(158 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 90Yttrium Brachytherapy Source is a singly-encapsulated 99Yttrium Brachytherapy Source. It consists of a titanium capsule containing a solid radioactive 99Yttrium 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 document is a 510(k) summary for the LV Liberty Vision Model 1 90Yttrium Brachytherapy Source. It describes the device, its intended use, and a comparison to a legally marketed predicate device (K163572), also the LV Liberty Vision Model 1 90Yttrium Brachytherapy Source. This submission focuses on demonstrating substantial equivalence to an existing device rather than establishing novel performance metrics through clinical trials or standalone AI studies.
Here's an analysis based on your requested information:
1. Table of acceptance criteria and reported device performance
The document does not specify general "acceptance criteria" in the sense of performance targets for a new AI/diagnostic device. Instead, it demonstrates equivalence to a predicate device through physical and dosimetric characteristics.
| Characteristic | Acceptance Criteria (Predicate Device Performance - K163572) | Reported Device Performance (LV Liberty Vision Model 1 - This Version) |
|---|---|---|
| Design: 90Yttrium Active Element | Max diameter: 9.6 mm, Max thickness: 0.75 mm | Max diameter: 9.4 mm, Max thickness: 0.25 mm |
| Encapsulation Material | Titanium | Titanium |
| Central Axis Dose Rate at 0.6 mm | 6 mm dia source: 1.02 Gy/min-mCi | |
| 8 mm dia source: 0.62 Gy/min-mCi | ||
| 10 mm dia source: 0.42 Gy/min-mCi | 6 mm dia source: 1.08 Gy/min-mCi | |
| 8 mm dia source: 0.63 Gy/min-mCi | ||
| 10 mm dia source: 0.40 Gy/min-mCi | ||
| Central Axis Dose Rate at 1.0 mm | 6 mm dia source: 0.81 Gy/min-mCi | |
| 8 mm dia source: 0.50 Gy/min-mCi | ||
| 10 mm dia source: 0.34 Gy/min-mCi | 6 mm dia source: 0.81 Gy/min-mCi | |
| 8 mm dia source: 0.50 Gy/min-mCi | ||
| 10 mm dia source: 0.32 Gy/min-mCi | ||
| Sterility Requirement | Not required (did not directly contact patient) | Required (may directly contact patient) |
| Biocompatibility Assessment | Not applicable (did not directly contact patient) | Required (outside of assembly fabricated from biocompatible titanium) |
| Mechanical Safety Standard | ISO 2919/ANSI N43.6 Class C53211 | ISO 2919/ANSI N43.6 Class C53211 |
| Chemical Safety Assessment | Not applicable (did not directly contact patient) | Required (outside of assembly fabricated from titanium, will not chemically react with body tissue) |
| Mechanical Standards Met | ISO 2919/ANSI N43.6 Classification C54213 | ISO 2919/ANSI N43.6 Classification C54213 |
Study Proving Device Meets Acceptance Criteria:
The study that proves the device meets the "acceptance criteria" (defined here as demonstrating substantial equivalence to the predicate device) is documented through nonclinical physical testing and dosimetric analysis.
- Physical Testing: Prototype sources of the LV Liberty Vision Model 1 90Yttrium Brachytherapy Source were subjected to tests specified in American National Standard (ANSI) N43.6 and International Organization for Standardization (ISO) Standard 2919. The results "equaled or exceeded the requirements corresponding to a classification of C53211," which is the requirement for brachytherapy sources. This was deemed equivalent to the physical testing of the predicate device (K163572).
- Dosimetry: The dose distribution around the new device was calculated by Monte Carlo simulation. This was stated to be "similar to the dosimetry of the predicate device."
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
- Test Set Sample Size: The document refers to testing of "prototype sources." It does not specify a numerical sample size but implies a sufficient number of prototypes were tested to satisfy the standards.
- Data Provenance: Not explicitly stated, however, the testing standards (ANSI and ISO) are international. The company is based in Portsmouth, New Hampshire, USA. The testing would have been conducted to demonstrate compliance with US FDA requirements. The data is prospective in the sense that physical and dosimetric measurements/simulations were performed on the prototypes or models of this specific device to demonstrate its properties.
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)
This is not applicable as the study involves physical and dosimetric testing against established engineering standards (ANSI, ISO) and computational simulations (Monte Carlo), not clinical data requiring expert human interpretation for ground truth.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
This is not applicable for physical and dosimetric testing. Adjudication methods are typically relevant for clinical studies where human expert consensus is used to establish ground truth for image or diagnostic interpretations.
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, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This device is a brachytherapy source, a physical medical device, not an AI or diagnostic software tool that would involve human readers or AI assistance.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
No, a standalone (algorithm only) performance study was not done. As stated above, this is a physical medical device, not an algorithm or AI.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For the physical testing and dosimetry, the "ground truth" is based on:
- Established Engineering Standards: ANSI N43.6 and ISO 2919 provide objective pass/fail criteria and specifications for brachytherapy sources.
- Physics Principles and Computational Models: Monte Carlo simulations for dosimetry are based on established physics principles to calculate dose distribution.
8. The sample size for the training set
This is not applicable. There is no training set mentioned or implied as this is not an AI/machine learning device.
9. How the ground truth for the training set was established
This is not applicable as there is no training set.
§ 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.