The Lantos 3D Ear Scanner is intended for use by a trained hearing professional on patients 18 years of age and older presenting for inspection of the external ear canal.

The Lantos 3D Ear scanner:

. provides a magnified visual image for inspection of the external ear canal and tympanic membrane, and provides illumination of the ear canal for inspection and;
includes an expanding membrane that can be inserted and conforms to the external ear . canal when filled with an absorbing medium which enables the 3D scan and;
records and presents to the hearing professional in an image file a topology measurement . of the external ear canal

Device Description

The device consists of a hand held scanner, a single patient use disposable with a silicone conforming membrane, which when in use is filled with an absorbing medium, and a laptop computer. The hand held scanner, when not in use, is placed in a docking stand.

The hand held scanner is tethered to the docking stand with a custom cable. The laptop computer is mounted on the docking stand. The hand held scanner contains LED illumination, optics, a camera, a motor to move the probe tip, and a motor-driven reservoir.

User Interface (UI) software screens are displayed on the laptop and the user interacts with the device via the laptop keyboard and touchpad, and control buttons on the hand held scanner, as guided by the UI screens. Image data from the patient is stored in the laptop, and may be transmitted by the user via a wireless connection. No patient identifiable data is stored in the Lantos device.

A single use disposable, which includes the conforming membrane, is placed over the hand held scanner probe tip, in a manner similar to placing an ear speculum over the viewing tip of a conventional otoscope. The disposable includes a clear window over the probe tip. The probe can be used to inspect the ear canal, when inserted into the ear canal no closer than 4-5 mm from the tympanic membrane.

Additionally, the disposable can be filled with an absorbing medium so the membrane conforms to the ear, to enable the 3D scanning functionality of the device. After scanning is complete, the absorbing medium drains from the disposable so that the probe and disposable can be removed from the ear canal. The topographical measurement (scan) of the ear may be transmitted and may be used in the same manner as a desktop scan of a silicone earmold impression.

AI/ML Overview

The provided text describes the Lantos 3D Ear Scanner and its regulatory submission (K121326). However, the document does not contain explicit acceptance criteria or a dedicated study section detailing performance against such criteria for AI/algorithm-driven features.

Instead, the performance evaluation focuses on the accuracy and safety of the 3D scanning functionality and general device characteristics.

Here's an attempt to extract relevant information and note what is missing based on your request:

Acceptance Criteria and Study for the Lantos 3D Ear Scanner

The Lantos 3D Ear Scanner is primarily described as an imaging and 3D measurement device for the ear canal. The provided document focuses on its technological characteristics, safety, and substantial equivalence to a predicate otoscope. It does not present an AI algorithm performance against specific diagnostic acceptance criteria.

The closest information related to performance evaluation concerns the accuracy of its 3D measurement capability.

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Acceptance Criteria (If Stated)	Reported Device Performance
3D Topographical Measurement Accuracy	"required to have a mean difference between the model and the scan consistent with manufacturer's requirements for fabrication of devices inserted in the ear." (Quantitative values for "manufacturer's requirements" are not provided.)	"All scans were required to have a mean difference between the model and the scan consistent with manufacturer's requirements for fabrication of devices inserted in the ear." The method involved validating the output "using two known models (cylindrical and anatomical) with given values and obtaining multiple scans on each using multiple Scanner units." (Specific numerical results of the mean difference are not provided in this document.)
Photobiological Safety	Within ACGIH Threshold Limit Values for retinal thermal exposure, blue light exposure, actinic ultraviolet radiation, and near UV exposure. Risk Group 1 classification for blue-violet LED.	The Scanner falls within ACGIH Threshold Limit Values for retinal thermal exposure (within 10 seconds), blue light exposure (within 10,000 seconds), actinic ultraviolet radiation (within 8 hours), and near UV exposure. Evaluated according to ANSI/IESNA RP-27.3-2007, resulting in a "Risk Group 1" classification for the blue-violet LED. Exposure time limit for Risk Group 1 was 15 minutes of direct, continuous exposure without membrane.
Biocompatibility	Conformance to ISO 10993 Parts 1-13 as applicable.	The device "meets the following Recognized Performance Standards: ISO 10993 Parts 1-13 as applicable."
Electrical Safety & EMC	Conformance to IEC 60601-1, IEC 60601-1-2, IEC 60601-2-18.	The device "meets the following Recognized Performance Standards: IEC 60601-1, IEC 60601-1-2, IEC 60601-2-18."
Quality/Risk Management System	Conformance to ISO 14971.	The device "meets the following Recognized Performance Standards: ISO 14971."

