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Chabner XRT™ Garments are intended to be used as an aid in the support of the patient during X-ray, computed tomography, magnetic resonance imaging, radiotherapy, and other diagnostic radiological procedures. The Chabner XRT™ Garments are not intended for pediatric use.

The device is a non-sterile garment worn by patients as an aid in the support and positioning of patients during X-ray, computed tomography, magnetic resonance imaging, radiotherapy, and other diagnostic radiological procedures. There are three versions of the garment: 1) brassiere; 2) athletic style shorts; and 3} girdle. All versions of the device are devoid of metal and can be worn for use with all treatment or diagnostic machines without causing a bolus (i.e., the materials do not mimic the properties of tissue during a radiological procedure) or attenuation effect. All materials used in the device's construction are < 1 mm in thickness. Clear thermoplastic polyurethane (TPU) windows are incorporated into the device to enable clinicians to view index tattoos, the midline, bony landmarks, and other treatment parameters, as created by the light field that is projected by the treatment or diagnostic machine onto the patient's body. The compressive nature of the materials used in the device's construction, along with various adjustment features incorporated into the device, assist the clinician in positioning the body and to reproduce the desired body geometry, treatment position, and patient-to-machine alignment prior to each radiological procedure. Radiation passes through the TPU material without affecting therapy or diagnosis. Because the device is worn as a garment, they offer the added benefit of protecting the patient's dignity during such procedures that, in turn, increases the patient's overall comfort during the process.

The provided document, K121284, is a 510(k) summary for the Chabner XRT™ Garments, a patient support and positioning device. It primarily focuses on demonstrating substantial equivalence to legally marketed predicate devices rather than providing a detailed study proving the device meets specific acceptance criteria through performance metrics.

Therefore, many of the requested details about acceptance criteria, efficacy studies, and ground truth establishment are not explicitly present in this type of regulatory submission, which is for demonstrating substantial equivalence rather than novel efficacy.

Here's an attempt to extract and describe the information based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not present specific quantitative acceptance criteria or detailed performance results from a study directly comparing the Chabner XRT™ Garments against such criteria. Instead, the "acceptance criteria" are implied by demonstrating substantial equivalence to predicate devices based on shared fundamental characteristics.

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

The document does not describe a specific "test set" or a study involving human subjects or data where performance metrics were measured. This is a 510(k) submission focused on demonstrating substantial equivalence through comparison to existing devices, not a clinical trial or performance study with a test set in the traditional sense. Therefore, details about sample size, country of origin, or retrospective/prospective nature are not applicable or provided.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

As there is no described "test set" or performance study, there is no information on experts establishing ground truth.

4. Adjudication Method

Not applicable, as no test set or expert adjudication process is described.

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

The document does not mention or describe a MRMC comparative effectiveness study. The submission focuses on the physical and functional characteristics of the garment compared to predicate devices, not on the impact of the device on human reader performance.

6. Standalone Performance (Algorithm Only Without Human-in-the-Loop Performance)

This is a physical medical device (garment), not an algorithm or software. Therefore, the concept of "standalone (algorithm only)" performance is not applicable here. Its performance is inherent in its physical properties and how it aids patient positioning.

7. Type of Ground Truth Used

Given the nature of the submission (substantial equivalence for a physical garment), the "ground truth" is established by showing that the device shares fundamental technological characteristics and intended use with other legally marketed devices. It's not based on expert consensus, pathology, or outcomes data in the context of a performance study validating specific diagnostic or therapeutic efficacy. Instead, it relies on regulatory precedent and comparison of device features.

8. Sample Size for the Training Set

The concept of a "training set" is not applicable to this type of device. There is no algorithm or model that requires training data.

9. How Ground Truth for the Training Set Was Established

Not applicable, as there is no training set mentioned.

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