHA Divino is a bone conduction-type hearing aid. Unlike conventional hearing aids, which depend on acoustic coupling through the air, the Divino is based on a bone conduction technology.

The Divino hearing aid is connected to a fixture pillar, which has been surgically placed in the bone behind the deaf ear. Sound is transmitted through the bones of the skull to the hearing ear with the normal functioning cochlea.

AI/ML Overview

Here's a breakdown of the acceptance criteria and study information for the BAHA Divino hearing aid, based on the provided document:

Acceptance Criteria and Device Performance

Acceptance Criteria / Characteristic	BAHA-Branemark Bone Anchored Hearing Aid (Predicate)	BAHA Divino (Reported Device Performance)
Material (Implant)	Titanium	Same as BAHA (Titanium)
Material (Abutment Snap)	PEEK	Same as BAHA (PEEK)
Intended Use	Improvement of hearing for patients with conductive and mixed hearing losses, bilateral fitting and single sided deafness	Same as BAHA
Power Requirement	Zinc-air	Same as BAHA (Zinc-air)
Max Gain	33dB	Same as BAHA (33dB)
Frequency Response	125 Hz - 8 KHz	Same as BAHA (125 Hz - 8 KHz)
Sound Processing	Analogue	Digital
Manufacturer	Entific Medical Systems	Entific Medical Systems

Study Details

The provided document describes a 510(k) Premarket Notification for the BAHA Divino. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than conducting new clinical trials to establish independent safety and effectiveness thresholds. Therefore, much of the information typically found in a clinical study report (like detailed sample sizes, expert qualifications for ground truth, MRMC studies, or standalone performance metrics) is not present in this document.

Here's what can be extracted and what is missing:

Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- Not explicitly stated. The document mentions "software validation and functional testing" but does not provide details on specific test sets (patient data, etc.) or their provenance. This is typical for a 510(k) submission where the primary evidence is a comparison to a predicate device and technical verification/validation.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable/Not explicitly stated. The submission relies on demonstrating technical and functional equivalence, not on a clinical "ground truth" validation against expert consensus on a patient cohort in the way a diagnostic AI might.
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable/Not explicitly stated. No clinical adjudication method is described.
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. This is not an MRMC study. The device is a hearing aid, not a diagnostic AI system for image interpretation.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. While the device has "digital sound processing," the document describes "software validation and functional testing" to verify functional equivalence. It doesn't present "standalone performance" in the context of an algorithm making a decision, but rather as a device performing its intended function.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Functional equivalence to predicate device and internal technical specifications. The "ground truth" for this submission is that the BAHA Divino performs its intended function (sound amplification via bone conduction) in a manner substantially equivalent to existing BAHA devices and compliant with its own design specifications validated through software and functional testing. It is not based on a clinical "ground truth" related to disease detection or specific outcomes in a trial.
The sample size for the training set:
- Not applicable/Not explicitly stated. As this is a medical device (hearing aid) and not an AI/ML model being "trained" on a dataset for prediction, there isn't a "training set" in the conventional sense of machine learning. The digital sound processing would be designed and validated based on engineering principles and performance specifications.
How the ground truth for the training set was established:
- Not applicable. See point 7.

Summary of the Study:

The "study" described in this 510(k) submission is primarily a comparison of the BAHA Divino to legally marketed predicate devices (previous BAHA models and air conduction hearing aids with digital sound processing) to demonstrate substantial equivalence.

Focus: Substantial equivalence based on technological characteristics, intended use, and materials.
Testing: Included "software validation and functional testing" to verify that the Divino is functionally equivalent to the predicate BAHA devices. The details of these tests (e.g., number of units tested, specific metrics) are not provided in this summary.
Conclusion: Entific Medical Systems concluded that the BAHA Divino is substantially equivalent and presents no new concerns about safety and effectiveness. The FDA concurred with this determination.

Crucially, no new clinical trials or studies generating novel clinical evidence of safety or effectiveness are described, nor are they typically required for a 510(k) submission that demonstrates substantial equivalence to predicate devices for which safety and effectiveness have already been established.

Summary

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1042017

AUG 2 6 2004

SECTION 0. SUMMARY AND CERTIFICATION

A. 510(K) SUMMARY

Summary of Safety and Effectiveness

SUBMITTER'S NAME:	Entific Medical Systems
ADDRESS:	P:O: Box 16024SE-412 21 G\u00f6teborgSweden
CONTACT PERSON:	Constance Bundy
TELEPHONE NUMBER:	763-574-1976
FAX NUMBER:	763-574-2437
DATE OF SUBMISSION:	July 26, 2004

1. Identification of device

Proprietary Name: BAHA Divino® Common Name: Hearing Aid, Bone Conduction Classification Status: Class II per regulations 21 CFR & 874.3300 Product Codes: LXB

2. Equivalent devices

Entific Medical Systems believes that the BAHA Divino has substantially equivalent technology as air conduction hearing aids with digital sound processing (exempt from 510(k)) and, regarding intended use, function and fitting procedure, is equivalent to previous models of BAHA cleared in 510(k) K955713, K984162, K011438 and K021837.

