(90 days)
The Accessories to the Stereotactic Body Frame is a device designed for stereotactic diagnostic localization and stereotactic radiotherapy of extra cranial targets.
The Stereotactic Body Frame utilizes a reference system of coordinates that can be reproducibly localized during diagnostic examination and treatment. The Accessories to the Stereotactic Body Frame include a laser chest pointer which is mounted on an arc-ruler and is used for alignment of the patient. The coordinates used for patient positioning can be easily read on the arc-ruler holding the chest pointer and on the longitudinal ruler, along which the arc-ruler can be moved. An additional accessory to the Stereotactic Body Frame is the pillow holder, or shell. This framework is affixed to the body frame and allows for reproducible positioning of the patient within the frame. The pillow holder also allows for removal and insertion of the pillow. The pillow is available as either a vacuum bag filled with polystyrene spheres, or as a polyurethane foam-filled bag. The Stereotactic Body Frame comes equipped with a quality check instrument for verifying the accuracy of the coordinate set-up.
The provided text is a 510(k) summary for accessories to a medical device, specifically a Stereotactic Body Frame. It focuses on demonstrating substantial equivalence to a predicate device rather than presenting analytical or clinical study data for a new device. Therefore, much of the requested information regarding acceptance criteria, performance studies, sample sizes, ground truth establishment, expert qualifications, and MRMC studies is not available in this document.
Here's a breakdown of what can be extracted and what cannot:
1. A table of acceptance criteria and the reported device performance
- Acceptance Criteria: Not explicitly stated as pass/fail metrics. The document focuses on "substantial equivalence" and states that "The addition of these accessories does not affect the relative safety or effectiveness of the device." This implies the acceptance criterion is that the accessories maintain the safety and effectiveness profile of the predicate device.
- Reported Device Performance: No specific performance metrics or data (e.g., accuracy, precision) are reported for the new accessories, as the filing relies on demonstrating equivalence rather than proving novel performance.
| Acceptance Criterion (Implied) | Reported Device Performance |
|---|---|
| Maintain relative safety | Claimed as "does not affect relative safety" |
| Maintain relative effectiveness | Claimed as "does not affect relative effectiveness" |
| Enable reproducible positioning | Aided by "addition of the pillow holder" |
| Aid in patient alignment | Enabled by "conversion of the chest marker to a laser pointer" |
2. Sample size used for the test set and the data provenance
- Not Applicable. The document does not describe a test set or a study where a sample size would be relevant. The submission is based on demonstrating substantial equivalence through a comparison of technological characteristics with a predicate device, rather than new performance testing with patient data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not Applicable. There is no mention of a test set, ground truth establishment, or expert involvement in this type of submission.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
- Not Applicable. No test set or adjudication process is described.
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 document is for medical device accessories, not an AI or imaging diagnostic device. No MRMC study or AI-related effectiveness is discussed.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not Applicable. This device is an accessory to a physical medical device (Stereotactic Body Frame) used for patient positioning, not an algorithm or software. "Standalone performance" in the context of an algorithm is not relevant here.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not Applicable. Ground truth is not established or used in this type of regulatory submission, which focuses on device comparison.
8. The sample size for the training set
- Not Applicable. This document does not describe a machine learning algorithm or a training set.
9. How the ground truth for the training set was established
- Not Applicable. There is no training set mentioned in this submission.
Summary of the study that proves the device meets the acceptance criteria:
The "study" in this context is the 510(k) submission itself, which aims to prove "substantial equivalence" to a legally marketed predicate device (Elekta Stereotactic Body Frame, K960338). The acceptance criteria are indirectly met by demonstrating that the new accessories (laser chest pointer and pillow holder) do not negatively affect the safety or effectiveness of the Stereotactic Body Frame and that their fundamental technical characteristics are similar to the predicate. The document states:
- "The Elekta Accessories to the Stereotactic Body Frame is substantially equivalent to other stereotactic frames currently in commercial distribution by Elekta Instruments AB in terms of the intended use of achieving a safe and accurate fixation and refixation of a patients' body for localization of targets for radiotherapy treatment."
- "The fundamental technical characteristics are similar to those of the predicate device..."
- "Differences that exist between these systems is the addition of the pillow holder which aids in the accuracy of the positioning of the patient within the frame and the conversion of the chest marker to a laser pointer. The addition of these accessories does not affect the relative safety or effectiveness of the device."
This type of submission relies on a comparison table of features and characteristics between the new device and the predicate, along with a reasoned argument that any differences do not raise new questions of safety or effectiveness. No specific study data, clinical trials, or performance metrics are presented in this summary to "prove" meeting acceptance criteria in the traditional sense of a clinical or analytical study.
§ 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.