2. Sample size used for the test set and the data provenance

Test Set (for 3D Measurement Accuracy): The document states validation was performed "using two known models (cylindrical and anatomical)" and "obtaining multiple scans on each using multiple Scanner units."
- Sample Size:
  - Number of models: 2 (cylindrical and anatomical)
  - Number of scanners: "multiple Scanner units" (specific number not given)
  - Number of scans per model/scanner: "multiple scans on each" (specific number not given)
- Data Provenance: Not applicable as it uses physical models rather than patient data. No country of origin is specified for these models or the testing activities. It is an internal validation rather than a retrospective or prospective patient study.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

For the 3D measurement accuracy, the ground truth was established by the "known models (cylindrical and anatomical) with given values." This implies a physical, engineered ground truth rather than expert assessment.
No experts were mentioned for establishing ground truth for the 3D measurement accuracy test.

4. Adjudication method for the test set

Not applicable as the ground truth was based on measurements from known physical models, not on human interpretation or consensus.

5. 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, an MRMC comparative effectiveness study was not done. The document describes a device for producing visual images and 3D topographical measurements, not an AI-assisted diagnostic tool that would improve human reader performance. Its core function is to provide data, not to interpret it in an AI-driven manner for a human.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

The document describes the performance of the "Lantos 3D Ear Scanner" system, which includes hardware (scanner, disposable, laptop) and software. The "3D scan" is a direct output of the device's optical and mechanical system.
While an algorithm processes the raw scan data to create the "topology measurement," this is presented as an inherent function of the device itself, not as an AI-driven standalone diagnostic algorithm whose performance needs to be assessed independently against human interpretation in a clinical context. The "algorithm" here is for data processing to generate the 3D model, not for diagnostic interpretation.
Therefore, a standalone AI diagnostic algorithm performance study, as typically understood for AI medical devices, was not performed, nor is it applicable to the description of this device's reported functionality.

7. The type of ground truth used

For the 3D topographical measurement, the ground truth was based on measurements from known physical models (cylindrical and anatomical models with given values).
For safety aspects (photobiological, electrical, biocompatibility), ground truth was established by recognized industry standards (e.g., ACGIH, ANSI/IESNA, ISO, IEC).

8. The sample size for the training set

The document does not mention a training set. This device, as described, generates a 3D digital model from optical scanning. It's not explicitly presented as an AI/machine learning model that learns from a dataset. The "ground truth" for its measurement accuracy is physical models, not a dataset it was trained on.

9. How the ground truth for the training set was established

Not applicable, as no training set for an AI/ML algorithm is mentioned.

Summary

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K121326

Image /page/0/Picture/1 description: The image shows the logo for Lantos Technologies. The logo consists of a circular graphic on the left and the company name on the right. The graphic is a black square with three white concentric circles inside. The text "LANTOS" is in large, bold, sans-serif letters above the text "TECHNOLOGIES", which is in smaller, sans-serif letters.

101 Main Street, Suite 1770 Cambridge, MA 02142 · +1.617.500.9800 www.lantostechnologies.com

6. 510K Summary

JAN 2 5 2013

Applicant:

Lantos Technologies 101 Main Street, Suite 1770 Cambridge, MA 02142, USA Tel: 1-617-500-9800

Date Prepared: January 17, 2013

Contact: Lora Allemeier

Device Identification:

Trade Name - Lantos 3D Ear Scanner Common Name - otoscope Classification Name - otoscope (21 CFR 874.4770, Product Code ERA) hearing aid, accessory (21 CFR 874.3300. Product Code ESD)

510(k) Numbers and Product Codes of equivalent devices:

Welch Allyn Video Otoscope (Skaneateles Falls, NY) Welch Allyn Otoscope; K943916 - SE 08/25/1994 Code: ERA: 874.7440

Device Description

A single use disposable, which includes the conforming membrane, is placed over the hand held scanner probe tip, in a manner similar to placing an ear

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speculum over the viewing tip of a conventional otoscope. The disposable includes a clear window over the probe tip. The probe can be used to inspect the ear canal, when inserted into the ear canal no closer than 4-5 mm from the tympanic membrane.

Indications for Use

The Lantos 3D Ear Scanner is intended for use bv a trained hearing professional on patients 18 years of age and older presenting for inspection of the external ear canal.

The Lantos 3D Ear scanner:

. provides a magnified visual image for inspection of the external ear canal and tympanic membrane, and provides illumination of the ear canal for inspection and;
. includes an expanding membrane that can be inserted and conforms to the external ear canal when filled with an absorbing medium which enables the 3D scan and;
. records and presents to the hearing professional in an image file a topology measurement of the external ear canal

Intended Use Population

The Lantos 3D Ear Scanner is indicated for use by trained hearing professionals on patients 18 years of age and older presenting for inspection of the external ear canal.

