Predicate Devices

Reference Devices

AI/ML (Artificial Intelligence / Machine Learning)

No
The description focuses on independent dose and MU calculation algorithms, which are traditional physics-based methods, and there is no mention of AI, ML, or related concepts in the summary.

Therapeutic

No.
The device is described as software to assist radiation treatment planners in verifying calculations, not for direct diagnosis, treatment, or prevention of disease.

Diagnostic

No

The device is described as software that performs dose and/or monitor unit (MU) calculations to verify the accuracy of treatment planning calculations. It does not diagnose medical conditions.

SaMD (Software as a Medical Device)

Yes

The device description explicitly states that the ClearCalc Model RADCA V2 device is "software that uses treatment data, image data, and structure set data obtained from supported Treatment Planning System and Application Programming interfaces". There is no mention of any accompanying hardware component being part of the device itself.

IVD (In Vitro Diagnostic)

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
ClearCalc's Function: ClearCalc is described as software that performs dose and monitor unit calculations based on treatment planning parameters, image data (CT), and structure set data. Its purpose is to verify the accuracy of radiation treatment planning calculations.
Lack of Biological Sample Analysis: The description does not mention any analysis of biological samples from a patient. The inputs are related to the treatment plan and patient anatomy derived from imaging, not biological specimens.

Therefore, ClearCalc falls under the category of medical device software used in radiation oncology for treatment planning verification, not as an in vitro diagnostic device.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

ClearCalc is intended to assist radiation treatment planners in determining if their treatment planning calculations are accurate using an independent Monitor Unit (MU) and dose calculation algorithm.

Product codes

MUJ

Device Description

The ClearCalc Model RADCA V2 device is software that uses treatment data, image data, and structure set data obtained from supported Treatment Planning System and Application Programming interfaces to perform a dose and/or monitor unit (MU) calculation on the incoming treatment planning parameters. It is designed to assist radiation treatment planners in determining if their treatment planning calculations are accurate using an independent Monitor Unit (MU) and dose calculation algorithm.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

CT

Anatomical Site

Not Found

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Trained radiation oncology personnel

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies

Verification tests were performed to ensure that the software works as intended and pass/fail criteria were used to verify requirements. Validation testing was performed to ensure that the software was behaving as intended, and results from ClearCalc were validated against accepted results for known planning parameters from clinically-utilized treatment planning systems. All passing criteria for ClearCalc's primary dose calculation algorithms (FSPB for photon plans, TG-71 for electron plans, and TG-43 for brachytherapy plans) remain consistent with the Predicate Device. Passing criteria for monte carlo calculations was a gamma analysis passing rate of >93% with +/-3% relative dose agreement and 3mm distance to agreement (DTA). The verification and validation testing passed in all test cases.

Key Metrics

gamma analysis passing rate of >93% with +/-3% relative dose agreement and 3mm distance to agreement (DTA)

Predicate Device(s)

K193640

Reference Device(s)

K193381, K201798

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

Regulation Number and Section

§ 892.5050 Medical charged-particle radiation therapy system.

(a)
Identification. A medical charged-particle radiation therapy system is a device that produces by acceleration high energy charged particles (e.g., electrons and protons) intended for use in radiation therapy. This generic type of device may include signal analysis and display equipment, patient and equipment supports, treatment planning computer programs, component parts, and accessories.(b)
Classification. Class II. When intended for use as a quality control system, the film dosimetry system (film scanning system) included as an accessory to the device described in paragraph (a) of this section, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.

Summary

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Image /page/0/Picture/0 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, with the words "U.S. FOOD & DRUG" on one line and "ADMINISTRATION" on the line below. The FDA logo is in blue.

Radformation, Inc. % Kurt Sysock Co-founder/CEO 335 Madison Avenue, 4th floor NEW YORK NY 10017

Re: K220582

Trade/Device Name: ClearCalc Model RADCA V2 Regulation Number: 21 CFR 892.5050 Regulation Name: Medical charged-particle radiation therapy system Regulatory Class: Class II Product Code: MUJ Dated: July 18, 2022 Received: July 21, 2022

Dear Kurt Sysock:

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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see

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https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

for

Julie Sullivan, Ph.D. Assistant Director DHT8C: Division of Radiological Imaging and Radiation Therapy Devices OHT8: Office of Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known)

K220582

Device Name ClearCalc Model RADCA V2

Indications for Use (Describe)

ClearCalc is intended to assist radiation treatment planners in determining if their treatment planning calculations are accurate using an independent Monitor Unit (MU) and dose calculation algorithm.

