(258 days)
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:
| 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)
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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.
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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.
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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.
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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.
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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.
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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.
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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.
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How the ground truth for the training set was established:
- Not applicable. As above, no training set for an algorithm.
§ 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.