The FS Ergo sensor is a digital sensor which is indicated for acquiring dental intra-oral radiography images. The FS Ergo sensor shall be operated by healthcare professionals, who are educated and competent to perform the acquisition of dental intraoral radiographs.

Device Description

The FS Ergo is a USB-driven sensor designed to capture intraoral digital dental x-ray images. FS Ergo can be used with any X-ray units intended for dental intraoral purposes. When connected to a computer with an appropriate image capturing software application, images are automatically acquired when the FS Ergo sensor receives a perceptible X-ray dose. The FS Ergo sensor is designed with advanced ergonomic principles. It has a bendable sensor housing together with other physical features supporting advanced erqonomics: small diameter flexible cable, 32 degrees' cable exit and sensor dimensions that fit all needs (size 1.5). Comfort is achieved in with large corner chamfers, rounded edges, and thicker sensor structure. The basic system of the FS Ergo consists of senor unit, sensor holders and hygienic covers (which are medical devices separately cleared by the FDA). A connection to a computer is required but the computer is provided by the users e.q. the computer is not part of the sensor system itself.

AI/ML Overview

The provided text is a 510(k) summary for the FS Ergo dental intraoral sensor. It describes the device, its indications for use, and how it demonstrates substantial equivalence to predicate devices. However, it does not contain detailed information about specific acceptance criteria for algorithm performance, sample sizes for test sets (beyond general bench testing), or the methodologies typically associated with assessing the performance of AI/ML-driven medical devices (like MRMC studies, ground truth establishment methods for large datasets, or detailed expert adjudication processes).

The document is for an X-ray sensor device (hardware and associated image acquisition), not an AI/ML algorithm that interprets images or provides diagnostic assistance. Therefore, many of the questions asked in the prompt (related to AI acceptance criteria, training sets, test sets, ground truth, expert review for AI, etc.) are not directly applicable to this specific device submission as described.

The device's performance is primarily assessed through bench testing for image quality and other physical/electrical characteristics, and compliance with relevant safety and performance standards. The "study" proving the device meets criteria is primarily these non-clinical performance data and bench tests.

Here's an attempt to answer the questions based solely on the provided text, highlighting where the information is not present or not applicable:

Acceptance Criteria and Device Performance for FS Ergo (based on K173646)

This submission focuses on the substantial equivalence of a digital intraoral X-ray sensor (hardware) and its ability to acquire images, rather than the performance of an AI model analyzing these images. Therefore, the "acceptance criteria" discussed are largely related to image quality, electrical safety, mechanical integrity, and biocompatibility to demonstrate equivalence to a predicate device.

1. A table of acceptance criteria and the reported device performance

The document does not provide a specific table of quantitative acceptance criteria for image quality or a direct "reported performance" against those criteria in a tabular format. Instead, it states:

Bench Test Images: "Bench test images of skull phantoms were acquired using FS Ergo sensor, the images were reviewed by qualified external clinician to be of acceptable quality for the proposed intended use."
Bench Testing Results: "Bench testing results indicate substantial equivalence to the predicate device Snapshot."
Standards Compliance: The device successfully passed testing according to various IEC standards (electrical, mechanical, safety, usability, EMC). Biocompatibility was also confirmed.

Inferred "Acceptance" for Image Quality (Qualitative based on text):

Acceptance Criteria Category	Reported Device Performance (as stated in document)
Image Quality	"acceptable quality for the proposed intended use" (based on skull phantom images reviewed by a qualified external clinician)
Equivalence to Predicate	"substantial equivalence to the predicate device Snapshot" (based on bench testing results)
Safety & Performance	Passed all tests according to IEC 60601-1:2005, IEC 60601-1-6:2013, IEC 62366:2014, IEC 62304:2006, IEC 60601-1-2:2014. Biocompatibility conforms to ISO 10993-1:2009.

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

Sample Size: Not explicitly stated for specific image quality tests. The mention of "skull phantoms" implies a limited, controlled setup rather than a large clinical test set of patient images.
Data Provenance: Not specified. "Bench test images of skull phantoms" suggests a laboratory controlled environment, not clinical patient data from a specific country.
Retrospective/Prospective: Not applicable in the context of bench testing phantoms.

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

Number of Experts: "qualified external clinician" (singular, or implies a group but only states "clinician"). The number of experts is not specified if it was more than one.
Qualifications of Experts: "qualified external clinician." No specific details on years of experience, subspecialty, or board certification are provided beyond "qualified."
Ground Truth Establishment: For this type of device (an image acquisition sensor), the "ground truth" for image quality is typically visual assessment of clarity, contrast, resolution (e.g., ability to discern features), and absence of artifacts by a qualified radiologist or dental professional, often compared to images from established devices. The document implies a qualitative assessment rather than a quantitative ground truth for diagnostic accuracy, as this is a device for image acquisition, not diagnosis.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Adjudication Method: Not specified. Given the qualitative statement about "acceptable quality" from a "qualified external clinician," a formal adjudication process for discordant reads (like 2+1 or 3+1) is not described or implied for this type of image quality assessment. It's likely a direct expert review for the purpose of validating image quality from the phantom.