Type of Use (Select one or both, as applicable)X Prescription Use (Part 21 CFR 801 Subpart D)

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

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This 510(k) Summary has been created per the requirements of the Safe Medical Device Act (SMDA) of 1990, and the content is provided in conformance with 21 CFR Part 807.92.

Table 1 : Submitter's Information
Submitter's Name:	Kurt Sysock
Company:	Radformation, Inc.
Address:	335 Madison Avenue, 16th Floor
New York, NY 10017
Contact Person:	Alan Nelson
Chief Science Officer, Radformation
Phone:	518-888-5727
Fax:	--------
Email:	anelson@radformation.com
Date of Summary Preparation	8/21/2022

5.1. Submitter's Information

5.2. Device Information

Table 2 : Device Information
Trade Name:	ClearCalc Model RADCA V2
Common Name:	Secondary Check Quality Assurance Software, Patient
Quality Assurance Software
Classification Name:	Class II
Classification:	Medical charged-particle radiation therapy system
Regulation Number:	892.5050
Product Code:	MUJ
Classification Panel:	Radiology

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5.3. Predicate Device and Reference Device Information

Primary Predicate Device

ClearCalc Model RADCA V2 (Subject Device) makes use of its prior submission - ClearCalc Model RADCA (K193640) - as the primary Predicate Device.

Reference Devices

With the additions included in the submission, ClearCalc Model RADCA V2 also makes use of RadCalc Version 7.1 (K193381) and myQA iON (K201798) as Reference Devices for the new functionality.

5.4. Device Description

The ClearCalc Model RADCA V2 device is software that uses treatment data, image data, and structure set data obtained from supported Treatment Planning System and Application Programming interfaces to perform a dose and/or monitor unit (MU) calculation on the incoming treatment planning parameters. It is designed to assist radiation treatment planners in determining if their treatment planning calculations are accurate using an independent Monitor Unit (MU) and dose calculation algorithm.

5.5. Indications for Use

ClearCalc is intended to assist radiation treatment planners in determining if their treatment planning calculations are accurate using an independent Monitor Unit (MU) and dose calculation algorithm.

5.6. Technological Characteristics

Predicate Device

ClearCalc Model RADCA V2 (Subject Device) makes use of its prior submission - ClearCalc Model RADCA (K193640) - as the Predicate Device. The functionality and technical components of this prior submission remain unchanged in ClearCalc Model RADCA V2. This submission is intended to build on the functionality and technological components of the 510(k) cleared ClearCalc Model RADCA.

Similar to the Predicate Device software, ClearCalc Model RADCA V2 is designed to run on Windows Operating Systems, performs dose and/or monitor unit (MU) calculations on the incoming supported treatment data, and displays the calculated results to the user. Supported Treatment Planning System and Application Programming Interfaces are used by trained, clinically-qualified radiation oncology personnel to simulate radiation therapy treatments for malignant or benign diseases. The intended user base has not changed from the Predicate Device. ClearCalc may call either its local calculation engine (the same finite-size pencil beam algorithm as with the Predicate Device) or now optionally call a monte carlo dose calculation engine to perform dose and/or MU calculations. Though the monte carlo dose calculation

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engine is new functionality, it serves the same purpose as the currently-implemented Finite-Size Pencil Beam (FSPB) algorithm and is launched from the local User Interface (UI). Additionally, this new algorithm is a monte carlo-based calculation, which is the "gold standard" for radiotherapy treatment planning and can improve the accuracy of the results provided by ClearCalc.

Additionally, new input files are being supported with the Subject Device, namely machine treatment log files and virtual source models. Machine log files record the precise machine parameter setting of linear accelerator deliveries during a set treatment delivery. These files record parameters similar to the treatment plan except they are recorded from a pre-treatment delivery at the machine instead of from a Treatment Planning System. Instead of using the treatment planning parameters, ClearCalc will use the delivered treatment parameters from the machine to re-calculate the dose from the given plan. Since the parameters in machine treatment log files are nearly identical to those captured in a treatment plan, this functionality does not raise any new questions in terms of safety and effectiveness compared to the predicate. The virtual source models are used by the monte carlo dose calculation engine to complete calculations and do not affect the current technological functionality when compared to the Predicate Device. Virtual source models are a different way to store pertinent beam data for dose calculation and originate from the beam data already stored in the Predicate Device. As such, they do not raise any new concerns regarding the safety or effectiveness of the Subject Device compared to the predicate.

