The BelSensor GOLD is a USB-driven digital sensor which is intended to acquire dental intra-oral radiology images. The BelSensor GOLD shall be operated by healthcare professionals, who are educated and competent to perform the acquisition of dental intra-oral radiographs. The BelSensor GOLD can be used either in combination with special positioning devices to facilitate positioning and alignment with the x-ray beam or it may also be positioned by hand with the assistance of a patient.

Device Description

The BelSensor GOLD is an indirect converting x-ray detector that converts incident xrays by a scintilator into visable light, which is coupled optically to a light detection imager based on CMOS technology. Incident x-rays are automatically detected to generate digital images for dental intra-oral applications.

The BelSensor GOLD supports USB 2.0 connectivity to personal computer.

AI/ML Overview

Here's an analysis of the provided text regarding the acceptance criteria and study for the BelSensor GOLD:

The provided document describes a 510(k) summary for the BelSensor GOLD, a digital X-ray sensor for dental intra-oral applications. It is crucial to note that this document is a 510(k) summary for premarket notification, which focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than presenting a standalone clinical study with detailed performance metrics against specific acceptance criteria.

Therefore, much of the requested information about acceptance criteria, specific performance metrics, sample sizes, ground truth establishment, expert qualifications, and MRMC studies is not explicitly present in this type of regulatory submission summary. The demonstration of safety and effectiveness relies on comparison to a predicate device and adherence to relevant standards.

Let's break down what can be extracted and what is missing:

1. Table of Acceptance Criteria and Reported Device Performance

Based on the provided text, specific numerical acceptance criteria (e.g., minimum sensitivity, spatial resolution targets) and their corresponding measured performance values are NOT explicitly stated in this 510(k) summary.

The primary "performance" discussed is in comparison to the predicate device in terms of technological characteristics.

Characteristic	Acceptance Criterion (Implicitly, to be equivalent/similar to predicate)	Reported Device Performance (BelSensor GOLD)
Intended Use	Acquire dental intra-oral radiology images, operated by healthcare professionals, can use positioning devices or be handheld.	Same as predicate
Technology	CMOS	CMOS
Interface with PC	USB	USB
Dynamic Range	Similar or better than predicate (16,384:1)	15,000:1 (Slightly lower than predicate, but within typical ranges for such devices and likely considered acceptable for substantial equivalence)
Sensor Cable Length	Similar or better than predicate (2.8m)	3m (Slightly longer, which is generally a practical improvement)
Sensor Size	No direct criterion, but various sizes offered by predicate	30 x 20 mm, 36 x 26 mm (Predicate has 30 x 39 mm, implying multiple sizes are acceptable)
Number of Sensors	Not applicable as a direct performance metric; design choice	2 (Predicate has 1)
Safety	Adherence to IEC 60601-1 (2005)	Performed and compliant
EMC	Adherence to IEC 60601-1: 1988 + A1: 1991 + A2:1995, IEC 60601-1:2005, EN 60601-1: 2006, EN 60601-1-2: 2007	Performed and compliant
Biocompatibility	Adherence to USP testing guidelines	Performed and compliant

Missing: Specific quantitative performance metrics like spatial resolution (lp/mm), signal-to-noise ratio (SNR), contrast-to-noise ratio (CNR), DQE (Detective Quantum Efficiency), exposure latitude, etc., that would typically be associated with acceptance criteria for image quality.

2. Sample Size Used for the Test Set and Data Provenance

Not explicitly stated for a clinical performance test set. The document primarily relies on non-clinical testing (electrical, mechanical, environmental safety, EMC, biocompatibility) and comparison to a predicate device. If human imaging tests were performed, the details are not provided in this summary.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications

Not applicable/Not stated. This summary does not describe a clinical study where expert ground truth establishment would be required. The evaluation focuses on technical equivalence and compliance with standards.

4. Adjudication Method for the Test Set

Not applicable/Not stated. No clinical adjudication process is mentioned.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No, an MRMC comparative effectiveness study is not mentioned or described. This type of study is more common for diagnostic AI devices and involves evaluating how human performance changes with or without AI assistance. This device is an imaging sensor, not an AI diagnostic tool.

6. Standalone (Algorithm Only) Performance Study

Not applicable. The BelSensor GOLD is an imaging sensor (hardware), not an algorithm or software-only device. Therefore, a "standalone" algorithm performance study is not relevant in this context. The standalone performance would be its physical performance characteristics, which are implicitly covered by the technical comparisons and standards compliance.

7. Type of Ground Truth Used

Not explicitly stated in terms of a clinical ground truth. For non-clinical testing, the "ground truth" would be the specifications of the tests and standards (e.g., a specific electrical property should measure within a certain range, or a material should not cause a toxic reaction).

8. Sample Size for the Training Set

Not applicable. The BelSensor GOLD is a hardware imaging sensor. It does not utilize machine learning or AI algorithms that require a "training set" in the conventional sense.

9. How the Ground Truth for the Training Set Was Established

Not applicable. As above, there is no "training set" for this device.

Summary of Device Evaluation in the 510(k) Filing:

The safety and effectiveness of the BelSensor GOLD are primarily established through:

Substantial Equivalence: Direct comparison of its intended use and technological characteristics to a legally marketed predicate device (Dexis Sensor K090458).
Adherence to Standards: Compliance with recognized international standards for electrical, mechanical, environmental safety (IEC 60601-1 series), EMC (IEC 60601-1-2), and biocompatibility (USP testing guidelines).

The 510(k) process is less about presenting de novo clinical study data with specific acceptance criteria and more about demonstrating that a new device is as safe and effective as a previously cleared device.