3. Description of the Device

The BAHA Divino is a bone conduction-type hearing aid. Unlike conventional hearing aids, which depend on acoustic coupling through the air, the Divino is based on a bone conduction technology.

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4. Intended use

The BAHA Divino is intended for the following patients and indications:

Patients who have a conductive or mixed hearing loss and can still benefit from sound amplification. The pure tone average bone conduction threshold should be better than or equal to 45 dB HL (measured at 0.5, 1, 2 and 3 kHz)
Bilateral fitting of the Divino is intended for patients who suffer from moderate to severe bilateral symmetric conductive and/or mixed hearing losses. Symmetric bone conductive thresholds are defined as less than 10 dB in average (measured at 0.5, 1, 2 and 4 kHz) or less than 15 dB at individual frequencies
The single sided deafness (SSD) indication for the Divino hearing aid is intended for patients who suffer from unilateral sensorineural deafness on one ear while the other ear has normal hearing. Normal hearing is defined as PTA AC threshold equal to or better than 20dB measured at 0.5, 1, 2 and 3 kHz

BAHA for SSD is also indicated for patients who are indicated for an AC CROS but who for some reason cannot or will not use an AC CROS.

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న్. Technological characteristics, comparison to predicate device.

Comparison table

Characteristic	BAHA -BranemarkBone AnchoredHearing aid	Air conductionHearing Aids withdigital soundprocessing	BAHA Divino
Material	Implant: TitaniumAbutment Snap:PEEK	Multiple	Same as BAHA
Intended use	Improvement ofhearing for patientswith conductive andmixed hearing losses,bilateral fitting andsingle sided deafness	Improvement ofhearing	Same as BAHA
Powerrequirement	Zinc-air	N/A	Same as BAHA
Max gain	33dB	N/A	Same as BAHA
Frequencyresponse	125 Hz - 8 KHz	N/A	Same as BAHA
Soundprocessing	Analogue	Digital	Digital
Manufacturer	Entific MedicalSystems	N/A	Entific MedicalSystems
K-number	K955713, K984162,K011438 andK021837	Exempt	Pending

6. Discussion of testing

Testing of the BAHA Divino included software validation and functional testing. These tests verify that the Divino is functionally equivalent to the BAHA.

7. Conclusion

It is the conclusion of Entific Medical Systems that the BAHA Divino with digital sound processing is substantially equivalent to devices already on the market, both cleared by and exempt from the 510(k) process, and presents no new concerns about safety and effectiveness.

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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three stripes forming its wing and body. The eagle is positioned to the right of the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA", which is arranged in a circular fashion around the left side of the logo.

Public Health Service

Food and Drug Administration Rockville MD 20857

AUG 2 6 2004

Entific Medical Systems c/o/ Ms. Constance Bundy C.G. Bundy Associates, Inc. 6740 Riverview Terrace Minneapolis, MN 55432

Re: K042017

Trade/Device Name: BAHA Divino® Regulation Number: 21 CFR 874.3300 Regulation Name: Bone Conduction Hearing Aid Regulatory Class: Class II Product Code: LXB Dated: July 26, 2004 Received: July 27, 2004

Dear Ms. Bundy:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

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); 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 531-542 of the Act); 21 CFR 1000-1050.

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Page 2 - Ms. Constance Bundy

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (301) 594-4613. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

A kalgi korenthal

A. Ralph Rosenthal, M.D. Director Division of Ophthalmic and Ear, Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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B. INDICATIONS FOR USE

Koy 2017 510(k) Number

Device Name: BAHA Divino®

Indications for Use:

The BAHA Divino is intended for the following patients and indications:

Patients who have a conductive or mixed hearing loss and can still benefit from sound amplification. The pure tone average bone conduction threshold should be better than or equal to 45 dB HL (measured at 0.5, 1, 2 and 3 kHz)
Bilateral fitting of the Divino is intended for patients who suffer from moderate to severe bilateral symmetric conductive and/or mixed hearing losses. Symmetric bone conductive thresholds are defined as less than 10 dB in average (measured at 0.5, 1, 2 and 4 kHz) or less than 15 dB at individual frequencies
The single sided deafness (SSD) indication for the Divino hearing aid is intended for patients who suffer from unilateral sensorineural deafness on one ear while the other ear has normal hearing. Normal hearing is defined as PTA AC threshold equal to or better than 20dB measured at 0.5, 1, 2 and 3 kHz

BAHA for SSD is also indicated for patients who are indicated for an AC CROS but who for some reason cannot or will not use an AC CROS.

(Please do not write below this line - continue on another page if needed)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per 21 CFR 801.109)

Over the Counter Use -------

Kaiser Schlin

510(k) Number K042017

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.