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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:

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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.

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.

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:

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

1. 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.

2. 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.

3. 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.

4. 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.

5. 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.

6. 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.

7. 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.

8. How the ground truth for the training set was established:

   • Not applicable. As above, no training set for an algorithm.

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