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

MRMC Study: No, an MRMC comparative effectiveness study was not done. This type of study (often used for AI-assisted diagnostic tools) is not relevant for an X-ray sensor device whose primary function is image acquisition.
Effect Size: Not applicable.

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

Standalone Performance: Not applicable. This device is an X-ray sensor and does not perform image interpretation or diagnosis independently; it generates images for human review. Therefore, there is no "algorithm only" performance to evaluate in the context of an AI.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

Type of Ground Truth: For the "bench test images of skull phantoms," the ground truth appears to be expert qualitative assessment of image quality (e.g., visual clarity, diagnostic utility for dental structures) compared to known characteristics of the phantom and reference images from predicate devices. It is not pathological, clinical outcome, or a broad expert consensus on patient cases.

8. The sample size for the training set

Training Set Sample Size: Not applicable. This is a hardware device (X-ray sensor), not a machine learning algorithm that requires a training set in the conventional sense.

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

Ground Truth for Training Set Establishment: Not applicable. As there is no training set for an AI/ML algorithm.

Summary

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December 19, 2017

Image /page/0/Picture/1 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

PaloDEx Group Oy % Anni Lundholm Regulatory Manager Nahkelantie 160 Tuusula 04300 FINLAND

Re: K173646

Trade/Device Name: FS Ergo Regulation Number: 21 CFR 872.1800 Regulation Name: Extraoral source x-ray system Regulatory Class: II Product Code: MUH Dated: November 10, 2017 Received: November 27, 2017

Dear Anni Lundholm:

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

U.S. Food & Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993 www.fda.qov

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Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn

(http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Robert Oolo

Robert Ochs, Ph.D. Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health

Enclosure

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Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.

510(k) Number (if known)

K173646

Device Name FS Ergo

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)

Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

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December 19, 2017

510(k) SUMMARY for FS Ergo

Submitter Information

Name:	Palodex Group Oy
Address:	Nahkelantie 160FI-04300 TuusulaFinland
Contact Person:	Anni Lundholm
Email:	regulatory@kavokerr.com
Telephone Number:	+358 10 270 2000
Fax Number:	+358 10 270 2230

Device Name

Proprietary Name: FS Ergo Common Name: Digital intraoral sensor system Classification Name: System, X-Ray, Extraoral source, Digital FDA CDRH Panel: Radiology Product Code: MUH Requlation Number: 21 CFR 872.1800 Device Class: Class 11

Primary Predicate Device

Proprietary Name:	Snapshot
510(k) Number:	K081925
Manufacturer:	Instrumentarium Dental, PaloDEX Group Oy
Regulation Number:	21 CFR 872.1800
Regulation Name:	Extraoral source x-ray system
Product Code:	MUH
Device Class:	II

Reference Predicate Device

Proprietary Name:	EzSensor Soft (EzSensor Soft, EzSensor Soft i, EzSensor Bio and EzSensor Bio I)
510(k) Number:	K151707
Manufacturer:	Rayence Co., Ltd.
Regulation Number:	21 CFR 872.1800
Regulation Name:	Extraoral source x-ray system
Product Code:	MUH
Device Class:	II

Description of the Device

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features supporting advanced erqonomics: small diameter flexible cable, 32 degrees' cable exit and sensor dimensions that fit all needs (size 1.5). Comfort is achieved in with large corner chamfers, rounded edges, and thicker sensor structure.

The basic system of the FS Ergo consists of senor unit, sensor holders and hygienic covers (which are medical devices separately cleared by the FDA). A connection to a computer is required but the computer is provided by the users e.q. the computer is not part of the sensor system itself.

Indications for Use

Description of Substantial Equivalence

The substantial equivalence of the FS Ergo is demonstrated by two predicate devices: primary predicate device Snapshot cleared under K081925 and manufactured by Instrumentarium Dental, Palodex Group Oy and secondary predicate device EzSensor Soft cleared under K151707 and manufactured by Rayence Co., Ltd. Indications for use of the FS Erqo and the predicate devices Snapshot (K081925) and EzSensor Soft (K151707) are not identical but they include the same fundamental elements of producing x-ray radiography images for professional use.

Snapshot (K081925) is the primary predicate device since its technological characteristics is most similar to the FS Ergo. EzSensor Soft (K151707) is the secondary predicate device since its structure (sensor head) is soft like the FS Ergo. EzSensor Soft is not, however, available for technical testing and image quality comparison.

Technical characteristics of the FS Ergo sensor and the predicate devices Snapshot cleared under K081925 and EzSensor Soft cleared under K151707 are described in the table 7-1 below.