Due to the technological characteristic similarities, the Subject Device raises no new concerns regarding safety and effectiveness compared to the predicate.

| Table 3: Substantial Equivalence ClearCalc Model RADCA V2 vs. Predicate Device and

Reference Devices
Parameters	Subject Device:
ClearCalc Model
RADCA V2	Predicate Device:
ClearCalc Model
RADCA	Reference Device:
RadCalc Version
7.1 (K193381)	Reference
Device:
myQA iON
(K201798)
Summarized
Indications
for use	Intended to assist
radiation treatment
planners in
determining if their
treatment planning
calculations are
accurate using an
independent Monitor
Unit (MU) and dose
calculation algorithm.
(Equivalent)	Intended to assist
radiation treatment
planners in
determining if their
treatment planning
calculations are
accurate using an
independent
Monitor Unit (MU)
and dose
calculation
algorithm.	A means of
validating the
monitors units or
radiation dose to
points that have
been calculated by
the primary radiation
therapy planning
system for external
beam radiation
therapy and/or
brachytherapy
treatments. In
addition to this,	To perform patient
quality assurance
activities for
radiation therapy
treatment delivery
systems. myQA
iON is a software
toolbox allowing
the
Medical Physicist
to perform quality
assurance
activities before
and after the
			RadCalc Software
can also be used as
the primary means of
calculating monitor
units for external
beam radiation
treatments in
situations where the
physician does not
order the use of a
radiation therapy
plan. Users may also
send/receive results
from an eternal dose
calculation engine,
whereby the results
are displayed in
RadCalc for
evaluation.	patient treatment
fractions for all
patients
undergoing
radiation therapy.
Energy
Used and/or
Delivered	None - software-only
application. The
software application
does not deliver or
depend on energy
delivered to or from
patients.
(Substantially
equivalent)	None -
software-only
application. The
software
application does
not deliver or
depend on energy
delivered to or
from patients.	None - software only
application. The
software application
does not deliver or
depend on energy
delivered to or from
patients	None - software
only application.
The software
application does
not deliver or
depend on energy
delivered to or
from patients
Intended
users	Trained radiation
oncology personnel
(Substantially
equivalent)	Trained radiation
oncology
personnel	Trained radiation
oncology personnel	Trained radiation
oncology health
professionals
OTC/Rx	Rx (Substantially
equivalent)	Rx	Rx	Rx
Design:
Graphical
User
Interface	Contains a Data
Visualization /
Graphical User
Interface
(Substantially
Equivalent)	Contains a Data
Visualization /
Graphical User
Interface	Contains a Data
Visualization /
Graphical User
Interface	Contains a Data
Visualization /
Graphical User
Interface
Design:
Supported
files	Files/Treatment
Planning System
API-provided data
containing CT,
Structure Set, and
Treatment Plan
(including treatment
field parameters)
data as well as	Files/Treatment
Planning System
API-provided data
containing CT,
Structure Set, and
Treatment Plan
(including
treatment field
parameters) data	Files containing
Structure Set, and
Treatment Plan
(including treatment
field parameters)
data	Files containing
Structure Set, and
Treatment Plan
(including
treatment field
parameters) data
as well as machine
treatment log files
	machine treatment
log files
(Substantially
equivalent)
Design:
Reporting
and data
routing	Reporting built-in
and user has ability
to customize
(Substantially
equivalent)	Reporting built-in
and user has
ability to customize	Reporting built-in
and user has ability
to customize	Reporting built-in
and user has
ability to customize
Input	Files/Treatment
Planning System
API-provided data
containing CT,
Structure Set, and
Treatment Plan
(including treatment
field parameters)
data (Substantially
equivalent)	Files/Treatment
Planning System
API-provided data
containing CT,
Structure Set, and
Treatment Plan
(including
treatment field
parameters) data	Files containing
Structure Set, and
Treatment Plan
(including treatment
field parameters)
data	N/A
Functionality	Utilizes a Finite-Size
Pencil Beam (FSPB)
algorithm to calculate
MU/Dose on a
per-field
basis.ClearCalc
utilizes the full 3D
geometry of the
patient for
heterogeneity
corrections and
simulating the scatter
conditions of the
actual patient. Users
may also
send/receive data
from its monte carlo
dose calculation
engine (branded as
RadMonteCarlo),
whereby the results
are displayed in
ClearCalc for
evaluation.
(Substantially
equivalent)	Utilizes a
Finite-Size Pencil
Beam (FSPB)
algorithm to
calculate MU/Dose
on a per-field
basis.ClearCalc
utilizes the full 3D
geometry of the
patient for
heterogeneity
corrections and
simulating the
scatter conditions
of the actual
patient.	Utilizes a Clarkson
summation algorithm
to calculate
MU/Dose on a
per-field basis.
RadCalc utilizes a
consistent flat
phantom geometry
using radiological
equivalent depth for
heterogeneity
corrections and
includes modules
that allow the user to
indicate changes in
scatter conditions
(e.g. for breast
treatments). Users
may also
send/receive results
from an eternal dose
calculation engine,
whereby the results
are displayed in
RadCalc for
evaluation.	N/A
Output	ClearCalc calculates
the dose from fields	ClearCalc
calculates the	RadCalc calculates
the dose from fields	N/A
	in a plan and
displays results for
per-field MU and
provides a difference
metric for evaluation
in tabular format.
Users can also
evaluate global point
doses, as well as
per-field doses and,
when applicable, a
generated dose
volume histogram..
(Substantially
equivalent)	dose from fields in
a plan and
displays results for
