(264 days)
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.
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.
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 |
§ 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.