LIAC S is mobile electron linear accelerator for intra-operative radiotherapy (IORT). Known as intraoperative radiation therapy (IORT), this technique allows delivery of high doses of radiation directly aimed at tumours or other sites. The LIAC S is meant to be used for radiotherapy in the operating theatre on a patient to which the surgeon has just removed a neoplasm. The device must be sold by or on the order of a physician. The device is not for use by the general public or over-the-counter. LIAC S is an electron accelerator that can work in an operating theatre respecting its specific characteristics in terms of cleaning possibility, noise and heat dissipation; in particular, they do not require to move the patient.

Device Description

LIAC S is an electron linear Accelerator used to perform radiation therapy during surgical procedures in an operating room on a patient from whom the Surgeon has just removed a tumor. This technique is known as Intra-Operative Radiation Therapy (IORT) and it is used for the treatment of malignant and benign conditions. IORT allows delivering of high doses of radiation directly to turnour site, while normal tissues are protected against dosage impact. The available version of LIAC S is the 12 MeV one, with selectable energies of 6, 8, 10, 12 MeV and with electrical power requirement of 230 V, 50 Hz and 3kVA. LIAC S model employs the same technology as its predicate, LIAC HWL, with the following differences: 1. The Control Unit frame; 2. The total length of the applicator; 3. The design of the remote controller. All the differences have no impact on the product performances. The Equipment, LIAC S, is a system for Intraoperative Radiotherapy comprised of two main parts, Control and Mobile Unit, and the applicators. The main parts, connected by a ten meters-long cable which transfers the signals and the power are: 1) MOBILE UNIT (STAND). The Mobile Unit is a mobile component which emits the radiation. It is placed in the operating room near the patient with a remote-control device; 2) CONTROL UNIT. The Control Unit is a mobile component too. It is connected to the mobile unit through a group of cables. It is the part of the device that controls the equipment. Both the above listed components, the mobile unit (1) and the control unit (2), are joined by a cable of about 10 meters, to allow positioning the mobile unit in the operating theatre close to the patient, while the console control unit remains outside of the operating theatre allowing the operator to control the radiation. The equipment can perform its action only if the Mobile Unit and the Control Unit are connected adequately and the applicator is installed.

AI/ML Overview

Here's a breakdown of the acceptance criteria and study information for the LIAC S device, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state formal "acceptance criteria" in the sense of specific thresholds for clinical performance metrics (e.g., sensitivity, specificity, accuracy) for a new algorithm. Instead, it focuses on demonstrating substantial equivalence to a predicate device (LIAC HWL) through technical and performance comparisons.

The "acceptance criteria" are implicitly met if the LIAC S device's performance parameters are comparable or superior to those of the predicate device, or if any differences are deemed not to impact safety and effectiveness.

Here's a table summarizing the comparison, which serves as the basis for demonstrating equivalence:

Characteristic	Proposed Device (LIAC S) Performance	Predicate Device (LIAC HWL) Performance	Assessment / Equivalence
Device Name	LIAC S (12 MeV)	LIAC HWL (Model: 12 MeV)	Substantially Equivalent
Manufacturer	S.I.T. - SORDINA IORT TECHNOLOGIES SPA	S.I.T. - SORDINA IORT TECHNOLOGIES SPA	Same
Classification	Class II	Class II	Same
Intended Use	Mobile electron linear accelerator for intra-operative radiotherapy (IORT) for malignant/benign conditions.	Mobile electron linear accelerator for intra-operative radiotherapy (IORT) for malignant/benign conditions.	Same
Emission	Electron beam	Electron beam	Same
Type of structure	LINAC	LINAC	Same
Docking	Hard docking	Hard docking	Same
Remote control	Yes	Yes	Same
Nominal energies	6, 8, 10, 12 MeV (12 MeV)	6, 8, 10, 12 MeV (12 MeV)	Same
Maximum operating temperature	25°C	25°C	Same
Electrical power requirement	230 V, 50 Hz, 3 kVA	230 V, 50 Hz, 3 kVA	Same
Applied Standards	IEC 60601-1, IEC 60601-1-2, IEC 60601-2-1, IEC 62304, ISO 14971	IEC 60601-1, IEC 60601-1-2, IEC 60601-2-1, IEC 62304	Conformance claimed for LIAC S
Surface dose	≥ 85%	≥ 90% (12 MeV)	Difference noted, but deemed not relevant for safety/effectiveness (implicitly accepted as equivalent)
Field symmetry	≤ 3 %	≤ 3 %	Same
Pulse repetition frequency	5 - 50 Hz	5 - 50 Hz (depended on the selected energy)	Equivalent
Beam current	1.5 mA	≤ 1.5 mA	Equivalent
Long term stability	≤ 3 %	≤ 3 %	Same
Short term stability	≤ 1 %	≤ 1 %	Same
Dosimetric system linearity	≤ 1 %	≤ 1 %	Same
Dose rate (applicator Ø 10 cm)	2 - 20 Gy/min	10-30 Gy/min	Difference noted, but deemed not relevant for safety/effectiveness (implicitly accepted as equivalent)
Stray X-radiation (PDD Bremsstrahlung tail)	≤ 0.7%	≤ 0.4%	Difference noted, but deemed not relevant for safety/effectiveness (implicitly accepted as equivalent)
Source Surface Distance (SSD)	60 cm	64.5 cm	Difference noted, but deemed not relevant for safety/effectiveness (implicitly accepted as equivalent)
Uniformity or Field Flatness (value in conformity with 60601-2-1 at max energy bevel angle 0° for applicator Ø 10 cm)	≤ 5%	≤ 7%	LIAC S shows better performance, deemed equivalent or superior
Mobile Unit movement capability	2 degrees of movement (Translation), 1 degree (Roll), 1 degree (Pitch), 1 degree (Elevation)	2 freedom degrees (Translation), 1 freedom degree (Roll), 1 freedom degree (Pitch), 1 freedom degree (Elevation)	Equivalent (different wording, same functionality)
Hard docking velocity	Up to 0.01 m/s	0.1 m/s	Difference noted, but deemed not relevant for safety/effectiveness (implicitly accepted as equivalent)
Mobile Unit length	185 cm	210 cm	Difference noted, but deemed not relevant for safety/effectiveness (implicitly accepted as equivalent)
Mobile Unit Width	76 cm	76 cm	Same
Mobile Unit height	180 cm	180 cm	Same
Mobile Unit weight	< 550 Kg	570+ (< 230, shield) kg	Difference noted, but deemed not relevant for safety/effectiveness (implicitly accepted as equivalent)
Control unit dimensions	30 cm x 80 cm x 170 cm (length, width, height)	80 cm x 60 cm x 120 cm (width, depth, height)	Difference in dimensions, but deemed not relevant for safety/effectiveness
Control unit weight	< 50 Kg	120 kg	Difference in weight, but deemed not relevant for safety/effectiveness
Applicator length	50 cm (total length)	40 cm	Difference in length, but deemed not relevant for safety/effectiveness
Applicator size	Ø: 3,4,5,6,7,8 and 10 cm each with cutting angles of 0°, 15°, 30°, 45°	Ø: 3, 4, 5, 6, 7, 8, 9, 10 and 12 cm each with bevel angels of 0°, 15°, 30°, 45°	Differences in available diameters, but deemed not relevant for safety/effectiveness
Applicator Material	PMMA	PMMA	Same

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

The provided document describes a device comparison/equivalence study rather than a study on an AI/algorithm's performance. Therefore, there is no specific "test set" in the context of clinical data for an algorithm. The evaluation relies on comparing the technical specifications and performance characteristics of the LIAC S device against its predicate device (LIAC HWL).

The "data provenance" mentioned is the technical specifications and performance measurements derived from the LIAC S device during its product development and verification, and similar data for the predicate device. These are likely from internal testing and engineering assessments rather than clinical trials with patient data.

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

This information is not applicable as there is no clinical "ground truth" derived from expert review in this type of submission. The ground truth for device performance is based on physical measurements and engineering standards.

4. Adjudication method for the test set

This is not applicable for the same reasons as #3.

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

An MRMC study is not applicable because the LIAC S is a medical radiation therapy device, not an AI or imaging diagnostic tool that relies on human readers interpreting output.