January 17, 2013 Proprietary ~ Page 2 of 4

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Technological Characteristics

The Lantos 3D Ear Scanner is not a change or modification to the predicate device that could significantly affect safety or effectiveness. In other words, there is no change in the intended use (otoscope and hearing aid accessory), design (hand-held with illuminating LED probe tip covered by silicone cover), materials (polymers and silicone), and power source that could raise new issues of safety or effectiveness.

The Lantos 3D Ear Scanner followed ACGIH American Conference of Governmental Industrial Hygienists Threshold Limit Values for chemical substances and physical agents and Biological Exposure Indices. 2011. For both intended use and reasonably foreseeable misuse, the Scanner falls within ACGIH Threshold Limit Values for retinal thermal exposure within 10 seconds, blue light exposure within 10000 seconds, actinic ultraviolet radiation within 8 hours of operation and near UV exposure. In addition, the illumination subsystem was evaluated according to ANSI/IESNA RP-27.3-2007 Recommended Practice for Photobiological Safety for Lamps-Risk Group Classification & Labeling to provide a photobiological hazard evaluation (including blue light hazard exposure limits). This evaluation resulted in a "Risk Group 1" classification for the blueviolet LED. The exposure time limit for Risk Group 1 was 15 minutes of direct, continuous exposure to the scanner tip without the membrane attached. Package labeling includes a caution: "Do not stare at the scanner tip, or direct scanner tip toward patient's face, while illumination is active. Staring at scanner tip for more than 15 minutes with no membrane attached under fault conditions may exceed photobiological exposure. May be harmful to the eves."

The output of the Lantos 3D Ear Scanner was validated using two known models (cylindrical and anatomical) with given values and obtaining multiple scans on each using multiple Scanner units. All scans were required to have a mean difference between the model and the scan consistent with manufacturer's requirements for fabrication of devices inserted in the ear.

Performance Standards

The Lantos 3D Ear Scanner meets the following Recognized Performance Standards:

ISO 10993 Parts 1-13 as applicable
January 17, 2013 Proprietary

Page 3 of 4

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IEC 60601-1 Medical Electrical Equipment Part 1: General requirements for basic safety and essential performance
IEC 60601-1-2 Medical Electrical Equipment Part 1-2 General requirements for basic safety and essential performance -Collateral standard: Electromagnetic Compatibility - Requirements and Tests
· IEC 60601-2-18 Medical electrical equipment Part 2-18: Particular requirements for the basic safety and essential performance of endoscopic equipment
ISO 14971: Medical devices—Application of risk management to medical devices

Conclusion

Based on the comparison of the technological characteristics (including the intended use) and verification tests of the Lantos 3D Ear Scanner, there are no significant new issues of safety and effectiveness that are raised when compared to the predicate device. The Lantos 3D Ear Scanner provides for inspection of the ear canal comparable to the predicate otoscope device and also allows for ear canal measurements, which may be used for the manufacture of hearing devices.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three wavy lines representing the department's mission of promoting health, well-being, and human services. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the eagle symbol. The logo is black and white.

January 25, 2013

Public Health Service

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

Lantos Technologies % Mr. John Greenbaum Generic Devices Consulting, Inc. 20310 SW 48th Street Southwest Ranches, FL 33332

Re: K121326

Trade/Device Name: Lantos 3D Ear Scanner Regulation Number: 21 CFR 874.4770 Regulation Name: Otoscope Regulatory Class: Class I Product Code: ERA, ESD Dated: December 18, 2012 Received: December 19, 2012

Dear Mr. Greenbaum:

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA). it may be subject to 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); medical device reporting (reporting of medical

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Page 2 - Mr. John Greenbaum

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 531-542 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/CDRH0ffices/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.

Sincerely yours,

Eric A. Mann for

Malvina B. Eydelman, 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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INDICATIONS FOR USE

K121326 510(k) Number (If Known):

Device Name: Lantos 3D Ear Scanner

Indications for Use:

The Lantos 3D Ear Scanner is intended for use by a trained hearing professional on patients 18 years of age and older presenting for inspection of the external ear canal.

The Lantos 3D Ear scanner:

. provides a magnified visual image for inspection of the external ear canal and tympanic membrane, and provides illumination of the ear canal for inspection and;
includes an expanding membrane that can be inserted and conforms to the external ear . canal when filled with an absorbing medium which enables the 3D scan and;
records and presents to the hearing professional in an image file a topology measurement . of the external ear canal

Prescription Use _ X

AND/OR

Over-the Counter Use

(Part 21 CFR 801 Subpart D)

(21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off)
Division of Ophthalmic and Ear, Nose and Throat Devices
510(k) Number	K121326

Regulation Number and Section

§ 874.4770 Otoscope.

(a)
Identification. An otoscope is a device intended to allow inspection of the external ear canal and tympanic membrane under magnification. The device provides illumination of the ear canal for observation by using an AC- or battery-powered light source and an optical magnifying system.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 874.9 only when used in the external ear canal.