(117 days)
The TruGuard Custom Tongue and Jaw Positioner from Bionix Development Corporation is intended to be used for repeat positioning 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.
The TruGuard Custom Tongue and Jaw Positioner consists of two dental bite trays composed of rigid plastic and connected at the base of their arcs in a bivalve fashion so as to allow the upper and lower bite trays to open and close in similar fashion as the upper and lower jaws of the patient. The two bite trays are each lined with an insert of low-temperature EVA (ethylene vinyl acetate) thermoplastic material similar to that used in commercial mouth guards. Projections on the lower and upper bite trays mate securely to a plastic indexing tab component that has holes at pre-set locations. When the plastic indexing tab is joined to the upper and lower bite trays the jaw is held open at pre-set angles, depending on the hole selected. This allows the mouth to be positioned and repositioned as needed, and ensures unrestricted air flow to the patient. An optional tongue depressor interlocks with the lower bite tray to restrict the tongue position to the lower portion of the oral cavity.
The provided document describes the TruGuard Custom Tongue and Jaw Positioner from Bionix Development Corporation and its substantial equivalence to a predicate device. It primarily focuses on comparing the new device against an existing one, the Dental Tray for use with the Gill-Thomas-Cosman Relocatable Head Holder, manufactured by Integra.
Here's an analysis of the acceptance criteria and study information, based on the provided text:
Acceptance Criteria and Reported Device Performance
The document doesn't explicitly state quantitative acceptance criteria for the TruGuard device in terms of performance metrics like accuracy, specificity, or recall. Instead, it demonstrates "substantial equivalence" to a predicate device, focusing on similar design, features, composition, and function, particularly concerning reproducible patient positioning and shielding efficacy.
The key performance described is related to shielding efficacy against backscatter radiation.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Reproducible Patient Positioning: Equivalent to predicate device. | The device is designed to provide reproducible opening of the jaw to multiple pre-set angles and to allow accurate repositioning of the dental trays between treatments due to individualized dental impressions. The report states "The similarity of design, features, composition, and function indicate that TruGuard ... will perform as well as the legally marketed Dental Tray ... for the intended use for repeat positioning and immobilization..." |
| Shielding against Backscatter Radiation: Effective reduction of backscatter radiation to a Dose Enhancement Ratio of approximately 1.0. | Bench testing showed that the Dose Enhancement Ratios for the phantom when covered by the EVA insert material only, the Dental Tray material only, and the assembled TruGuard are effectively 1.0, indicating "near total shielding efficacy of the TruGuard device in shielding against backscatter radiation." |
Study Information
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Sample size used for the test set and the data provenance:
- Sample Size: The bench testing involved a "phantom (teeth with amalgam fillings)". The number of phantoms or trials is not specified beyond this.
- Data Provenance: The study was a bench test, so no human patient data was used. The provenance is internal Bionix Development Corporation testing.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience):
- This information is not provided. Given it was a bench test, expert consensus for ground truth might not be directly applicable in the same way as clinical studies. The ground truth for backscatter radiation was measured using Gafchromic EBT3 film.
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Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- This information is not applicable as the test was a bench test measuring physical properties (radiation dose), not a clinical study requiring human adjudication of results.
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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:
- An MRMC study was not done. This device is a physical medical device (positioner/immobilizer) for radiation therapy, not an AI software device.
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If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- A standalone algorithm performance study was not done. This device is a physical medical device, not an algorithm.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- For the shielding efficacy test, the ground truth was quantitative measurement of radiation dose using "industry standard Gafchromic EBT3 film." This is a physical and objective measurement.
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The sample size for the training set:
- This information is not applicable. This is a physical device, not a machine learning model, so there is no "training set."
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How the ground truth for the training set was established:
- This information is not applicable as there is no training set for a physical device.
§ 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.