(82 days)
The GrayDuck Stent™ custom tongue and jaw positioner from POLL Medical LLC is intended to be used for repeat positioning and immobilization of a patient's tongue and jaw while undergoing or receiving a course of external beam radiation therapy for treatment of cancer and other diseases. The GrayDuck Stent is intended to be used by or under the direction of a licensed physician.
The GrayDuck Stent™ custom tongue and jaw positioner from POLL Medical is design to provide reproducible opening of the jaw and positioning of the tongue for a patient undergoing external beam radiation therapy treatment. In addition, the GrayDuck Stent provides shielding against secondary low-energy backscatter radiation emitted from metal fillings and bridgework. The stent is a custom-fitted bite block with a boil-and-bite insert that allows for formation of dental impressions for repeatable positioning. The Stent is made of an injection molded plastic material with moldable EVA bite inserts. The GrayDuck Stent is available in two sizes. The patient's tongue can be deviated laterally left, laterally right, downward (depressed), or a combination of laterally left/depressing or laterally right/depressing by using one of the GrayDuck Stent tongue paddles, which allows many degrees of freedom in positioning the patient's tongue and jaw.
The user is asking for information about the acceptance criteria and study proving the device meets the criteria based on the provided text. However, the document is a 510(k) summary for a medical device (GrayDuck Stent™) which is a physical device for positioning and immobilization during radiation therapy, not a software or AI-driven diagnostic device.
Therefore, many of the requested categories (e.g., sample size for test/training sets, number of experts for ground truth, adjudication method, MRMC study, standalone performance, type of ground truth) are not applicable to the information presented in this regulatory document. The document focuses on demonstrating substantial equivalence to a predicate device through non-clinical performance and material testing.
Here's a breakdown of what can be extracted or deduced from the provided text:
1. A table of acceptance criteria and the reported device performance
The document doesn't explicitly state "acceptance criteria" in a quantitative, pass/fail table format often seen for software performance. Instead, it discusses demonstrating similar performance to the predicate device for various characteristics. The "reported device performance" is qualitative and comparative.
| Acceptance Criteria (Implied) | Reported Device Performance (GrayDuck Stent™) |
|---|---|
| Biocompatibility | Plastic polymer and EVA thermoplastic insert found acceptable based on contact category. |
| Backscatter Shielding Performance (Attenuation) | Dose ratio for both high-energy photon beam levels (6 MeV and 18 MeV) was just below 1, demonstrating shielding performance similar to the predicate. |
| Dental Impression Depth (Repeatability) | Produces similar impression depth when comparing its current timeframe to the longer timeframe of the predicate device's instructions. |
| Repeatable positioning and immobilization (Intended Use) | Based on "boil-and-bite insert that allows for formation of dental impressions for repeatable positioning." |
| Multiple sizes and tongue paddles for deviation (Functionality) | Available in multiple sizes and includes tongue paddles for positioning and immobilizing the patient's tongue. |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not provided. The testing described is non-clinical (biocompatibility, attenuation, impression depth comparison) and does not involve patient data or clinical trials with specific test sets in the context of AI/software.
3. 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)
Not applicable. The ground truth for this physical device's performance is based on physical measurements and material properties, not expert interpretations of data.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. There's no expert adjudication involved in the non-clinical tests described.
5. 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
No. This is a physical medical device, not an AI software. No MRMC study was conducted.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is a physical medical device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For the non-clinical tests:
- Biocompatibility: Likely against ISO standards or similar material safety criteria.
- Attenuation testing: Measured dose ratios against what would be expected for shielding performance.
- EVA dental impression depth comparison: Measurement of impression depth.
8. The sample size for the training set
Not applicable. This is a physical medical device. There is no training set as would be found in an AI/ML context.
9. How the ground truth for the training set was established
Not applicable. No training set for ground truth in this context.
§ 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.