per-field MU and
provides a
difference metric
for evaluation in
tabular format.
Users can also
evaluate global
point doses, as
well as per-field
doses.	in a plan and
displays results for
per-field MU and
provides a difference
metric for evaluation
in tabular format.
Users can also
evaluate global point
doses, as well as
per-field doses.
	ClearCalc vs. Predicate Devices Electron MU and Dose Calculation
Input	Files/Treatment
Planning System
API-provided data
containing CT,
Structure Set, and
Treatment Plan
(including treatment
field parameters)
data (Substantially
equivalent)	Files/Treatment
Planning System
API-provided data
containing CT,
Structure Set, and
Treatment Plan
(including
treatment field
parameters) data	Files containing
Treatment Plan
(including treatment
field parameters)
data	N/A
Functionality	Utilize a library of
custom cutouts and
computes cutout
factors using a
sector integration
method. Cutout
factors may also be
user-entered. Users
may also
send/receive results
from its monte carlo
dose calculation
engine (branded as
RadMonteCarlo),
whereby the results
are displayed in
ClearCalc for
evaluation.
(Substantially
equivalent)	Utilize a library of
custom cutouts
and computes
cutout factors
using a sector
integration
method. Cutout
factors may also
be user-entered.	Utilize a library of
custom cutouts and
computes cutout
factors using a
sector integration or
square root method.
Cutout factors may
also be user-entered.
Users may also
send/receive results
from an eternal dose
calculation engine,
whereby the results
are displayed in
RadCalc for
evaluation.	N/A
Output	ClearCalc calculates
dose based on
electron field	ClearCalc
calculates dose
based on electron	RadCalc calculates
dose based on
electron field	N/A
	parameters and
cutout geometry, and
displays results for
per-field MU and/or
dose and provides a
difference metric for
evaluation in tabular
format and, when
applicable, a
generated dose
volume histogram.
(Substantially
equivalent)	field parameters
and cutout
geometry, and
displays results for
per-field MU
and/or dose and
provides a
difference metric
for evaluation in
tabular format.	parameters and
cutout geometry, and
displays results for
per-field MU and/or
dose and provides a
difference metric for
evaluation in tabular
format.
	ClearCalc vs. RadCalc Brachytherapy Dose Calculation
Input	Files or Treatment
Planning System
API-provided data
containing Treatment
Plan (including
source positions and
dwell times) data
(Substantially
equivalent)	Files or Treatment
Planning System
API-provided data
containing
Treatment Plan
(including source
positions and dwell
times) data	Files containing
Treatment Plan
(including source
positions and dwell
times) data	N/A
Functionality	Utilizes the AAPM
TG-43 protocol for its
brachytherapy dose
calculations
(Substantially
equivalent)	Utilizes the AAPM
TG-43 protocol for
its brachytherapy
dose calculations	Utilizes the AAPM
TG-43 protocol for its
brachytherapy dose
calculations	N/A
Output	ClearCalc calculates
dose to arbitrary
calculation point
locations and
presents difference
metrics comparing
the TPS dose vs.
ClearCalc dose in a
tabular format.
(Substantially
equivalent)	ClearCalc
calculates dose to
arbitrary
calculation point
locations and
presents difference
metrics comparing
the TPS dose vs.
ClearCalc dose in
a tabular format.	RadCalc calculates
dose to arbitrary
calculation point
locations and
presents difference
metrics comparing
the TPS dose vs.
RadCalc dose in a
tabular format.	N/A
Parameters	Subject Device:
ClearCalc Model
RADCA V2	Predicate Device:
ClearCalc Model
RADCA	Predicate Device:
RadCalc Version
7.1 (K193381)	Predicate Device:
myQA iON
(K201798)
ClearCalc vs. myQA iON Proton MU and Dose Calculation
Input	Files/Treatment
Planning System	N/A	N/A	Files containing
Structure Set, and
	API-provided data
containing CT,
Structure Set, and
Treatment Plan
(including treatment
field parameters)
data (Minor
differences)			Treatment Plan
(including
treatment field
parameters) data
Functionality	Sends/receives data
from its monte carlo
dose calculation
engine (branded as
RadMonteCarlo) to
calculate proton
plans from the
necessary files and
displays the results
to the user.
(Substantially
equivalent)	N/A	N/A	Sends/receives
data from an
external dose
calculation engine
to calculate proton
plans from the
necessary files
and displays the
results to the user.
Output	ClearCalc displays
the dose results
received from the
RadMonteCarlo dose
calculation engine
and allows the user
to analyze the results
in the UI.
(Substantially
equivalent)	N/A	N/A	myQA iON
displays the dose
results received
from the external
dose calculation
engine and allows
the user to analyze
the results in the
UI.
ClearCalc vs. myQA iON Machine Treatment Log File Analysis
Input	Files or Treatment
Planning System
API-provided data
containing Treatment
Plan data as well as
machine log files
from a pre-treatment
or treatment session
(Substantially
equivalent)	N/A	N/A	Files containing
Treatment Plan
data as well as
machine log files
from a
pre-treatment or
treatment session
Functionality	Utilizes the machine
logs files to
reconstruct the
delivered dose
utilizing a dose
calculation from the
set machine
parameters.	N/A	N/A	Utilizes the
machine logs files
to reconstruct the
delivered dose
utilizing a dose
calculation from the
set machine
parameters.
	(Substantially
equivalent)
Output	ClearCalc displays
the log file
calculation result to
the user via
displayed dose
information and
provides a difference
metric for evaluation.
(Substantially
equivalent)	N/A	N/A	myQA iON
displays the log file
calculation result
to the user via
displayed dose
information and
provides a
difference metric
for evaluation.