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

This is not applicable as the LIAC S is a physical medical device, not a standalone algorithm. Its function is to deliver radiation therapy directly.

7. The type of ground truth used

The "ground truth" here refers to engineering specifications, physical measurements, and conformity to recognized technical standards (e.g., IEC 60601 series, ISO 14971). The evaluation confirms that the LIAC S device meets these established performance benchmarks and standards for safety and effectiveness, and that its differences from the predicate are not significant enough to raise new safety or effectiveness concerns.

8. The sample size for the training set

This is not applicable as the submission describes a physical medical device, not an AI model that requires a training set of data.

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

This is not applicable for the same reasons as #8.

In summary: This 510(k) submission for the LIAC S device focuses on demonstrating substantial equivalence to an existing predicate device (LIAC HWL) through a detailed comparison of technical specifications, intended use, and performance parameters. The "study" here is essentially a technical validation and verification process, with "acceptance criteria" met by showing that the new device is as safe and effective as the predicate, despite some minor design and numerical differences which were deemed not to impact overall safety or effectiveness. It does not involve AI, clinical efficacy trials, or expert-based ground truth establishment in the way typically seen for diagnostic algorithms.

Summary

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Sit Sordina Iort Technologies Spa % Maurizio Pantaleoni CEO Isemed Srl Via P. Togliatti, 19/X Imola, BO 40026 ITALY

May 22, 2019

Re: K182374

Trade/Device Name: LIAC S Regulation Number: 21 CFR 892.5050 Regulation Name: Medical charged-particle radiation therapy system Regulatory Class: Class II Product Code: IYE Dated: April 8, 2019 Received: April 11, 2019

Dear Maurizio Pantaleoni:

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 and Part 809); medical device reporting of medical device-related adverse events) (21 CFR

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for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.

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/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,

For

Thalia T. Mills, Ph.D. Director Division of Radiological Health OHT7: Office of In Vitro Diagnostics and Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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IV - STATEMENT of INDICATIONS FOR USE

Indications for Use Statement of the LIAC S manufactured by SIT SORDINA IORT TECHNOLOGIES SPA device is provided on the next page.

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Indications for Use

510(k) Number (if known)

Device Name LIAC S

Indications for Use (Describe)

The devices must be sold by or on the order of a physician. The device is not for use by the general public or over thecounter.

LIAC S is an electron accelerator that can work in an operating its specific characteristics in terms of cleaning possibility, noise and heat dissipation; in particular, they do not require to move the patient.

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

X Prescription Use (Part 21 CFR 801 Subpart D)

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Traditional 510(k) Summary

This Traditional 510(k) Summary is being submitted as required by 21 CFR 807.92.

1. General Information
Submitter :	SIT SORDINA IORT TECHNOLOGIES SPA
	Galleria del Pozzo Rosso, 13,
	36100 Vicenza VI, Italy
	Tel. +39 0444 233711
	Registration Number: 3010625741
	Owner/Operator Number: 10043521
Consultant/ Contact:	Maurizio Pantaleoni
	ISEMED srl
	Via P.Togliatti, 19/X
	40026 Imola (BO) - ITALY
	Mob. +39 348 4435155
	Tel. +39 0542 683803
	Fax +39 0542 698456
	Email: regulatory@isemed.eu
Summary Prepared Date:	August 28, 2018

1. Names
  .

Device Name:	LIAC S
Common Name:	Radiosurgery/radiotherapy treatment planning and delivery system
Regulation Name:	Medical charged particle radiation therapy system
Product Code:	IYE
Classification:	21CFR 892.5050; Class II

3. Predicate Device

The LIAC S is substantially equivalent to the following predicate device, which is legally marketed in the US.

Applicant	Device name	510(k) Number
SIT SORDINA IORTTECHNOLOGIES SPA.	LIAC HWL	K172961

LIAC S and its predicate device LIAC HWL (K172961) are both electron linear accelerators used for radiation therapy during surgical procedures in an operating room and they are both Class II devices.

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LIAC S and the predicate LIAC HWL, at the same time, are both regulated under the regulation number 892.5050 and product code IYE.

