LIAC HWL are mobile electron linear accelerators for intra-operative radiotherapy (IORT). Known as intraoperative radiation therapy (IORT), this technique allows delivery of high doses of radiation directly aimed at tumors or other sites. The LIAC HWL are meant to be used for radiotherapy in the operating theatre on a patient to which the surgeon has just removed a neoplasm. The devices 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 HWL are electron accelerators that can work in an operating theater 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 HWL are mobile electron linear accelerators for intra-operative radiotherapy (IORT). The device consists of a STAND (irradiating unit), CONTROL UNIT, and APPLICATORS. It is a LINAC type structure with HARD DOCKING. It emits an ELECTRON BEAM.

AI/ML Overview

Here's an analysis of the provided text to extract information about the acceptance criteria and study proving device performance:

It is important to note that the provided text is a 510(k) summary for a medical device (LIAC HWL), which primarily focuses on demonstrating substantial equivalence to predicate devices. It does not present a detailed clinical study with performance metrics in the typical sense of an AI/human-in-the-loop diagnostic accuracy study. Instead, the performance is evaluated by comparing the technical specifications and radiation performance of the new device (LIAC HWL) against its legally marketed predicate devices.

Therefore, many of the requested categories for acceptance criteria and study details (like multi-reader multi-case studies, expert consensus for ground truth, training set details, adjudication methods) are not applicable in this context, as this is a medical device clearance based on engineering and physics performance, not a diagnostic algorithm.

Acceptance Criteria and Reported Device Performance

The acceptance criteria are implicitly defined by the parameters of the predicate devices. The new device (LIAC HWL) must perform comparably or better than the predicate devices within ranges considered safe and effective for its indicated use. The "reported device performance" are the values measured for the LIAC HWL, which are then compared to the predicates.

Here's a table based on the "DEVICE DESIGN – RADIATION PERFORMANCE" section:

Characteristic	Acceptance Criteria (Predicate LIAC)	Acceptance Criteria (Predicate NOVAC11)	Reported Device Performance (LIAC HWL)
Surface dose (10 MeV)	≥ 85 %	≥ 80-85%	≥ 88 %
Surface dose (12 MeV)	≥ 87 %	N/A (for 12 MeV)	≥ 90 %
Field symmetry	≤ 3 %	≤ 2 %	≤ 3 %
Pulse repetition frequency	5 - 50 Hz	9 Hz	5 - 50 Hz
Beam current	≤ 1.5 mA	≤ 1.5 mA	≤ 1.5 mA
Long term stability	≤ 3%	≤ 2 %	≤ 3%
Short term stability	≤ 1%	≤ 1 %	≤ 1%
Dosimetric system linearity	≤ 1 %	≤ 1 %	≤ 1 %
Dose rate (applicator ∅ 10 cm)	3 - 20 Gy/min	According to applicator (6-39 Gy/min)	10 - 30 Gy/min
Stray X-radiation	≤ 0.7 %	≤ 0.2 %	≤ 0.4 %
Source Surface Distance (SSD)	71.3 cm	65-80 cm	64.5 cm
Uniformity or Field Flatness	≤3% Ø 10, 8, 7, 6 [cm], ≤9% Ø 4,5 [cm], ≤12% Ø 3 [cm]	≤5%	≤3% Ø 8,7,6 [cm], ≤7% Ø 10 [cm], ≤9% Ø 4,5 [cm], ≤12% Ø 3, 12 [cm], ≤4% Ø 9[cm]

Study Details (as applicable to a 510(k) for a linear accelerator)

Sample sized used for the test set and the data provenance:
- Test Set: No "test set" in the sense of patient data or images for a diagnostic algorithm. The "test" in this context refers to physical measurements and engineering validations of the device's radiation characteristics and physical specifications. These tests would have been performed on the LIAC HWL device itself in a controlled environment.
- Data Provenance: The data comes from direct measurements and engineering tests of the LIAC HWL prototype/production unit. The country of origin of the manufacturer is Italy. This is a prospective evaluation of the new device's performance.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable in the context of diagnostic "ground truth." The "ground truth" for these physical parameters is established by standard physics principles, dosimetry protocols, and engineering specifications. While experts (e.g., medical physicists, engineers) would have performed and analyzed these measurements, their role is not to establish "ground truth" in an interpretive sense, but to conduct and verify the measurements against established physical standards.
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable. This is not a study requiring human interpretation or adjudication of diagnostic findings. Device performance is determined through reproducible physical measurements.
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:
- Not applicable. This is not a diagnostic AI device or a study involving human readers. It's a linear accelerator for radiation therapy application.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Yes, in spirit. The "standalone" performance here refers to the measured physical and radiation characteristics of the LIAC HWL itself, independent of operator influence on the inherent physics of the beam. The system is designed to produce a specific electron beam with defined characteristics, and these characteristics are measured directly.
The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- Physical and Dosimetric Standards: The "ground truth" for this device's performance is established by internationally recognized standards for medical linear accelerator dosimetry and performance (e.g., IAEA TRS-398, AAPM TG-51 protocols, IEC standards like IEC 60601-2-1). Compliance with these physical standards ensures the device performs as expected for its therapeutic application.
The sample size for the training set:
- Not applicable. This is not a machine learning model that requires a training set. The device's design and performance are based on physics and engineering principles, not on learned patterns from a dataset.
How the ground truth for the training set was established:
- Not applicable. As above, no training set for an algorithm.

