(86 days)
LV Liberty Vision Model 1 90 Yttrium Brachytherapy Source with individual activity up to 20 mCi (740 MBq), is indicated for episcleral brachytherapy of tumors and benign growths. The Model 1 source is intended for use within a manual brachytherapy system.
LV Liberty Vision Model 1 ®Yttrium Brachytherapy Source is a singly-encapsulated ®º (ttrium Brachytherapy Source. It consists of a titanium capsule containing a solid radioactive ®Yttrium element. The radioactive element is hermetically sealed in the titanium capsule and, in use, will be attached to a manual radionuclide applicator system (21 CFR 892.5650).
The provided text describes the LV Liberty Vision Model 1 90Yttrium Brachytherapy Source and its substantial equivalence to a predicate device, rather than providing a detailed study that proves the device meets specific acceptance criteria in the format requested. The document focuses on comparing the new device's technological characteristics and performance to a legally marketed predicate device (Salutaris Medical Devices, Inc. Smd Sr90-1 Radionuclide Brachytherapy Source).
However, I can extract the information provided about the nonclinical tests and their outcomes, which serve as the basis for the device's acceptance.
Here's the information based on the provided document:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly state "acceptance criteria" in a quantitative table with pass/fail thresholds for clinical performance metrics (like sensitivity, specificity, etc.) that would typically be associated with AI/medical image analysis devices. Instead, it demonstrates equivalence to a predicate device through nonclinical (physical and dosimetry) testing and technological characteristics.
The qualitative "acceptance criteria" are implied by meeting or exceeding the standards relevant to brachytherapy sources and demonstrating comparable dosimetry and safety characteristics to the predicate.
| Characteristic / Test | Acceptance Criterion (Implicit) | Reported Device Performance (LV Liberty Vision Model 1 90Yttrium Brachytherapy Source) |
|---|---|---|
| Physical Testing | Meet or exceed requirements of ANSI N43.6 and ISO 2919 for brachytherapy sources, corresponding to a classification of C53211. | Equaled or exceeded the requirements corresponding to a classification of C53211 (as per ANSI N43.6-2007 and ISO 2919-2012). This exceeds the physical testing of the predicate device. |
| Dosimetry | Comparable dose distribution to the predicate device. | Dose distribution calculated by Monte Carlo simulation, which is stated to be equivalent to the dosimetry of the predicate device. |
| Intended Use | For episcleral brachytherapy of tumors and benign growths, within a manual brachytherapy system, with individual activity up to 20 mCi (740 MBq). | Same as the stated indication for use for the device. |
| Technological Characteristics | Similar design, materials (radionuclide, encapsulation), and safety features (sterility, biocompatibility, mechanical, chemical, radiation safety, compatibility with environment and other devices, where used, standards met) to the predicate device. | Detailed comparison provided in the tables on pages 4 and 5, demonstrating similarity or better performance where applicable (e.g., physical testing explicitly states "exceeds"). Specific dose rates are provided. |
2. Sample size used for the test set and the data provenance
- Sample Size: The document does not refer to a "test set" in the context of clinical data for performance evaluation in the way AI devices are typically evaluated. The "tests" mentioned are nonclinical physical and dosimetry tests. For physical testing, "Prototype sources were subjected to the tests." The exact number of prototypes isn't specified, but it's likely a small number of physical samples for laboratory testing.
- Data Provenance: Not applicable for nonclinical physical and dosimetry testing.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. Ground truth for clinical cases or image interpretations is not relevant to the nonclinical physical and dosimetry testing performed for this brachytherapy source.
4. Adjudication method for the test set
Not applicable. No expert adjudication process for clinical ground truth is 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
Not applicable. This device is a brachytherapy source, not an AI software or a device that assists human readers in interpretation.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an algorithm-based device. The "performance" relates to the physical and dosimetric properties of the radioactive source itself.
7. The type of ground truth used
For physical testing, the "ground truth" would be the direct measurement of physical properties and verification against defined engineering standards (ANSI N43.6 and ISO 2919).
For dosimetry, the "ground truth" is established through Monte Carlo simulation, which is a widely accepted method for calculating dose distribution in radiophysics.
8. The sample size for the training set
Not applicable. There is no concept of a "training set" for this type of medical device evaluation.
9. How the ground truth for the training set was established
Not applicable.
§ 892.5730 Radionuclide brachytherapy source.
(a)
Identification. A radionuclide brachytherapy source is a device that consists of a radionuclide which may be enclosed in a sealed container made of gold, titanium, stainless steel, or platinum and intended for medical purposes to be placed onto a body surface or into a body cavity or tissue as a source of nuclear radiation for therapy.(b)
Classification. Class II (special controls). A prostate seeding kit intended for use with a radionuclide brachytherapy source only is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.