Characteristics	Primary Predicate DeviceSnapshot(K081925)	Secondary Predicate DeviceEzSensor Soft(K151707)	Subject DeviceFS Ergo
Indications for Use	Snapshot isintended to be usedby dentists andother qualifiedprofessional forproducing diagnosticx-ray radiographs ofdefinition, jaws andother oralstructures.	EzSensor Soft,EzSensor Soft i,EzSensor Bio andEzSensor Bio iDigital Dental IntraOral Sensors areintended to collectdental x-rayphotons and convertthem into electronic	The FS Ergo sensoris a digital sensorwhich is indicatedfor acquiring dentalintra-oralradiography images.The FS Ergo sensorshall be operated byhealthcareprofessionals, who

Table 7-1. Significant characteristics comparison table.

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Characteristics	Primary PredicateDeviceSnapshot(K081925)	SecondaryPredicate DeviceEzSensor Soft(K151707)	Subject DeviceFS Ergo
		impulses that maybe stored, viewedand manipulated fordiagnostic use bydentists.	are educated andcompetent toperform theacquisition of dentalintraoralradiographs.
Sensor type	Intra-oral	Intra-oral	Intra-oral
SensorDimensions(mm)	Size 1: 37 x 26Size 2: 42 x 31	Size 1.0: 38 x 27Size 1.5: 41 x 31Size 2.0: 44 x 33	Size 1.5: 40 x 30
SensorThickness (mm)	12	5.5	8.5
Sensor Shape	Rectangular, fourrounded corners	Rectangular, fourrounded corners	Rectangular, fourrounded corners
Resolution –Pixel Size ( μm)	19 x 19	14.8 x 14.8	17 x 17
TheoreticalResolution	26.3 lp/mm	33.78 lp/mm	29.4 lp/mm
Sensor ActiveArea (mm)	Size 1: 30 x 20Size 2: 36 x 26	Size 1.0: 30 x 20Size 1.5: 33 x 24Size 2.0: 36 x 26	Size 1.5: 32 x 25
Sensor Housing	Rigid, polyamide(PA)	Soft, silicone withurethane coating	Soft, silicone withurethane coating
Connection toPC	USB 2.0	USB 2.0	USB 2.0
Electrical Rating	5 Vdc / 500 mA	5 Vdc / 500 mA	5 Vdc / 500 mA
IP Classification	Sensor: IP67	Sensor: IP68	Sensor: IP68
Mode ofOperation	Continuous mode	Continuous mode	Continuous mode
Electrical Safety	IEC 60601-1:1998	IEC 60601-1:2015	IEC 60601-1:2015

Principle of Operation

The FS Ergo sensor is automatically powered when connected to the USB port on a workstation. No power switch is needed. User activates image capturing from an image capturing software installed on the connected workstation. The sensor detects x-ray exposure automatically and transfers the image to the software without additional user interaction. The FS Ergo can be used with any x-ray units intended for dental intraoral purposes in the range of 60 to 70 kV and at minimal 40 µGy incident dose.

After transmitting the image, the sensor is ready for the next exposure. A full mouth s series of image can be easily captured by sequentially activating the sensor from the software application. Image capture session can be terminated from the software application.

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Non-Clinical Performance Data

The FS Ergo sensor has successfully passed internal design verification and validation.

Electrical, mechanical, safety and performance testing according to standards IEC 60601-1:2005, IEC 60601-1-6:2013, IEC 62366:2014 and IEC 62304:2006 were performed, and EMC testing was conducted in accordance with standard IEC 60601-1-2:2014. Testing was completed by 3rd party test house, and the FS Ergo sensor has passed all tests.

Biocompatibility evaluation was conducted on patient contacting accessory parts and the materials. The parts are found to be in conformance with ISO 10993-1:2009.

Bench test images of skull phantoms were acquired using FS Ergo sensor, the images were reviewed by qualified external clinician to be of acceptable quality for the proposed intended use. Bench testing for the FS Ergo sensor was performed as recommended by the FDA's Guidance for the Submission of 510(k)s for Solid State X-Ray Imaging Devices. Bench testing results indicate substantial equivalence to the predicate device Snapshot.

Clinical Performance Data

Clinical data was not needed to support substantial equivalence.

Conclusion as to Substantial Equivalence

Based on the substantial equivalence comparison of intended use, design, technological characteristics, performance, labeling, biocompatibility, standards, and other characteristics, there are no significant differences found between the FS Ergo and the predicate devices Snapshot (cleared under K081925) and EzSensor Soft (cleared under K151707). Minor differences have not been shown to raise new concerns for the proposed indications for use.

The device does not introduce a fundamentally new scientific technology and the nonclinical tests demonstrate that the device is substantially equivalent to the predicate device. All internal verification and validation has been completed successfully.

In summary, FS Ergo sensor described in this submission is substantially equivalent to the Snapshot (cleared under K081925) and the EzSensor Soft (cleared under K151707) and satisfies all criteria of substantial equivalence.

Regulation Number and Section

§ 872.1800 Extraoral source x-ray system.

(a)
Identification. An extraoral source x-ray system is an AC-powered device that produces x-rays and is intended for dental radiographic examination and diagnosis of diseases of the teeth, jaw, and oral structures. The x-ray source (a tube) is located outside the mouth. This generic type of device may include patient and equipment supports and component parts.(b)
Classification. Class II.