Summary

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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health and Human Services seal on the left and the FDA acronym along with the full name of the agency on the right. The FDA part of the logo is in blue, with the acronym in a square and the full name written out to the right of the square.

SIT SORDINA IORT TECHNOLOGIES SPA % Maurizio Pantaleoni CEO Isemed Srl Via P. Togliatti, 19/X Imola, Bo 40026 ITALY

Re: K172961

Trade/Device Name: LIAC HWL Regulation Number: 21 CFR 892.5050 Regulation Name: Medical charged-particle radiation therapy system Regulatory Class: II Product Code: IYE Dated: May 8, 2017 Received: May 10, 2017

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. 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 (OS) regulation (21 CFR Part 820);

June 11, 2018

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Page 2 - Maurizio Pantaleoni

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 the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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,

Michael D. O'Hara For

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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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

510(k) Number (if known)

K172961

Device Name LIAC HWL

Indications for Use (Describe)

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

The devices must be sold by or on the order of a physician. They are by the general public or over-the-counter.

LIAC HWL are electron accelerators 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)

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

CONTINUE ON A SEPARATE PAGE IF NEEDED.

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S.I.T. -SORDINA IORT TECHNOLOGIES S.p.A TRADITIONAL 510(K) PREMARKET NOTIFICATION

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 SPAGalleria del Pozzo Rosso, 13,36100 Vicenza VI, ItalyTel. +39 0444 233711Registration Number: 3010625741Owner/Operator Number: 10043521
	Consultant/ Contact:	Maurizio PantaleoniISEMED srlVia P.Togliatti, 19/X40026 Imola (BO) - ITALYMob. +39 348 4435155Tel. +39 0542 683803Fax +39 0542 698456Email: regulatory@isemed.eu
	Summary Prepared Date:	November 24, 2017.

2. Names

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

3. Predicate Devices

The LIAC HWL is substantially equivalent to the following predicate devices, which are legally marketed in the US.

Applicant	Device name	510(k) Number
SIT SORDINA IORT	LIAC	K110840
TECHNOLOGIES SPA.	NOVAC11	K112286

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LIAC HWL (10 MeV &12 MeV)

S.I.T. -SORDINA IORT TECHNOLOGIES S.p.A TRADITIONAL 510(K) PREMARKET NOTIFICATION

The primary predicate device is LIAC (K110840) and secondary predicate device is NOVAC11 (K112286). Both devices are manufactured by SIT SORDINA IORT TECHNOLOGIES SPA. And they have not been subject of any device recalls.

LIAC HWL is a modified model of its primary predicate device LIAC (K110840). Both have the same intended use and the same operation mode. LIAC HWL and its predicate devices are electron linear Accelerators used to perform radiation therapy during surgical procedures in an operating room. This technique is known as Intra-Operative Radiation Therapy (IORT) ant it is used for the treatment of malignant and benign conditions. IORT allows delivering of high doses of radiation directly to tumour site, while normal tissues are protected against dosage impact.

SIT SORDINA IORT TECHNOLOGIES SPA was written this Traditional 510(k) for the LIAC HWL in accordance to "Letter to Manufacturers of Linear Accelerators, Radiation Therapy Treatment Planning Systems, and Ancillary Devices" released in 2010 by CDRH.

LIAC HWL (10MeV & 12 MeV) and LIAC (10MeV & 12 MeV) (K110840) have the following technological differences:

1. LIAC HWL has additional shielding system in the radiant head to reduce scattered radiation.
1. LIAC HWL has lower length applicators to reduce SSD.
1. LIAC HWL has a higher dose rate.
1. LIAC HWL and predicate device LIAC (K110840) have a modified remote control.

SIT SORDINA IORT TECHNOLOGIES SPA has evaluated each modification of LIAC HWL to establish if the intended use or the technological features are different from those of predicate devices LIAC (K110840) and NOVAC 11 (K112286).