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5.7. Performance Data

As with the Predicate Device and Reference Devices, no clinical trials were performed for ClearCalc. Verification tests were performed to ensure that the software works as intended and passffail criteria were used to verify requirements. Validation testing was performed to ensure that the software was behaving as intended, and results from ClearCalc were validated against accepted results for known planning parameters from clinically-utilized treatment planning systems. All passing criteria for ClearCalc's primary dose calculation algorithms (FSPB for photon plans, TG-71 for electron plans, and TG-43 for brachytherapy plans) remain consistent with the Predicate Device. Passing criteria for monte carlo calculations was a gamma analysis passing rate of >93% with +/-3% relative dose agreement and 3mm distance to agreement (DTA). The verification and validation testing passed in all test cases.

5.8. Conclusion

ClearCalc Model RADCA V2 is deemed substantially equivalent to the scope of Predicate Device, ClearCalc Model RADCA (K193640). Additional functionality for monte carlo calculations was supported with Reference Device RadCalc Version 7.1 (K1933981) and proton and machine treatment log file analysis for photons functionality was demonstrated with Reference Device myQA iON (K201798). Verification and Validation testing and the Risk Management Report demonstrate that ClearCalc is as safe and effective as the Predicate Device and Reference Devices. The minor technological differences between ClearCalc and the Predicate Device and Reference Devices do not raise any questions on the safety and effectiveness of the Subject Device.