Summary

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510(k) Summary

This summary of 510(k) safety and effectiveness is being submitted in accordance with the requirements of Safe Medical Devices Act of 1990 and 21 CFR 807.92.

The assigned 510(k) number is Kload S6

Submitter Information (21 CFR 807.92(a)(1))

Submitter:

ﻨﺎ ﺍﻟﻤﺴﺎﺣﺔ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟ

Takara Belmont USA, Inc.

Belmont Equipment Division

101 Belmont Drive

Somerset, NJ 08873-1204

Contact Person:	Robert Schiff
Telephone:	973-227-1830
Summary Date:	August 20, 2010

Device Name/Classification (21 CFR 807.92(a)(2))

Proprietary Name:	Intraoral BelSensor GOLD
Common/Usual Name:	Digital X-ray Sensor
Classification Name:	Class II Extraoral source x-ray system, per 21 CFR § 872.1800
Classification Code:	MUH

Substantially Equivalent/Predicate Devices (21 CFR 807.92(a)(3))

Predicate Device 1: Dexis Sensor (K090458)

Device Description (21 CFR 807.92(a)(4))

The BelSensor GOLD supports USB 2.0 connectivity to personal computer.

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Device Intended Use (21 CFR 807.92(a){5))

Technological Characteristics (21 CFR 807.92(a)(6))

Comparison of the Principal Characteristics of the Belmont BelSensor and the DEXIS Sensor ·

DescriptiveInformation	Belmont BelSensor GOLD	Dexis Sensor(K090458)
Indication for Use	The BelSensor GOLD is a USB-driven digital sensor which isintended to acquire dental intra-oral radiology images. TheBelSensor GOLD shall beoperated by healthcareprofessionals, who are educatedand competent to perform theacquisition of dental intra-oralradiographs. The BelSensorGOLD can be used either incombination with specialpositioning devices to facilitatepositioning and alignment with thex-ray beam or it may also bepositioned by hand with theassistance of a patient.	The DEXIS sensor is a USB-drivendigital sensor which is intended toacquire dental intra-oral radiologyimages. The DEXIS sensor shallbe operated by healthcareprofessionals, who are educatedand competent to perform theacquisition of dental intra-oralradiographs. The DEXIS sensorcan be used either in combinationwith special positioning devices tofacilitate positioning and alignmentwith the x-ray beam or it may alsobe positioned by hand with theassistance of a patient.
Number ofSensors	2	1
Sensor Size (mm)	30 x 2036 x 26	30 x 39
Technology	CMOS	CMOS
Interface with PC	USB	USB
Dynamic Range	15,000:1	16,384:1
Sensor CableLength (m)	3	2.8

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Safety, EMC, Biocompatability and Performance Data

Electrical, mechanical, environmental safety and performance testing according to IEC 60601-1 (2005) was performed, and EMC testing was conducted in accordance with standard IEC 60601-1: 1988 + A1: 1991 + A2:1995, IEC 60601-1:2005 (without 60601-1-6), EN 60601-1: 2006, (without 60601-1-6), EN 60601-1-2: 2007.

Biocompatability for the cable and housing material was conducted under USP testing guidelines. Detailed information can be found in Attachment 7.

Conclusion: The Belmont BelSensor GOLD is substantially equivalent to other legally marketed devices in the United States. The Belmont BelSensor GOLD is substantially equivalent in intended use and technical characteristics to the DEXIS Sensor marketed by Sybron Dental Specialties, Inc.

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Image /page/3/Picture/0 description: The image shows the seal of the Department of Health and Human Services (HHS) of the United States. The seal features a stylized caduceus, a symbol often associated with medicine and healthcare, with three lines forming the wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the caduceus.

DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

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

Takara Belmont USA. Inc. % Robert Schiff, Ph.D., RAC, COA, FRAPS President and CEO Schiff & Company 1129 Bloomfield Avenue WEST CALDWELL NJ 07006

DEC 1 5 2011

Re: K102456

Trade/Device Name: BelSensor GOLD Regulation Number: 21 CFR 872.1800 Regulation Name: Extraoral source x-ray system Regulatory Class: II Product Code: MUH Dated: November 10, 2011 Received: November 14, 2011

Dear Dr. Schiff:

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 class II (Special Controls), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. 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 Parts 801 and 809); medical device reporting (reporting of

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medical device-related adverse events) (21 CFR 803); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820). 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 Parts 801 and 809), please contact the Office of In Vitro Diagnostic Device Evaluation and Salety at (301) 796-5450. 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.

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/cdrh/industry/support/index.html.

Sincerely Yours,

Mary Pastel

Mary S. Pastel, Sc.D. Director Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

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ﻧﻢ - ----

・

INDICATIONS FOR USE STATEMENT

510(k) Number (if known):	Not assigned yet K102456
Device Name:	BelSensor GOLD

Indications for Use: The BelSensor GOLD is a USB-driven digital sensor which is intended to acquire dental intra-oral radiology images. The BelSensor GOLD shall be operated by healthcare professionals, who are educated and competent to perform the acquisition of dental intra-oral radiographs. The BelSensor GOLD can be used either in combination with special positioning devices to facilitate positioning and alignment with the x-ray beam or it may also be positioned by hand with the assistance of a patient.

Prescription Use	X	Over-The-Counter Use	_________________
(Per 21 CFR 801 Subpart D)		(21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off)

Division of Radiological Devices

Office of In Vitro Diagnostic Device Evaluation and Safety

510K: K102456

SUBMITTED BY SCHIFF & COMPANY, WEST CALDWELL, NJ

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.