The differences between LIAC HWL and the predicate devices are summarized in the following comparison table:

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SIT SORDINA IORT TECHNOLOGIES SP
TRADITIONAL 510(K)
PREMARKET NOTIFICATION

LIAC HWL
(10 MeV &12 MeV)

CharacteristicDevice Name	PROPOSE DEVICE	PREDICATE DEVICE	Remote control	YES	YES	YES
	LIAC HWL(MODELS: 10MEV AND 12MEV)	LIAC(MODELS: 10MEV AND 12MEV)	NOVAC11	Nominal energies	4, 6, 8, 10 MeV (10 MeV)6, 8, 10, 12 MeV (12 MeV)	4, 6, 8, 10 MeV (10 MeV)6, 8, 10, 12 MeV (12 MeV)	4, 6, 8, 10 MeV
	Image: LIAC HWL	Image: LIAC	Image: NOVAC11	Maximum operatingtemperature	25°C	25°C	25°C
Manufacture	SORDINA IORT TECHNOLOGIES SPAS.I.T. -	SORDINA IORT TECHNOLOGIES SPAK110840S.I.T. -	SORDINA IORT TECHNOLOGIES SPAK112286S.I.T. -	Maximum powerdissipation	< 2.5 kW	< 2.5 kW	< 1 kW
GENERAL FEATURES				Electrical powerrequirement	230 V, 50 Hz, 3 kVA	230 V, 50 Hz, 3 kVA	230 V, 50 Hz, 2.5 kVA
Classification	II	II	II	Applied Standards	IEC 60601-1 IEC 60601-2-1 IEC 62304	IEC 60601-1 IEC 60601-1 Rev.2nd (IEC 60601-1-4 ) IEC 60601-1-2 IEC 62304	IEC 60601-1 IEC 60601-1-2 IEC 60601-1-4 IEC 62304 EN60601-2-1
Regulation number	892.5050	892.5050	892.5050	DEVICE DESIGN – RADIATION PERFORMANCE
Product code	IYE	IYE	IYE	Surface dose	≥ 88 % (10 MeV)≥ 90 % (12 MeV)	≥ 85 % (10 MeV)≥ 87 %(12 MeV)	≥ 80-85%
Product Code description	Accelerator, linear, medicalMedical charged-particle radiationTherapy system	Accelerator, linear, medicalMedical charged-particle radiationTherapy system	Accelerator, linear, medicalMedical charged-particle radiationTherapy system	Field symmetry	≤ 3 %	≤ 3 %	≤ 2 %
Indications for Use				Pulse repetitionfrequency	5 - 50 Hz (depended on the selectedenergy)	5 - 50 Hz (depended on the selectedenergy)	9 Hz
	LIAC (MODELS: 10MEV AND 12MEV) IS A MOBILEELECTRON LINEAR ACCELERATOR FOR INTRA-OPERATIVE RADIOTHERAPY (IORT).KNOWN AS INTRAOPERATIVE RADIATIONTHERAPY (IORT), THIS TECHNIQUE ALLOWSDELIVERY OF HIGH DOSES OF RADIATION DIRECTLYAIMED AT TUMORS OR OTHER SITES.THE LIAC IS MEANT TO BE USED FORRADIOTHERAPY IN THE OPERATING THEATRE ON APATIENT TO WHICH THE SURGEON HAS JUSTREMOVED A NEOPLASM.THE DEVICE MUST BE SOLD BY OR ON THE ORDEROF A PHYSICIAN. IT IS NOT FOR USE BY THEGENERAL PUBLIC OR OVER-THE-COUNTER.	NOVAC11 IS AN ELECTRON LINEARACCELERATOR USED FOR RADIATION THERAPYDURING SURGICAL PROCEDURES IN ANOPERATING ROOM FOR THE TREATMENT OFMALIGNANT AND BENIGN CONDITIONS.KNOWN AS INTRAOPERATIVE RADIATIONTHERAPY (IORT), THIS TECHNIQUEALLOWS DELIVERY OF HIGH DOSES OFRADIATION DIRECTLY AIMED AT TUMORS OROTHER SITES WHILE AVOIDING DOSAGE TOSURGICALLY MOBILIZED NORMAL TISSUES.NOVAC11 IS A MOBILE ANDARTICULATED MACHINE THAT CAN BEMOVED TOWARDS THE PATIENT AN PUT INTHE APPROPRIATE POSITION TO CARRY OUTTHE NECESSARY RADIOTHERAPY.APPLICATORS LEAD THE ELECTRON BEAM TOTHE SURGICAL AREA OF INTEREST.		Beam current	≤ 1.5 mA	≤ 1.5 mA	≤ 1.5 mA
LIAC HWL ARE MOBILE ELECTRON LINEARACCELERATORS FOR INTRA-OPERATIVERADIOTHERAPY (IORT). KNOWN ASINTRAOPERATIVE RADIATION THERAPY(IORT), THIS TECHNIQUE ALLOWS DELIVERYOF HIGH DOSES OF RADIATION DIRECTLYAIMED AT TUMORS OR OTHER SITES.THE LIAC HWL ARE MEANT TO BE USED FORRADIOTHERAPY IN THE OPERATING THEATREON A PATIENT TO WHICH THE SURGEON HASJUST REMOVED A NEOPLASM.THE DEVICES MUST BE SOLD BY OR ON THEORDER OF A PHYSICIAN. THEY ARE NOT FORUSE BY THE GENERAL PUBLIC OR OVER-THE-COUNTER.			LIAC HWL ARE ELECTRON ACCELERATORSTHAT CAN WORK IN AN OPERATINGTHEATER RESPECTING ITS SPECIFICCHARACTERISTICS IN TERMS OF CLEANINGPOSSIBILITY, NOISE AND HEAT DISSIPATION; INPARTICULAR, THEY DO NOT REQUIRE TOMOVE THE PATIENT.	Long term stability	≤ 3%	≤ 3%	≤ 2 %
DEVICE DESIGN – TECHNICAL FEATURES				Short term stability	≤ 1%	≤ 1%	≤ 1 %
Design structure	STAND (irradiating unit) CONTROL UNIT APPLICATORS	STAND (irradiating unit) CONTROL UNIT APPLICATORS(ACCESSORY)	STAND (irradiating unit) CONTROL PANEL APPLICATORS PROTECTION DISC (ACCESSORY)	Dosimetric systemlinearity	≤ 1 %	≤ 1 %	≤ 1 %
Emission	ELECTRON BEAM	ELECTRON BEAM	ELECTRON BEAM	Dose rate (applicator∅ 10 cm)	10 - 30 Gy/min	3 - 20 Gy/min	According to applicatorFrom 6 to 39 Gy/min
Type of structure	LINAC	LINAC	LINAC	Stray X-radiation(PDD Bremsstrahlungtail)	≤ 0.4 %	≤ 0.7 %	≤ 0.2 %
Docking	HARD DOCKING	HARD DOCKING	HARD DOCKING

