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The Disposable Thyroid Collar is intended for use as a radiation shield against scatter radiation. It is intended to be placed around the neck of the user who remains outside of the primary radiation beam.

Device Description

The Disposable Thyroid Collar is a radiation protective shield for the thyroid intended to be used in various medical procedures where X-ray radiation is used. It is a non-sterile device, designed for single use. The device is constructed with environmentally friendly radiation attenuating materials, which do not contain lead or heavy metals. The radiation attenuating material is encased in a medical grade polypropylene (PP) non-woven drape material. The device is available in three sizes, small, medium, and large.

The device blocks radiation in a similar manner to lead - via absorption of the photon energy from ionizing radiation. This photon energy is dissipated as phonon energy within the atomic lattice structure of the radiation attenuating material, in a manner identical to lead.

AI/ML Overview

The provided document describes the BloXR Disposable Thyroid Collar, a device intended to attenuate scatter radiation. The study focuses on demonstrating its substantial equivalence to predicate devices rather than establishing novel acceptance criteria or conducting extensive clinical trials typical for software or complex medical devices.

Here's the breakdown of the information based on your request:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria for Substantial Equivalence (Inferred from the document):
The primary acceptance criterion was demonstrating that the BloXR Disposable Thyroid Collar provides similar radiation attenuation to legally marketed predicate devices and a 0.5 mm lead sheet control. Specifically, the device should achieve a radiation attenuation level equivalent to 0.5 mm of lead.

Criterion	Acceptance Level (Inferred)	Reported Device Performance
Radiation Attenuation (Lead Equivalence)	Equivalent to 0.5 mm lead sheet and predicate devices	"The attenuation level provided by BloXR materials was similar to the predicate devices and the 0.5 mm lead sheet, demonstrating substantial equivalence." Tested at X-ray radiation levels of 60, 90, 100, and 120 KVp.
Materials Safety and Suitability for Contact	Known and established safe history, suitable for skin contact	"The BloXR Disposable Thyroid Collar is made from materials with a known and established safe history of use in medical devices, which are suitable and safe for skin contact."

2. Sample Size for the Test Set and Data Provenance

Sample Size for Test Set: The document does not specify a numerical "sample size" in terms of number of devices tested. It mentions "two laboratory studies" that evaluated "the device materials of the Disposable Thyroid Collar to the two predicate devices and to a 0.5 millimeter (mm) lead sheet, as a control." This implies a comparison of material properties rather than a large-scale clinical trial. The "sample" in this context refers to the specific materials chosen for testing (BloXR's material, predicate device materials, and a lead control).
Data Provenance: The studies were laboratory studies, one conducted at an independent laboratory and the other in-house by BloXR. There is no information about the country of origin of the data beyond the location of the independent lab and BloXR itself. The studies are explicitly described as performance testing and are not clinical studies involving human subjects, therefore the terms "retrospective" or "prospective" do not apply.

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

Not Applicable. This type of device (a physical radiation shield) does not involve "ground truth" derived from expert interpretation in the way an AI diagnostic algorithm would. The performance was measured directly using scientific instrumentation to assess radiation attenuation, not expert consensus on medical images or diagnoses.

4. Adjudication Method for the Test Set

Not Applicable. As the performance assessment involved direct physical measurements of radiation attenuation using a standardized methodology (ASTM F 2547-06), there was no need for an adjudication method by experts. The results were quantitative and objectively measured.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done

No. This was not a MRMC comparative effectiveness study. This type of study is relevant for diagnostic devices (especially imaging AI) where human readers interpret cases. The BloXR Disposable Thyroid Collar is a physical protective device, and its performance was assessed through laboratory measurements of its material properties.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was Done

Not Applicable. The device is a physical product, not an algorithm. Therefore, the concept of "standalone algorithm performance" does not apply.

7. The Type of Ground Truth Used

Measured Physical Properties (Radiation Attenuation): The "ground truth" in this context was the scientifically measured radiation attenuation provided by the materials, as compared against a known standard (0.5 mm lead sheet) and the predicate devices. This is based on objective physical measurements using a standardized method (ASTM F 2547-06).