(90 days)
Embrace Thermoplastic from Bionix Development Corporation is intended to be used for the external support and immobilization of patients undergoing or receiving a course of external beam radiation therapy for the treatment of cancer and other diseases.
Silhouette Thermoplastic from Bionix Development Corporation is intended to be used for the external support and immobilization of patients undergoing or receiving a course of external beam radiation therapy for the treatment of cancer and other diseases. It is intended to be used by or under the direction of a licensed physician.
Embrace Thermoplastic from Bionix Development Corporation is a moldable lowtemperature thermoplastic comprised of polycaprolactone, a biodegradable thermoplastic polymer that has been approved by the Food and Drug Administration for other medical device applications.
Embrace Thermoplastic becomes pliable and moldable by hand at temperatures of about 160 to 170 degrees Fahrenheit. This heating is most often done by immersion in hot water. To improve the ease of handling the polycaprolactone material in its heated, softened state, the Embrace Thermoplastic sheets will be bonded to a non-low temperature rigid thermoplastic frame. These frames also serve as convenient points to affix the Embrace Thermoplastic to an underlying patient support device.
Embrace Thermoplastic will be supplied in a variety of configurations and sizes, depending on the size and location of the body part to be immobilized, and to enable compatibility with other radiation therapy immobilization devices already in use. The Embrace Thermoplastic sheets may be perforated to enhance an even stretch over anatomical protuberances such as the nose and chin. This improves the conformity and rigidity of the resulting mask by preventing over-stretching and thinning in these areas. Perforation patterns may be uniform (as in a sheet intended to be used over a limb) or variable (such as in a sheet intended to be used with the head), all designed to enhance the even stretch of the material and the rigidity of the resultant mask.
The typical application of Embrace Thermoplastic is to create a conformal "mask" of an anatomical body part, such as the head, by stretching the pliable heated polycaprolactone sheet over the body part and allowing it to cool and become rigid. The resulting conformal "mask" can then be used to position and reposition a patient undergoing a course of external beam radiation therapy with a high degree of accuracy and reproducibility.
Here's a breakdown of the acceptance criteria and study information for the Embrace Thermoplastic, based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
The device is marketed as substantially equivalent to predicate devices, meaning its performance is considered acceptable if it is comparable to these devices. The acceptance criteria are implicitly defined by the performance characteristics of the predicate devices.
| Attribute | Acceptance Criteria (Predicate Devices Range) | Reported Embrace Thermoplastic Performance |
|---|---|---|
| Intended Use | Support and immobilize patients receiving external beam radiation therapy | Support and immobilize patients receiving external beam radiation therapy |
| Composition | Polycaprolactone | Polycaprolactone |
| Melting Temperature | 160 - 170 degrees F | 160 - 170 degrees F |
| Rigidity | 1.388 lbs/in² (Klarity) to 3.459 lbs/in² (Aquaplast) | 1.080 lbs/in² |
| Shrinkage | 1.5 % (Aquaplast) to 1.9 % (Klarity) | 1.1 % |
| Features | Available as perforated and non-perforated sheets | Available as perforated and non-perforated sheets |
| Sheet Thickness | 2.4 mm and 3.2 mm | 2.4 mm and 3.2 mm |
| Non-Low Temperature Thermoplastic Frame | Yes | Yes |
| Attaches to Patient Support Device | Yes | Yes |
| Radiolucency @ 6 MeV (0 degrees) | 0.9844 (Klarity) to 0.9915 (Aquaplast) | 0.9888 |
| Radiolucency @ 6 MeV (45 degrees) | 0.9783 (Klarity) to 0.9872 (Aquaplast) | 0.9827 |
| Radiolucency @ 10 MeV (0 degrees) | 0.9880 (Klarity) to 0.9935 (Aquaplast) | 0.9885 |
| Radiolucency @ 10 MeV (45 degrees) | 0.9855 (Klarity) to 0.9906 (Aquaplast) | 0.9891 |
| Radiolucency @ 18 MeV (0 degrees) | 0.9914 (Klarity) to 0.9949 (Aquaplast) | 0.9934 |
| Radiolucency @ 18 MeV (45 degrees) | 0.9868 (Klarity) to 0.9924 (Aquaplast) | 0.9904 |
| Measured Thickness (3.2 mm sample) | 3.2 mm (Klarity) to 3.54 mm (Aquaplast) | 3.2 mm |
| Mfr Recommended Melting Temp. (°F) | 165 | 160 |
| Mfr Recommended Heating Time (Minutes) | 2 (Klarity) to 4 (Aquaplast) | 2 |
| Time To Transparency (Seconds) | 41 (Aquaplast) to 60 (Klarity) | 49 |
| Mfr Recommended Cooling Time (Minutes) | 5 | 5 |
| Available Forming time (Seconds) | 29 (Klarity) to 50 (Aquaplast) | 54 |
2. Sample Size Used for the Test Set and Data Provenance
- Test Set Sample Size: The document does not specify a distinct "test set" in the context of typical machine learning or diagnostic device studies. Instead, samples of each thermoplastic material (Embrace, Klarity, Aquaplast) were used for bench testing. The exact number of individual samples tested for each attribute (e.g., number of rigidity measurements) is not provided, but it implies a sufficient number for representative physical and radiation attenuation measurements.
- Data Provenance: The data is generated from bench testing of the actual materials. No mention of geographical origin or retrospective/prospective nature is applicable as it's not human subject data.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
Not applicable. The ground truth for physical properties (rigidity, shrinkage, melting point, etc.) and radiation attenuation for this type of medical device is established through instrumental measurements and standardized testing methods, not expert consensus.
4. Adjudication Method for the Test Set
Not applicable, as the "ground truth" is derived from direct instrumental measurements, not human interpretation requiring adjudication.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No. This study is focused on the physical and radiation-attenuation properties of a thermoplastic material used for patient immobilization. It does not involve human readers interpreting medical images or making diagnoses, thus an MRMC study is not relevant.
6. Standalone (i.e. algorithm only without human-in-the loop performance) Study
Not applicable. This device is a physical product (a thermoplastic), not an algorithm or software. Therefore, there is no standalone algorithm performance to evaluate.
7. Type of Ground Truth Used
The ground truth used in this study is based on direct physical measurements and instrumental radiation attenuation measurements. These are objective, quantifiable properties of the material itself.
8. Sample Size for the Training Set
Not applicable. This device is a physical product and the study involves bench testing of its properties. There is no machine learning model being trained, and therefore no "training set."
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no training set.
§ 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.