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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.

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.

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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.

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.

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