(90 days)
The Stereotactic Body Frame is a device designed for stereotactic diagnostic localization and stereotactic radiotherapy of extracranial targets.
The Stereotactic Body Frame utilizes a reference system which is external to the patient's body. Using this stereotactic system, the coordinates of a target can be reproducibly localized during diagnostic examination and treatment. The Frame has built-in copper or copper sulfate solution reference indicators for CT or MR determination of target coordinates. These reference indicators, which produce fiducials on the CT or MR images, permit x, y and z coordinate determination for localization of the target. A diaphragm control attached to the Frame can be used to minimize respiratory movements. Horizontal positioning of the Frame, in the scanner or on the treatment couch, is achieved using an adjustable base on the Frame.
Marker devices are used for reproducible positioning, after fixation of the patient in a vacuum pillow. An arc-ruler is attached to the Frame and a chest marker device on the arc-ruler is used for alignment of the patient. This is based on two skin marks over the patient's sternum. Longitudinal alignment is controlled by skin marks over the tibia using a frame-mounted laser. The coordinates used for patient positioning can be easily read on the arc-ruler holding the sternum marker and on the longitudinal ruler, along which the arcruler can be moved.
This 510(k) submission (K960338) details a medical device for patient positioning and stereotactic radiotherapy. However, it does not contain the specific information required to complete the table or answer the questions comprehensively regarding acceptance criteria and a study proving the device meets those criteria. The provided text is a summary of safety and effectiveness, typical of a 510(k) submission from 1996, which, while outlining the device's purpose and comparison to predicates, does not include rigorous performance metrics or detailed study methodologies that would be expected in more recent regulatory submissions.
Here's an attempt to address your request based only on the provided text, highlighting where information is missing:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Anticipated for this type of device) | Reported Device Performance (from K960338) |
|---|---|
| Strength and Deformation under normal use | "demonstrated that the Stereotactic Body Frame is capable of safely and accurately repositioning the patient..." * (Details on specific acceptable deformation limits or strength values are not provided)* |
| Influence of radiation on material behavior (repeated use) | "demonstrated that the Stereotactic Body Frame is capable of safely and accurately repositioning the patient..." * (Details on specific acceptable changes in material behavior or number of cycles are not provided)* |
| Radiation attenuation | "demonstrated that the Stereotactic Body Frame is capable of safely and accurately repositioning the patient..." * (Details on specific acceptable attenuation percentage or methods are not provided)* |
| Accuracy of repositioning | "demonstrated that the Stereotactic Body Frame is capable of safely and accurately repositioning the patient in relation to an external reference system." * (No specific quantitative accuracy metrics like millimeters of deviation are reported.)* |
| Safety | "demonstrated that the Stereotactic Body Frame is capable of safely and accurately repositioning the patient..." * (No specific safety endpoints or thresholds are mentioned.)* |
Key takeaway: The document states the device is capable of safely and accurately repositioning the patient, but it does not specify what the acceptance criteria were for "safe" or "accurate," nor does it provide quantitative performance data against those (unspecified) criteria.
2. Sample size used for the test set and the data provenance
The document mentions "A study was conducted," but does not specify any sample size for a test set, nor does it provide information about data provenance (e.g., country of origin, retrospective or prospective). It seems to be a mechanical or material property test, not a clinical study involving patients or a dataset.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This information is not applicable or provided. The "study" described focuses on the physical properties of the device (strength, deformation, radiation influence, attenuation). There is no mention of a "test set" that would require expert-established ground truth in a clinical or image-based context.
4. Adjudication method for the test set
This information is not applicable or provided. Given the nature of the study described (mechanical/material properties), an adjudication method for a test set that would require expert consensus is not relevant.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done
No, an MRMC comparative effectiveness study was not done. The described study focuses on the physical characteristics of the device itself, not on how human readers interact with or are impacted by the device's output.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This question is not applicable. The device is a physical stereotactic body frame, not an algorithm, and therefore does not have a "standalone" algorithmic performance in the sense of AI. The study described evaluated the physical device's performance.
7. The type of ground truth used
For the specific "study" mentioned, the "ground truth" would be established by engineering measurements and material science standards. For example:
- Strength: Measured forces at which the material deforms or fractures, compared against design specifications.
- Deformation: Measured physical changes in shape or dimension under stress, compared against allowable tolerances.
- Radiation Attenuation: Measured reduction in radiation dose passing through the material, compared against acceptable levels.
The document does not detail these specific "ground truth" methods but implies their use through the nature of the tests described.
8. The sample size for the training set
This information is not applicable or provided. The device is a physical medical device, not an AI or algorithmic system that requires a "training set."
9. How the ground truth for the training set was established
This information is not applicable or provided for the same reasons as point 8.
§ 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.