LIAC S has the same intended use of the predicate device LIAC HWL (K172961). Both devices are electron accelerators that produce beams of electrons used in the radiation therapy treatment of both malignant and benign conditions.

The identified intended use is the radiation therapy treatment of both malignant and benign conditions, during surgical procedures. This technique is also known as "Intraoperative Radiation Therapy (IORT)" and it allows delivery of high doses of radiation directly to tumours or other sites while protecting surgically mobilized normal tissues against dosage impact.

LIAC S and its predicate LIAC HWL are equivalent devices. The only design differences between LIAC S and LIAC HWL are:

1. Radiation performance parameters
- a) Dose Rate
- b) The surface dose
- c) Stray X-radiation
- d) Surface Surface Distance (SSD)
- e) Uniformity or Field Flatness
1. Mobile and Control Unit mechanical design
1. Components Applicator
- a) Applicator length

The differences listed above resulted not relevant for the device safety and effectiveness because, as stated into the comparison discussion, they are substantially equivalent to the predicate device LIAC HWL.

All the characteristics and/or performances have been validated with the same methods (i.e. standard compliance) used for the predicate device.

Thus, LIAC S is substantially equivalent to the predicate device LIAC HWL (K172961).

The differences between LIAC S and the predicate device are summarized in the following comparison table:

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Characteristic	PROPOSE DEVICE	PREDICATE DEVICE
Device Name	LIAC S(12mev)	LIAC HWL(Model: 12mev)
	Image: LIAC S	Image: LIAC HWL
Manufacturer	S.I.T. -SORDINA IORT TECHNOLOGIES SPA	S.I.T. -SORDINA IORT TECHNOLOGIES SPA
Classification	II	II
Device Design - Technical features
Design structure	Stand (irradiating unit) Control unit Applicators	Stand (irradiating unit) Control unit Applicators
Emission	Electron beam	Electron beam
Type of structure	LINAC	LINAC
Docking	Hard docking	Hard docking
Remote control	Yes	Yes
Nominal energies	6, 8, 10, 12 MeV (12 MeV)	6, 8, 10, 12 MeV (12 MeV)
Maximumoperatingtemperature	25°C	25°C
Electrical powerrequirement	230 V, 50 Hz, 3 kVA	230 V, 50 Hz, 3 kVA
AppliedStandards	IEC 60601-1 IEC 60601-1-2 IEC 60601-2-1 IEC 62304	IEC 60601-1 IEC 60601-1-2 IEC 60601-2-1 IEC 62304
Device Design - Radiation performance
Surface dose	≥ 85%	≥ 90% (12 MeV)
Field symmetry	≤ 3 %	≤ 3 %
Pulse repetitionfrequency	5 - 50 Hz	5 - 50 Hz (depended on the selected energy)
Beam current	1.5 mA	≤ 1.5 mA
Long termstability	≤ 3 %	≤ 3 %
Short termstability	≤ 1 %	≤ 1 %
Dosimetricsystemlinearity	≤ 1 %	≤ 1 %
Dose rate(applicator Ø 10cm)	$2 \div 20$ Gy/min	10-30 Gy/min
Stray X-radiation(PDDBremsstrahlungtail)	≤0.7%	≤ 0.4%
Source SurfaceDistance (SSD)	60 cm	64.5 cm
Uniformity orField Flatness(value inconformity with60601-2-1 at themaximum energybevel angle 0°for applicator Ø10 cm )	≤ 5%	≤ 7%
COMPONENTS -Mobile Unit
Mobile Unit movement capability
Translation	2 degrees of movement	2 freedom degrees
Roll	1 degree of movement	1 freedom degree
Pitch	1 degree of movement	1 freedom degree
Elevation	1 degree of movement	1 freedom degree
Mobile Unit velocity
Hard dockingvelocity	Up to 0.01 m/s	0.1 m/s
Mobile Unit size and weight
length	185 cm	210 cm
Width	76 cm	76 cm
height	180 cm	180 cm
weight	<550 Kg	570+ (< 230, shield) kg
Focusing &Collimation	Linac + applicators	Linac + applicators
COMPONENTS -Control unit
Control unitdimensions	30 cm x 80 cm x 170 cm(length, width, height)	80 cm x 60 cm x 120 cm(width, depth, height)
Control unitweight	< 50 Kg	120 kg
	Applicator length	50 cm (total length)	40 cm
	Applicator size	$\emptyset$ : 3,4,5,6,7,8 and 10 cm each with cutting angles of 0°, 15°, 30°, 45°	$\emptyset$ : 3, 4, 5, 6, 7, 8, 9, 10 and 12 cm each with bevel angels of 0°, 15°, 30°, 45°
	Applicator Material	PMMA	PMMA

