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This product is intended to be used by radiologists and surgeons for the following: . Patient positioning and immobilization - Stereotactic diagnostic localization . - Patient positioning and immobilization device for . stereotactic radiotherapy of extracranial targets

The BodyFIX System is a patient positioning and immobilization device for use with radiotherapy, radiosurgery, sonography, surgery/CAS, imaging neurosurgery and brachytherapy treatments of extracranial targets. The principal parts of the system include the vacuum cushion, cover sheet, vacuum supply (vacuum pump), target positioner and localizer, and carbon fiber baseplate. The BodyFIX Vacuum Pump P3 is a high-performance vacuum pump that contains two separate pumps; the BlueBAG pump and the BodyFIX pump. - 1- BlueBAG pump provides the vacuum for inflating, forming and deflating the BlueBAG vacuum cushions.

Acceptance Criteria and Study Details for BodyFIX System

1. Table of Acceptance Criteria and Reported Device Performance

Note: The provided document primarily focuses on establishing substantial equivalence to a predicate device (BodyFIX K013391). The "Acceptance Criteria" column above is derived from the predicate device's characteristics as a benchmark for the new device. Specific quantitative acceptance criteria for the new device's performance are not detailed in the provided text as separate, predefined thresholds for "passing" a study, but rather a comparison to the predicate's reported performance. The study described shows the new device's performance metrics.

2. Sample Size Used for the Test Set and Data Provenance

The provided document does not explicitly state the sample size used for the test set.

The data provenance (country of origin, retrospective/prospective) is not explicitly stated in the provided summary. However, given the device's manufacturer (Medical Intelligence Medizintechnik GmbH in Schwabmuenchen, Germany), it is likely that any testing involved German facilities, but this is not confirmed.

3. Number of Experts Used to Establish Ground Truth and Qualifications

The provided document does not specify the number of experts used to establish ground truth for the test set, nor does it detail their qualifications.

4. Adjudication Method

The provided document does not describe any adjudication method (e.g., 2+1, 3+1, none) used for the test set.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

The provided document does not mention or describe a Multi-Reader Multi-Case (MRMC) comparative effectiveness study. There is no information regarding human readers improving with or without AI assistance, as the device is a physical patient positioning and immobilization system, not an AI software.

6. Standalone (Algorithm Only) Performance Study

The provided document does not describe a standalone (algorithm only) performance study. The BodyFIX System is a physical medical device for patient positioning and immobilization, not an algorithm.

7. Type of Ground Truth Used

The "ground truth" for the performance metrics (localization and set-up errors) appears to be derived from direct measurements of the device's accuracy in a controlled or simulated environment, as indicated by "Transversal plane CT localisation error x,y" and "Longitudinal plane localisation error z" and "Linac set-up error." This suggests a technical or engineering validation rather than expert consensus, pathology, or outcomes data in the traditional sense of diagnostic accuracy.

8. Sample Size for the Training Set

The provided document does not mention or specify a sample size for a training set. This is expected as the BodyFIX System is a physical device, not an AI or machine learning algorithm that requires a training set.

9. How Ground Truth for the Training Set Was Established

As there is no training set mentioned or implied for this physical device, the concept of establishing ground truth for a training set is not applicable here.

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