(212 days)
The Table Tilt Device is an additional device for treatment tables used for radiation treatment. It enables a motorized table tilt around the lateral and longitudinal axis to compensate for patient rotation. In this fashion misalignments and shift of the patient can be precisely compensated.
The Table Tilt Device is a device used to compensate rotational patient misalignment (roll and pitch) in a linear accelerator environment for stereotactic radiosurgery or radiotherapy procedures.
The Table Tilt Device is a powered patient support assembly for use in radiotherapy and radiosurgery treatments. It allows the user to undertake motorized tilt adjustment of a patient misalignment to eliminate the need to manually move the patient on the table.
The provided text is a 510(k) summary for a "Table Tilt Device." This document focuses on demonstrating substantial equivalence to a predicate device for regulatory approval, rather than presenting a detailed study proving performance against specific acceptance criteria. Therefore, most of the requested information regarding detailed study design, sample sizes, ground truth establishment, expert qualifications, and specific performance metrics is not available in the provided text.
Here's what can be extracted and what is missing:
Acceptance Criteria and Device Performance (Limited Information)
The document primarily focuses on demonstrating "substantial equivalence" rather than specific numerical acceptance criteria. The "Intended Use" and "Device Description" sections implicitly define the functional requirements.
| Acceptance Criteria (Implicit) | Reported Device Performance (Implied) |
|---|---|
| Compensation for patient rotation (roll and pitch) in a linear accelerator environment. | The device enables motorized table tilt around the lateral and longitudinal axis to compensate for patient rotation, precisely compensating for misalignments and shifts. |
| Safety and Effectiveness | The validation proves the safety and effectiveness of the system, supporting its substantial equivalence to the predicate. |
1. A table of acceptance criteria and the reported device performance
As mentioned above, the provided text does not present explicit, quantifiable acceptance criteria with corresponding reported performance metrics. The core statement is: "The validation proves the safety and effectiveness of the system."
2. Sample size used for the test set and the data provenance
- Sample Size for Test Set: Not specified.
- Data Provenance: Not specified. The document states "The Table Tilt Device will be verified and validated according to BrainLAB's procedures for product design and development." This implies internal testing.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable/Not specified. The validation described is for a mechanical device; "ground truth" in the context of expert consensus on medical images or diagnoses is not relevant here. The validation would likely involve engineering tests against specifications.
4. Adjudication method for the test set
Not applicable/Not specified. As it's a mechanical device, adjudication in the sense of resolving discrepancies in expert interpretations is not relevant.
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
Not applicable. This is not an AI/imaging device, and no MRMC study is mentioned.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
A standalone performance evaluation would be inherent in the "verification and validation" mentioned, but details of how this was done (e.g., specific test protocols, performance metrics) are not provided. The device itself is a standalone mechanical component that assists in patient positioning.
7. The type of ground truth used
For a mechanical device like a table tilt mechanism, "ground truth" would typically refer to engineering specifications and measurements (e.g., accuracy of tilt, range of motion, load bearing capacity, stability). This would likely involve:
- Engineering drawings and design specifications.
- Physical measurements using calibrated instruments.
- Stress tests and durability tests.
However, the specific methods are not detailed in this summary.
8. The sample size for the training set
Not applicable. This device is not described as involving machine learning or AI, so there is no "training set."
9. How the ground truth for the training set was established
Not applicable. There is no training set for this device.
§ 892.5770 Powered radiation therapy patient support assembly.
(a)
Identification. A powered radiation therapy patient support assembly is an electrically powered adjustable couch intended to support a patient during radiation therapy.(b)
Classification. Class II.