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SIT SORDINA IORT TECHNOLOGIES SP
TRADITIONAL 510(K)
PREMARKET NOTIFICATION

LIAC HWL LIAC HWL

(10 MeV &12 MeV)

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SIT SORDINA IORT TECHNOLOGIES SP
TRADITIONAL 510(K)
PREMARKET NOTIFICATION

LIAC HWL LIAC HWL
(10 MeV &12 MeV)

Vol001-27

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SIT SORDINA IORT TECHNOLOGIES SP.
TRADITIONAL 510(K)
PREMARKET NOTIFICATION

LIAC HWL
(10 MeV &12 MeV)

Source SurfaceDistance (SSD)	64.5 cm	71.3 cm	65-80 cm
Uniformity or FieldFlatness (value at themaximum energylevel angle 0°)	≤3% Ø 8,7,6 [cm]≤7% Ø 10 [cm] (60601-2-1 conformity)≤9% Ø 4,5 [cm]≤12% Ø 3, 12 [cm]≤4% Ø 9[cm]	≤3% Ø 10, 8, 7, 6 [cm]≤9% Ø 4,5 [cm]≤12% Ø 3 [cm]	≤5%
COMPONENTS -Mobile Unit
Length	210 cm	210 cm	230 cm
Width	76 cm	76 cm	95 cm
Height	180 cm	180 cm	199 cm
Weight	570+ (< 230, shield) kg	400+ (< 230, shield) kg	630 kg
Focusing &Collimation	Linac + applicators	Linac + applicators	Linac + applicators
COMPONENTS -Control unit
Control unitdimensions	80 cm x 60 cm x 120 cm(width, depth, height)	80 cm x 57 cm x 114 cm(width, depth, height)
Control unit weight	120 kg	100 kg
COMPONENTS -Applicator
Applicator length	40 cm	60 cm	100 cm
Applicator size	Ø: 3, 4, 5, 6, 7, 8, 9, 10 and 12 cm eachwith bevel angels of 0°, 15°, 30°, 45°	Ø: 3, 4, 5, 6, 7, 8, 10 cm each with bevelangels of 0°, 15°, 30°, 45°	Ø: 3, 4, 5, 6, 7, 8, 10 cm
Applicator Material	PMMA	PMMA	PMMA

Regulation Number and Section

N/A