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After comparing predicate device LIAC S to LIAC HWL, the results show that devices have the same intended use and equivalent technological features, thus they are equivalent in terms of safety and effectiveness.

5. Device Description

The available version of LIAC S is the 12 MeV one, with selectable energies of 6, 8, 10, 12 MeV and with electrical power requirement of 230 V, 50 Hz and 3kVA.

******************************************************************************************************************************************************************************		E Color College REF. Comment Version Come Commendent Commendent ISSUE[
IACC	S100000-01-03	AC S (12	10 17
้		MeV	Mev

LIAC S model employs the same technology as its predicate, LIAC HWL, with the following differences:

1. The Control Unit frame;
1. The total length of the applicator;
1. The design of the remote controller.

All the differences have no impact on the product performances.

The Equipment, LIAC S, is a system for Intraoperative Radiotherapy comprised of two main parts, Control and Mobile Unit, and the applicators.

The main parts, connected by a ten meters-long cable which transfers the signals and the power are:

1. MOBILE UNIT (STAND). The Mobile Unit is a mobile component which emits the radiation. It is placed in the operating room near the patient with a remote-control device;

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1. CONTROL UNIT. The Control Unit is a mobile component too. It is connected to the mobile unit through a group of cables. It is the part of the device that controls the equipment.
  Both the above listed components, the mobile unit (1) and the control unit (2), are joined by a cable of about 10 meters, to allow positioning the mobile unit in the operating theatre close to the patient, while the console control unit remains outside of the operating theatre allowing the operator to control the radiation.

The equipment can perform its action only if the Mobile Unit and the Control Unit are connected adequately and the applicator is installed.

6. Indications for Use

LIAC S is a mobile electron linear accelerator for intra-operative radiotherapy (IORT). Known as intraoperative radiation therapy (IORT), this technique allows delivery of high doses of radiation directly aimed at tumours or other sites.

The LIAC S is meant to be used for radiotherapy in the operating theatre on a patient to which the surgeon has just removed a neoplasm.

The device must be sold by or on the order of a physician. They are not for use by the general public or over-the-counter.

LIAC S is an electron accelerator that can work in an operating theatre respecting its specific characteristics in terms of cleaning possibility, noise and heat dissipation; in particular, they do not require to move the patient.

7. Non-Clinical Performance Testing

Non-clinical testing was conducted for the LIAC S during product development. The modifications described in this Premarket Notification were supported with verification and validation testing. SIT S.p.A claims conformance to the following standards:

IEC 60601-1 Medical Electrical Equipment Part.1: General requirements for safety. 1: . Collateral standard: safety requirements for Medical Electrical Systems.
IEC 60601-1-2 Medical Electrical Equipment Part.1: General requirements for safety. . 2 Collateral standard: electromagnetic compatibility – requirements and tests.
. IEC 60601-2-1 Medical electrical equipment -- Part 2-1: Particular requirements for the safety of electron accelerators in the range of 1 MeV to 50 MeV.
ISO 14971 Medical Devices - Application of risk management to medical devices.
. IEC EN 62304 Medical device software - Software life cycle processes.

Evidence provided within this submission demonstrates the compliance of the LIAC S with the applicable standards.

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Furthermore, S.I.T. - SORDINA IORT TECHNOLOGIES S.p.A, has also considered the guidance document "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices – FDA – May 2005".

8. Conclusions

After comparison of LIAC S to LIAC HWL (K172961), results show that all devices have the same intended use, the same operating principle (linear acceleration) and equivalent technical characteristics. In light of above considerations LIAC S may be considered substantially equivalent to the predicate device.

Regulation Number and Section

N/A